By Authority Of

THE UNITED STATES OF AMERICA

Legally Binding Document
By the Authority Vested By Part 5 of the United States Code § 552(a) and
Part 1 of the Code of Regulations § 51 the attached document has been duly
INCORPORATED BY REFERENCE and shall be considered legally
binding upon all citizens and residents of the United States of America.
HEED THIS NOTICE: Criminal penalties may apply for noncompliance.

e
Document Name: ASQC Q9004-1: Quality Management and Quality
Systems Elements-Guidelines

CFR Section(s): 24 CFR 200.935(d)(4)(ii)(A)(5)

Standards Body: American Society for Quality Control

Official Incorporator:
THE EXECUTIVE DIRECTOR
OFFICE OF THE FEDERAL REGISTER
WASHINGTON, D.C.
 ANSIiAsac Q9004-1

ADOPTION NOTICE

ANSIIASOC 09004-1, -Quality Management and Quality System Elements--

Guidelines, U was adopted on 15 September 1994 for use by the Department of Defense
(000). Proposed changes by 000 activities must be submitted to the 000 Adopting
Activity: Office of the Assistant Secretary of the Air Force for Acquisition, Deputy
Assistant Secretary for Management Policy and Program Integration, Manufacturing
and Quality Division, AnN: SAF/AQXM, 1060 Air Force Pentagon, Washington, DC
20330-1060. DoD activities may obtain copies of this standard from the
Standardization Document Order Desk, 700 Robbins Avenue, Building 40,
Philadelphia, PA 19111-5094. The private sector and other Government agencies
may purchase copies from The American Society for Quality Control, 611 East
Wisconsin Avenue, Milwaukee, WI 53202.

Custodians: Adopting Activity:

Army - AR Air Force- 05
Navy - OS (Project QCIC-0188)
Air Force - 05

AREA QCIC

DISTRIBUTION STATEMENT A: Approved for public release; distribution is unlimited.

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 ANSVASac 09004-1-1994

AMERICAN NATIONAL STANDARD

Quality Management and Quality System

Elements-Guidelines

Prepared by
American Society for Quality Control Standards Committee
for
American National Standards Committee Z-1 on Quality Assurance

An American National Standard Approved on July 18, 1994

Descriptors: quality management, quality ~s. canponents. general conditions.

American NadonaJ Sklndards: An AmeJ'k:an National Standard implies a coosensus of those substantially concerned with
its scq>e and provisions. An Amerbn National Standard is intended as a guide to aid the manufac~ the consume!;
and the general public. The existence of an American National Standard does not in any respect preclude an)9ne. whether
he oc she bas approo.ed the standard or not. Ii:ml manufacturing, purchasing. or using pudO::Is, ~, or puredures
not contOOning to the standan:l. Amerbn Nati>nal Standards are subject to periodic review and users are cautioned to
obtain the latest edition.
Caution Notice: This American National Standard may be revised or withdrawn at any time. The procedures of the
American National Slandards Institute require that acfun be taken 10 reaffirm. revise, or withdraw this standard no later
than fhe years fmn the date of publication. Purchasers of American National Standards may receive current information
on all standards by calling or writing the American National Standards Institute.

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 © 1994 by ASQ!::.
All rights reserwd. No part ct this bocic may be reproduced in any 1brm ex by any means, electronic, mechanical, photo-
cqJying, recording, cr otherwise. without the prior written permission of the pubiN1et
~ Mission: 10 facilitate continuous irnprmemeot and increase cusloroer satigfacJjoo by identifying. communicating,
and pomoting the use of quality principles, concepts, and technologies; and thereby be recognized throughout the world
as the leading authority on, and champion for, quality. .
10987 6 5 4 3