answer these questions related to the laboratory

questions are in File QAQC..

Quality management systems —

Requirements
Systèmes de management de la qualité — Exigences

INTERNATIONAL
STANDARD

ISO
9001

Fifth edition
2015-09-15

Reference number

ISO 9001:2015(E)

International Organization for Standardization
Provided by IHS under license with ISO

Licensee=ADNOC 9999103
Not for Resale, 2015/10/5 19:20:06
No reproduction or networking permitted without license from IHS

–`,,“,,,`,,`,,`,““““-`-“,“`,,,`—

ISO 9001:2015(E)

© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.

ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org

International Organization for Standardization
Provided by IHS under license with ISO
Licensee=ADNOC 9999103
Not for Resale, 2015/10/5 19:20:06
No reproduction or networking permitted without license from IHS
–`,,“,,,`,,`,,`,““““-`-“,“`,,,`—

ISO 9001:2015(E)

Foreword

………………………………………………………………………………………………………………………………………………………………………………………………………………v

Introduction

……………………………………………………………………………………………………………………………………………………………………………………………………..vi
1 Scope ……………………………………………………………………………………………………………………………………………………………………………………………………… 1
2 Normative references ……………………………………………………………………………………………………………………………………………………………….. 1
3 Terms and definitions ………………………………………………………………………………………………………………………………………………………………. 1
4 Context of the organization ………………………………………………………………………………………………………………………………………………….. 1

4.1 Understanding the organization and its context …………………………………………………………………………………………. 1
4.2 Understanding the needs and expectations of interested parties …………………………………………………….. 2
4.3 Determining the scope of the quality management system ………………………………………………………………….. 2
4.4 Quality management system and its processes ……………………………………………………………………………………………. 2

5 Leadership ………………………………………………………………………………………………………………………………………………………………………………………… 3
5.1 Leadership and commitment ………………………………………………………………………………………………………………………………….. 3

5.1.1 General……………………………………………………………………………………………………………………………………………………………….. 3
5.1.2 Customer focus ……………………………………………………………………………………………………………………………………………… 3

5.2 Policy ……………………………………………………………………………………………………………………………………………………………………………………… 4
5.2.1 Establishing the quality policy …………………………………………………………………………………………………………….. 4
5.2.2 Communicating the quality policy …………………………………………………………………………………………………….. 4

5.3 Organizational roles, responsibilities and authorities……………………………………………………………………………… 4
6 Planning ………………………………………………………………………………………………………………………………………………………………………………………………. 4

6.1 Actions to address risks and opportunities ……………………………………………………………………………………………………. 4
6.2 Quality objectives and planning to achieve them ………………………………………………………………………………………… 5
6.3 Planning of changes ………………………………………………………………………………………………………………………………………………………. 5

7 Support ………………………………………………………………………………………………………………………………………………………………………………………………… 6
7.1 Resources …………………………………………………………………………………………………………………………………………………………………………….. 6

7.1.1 General……………………………………………………………………………………………………………………………………………………………….. 6
7.1.2 People …………………………………………………………………………………………………………………………………………………………………. 6
7.1.3 Infrastructure ………………………………………………………………………………………………………………………………………………… 6
7.1.4 Environment for the operation of processes ………………………………………………………………………………. 6
7.1.5 Monitoring and measuring resources …………………………………………………………………………………………….. 7
7.1.6 Organizational knowledge ……………………………………………………………………………………………………………………… 7

7.2 Competence ……………………………………………………………………………………………………………………………………………………………………….. 8
7.3 Awareness …………………………………………………………………………………………………………………………………………………………………………… 8
7.4 Communication ……………………………………………………………………………………………………………………………………………………………….. 8
7.5 Documented information …………………………………………………………………………………………………………………………………………… 8

7.5.1 General……………………………………………………………………………………………………………………………………………………………….. 8
7.5.2 Creating and updating ………………………………………………………………………………………………………………………………. 9
7.5.3 Control of documented information ………………………………………………………………………………………………… 9

8 Operation …………………………………………………………………………………………………………………………………………………………………………………………… 9
8.1 Operational planning and control ………………………………………………………………………………………………………………………… 9
8.2 Requirements for products and services ………………………………………………………………………………………………………. 10

8.2.1 Customer communication ……………………………………………………………………………………………………………………. 10
8.2.2 Determining the requirements for products and services ………………………………………………. 10
8.2.3 Review of the requirements for products and services …………………………………………………….. 10
8.2.4 Changes to requirements for products and services …………………………………………………………… 11

8.3 Design and development of products and services …………………………………………………………………………………. 11
8.3.1 General…………………………………………………………………………………………………………………………………………………………….. 11
8.3.2 Design and development planning …………………………………………………………………………………………………. 11
8.3.3 Design and development inputs ………………………………………………………………………………………………………. 11
8.3.4 Design and development controls ………………………………………………………………………………………………….. 12
8.3.5 Design and development outputs …………………………………………………………………………………………………… 12
8.3.6 Design and development changes …………………………………………………………………………………………………… 12

Contents Page

–
–
`
,
,
`
`
,
,
,
`
,
,
`
,
,
`
,
`
`
`
`
`
`
`
`
–
`
–
`
`
,
`
`
`
,
,
,
`
–
–
–

ISO 9001:2015(E)

8.4 Control of externally provided processes, products and services ………………………………………………….. 13
8.4.1 General…………………………………………………………………………………………………………………………………………………………….. 13
8.4.2 Type and extent of control …………………………………………………………………………………………………………………… 13
8.4.3 Information for external providers ………………………………………………………………………………………………… 13

8.5 Production and service provision ………………………………………………………………………………………………………………………. 14
8.5.1 Control of production and service provision ……………………………………………………………………………. 14
8.5.2 Identification and traceability …………………………………………………………………………………………………………… 14
8.5.3 Property belonging to customers or external providers …………………………………………………… 15
8.5.4 Preservation …………………………………………………………………………………………………………………………………………………. 15
8.5.5 Post-delivery activities ………………………………………………………………………………………………………………………….. 15
8.5.6 Control of changes ……………………………………………………………………………………………………………………………………. 15

8.6 Release of products and services ……………………………………………………………………………………………………………………….. 15
8.7 Control of nonconforming outputs ……………………………………………………………………………………………………………………. 16

9 Performance evaluation ……………………………………………………………………………………………………………………………………………………….16
9.1 Monitoring, measurement, analysis and evaluation ……………………………………………………………………………….. 16

9.1.1 General…………………………………………………………………………………………………………………………………………………………….. 16
9.1.2 Customer satisfaction …………………………………………………………………………………………………………………………….. 17
9.1.3 Analysis and evaluation ………………………………………………………………………………………………………………………… 17

9.2 Internal audit ………………………………………………………………………………………………………………………………………………………………….. 17
9.3 Management review …………………………………………………………………………………………………………………………………………………… 18

9.3.1 General…………………………………………………………………………………………………………………………………………………………….. 18
9.3.2 Management review inputs ………………………………………………………………………………………………………………… 18
9.3.3 Management review outputs …………………………………………………………………………………………………………….. 18

10 Improvement …………………………………………………………………………………………………………………………………………………………………………………19
10.1 General ……………………………………………………………………………………………………………………………………………………………………………….. 19
10.2 Nonconformity and corrective action ……………………………………………………………………………………………………………… 19
10.3 Continual improvement …………………………………………………………………………………………………………………………………………… 19

Annex A (informative) Clarification of new structure, terminology and concepts ……………………………………..21
Annex B (informative) Other International Standards on quality management and quality

management systems developed by ISO/TC 176 ……………………………………………………………………………………………….25

Bibliography

…………………………………………………………………………………………………………………………………………………………………………………………………..28

iv © ISO 2015 – All rights reservedInternational Organization for Standardization
Provided by IHS under license with ISO

Licensee=ADNOC 9999103
Not for Resale, 2015/10/5 19:20:06
No reproduction or networking permitted without license from IHS
–`,,“,,,`,,`,,`,““““-`-“,“`,,,`—

ISO 9001:2015(E)

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.

For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment,
as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in the
Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.

The committee responsible for this document is Technical Committee ISO/TC 176, Quality management
and quality assurance, Subcommittee SC 2, Quality systems.

This fifth edition cancels and replaces the fourth edition (ISO 9001:2008), which has been technically
revised, through the adoption of a revised clause sequence and the adaptation of the revised quality
management principles and of new concepts. It also cancels and replaces the Technical Corrigendum
ISO 9001:2008/Cor.1:2009.

Licensee=ADNOC 9999103
Not for Resale, 2015/10/5 19:20:06
No reproduction or networking permitted without license from IHS
–`,,“,,,`,,`,,`,““““-`-“,“`,,,`—

http://www.iso.org/directives

http://www.iso.org/patents

http://www.iso.org/iso/foreword.html

ISO 9001:2015(E)

Introduction

0.1 General

The adoption of a quality management system is a strategic decision for an organization that can help
to improve its overall performance and provide a sound basis for sustainable development initiatives.

The potential benefits to an organization of implementing a quality management system based on this
International Standard are:

a) the ability to consistently provide products and services that meet customer and applicable
statutory and regulatory requirements;

b) facilitating opportunities to enhance customer satisfaction;

c) addressing risks and opportunities associated with its context and objectives;

d) the ability to demonstrate conformity to specified quality management system requirements.

This International Standard can be used by internal and external parties.

It is not the intent of this International Standard to imply the need for:

— uniformity in the structure of different quality management systems;

— alignment of documentation to the clause structure of this International Standard;

— the use of the specific terminology of this International Standard within the organization.

The quality management system requirements specified in this International Standard are
complementary to requirements for products and services.

This International Standard employs the process approach, which incorporates the Plan-Do-Check-Act
(PDCA) cycle and risk-based thinking.

The process approach enables an organization to plan its processes and their interactions.

The PDCA cycle enables an organization to ensure that its processes are adequately resourced and
managed, and that opportunities for improvement are determined and acted on.

Risk-based thinking enables an organization to determine the factors that could cause its processes and
its quality management system to deviate from the planned results, to put in place preventive controls
to minimize negative effects and to make maximum use of opportunities as they arise (see Clause A.4).

Consistently meeting requirements and addressing future needs and expectations poses a challenge
for organizations in an increasingly dynamic and complex environment. To achieve this objective, the
organization might find it necessary to adopt various forms of improvement in addition to correction
and continual improvement, such as breakthrough change, innovation and re-organization.

In this International Standard, the following verbal forms are used:

— “shall” indicates a requirement;

— “should” indicates a recommendation;

— “may” indicates a permission;

— “can” indicates a possibility or a capability.

Information marked as “NOTE” is for guidance in understanding or clarifying the associated requirement.

vi © ISO 2015 – All rights reservedInternational Organization for Standardization
Provided by IHS under license with ISO

Licensee=ADNOC 9999103
Not for Resale, 2015/10/5 19:20:06
No reproduction or networking permitted without license from IHS
–
–
`
,
,
`
`
,
,
,
`
,
,
`
,
,
`
,
`
`
`
`
`
`
`
`
–
`
–
`
`
,
`
`
`
,
,
,
`
–
–
–

ISO 9001:2015(E)

0.2 Quality management principles

This International Standard is based on the quality management principles described in ISO 9000. The
descriptions include a statement of each principle, a rationale of why the principle is important for the
organization, some examples of benefits associated with the principle and examples of typical actions
to improve the organization’s performance when applying the principle.

The quality management principles are:

— customer focus;

— leadership;

— engagement of people;

— process approach;

— improvement;

— evidence-based decision making;

— relationship management.

0.3 Process approach

0.3.1 General

This International Standard promotes the adoption of a process approach when developing,
implementing and improving the effectiveness of a quality management system, to enhance customer
satisfaction by meeting customer requirements. Specific requirements considered essential to the
adoption of a process approach are included in 4.4.

Understanding and managing interrelated processes as a system contributes to the organization’s
effectiveness and efficiency in achieving its intended results. This approach enables the organization
to control the interrelationships and interdependencies among the processes of the system, so that the
overall performance of the organization can be enhanced.

The process approach involves the systematic definition and management of processes, and their
interactions, so as to achieve the intended results in accordance with the quality policy and strategic
direction of the organization. Management of the processes and the system as a whole can be achieved
using the PDCA cycle (see 0.3.2) with an overall focus on risk-based thinking (see 0.3.3) aimed at taking
advantage of opportunities and preventing undesirable results.

The application of the process approach in a quality management system enables:

a) understanding and consistency in meeting requirements;

b) the consideration of processes in terms of added value;

c) the achievement of effective process performance;

d) improvement of processes based on evaluation of data and information.

Figure 1 gives a schematic representation of any process and shows the interaction of its elements. The
monitoring and measuring check points, which are necessary for control, are specific to each process
and will vary depending on the related risks.

© ISO 2015 – All rights reserved viiInternational Organization for Standardization
Provided by IHS under license with ISO

ISO 9001:2015(E)

Figure 1 — Schematic representation of the elements of a single process

0.3.2 Plan-Do-Check-Act cycle

The PDCA cycle can be applied to all processes and to the quality management system as a whole.
Figure 2 illustrates how Clauses 4 to 10 can be grouped in relation to the PDCA cycle.

NOTE Numbers in brackets refer to the clauses in this International Standard.

Figure 2 — Representation of the structure of this International Standard in the PDCA cycle

viii © ISO 2015 – All rights reservedInternational Organization for Standardization
Provided by IHS under license with ISO

ISO 9001:2015(E)

The PDCA cycle can be briefly described as follows:

— Plan: establish the objectives of the system and its processes, and the resources needed to deliver
results in accordance with customers’ requirements and the organization’s policies, and identify
and address risks and opportunities;

— Do: implement what was planned;

— Check: monitor and (where applicable) measure processes and the resulting products and services
against policies, objectives, requirements and planned activities, and report the results;

— Act: take actions to improve performance, as necessary.

0.3.3 Risk-based thinking

Risk-based thinking (see Clause A.4) is essential for achieving an effective quality management system.
The concept of risk-based thinking has been implicit in previous editions of this International Standard
including, for example, carrying out preventive action to eliminate potential nonconformities, analysing
any nonconformities that do occur, and taking action to prevent recurrence that is appropriate for the
effects of the nonconformity.

To conform to the requirements of this International Standard, an organization needs to plan and
implement actions to address risks and opportunities. Addressing both risks and opportunities
establishes a basis for increasing the effectiveness of the quality management system, achieving
improved results and preventing negative effects.

Opportunities can arise as a result of a situation favourable to achieving an intended result, for
example, a set of circumstances that allow the organization to attract customers, develop new products
and services, reduce waste or improve productivity. Actions to address opportunities can also include
consideration of associated risks. Risk is the effect of uncertainty and any such uncertainty can have
positive or negative effects. A positive deviation arising from a risk can provide an opportunity, but not
all positive effects of risk result in opportunities.

0.4 Relationship with other management system standards

This International Standard applies the framework developed by ISO to improve alignment among its
International Standards for management systems (see Clause A.1).

This International Standard enables an organization to use the process approach, coupled with the
PDCA cycle and risk-based thinking, to align or integrate its quality management system with the
requirements of other management system standards.

This International Standard relates to ISO 9000 and ISO 9004 as follows:

— ISO 9000 Quality management systems — Fundamentals and vocabulary provides essential
background for the proper understanding and implementation of this International Standard;

Annex B provides details of other International Standards on quality management and quality
management systems that have been developed by ISO/TC 176.

This International Standard does not include requirements specific to other management systems,
such as those for environmental management, occupational health and safety management, or
financial management.

Sector-specific quality management system standards based on the requirements of this International
Standard have been developed for a number of sectors. Some of these standards specify additional
quality management system requirements, while others are limited to providing guidance to the
application of this International Standard within the particular sector.

ISO 9001:2015(E)

A matrix showing the correlation between the clauses of this edition of this International Standard and
the previous edition (ISO 9001:2008) can be found on the ISO/TC 176/SC 2 open access web site at:
www.iso.org/tc176/sc02/public.

x © ISO 2015 – All rights reservedInternational Organization for Standardization
Provided by IHS under license with ISO

http://www.iso.org/tc176/sc02/public

Quality management systems — Requirements

1 Scope

This International Standard specifies requirements for a quality management system when an
organization:

a) needs to demonstrate its ability to consistently provide products and services that meet customer
and applicable statutory and regulatory requirements, and

b) aims to enhance customer satisfaction through the effective application of the system, including
processes for improvement of the system and the assurance of conformity to customer and
applicable statutory and regulatory requirements.

All the requirements of this International Standard are generic and are intended to be applicable to any
organization, regardless of its type or size, or the products and services it provides.

NOTE 1 In this International Standard, the terms “product” or “service” only apply to products and services
intended for, or required by, a customer.

NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.

2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.

ISO 9000:2015, Quality management systems — Fundamentals and vocabulary

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 9000:2015 apply.

4 Context of the organization

4.1 Understanding the organization and its context

The organization shall determine external and internal issues that are relevant to its purpose
and its strategic direction and that affect its ability to achieve the intended result(s) of its quality
management system.

The organization shall monitor and review information about these external and internal issues.

NOTE 1 Issues can include positive and negative factors or conditions for consideration.

NOTE 2 Understanding the external context can be facilitated by considering issues arising from legal,
technological, competitive, market, cultural, social and economic environments, whether international, national,
regional or local.

NOTE 3 Understanding the internal context can be facilitated by considering issues related to values, culture,
knowledge and performance of the organization.

INTERNATIONAL STANDARD ISO 9001:2015(E)

ISO 9001:2015(E)

4.2 Understanding the needs and expectations of interested parties

Due to their effect or potential effect on the organization’s ability to consistently provide products and
services that meet customer and applicable statutory and regulatory requirements, the organization
shall determine:

a) the interested parties that are relevant to the quality management system;

b) the requirements of these interested parties that are relevant to the quality management system.

The organization shall monitor and review information about these interested parties and their
relevant requirements.

4.3 Determining the scope of the quality management system

The organization shall determine the boundaries and applicability of the quality management system
to establish its scope.

When determining this scope, the organization shall consider:

a) the external and internal issues referred to in 4.1;

b) the requirements of relevant interested parties referred to in 4.2;

c) the products and services of the organization.

The organization shall apply all the requirements of this International Standard if they are applicable
within the determined scope of its quality management system.

The scope of the organization’s quality management system shall be available and be maintained as
documented information. The scope shall state the types of products and services covered, and provide
justification for any requirement of this International Standard that the organization determines is not
applicable to the scope of its quality management system.

Conformity to this International Standard may only be claimed if the requirements determined as not
being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its
products and services and the enhancement of customer satisfaction.

4.4 Quality management system and its processes

4.4.1 The organization shall establish, implement, maintain and continually improve a quality
management system, including the processes needed and their interactions, in accordance with the
requirements of this International Standard.

The organization shall determine the processes needed for the quality management system and their
application throughout the organization, and shall:

a) determine the inputs required and the outputs expected from these processes;

b) determine the sequence and interaction of these processes;

c) determine and apply the criteria and methods (including monitoring, measurements and related
performance indicators) needed to ensure the effective operation and control of these processes;

d) determine the resources needed for these processes and ensure their availability;

e) assign the responsibilities and authorities for these processes;

f ) address the risks and opportunities as determined in accordance with the requirements of 6.1;

g) evaluate these processes and implement any changes needed to ensure that these processes achieve
their intended results;

2 © ISO 2015 – All rights reservedInternational Organization for Standardization
Provided by IHS under license with ISO

ISO 9001:2015(E)

h) improve the processes and the quality management system.

4.4.2 To the extent necessary, the organization shall:

a) maintain documented information to support the operation of its processes;

b) retain documented information to have confidence that the processes are being carried out as
planned.

5 Leadership

5.1 Leadership and commitment

5.1.1 General

Top management shall demonstrate leadership and commitment with respect to the quality
management system by:

a) taking accountability for the effectiveness of the quality management system;

b) ensuring that the quality policy and quality objectives are established for the quality management
system and are compatible with the context and strategic direction of the organization;

c) ensuring the integration of the quality management system requirements into the organization’s
business processes;

d) promoting the use of the process approach and risk-based thinking;

e) ensuring that the resources needed for the quality management system are available;

f ) communicating the importance of effective quality management and of conforming to the quality
management system requirements;

g) ensuring that the quality management system achieves its intended results;

h) engaging, directing and supporting persons to contribute to the effectiveness of the quality
management system;

i) promoting improvement;

j) supporting other relevant management roles to demonstrate their leadership as it applies to their
areas of responsibility.

NOTE Reference to “business” in this International Standard can be interpreted broadly to mean those
activities that are core to the purposes of the organization’s existence, whether the organization is public, private,
for profit or not for profit.

5.1.2 Customer focus

Top management shall demonstrate leadership and commitment with respect to customer focus by
ensuring that:

a) customer and applicable statutory and regulatory requirements are determined, understood and
consistently met;

b) the risks and opportunities that can affect conformity of products and services and the ability to
enhance customer satisfaction are determined and addressed;

c) the focus on enhancing customer satisfaction is maintained.

ISO 9001:2015(E)

5.2 Policy

5.2.1 Establishing the quality policy

Top management shall establish, implement and maintain a quality policy that:

a) is appropriate to the purpose and context of the organization and supports its strategic direction;

b) provides a framework for setting quality objectives;

c) includes a commitment to satisfy applicable requirements;

d) includes a commitment to continual improvement of the quality management system.

5.2.2 Communicating the quality policy

The quality policy shall:

a) be available and be maintained as documented information;

b) be communicated, understood and applied within the organization;

c) be available to relevant interested parties, as appropriate.

5.3 Organizational roles, responsibilities and authorities

Top management shall ensure that the responsibilities and authorities for relevant roles are assigned,
communicated and understood within the organization.

Top management shall assign the responsibility and authority for:

a) ensuring that the quality management system conforms to the requirements of this
International Standard;

b) ensuring that the processes are delivering their intended outputs;

c) reporting on the performance of the quality management system and on opportunities for
improvement (see 10.1), in particular to top management;

d) ensuring the promotion of customer focus throughout the organization;

e) ensuring that the integrity of the quality management system is maintained when changes to the
quality management system are planned and implemented.

6 Planning

6.1 Actions to address risks and opportunities

6.1.1 When planning for the quality management system, the organization shall consider the issues
referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that
need to be addressed to:

a) give assurance that the quality management system can achieve its intended result(s);

b) enhance desirable effects;

c) prevent, or reduce, undesired effects;

d) achieve improvement.

4 © ISO 2015 – All rights reservedInternational Organization for Standardization
Provided by IHS under license with ISO

ISO 9001:2015(E)

6.1.2 The organization shall plan:

a) actions to address these risks and opportunities;

b) how to:

1) integrate and implement the actions into its quality management system processes (see 4.4);

2) evaluate the effectiveness of these actions.

Actions taken to address risks and opportunities shall be proportionate to the potential impact on the
conformity of products and services.

NOTE 1 Options to address risks can include avoiding risk, taking risk in order to pursue an opportunity,
eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by
informed decision.

NOTE 2 Opportunities can lead to the adoption of new practices, launching new products, opening new
markets, addressing new customers, building partnerships, using new technology and other desirable and viable
possibilities to address the organization’s or its customers’ needs.

6.2 Quality objectives and planning to achieve them

6.2.1 The organization shall establish quality objectives at relevant functions, levels and processes
needed for the quality management system.

The quality objectives shall:

a) be consistent with the quality policy;

b) be measurable;

c) take into account applicable requirements;

d) be relevant to conformity of products and services and to enhancement of customer satisfaction;

e) be monitored;

f ) be communicated;

g) be updated as appropriate.

The organization shall maintain documented information on the quality objectives.

6.2.2 When planning how to achieve its quality objectives, the organization shall determine:

a) what will be done;

b) what resources will be required;

c) who will be responsible;

d) when it will be completed;

e) how the results will be evaluated.

6.3 Planning of changes

When the organization determines the need for changes to the quality management system, the changes
shall be carried out in a planned manner (see 4.4).

ISO 9001:2015(E)

The organization shall consider:

a) the purpose of the changes and their potential consequences;

b) the integrity of the quality management system;

c) the availability of resources;

d) the allocation or reallocation of responsibilities and authorities.

7 Support

7.1 Resources

7.1.1 General

The organization shall determine and provide the resources needed for the establishment,
implementation, maintenance and continual improvement of the quality management system.

The organization shall consider:

a) the capabilities of, and constraints on, existing internal resources;

b) what needs to be obtained from external providers.

7.1.2 People

The organization shall determine and provide the persons necessary for the effective implementation
of its quality management system and for the operation and control of its processes.

7.1.3 Infrastructure

The organization shall determine, provide and maintain the infrastructure necessary for the operation
of its processes and to achieve conformity of products and services.

NOTE Infrastructure can include:

a) buildings and associated utilities;

b) equipment, including hardware and software;

c) transportation resources;

d) information and communication technology.

7.1.4 Environment for the operation of processes

The organization shall determine, provide and maintain the environment necessary for the operation
of its processes and to achieve conformity of products and services.

NOTE A suitable environment can be a combination of human and physical factors, such as:

a) social (e.g. non-discriminatory, calm, non-confrontational);

b) psychological (e.g. stress-reducing, burnout prevention, emotionally protective);

c) physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise).

These factors can differ substantially depending on the products and services provided.

6 © ISO 2015 – All rights reservedInternational Organization for Standardization
Provided by IHS under license with ISO

ISO 9001:2015(E)

7.1.5 Monitoring and measuring resources

7.1.5.1 General

The organization shall determine and provide the resources needed to ensure valid and reliable
results when monitoring or measuring is used to verify the conformity of products and services to
requirements.

The organization shall ensure that the resources provided:

a) are suitable for the specific type of monitoring and measurement activities being undertaken;

b) are maintained to ensure their continuing fitness for their purpose.

The organization shall retain appropriate documented information as evidence of fitness for purpose of
the monitoring and measurement resources.

7.1.5.2 Measurement traceability

When measurement traceability is a requirement, or is considered by the organization to be an essential
part of providing confidence in the validity of measurement results, measuring equipment shall be:

a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards
traceable to international or national measurement standards; when no such standards exist, the
basis used for calibration or verification shall be retained as documented information;

b) identified in order to determine their status;

c) safeguarded from adjustments, damage or deterioration that would invalidate the calibration
status and subsequent measurement results.

The organization shall determine if the validity of previous measurement results has been adversely
affected when measuring equipment is found to be unfit for its intended purpose, and shall take
appropriate action as necessary.

7.1.6 Organizational knowledge

The organization shall determine the knowledge necessary for the operation of its processes and to
achieve conformity of products and services.

This knowledge shall be maintained and be made available to the extent necessary.

When addressing changing needs and trends, the organization shall consider its current knowledge
and determine how to acquire or access any necessary additional knowledge and required updates.

NOTE 1 Organizational knowledge is knowledge specific to the organization; it is generally gained by
experience. It is information that is used and shared to achieve the organization’s objectives.

NOTE 2 Organizational knowledge can be based on:

a) internal sources (e.g. intellectual property; knowledge gained from experience; lessons learned from
failures and successful projects; capturing and sharing undocumented knowledge and experience; the results of
improvements in processes, products and services);

b) external sources (e.g. standards; academia; conferences; gathering knowledge from customers or
external providers).

Licensee=ADNOC 9999103
Not for Resale, 2015/10/5 19:20:06
No reproduction or networking permitted without license from IHS
–`,,“,,,`,,`,,`,““““-`-“,“`,,,`—

ISO 9001:2015(E)

7.2 Competence

The organization shall:

a) determine the necessary competence of person(s) doing work under its control that affects the
performance and effectiveness of the quality management system;

b) ensure that these persons are competent on the basis of appropriate education, training, or
experience;

c) where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness
of the actions taken;

d) retain appropriate documented information as evidence of competence.

NOTE Applicable actions can include, for example, the provision of training to, the mentoring of, or the re-
assignment of currently employed persons; or the hiring or contracting of competent persons.

7.3 Awareness

The organization shall ensure that persons doing work under the organization’s control are aware of:

a) the quality policy;

b) relevant quality objectives;

c) their contribution to the effectiveness of the quality management system, including the benefits of
improved performance;

d) the implications of not conforming with the quality management system requirements.

7.4 Communication

The organization shall determine the internal and external communications relevant to the quality
management system, including:

a) on what it will communicate;

b) when to communicate;

c) with whom to communicate;

d) how to communicate;

e) who communicates.

7.5

Documented information

7.5.1 General

The organization’s quality management system shall include:

a) documented information required by this International Standard;

b) documented information determined by the organization as being necessary for the effectiveness
of the quality management system.

NOTE The extent of documented information for a quality management system can differ from one
organization to another due to:

— the size of organization and its type of activities, processes, products and services;

8 © ISO 2015 – All rights reservedInternational Organization for Standardization
Provided by IHS under license with ISO

Licensee=ADNOC 9999103
Not for Resale, 2015/10/5 19:20:06
No reproduction or networking permitted without license from IHS
–`,,“,,,`,,`,,`,““““-`-“,“`,,,`—

ISO 9001:2015(E)

— the complexity of processes and their interactions;

— the competence of persons.

7.5.2 Creating and updating

When creating and updating documented information, the organization shall ensure appropriate:

a) identification and description (e.g. a title, date, author, or reference number);

b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic);

c) review and approval for suitability and adequacy.

7.5.3 Control of documented information

7.5.3.1 Documented information required by the quality management system and by this International
Standard shall be controlled to ensure:

a) it is available and suitable for use, where and when it is needed;

b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).

7.5.3.2 For the control of documented information, the organization shall address the following
activities, as applicable:

a) distribution, access, retrieval and use;

b) storage and preservation, including preservation of legibility;

c) control of changes (e.g. version control);

d) retention and disposition.

Documented information of external origin determined by the organization to be necessary for the
planning and operation of the quality management system shall be identified as appropriate, and
be controlled.

Documented information retained as evidence of conformity shall be protected from unintended
alterations.

NOTE Access can imply a decision regarding the permission to view the documented information only, or
the permission and authority to view and change the documented information.

8 Operation

8.1 Operational planning and control

The organization shall plan, implement and control the processes (see 4.4) needed to meet the
requirements for the provision of products and services, and to implement the actions determined in
Clause 6, by:

a) determining the requirements for the products and services;

b) establishing criteria for:

1) the processes;

2) the acceptance of products and services;

c) determining the resources needed to achieve conformity to the product and service requirements;

Licensee=ADNOC 9999103
Not for Resale, 2015/10/5 19:20:06
No reproduction or networking permitted without license from IHS
–`,,“,,,`,,`,,`,““““-`-“,“`,,,`—

ISO 9001:2015(E)

d) implementing control of the processes in accordance with the criteria;

e) determining, maintaining and retaining documented information to the extent necessary:

1) to have confidence that the processes have been carried out as planned;

2) to demonstrate the conformity of products and services to their requirements.

The output of this planning shall be suitable for the organization’s operations.

The organization shall control planned changes and review the consequences of unintended changes,
taking action to mitigate any adverse effects, as necessary.

The organization shall ensure that outsourced processes are controlled (see 8.4).

8.2 Requirements for products and services

8.2.1 Customer communication

Communication with customers shall include:

a) providing information relating to products and services;

b) handling enquiries, contracts or orders, including changes;

c) obtaining customer feedback relating to products and services, including customer complaints;

d) handling or controlling customer property;

e) establishing specific requirements for contingency actions, when relevant.

8.2.2 Determining the requirements for products and services

When determining the requirements for the products and services to be offered to customers, the
organization shall ensure that:

a) the requirements for the products and services are defined, including:

1) any applicable statutory and regulatory requirements;

2) those considered necessary by the organization;

b) the organization can meet the claims for the products and services it offers.

8.2.3 Review of the requirements for products and services

8.2.3.1 The organization shall ensure that it has the ability to meet the requirements for products and
services to be offered to customers. The organization shall conduct a review before committing to supply
products and services to a customer, to include:

a) requirements specified by the customer, including the requirements for delivery and post-
delivery activities;

b) requirements not stated by the customer, but necessary for the specified or intended use, when
known;

c) requirements specified by the organization;

d) statutory and regulatory requirements applicable to the products and services;

e) contract or order requirements differing from those previously expressed.

10 © ISO 2015 – All rights reservedInternational Organization for Standardization
Provided by IHS under license with ISO

ISO 9001:2015(E)

The organization shall ensure that contract or order requirements differing from those previously
defined are resolved.

The customer’s requirements shall be confirmed by the organization before acceptance, when the
customer does not provide a documented statement of their requirements.

NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead, the
review can cover relevant product information, such as catalogues.

8.2.3.2 The organization shall retain documented information, as applicable:

a) on the results of the review;

b) on any new requirements for the products and services.

8.2.4 Changes to requirements for products and services

The organization shall ensure that relevant documented information is amended, and that relevant
persons are made aware of the changed requirements, when the requirements for products and
services are changed.

8.3 Design and development of products and services

8.3.1 General

The organization shall establish, implement and maintain a design and development process that is
appropriate to ensure the subsequent provision of products and services.

8.3.2 Design and development planning

In determining the stages and controls for design and development, the organization shall consider:

a) the nature, duration and complexity of the design and development activities;

b) the required process stages, including applicable design and development reviews;

c) the required design and development verification and validation activities;

d) the responsibilities and authorities involved in the design and development process;

e) the internal and external resource needs for the design and development of products and services;

f ) the need to control interfaces between persons involved in the design and development process;

g) the need for involvement of customers and users in the design and development process;

h) the requirements for subsequent provision of products and services;

i) the level of control expected for the design and development process by customers and other
relevant interested parties;

j) the documented information needed to demonstrate that design and development requirements
have been met.

8.3.3 Design and development inputs

The organization shall determine the requirements essential for the specific types of products and
services to be designed and developed. The organization shall consider:

a) functional and performance requirements;

Licensee=ADNOC 9999103
Not for Resale, 2015/10/5 19:20:06
No reproduction or networking permitted without license from IHS
–`,,“,,,`,,`,,`,““““-`-“,“`,,,`—

ISO 9001:2015(E)

b) information derived from previous similar design and development activities;

c) statutory and regulatory requirements;

d) standards or codes of practice that the organization has committed to implement;

e) potential consequences of failure due to the nature of the products and services.

Inputs shall be adequate for design and development purposes, complete and unambiguous.

Conflicting design and development inputs shall be resolved.

The organization shall retain documented information on design and development inputs.

8.3.4 Design and development controls

The organization shall apply controls to the design and development process to ensure that:

a) the results to be achieved are defined;

b) reviews are conducted to evaluate the ability of the results of design and development to meet
requirements;

c) verification activities are conducted to ensure that the design and development outputs meet the
input requirements;

d) validation activities are conducted to ensure that the resulting products and services meet the
requirements for the specified application or intended use;

e) any necessary actions are taken on problems determined during the reviews, or verification and
validation activities;

f ) documented information of these activities is retained.

NOTE Design and development reviews, verification and validation have distinct purposes. They can be
conducted separately or in any combination, as is suitable for the products and services of the organization.

8.3.5 Design and development outputs

The organization shall ensure that design and development outputs:

a) meet the input requirements;

b) are adequate for the subsequent processes for the provision of products and services;

c) include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria;

d) specify the characteristics of the products and services that are essential for their intended purpose
and their safe and proper provision.

The organization shall retain documented information on design and development outputs.

8.3.6 Design and development changes

The organization shall identify, review and control changes made during, or subsequent to, the design
and development of products and services, to the extent necessary to ensure that there is no adverse
impact on conformity to requirements.

The organization shall retain documented information on:

a) design and development changes;

b) the results of reviews;

12 © ISO 2015 – All rights reservedInternational Organization for Standardization
Provided by IHS under license with ISO

ISO 9001:2015(E)

c) the authorization of the changes;

d) the actions taken to prevent adverse impacts.

8.4 Control of externally provided processes, products and services

8.4.1 General

The organization shall ensure that externally provided processes, products and services conform to
requirements.

The organization shall determine the controls to be applied to externally provided processes, products
and services when:

a) products and services from external providers are intended for incorporation into the organization’s
own products and services;

b) products and services are provided directly to the customer(s) by external providers on behalf of
the organization;

c) a process, or part of a process, is provided by an external provider as a result of a decision by the
organization.

The organization shall determine and apply criteria for the evaluation, selection, monitoring of
performance, and re-evaluation of external providers, based on their ability to provide processes or
products and services in accordance with requirements. The organization shall retain documented
information of these activities and any necessary actions arising from the evaluations.

8.4.2 Type and extent of control

The organization shall ensure that externally provided processes, products and services do not
adversely affect the organization’s ability to consistently deliver conforming products and services to
its customers.

The organization shall:

a) ensure that externally provided processes remain within the control of its quality management
system;

b) define both the controls that it intends to apply to an external provider and those it intends to apply
to the resulting output;

c) take into consideration:

1) the potential impact of the externally provided processes, products and services on the
organization’s ability to consistently meet customer and applicable statutory and regulatory
requirements;

2) the effectiveness of the controls applied by the external provider;

d) determine the verification, or other activities, necessary to ensure that the externally provided
processes, products and services meet requirements.

8.4.3 Information for external providers

The organization shall ensure the adequacy of requirements prior to their communication to the
external provider.

The organization shall communicate to external providers its requirements for:

a) the processes, products and services to be provided;

ISO 9001:2015(E)

b) the approval of:

1) products and services;

2) methods, processes and equipment;

3) the release of products and services;

c) competence, including any required qualification of persons;

d) the external providers’ interactions with the organization;

e) control and monitoring of the external providers’ performance to be applied by the organization;

f ) verification or validation activities that the organization, or its customer, intends to perform at the
external providers’ premises.

8.5 Production and service provision

8.5.1 Control of production and service provision

The organization shall implement production and service provision under controlled conditions.

Controlled conditions shall include, as applicable:

a) the availability of documented information that defines:

1) the characteristics of the products to be produced, the services to be provided, or the activities
to be performed;

2) the results to be achieved;

b) the availability and use of suitable monitoring and measuring resources;

c) the implementation of monitoring and measurement activities at appropriate stages to verify that
criteria for control of processes or outputs, and acceptance criteria for products and services,
have been met;

d) the use of suitable infrastructure and environment for the operation of processes;

e) the appointment of competent persons, including any required qualification;

f ) the validation, and periodic revalidation, of the ability to achieve planned results of the processes
for production and service provision, where the resulting output cannot be verified by subsequent
monitoring or measurement;

g) the implementation of actions to prevent human error;

h) the implementation of release, delivery and post-delivery activities.

8.5.2 Identification and traceability

The organization shall use suitable means to identify outputs when it is necessary to ensure the
conformity of products and services.

The organization shall identify the status of outputs with respect to monitoring and measurement
requirements throughout production and service provision.

The organization shall control the unique identification of the outputs when traceability is a
requirement, and shall retain the documented information necessary to enable traceability.

14 © ISO 2015 – All rights reservedInternational Organization for Standardization
Provided by IHS under license with ISO

ISO 9001:2015(E)

8.5.3 Property belonging to customers or external providers

The organization shall exercise care with property belonging to customers or external providers while
it is under the organization’s control or being used by the organization.

The organization shall identify, verify, protect and safeguard customers’ or external providers’ property
provided for use or incorporation into the products and services.

When the property of a customer or external provider is lost, damaged or otherwise found to be
unsuitable for use, the organization shall report this to the customer or external provider and retain
documented information on what has occurred.

NOTE A customer’s or external provider’s property can include materials, components, tools and equipment,
premises, intellectual property and personal data.

8.5.4 Preservation

The organization shall preserve the outputs during production and service provision, to the extent
necessary to ensure conformity to requirements.

NOTE Preservation can include identification, handling, contamination control, packaging, storage,
transmission or transportation, and protection.

8.5.5 Post-delivery activities

The organization shall meet requirements for post-delivery activities associated with the products
and services.

In determining the extent of post-delivery activities that are required, the organization shall consider:

a) statutory and regulatory requirements;

b) the potential undesired consequences associated with its products and services;

c) the nature, use and intended lifetime of its products and services;

d) customer requirements;

e) customer feedback.

NOTE Post-delivery activities can include actions under warranty provisions, contractual obligations such
as maintenance services, and supplementary services such as recycling or final disposal.

8.5.6 Control of changes

The organization shall review and control changes for production or service provision, to the extent
necessary to ensure continuing conformity with requirements.

The organization shall retain documented information describing the results of the review of changes,
the person(s) authorizing the change, and any necessary actions arising from the review.

8.6 Release of products and services

The organization shall implement planned arrangements, at appropriate stages, to verify that the
product and service requirements have been met.

The release of products and services to the customer shall not proceed until the planned arrangements
have been satisfactorily completed, unless otherwise approved by a relevant authority and, as
applicable, by the customer.

ISO 9001:2015(E)

The organization shall retain documented information on the release of products and services. The
documented information shall include:

a) evidence of conformity with the acceptance criteria;

b) traceability to the person(s) authorizing the release.

8.7 Control of nonconforming outputs

8.7.1 The organization shall ensure that outputs that do not conform to their requirements are
identified and controlled to prevent their unintended use or delivery.

The organization shall take appropriate action based on the nature of the nonconformity and its effect
on the conformity of products and services. This shall also apply to nonconforming products and
services detected after delivery of products, during or after the provision of services.

The organization shall deal with nonconforming outputs in one or more of the following ways:

a) correction;

b) segregation, containment, return or suspension of provision of products and services;

c) informing the customer;

d) obtaining authorization for acceptance under concession.

Conformity to the requirements shall be verified when nonconforming outputs are corrected.

8.7.2 The organization shall retain documented information that:

a) describes the nonconformity;

b) describes the actions taken;

c) describes any concessions obtained;

d) identifies the authority deciding the action in respect of the nonconformity.

9 Performance evaluation

9.1 Monitoring, measurement, analysis and evaluation

9.1.1 General

The organization shall determine:

a) what needs to be monitored and measured;

b) the methods for monitoring, measurement, analysis and evaluation needed to ensure valid results;

c) when the monitoring and measuring shall be performed;

d) when the results from monitoring and measurement shall be analysed and evaluated.

The organization shall evaluate the performance and the effectiveness of the quality management system.

The organization shall retain appropriate documented information as evidence of the results.

16 © ISO 2015 – All rights reservedInternational Organization for Standardization
Provided by IHS under license with ISO

ISO 9001:2015(E)

9.1.2 Customer satisfaction

The organization shall monitor customers’ perceptions of the degree to which their needs and
expectations have been fulfilled. The organization shall determine the methods for obtaining,
monitoring and reviewing this information.

NOTE Examples of monitoring customer perceptions can include customer surveys, customer feedback
on delivered products and services, meetings with customers, market-share analysis, compliments, warranty
claims and dealer reports.

9.1.3 Analysis and evaluation

The organization shall analyse and evaluate appropriate data and information arising from monitoring
and measurement.

The results of analysis shall be used to evaluate:

a) conformity of products and services;

b) the degree of customer satisfaction;

c) the performance and effectiveness of the quality management system;

d) if planning has been implemented effectively;

e) the effectiveness of actions taken to address risks and opportunities;

f ) the performance of external providers;

g) the need for improvements to the quality management system.

NOTE Methods to analyse data can include statistical techniques.

9.2 Internal audit

9.2.1 The organization shall conduct internal audits at planned intervals to provide information on
whether the quality management system:

a) conforms to:

1) the organization’s own requirements for its quality management system;

2) the requirements of this International Standard;

b) is effectively implemented and maintained.

9.2.2 The organization shall:

a) plan, establish, implement and maintain an audit programme(s) including the frequency, methods,
responsibilities, planning requirements and reporting, which shall take into consideration the
importance of the processes concerned, changes affecting the organization, and the results of
previous audits;

b) define the audit criteria and scope for each audit;

c) select auditors and conduct audits to ensure objectivity and the impartiality of the audit process;

d) ensure that the results of the audits are reported to relevant management;

e) take appropriate correction and corrective actions without undue delay;

Licensee=ADNOC 9999103
Not for Resale, 2015/10/5 19:20:06
No reproduction or networking permitted without license from IHS
–`,,“,,,`,,`,,`,““““-`-“,“`,,,`—

ISO 9001:2015(E)

f ) retain documented information as evidence of the implementation of the audit programme and the
audit results.

NOTE See ISO 19011 for guidance.

9.3 Management review

9.3.1 General

Top management shall review the organization’s quality management system, at planned intervals, to
ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of
the organization.

9.3.2 Management review inputs

The management review shall be planned and carried out taking into consideration:

a) the status of actions from previous management reviews;

b) changes in external and internal issues that are relevant to the quality management system;

c) information on the performance and effectiveness of the quality management system, including
trends in:

1) customer satisfaction and feedback from relevant interested parties;

2) the extent to which quality objectives have been met;

3) process performance and conformity of products and services;

4) nonconformities and corrective actions;

5) monitoring and measurement results;

6) audit results;

7) the performance of external providers;

d) the adequacy of resources;

e) the effectiveness of actions taken to address risks and opportunities (see 6.1);

f ) opportunities for improvement.

9.3.3 Management review outputs

The outputs of the management review shall include decisions and actions related to:

a) opportunities for improvement;

b) any need for changes to the quality management system;

c) resource needs.

The organization shall retain documented information as evidence of the results of management reviews.

18 © ISO 2015 – All rights reservedInternational Organization for Standardization
Provided by IHS under license with ISO

ISO 9001:2015(E)

10 Improvement

10.1 General

The organization shall determine and select opportunities for improvement and implement any
necessary actions to meet customer requirements and enhance customer satisfaction.

These shall include:

a) improving products and services to meet requirements as well as to address future needs and
expectations;

b) correcting, preventing or reducing undesired effects;

c) improving the performance and effectiveness of the quality management system.

NOTE Examples of improvement can include correction, corrective action, continual improvement,
breakthrough change, innovation and re-organization.

10.2 Nonconformity and corrective action

10.2.1 When a nonconformity occurs, including any arising from complaints, the organization shall:

a) react to the nonconformity and, as applicable:

1) take action to control and correct it;

2) deal with the consequences;

b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not
recur or occur elsewhere, by:

1) reviewing and analysing the nonconformity;

2) determining the causes of the nonconformity;

3) determining if similar nonconformities exist, or could potentially occur;

c) implement any action needed;

d) review the effectiveness of any corrective action taken;

e) update risks and opportunities determined during planning, if necessary;

f ) make changes to the quality management system, if necessary.

Corrective actions shall be appropriate to the effects of the nonconformities encountered.

10.2.2 The organization shall retain documented information as evidence of:

a) the nature of the nonconformities and any subsequent actions taken;

b) the results of any corrective action.

10.3 Continual improvement

The organization shall continually improve the suitability, adequacy and effectiveness of the quality
management system.

ISO 9001:2015(E)

The organization shall consider the results of analysis and evaluation, and the outputs from
management review, to determine if there are needs or opportunities that shall be addressed as part of
continual improvement.

20 © ISO 2015 – All rights reservedInternational Organization for Standardization
Provided by IHS under license with ISO

ISO 9001:2015(E)

Annex A
(informative)

Clarification of new structure, terminology and concepts

A.1 Structure and terminology

The clause structure (i.e. clause sequence) and some of the terminology of this edition of this
International Standard, in comparison with the previous edition (ISO 9001:2008), have been changed
to improve alignment with other management systems standards.

There is no requirement in this International Standard for its structure and terminology to be applied
to the documented information of an organization’s quality management system.

The structure of clauses is intended to provide a coherent presentation of requirements, rather than a
model for documenting an organization’s policies, objectives and processes. The structure and content
of documented information related to a quality management system can often be more relevant to its
users if it relates to both the processes operated by the organization and information maintained for
other purposes.

There is no requirement for the terms used by an organization to be replaced by the terms used in this
International Standard to specify quality management system requirements. Organizations can choose
to use terms which suit their operations (e.g. using “records”, “documentation” or “protocols” rather
than “documented information”; or “supplier”, “partner” or “vendor” rather than “external provider”).
Table A.1 shows the major differences in terminology between this edition of this International
Standard and the previous edition.

Table A.1 — Major differences in terminology between ISO 9001:2008 and ISO 9001:2015

ISO 9001:2008 ISO 9001:2015

Products Products and services
Exclusions Not used

(See Clause A.5 for clarification of applicability)
Management representative Not used

(Similar responsibilities and authorities are assigned
but no requirement for a single management repre-
sentative)

Documentation, quality manual, documented pro-
cedures, records

Documented information

Work environment Environment for the operation of processes
Monitoring and measuring equipment Monitoring and measuring resources
Purchased product Externally provided products and services
Supplier External provider

A.2 Products and services

ISO 9001:2008 used the term “product” to include all output categories. This edition of this International
Standard uses “products and services”. “Products and services” include all output categories (hardware,
services, software and processed materials).

ISO 9001:2015(E)

The specific inclusion of “services” is intended to highlight the differences between products and
services in the application of some requirements. The characteristic of services is that at least part of
the output is realized at the interface with the customer. This means, for example, that conformity to
requirements cannot necessarily be confirmed before service delivery.

In most cases, products and services are used together. Most outputs that organizations provide to
customers, or are supplied to them by external providers, include both products and services. For
example, a tangible or intangible product can have some associated service or a service can have some
associated tangible or intangible product.

A.3 Understanding the needs and expectations of interested parties

Subclause 4.2 specifies requirements for the organization to determine the interested parties that
are relevant to the quality management system and the requirements of those interested parties.
However, 4.2 does not imply extension of quality management system requirements beyond the scope
of this International Standard. As stated in the scope, this International Standard is applicable where
an organization needs to demonstrate its ability to consistently provide products and services that
meet customer and applicable statutory and regulatory requirements, and aims to enhance customer
satisfaction.

There is no requirement in this International Standard for the organization to consider interested
parties where it has decided that those parties are not relevant to its quality management system. It is
for the organization to decide if a particular requirement of a relevant interested party is relevant to its
quality management system.

A.4 Risk-based thinking

The concept of risk-based thinking has been implicit in previous editions of this International Standard,
e.g. through requirements for planning, review and improvement. This International Standard
specifies requirements for the organization to understand its context (see 4.1) and determine risks as
a basis for planning (see 6.1). This represents the application of risk-based thinking to planning and
implementing quality management system processes (see 4.4) and will assist in determining the extent
of documented information.

One of the key purposes of a quality management system is to act as a preventive tool. Consequently,
this International Standard does not have a separate clause or subclause on preventive action. The
concept of preventive action is expressed through the use of risk-based thinking in formulating quality
management system requirements.

The risk-based thinking applied in this International Standard has enabled some reduction in
prescriptive requirements and their replacement by performance-based requirements. There is greater
flexibility than in ISO 9001:2008 in the requirements for processes, documented information and
organizational responsibilities.

Although 6.1 specifies that the organization shall plan actions to address risks, there is no requirement
for formal methods for risk management or a documented risk management process. Organizations can
decide whether or not to develop a more extensive risk management methodology than is required by
this International Standard, e.g. through the application of other guidance or standards.

Not all the processes of a quality management system represent the same level of risk in terms of the
organization’s ability to meet its objectives, and the effects of uncertainty are not the same for all
organizations. Under the requirements of 6.1, the organization is responsible for its application of risk-
based thinking and the actions it takes to address risk, including whether or not to retain documented
information as evidence of its determination of risks.

22 © ISO 2015 – All rights reservedInternational Organization for Standardization
Provided by IHS under license with ISO

ISO 9001:2015(E)

A.5 Applicability

This International Standard does not refer to “exclusions” in relation to the applicability of its
requirements to the organization’s quality management system. However, an organization can review
the applicability of requirements due to the size or complexity of the organization, the management
model it adopts, the range of the organization’s activities and the nature of the risks and opportunities
it encounters.

The requirements for applicability are addressed in 4.3, which defines conditions under which an
organization can decide that a requirement cannot be applied to any of the processes within the scope
of its quality management system. The organization can only decide that a requirement is not applicable
if its decision will not result in failure to achieve conformity of products and services.

A.6 Documented information

As part of the alignment with other management system standards, a common clause on “documented
information” has been adopted without significant change or addition (see 7.5). Where appropriate,
text elsewhere in this International Standard has been aligned with its requirements. Consequently,
“documented information” is used for all document requirements.

Where ISO 9001:2008 used specific terminology such as “document” or “documented procedures”,
“quality manual” or “quality plan”, this edition of this International Standard defines requirements to
“maintain documented information”.

Where ISO 9001:2008 used the term “records” to denote documents needed to provide evidence
of conformity with requirements, this is now expressed as a requirement to “retain documented
information”. The organization is responsible for determining what documented information needs to
be retained, the period of time for which it is to be retained and the media to be used for its retention.

A requirement to “maintain” documented information does not exclude the possibility that the
organization might also need to “retain” that same documented information for a particular purpose,
e.g. to retain previous versions of it.

Where this International Standard refers to “information” rather than “documented information” (e.g. in
4.1: “The organization shall monitor and review the information about these external and internal issues”),
there is no requirement that this information is to be documented. In such situations, the organization
can decide whether or not it is necessary or appropriate to maintain documented information.

A.7 Organizational knowledge

In 7.1.6, this International Standard addresses the need to determine and manage the knowledge
maintained by the organization, to ensure the operation of its processes and that it can achieve
conformity of products and services.

Requirements regarding organizational knowledge were introduced for the purpose of:

a) safeguarding the organization from loss of knowledge, e.g.

— through staff turnover;

— failure to capture and share information;

b) encouraging the organization to acquire knowledge, e.g.

— learning from experience;

— mentoring;

— benchmarking.

ISO 9001:2015(E)

A.8 Control of externally provided processes, products and services

All forms of externally provided processes, products and services are addressed in 8.4, e.g. whether
through:

a) purchasing from a supplier;

b) an arrangement with an associate company;

c) outsourcing processes to an external provider.

Outsourcing always has the essential characteristic of a service, since it will have at least one activity
necessarily performed at the interface between the provider and the organization.

The controls required for external provision can vary widely depending on the nature of the processes,
products and services. The organization can apply risk-based thinking to determine the type and extent
of controls appropriate to particular external providers and externally provided processes, products
and services.

24 © ISO 2015 – All rights reservedInternational Organization for Standardization
Provided by IHS under license with ISO

ISO 9001:2015(E)

Annex B
(informative)

Other International Standards on quality management and quality

management systems developed by ISO/TC 176

The International Standards described in this annex have been developed by ISO/TC 176 to provide
supporting information for organizations that apply this International Standard, and to provide
guidance for organizations that choose to progress beyond its requirements. Guidance or requirements
contained in the documents listed in this annex do not add to, or modify, the requirements of this
International Standard.

Table B.1 shows the relationship between these standards and the relevant clauses of this
International Standard.

This annex does not include reference to the sector-specific quality management system standards
developed by ISO/TC 176.

This International Standard is one of the three core standards developed by ISO/TC 176.

— ISO 9000 Quality management systems — Fundamentals and vocabulary provides an essential
background for the proper understanding and implementation of this International Standard.
The quality management principles are described in detail in ISO 9000 and have been taken into
consideration during the development of this International Standard. These principles are not
requirements in themselves, but they form the foundation of the requirements specified by this
International Standard. ISO 9000 also defines the terms, definitions and concepts used in this
International Standard.

— ISO 9001 (this International Standard) specifies requirements aimed primarily at giving confidence in
the products and services provided by an organization and thereby enhancing customer satisfaction.
Its proper implementation can also be expected to bring other organizational benefits, such as
improved internal communication, better understanding and control of the organization’s processes.

— ISO 9004 Managing for the sustained success of an organization — A quality management approach
provides guidance for organizations that choose to progress beyond the requirements of this
International Standard, to address a broader range of topics that can lead to improvement of the
organization’s overall performance. ISO 9004 includes guidance on a self-assessment methodology
for an organization to be able to evaluate the level of maturity of its quality management system.

The International Standards outlined below can provide assistance to organizations when they are
establishing or seeking to improve their quality management systems, their processes or their activities.

— ISO 10001 Quality management — Customer satisfaction — Guidelines for codes of conduct for
organizations provides guidance to an organization in determining that its customer satisfaction
provisions meet customer needs and expectations. Its use can enhance customer confidence in an
organization and improve customer understanding of what to expect from an organization, thereby
reducing the likelihood of misunderstandings and complaints.

— ISO 10002 Quality management — Customer satisfaction — Guidelines for complaints handling
in organizations provides guidance on the process of handling complaints by recognizing and
addressing the needs and expectations of complainants and resolving any complaints received.
ISO 10002 provides an open, effective and easy-to-use complaints process, including training of
people. It also provides guidance for small businesses.

— ISO 10003 Quality management — Customer satisfaction — Guidelines for dispute resolution external
to organizations provides guidance for effective and efficient external dispute resolution for

ISO 9001:2015(E)

product-related complaints. Dispute resolution gives an avenue of redress when organizations
do not remedy a complaint internally. Most complaints can be resolved successfully within the
organization, without adversarial procedures.

— ISO 10004 Quality management — Customer satisfaction — Guidelines for monitoring and measuring
provides guidelines for actions to enhance customer satisfaction and to determine opportunities for
improvement of products, processes and attributes that are valued by customers. Such actions can
strengthen customer loyalty and help retain customers.

— ISO 10005 Quality management systems — Guidelines for quality plans provides guidance on
establishing and using quality plans as a means of relating requirements of the process, product,
project or contract, to work methods and practices that support product realization. Benefits of
establishing a quality plan are increased confidence that requirements will be met, that processes
are in control and the motivation that this can give to those involved.

— ISO 10006 Quality management systems — Guidelines for quality management in projects is applicable
to projects from the small to large, from simple to complex, from an individual project to being part
of a portfolio of projects. ISO 10006 is to be used by personnel managing projects and who need to
ensure that their organization is applying the practices contained in the ISO quality management
system standards.

— ISO 10007 Quality management systems — Guidelines for configuration management is to assist
organizations applying configuration management for the technical and administrative direction
over the life cycle of a product. Configuration management can be used to meet the product
identification and traceability requirements specified in this International Standard.

— ISO 10008 Quality management — Customer satisfaction — Guidelines for business-to-consumer
electronic commerce transactions gives guidance on how organizations can implement an effective
and efficient business-to-consumer electronic commerce transaction (B2C ECT) system, and
thereby provide a basis for consumers to have increased confidence in B2C ECTs, enhance the ability
of organizations to satisfy consumers and help reduce complaints and disputes.

— ISO 10012 Measurement management systems — Requirements for measurement processes and
measuring equipment provides guidance for the management of measurement processes and
metrological confirmation of measuring equipment used to support and demonstrate compliance
with metrological requirements. ISO 10012 provides quality management criteria for a measurement
management system to ensure metrological requirements are met.

— ISO/TR 10013 Guidelines for quality management system documentation provides guidelines for
the development and maintenance of the documentation necessary for a quality management
system. ISO/TR 10013 can be used to document management systems other than those of the
ISO quality management system standards, e.g. environmental management systems and safety
management systems.

— ISO 10014 Quality management — Guidelines for realizing financial and economic benefits is addressed
to top management. It provides guidelines for realizing financial and economic benefits through the
application of quality management principles. It facilitates application of management principles
and selection of methods and tools that enable the sustainable success of an organization.

— ISO 10015 Quality management — Guidelines for training provides guidelines to assist organizations
in addressing issues related to training. ISO 10015 can be applied whenever guidance is required
to interpret references to “education” and “training” within the ISO quality management system
standards. Any reference to “training” includes all types of education and training.

— ISO/TR 10017 Guidance on statistical techniques for ISO 9001:2000 explains statistical techniques
which follow from the variability that can be observed in the behaviour and results of processes,
even under conditions of apparent stability. Statistical techniques allow better use of available data
to assist in decision making, and thereby help to continually improve the quality of products and
processes to achieve customer satisfaction.

26 © ISO 2015 – All rights reservedInternational Organization for Standardization
Provided by IHS under license with ISO

ISO 9001:2015(E)

— ISO 10018 Quality management — Guidelines on people involvement and competence provides
guidelines which influence people involvement and competence. A quality management system
depends on the involvement of competent people and the way that they are introduced and
integrated into the organization. It is critical to determine, develop and evaluate the knowledge,
skills, behaviour and work environment required.

— ISO 10019 Guidelines for the selection of quality management system consultants and use of their services
provides guidance for the selection of quality management system consultants and the use of their
services. It gives guidance on the process for evaluating the competence of a quality management
system consultant and provides confidence that the organization’s needs and expectations for the
consultant’s services will be met.

— ISO 19011 Guidelines for auditing management systems provides guidance on the management of an
audit programme, on the planning and conducting of an audit of a management system, as well as
on the competence and evaluation of an auditor and an audit team. ISO 19011 is intended to apply to
auditors, organizations implementing management systems, and organizations needing to conduct
audits of management systems.

Table B.1 — Relationship between other International Standards on quality management and
quality management systems and the clauses of this International Standard

Other Interna-
tional Standard

Clause in this International Standard
4 5 6 7 8 9 10

ISO 9000 All All All All All All All
ISO 9004 All All All All All All All
ISO 10001 8.2.2, 8.5.1 9.1.2
ISO 10002 8.2.1, 9.1.2 10.2.1
ISO 10003 9.1.2
ISO 10004 9.1.2, 9.1.3
ISO 10005 5.3 6.1, 6.2 All All 9.1 10.2
ISO 10006 All All All All All All All
ISO 10007 8.5.2
ISO 10008 All All All All All All All
ISO 10012 7.1.5
ISO/TR 10013 7.5
ISO 10014 All All All All All All All
ISO 10015 7.2
ISO/TR 10017 6.1 7.1.5 9.1
ISO 10018 All All All All All All All
ISO 10019 8.4
ISO 19011 9.2
NOTE “All” indicates that all the subclauses in the specific clause of this International Standard are related to the other
International Standard.

Licensee=ADNOC 9999103
Not for Resale, 2015/10/5 19:20:06
No reproduction or networking permitted without license from IHS
–`,,“,,,`,,`,,`,““““-`-“,“`,,,`—

ISO 9001:2015(E)

Bibliography

[1] ISO 9004, Managing for the sustained success of an organization — A quality management approach

[2] ISO 10001, Quality management — Customer satisfaction — Guidelines for codes of conduct for
organizations

[3] ISO 10002, Quality management — Customer satisfaction — Guidelines for complaints handling in
organizations

[4] ISO 10003, Quality management — Customer satisfaction — Guidelines for dispute resolution
external to organizations

[5] ISO 10004, Quality management — Customer satisfaction — Guidelines for monitoring and measuring

[6] ISO 10005, Quality management systems — Guidelines for quality plans

[7] ISO 10006, Quality management systems — Guidelines for quality management in projects

[8] ISO 10007, Quality management systems — Guidelines for configuration management

[9] ISO 10008, Quality management — Customer satisfaction — Guidelines for business-to-consumer
electronic commerce transactions

[10] ISO 10012, Measurement management systems — Requirements for measurement processes and
measuring equipment

[11] ISO/TR 10013, Guidelines for quality management system documentation

[12] ISO 10014, Quality management — Guidelines for realizing financial and economic benefits

[13] ISO 10015, Quality management — Guidelines for training

[14] ISO/TR 10017, Guidance on statistical techniques for ISO 9001:2000

[15] ISO 10018, Quality management — Guidelines on people involvement and competence

[16] ISO 10019, Guidelines for the selection of quality management system consultants and use of
their services

[17] ISO 14001, Environmental management systems — Requirements with guidance for use

[18] ISO 19011, Guidelines for auditing management systems

[19] ISO 31000, Risk management — Principles and guidelines

[20] ISO 37500, Guidance on outsourcing

[21] ISO/IEC 90003, Software engineering — Guidelines for the application of ISO 9001:2008 to
computer software

[22] IEC 60300-1, Dependability management — Part 1: Guidance for management and application

[23] IEC 61160, Design review

[24] Quality management principles, ISO1)

[25] Selection and use of the ISO 9000 family of standards, ISO1)

[26] ISO 9001 for Small Businesses — What to do, ISO1)

1) Available from website: http://www.iso.org.

28 © ISO 2015 – All rights reservedInternational Organization for Standardization
Provided by IHS under license with ISO

Licensee=ADNOC 9999103
Not for Resale, 2015/10/5 19:20:06
No reproduction or networking permitted without license from IHS
–`,,“,,,`,,`,,`,““““-`-“,“`,,,`—

http://www.iso.org

ISO 9001:2015(E)

[27] Integrated use of management system standards, ISO1)

[28] www.iso.org/tc176/sc02/public

[29] www.iso.org/tc176/ISO9001AuditingPracticesGroup

http://www.iso.org/tc176/sc02/public

http://isotc.iso.org/livelink/livelink?func=ll&objId=3541460&objAction=browse&sort=name

ISO 9001:2015(E)

ICS 03.120.10
Price based on 29 pages

1 Scope
2 Normative references
3 Terms and definitions
4 Context of the organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.4 Quality management system and its processes
5 Leadership
5.1 Leadership and commitment
5.1.1 General
5.1.2 Customer focus
5.2 Policy
5.2.1 Establishing the quality policy
5.2.2 Communicating the quality policy
5.3 Organizational roles, responsibilities and authorities
6 Planning
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
7 Support
7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the operation of processes
7.1.5 Monitoring and measuring resources
7.1.6 Organizational knowledge
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented information
8 Operation
8.1 Operational planning and control
8.2 Requirements for products and services
8.2.1 Customer communication
8.2.2 Determining the requirements for products and services
8.2.3 Review of the requirements for products and services
8.2.4 Changes to requirements for products and services
8.3 Design and development of products and services
8.3.1 General
8.3.2 Design and development planning
8.3.3 Design and development inputs
8.3.4 Design and development controls
8.3.5 Design and development outputs
8.3.6 Design and development changes
8.4 Control of externally provided processes, products and services
8.4.1 General
8.4.2 Type and extent of control
8.4.3 Information for external providers
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes
8.6 Release of products and services
8.7 Control of nonconforming outputs
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation
9.2 Internal audit
9.3 Management review
9.3.1 General
9.3.2 Management review inputs
9.3.3 Management review outputs
10 Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
Annex€A (informative) Clarification of new structure, terminology and concepts
Annex€B (informative) Other International Standards on quality management and quality management systems developed by ISO/TC 176

Bibliography

Designation: D 6792 – 07 An American National Standard

Standard Practice for
Quality System in Petroleum Products and Lubricants
Testing Laboratories

This standard is issued under the fixed designation D 6792; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.

Scope

1.1 This practice covers the establishment and maintenance
of the essentials of a quality system in laboratories engaged in
the analysis of petroleum products and lubricants. It is de-
signed to be used in conjunction with Practice D 6299.

NOTE 1—This practice is based on the quality management concepts
and principles advocated in ANSI/ISO/ASQ Q9000 standards, ISO/IEC
17025, ASQ Manual,2 and ASTM standards such as D 3244, D 4182,
D 4621, D 6299, D 6300, E 29, E 177, E 456, E 548, E 882, E 994,
E 1301, E 1323, STP 15D,3 and STP 1209.4

1.2 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
bility of regulatory requirements prior to use.

Referenced Documents

2.1 ASTM Standards: 5

D 3244 Practice for Utilization of Test Data to Determine
Conformance with Specifications

D 4182 Practice for Evaluation of Laboratories Using
ASTM Procedures in the Sampling and Analysis of Coal
and Coke

D 4621 Guide for Quality Management in an Organization
That Samples or Tests Coal and Coke

D 6299 Practice for Applying Statistical Quality Assurance
Techniques to Evaluate Analytical Measurement System
Performance

D 6300 Practice for Determination of Precision and Bias
Data for Use in Test Methods for Petroleum Products and
Lubricants

D 6617 Practice for Laboratory Bias Detection Using
Single Test Result from Standard Material

E 29 Practice for Using Significant Digits in Test Data to
Determine Conformance with Specifications

E 177 Practice for Use of the Terms Precision and Bias in
ASTM Test Methods

E 456

Terminology

Relating to Quality and Statistics
E 548 Guide for General Criteria Used for Evaluating

Laboratory Competence6

E 882 Guide for Accountability and Quality Control in the
Chemical Analysis Laboratory

E 994 Guide for Calibration and Testing Laboratory Ac-
creditation Systems General Requirements for Operation
and Recognition6

E 1301 Guide for Proficiency Testing by Interlaboratory
Comparisons

E 1323 Guide for Evaluating Laboratory Measurement
Practices and the Statistical Analysis of the Resulting Data

2.2 ISO Standards:7

ISO Guide 30 Terms and Definitions Used in Connection
with Reference Materials

ISO/IEC 17025 General Requirements for the Competence
of Testing and Calibration Laboratories

ISO 4259 Petroleum Products—Determination and Appli-
cation of Precision Data in Relation to Methods of Test

ANSI/ISO/ASQ Q9000 Quality Management System Stan-
dards

3. Terminology

3.1 Definitions:
3.1.1 accepted reference value, ARV, n—a value that serves

as an agreed upon reference for comparison, and which is
derived as: (1) a theoretical or established value, based on
scientific principles, (2) an assigned value, based on experi-
mental work of some national or international organization

1 This practice is under the jurisdiction of ASTM Committee D02 on Petroleum
Products and Lubricants and is the direct responsibility of Subcommittee D02.94 on
Coordinating Subcommittee on Quality Assurance and Statistics.

Current edition approved July 1, 2007. Published August 2007. Originally
approved in 2002. Last previous edition approved in 2006 as D 6792–06.

2 “Quality Assurance for The Chemical and Process Industries: A Manual of
Good Practices,” 1987, available from American Society for Quality (ASQ), 600 N.
Plankinton Ave., Milwaukee, WI 53203. www.asq.org.

3 ASTM STP 15D, ASTM Manual on Presentation of Data and Control Chart
Analysis, ASTM International, W. Conshohocken, PA.

4 ASTM STP 1209, ASTM Manual on Total Quality Management, ASTM
International, W. Conshohocken, PA.

5 For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.

6 Withdrawn.
7 Available from American National Standards Institute (ANSI), 25 W. 43rd St.,

4th Floor, New York, NY 10036, http://www.ansi.org.

*A Summary of Changes section appears at the end of this standard.

Not for ResaleNo reproduction or networking permitted without license from IHS

–
–
`
,
,
`
`
`
,
,
,
,
`
`
`
`
–
`
–
`
,
,
`
,
,
`
,
`
,
,
`
–
–
–

//^:^^#^~^^”~@
:^”^:*^@

$~”#:*~^^*:@
*^^^~::^~:^*#^^””$

“\\

such as the U.S. National Institute of Standards and Technol-
ogy (NIST), or (3) a consensus value, based on collaborative
experimental work under the auspices of a scientific or
engineering group. E 456

3.1.2 accuracy, n—the closeness of agreement between a
test result and an accepted reference value. E 456

3.1.3 audit, n—a systematic examination of a laboratory’s
quality system procedure and related activities by an internal or
external team to determine whether these procedures or activi-
ties are implemented according to the documented system.

3.1.4 bias, n—the difference between the population mean
of the test results and an accepted reference value. E 456

3.1.5 calibration standard, n—a material with a certified
value for a relevant property, issued by or traceable to a
national organization such as NIST, and whose properties are
known with sufficient accuracy to permit its use to evaluate the
same property of another sample.

3.1.6 certified reference material, CRM, n—a reference
material one or more of whose property values are certified by
a technically valid procedure, accompanied by a traceable
certificate or other documentation which is issued by a certi-
fying body. ISO Guide 30

3.1.7 measurand, n—the measurable quantity subject to
measurement.

3.1.8 outlier, n—a result far enough in magnitude from
other results so as to be considered not a part of the set.

D 6300
3.1.9 precision, n—the closeness of agreement between test

results obtained under prescribed conditions. E 456
3.1.10 proficiency testing, n—determination of a laborato-

ry’s testing capability by evaluating its test results in interlabo-
ratory exchange testing or crosscheck programs.

3.1.10.1 Discussion—One example is the ASTM D02 com-
mittee’s proficiency testing programs in a wide variety of
petroleum products and lubricants, many of which may involve
more than a hundred laboratories.

3.1.11 quality assurance (QA), n—a system of activities, the
purpose of which is to provide to the producer and user of a
product, measurement, or service the assurance that it meets
the defined standards of quality with a stated level of confi-
dence.

3.1.11.1 Discussion—Quality assurance includes quality
planning and quality control.

3.1.12 quality control (QC), n—a planned system of activi-
ties whose purpose is to provide a level of quality that meets
the needs of users; also the uses of such a system.

3.1.13 quality control sample (QC sample), n—for use in
quality assurance program to determine and monitor the
precision and stability of a measurement system; a stable and
homogenous material having physical or chemical properties,
or both, similar to those of typical samples tested by the
analytical measurement system. The material is properly stored
to ensure sample integrity, and is available in sufficient quantity
for repeated long-term testing. D 6299

3.1.14 reference material (RM), n—a material with ac-
cepted reference value(s), accompanied by an uncertainty at a
stated level of confidence for desired properties, which may be
used for calibration or quality control purposes in the labora-
tory.

3.1.14.1 Discussion—Sometimes these may be prepared
“in-house” provided the reference values are established using
accepted standard procedures.

3.1.15 repeatability, n—the quantitative expression of the
random error associated with a single operator in a given
laboratory obtaining repetitive results with the same apparatus
under constant operating conditions on identical test material.
It is defined as the difference between two such results at the
95 % confidence level. D 6300

3.1.16 reproducibility, n—a quantitative expression of the
random error associated with different operators using different
apparatus, and so forth, each obtaining a single result on an
identical test sample when applying the same method. It is then
defined as the 95 % confidence limit for the difference between
two such single and independent results. D 6300

3.1.17 site precision (R8), n—the value below which the
absolute difference between two individual test results obtained
under site precision conditions may be expected to occur with
a probability of approximately 0.95 (95 %). It is defined as 2.77
times the standard deviation of results obtained under site
precision conditions. D 6299

3.1.18 site precision conditions, n—conditions under which
test results are obtained by one or more operators in a single
site location practicing the same test method on a single
measurement system using test specimens taken at random
from the same sample of material over an extended period of
time spanning at least a 15 day interval. D 6299

3.1.19 traceability, n—property of the result of a measure-
ment or the value of a standard whereby it can be related to
stated references, usually national or international standards,
through an unbroken chain of comparisons all having stated
uncertainties.

3.2 Definitions of Terms Specific to This Standard:
3.2.1 precision ratio (PR), n—an estimate of relative mag-

nitude of repeatability and reproducibility. The PR for a given
standard test method can provide information on the relative
significance between variation caused by different operators
and laboratories compared to a single operator in a laboratory
performing the standard test method.

3.2.2 test performance index (TPI), n—an approximate
measure of a laboratory’s testing capability, defined as the ratio
of test method reproducibility to site precision.

3.3 Acronyms:
3.3.1 NIST—National Institute of Standards and Technol-

ogy (formerly called National Bureau of Standards), Gaithers-
burg, MD.

Significance and Use

4.1 A petroleum products and lubricants testing laboratory
plays a crucial role in product quality management and
customer satisfaction. It is essential for a laboratory to provide
quality data. This document provides guidance for establishing
and maintaining a quality system in a laboratory.

D 6792 – 07

2Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS
–
–
`
,
,
`
`
`
,
,
,
,
`
`
`
`
–
`
–
`
,
,
`
,
,
`
,
`
,
,
`
–
–
–
//^:^^#^~^^”~@
:^”^:*^@

$~”#:*~^^*:@
*^^^~::^~:^*#^^””$”\\

General Quality Requirements for the Laboratory

5.1 Establishment and maintenance of a quality system shall
include stated objectives in the following areas: a laboratory’s
adherence to test method requirements, calibration and main-
tenance practices, and its quality control program. Laboratory
quality objectives should encompass the laboratory’s continu-
ous improvement goals as well as meeting customer require-
ments.

5.2 Management shall appoint a representative to imple-
ment and maintain the quality system in the laboratory.

5.3 Laboratory management shall review the adequacy of
the quality system and the activities of the laboratory for
consistency with the stated quality objectives at least annually.

5.4 The quality system shall have documented processes
for:

5.4.1 Sample management (see Section 6),
5.4.2 Data and record management (see Section 7),
5.4.3 Producing accurate, reliable, and properly represented

test results (see Section 8),
5.4.4 Audits and proficiency testing (see Section 9),
5.4.5 Corrective and preventive action (see Section 11),
5.4.6 Ensuring that procured services and materials meet the

contracted requirements, and
5.4.7 Ensuring that personnel are adequately trained to

obtain quality results.

Sample Management

6.1 The elements of sample management shall include at a
minimum:

6.1.1 Procedures for unique identification of samples sub-
mitted to the laboratory.

6.1.2 Criteria for sample acceptance.
6.1.3 Procedures for sample handling.
6.1.4 Procedures for sample storage and retention. Items to

consider when creating these procedures include:
6.1.4.1 Applicable government—local, state, or national—

regulatory requirements for shelf life and time-dependent tests
that set product stability limits,

6.1.4.2 Type of sample containers required to preserve the
sample,

6.1.4.3 Control of access to the retained samples to protect
their validity and preserve their original integrity,

6.1.4.4 Storage conditions,
6.1.4.5 Required safety precautions, and
6.1.4.6 Customer requirements.
6.1.5 Procedures for sample disposal in accordance with

applicable government regulatory requirements.

NOTE 2—This may be handled through a separate chemical hygiene or
waste disposal plan.

Data and Record Management

7.1 Reports of Analysis:
7.1.1 The work carried out by a laboratory shall be covered

by a certificate or report that accurately and unambiguously
presents the test results and all other relevant information.

NOTE 3—This report may be an entry in a Laboratory Information
Management System (LIMS) or equivalent system.

7.1.2 The following items are suggested for inclusion in
laboratory reports:

7.1.2.1 Name and address of the testing laboratory,
7.1.2.2 Unique identification of the report (such as serial

number) on each page of the report,
7.1.2.3 Name and address of the customer,
7.1.2.4 Order number,
7.1.2.5 Description and identification of the test sample,
7.1.2.6 Date of receipt of the test sample and date(s) of

performance of test, as appropriate,
7.1.2.7 Identification of the test specification, method, and

procedure,
7.1.2.8 Description of the sampling procedure, where rel-

evant,
7.1.2.9 Any deviations, additions to or exclusions from the

specified test requirements, and any other information relevant
to a specific test,

7.1.2.10 Disclosure of any nonstandard test method or
procedure utilized,

7.1.2.11 Measurements, examinations, and derived results,
supported by tables, graphs, sketches, and photographs as
appropriate, and any failures identified,

7.1.2.12 Minimum-maximum product specifications, if ap-
plicable,

7.1.2.13 A statement of the measurement uncertainty (where
relevant or required by the customer),

7.1.2.14 Any other information which might be required by
the customer,

7.1.2.15 A signature and job title of person(s) accepting
technical responsibility for the test report and the date of issue,
and

7.1.2.16 A statement on the laboratory policy regarding the
reproduction of test reports.

7.1.3 Items actually included in laboratory reports should be
specified by laboratory management or agreements with cus-
tomers, or both.

7.1.4 Procedures for corrections or additions to a test report
after issue shall be established.

7.2 Reporting and Rounding the Data:
7.2.1 The reporting requirements specified in the test

method or procedure shall be used (unless specifically required
otherwise by the customer or applicable regulations).

7.2.2 If rounding is performed, the rounding protocol of
Practice E 29 should be used unless otherwise specified in the
method or procedure.

7.3 Records of Calibration and Maintenance:
7.3.1 Procedures shall be established for the management of

instrument calibration records. Such records usually indicate
the instrument calibrated, method or procedure used for cali-
bration, the dates of last and next calibrations, the person
performing the calibration, the values obtained during calibra-
tion, and the nature and traceability (if applicable) of the
calibration standards (that is, certified values). Records may be
electronic.

7.3.2 Procedures shall be established for the management of
instrument maintenance records. Such records usually indicate

D 6792 – 07

3Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS
–
–
`
,
,
`
`
`
,
,
,
,
`
`
`
`
–
`
–
`
,
,
`
,
,
`
,
`
,
,
`
–
–
–

//^:^^#^~^^”~@:^”^:*^@$~”#:*~^^*:@*^^^~::^~:^*#^^””$”\\

the instrument maintained, the dates of last and next mainte-
nance, and the person performing the maintenance. Records
may be electronic.

NOTE 4—For instruments that require calibration, calibration and main-
tenance records may be combined.

7.4 Quality Control (QC) Testing Records:
7.4.1 The laboratory shall have documented procedures for

creating and maintaining records for analysis of QC samples. It
is recommended that such records include the sample name and
source, the test(s) for which it is to be used, the assigned values
and their uncertainty where applicable, and values obtained
upon analysis. Additionally, it is recommended that the receipt
date or date put into active QC use in the laboratory be
documented, along with the expiration date (if applicable).

7.4.2 Procedures for retaining completed control charts
should be established. It is recommended that these records
include the date the control charts were changed and the reason
for the change.

7.5 Record Retention:
7.5.1 The record system should suit the laboratory’s particu-

lar circumstances and comply with any existing regulations and
customer specifications.

7.5.2 All data shall be maintained according to laboratory,
company, or regulatory agency requirements, or a combination
thereof.

7.5.3 Procedures for retaining records of all original obser-
vations, calculations and derived data, calibration records, and
final test reports for an appropriate period shall be established.
The records for each test should contain sufficient information
to permit satisfactory replication of the test and recalculation of
the results.

7.5.4 The records shall be held in a safe and secure storage.
A system shall exist that allows locating the required docu-
ments in a reasonable period of time.

8. Producing Accurate, Reliable, and Properly
Represented Test Results

8.1 The laboratory shall have documented test methods and
procedures for performing the required tests. These shall be
maintained up-to-date and be readily available to the laboratory
staff. The test methods that are stated in the product specifica-
tions or agreed upon with customers should be used for sample
analysis.

8.2 The laboratory shall have procedures for the approval,
documentation, and reporting of deviations from the test
method requirements or the use of alternative methods.

8.3 Procedures shall be established to ensure that measuring
and testing equipment is calibrated, maintained properly, and is
in statistical control. Items to consider when creating these
procedures include:

8.3.1 Records of calibration and maintenance (see 7.3),
8.3.2 Calibration and maintenance schedule,

NOTE 5—The calibration frequency may vary with the instrument type
and its frequency of use, some needing calibration before each set of
analyses, others requiring calibration at less frequent periods, or triggered
by a QC chart out-of-statistical-control situation.

8.3.3 Traceability to national or international standards,

NOTE 6—Where the concept of traceability to national or international
standards of measurement is not applicable, the testing laboratory shall
provide satisfactory evidence of test result accuracy (for example, by
participation in a program of interlaboratory comparisons).

8.3.4 Requirements of the test method or procedure,
8.3.5 Customer requirements, and
8.3.6 Corrective actions (see Section 11).
8.4 The performance of apparatus and equipment used in

the laboratory but not calibrated in that laboratory (that is,
pre-calibrated, vendor supplied) should be verified by using a
documented, technically valid procedure at periodic intervals.

8.5 Calibration standards shall be appropriate for the
method and characterized with the accuracy demanded by the
analysis to be performed. Quantitative calibration standards
should be prepared from constituents of known purity. Use the
primary calibration standards or CRMs specified or allowed in
the test method.

8.5.1 Where appropriate, values for reference materials
should be produced following the certification protocol used by
NIST8,9,10 or other standards issuing bodies, and, should be
traceable to national or international standard reference mate-
rials, if required or appropriate.

8.5.2 The materials analyzed in proficiency testing pro-
grams meeting the requirements of Practice D 6300 or
ISO 4259 may be used as reference materials, provided no
obvious bias or unusual frequency distribution of results are
observed. The consensus value is most likely the value closest
to the true value of this material; however, the uncertainty
attached to this mean value will be dependent on the precision
and the total number of the participating laboratories.

8.6 The laboratory shall establish procedures for the storage
of reference materials in a manner to ensure their safety,
integrity, and protection from contamination (see 6.1.4).

8.7 Records of instrument calibration shall be maintained
(see Section 7).

8.8 If an instrument is found to be out of calibration, and the
situation cannot be immediately addressed, then the instrument
shall be taken out of operation and tagged as such until the
situation is corrected (see Section 11).

8.9 Quality Control Practices:
8.9.1 Use appropriate quality control charts or other quality

control practices (for example, like those described in Practice
D 6299) for each test method performed by the laboratory
unless specifically excluded. Document cases where quality
control practices are not employed and include the rationale.

8.9.2 This practice advocates the regular testing of quality
control samples with timely interpretation of test results. This
practice also advocates using appropriate control charting
techniques to ascertain the in-statistical-control status of test
methods in terms of precision, bias (if a standard is being
used), and method stability over time. For details concerning
QC sample requirements and control charting techniques, refer
to Practice D 6299. The generally accepted practices are
outlined in 8.9.3 through 8.12.4.

8 Cali, J. P., Anal. Chem., 48, 802A, 1976.
9 Uriano, G. A., and Gravatt, C. C., CRC Crit. Revs, in Anal. Chem., 6, 361, 1977.
10 Alvarez, R., Rasberry, S. D., and Uriano, G. A., Anal. Chem., 54, 1226A, 1982.

D 6792 – 07

4Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS

–`,,“`,,,,““-`-`,,`,,`,`,,`—

//^:^^#^~^^”~@:^”^:*^@$~”#:*~^^*:@*^^^~::^~:^*#^^””$”\\

8.9.3 Test QC samples on a regular schedule. Principal
factors to be considered for determining the frequency of
testing include: (1) frequency of use of the analytical measure-
ment system, (2) criticality of the parameter being measured
and business economics, (3) established system stability and
precision performance based on historical data, (4) regulatory
requirements, (5) contractual provisions, and (6) test method
requirements.

8.9.3.1 If site precision for a specific test has not been
established as defined by Practice D 6299, then the recom-
mended frequency for analysis of QC samples is one QC out of
every ten samples analyzed. Alternatively, one QC sample is
analyzed each day that samples are analyzed, whichever is
more frequent.

8.9.3.2 Once the site precision has been established as
defined by Practice D 6299, and to ensure similar quality of
data is achieved with the documented method, the minimal QC
frequency may be adjusted based on the Test Performance
Index (TPI) and the Precision Ratio (PR).

(1) For standard test methods with PR (as defined in 10.2)
less than 4 and a TPI (as defined in 10.1) less than 0.8, consult
10.3 and the Standard Test Method for appropriate corrective
action.

(2) For standard test methods with PR (as defined in 10.2)
greater than or equal to 4 and a TPI (as defined in 10.1) less
than 1.6, consult 10.3 and the Standard Test Method for
appropriate corrective action.

8.9.3.3 Table 1 provides recommended minimal QC fre-
quencies as a function of PR and TPI. For those tests, which are
performed infrequently, for example less than 25 samples are
analyzed monthly, it is recommended that at least one QC
sample be analyzed each time samples are analyzed.

8.9.3.4 In many situations, the minimal QC frequency as
recommended by Table 1 may not be sufficient to ensure
adequate statistical quality control, considering, for example,
the significance of use of the results. Hence, it is recommended
that the flowchart in Fig. 1 be followed to determine if a higher
QC frequency should be used.

8.9.3.5 The TPI should be recalculated and reviewed at least
annually. Adjustments to QC frequency should be made based
on the recalculated TPI by following sections 8.9.3.2 and
8.9.3.4.

8.9.4 QC testing frequency, QC samples, and their test
values shall be recorded.

8.9.5 All persons who routinely operate the system shall
participate in generating QC test data. QC samples should be
treated as regular samples.

NOTE 7—Avoid special treatment of QC samples designed to “get a
better result.” Special treatment seriously undermines the integrity of
precision and bias estimates.

8.9.6 The laboratory may establish random or blind testing,
or both, of QC or other known materials.

8.10 Quality Control Sample and Test Data Evaluation:
8.10.1 QC samples should be stable and homogeneous

materials having physical or chemical properties, or both,
representative of the actual samples being analyzed by the test
method. This material shall be well-characterized for the
analyses of interest, available in sufficient quantities, have
concentration values that are within the calibration range of the
test method, and reflect the most common values tested by the
laboratory. For QC testing that is strictly for monitoring the test
method stability and precision, the QC sample expected value
is the control chart centerline, established using data obtained
under site precision conditions. For regular QC testing that is
intended to assess test method bias, RMs, or CRMs with
independently assigned ARVs should be used. The results
should be assessed in accordance with Practice D 6299 require-
ments for check standard testing. For infrequent QC testing for
bias assessment, refer to Practice D 6617.

NOTE 8—It is not advisable to use the same sample for both a calibrant
and a QC sample. It is not advisable to use the same chemical lot number
for both a calibrant and a QC sample.

8.10.2 If the QC material is observed to be degrading or
changing in physical or chemical characteristics, this shall be
immediately investigated and, if necessary, a replacement QC
material shall be prepared for use.

NOTE 9—In a customer-supplier quality dispute, it may be beneficial to
provide the customer with the laboratory’s test results on QC material to
demonstrate testing proficiency. Practice D 3244 may be useful.

8.11 Quality Control Charts:
8.11.1 QC sample test data should be promptly plotted on a

control chart and evaluated to determine if the results obtained
are within the method specifications and laboratory-established
control limits. The charts used should be appropriate for the
testing conditions and statistical objectives. Corrective action
should be taken and documented for any analyses that are
out-of-control (see Section 11).

NOTE 10—Charts such as individual, moving average and moving
range, exponentially weighted moving average, or cumulative summation
charts may be used as appropriate. Refer to Practice D 6299 for guidance
on plotting these charts.

8.11.1.1 The charts should indicate the test method, date
when the QC analyses were performed, and who performed
them. Test samples should not be analyzed or results for
samples should not be reported until the corresponding QC
data are assessed and the testing process is verified to be in
statistical control. (See 8.9.)

8.11.2 Adequate training should be given to the analysts to
enable them to generate and interpret the charts.

8.11.3 It is suggested that the charts be displayed promi-
nently near the analysis workstation, so that all can view and,
if necessary, help in improving the analyses.

8.11.4 Supervisory and technical personnel should periodi-
cally review the QC charts.

TABLE 1

Minimal QC Frequency as a Function of
Test Performance Index

TPI for
Standard

Test Methods

with PR<4

TPI for
Standard

Test Methods

with PR$4

Nominal QC Frequency
(1 QC out of every

X Samples)
Values of X

Approximate
Percentage

of QC Samples/
Total Analyses

Not determined Not determined 10 9
<0.8 <1.6 10 9

0.8–1.2 1.6–2.4 20 5
1.2–2.0 2.4–4.0 35 3

>2.0 >4.0 40 2

D 6792 – 07

5Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS
–
–
`
,
,
`
`
`
,
,
,
,
`
`
`
`
–
`
–
`
,
,
`
,
,
`
,
`
,
,
`
–
–
–
//^:^^#^~^^”~@
:^”^:*^@
$~”#:*~^^*:@
*^^^~::^~:^*#^^””$”\\

FIG. 1

Flowchart for QC Frequency

D 6792 – 07

6Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS
–
–
`
,
,
`
`
`
,
,
,
,
`
`
`
`
–
`
–
`
,
,
`
,
,
`
,
`
,
,
`
–
–
–
//^:^^#^~^^”~@:^”^:*^@$~”#:*~^^*:@*^^^~::^~:^*#^^””$”\\

8.11.5 The laboratory should establish written procedures
outlining the appropriate interpretation of QC charts and
responses to out-of-statistical-control situations observed.

8.11.5.1 When an out-of-statistical-control situation has
been identified, remedial action should be taken before analyz-
ing further samples. In all such cases, run the QC sample and
ensure that a satisfactory result can be obtained before analyz-
ing unknown samples.

NOTE 11—A generic checklist for investigating the root cause of
unsatisfactory analytical performance is given in Appendix X1.

8.11.6 Out-of-control situations may be detected by one or
more analyses. In these cases, it may be necessary to retest
samples analyzed during the period between the last in-control
QC data point and the QC data point that triggered the
out-of-statistical-control notice (or event) using retained
samples and equipment known to be in control. If the new
analysis shows a difference that is statistically different from
the original results, and the difference exceeds the established
site precision of that test, the laboratory should decide on what
further actions are necessary (see Section 11).

8.12 Revision of Control Charts—QC chart revision is
covered in detail in Practice D 6299. Control charts shall be
revised only when the existing limits are no longer appropriate.
As a guideline, revisions may be needed when:

8.12.1 Additional information becomes available,
8.12.2 The process has improved,
8.12.3 A new QC material is initiated and the mean value is

different than the previous QC material, or
8.12.4 There are major changes to the test procedure.

Audits and Proficiency Testing

9.1 Audits:
9.1.1 A laboratory shall have a system to periodically

review its own practices to confirm continued conformance to
the laboratory’s documented quality system. Even if the
laboratory is subjected to a formal external audit (for example,
as a requirement of ANSI/ISO/ASQ Q9000), it is important to
have internal audits since the internal reviewers may be more
familiar with their laboratory’s requirements than the external
auditors.

9.1.2 Audits of test methods should be conducted to confirm
adherence to the documented test methods. The performance of
the entire test should be observed and checked against the
official specified test method. An annual audit of test methods
is recommended.

NOTE 12—These audits may be part of the quality system audits or may
be separate.

9.1.3 Audit results shall be promptly documented. The team
shall report the audit results to management having the
authority and responsibility to take corrective action and to its
management.

9.1.4 The findings and recommendations of these internal
audits shall be reviewed by the laboratory management and
acted upon to correct the deficiencies or nonconformances.

9.1.5 The effectiveness of any corrective actions taken in
response to an audit shall be verified. The follow-up results
shall be documented as required by the quality system proce-
dures or laboratory policy, or both.

9.2 Proficiency Testing:
9.2.1 Regular participation in interlaboratory proficiency

testing programs, where appropriate samples are tested by
multiple test facilities using a specified test protocol, shall be
integrated into the laboratory’s quality control program. Pro-
ficiency test programs should be used as appropriate by the
laboratory to demonstrate testing proficiency relative to other
industry laboratories.

NOTE 13—Document the rationale for not participating in a proficiency
test program.

9.2.2 The laboratory shall establish criteria for guiding their
participation in interlaboratory testing programs. Such criteria
may include factors such as the frequency of use of the target
test method, the critical nature of how the customer uses the
data, and regulatory considerations. Participation in proficiency
test programs can provide a cost-effective alternative to regular
CRM testing.

9.2.3 Participants may plot their deviations from the con-
sensus values established by the proficiency test program
averages on a control chart to ascertain if their measurement
processes are non-biased. The precision of these exchange
performance data can also be assessed against precision
established by in-house QC sample testing for consistency (see
Practice D 6299 for details).

9.2.4 Participation in proficiency testing shall not be con-
sidered as a substitute for in-house quality control, as described
in 8.9, and vice versa.

10.

Test Method Precision Performance Assessment

10.1 The test performance index (TPI) can be used to
compare the precision of the laboratory measurements with the
published reproducibility of a standard test method. The term
TPI is defined as:

test performance index 5
test method reproducibility

site precision (1)

NOTE 14—The ASTM International Committee D02 sponsored Inter-
laboratory Crosscheck Program employs a test performance index based
on the ratio of the published ASTM reproducibility to the Robust
Reproducibility calculated from the program data. This index is termed the
TPI (Industry) to distinguish from the definition in 10.1.

10.2 A precision ratio (PR) is determined for a given
published test method so that the appropriate action criteria
may be applied for a laboratory’s TPI. The PR for a published
test method estimates the influence that non-site specific
variations has on the published precision. The PR can be
calculated by dividing the test method’s Reproducibility by the
repeatability as shown in Eq 2.

Precision Ratio, PR 5
Test Method reproducibility ~R!

Test Method repeatability ~r! (2)

where the ratio of R/r is calculated to the nearest integer (that
is, 1, 2, 3, 4, …).

10.2.1 A test method with PR greater than or equal to 4, for
the purpose of this practice, is deemed to exhibit a significant
difference between repeatability and reproducibility. For fur-
ther explanation on why the greater than or equal to 4 criterion
was chosen, please see Appendix X3.

D 6792 – 07

7Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS
–
–
`
,
,
`
`
`
,
,
,
,
`
`
`
`
–
`
–
`
,
,
`
,
,
`
,
`
,
,
`
–
–
–
//^:^^#^~^^”~@:^”^:*^@$~”#:*~^^*:@*^^^~::^~:^*#^^””$”\\

10.3 A laboratory’s TPI may be a function of the sample
type being analyzed and variations associated with that labo-
ratory. As general guidelines Table 2 may be used once the TPI
of that laboratory and the PR of the published standard test
method has been calculated. Similar information to that pro-
vided in Table 2 is provided in 10.3.1 through 10.3.2.3.

10.3.1 For a published standard test method with a PR less
than 4 the following TPI criteria should be applied.

10.3.1.1 A TPI greater than 1.2 indicates that the perfor-
mance is probably satisfactory relative to ASTM published
precision.

10.3.1.2 A TPI greater than or equal to 0.8 and less than or
equal to 1.2 indicated performance may be marginal and the
laboratory should consider method review for improvement.

10.3.1.3 A TPI less than 0.8 suggests that the method as
practiced at this site is not consistent with the ASTM published
precision. Either laboratory method performance improvement
is required, or ASTM published precision does not reflect
achievable precision. Existing interlaboratory exchange perfor-
mance (if available) should be reviewed to determine if the
latter is plausible.

10.3.2 For a published standard test method with a PR
greater than or equal to 4 the following TPI criteria should be
applied.

10.3.2.1 A TPI greater than 2.4 indicates that the perfor-
mance is probably satisfactory relative to ASTM published
precision.

10.3.2.2 A TPI greater than or equal to 1.6 and less than or
equal to 2.4 indicated performance may be marginal and the
laboratory should consider method review for improvement.

10.3.2.3 A TPI less than 1.6 suggests that the method as
practiced at this site is not consistent with the ASTM published
precision. Either laboratory method performance improvement
is required, or ASTM published precision does not reflect
precision achievable. Existing interlaboratory exchange perfor-
mance (if available) should be reviewed to determine if the
latter is plausible.

10.3.3 A laboratory may choose to set other benchmarks for
TPI, keeping in mind that site precision of an adequately
performing laboratory cannot, in the long run, exceed the
practically achievable reproducibility of the method when PR
is less than 4 or approaches repeatability when PR is much
greater than 4.

NOTE 15—Experience has shown, for some methods, published repro-
ducibility is not in good agreement with the precision achieved by
participants in well-managed crosscheck programs. Users should consider
this fact when evaluating laboratory performance using TPI.

10.4 A laboratory should review their precision obtained for
multiple analyses on the same sample. The site precision of the
QC samples can be compared with the reproducibility or
repeatability given in the standard test methods to indicate how
well a laboratory is performing against the industry standards.

10.5 A laboratory precision significantly worse than the
published test method reproducibility may indicate poor per-
formance. An investigation should be launched to determine
the root cause for this performance so that corrective action can
be undertaken if necessary. Such a periodic review is a key
feature of a laboratory’s continuous improvement program.

11.

Corrective and Preventive Action

11.1 The need for corrective and preventive action may be
indicated by one or more of the following unacceptable
situations:

11.1.1 Equipment out of calibration,
11.1.2 QC or check sample result out of control,
11.1.3 Test method performance by the laboratory does not

meet performance criteria (for example, precision, bias, and the
like) documented in the test method,

11.1.4 Product, material, or process out of specification
data,

11.1.5 Outlier or unacceptable trend in an interlaboratory
cross-check program,

11.1.6 Nonconformance identified in an external or internal
audit,

11.1.7 Nonconformance identified during review of labora-
tory data or records,

11.1.8 Customer complaint.
11.2 When any of these situations occur, the root cause

should be investigated and identified. Procedures for investi-
gating root cause should be established. Items to consider when
creating these procedures include:

11.2.1 Determining when the test of equipment was last
known to be in control,

11.2.2 Identifying results that may have been adversely
affected,

TABLE 2

Guidelines for Action Based on TPI

TPI for Standard
Test Methods

with PR<4 TPI for Standard Test Methods with PR$4

Recommended Quality
Improvement Action

>1.2 >2.4 Indicates that the performance is probably satisfactory relative to
ASTM published precision.

>0.8 and <1.2 >1.6 and <2.4 Indicates that the performance is probably satisfactory relative to ASTM published precision, however a method review could be necessary to improve its performance.

<0.8 <1.6 This condition suggests that the method as practiced at this site is not consistent with the ASTM published precision. Either laboratory method performance improvement is required, or the ASTM published precision does not reflect precision achievable. Existing interlaboratory exchange performance (if available) should be reviewed to determine if the latter is plausible.

D 6792 – 07

8Copyright ASTM International
Provided by IHS under license with ASTM

11.2.3 How to handle affected results already reported to a
customer,

11.2.4 What to do if the root cause cannot be determined,
and

11.2.5 What to do if it is determined that the original data is
correct.

11.2.6 It is possible that the analytical results are correct,
even if they don’t meet specifications. Procedures should
consider this possibility. See Appendix X1 for a checklist for
investigating the root cause of unsatisfactory analytical perfor-
mance.

11.3 Procedures should also be established for the identi-
fication and implementation of appropriate corrective and
preventive action so that the situation does not reoccur. This
may involve:

11.3.1

Training

or retraining personnel,
11.3.2 Reviewing customer specifications,
11.3.3 Reviewing test methods and procedures,
11.3.4 Establishing new or revised procedures,
11.3.5 Instrument maintenance and repair,
11.3.6 Re-preparation of reagents and standards,
11.3.7 Recalibration of equipment,
11.3.8 Re-analysis of samples, and
11.3.9 Additional QC sample analysis.
11.3.10 The situation, root cause, and corrective/preventive

action taken should be documented promptly. A corrective and
preventive action report is a suitable format for documentation.

11.3.11 The report should be reviewed and approved by
management and then verified for effectiveness of corrective/
preventive action.

11.4 Quality control charts (see 8.11) are a method of
preventive action and should be evaluated on a regular basis to
prevent, when possible, out-of-statistical-control situations.

12.

Customer Complaints

12.1 A procedure shall exist to follow-up on customer
complaints or non-conformances brought to the laboratory’s
attention by a client. The result of such investigation should be
communicated to the customer as soon as practical.

13. Training

13.1 Laboratory management shall ensure that all staff
performing testing or interpreting data, or both, are appropri-
ately trained.

13.2 Laboratory training should cover at a minimum the
following areas: safety, test methods, and company policies

and procedures. Training is specifically required as specified
in: 5.4.7, 8.11.2, 11.3, and X1.1.12.

13.3 Records of training should be maintained.

14.

Relationship with Other Quality Standards

14.1 Some laboratories in the petrochemicals testing area
have been registered to ISO/IEC 17025. There are a number of
similarities between the ISO standard and this practice in key
areas of managing laboratory quality. For example:

Requirement ISO/IEC
17025

ASTM
Practice D 6792

Quality System 4.2 5.1
Document Control 4.3 8.1; 8.2
Contract Review 4.4 5.4.6

Complaints 4.8 12.1
Corrective Action 4.10 11; Appendix

X1
Preventive Action 4.11 11.4

Control of Records 4.12 7.3.1; 7.4; 7.5
Internal Audits 4.13 9.1

Management Reviews 4.14 5.3
Personnel 5.2 5.4.7, 13.1,

13.2
Calibration 5.6.2.1 8.3–8.8

Sample Handling 5.8 6.1
Quality Control Procedures 5.9 8.9

Use of Quality Control Materi-
als

5.9.a 8.10

Proficiency Testing 5.9.b 9.2
Data Reports 5.10 7.1

14.2 Measurement Uncertainty—For test methods under the
jurisdiction of Committee D02, measurement uncertainty as
required in ISO/IEC 17025, as practiced by a laboratory, can be
estimated by multiplying 23 the site precision standard devia-
tion as defined in Practice D 6299.

NOTE 16—The complexity and empirical nature of the majority of D02
methods preclude the application of rigorous measurement uncertainty
algorithms. In many cases, interactions between the test method variables
and the measurand cannot be reasonably estimated due to the covariance
of the variables that affect the measurand. The site precision approach
estimates the combined effects of these variables on the total uncertainty
for the measurand.

NOTE 17—The methodology of using site precision established using
QC materials and control charts to estimate measurement uncertainty
assumes that the laboratory is unbiased. This assumption should be
validated periodically using check standards. See Practice D 6617 or
Practice D 6299 for further guidance.

15.

Keywords

15.1 audit; calibration; control charts; proficiency testing;
quality assurance; quality control; test performance index

D 6792 – 07

9Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS
–`,,“`,,,,““-`-`,,`,,`,`,,`—
//^:^^#^~^^”~@:^”^:*^@$~”#:*~^^*:@*^^^~::^~:^*#^^””$”\\

APPENDIXES

(Nonmandatory Information)

X1. CHECKLIST FOR INVESTIGATING THE ROOT CAUSE OF UNSATISFACTORY ANALYTICAL PERFORMANCE

X1.1

To identify why a laboratory’s data may have been
considered a statistical outlier or to improve the precision, or
both, the following action items (not necessarily in the order of
preference) are suggested. There may be additional ways to
improve the performance.

X1.1.1 Check the results for typos, calculation errors, and
transcription errors.

X1.1.2 Reanalyze the sample; compare to site precision, or,
if not available, test method repeatability.

X1.1.3 Check the sample for homogeneity or contamina-
tion, and that a representative sample has been analyzed.

X1.1.4 Review the test method and ensure that the latest
version of the ASTM test method is being used. Check the
procedure step-by-step with the analyst.

X1.1.5 Check the instrument calibration.

X1.1.6 Check the statistical quality control chart to see if the
problem has been developing earlier.

X1.1.7 Check the quality of the reagents and standards used,
and whether they are expired or contaminated.

X1.1.8 Check the equipment for proper operation against
the vendor’s operating manual.

X1.1.9 Perform maintenance or repairs, or both, on the
equipment following guidelines established by the vendor.

X1.1.10 After the problem has been resolved, analyze a
certified reference material if one is available, or the laboratory
quality control sample, to ascertain that the analytical operation
is under control.

X1.1.11 Provide training to new analysts and, if necessary,
refresher training to experienced analysts.

X1.1.12 Document the incident and the learnings for use in
the future if a similar problem occurs.

X2. SELF-ASSESSMENT CHECKLIST TO EVALUATE COMPLIANCE WITH PRACTICE D 6792

X2.1

See the checklist in Fig. X2.1.

D 6792 – 07

10Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS
–
–
`
,
,
`
`
`
,
,
,
,
`
`
`
`
–
`
–
`
,
,
`
,
,
`
,
`
,
,
`
–
–
–
//^:^^#^~^^”~@:^”^:*^@$~”#:*~^^*:@*^^^~::^~:^*#^^””$”\\

FIG. X2.1

Self-Assessment Checklist to Evaluate Compliance with Practice D 6792

D 6792 – 07

11Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS
–
–
`
,
,
`
`
`
,
,
,
,
`
`
`
`
–
`
–
`
,
,
`
,
,
`
,
`
,
,
`
–
–
–

//^
:^

^#
^~

^^
“~

@
:^

“^
:*

^@
$~

“#
:*

~^
^*

:@
*^

^^
~:

:^
~:

^*
#^

^”
“$

“\\

FIG. X2.1 Self-Assessment Checklist to Evaluate Compliance with Practice D 6792 (continued)

D 6792 – 07

12Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS
–`,,“`,,,,““-`-`,,`,,`,`,,`—
//^:^^#^~^^”~@
:^”^:*^@
$~”#:*~^^*:@
*^^^~::^~:^*#^^””$”\\

FIG. X2.1 Self-Assessment Checklist to Evaluate Compliance with Practice D 6792 (continued)
D 6792 – 07

13Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS
–`,,“`,,,,““-`-`,,`,,`,`,,`—
//^
:^
^#
^~
^^
“~
@
:^
“^
:*
^@
$~
“#
:*
~^
^*
:@
*^
^^
~:
:^
~:
^*
#^
^”
“$
“\\

FIG. X2.1 Self-Assessment Checklist to Evaluate Compliance with Practice D 6792 (continued)
D 6792 – 07

14Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS
–
–
`
,
,
`
`
`
,
,
,
,
`
`
`
`
–
`
–
`
,
,
`
,
,
`
,
`
,
,
`
–
–
–
//^:^^#^~^^”~@:^”^:*^@$~”#:*~^^*:@*^^^~::^~:^*#^^””$”\\

FIG. X2.1 Self-Assessment Checklist to Evaluate Compliance with Practice D 6792 (continued)
D 6792 – 07

15Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS
–
–
`
,
,
`
`
`
,
,
,
,
`
`
`
`
–
`
–
`
,
,
`
,
,
`
,
`
,
,
`
–
–
–
//^
:^
^#
^~
^^
“~
@
:^
“^
:*
^@
$~
“#
:*
~^
^*
:@
*^
^^
~:
:^
~:
^*
#^
^”
“$
“\\

FIG. X2.1 Self-Assessment Checklist to Evaluate Compliance with Practice D 6792 (continued)
D 6792 – 07

16Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS
–`,,“`,,,,““-`-`,,`,,`,`,,`—
//^:^^#^~^^”~@:^”^:*^@$~”#:*~^^*:@*^^^~::^~:^*#^^””$”\\

FIG. X2.1 Self-Assessment Checklist to Evaluate Compliance with Practice D 6792 (continued)
D 6792 – 07

17Copyright ASTM International
Provided by IHS under license with ASTM

X3. COMPARISON OF REPEATABILITY, REPRODUCIBILITY, PRECISION RATIO AND VARIANCE RATIO TEST OF
VARIOUS ROUND ROBINS

X3.1

Practice D 6300, subsection A1.7 on Variance Ratio
Test (F-Test), provides a detailed discussion of how to deter-
mine when significant bias exists for two data sets using the
variance ratio. Both the variance ratio, F value and precision
ratio, PR were calculated for 38 round robin data sets.
Generally, the correlation between F and R/r is not statistically
significant to suggest that PR could be used to accurately
predict the existence of laboratory-laboratory bias for a given
test method. However, this practice is not intended as a detailed
statistical analysis of bias between laboratories, rather, the
purpose of this practice is to provide some general guidelines
for assessing the performance on a laboratory.

X3.2

Generally, for a typical ASTM test method (for
example, a typical number of laboratories, six or more, and a
typical number of samples studied, ten or more) a F value of 5
or greater exceeds the 5 % critical value given in Practice
D 6300, Table A1.6 on critical 5 % values of F, suggesting a
bias exists between the laboratories. In addition, when the PR
value is equal to or greater than 4, the F value is greater than
5. This suggests that some laboratory bias may exist in the test
method’s reproducibility statement. This observation was the
rationale for selecting equal to or greater than 4 as the criterion
for switching to more severe performance assessment criteria.

X3.3

The relationship of repeatability, Reproducibility and
Site Precision as it relates to performance assessment criteria of
a test method with PR<4 for a laboratory is represented in Fig. X3.1. This figure illustrates that a laboratory may have a site precision less than Reproducibility and is similar in magnitude to the published method’s repeatability.

X3.4

In Fig. X3.2, there is a similar relationship of
repeatability, Reproducibility and Site Precision for a test
method with PR>4 as shown in Fig. X3.1. However, the
illustration shown in Fig. X3.2 has performance assessment
criteria for when PR<4 and PR>4 applied to demonstrate the
difference between these two criteria.

X3.4.1 Reviewing Fig. X3.2, a laboratory may have a site
precision similar to the test method’s reproducibility, that is
significantly greater than the published methods repeatability,
but based on the PR<4 performance assessment criteria, is still considered to be generating acceptable results. Using the PR>4
performance criterion forces acceptable site precision to be
more evenly distributed between repeatability and reproduc-
ibility so that a more thorough review of the lab performance
may be assessed.

FIG. X3.1

Comparison of Reproducibility, Repeatability and TPI Guideliens for Action for a Test Method with PR<4

D 6792 – 07

18Copyright ASTM International
Provided by IHS under license with ASTM

SUMMARY OF CHANGES

Subcommittee D02.94 has identified the location of selected changes to this standard since the last issue
(D 6792–06) that may impact the use of this standard. (Approved July 1, 2007.)

(1) Changed type of standard from Guide to Practice through-
out.
(2) Revised 6.1.1, 7.1.2.13, 7.2.1, 8.6, 8.11.5, and 11.1.3.

(3) Added 8.9.1, 9.2.1, 9.2.2, Section 12, Section 13, and Note
13 and Note 14.

Subcommittee D02.94 has identified the location of selected changes to this standard since the last issue
(D 6792–05) that may impact the use of this standard. (Approved May 1, 2006.)

(1) Added 3.2.1.
(2) Revised throughout 8.9.
(3) Revised Table 1.
(4) Revised throughout 10.2.

(5) Added 10.3.1.
(6) Added Table 2.
(7) Revised Fig. 1.
(8) Added Appendix X3.

ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentioned
in this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the risk
of infringement of such rights, are entirely their own responsibility.

This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years and
if not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standards
and should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of the
responsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you should
make your views known to the ASTM Committee on Standards, at the address shown below.

FIG. X3.2

Comparison of Reproducibility, Repeatability and TPI PR<4 and PR$4 Guidelines for Action for a Test Method with PR$4

D 6792 – 07

19Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS
–`,,“`,,,,““-`-`,,`,,`,`,,`—
//^:^^#^~^^”~@:^”^:*^@$~”#:*~^^*:@*^^^~::^~:^*#^^””$”\\

Producing Accurate, Reliable, and Properly Represented Test Results

TABLE 1
FIG. 1
Audits and Proficiency Testing
Test Method Precision Performance Assessment
Corrective and Preventive Action
TABLE 2
Customer Complaints
Training
Relationship with Other Quality Standards
Keywords
X1. CHECKLIST FOR INVESTIGATING THE ROOT CAUSE OF UNSATISFACTORY ANALYTICAL PERFORMANCE
X1.1
X2. SELF-ASSESSMENT CHECKLIST TO EVALUATE COMPLIANCE WITH PRACTICE D 6792
X2.1
FIG. X2.1
FIG. X2.1
FIG. X2.1
FIG. X2.1
FIG. X2.1
FIG. X2.1
FIG. X2.1

X3. COMPARISON OF REPEATABILITY, REPRODUCIBILITY, PRECISION RATIO AND VARIANCE RATIO TEST OF VARIOUS ROUND ROBINS

X3.1
X3.2
X3.3
X3.4
FIG. X3.1
FIG. X3.2

How to Create SQC Chart

Designation: D6299 − 13 An American National Standard

Standard Practice for
Applying Statistical Quality Assurance and Control Charting
Techniques to Evaluate Analytical Measurement System
Performance1

This standard is issued under the fixed designation D6299; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.

1. Scope*

1.1 This practice covers information for the design and
operation of a program to monitor and control ongoing stability
and precision and bias performance of selected analytical
measurement systems using a collection of generally accepted
statistical quality control (SQC) procedures and tools.

NOTE 1—A complete list of criteria for selecting measurement systems
to which this practice should be applied and for determining the frequency
at which it should be applied is beyond the scope of this practice.
However, some factors to be considered include (1) frequency of use of
the analytical measurement system, (2) criticality of the parameter being
measured, (3) system stability and precision performance based o

historical data, (4) business economics, and (5) regulatory, contractual, or
test method requirements.

1.2 This practice is applicable to stable analytical measure-
ment systems that produce results on a continuous numerical
scale.

1.3 This practice is applicable to laboratory test methods.

1.4 This practice is applicable to validated process stream
analyzers.

1.5 This practice is applicable to monitoring the differences
between two analytical measurement systems that purport to
measure the same property provided that both systems have
been assessed in accordance with the statistical methodology in
Practice D6708 and the appropriate bias applied.

NOTE 2—For validation of univariate process stream analyzers, see also
Practice D3764.

NOTE 3—One or both of the analytical systems in 1.5 can be laboratory
test methods or validated process stream analyzers.

1.6 This practice assumes that the normal (Gaussian) model
is adequate for the description and prediction of measurement
system behavior when it is in a state of statistical control.

NOTE 4—For non-Gaussian processes, transformations of test results
may permit proper application of these tools. Consult a statistician for

further guidance and information.

2. Referenced Documents

2.1 ASTM Standards:

D3764 Practice for Validation of the Performance of Process
Stream Analyzer Systems

D5191 Test Method for Vapor Pressure of Petroleum Prod-
ucts (Mini Method)

D6708 Practice for Statistical Assessment and Improvement
of Expected Agreement Between Two Test Methods that
Purport to Measure the Same Property of a Material

D6792 Practice for Quality System in Petroleum Products
and Lubricants Testing Laboratories

D7372 Guide for Analysis and Interpretation of Proficiency
Test Program Results

E177 Practice for Use of the Terms Precision and Bias in
ASTM Test Methods

E178 Practice for Dealing With Outlying Observations
E456 Terminology Relating to Quality and Statistics
E691 Practice for Conducting an Interlaboratory Study to

Determine the Precision of a Test Method

3. Terminology

3.1 Definitions:
3.1.1 accepted reference value, n—a value that serves as an

agreed-upon reference for comparison and that is derived as (1)
a theoretical or established value, based on scientific principles,
(2) an assigned value, based on experimental work of some
national or international organization, such as the U.S. Na-
tional Institute of Standards and Technology (NIST), or (3) a
consensus value, based on collaborative experimental work
under the auspices of a scientific or engineering group. E177,

E456

3.1.2 accuracy, n—the closeness of agreement between an
observed value and an accepted reference value. E177, E456

3.1.3 assignable cause, n—a factor that contributes to varia-
tion and that is feasible to detect and identify. E456

1 This practice is under the jurisdiction of ASTM Committee D02 on Petroleum
Products, Liquid Fuels, and Lubricants and is the direct responsibility of Subcom-
mittee D02.94 on Coordinating Subcommittee on Quality Assurance and Statistics.

Current edition approved Oct. 1, 2013. Published October 2013. Originally
approved in 1998. Last previous edition approved in 2010 as D6299 – 10ε2. DOI:
10.1520/D6299-13.

2 For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.

*A Summary of Changes section appears at the end of this standard

1Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS

–`,,“`,,,,““-`-`,,`,,`,`,,`—

//^
:^

^#
^~

^^
“~

@
:^

“^
:*

^@
$~

“#
:*

~^
**

“#
$^

~*
~:

@
^~

:^
*#

^^
“”

$”
\\

3.1.4 bias, n—a systematic error that contributes to the
difference between a population mean of the measurements or
test results and an accepted reference or true value. E177, E456

3.1.5 control limits, n—limits on a control chart that are
used as criteria for signaling the need for action or for judging
whether a set of data does or does not indicate a state of
statistical control. E456

3.1.6 lot, n—a definite quantity of a product or material
accumulated under conditions that are considered uniform for
sampling purposes. E456

3.1.7 precision, n—the closeness of agreement between test
results obtained under prescribed conditions. E456

3.1.8 repeatability conditions, n—conditions where mutu-
ally independent test results are obtained with the same test
method in the same laboratory by the same operator with the
same equipment within short intervals of time, using test
specimens taken at random from a single sample of material.

3.1.9 reproducibility conditions, n—conditions under which
test results are obtained in different laboratories with the same
test method, using test specimens taken at random from the
same sample of material.

3.2 Definitions of Terms Specific to This Standard:
3.2.1 analytical measurement system, n—a collection of one

or more components or subsystems, such as samplers, test
equipment, instrumentation, display devices, data handlers,
printouts or output transmitters, that is used to determine a
quantitative value of a specific property for an unknown
sample in accordance with a test method.

3.2.1.1 Discussion—A standard test method (for example,
ASTM, ISO) is an example of an analytical measurement
system.

3.2.1.2 Discussion—An analytical measurement system
may comprise multiple instruments being used for the same
test method provided there is no statistically observable bias
and precision differences between the multiple instruments.

3.2.2 blind submission, n—submission of a check standard
or quality control (QC) sample for analysis without revealing
the expected value to the person performing the analysis.

3.2.3 check standard, n—in QC testing, a material having an
accepted reference value used to determine the accuracy of a
measurement system.

3.2.3.1 Discussion—A check standard is preferably a mate-
rial that is either a certified reference material with traceability
to a nationally recognized body or a material that has an
accepted reference value established through interlaboratory
testing. For some measurement systems, a pure, single com-
ponent material having known value or a simple gravimetric or
volumetric mixture of pure components having calculable
value may serve as a check standard. Users should be aware
that for measurement systems that show matrix dependencies,
accuracy determined from pure compounds or simple mixtures
may not be representative of that achieved on actual samples.

3.2.4 common (chance, random) cause, n—for quality as-
surance programs, one of generally numerous factors, individu-
ally of relatively small importance, that contributes to
variation, and that is not feasible to detect and identify.

3.2.5 double blind submission, n—submission of a check
standard or QC sample for analysis without revealing the check
standard or QC sample status and expected value to the person
performing the analysis.

3.2.6 in-statistical-control, adj—a process, analytical mea-
surement system, or function that exhibits variations that can
only be attributable to common cause.

3.2.7 proficiency testing, n—determination of a laboratory’s
testing capability by participation in an interlaboratory cross-
check program.

3.2.7.1 Discussion—ASTM Committee D02 conducts pro-
ficiency testing among hundreds of laboratories, using a wide
variety of petroleum products and lubricants.

3.2.8 quality control (QC) sample, n—for use in quality
assurance programs to determine and monitor the precision and
stability of a measurement system, a stable and homogeneous
material having physical or chemical properties, or both,
similar to those of typical samples tested by the analytical
measurement system. The material is properly stored to ensure
sample integrity, and is available in sufficient quantity for
repeated, long term testing.

3.2.9 site expected value (SEV), n—for a QC sample this is
an estimate of the theoretical limiting value towards which the
average of results collected from a single in-statistical-control
measurement system under site precision conditions tends as
the number of results approaches infinity.

3.2.9.1 Discussion—The SEV is associated with a single
measurement system; for control charts that are plotted in
actual measured units, the SEV is required, since it is used as
a reference value from which upper and lower control limits for
the control chart specific to a batch of QC material are
constructed.

3.2.10 site precision (R’), n—the value below which the
absolute difference between two individual test results obtained
under site precision conditions may be expected to occur with
a probability of approximately 0.95 (95 %). It is defined as 2.77
times the standard deviation of results obtained under site
precision conditions.

3.2.11 site precision conditions, n—conditions under which
test results are obtained by one or more operators in a single
site location practicing the same test method on a single
measurement system which may comprise multiple
instruments, using test specimens taken at random from the
same sample of material, over an extended period of time
spanning at least a 15 day interval.

3.2.11.1 Discussion—Site precision conditions should in-
clude all sources of variation that are typically encountered
during normal, long term operation of the measurement sys-
tem. Thus, all operators who are involved in the routine use of
the measurement system should contribute results to the site
precision determination. If multiple results are obtained within
a 24–h period, then it is recommended that the number of
results used in site precision calculations be increased to
capture the longer term variation in the system.

3.2.12 site precision standard deviation, n—the standard
deviation of results obtained

under site precision conditions.

D6299 − 13

2Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS

–
–
`
,
,
`
`
`
,
,
,
,
`
`
`
`
–
`
–
`
,
,
`
,
,
`
,
`
,
,
`
–
–
–

//^:^^#^~^^”~@
:^”^:*^@

$~”#:*~^**”#$^~*~:@
^~:^*#^^””$”\\

3.2.13 validation audit sample, n—a QC sample or check
standard used to verify precision and bias estimated from
routine quality assurance testing.

3.3 Symbols:
3.3.1 ARV—accepted reference value.

3.3.2 EWMA—exponentially weighted moving average.

3.3.3 I—individual observation (as in I-chart).

3.3.4 MR—moving range.

3.3.5 MR̄—average of moving range.

3.3.6 QC—quality control.

3.3.7 R’—site precision.

3.3.8 SEV—site expected value.

3.3.9 σR’—site precision standard deviation.
3.3.10 VA—validation audit.

3.3.11 χ2—chi squared.
3.3.12 λ—lambda.

4. Summary of Practice

4.1 QC samples and check standards are regularly analyzed
by the measurement system. Control charts and other statistical
techniques are presented to screen, plot, and interpret test
results in accordance with industry-accepted practices to as-
certain the in-statistical-control status of the measurement
system.

4.2 Statistical estimates of the measurement system preci-
sion and bias are calculated and periodically updated using
accrued data.

4.3 In addition, as part of a separate validation audit
procedure, QC samples and check standards may be submitted
blind or double-blind and randomly to the measurement system
for routine testing to verify that the calculated precision and
bias are representative of routine measurement system perfor-
mance when there is no prior knowledge of the expected value
or sample status.

5. Significance and Use

5.1 This practice can be used to continuously demonstrate
the proficiency of analytical measurement systems that are
used for establishing and ensuring the quality of petroleum and
petroleum products.

5.2 Data accrued, using the techniques included in this
practice, provide the ability to monitor analytical measurement
system precision and bias.

5.3 These data are useful for updating test methods as well
as for indicating areas of potential measurement system im-
provement.

6. Reference Materials

6.1 QC samples are used to establish and monitor the
precision of the analytical measurement system.

6.1.1 Select a stable and homogeneous material having
physical or chemical properties, or both, similar to those of
typical samples tested by the analytical measurement system.

NOTE 5—When the QC sample is to be utilized for monitoring a process
stream analyzer performance, it is often helpful to supplement the process
analyzer system with a subsystem to automate the extraction, mixing,
storage, and delivery functions associated with the QC sample.

6.1.2 Estimate the quantity of the material needed for each
specific lot of QC sample to (1) accommodate the number of
analytical measurement systems for which it is to be used
(laboratory test apparatuses as well as process stream analyzer
systems) and (2) provide determination of QC statistics for a
useful and desirable period of time.

6.1.3 Collect the material into a single container and isolate
it.

6.1.4 Thoroughly mix the material to ensure homogeneity.
6.1.5 Conduct any testing necessary to ensure that the QC

sample meets the characteristics for its intended use.
6.1.6 Package or store QC samples, or both, as appropriate

for the specific analytical measurement system to ensure that
all analyses of samples from a given lot are performed on
essentially identical material. If necessary, split the bulk
material collected in 6.1.3 into separate and smaller containers
to help ensure integrity over time. (Warning—Treat the
material appropriately to ensure its stability, integrity, and
homogeneity over the time period for which it is to stored and
used. For samples that are volatile, such as gasoline, storage in
one large container that is repeatedly opened and closed can
result in loss of light ends. This problem can be avoided by
chilling and splitting the bulk sample into smaller containers,
each with a quantity sufficient to conduct the analysis.
Similarly, samples prone to oxidation can benefit from splitting
the bulk sample into smaller containers that can be blanketed
with an inert gas prior to being sealed and leaving them sealed
until the sample is needed.)

6.2 Check standards are used to estimate the accuracy of the
analytical measurement system.

6.2.1 A check standard may be a commercial standard
reference material when such material is available in appropri-
ate quantity, quality and composition.

NOTE 6—Commercial reference material of appropriate composition
may not be available for all measurement systems.

6.2.2 Alternatively, a check standard may be prepared from
a material that is analyzed under reproducibility conditions by
multiple measurement systems. The accepted reference value
(ARV) for this check standard shall be the average after
statistical examination and outlier treatment has been applied.3

6.2.2.1 Exchange samples circulated as part of an interlabo-
ratory exchange program, or round robin, may be used as check
standards. For an exchange sample to be usable as a check
standard, the standard deviation of the interlaboratory ex-
change program shall not be statistically greater than the
reproducibility standard deviation for the test method. An
F-test should be applied to test acceptability.

NOTE 7—The uncertainty in the ARV is inversely proportional to the
square root of the number of values in the average. This practice
recommends that a minimum of 16 non-outlier results be used in

3 For guidance in statistical and outlier treatment of data, refer to Research
Report RR:D02-1007, Practices E178 and E691, and ASTM Standards on Precision
and Bias for Various Applications, ASTM International, 1997.

D6299 − 13

3Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS
–
–
`
,
,
`
`
`
,
,
,
,
`
`
`
`
–
`
–
`
,
,
`
,
,
`
,
`
,
,
`
–
–
–

//^:^^#^~^^”~@:^”^:*^@$~”#:*~^**”#$^~*~:@^~:^*#^^””$”\\

calculating the ARV to reduce the uncertainty of the ARV by a factor of
4 relative to the measurement system single value precision. The bias tests
described in this practice assume that the uncertainty in the ARV is
negligible relative to the measurement system precision. If less than 16
values are used in calculating the average, this assumption may not be
valid.

NOTE 8—Examples of exchanges that may be acceptable are ASTM
D02.CS92 ILCP program; ASTM D02.01 N.E.G.; ASTM D02.01.A
Regional Exchanges; International Quality Assurance Exchange Program,
administered by Alberta Research Council.

6.2.3 For some measurement systems, single, pure compo-
nent materials with known value, or simple gravimetric or
volumetric mixtures of pure components having calculable
value may serve as a check standard. For example, pure
solvents, such as 2,2-dimethylbutane, are used as check stan-
dards for the measurement of Reid vapor pressure by Test
Method D5191. Users should be aware that for measurement
systems that show matrix dependencies, accuracy determined
from pure compounds or simple mixtures may not be repre-
sentative of that achieved on actual samples.

6.3 Validation audit (VA) samples are QC samples and
check standards, which may, at the option of the users, be
submitted to the measurement system in a blind, or double
blind, and random fashion to verify precision and bias esti-
mated from routine quality assurance testing.

7. Quality Assurance (QA) Program for Individual
Measurement Systems

7.1 Overview—A QA program (1)4 can consist of five
primary activities: (1) monitoring stability and precision
through QC sample testing, (2) monitoring accuracy, (3)
periodic evaluation of system performance in terms of preci-
sion or bias, or both, (4) proficiency testing through participa-
tion in interlaboratory exchange programs where such pro-
grams are available, and (5) a periodic and independent system
validation using VA samples may be conducted to provide
additional assurance of the system precision and bias metrics
established from the primary testing activities. At minimum,
the QA program must include at least item one and item two,
subject to check standard availability (see 7.1.1).

7.1.1 For some measurement systems, suitable check stan-
dard materials may not exist, and there may be no reasonably
available exchange programs to generate them. For such
systems, there is no means of verifying the accuracy of the
system, and the QA program will only involve monitoring
stability and precision through QC sample testing.

NOTE 9—For guidance on the establishment and maintenance of the
essentials of a quality system, see Practice D6792.

NOTE 10—For guidance on the analysis and interpretation of profi-
ciency test (PT) program results, see Guide D7372.

7.2 Monitoring System Stability and Precision Through QC
Sample Testing—QC test specimen samples from a specific lot
are introduced and tested in the analytical measurement system
on a regular basis to establish system performance history in
terms of both stability and precision.

7.3 Monitoring Accuracy:

7.3.1 Check standards can be tested in the analytical mea-
surement system on a regular basis to establish system perfor-
mance history in terms of accuracy.

7.3.2 For measurement systems where calibration is estab-
lished by using multiple standards of known values, such as
materials certified by or traceable to the national certification
bodies such as NIST, JIS, BSI, and so forth, and where the total
number of standards used exceed the number of parameters
estimated by the calibration equation, an alternative approach
(instead of check standard testing) to infer system accuracy is
to compare the statistics associated with the calibration equa-
tion to previously established measurement system precision
and to standard errors of the calibration standards used.
Coverage of this type of statistical techniques for accuracy
inference is beyond the scope of this practice. Users are
advised to enlist the services of a statistician when using this
approach to infer system accuracy instead of check standard
testing.

7.4 Test Program Conditions/Frequency :
7.4.1 Conduct both QC sample and check standard testing

under site precision conditions.

NOTE 11—It is inappropriate to use test data collected under repeat-
ability conditions to estimate the long term precision achievable by the site
because the majority of the long term measurement system variance is due
to common cause variations associated with the combination of time,
operator, reagents, instrumentation calibration factors, and so forth, which
would not be observable in data obtained under repeatability conditions.

7.4.2 Test the QC and check standard samples on a regular
schedule, as appropriate. Principal factors to be considered for
determining the frequency of testing are (1) frequency of use of
the analytical measurement system, (2) criticality of the pa-
rameter being measured, (3) established system stability and
precision performance based on historical data, (4) business
economics, and (5) regulatory, contractual, or test method
requirements.

NOTE 12—At the discretion of the laboratory, check standards may be
used as QC samples. In this case, the results for the check standards may
be used to monitor both stability (see 7.2) and accuracy (see 7.3)
simultaneously. If check standards are expensive, or not available in
sufficient quantity, then separate QC samples are employed. In this case,
the accuracy (see 7.3) is monitored less frequently, and the QC sample
testing (see 7.2) is used to demonstrate the stability of the measurement
system between accuracy tests.

7.4.3 It is recommended that a QC sample be analyzed at the
beginning of any set of measurements and immediately after a
change is made to the measurement system.

7.4.4 Establish a protocol for testing so that all persons who
routinely operate the system participate in generating QC test
data.

7.4.5 Handle and test the QC and check standard samples in
the same manner and under the same conditions as samples or
materials routinely analyzed by the analytical measurement
system.

7.4.6 When practical, randomize the time of check standard
and additional QC sample testing over the normal hours of
measurement system operation, unless otherwise prescribed in
the specific test method.

NOTE 13—Avoid special treatment of QC samples designed to get a
4 The boldface numbers in parentheses refer to the list of references at the end of

this standard.

D6299 − 13

4Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS
–
–
`
,
,
`
`
`
,
,
,
,
`
`
`
`
–
`
–
`
,
,
`
,
,
`
,
`
,
,
`
–
–
–
//^:^^#^~^^”~@:^”^:*^@$~”#:*~^**”#$^~*~:@^~:^*#^^””$”\\

better result. Special treatment seriously undermines the integrity of
precision estimates.

7.5 Evaluation of System Performance in Terms of Precision
and Bias:

7.5.1 Pretreat and screen results accumulated from QC and
check standard testing. Apply statistical techniques to the
pretreated data to identify erroneous data. Plot appropriately
pretreated data on control charts.

7.5.2 Periodically analyze results from control charts, ex-
cluding those data points with assignable causes, to quantify
the bias and precision estimates for the measurement system.

7.6 Proficiency Testing:
7.6.1 Participation in regularly conducted interlaboratory

exchanges where typical production samples are tested by
multiple measurement systems, using a specified (ASTM) test
protocol, provide a cost-effective means of assessing measure-
ment system accuracy relative to average industry perfor-
mance. Such proficiency testing can be used instead of check
standard testing for systems where the timeliness of the
accuracy check is not critical. Proficiency testing may be used
as a supplement to accuracy monitoring by way of check
standard testing.

7.6.2 Participants plot their signed deviations from the
consensus values (exchange averages) on control charts in the
same fashion described below for check standards, to ascertain
if their measurement processes are non-biased relative to
industry average.

7.7 Independent System Validation—Periodically, at the dis-
cretion of users, VA samples may be submitted blind or double
blind for analysis. Precision and bias estimates calculated using
VA samples test data can be used as an independent validation
of the routine QA program performance statistics.

NOTE 14—For measurement systems susceptible to human influence,
the precision and bias estimates calculated from data where the analyst is
aware of the sample status (QC or check standard) or expected values, or
both, may underestimate the precision and bias achievable under routine
operation. At the discretion of the users, and depending on the criticality
of these measurement systems, the QA program may include periodic
blind or double-blind testing of VA samples.

7.7.1 The specific design and approach to the VA testing
program will depend on features specific to the measurement
system and organizational requirements, and is beyond the
intended scope of this practice. Some possible approaches are
noted as follows.

7.7.1.1 If all QC samples or check standards, or both, are
submitted blind or double blind and the results are promptly
evaluated, then additional VA sample testing may not be
necessary.

7.7.1.2 QC samples or check standards, or both, may be
submitted as unknown samples at a specific frequency. Such
submissions should not be so regular as to compromise their
blind status.

7.7.1.3 Retains of previously analyzed samples may be
resubmitted as unknown samples under site precision condi-
tions. Generally, data from this approach can only yield
precision estimates as retain samples do not have ARVs.
Typically, the differences between the replicate analyses are
plotted on control charts to estimate the precision of the

measurement system. If precision is level dependent, the
differences are scaled by the standard deviation of the mea-
surement system precision at the level of the average of the two
results.

8. Procedure for Pretreatment, Assessment, and
Interpretation of Test Results

8.1 Overview—Results accumulated from QC, check
standard, and VA sample testing are pretreated and screened.
Statistical techniques are applied to the pretreated data to
achieve the following objectives:

8.1.1 Identify erroneous data (outliers).
8.1.2 Assess initial results to validate system stability and

assumptions associated with use of control chart technique (for
example, dataset normality, adequacy of variations in the
dataset relative to measurement resolution).

8.1.3 Deploy, interpret, and maintain control charts.
8.1.4 Quantify long term measurement precision and bias.

NOTE 15—Refer to the annex for examples of the application of the
techniques that are discussed below and described in Section 9.

8.2 Pretreatment of Test Results—The purpose of pretreat-
ment is to standardize the control chart scales so as to allow for
data from multiple check standards or different batches of QC
materials with different property levels to be plotted on the
same chart.

8.2.1 For QC sample test results, no data pretreatment is
necessary if results for different QC samples are plotted in
actual measurement units on different control charts.

8.2.2 For check standard sample test results that are to be
plotted on the same control chart, two cases apply, depending
on the measurement system precision:

8.2.2.1 Case 1—If either (1) all of the check standard test
results are from one or more lots of check standard material
having the same ARV(s), or (2) the precision of the measure-
ment system is constant across levels, then pretreatment
consists of calculating the difference between the test result and
the ARV:

Pretreated result 5 test result 2 ARV~for the sample! ( 1 )

8.2.2.2 Case 2—Test results are for multiple lots of check
standards with different ARVs, and the precision of the
measurement system is known to vary with level,

Pretreated result5 ( 2 )

@test result 2 check standard ARV#/sqrt @~standard error of ARV! 2 1

~std dev of site test method at the ARV level! 2#
where the standard error of the ARV is the uncertainty asso-
ciated with the ARV as supplied by the check standard sup-
plier; the standard deviation of site test method at the ARV
level is the established standard deviation of the site’s test
method under site precision conditions at nominally the ARV
level. In the event the ARV was established through round
robin testing, standard deviations determined from outlier-
free and normally distributed round robin test results may be
used to calculate the standard error of the ARV in accor-
dance with statistical theory. (See Note 16.)

8.2.2.3 If the ARV was not arrived at by round robin testing,
a standard error of the ARV should be determined by users in
a technically acceptable manner.

D6299 − 13

5Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS
–
–
`
,
,
`
`
`
,
,
,
,
`
`
`
`
–
`
–
`
,
,
`
,
,
`
,
`
,
,
`
–
–
–
//^
:^
^#
^~
^^
“~
@
:^
“^
:*
^@
$~
“#
:*
~^
**
“#
$^
~*
~:
@
^~
:^
*#
^^
“”
$”
\\

NOTE 16—It is recommended that the method used to determine the
standard error of the ARV be developed under the guidance of a
statistician.

8.2.3 Pretreatment of results for VA samples is done in the
same manner as described in 8.2.1 and 8.2.2.

8.3 Control Charts (1, 2)—Individual (I), moving range of
two (MR) control charts, and either Strategy 1 (additional run
rules) or Strategy 2 (EWMA) are the recommended toolset (see
Annex A1) for (a) routine recording of QC sample and check
standard test results, and (b) immediate assessment of the “in
statistical control” (3) status of the system that generated the
data. The I chart is intended to detect occurrence of a sudden,
unique event that causes a large deviation from the expected
value for the QC material. Strategy 1 (additional Run Rules) or
Strategy 2 (EWMA) is intended to detect small levels of
sustained shifts or drifts of the complete analytical system. MR
chart is intended to detect changes in the analytical system
overall variability.

NOTE 17—The control charts and statistical techniques described in this
practice are chosen for their simplicity and ease of use. It is not the intent
of this practice to preclude use of other statistically equivalent or more
advanced techniques, or both.

8.3.1 Control charting can be viewed as a two-staged work
process where:

Stage 1 comprises assessment of initial test results (for a
QC material) and construction of the control chart with
graphically represented assessed results and statistical values
that describes the location of where future test results for this
QC material from the measurement systems are expected to fall
within, on the assumption that the measurement system and
QC material remains unchanged.

Stage 2 comprises regular assessment of future test results
(for the QC material) as they arrive in chronological order
against the established expectations in Stage 1; as well as a
periodic reevaluation of the expectation statistics of all accrued
results to update the expectations statistics established from
Stage 1, if necessary.

STAGE 1—Assessment and Chart Construction

8.4 Assessment of Initial Results—Assessment techniques
are applied to test results collected during the initial startup
phase of or after significant modifications to a measurement
system (see Note 19). Perform the following assessment after
at least 20 pretreated results have become available. The
purpose of this assessment is to ensure that these results are
suitable for deployment of control charts (described in A1.4).

NOTE 18—These techniques can also be applied as diagnostic tools to
investigate out-of-control situations.

NOTE 19—During the data collection phase in Stage 1, users can deploy
the procedures described in 8.7.2.3 and 8.7.3 ( Q–procedure) to monitor
measurement process performance.

8.4.1 Screen for Suspicious Results—Pretreated results
should first be visually screened for values that are inconsistent
with the remainder of the data set, such as those that could have
been caused by transcription errors. Those flagged as suspi-
cious should be investigated. Discarding data at this stage must
be supported by evidence gathered from the investigation. If,
after discarding suspicious pretreated results there are less than
15 values remaining, collect additional data and start over.

8.4.2 Screen for Unusual Patterns—The next step is to
examine the pretreated results for non-random patterns such as
continuous trending in either direction, unusual clustering, and
cycles. One way to do this is to plot the results on a run chart
(see A1.3) and examine the plot. If any non-random pattern is
detected, investigate for and eliminate the root cause(s).
Discard the data set and start the procedure again.

8.4.3 Test “Normality” Assumption, Independence of Test
Results, and Adequacy of Measurement Resolution—For mea-
surement systems with no prior performance history, or as a
diagnostic tool, it is useful to test that the results from the
measurement system are reasonably independent, with ad-
equate measurement resolution, and can be adequately mod-
elled by a normal distribution. One way to do this is to use a
normal probability plot and the Anderson-Darling Statistic (see
A1.4). If the results show obvious deviation from normality or
obvious measurement resolution inadequacy (see A1.4), follow
the guidance in A1.4.2.6, Case 2.

NOTE 20—Transformations may lead to normally distributed data, but
these techniques are outside the scope of this practice.

8.4.4 Construction of Control Charts—If no obvious un-
usual patterns are detected from the run charts, and no obvious
deviation from normality is detected, proceed with construc-
tion of the control charts

8.4.4.1 Construct an MR plot and examine it for unusual
patterns. If no unusual patterns are found in the MR plot,
calculate and overlay the control limits on the MR plot to
complete the MR chart.

8.4.4.2 I Chart—Calculate control limits and overlay them
on the “run chart” to produce the I chart.

8.4.4.3 EWMA Overlay—Optionally, calculate the EWMA
values and plot them on the I chart. Calculate the EWMA
control limits and overlay them on the I chart.

STAGE 2—Deployment for Monitoring and Periodic Re-
assessment

8.4.5 Control Chart Deployment—Put these control charts
into operation by regularly plotting the pretreated test results
on the charts and immediately interpreting the charts.

8.5 Control Chart Interpretation :
8.5.1 Apply control chart rules (see A1.5) to determine if

the data supports the hypothesis that the measurement system
is under the influence of common causes variation only (in
statistical control).

8.5.2 Investigate Out-of-Control Points in Detail—Exclude
from further data analysis those associated with assignable
causes, provided the assignable causes are deemed not to be
part of the normal process.

NOTE 21—All data, regardless of in-control or out-of-control status,
needs to be recorded.

8.6 Scenario 1 for Periodic Updating of Control Charts
Parameters:

8.6.1 Scenario 1 covers (1) control charts for a QC material
where there had been no change in the system, but more data
of the same level has been accrued; or (2) control charts for
check standard pretreated results.

D6299 − 13

6Copyright ASTM International
Provided by IHS under license with ASTM

8.6.2 When a minimum of 20 new in-control data points
becomes available, perform an F-test (see A1.8) of sample
variances for the new data set versus the sample variance used
to calculate the current control chart limits. If the outcome of
the F-test is not significant, and, if the sample variance used to
calculate the current control limits is based on less than 100
data points, statistically pool both sample variances and then
update the current control limits based on this new pooled
variance.

8.6.3 If the outcome of the F-test is not significant, and if
the sample variance used to calculate the current control limits
is based on more than 100 data points, the statistical pooling of
both sample variances and update of the current control limits
can be at the discretion of the user.

8.6.4 If the outcome of the F-test is significant, investigate
for assignable causes. Update the current control limits based
on this new sample variance if it is determined that this new
variance is representative of current system performance.

8.7 Scenario 2 for Periodic Updating of Control Charts
Parameters:

8.7.1 Scenario 2 covers control chart for QC materials
where an assignable cause change in the system had occurred
due to a change of QC material as the current QC material
supply is exhausted. Minor or major differences in measured
property level may exist between QC material batches. Since
control limit calculations for the I chart require a center value
established by the measurement system, a special transition
procedure is required to ensure that the center value for a new
batch of QC material is established using results produced by
a measurement system that is in statistical control. This
practice presents two procedures to be selected at the users’
discretion.

8.7.2 Procedure 1, Concurrent Testing:
8.7.2.1 Collect and prepare a new batch of QC material

when the current QC material supply remaining can support no
more than 20 analyses.

8.7.2.2 Concurrently test and record data for the new
material each time a current QC sample is tested. The result for
the new material is deemed valid if the measurement process
in-control status is validated by the current QC material and
control chart.

8.7.2.3 Optionally, to provide an early indication of the
status of the new batch of QC material, immediately start a run
chart and an MR plot for the new material. After five valid
results become available for the new material, convert the run
chart into an I chart with trial control limits by adding a center
line based on the average of the five results and control limits
based on the MR̄ from previous control charts for materials at
the same nominal level. Set trial control limits for the MR chart
based on limits from previous charts for materials at the same
nominal level.

8.7.2.4 After a minimum of 20 in-control data points are
collected on the new material, perform an F-test of sample
variances for the new data set versus the historical variance
demonstrated at nominal level of the new material. If the
outcome of the F-test is not significant, and, if the historical
variance demonstrated at nominal level of the new material is
based on less than 100 data points, statistically pool both

sample variances and then update the current control limits
based on this new pooled variance.

8.7.2.5 If the outcome of the F-test is not significant, and, if
the historical variance demonstrated at nominal level of the
new material is based on more than 100 data points, the
statistical pooling of both sample variances and update of the
current control limits can be at the discretion of the user.

8.7.2.6 If the outcome of the F-test is significant, investigate
for assignable causes. Update the current control limits based
on this new sample variance if it is determined that this new
variance is representative of current system performance.

8.7.2.7 Construct new I and MR charts (and EWMA overlay
for strategy 2) for this new material as per Section 8, using the
pooled MR̄.

8.7.2.8 Switch over to the new I and MR charts upon
depletion of current QC material.

8.7.3 Procedure 2, Q–Procedure (see A1.9)(4):
8.7.3.1 This procedure is designed to alleviate the need for

concurrent testing of two materials. A priori knowledge of the
measurement process historical standard deviation applicable
at the new QC material composition and property level is
required.

NOTE 22—It is recommended that this standard deviation estimate be
based on at least 50 data points.

8.7.3.2 When the Q–procedure is operational (minimum of
two data points), it can be used in conjunction with a MR chart
constructed using the observations to provide QA of the
measurement process.

8.7.3.3 Because the Q–procedure is technically equivalent
to the I chart procedure, after 20 data points have been accrued
(by the Q–procedure), the user can either follow the steps
described in 8.7.2 on Concurrent Testing after 20 data points
have been accrued to construct a new I/MR control chart for the
new batch of QC material, or continue to operate the Q–chart
and MR chart for measurement process stability and precision
monitoring, respectively, using the new batch of QC material.

8.7.3.4 It is necessary to start a new Q–chart with each new
batch of QC material if the plotted results are not pre-treated,
or, if the new batch of material has a different historical
standard deviation and the plotted results are not pre-treated.

8.7.3.5 A common Q–chart and MR chart can be used for
pre-treated results as per Case I and Case II in 8.2. For Case I,
the standard deviation shall be the applicable standard devia-
tion for the QC material; for Case II, the standard deviation is
the value in the denominator of Eq 2.

8.8 Short Run Scenario—The Q–procedure (described in
8.7.3) can also be used to address short run situations where a
single batch of QC material can provide only a limited number
(less than 20) of QC test results and replacement of exactly the
same material is not feasible or possible. For these short run
QC batches, since there is insufficient data to properly charac-
terize the mean of batch, the Q–procedure, in conjunction with
the MR chart, can be used to monitor stability and precision of
the measurement process, respectively.

9. Evaluation of System Performance in Terms of
Precision and Bias

9.1 Site Precision Estimated from Testing of QC Samples:

D6299 − 13

7Copyright ASTM International
Provided by IHS under license with ASTM

9.1.1 Estimate the site precision of the measurement system
at the level corresponding to a specific lot of QC sample using
the root-mean-square (rms) formula for standard deviation
(σR’).

σ R ’ 5 ! (i 5 1
n

n 2 1
~ I i 2 Ī!

2
( 3 )

R ‘ 5 2.77 3 σ R ’ ( 4 )

9.1.1.1 Alternatively, in the absence of auto-correlation in
the data (see A1.4), R’ may be estimated as 2.46 times the
average of the moving range ~ MR̄! from the MR chart for that
specific lot.

R ‘ 5 2.46 3 MR̄ ( 5 )
NOTE 23—The site precision standard deviation (σR’) is estimated from

the MR chart as R ‘ / 2.775~ MR̄! / 1.128.

9.1.1.2 For estimate of site precision standard deviation
(σR’) using retain results, first obtain the standard deviation of
differences by applying the root-mean-square formula below to
the differences between the original and retest results for
samples with same nominal property level. If measurement
process precision is known to be level independent, retest
results from samples with different property levels can be used.
Otherwise, sample pairs with nominally similar property level
(general rule is within 2R) should be used to estimate the site
precision at the nominal property level. Divide the standard
deviation of differences by 1.414 to obtain the estimate for site
precision standard deviation. (σR’).

standard deviation of differences5 ( 6 )

Œ( ~individual difference 2 average difference! 2
total number of differences

σ R ‘ 5 ~standard deviation of differences!÷ 1.414 ( 7 )

9.1.2 Compare R’ to published reproducibility of the test
method at the same level, if available. R’ is expected to be less
than or equal to the published value. Use the χ2 test described
in A1.7.

9.2 Measurement System Bias Estimated from Multiple
Measurements of a Single Check Standard—If a minimum of
15 test results is obtained on a single check standard material
under site precision conditions, then calculate the average of all
the in-control individual differences plotted on the I chart.
Perform a t-test (see A1.6) to determine if the average is
statistically different from zero.

9.2.1 If the outcome of the t-test is that the average is not
statistically different from zero, then the bias in the measure-
ment process is negligible.

9.2.2 If the outcome of the t-test is that the average is
statistically different from zero, then the best estimate of the
measurement process bias at the level of the check standard is
the average. If bias is deemed to be of practical significance by
the user, investigate for root causes, and take corrective
measures.

9.3 Measurement System Bias Estimated from Measure-
ments of Multiple Check Standards—When using multiple

check standards, determine if there is a relationship between
the bias and the measurement level.

9.3.1 Plot the pretreated results as per Section 8 versus their
corresponding ARVs. Examine the plot for patterns indicative
of level-dependent bias.

9.3.2 If there is no discernible pattern, perform the t-test as
described in 9.2 to determine if the average of all the pretreated
differences plotted on the I chart is statistically different from
zero.

9.3.2.1 If the outcome of the t-test is that the average is not
statistically different from zero, then the bias in the measure-
ment process is negligible.

9.3.2.2 If the outcome of the t-test is that the average is
statistically different from zero, then there is evidence that the
measurement system is biased. The bias may be level depen-
dent. However, the statistical methodology for estimating the
bias/level relationship is beyond the scope of this practice.

9.3.3 If there is a discernible pattern in the plot in 9.3.1, then
the measurement system may exhibit a level dependent bias.
The statistical methodology for estimating the bias/level rela-
tionship is beyond the scope of this practice.

9.3.4 If a bias is detected in 9.3.2.2, or if the plot in 9.3.3
exhibits discernible patterns, investigate for root cause(s).

9.3.4.1 If there is evidence of a bias versus level
relationship, or, if users wish to perform a more rigorous
examination of the bias versus level relationship with multiple
check standards, it is recommended that the principles of
Practice D6708 be employed under the guidance of qualified
statistical expertise.

10. Validation of System Performance Estimates Using
VA Samples

10.1 If the users decide to include VA sample testing as part
of their QA program, then they should periodically evaluate the
results obtained on the VA samples. The purpose of the
evaluation is to establish whether the system performance
estimates described in Section 9 are reasonably applicable to
routinely tested samples.

10.2 VA sample test results should be evaluated indepen-
dently through an internal or external audit system, or both. It
is recommended that the internal audit team not be limited to
the operators of the measurement system and their immediate
supervisors.

10.3 Insofar as possible, analyze the results obtained on the
VA samples separately and in the same manner as those from
the routine QC and check standard testing program.

10.4 Using F- or t- tests, or both (see A1.8 and A1.6),
statistically compare the system performance estimates ob-
tained from the VA sample testing program to the measurement
system accuracy and precision estimates from the QC sample
testing program.

10.5 If the comparison reveals that the two estimates of the
measurement system performance are not statistically
equivalent, there is cause for concern that the actual perfor-
mance of the measurement system may be significantly worse
than estimated. Investigate thoroughly for the assignable
cause(s) of this inconsistency, and eliminate it. Until the causes

D6299 − 13

8Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS
–`,,“`,,,,““-`-`,,`,,`,`,,`—
//^:^^#^~^^”~@:^”^:*^@$~”#:*~^**”#$^~*~:@^~:^*#^^””$”\\

are identified and eliminated, the lab precision estimates of
Section 9 should be considered suspect.

ANNE

(Mandatory Information)

A1. STATISTICAL QUALITY CONTROL TOOLS

A1.1 Purpose of this Annex

A1.1.1 The purpose of this annex is to provide guidance to
practitioners, including worked examples, for the proper ex-
ecution of the statistical procedures described in this practice.
See Tables A1.1-A1.13 and Figs. 1–15.

NOTE A1.1—For some examples in this annex, 15 data points are used
to illustrate calculation and plotting methodologies; it is not the intention
of this annex to override the mandatory requirement of 20 minimum data
points (see 8.4). Work is underway to revise the annex examples to use 20
data points for all examples.

A1.2 Pretreatment of Test Results (8.1 to 8.2.3)

A1.2.1 Throughout this annex, {Yi:i=1. . .n} denotes a
sequence of as measured test results. {Ii:i=1. . .n} will signify
a sequence of test results after pretreatment, if necessary.

A1.2.2 If {Yi:i=1. . .n} is a sequence of results from a single
QC sample, then

I i 5 Y i ( A 1 . 1 )

with no pretreatment being required.
A1.2.2.1 An example of a sequence of results, Yi, from a

single QC sample is given in Columns 2 and 4 of Table A1.3.

A1.2.3 If {Yi:i=1. . .n} is a sequence of results from a single
check standard, from multiple check standards having nomi-
nally the same ARV, or from multiple check standards having
different ARVs where the precision of the measurement system
does not vary with level, and if { Xi:i=1. . .n} is the sequence
of corresponding ARVs, then

I i 5 Y i 2 X i ( A 1 . 2 )

The site precision (R’) of the measurement process must be
essentially the same for all values {Xi}.

A1.2.3.1 An example of a sequence of results from a single
check standard is given in Table A1.4. The preprocessed result,
Ii, is given in Column 4 of Table A1.4.

A1.2.4 If {Yi} is a sequence of results from different check
standards, and if the reproducibility varies with the level of the
accepted reference values, { Xi}, then

I i 5 ~Y i 2 X i!/ σ i ( A 1 . 3 )

where σi are estimates of the standard deviation under site
precision conditions of the measurement process at levels {Xi}.

A1.2.4.1 Table A1.5 shows an example of results for mul-
tiple check standards where the precision of the measurement
system is level dependent.

A1.2.4.2 Discussion—Site precision (R’) estimates at ARV
values that are significantly different from those in the site’s

historical database can also be estimated proportionally using
the published R at the ARV level. Calculate the fraction of R’
and R at the ARV level with known R’ and multiply this
fraction by R at the new ARV level with unknown R’ to arrive
at the estimated R’ at the new ARV level. This approach is
based on the assumption that the fraction of R’ and R is
constant among different ARV levels. Users are cautioned that
this assumption may not be valid if the published precision has
different functional forms between r and R. Note that this
fraction is the inverse of TPI (Test Performance Index) as
defined in Practice D6792.

Example:
R’ of site (calculated from actual QC data) at sulfur level 10

ppm = 2 ppm (published R at sulfur level of 10 ppm = 3 ppm).
Fraction of R’/R at 10 ppm = 2/3
Estimated R’ of site at sulfur level at 15 ppm is estimated as:

(2/3)* (published R at sulfur level of 15 ppm).

A1.3 The Run Chart

A1.3.1 A run chart is a plot of results in chronological order
that can be used to screen data for unusual patterns. Preferably,
pretreated results are plotted. Use a run chart to screen data for
unusual patterns such as continuous trending in either
direction, unusual clustering, and cycles. Several non-random
patterns are described in control chart literature. When control
parameters have been added to a run chart, it becomes a control
chart of individual values (I chart).

A1.3.2 Plot results on the chart. Plot the first result at the
left, and plot each subsequent point one increment to the right
of its predecessor. The points may be connected in sequence to
facilitate interpretation of the run chart.

A1.3.3 Allow sufficient space in the x-axis direction to
accommodate as many results as should be obtained from a
consistent batch of material. Allow enough space in the y-axis
direction to accommodate the expected minimum and maxi-
mum of the data.

A1.3.4 Example of a Run Chart for QC Results—The first
15 results from Column 2 of Table A1.3 are plotted in sequence
as they are collected as shown in Fig. A1.1. The data would be
examined for unusual patterns.

A1.3.5 Example of a Run Chart for Multiple Results from a
Single Check Standard—The first 15 preprocessed results
(differences) from Column 4 of Table A1.4 are plotted in
sequence as they are collected as shown in Fig. A1.2. The data
would be examined for unusual patterns.

D6299 − 13

9Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS
–
–
`
,
,
`
`
`
,
,
,
,
`
`
`
`
–
`
–
`
,
,
`
,
,
`
,
`
,
,
`
–
–
–
//^:^^#^~^^”~@
:^”^:*^@
$~”#:*~^**”#$^~*~:@
^~:^*#^^””$”\\

A1.3.6 Example of a Run Chart for Results from Multiple
Check Standards—The first 15 preprocessed results (differ-
ences scaled by σi) from Table A1.5 are plotted in sequence as
they are collected as shown in Fig. A1.3. The data would be
examined for unusual patterns.

A1.4 Normality, Data Independence, and Resolution Ad-
equacy Checks

A1.4.1 A normal probability plot (a special case of a q-q
plot) is used to visually assess the validity of the assumption
that the observations are normally distributed. Since the control
chart and limits prescribed in this practice are based on the
assumption that the data behavior is adequately modeled by the
normal distribution, it is recommended that a test of this
normality assumption be conducted.

A1.4.1.1 To construct a normal probability plot:
(1) Create a column of the observations sorted in ascending

order.
(2) Select the appropriate column from Fig. A1.4, based on

the number of observations (n).
(3) Plot each observation in the sorted column (y-value)

against its corresponding value from Fig. A1.4 (z-value).
A1.4.1.2 Visually inspect the plot for an approximately

linear relationship. If the results are normally distributed, the
plot should be approximately linear. Major deviations from
linearity are an indication of nonnormal distributions of the
differences.

NOTE A1.2—The assessment methodology of the normal probability
plot advocated in this practice is strictly visual due to its simplicity. For
statistically more rigorous assessment techniques, users are advised to use
the Anderson-Darling technique described below, and consult a statisti-
cian.

A1.4.2 Anderson-Darling Statistic —The Anderson-Darling
(A-D) statistic is used to objectively test for normality, data
independence, and adequacy of measurement resolution rela-
tive to the overall variation in the dataset. Two A-D statistics
(A-Drms, A-DMR) are calculated using the identical procedure
outlined as follows, where A-Drms, A-DMR are the A-D statistic
calculated using numerical estimates of the sample standard
deviation(s) as per the rms (root-mean-square) and the MR-
(moving range of 2) techniques, respectively. The calculation
steps are as follows:

A1.4.2.1 Order the non-outlying results such that x1 ≤ x2 ≤ .
. . . xn

A1.4.2.2 Obtain standardized variate from the xi values as
follows:

w i 5 ~x i 2 x̄ !/ s ( A 1 . 4 )

for (i= 1 . . . n), where s is sample standard deviation of the
results using either the rms or MR technique, and x̄ is the
average of the results.

NOTE A1.3—One standard deviation estimate ~ 0.89 × [average MR] of
the dataset.

A1.4.2.3 Convert the wi values to standard normal cumula-
tive probabilities pi values using the cumulative probability
table for the standardized normal variate z (see Fig. A1.5):

p i 5 Probability ~z , w i! ( A 1 . 5 )

A1.4.2.4 Compute A2 as:

A 2 5 2
(
i 5 1

~2 i 2 1 ! @ln~p i!1 ln~1 2 p n 1 1 2 i!#

n
2 n ( A 1 . 6 )

A1.4.2.5 Compute the quantity A 2* as:

A 2* 5 A 2S 1 1 0.75n 1 2.25n 2 D ( A 1 . 7 )
The quantity A2* is referred to as the A-D statistic (A-D).
A1.4.2.6 Guidance on Interpretation of the Two A-D Statis-

tics (A-Drms and A-DMR): CASE 1—Both A-Drms and A-DMR
are << 1.0. This is to be interpreted as, “no compelling evidence to reject the hypotheses that the data is normal, independent, with adequate measurement resolution.” Proceed to construct control chart with either the rms-based or the MR-based standard deviation estimate.

CASE 2—Both A-Drms and A-DMR are >>> 1.0, and the q-q
plot shows a few distinct “staircases,” which really means the
majority of the data is clustered into a few unique values. This
is strong evidence that there is inadequate variation in the
dataset due to inadequate numerical resolution. Under these
circumstances, if the total number of unique values in the data
set is less than six, increase data resolution (carry an additional
decimal) and reevaluate both A-D statistics for the purpose of
control charting. Note that because results are used for internal
QA purposes, this should not be considered as a deviation from
test method reporting requirements. If additional data resolu-
tion is not possible, or, if the total number of unique values in
the data set is six or greater, or, if after increase in data
resolution, both A-D statistics are still >>1.0, users can still use
regular plotting of chronological QC data to monitor for
occurrence of an abnormal event. For the purpose of the latter,
it is recommended that the run-chart be used with a lower and
upper percentile-based action limits, provided that there is no
visual indication of process trending in the data set used to
determine the action limits. The suggested percentiles are 1st
and 99th, based on a data set of at least 75 results, collected
under site precision conditions. It is not the intent of this
practice to exclude use of other percentiles, or, use of other
user-defined action limits, provided the limits meet the appli-
cation requirements. Users are advised to seek qualified statis-
tical guidance on how to determine the appropriate action
limits and associated implications.

CASE 3—A-Drms is << 1.0, but A-DMR > 1.0. This is
indicative that the test results are serially correlated, or not
independent. A direct consequence of this non-independence is
that the standard deviation estimate using the moving range
technique will underestimate the variation of the total dataset.
The root cause for this non-independence is typically cyclic
data caused by diurnal effect of the environment, or moderate
trending of data due to normal degradation of test equipment.
If this is judged to be normal behavior of the measurement
data, proceed to construct control chart with the rms -based
standard deviation estimate.

A1.4.3 Example of Normal Probability Plot for QC
Results—Once 20 results have been obtained (Table A1.3),
they are sorted in ascending order and paired with the

D6299 − 13

10Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS
–
–
`
,
,
`
`
`
,
,
,
,
`
`
`
`
–
`
–
`
,
,
`
,
,
`
,
`
,
,
`
–
–
–
//^:^^#^~^^”~@
:^”^:*^@
$~”#:*~^**”#$^~*~:@
^~:^*#^^””$”\\

corresponding z-values from Fig. A1.4. The paired results (see
Table A1.6) are plotted as (x,y) points (see Fig. A1.6). A line
can be added to the plot to facilitate examination of the data for
deviations from linearity.

A1.4.3.1 For the above example, the wi and pi values used in
the calculation of the A-Drms statistic are shown in Table A1.6,
as is the individual terms in the summation for A2. The value
for A2 is 0.415, and the value for A2* (A-Drms) is 0.44. Similar
calculation using MR technique yields an A-Drms value of 0.60.
Since this is a CASE 1 outcome, the hypothesis of normality,
data independence, and adequate measurement resolution is
accepted.

A1.4.4 Example of Normal Probability Plot for Multiple
Results from a Single Check Standard—The first 15 prepro-
cessed results (Table A1.4, Column 4) are sorted in ascending
order and paired with the corresponding z-values from Fig.
A1.4. The paired results (Table A1.7) are plotted as x,y points
(Fig. A1.7). A line can be added to the plot to facilitate
examination of the data for deviations from linearity.

A1.4.5 Example of Normal Probability Plot for Results from
Multiple Check Standards—The first 15 preprocessed results
(Table A1.5, Column 6) are sorted in ascending order and
paired with the corresponding z-values from Fig. A1.4. The
paired results (Table A1.8) are plotted as x,y points (Fig. A1.8).
A line can be added to the plot to facilitate examination of the
data for deviations from linearity.

A1.4.5.1 For this example, the wi, and pi values used in the
calculation of the Anderson-Darling statistic are shown in
Table A1.8, as are the individual terms in the summation for A2.
The value for A2 is 0.673, and the value for A2* is 0.713. Since
this value is less than 0.752, the hypothesis of normality is
accepted at the 95 % confidence level.

A1.5 The Control Chart

A1.5.1 I Chart—The I chart is a run chart to which control
limits and center line have been added. To establish placement
positions of the control limits for the I chart, an estimate of the
variability of the measurement system will need to be obtained
from the data. While there are several statistical techniques that
can be used for this purpose, this practice advocates use of the
rms (root-mean-square) technique to estimate sigma, or,
alternatively, in the absence of auto-correlation, the mr (mov-
ing range of two) technique for its simplicity and robustness to
outliers. Produce an I chart only after a minimum of 20
preprocessed results have been obtained from the measurement
system, and the data have been screened (see 8.4.1 and 8.4.2)
and tested for normality (see A1.4).

A1.5.1.1 A horizontal center line is added at the level of the
mean of all the results, Ī:

Ī 5
(i 5 1

n
I i

n
( A 1 . 8 )

A1.5.1.2 Upper control limits (UCL) and lower control
limits (LCL) are added, indicating the limits within which
about 99.7% of all normally distributed measurement data are
expected to fall if variability of the measurement system is due
to random error only.

For standard deviation estimated from the moving range
technique, calculate UCL and LCL using Eq A1.9-A1.11:

MR̄ 5
(i 5 1

n 2 1
? I i 1 1 2 I i?
n 2 1

( A 1 . 9 )

UCL 5 Ī 1 2.66 MR̄ ( A 1 . 1 0 )

LCL 5 Ī 2 2.66 MR¯ ( A 1 . 1 1 )

NOTE A1.4—Explanation of the factor 2.66 in Eq A1.10 and Eq A1.11:
since (MR-bar/1.128) = σ, therefore, 3* σR’ = 3* (MR-bar/1.128) =
(3/1.128) * MR-bar = 2.66* MR-bar.

For standard deviation estimated from the root-mean-square
technique, calculate UCL and LCL using Eq 3 (reproduced
from 9.1.1) and Eq A1.12 and A1.13:

UCL 5 Ī 1 3 3 σ R ‘ ( A 1 . 1 2 )

LCL 5 Ī 2 3 3 σ R ‘ ( A 1 . 1 3 )

σ R ’ 5 ! (i 5 1
n
n 2 1
~ I i 2 Ī!
2

A1.5.1.3 Additionally, upper warning limits (UWL) and
lower warning limits (LWL) are added, and these indicate the
limits within which about 95 % of all normally distributed data
are expected to fall.

UWL 5 Ī 1 2 3 σ R ‘ ( A 1 . 1 4 )

LWL 5 Ī 2 2 3 σ R ‘ ( A 1 . 1 5 )
NOTE A1.5—Referring to Note A1.4, the UWL and LWL for sigma

calculated using (MR-bar/1.128) becomes I-bar 6 1.77 MR-bar.

A1.5.1.4 Individual values that are outside the upper (UCL)
or lower (LCL) control limits are strong indications of an
out-of-control system. Efforts shall be made to investigate for
assignable cause(s). Until the cause or causes have been found
and rectified, if necessary, results from the measurement
system under investigation should be considered suspect. In
addition, one of the following strategies shall be used to detect

changes in state of the measurement system that are considered
to constitute an out-of-control situation.

Strategy 1: Run Rule Strategy
Any one of the following occurrences shall be interpreted as

a strong signal that a change in state of the measurement
system has likely occurred:

(1) Two out of three consecutive results on the I chart that
are more than 2σR’ from the center line in

the same direction.

(2) Five consecutive results on the I chart that are more
than 1σR’ from the centerline in the same direction.

(3) Nine or more points in a row above or below the
centerline on the I chart.

(4) Seven points in a row steadily increasing or decreasing.

Strategy 2: EWMA (Exponentially Weighted Moving
Average) Strategy

Use of the EWMA overlay and its associated control limits
are described in this section. When the EWMA exceeds its
control limits, it shall be interpreted as a strong signal that a
change in state of the measurement system has likely occurred.

D6299 − 13

11Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS
–
–
`
,
,
`
`
`
,
,
,
,
`
`
`
`
–
`
–
`
,
,
`
,
,
`
,
`
,
,
`
–
–
–
//^:^^#^~^^”~@
:^”^:*^@
$~”#:*~^**”#$^~*~:@
^~:^*#^^””$”\\

A1.5.2 EWMA Overlay—A EWMA overlay is a trend line
constructed from EWMA values calculated using the I-values.
The EWMA trend line is typically overlaid on the I chart to
enhance its sensitivity in detecting mean shifts that are small
relative to the measurement system precision. Each EWMA
value is a weighted average of the current result and previous
results, with the weights decreasing exponentially with the age
of the reading.

A1.5.2.1 A sequence of values, EWMAi, are calculated, and
overlaid on the I chart and connected. Use the following
recursion equation:

EWMA1 5 I 1 ( A 1 . 1 6 )

EWMAi 5 ~1 2 λ !EWMAi 2 1 1 λ I i ( A 1 . 1 7 )

where λ is the exponential weighting factor. For application
of this practice, a λ value between 0.2 to 0.4 is recommended.

NOTE A1.6—For the EWMA trend, a λ value of 0.4 closely emulates the
run rule effects of conventional control charts, while a value of 0.2 has
optimal prediction properties for the next expected value. In addition,
these λ values also conveniently places the control limits (3-sigma) for the
EWMA trend at the 1 (for λ=0.2) to 1.5-sigma (for λ=0.4) values for I
chart.

A1.5.2.2 The control limits for the EWMA chart are calcu-
lated using a weight (λ) as follows:

UCLλ 5 I 1 3 σ R ’ Œ λ2 2 λ ( A 1 . 1 8 )
LCLλ 5 I 2 3 σ R ’Œ λ2 2 λ ( A 1 . 1 9 )

A1.5.3 If the control chart data exhibit a strong signal of
change in the state of the measurement system, investigate for
root causes. If this investigation leads to a significant change in
the measurement system, for example, a recalibration or other
major service to the measurement system, reset the run rule
counts or restart the EWMA. If frequent violation of run rules
or EWMA control limits is encountered, this may signal that
the measurement system is not properly validated and hence
lacks robustness. In this case, validate the measurement system
against its requirements. If the investigation into the root
causes does not lead to a significant change in the measurement
system, continue with the current control chart but treat results
as suspect and use them with great caution.

A1.5.4 MR Chart—A MR of two chart is obtained by
plotting the sequential range of two values given

by:

MRi 5 ? I i 2 I i 2 1? ( A 1 . 2 0 )

and connecting each point.
A1.5.4.1 The upper control limit for the MR chart is given

by:

UCLMR 5 3.27 MR̄ ( A 1 . 2 1 )

A1.5.4.2 There is no lower control limit for an MR chart.

A1.5.5 Examples of Control Charts for QC and Check
Standard Results:

A1.5.5.1 Example of a MR Chart for QC Results—MRi
values for the data from Table A1.3 are calculated and plotted

in sequence. After 15 results are obtained, the MR̄5 0.500 value
is calculated and added to the plot. Computations are shown in
Table A1.9. A UCLMR=1.64 is added to produce the MR chart
(Fig. A1.9).

A1.5.5.2 Example of I Chart and EWMA Overlay for QC
Results—The average of the first 15 QC results (Table A1.9,
Column 2) is calculated and plotted on the run chart as Ī
=55.73. The upper and lower control limits are calculated from
Eq A1.10 and Eq A1.11 as 54.25 and 57.21 and added to the
run chart to produce the I chart (Fig. A1.10). EWMA values
(Table A1.9, Column 4) and EWMA control limits, 54.99 and
56.47, are overlaid on the I chart. Additional results and
calculated EWMA values are added as they are determined.

A1.5.5.3 Example of a MR Chart for Multiple Results from
a Single Check Standard—MRi values are calculated and
plotted in sequence. After 15 results are obtained (Table A1.4),
the MR̄ value is calculated and added to the plot. A UCLMR is
added to produce the MR chart (see Fig. A1.11).

A1.5.5.4 Example of I Chart and EWMA Overlay for
Multiple Results from a Single Check Standard—The average
of the first 20 QC results (see Table A1.4, Column 4) is
calculated and plotted on the run chart as Ī. The upper and
lower control limits are calculated from Eq A1.9 through Eq
A1.11 and added to the run chart to produce the I chart. EWMA
values and EWMA control limits may be overlaid on the I chart
(Fig. A1.12). Additional results and calculated EWMA values
are added as they are determined.

A1.5.5.5 Example of a MR Chart for Results from Multiple
Check Standards— MRi values are calculated and plotted in
sequence. After 15 results are obtained (Table A1.5, Column 6,
displayed again in Table A1.10), the MR̄ value is calculated and
added to the plot. A UCLMR is added to produce the MR chart
(see Fig. A1.13).

A1.5.5.6 Example of I Chart and EWMA Overlay for
Results from Multiple Check Standards—The average of the
first 15 QC results (see Table A1.5, Column 6) is calculated and
plotted on the run chart as Ī. The upper and lower control limits
are calculated from Eq A1.10 and Eq A1.11 and added to the
run chart to produce the I chart. EWMA values and EWMA
control limits may be overlaid on the I chart (Fig. A1.14).
Additional results and calculated EWMA values are added as
they are determined.

A1.6 t-Test

A1.6.1 A two sided t-test is used to check if a sample of
values comes from a population with a mean different from an
hypothesized value, µ0. In this practice, a t-test may be
performed on pretreated check standard test results to check for
bias relative to the ARVs. Since during pretreatment, accepted
reference value(s) have been subtracted from the raw results,
the hypothesized mean value is zero.

A1.6.1.1 For the purpose of performing the t-test, two
methods for calculating the t value are presented:

(1) By the root-mean square method, the standard deviation
of the pretreated results is calculated as:

D6299 − 13

12Copyright ASTM International
Provided by IHS under license with ASTM

S I 5 ! (i 5 1
n

~ I i 2 Ī!
2

n 2 1
( A 1 . 2 2 )

(2)The t value is calculated as:

t 5 =n? Ī 2 µ 0? / S I ( A 1 . 2 3 )
where µ0 is the hypothesized mean, which is zero (see

A1.6.1).
(3) Alternatively, by the MR approach, compute the alternate

t value as:

t MR 5 =n? Ī 2 µ 0? /~ MR̄/ 1.128! ( A 1 . 2 4 )
where µ0 is the hypothesized mean, which is zero (see

A1.6.1).
A1.6.1.2 Compare the computed t value from Eq A1.23

with the critical t values in Table A1.1 for (n–1) degrees of
freedom. If tMR from Eq A1.24 is used, the appropriate degrees
of freedom are (n–1)/2.

A1.6.1.3 If the absolute value of the calculated t (or tMR)
value is less than or equal to the critical t value, then µ0 is
statistically indistinguishable from the mean of the distribution.
For the case of check standard testing, this would indicate that
there is no statistically identifiable bias.

A1.6.1.4 If the absolute value of t is greater than the critical
t value, then µ0 is statistically distinguishable from the mean of
the distribution, with 95 % confidence. For the case of check
standard testing, this would indicate a statistically identifiable
bias in the measurement system.

A1.6.2 Example of t-Test Applied to Multiple Results from a
Single Check Standard—For the first 15 preprocessed results in
Column 4 of Table A1.4,Ī is –0.153. Since the results being
analyzed are the difference relative to the ARV, µ0 is zero. The
standard deviation of the first 15 preprocessed results is 0.493,
and the t value is 1.2034. The t value is less than the critical
value for 14 degrees of freedom (t14 = 2.1448), so the average
difference between the check standard results and the accepted
reference value is statistically indistinguishable from zero.

A1.6.3 Example of t-Test Applied to Results from Multiple
Check Standards—For the first 15 preprocessed results in
Column 6 of Table A1.5,Ī is –0.0719. Since the results being
analyzed are the difference relative to the ARV, µ0 is zero. The
standard deviation of the first 15 preprocessed results is 0.550,
and the t value is 0.506. The t value is less than the critical
value for 14 degrees of freedom (t14 = 2.1448), so the average
difference between the check standard results and the accepted
reference value is statistically indistinguishable from zero.

A1.7 Approximate Chi-Square Test

A1.7.1 The chi-square (χ2) test is used to compare the
estimated site precision to a published reproducibility value, as
instructed in 9.1.2.

A1.7.2 Compute the chi-square statistic.
For R’ estimated using moving range:

χ 2 5
~n 2 1 !R ‘ 2

2 R 2
( A 1 . 2 5 )

For R’ estimated using root-mean-square:

χ 2 5
~n 2 1 !R ‘ 2

R 2
( A 1 . 2 6 )

where R’ is the estimated site precision (R’=2.77 × σR’ ) and
R is the published reproducibility of the method.

A1.7.3 Compare the computed χ2 value to the critical χ2
value in Table A1.11, with (n–1)/2 degrees of freedom for χ 2
using moving range-based R’, with (n-1) degrees of freedom
for χ2 using root-mean-square based R’.

A1.7.3.1 If the computed χ2 value exceeds the tabled value,
then the site precision exceeds the published reproducibility of
the method, with 95 % confidence.

A1.7.3.2 If the computed χ2 value is less than or equal to the
tabled value, then the site precision is either less than or
statistically indistinguishable from the published reproducibil-
ity of the test method.

A1.7.4 Example—The site precision calculated from R’ =
2.77 × σR’ for the first 20 QC results in Table A1.3 is 1.24. The
published reproducibility for the measurement method at the
58.88 level is 1.05. χ2 is therefore 19 × 1.242 / 1.052 = 26.50.
This value is less than the critical value of 30.1 for 19 degrees
of freedom, so the site precision is not statistically greater than
the published reproducibility of the test method.

A1.8 Approximate F-Test

A1.8.1 In this practice, an approximate F-test is used to
compare the variation exhibited by a measurement system over
two different time periods. It can also be used to compare the
site precision estimated from a series of results from one QC
sample with that estimated using a different QC sample (see
8.6.1).

A1.8.2 Compute the F value.
For σ estimated using moving range:

F 5 MR̄ 1
2/ MR̄2

2 ( A 1 . 2 7 )

where MR̄1 is the larger of the two average moving ranges,
and MR̄2 is the smaller.

For σ estimated using root-mean-square:

F 5
σ 1

σ 2
2 ( A 1 . 2 8 )

where precision 1 (σ1) is larger than (or equal to) precision 2
(σ2). So F ≥ 1.

A1.8.3 Compare the computed F value to the critical F
value read from Table A1.12, with (n1-1) degrees of freedom
for the numerator and (n2-1) degrees of freedom for the
denominator.

A1.8.3.1 If the computed F value exceeds the tabled value,
then the two precisions are statistically distinguishable. We can
be 95 % confident that the process that gave rise to precision 1
(σ1) is less precise (has larger site precision) than the process
that produced precision 2 (σ2).

A1.8.3.2 If the computed F value is smaller than the tabled
value, then the precisions of the two samplings of the mea-
surement process are statistically indistinguishable.

NOTE A1.7—Although the approximate F-test is conducted at the 95 %

D6299 − 13

13Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS
–`,,“`,,,,““-`-`,,`,,`,`,,`—
//^
:^
^#
^~
^^
“~
@
:^
“^
:*
^@
$~
“#
:*
~^
**
“#
$^
~*
~:
@
^~
:^
*#
^^
“”
$”
\\

probability level, the critical F values against which the calculated F is
compared come from the 97.5 percentiles of the F-statistic. If the ratio

MR̄a
2/ MR̄b

2 is calculated without requiring that the larger variance is in
the numerator, the ratio would have to be compared against both the lower
2.5 percentile point and the upper 97.5 percentile point of the
F-distribution to determine if the two variances were statistically distin-
guishable. Because of the nature of the F-distribution, comparing

MR̄a
2/ MR̄b

2 to the 2.5 percentile point when MR̄a
2/ MR̄b

2 is equivalent to

comparing MR̄b
2/ MR̄a

2 to the 97.5 percentile point. Requiring that larger
variance is always in the numerator allows the“ two-tailed” test to be
accomplished in one step. If the variance of the two populations were

equal, then there would be only a 2.5 % chance that MR̄1
2. MR̄2

2 by more

than the tabulated amount, and a 2.5 % chance that MR̄2
2. MR̄1

2 by more
than the tabulated amount with degrees of freedom reversed.

A1.8.4 If two precision estimates are statistically
indistinguishable, they may be pooled into a single estimate.
For example, if MR̄1 or precision 1 (σ1) was obtained from
measurements on a single lot of QC sample material, while
MR̄2 precision 2 (σ1) was obtained from measurements on a
different lot of material, and, if they are not statistically
distinguishable, they may be pooled. The appropriate pooled
precision estimate is:

For moving range based precision:

MRpooled 5 Œ~n 1 2 1 !~MR1! 21~n 2 2 1 ! ~MR2! 2n 1 1 n 2 2 2 ( A 1 . 2 9 )
For root-mean-square based precision:

σ pooled 5 Œ~n 1 2 1 !~σ 1! 21~n 2 2 1 ! ~σ 2! 2n 1 1 n 2 2 2 ( A 1 . 3 0 )
A1.8.5 Example—Table A1.13 contains QC results for a

second QC sample measured by the same measurement system
used to generate the results in Table A1.3. The standard
deviation (σ) for the 25 results from the original QC sample
(Table A1.3) is 0.439. The standard deviation (σ) for the 23
results for the new QC sample is 0.883. The F value is 4.05,
which is larger than the critical value of 2.36 for 22 and 24
degrees of freedom in the numerator and denominator, respec-
tively. Based on standard deviation, the precision of the
measurements for the two QC batches would be statistically
different, and hence the standard deviations should not be
pooled.

NOTE A1.8—For the example in A1.8.5 using Table A1.13 data, the
conclusion using root-mean-square based standard deviation is the correct
conclusion, and this is different than the conclusion reached using the
moving ranges based standard deviation. Visual examination with confir-
mation from the Q–procedure showed a downward trend that induced
autocorrelation in the data. The moving ranges based technique did not
capture the overall variation in the dataset, and therefore, it did not provide
the correct conclusion.

A1.9 Q-Procedure

A1.9.1 Collect and prepare a new batch of QC material.
A1.9.1.1 If the validity of the first result of the new QC

material is to be inferred by a test result of the previous QC
material, the new batch of QC material should be collected
when the current QC material supply remaining can support no
more than two analyses.

A1.9.2 Validate the first result obtained on the new QC
material either by a concurrent test of the soon-to-be-depleted

QC material, or by concurrently testing a check standard. If no
special-cause signals are noted, then the result for the new
material is considered to be valid.

A1.9.3 Plot the result from the new material as the first point
on the Q–chart.

NOTE A1.9—One way to better understand the difference between the I
/ EWMA and the Q / QEWMA techniques is: The I / EWMA uses a
“forward looking” strategy where the in-statistical-control decision limits
are fixed, and all future data is judged against these fixed limits. The Q /
QEWMA uses a “backwards looking” strategy where these decision limits
are recalculated with arrival of each new datum and then applied to the
current and all past data to judge if the process is in control (because if it
is, then current and all past data should be inside the decision limits).

A1.9.3.1 Center this value on the y-axis of the new chart.
Scale the y-axis to allow room for the initial result plus and
minus five historical standard deviations, where the standard
deviations are appropriate to the level of the first result.

A1.9.3.2 No center line, nor upper or lower control limits,
are plotted at this time.

A1.9.4 Subsequent QC sample testing may be done only on
the new material.

A1.9.5 Plot subsequent QC results as points on the new
Q–chart. Do not connect the points.

A1.9.6 As each point (the n th point) is plotted, compute and
plot the center value and the upper and lower control limits
applicable for this result.

A1.9.6.1 Center Value:

C n 5 (
i 5 1

I i/ n ( A 1 . 3 1 )

where the sum includes the latest result, In. Replace any pre-
vious center line with a new line at the latest value of Cn.
Optionally plot and connect the sequence of points {Cn}
with a broken line to show the trajectory of this statistic
with past data.

A1.9.6.2 Upper Control Limit:

UCLn 5 C n1 3 σŒ~n 2 1 !n ( A 1 . 3 2 )
where σ is the historical standard deviation appropriate for
test level Cn. For example, if the standard deviation is un-
changed from the exhausted QC sample, then σ 5 MR̄/ 1.128.
Replace any previous upper control limit lines with a new
line at the latest UCLn. Optionally, connect the sequence of
points {UCLi} with a broken line to show the trajectory of
this statistic with past data.

A1.9.6.3 Lower Control Limit:

LCLn 5 C n 2 3 σŒ~n 2 1 !n ( A 1 . 3 3 )
Replace any previous lower control limit lines with a new
line at the latest LCLn. Optionally, connect the sequence of
points {LCLi} with a broken line to show the trajectory of
this statistic with past data.

A1.9.7 Individual values, current or earlier, which are out-
side the current upper or lower control limits, are indications of
an unstable system, and efforts should be made to determine
the cause. In a similar fashion to the I chart (as described in
A1.5.1), one of the following strategies shall be used to detect

D6299 − 13

14Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS
–
–
`
,
,
`
`
`
,
,
,
,
`
`
`
`
–
`
–
`
,
,
`
,
,
`
,
`
,
,
`
–
–
–
//^:^^#^~^^”~@
:^”^:*^@
$~”#:*~^**”#$^~*~:@
^~:^*#^^””$”\\

changes in state of the measurement system that are considered
to constitute an out-of-control situation.
Strategy 1: Run Rule Strategy
Any one of the following occurrences shall be interpreted as
a strong signal that a change in state of the measurement
system has likely occurred:

A1.9.7.1 Two consecutive results on the Q–chart that are

more than 2 σŒ~n 2 1 !
n

distant from the current expected value,

Cn, in the same direction;

A1.9.7.2 Five consecutive results on the Q–chart that are

more than σŒ~n 2 1 !
n

distant from the current expected value in

the same direction.

A1.9.7.3 Nine or more consecutive results on the Q–chart
that are on the same side of the current expected value.

A1.9.7.4 Seven points in a row steadily increasing or
decreasing.

A1.9.8 Continue or replace the MR chart, as appropriate.
A1.9.8.1 If the standard deviation for the new QC material

is the same as for the old material, continue the old MR chart
beginning with MR2, that is, the second result from the new
material.

A1.9.8.2 If the standard deviation appropriate to the level of
the new material is different from the old, begin a new MR
chart, starting with MR2. The upper control limit for the new
chart should be placed at 3.69σ.

A1.9.8.3 After 15 results have been obtained with the new
material, use a chi-square (see A1.7) or F-test (see A1.8) to
check that σ is appropriate for the new material.

Strategy 2: EWMA (Exponentially Weighted Moving
Average) Strategy

A1.9.9 EWMA Overlay on a Q–Chart—An EWMA chart
may be overlaid on a Q–chart, although it will not be
meaningful until n > 5.

A1.9.9.1 The sequence of EWMA values, EWMAi, are
calculated, and overlaid on the I chart and connected. Use the
following recursion:

EWMA1 5 I 1 ( A 1 . 3 4 )

EWMAi 5 ~1 2 λ !EWMAi 2 1 1 λ I i ( A 1 . 3 5 )

where λ is the exponential weighting factor, typically set to
0.4.

A1.9.9.2 The upper control limit for the EWMA chart is

UCLEWMA 5 C n 1 3 σŒS λ2 2 λ D 1 2S 1 2 λ2 2 λ D ~1 2 λ ! 2 ~n 2 1 ! 2 1n
( A 1 . 3 6 )

A1.9.9.3 The lower control limit for the EWMA chart is

LCLEWMA 5 C n 2 3 σŒS λ2 2 λ D 1 2S 1 2 λ2 2 λ D ~1 2 λ ! 2 ~n 2 1 ! 2 1n
( A 1 . 3 7 )

A1.9.9.4 The upper and lower EWMA (UCLEWMA and
LCL

EWMA
) control limits associated with Cn are plotted in a

similar fashion as the UCLn and LCLn described in A1.9.6.2
and A1.9.6.3. Individual EMWA values, current or earlier,
which are outside the current EWMA upper or lower control
limits, are indications of an unstable system, and efforts should
be made to determine the cause.

A1.9.10 Q-Chart Example—Table A1.13 is a collection of
the QC results for a second batch of QC material for the
measurement system in Table A1.3. It is assumed that the first
result is validated. The individual values are plotted as they are
collected, (diamonds in Fig. A1.15a), and the Cn and UCLn and
LCLn values are calculated and added (solid lines in Fig.
A1.15a, b) for each new result. Recall that MR̄ from the first 15
measurements on batch 1 was 0.500. The new control limits
(Table A1.13, Columns 5 and 6) are compared to the current
and previous results. Note that, for this example, the second
result is considered “out of control” when UCL is calculated.
The “out-of-control” character of this result is confirmed as
UCL is updated with additional data. With point 2 excluded
from subsequent calculations, the Q chart detected an out-of-
control situation at point 11. The Q –chart clearly shows that
the results for the new QC sample trended downward with
time. Similarly, the EWMAn and associated control limits are
also plotted in Fig. A1.15a, b (values are not shown in Table
A1.12).

D6299 − 13

15Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS
–`,,“`,,,,““-`-`,,`,,`,`,,`—
//^:^^#^~^^”~@:^”^:*^@$~”#:*~^**”#$^~*~:@^~:^*#^^””$”\\

TABLE A1.1 95th Percentile of Student’s t Distribution (1 through
100)

Degrees of Freedom t

1 12.7062
2 4.3027
3 3.1824
4 2.7764
5 2.5706
6 2.4469
7 2.3646
8 2.3060
9 2.2622
10 2.2281
11 2.2010
12 2.1788
13 2.1604
14 2.1448
15 2.1314
16 2.1199
17 2.1098
18 2.1009
19 2.0930
20 2.0860
21 2.0796
22 2.0739
23 2.0687
24 2.0639
25 2.0595
26 2.0555
27 2.0518
28 2.0484
29 2.0452
30 2.0423
31 2.0395
32 2.0369
33 2.0345
34 2.0322
35 2.0301
36 2.0281
37 2.0262
38 2.0244
39 2.0227
40 2.0211
41 2.0195
42 2.0181
43 2.0167
44 2.0154
45 2.0141
46 2.0129
47 2.0117
48 2.0106
49 2.0096
50 2.0086
55 2.0040
60 2.0003
65 1.9971
70 1.9944
75 1.9921
80 1.99006
85 1.98827
90 1.98667
95 1.98525
100 1.98397

D6299 − 13

16Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS
–`,,“`,,,,““-`-`,,`,,`,`,,`—
//^:^^#^~^^”~@:^”^:*^@$~”#:*~^**”#$^~*~:@^~:^*#^^””$”\\

TABLE A1.2 95th Percentile of Student’s t Distribution (105
through 200)

Degrees of Freedom t

105 1.98282
110 1.98177
115 1.98081
120 1.97993
125 1.97912
130 1.97838
135 1.97769
140 1.97705
145 1.97646
150 1.97591
155 1.97539
160 1.97490
165 1.97445
170 1.97402
175 1.97361
180 1.97323
185 1.97287
190 1.97253
195 1.97220
200 1.97190

TABLE A1.3 Example of a Sequence of Results from a Single QC
Sample

Sequence Number
i

QC/Check Standard
Result
Yi = Ii

Sequence Number
i
QC/Check Standard
Result
Yi = Ii

1 55.3 14 55.2
2 55.8 15 56.5
3 56.3 16 55.7
4 56.1 17 55.6
5 55.8 18 55.2
6 55.5 19 55.7
7 55.3 20 56.1
8 55.4 21 56.3
9 56.6 22 55.2
10 56.1 23 55.4
11 55.0 24 55.4
12 55.5 25 55.6
13 55.5

TABLE A1.4 Example of a Sequence of Results from a Single
Check Standard

Sequence Number
Check Standard

Result
Accepted

Reference Value
Difference

Result – ARV
(Yi) (ARV = Xi) Ii

1 55.3 55.88 -0.58
2 55.8 55.88 -0.08
3 56.3 55.88 0.42
4 56.1 55.88 0.22
5 55.8 55.88 -0.08
6 55.5 55.88 -0.38
7 55.3 55.88 -0.58
8 55.4 55.88 -0.48
9 56.6 55.88 0.72
10 56.1 55.88 0.22
11 55.0 55.88 -0.88
12 55.5 55.88 -0.38
13 55.5 55.88 -0.38
14 55.2 55.88 -0.68
15 56.5 55.88 0.62
16 55.7 55.88 -0.18
17 55.6 55.88 -0.28
18 55.2 55.88 -0.68
19 55.7 55.88 -0.18
20 56.1 55.88 0.22
21 56.3 55.88 0.42
22 55.2 55.88 -0.68
23 55.4 55.88 -0.48
24 55.4 55.88 -0.48
25 55.6 55.88 -0.28

TABLE A1.5 Example of Results for Multiple Check Standards
Where the Precision of the Measurement System Is Level

Dependent

Result
Sequence
Number, i

Raw
Result Yi

ARV
Xi

Raw
Difference

σi
Preprocessed

Result
Ii

1 71.0 71.4 -0.40 1.14 -0.35
2 65.8 64.9 0.90 1.10 0.82
3 70.3 70.2 0.10 1.13 0.09
4 66.2 67.7 -1.50 1.11 -1.35
5 93.8 93.4 0.40 1.26 0.32
6 102.9 104.0 -1.10 1.33 -0.83
7 102.2 101.8 0.40 1.31 0.30
8 103.2 103.9 -0.70 1.32 -0.53
9 100 99.8 0.20 1.30 0.15
10 71.6 71.5 0.10 1.14 0.09
11 76.7 76.4 0.30 1.16 0.26
12 61.2 61.8 -0.60 1.08 -0.56
13 44.1 43.9 0.20 0.98 0.20
14 69.71 69.7 0.01 1.13 0.01
15 59.5 59.19 0.31 1.06 0.29
16 99.63 98.87 0.76 1.30 0.59
17 93.7 95.21 -1.51 1.27 -1.19
18 103.77 103.94 -0.17 1.32 -0.13
19 96.18 96.7 -0.52 1.28 -0.41
20 99.7 100.65 -0.95 1.31 -0.73
21 84.32 84.15 0.17 1.21 0.14
22 83.29 83.75 -0.46 1.21 -0.38
23 65.16 65.93 -0.77 1.10 -0.70
24 68.19 68.0 0.19 1.12 0.17

D6299 − 13

17Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS
–`,,“`,,,,““-`-`,,`,,`,`,,`—
//^:^^#^~^^”~@
:^”^:*^@
$~”#:*~^**”#$^~*~:@
^~:^*#^^””$”\\

TABLE A1.6 Example Data for a Normal Probability Plot for QC
Results

Original
Sequence

No., I
z-value Sorted Result wi pi

ith Term in Eq
A1.6

11 -1.83 55.0 -1.47 0.07 -5.91
14 -1.28 55.2 -1.07 0.14 -14.35
1 -0.97 55.3 -0.86 0.19 -18.70
7 -0.73 55.3 -0.86 0.19 -21.94
8 -0.52 55.4 -0.66 0.25 -25.77
6 -0.34 55.5 -0.46 0.32 -21.44
12 -0.17 55.5 -0.46 0.32 -25.34
13 0.00 55.5 -0.46 0.32 -22.80
2 0.17 55.8 0.15 0.56 -16.52
5 0.34 55.8 0.15 0.56 -18.46
10 0.52 56.1 0.76 0.78 -11.50
4 0.73 56.1 0.76 0.78 -10.80
3 0.97 56.3 1.16 0.88 -8.65
15 1.28 56.5 1.57 0.94 -5.79
9 1.83 56.6 1.77 0.96 -3.25

TABLE A1.7 Example Data for a Normal Probability Plot for
Multiple Results from a Single Check Standard

Sort No.
Original

Sequence
No.

Sorted
Result

z-value wi pi
ith Term in
Eq A1.6

1 11 -0.88 -1.83 -1.47 0.07 -5.91
2 14 -0.68 -1.28 -1.07 0.14 -14.35
3 1 -0.58 -0.97 -0.86 0.19 -18.70
4 7 -0.58 -0.73 -0.86 0.19 -21.94
5 8 -0.48 -0.52 -0.66 0.25 -25.77
6 6 -0.38 -0.34 -0.46 0.32 -21.44
7 12 -0.38 -0.17 -0.46 0.32 -25.34
8 13 -0.38 0 -0.46 0.32 -22.80
9 2 -0.08 0.17 0.15 0.56 -16.52
10 5 -0.08 0.34 0.15 0.56 -18.46
11 10 0.22 0.52 0.76 0.78 -11.50
12 4 0.22 0.73 0.76 0.78 -10.80
13 3 0.42 0.97 1.16 0.88 -8.65
14 15 0.62 1.28 1.57 0.94 -5.79
15 9 0.72 1.83 1.77 0.96 -3.25

TABLE A1.8 Example Data for a Normal Probability Plot for
Results from Multiple Check Standards

Sort No.
Original
Sequence
No.
Sorted
Result
z-value wi pi
ith Term in
Eq A1.6

1 4 -1.35 -1.83 -2.320 0.010 -7.535
2 6 -0.83 -1.28 -1.375 0.084 -11.721
3 12 -0.56 -0.97 -0.885 0.188 -15.301
4 8 -0.53 -0.73 -0.831 0.203 -20.722
5 1 -0.35 -0.52 -0.504 0.307 -22.310
6 14 0.01 -0.34 0.150 0.560 -19.259
7 3 0.09 -0.17 0.295 0.616 -20.207
8 10 0.09 0 0.295 0.616 -21.627
9 9 0.15 0.17 0.404 0.657 -23.418
10 13 0.2 0.34 0.495 0.690 -22.641
11 11 0.26 0.52 0.604 0.727 -14.400
12 15 0.29 0.73 0.659 0.745 -11.994
13 7 0.3 0.97 0.677 0.751 -12.376
14 5 0.32 1.28 0.713 0.762 -9.718
15 2 0.82 1.83 1.621 0.948 -1.860
A2* = 0.713

TABLE A1.9 Example Data for I Chart and EWMA Overlay for QC
Results

Sequence Number,
I

QC Result (Yi=Ii) Moving Range MRi EWMAi

1 55.3 55.3
2 55.8 0.5 55.50
3 56.3 0.5 55.82
4 56.1 0.2 55.93
5 55.8 0.3 55.88
6 55.5 0.3 55.73
7 55.3 0.2 55.56
8 55.4 0.1 55.49
9 56.6 1.2 55.94
10 56.1 0.5 56.00
11 55 1.1 55.60
12 55.5 0.5 55.56
13 55.5 0.0 55.54
14 55.2 0.3 55.40
15 56.5 1.3 55.84

Average (1 to 15) 55.73 0.500

16 55.7 0.8 55.78
17 55.6 0.1 55.71
18 55.2 0.4 55.51
19 55.7 0.5 55.58
20 56.1 0.4 55.79
21 56.3 0.2 55.99
22 55.2 1.1 55.68
23 55.4 0.2 55.57
24 55.4 0.0 55.50
25 55.6 0.2 55.54

TABLE A1.10 Example Data for a MR Chart for Results from
Multiple Check Standards

Result Sequence
Number, i

Preprocessed
Result, Ii

Moving Range, MRi EWMAi

1 -0.35 -0.35
2 0.82 1.17 0.12
3 0.09 0.73 0.11
4 -1.35 1.44 -0.48
5 0.32 1.67 -0.16
6 -0.83 1.15 -0.43
7 0.30 1.13 -0.14
8 -0.53 0.83 -0.29
9 0.15 0.68 -0.12
10 0.09 0.06 -0.03
11 0.26 0.17 0.08
12 -0.56 0.82 -0.17
13 0.20 0.76 -0.02
14 0.01 0.19 -0.01
15 0.29 0.28 0.11

Average -0.073 0.791

16 0.59 0.3 0.30
17 -1.19 1.78 -0.29
18 -0.13 1.06 -0.23
19 -0.41 0.28 -0.30
20 -0.73 0.32 -0.47
21 0.14 0.87 -0.23
22 -0.38 0.52 -0.29
23 -0.7 0.32 -0.45
24 0.17 0.87 -0.20

D6299 − 13

18Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS
–
–
`
,
,
`
`
`
,
,
,
,
`
`
`
`
–
`
–
`
,
,
`
,
,
`
,
`
,
,
`
–
–
–
//^:^^#^~^^”~@
:^”^:*^@
$~”#:*~^**”#$^~*~:@
^~:^*#^^””$”\\

TABLE A1.11 95th Percentiles of the Chi Square Distribution

Degrees
Freedom

7 14.1
8 15.5
9 16.9
10 18.3
11 19.7
12 21.0
13 22.4
14 23.7
15 25.0
16 26.3
17 27.6
18 28.9
19 30.1
20 31.4
21 32.7
22 33.9
23 35.2
24 36.4
25 37.7
26 38.9
27 40.1
28 41.3
30 43.8
35 49.8
40 55.8
45 61.7
50 67.5
60 79.1
70 90.5
80 101.9

TABLE A1.12 97.5 Percentiles of the F-Statistic

Denominator, Numerator
degrees of

freedom
7 8 9 10 12 14 16 18 20 25 30 40 50 100

7 4.99 4.90 4.82 4.76 4.67 4.60 4.54 4.50 4.47 4.40 4.36 4.31 4.28 4.21
8 4.53 4.43 4.36 4.30 4.20 4.13 4.08 4.03 4.00 3.94 3.89 3.84 3.81 3.74
9 4.20 4.10 4.03 3.96 3.87 3.80 3.74 3.70 3.67 3.60 3.56 3.51 3.47 3.40
10 3.95 3.85 3.78 3.72 3.62 3.55 3.50 3.45 3.42 3.35 3.31 3.26 3.22 3.15
11 3.76 3.66 3.59 3.53 3.43 3.36 3.30 3.26 3.23 3.16 3.12 3.06 3.03 2.96
12 3.61 3.51 3.44 3.37 3.28 3.21 3.15 3.11 3.07 3.01 2.96 2.91 2.87 2.80
13 3.48 3.39 3.31 3.25 3.15 3.08 3.03 2.98 2.95 2.88 2.84 2.78 2.74 2.67
14 3.38 3.29 3.21 3.15 3.05 2.98 2.92 2.88 2.84 2.78 2.73 2.67 2.64 2.56
15 3.29 3.20 3.12 3.06 2.96 2.89 2.84 2.79 2.76 2.69 2.64 2.59 2.55 2.47
16 3.22 3.12 3.05 2.99 2.89 2.82 2.76 2.72 2.68 2.61 2.57 2.51 2.47 2.40
17 3.16 3.06 2.98 2.92 2.82 2.75 2.70 2.65 2.62 2.55 2.50 2.44 2.41 2.33
18 3.10 3.01 2.93 2.87 2.77 2.70 2.64 2.60 2.56 2.49 2.44 2.38 2.35 2.27
19 3.05 2.96 2.88 2.82 2.72 2.65 2.59 2.55 2.51 2.44 2.39 2.33 2.30 2.22
20 3.01 2.91 2.84 2.77 2.68 2.60 2.55 2.50 2.46 2.40 2.35 2.29 2.25 2.17
25 2.85 2.75 2.68 2.61 2.51 2.44 2.38 2.34 2.30 2.23 2.18 2.12 2.08 2.00
30 2.75 2.65 2.57 2.51 2.41 2.34 2.28 2.23 2.20 2.12 2.07 2.01 1.97 1.88
35 2.68 2.58 2.50 2.44 2.34 2.27 2.21 2.16 2.12 2.05 2.00 1.93 1.89 1.80
40 2.62 2.53 2.45 2.39 2.29 2.21 2.15 2.11 2.07 1.99 1.94 1.88 1.83 1.74
45 2.58 2.49 2.41 2.35 2.25 2.17 2.11 2.07 2.03 1.95 1.90 1.83 1.79 1.69
50 2.55 2.46 2.38 2.32 2.22 2.14 2.08 2.03 1.99 1.92 1.87 1.80 1.75 1.66
60 2.51 2.41 2.33 2.27 2.17 2.09 2.03 1.98 1.94 1.87 1.82 1.74 1.70 1.60
70 2.47 2.38 2.30 2.24 2.14 2.06 2.00 1.95 1.91 1.83 1.78 1.71 1.66 1.56
80 2.45 2.35 2.28 2.21 2.11 2.03 1.97 1.92 1.88 1.81 1.75 1.68 1.63 1.53
90 2.43 2.34 2.26 2.19 2.09 2.02 1.95 1.91 1.86 1.79 1.73 1.66 1.61 1.50
100 2.42 2.32 2.24 2.18 2.08 2.00 1.94 1.89 1.85 1.77 1.71 1.64 1.59 1.48

TABLE A1.13 Example of QC Results for a Second QC Sample
Measured by the Same Measurement System

Sequence
Number

QC Result MR Cn LCL UCL

1 54.2
2 56.1 1.9 55.15 54.21 56.09
3 55.2 0.9 55.17 54.08 56.25
4 54.1 1.1 54.90 53.75 56.05
5 53.7 0.4 54.66 53.47 55.85
6 54 0.3 54.55 53.34 55.76
7 54.3 0.3 54.51 53.28 55.75
8 54.8 0.5 54.55 53.31 55.79
9 53.9 0.9 54.48 53.22 55.73
10 53.2 0.7 54.35 53.09 55.61
11 52.5 0.7 54.18 52.91 55.45
12 52.8 0.3 54.07 52.79 55.34
13 54.3 1.5 54.08 52.81 55.36
14 52.7 1.6 53.99 52.70 55.27
15 53.4 0.7 53.95 52.66 55.23
16 53.1 0.3 53.89 52.61 55.18
17 54 0.9 53.90 52.61 55.19
18 53.2 0.8 53.86 52.57 55.15
19 52.8 0.4 53.81 52.51 55.10
20 53.2 0.4 53.78 52.48 55.07
21 53.1 0.1 53.74 52.44 55.04
22 53.3 0.2 53.72 52.42 55.02
23 52.8 0.5 53.68 52.38 54.98

D6299 − 13

19Copyright ASTM International
Provided by IHS under license with ASTM

FIG. A1.1 Example of a Run Chart for QC Results

FIG. A1.2 Run Chart for Multiple Results from a Single Check
Standard

FIG. A1.3 Run Chart for Results from Multiple Check Standards

D6299 − 13

20Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS
–
–
`
,
,
`
`
`
,
,
,
,
`
`
`
`
–
`
–
`
,
,
`
,
,
`
,
`
,
,
`
–
–
–
//^:^^#^~^^”~@
:^”^:*^@
$~”#:*~^**”#$^~*~:@
^~:^*#^^””$”\\

FIG. A1.4 z–Values

D6299 − 13

21Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS
–`,,“`,,,,““-`-`,,`,,`,`,,`—
//^:^^#^~^^”~@
:^”^:*^@
$~”#:*~^**”#$^~*~:@
^~:^*#^^””$”\\

FIG. A1.4 z–Values (continued)

D6299 − 13

22Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS
–
–
`
,
,
`
`
`
,
,
,
,
`
`
`
`
–
`
–
`
,
,
`
,
,
`
,
`
,
,
`
–
–
–
//^:^^#^~^^”~@
:^”^:*^@
$~”#:*~^**”#$^~*~:@
^~:^*#^^””$”\\

NOTE 1—Probability (z < wi), where wi is the sum of the number in the left column and top row. FIG. A1.5 pi Values

D6299 − 13

23Copyright ASTM International
Provided by IHS under license with ASTM

Not for ResaleNo reproduction or networking permitted without license from IHS
–
–
`
,
,
`
`
`
,
,
,
,
`
`
`
`
–
`
–
`
,
,
`
,
,
`
,
`
,
,
`
–
–
–
//^:^^#^~^^”~@
:^”^:*^@
$~”#:*~^**”#$^~*~:@
^~:^*#^^””$”\\

FIG. A1.5 pi Values (continued)

D6299 − 13

24Copyright ASTM International
Provided by IHS under license with ASTM

FIG. A1.6 Example of a Normal Probability Plot for QC Results

FIG. A1.7 Example of a Normal Probability Plot for Multiple Re-
sults from a Single Check Standard

FIG. A1.8 Example of a Normal Probability Plot for Results from
Multiple Check Standards

FIG. A1.9 Example of a MR Chart for QC Results

FIG. A1.10 Example of an I-Chart with EWMA Overlay for QC Re-
sults

FIG. A1.11 Example of a MR Chart for Multiple Results from a
Single Check Standard

D6299 − 13

25Copyright ASTM International
Provided by IHS under license with ASTM

FIG. A1.12 Example of an I-Chart with EWMA Overlay for Multiple
Results from a Single Check Standard

FIG. A1.13 Example of a MR Chart for Results from Multiple
Check Standards

FIG. A1.14 Example of an I-Chart with EWMA Overlay for Results
from Multiple Check Standards

D6299 − 13

26Copyright ASTM International
Provided by IHS under license with ASTM

REFERENCES

(1) Quality and Statistics: Total Quality Management, STP 1209,
Kowalewski, Jr., Milton J., editor, ASTM International, 1994.

(2) Manual on Presentation of Data and Control Chart Analysis, Manual
7A, ASTM International, 2002.

(3) Glossary and Tables for Statistical Quality Control, ASQ Statistics
Division, 4th ed., American Society for Quality, 2004.

(4) Quesenberry, C. P., “SPC Q-Charts for Start-up Processes and Short
or Long Runs,” Journal of Quality Technology, Vol 23, No. 3, July
1991, pp. 213-224.

(5) Hunter, J. S., “The Exponentially Weighted Moving Average,” Jour-
nal of Quality Technology, Vol 18, No. 4, October 1986, pp. 203-210.

(6) Hunter, J. S., “A One-Point Plot Equivalent to the Shewhart Chart
with Western Electric Rules,” Quality Engineering, Vol 2, No. 1,
1989-1990, pp. 13-19.

a—Example of a Q-chart for a New QC Sample with 4 accrued data points and optional trajectory of control limits. Note—at Point 4, the system is deemed to be
Out of Control because not all points fall inside the control limits calculated at Point 4 (Point 2 is the offending datum).

b—Q-chart from Fig. A1.15a (above) with 11 accrued data points and optional trajectory of control limits. Note—at Point 11, the system is deemed to be Out of
Control because Point 11 is outside the control limits calculated at Point 11(Point 2 excluded in Control Limits Calculations Commencing from Point 3 onwards).

FIG. A1.15 Q–chart Examples

D6299 − 13

27Copyright ASTM International
Provided by IHS under license with ASTM

SUMMARY OF CHANGES

Subcommittee D02.94 has identified the location of selected changes to this standard since the last issue
(D6299 – 10ε2) that may impact the use of this standard. (Approved Oct. 1, 2013.)

(1) Revised 8.4.3 and A1.4.2.6.

This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,
United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the above
address or at 610-832-9585 (phone), 610-832-9555 (fax), or service@astm.org (e-mail); or through the ASTM website
(www.astm.org). Permission rights to photocopy the standard may also be secured from the Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http://www.copyright.com/

D6299 − 13

28Copyright ASTM International
Provided by IHS under license with ASTM

Write a brief overviews of the following areas, what is it and what purpose does it serve:

What is SQC?

What is TPI?

What is PM?

What is Correlation schemes?

What is Internal auditing?

What is NOC?

What is QI?

What is NCPR?

For example you can define as: SQC is the statistical tool to ensure the quality of product or service provided by continuous monitoring of product or service against approved/agreed quality.

In Lab SQC which is abbreviation of Statistical Quality Control. Meaning put a process in place to monitor the quality of analysis we produce by collecting 24 data point of a representative sample . For example if we want to monitor the DGA concentration analysis. we have to collect a sample from any of Unit 731 to 734 and perform the DGA analysis over period of time across each shift to get the results for different Technician. After collection of 24 data we have to calculate the sigma, 2 sigma and 3 sigma for upper and lower limits

Once SQC Chart created electronically in the system with all sigma and moving range. Technician will do the analysis and monitor against the run rules

For SQC refer to email which I sent to you earlier and reminder now. See ASTM D6299 for SQC in detail

There are 8 run rules for SQC monitoring which I mention in the QC/QA presentation which I sent to you.

Please go to the presentation for further detail regarding SQC run rules.

Next is TPI

TPI is the Test Performance index.

test performance index (TPI), n—an approximate measure of a laboratory’s testing capability, defined as the ratio of test method reproducibility to site precision.

Refer to ASTM D 6792 for TPI

However it can be calculated as under: Test Performance Index (TPI)= Test Method Reproducibility/ Site Precision.

Site Precision can be calculated as: site precision (R8), n—the value below which the absolute difference between two individual test results obtained under site precision conditions may be expected to occur with a probability of approximately 0.95 (95 %). It is defined as 2.77 times the standard deviation of results obtained under site precision conditions.

Site Precision=2.77*Standard Deviation of the analysis

So TPI=Test Method Reproducibility/2.77*Standard Deviation

For a published standard test method with a PR less than 4 the following TPI criteria should be applied. 10.3.1.1 A TPI greater than 1.2 indicates that the performance is probably satisfactory relative to ASTM published precision. 10.3.1.2 A TPI greater than or equal to 0.8 and less than or equal to 1.2 indicated performance may be marginal and the laboratory should consider method review for improvement. 10.3.1.3 A TPI less than 0.8 suggests that the method as practiced at this site is not consistent with the ASTM published precision. Either laboratory method performance improvement is required, or ASTM published precision does not reflect achievable precision. Existing interlaboratory exchange performance (if available) should be reviewed to determine if the latter is plausible.

It means that TPI index if >1.2 the lab performance is satisfactory and within the Precision of Standard method.

For more detail refer to ASTM D6792 for TPI

Next is correlation sample , which is the inter laboratory testing scheme like Fapas or IIS. In this international organization arrange samples of interest and different lab participate in the program and z-score of each lab evalute to rate their perfromance

NOC is Notification of Change

When ever there is any change in procedure or schedule or any thing in the lab which need to communicate .It should be via NOC

QI stand for Quality investigation to investigate any quality incident in which any breach of quality investigated to find out the root cause

NCPR is Non Conformance Product Report

Internal Audit is the audit which done by internally to follow the Plan, do, act and Check cycle for quality assurance.

It mean we have to check internally that all procedures are valid and update and we are following to get the purpose.

High light any observation for improvement within the lab

Turn in your highest-quality paper
Get a qualified writer to help you with

“ answer these questions related to the laboratory ”

Get high-quality paper

NEW! AI matching with writer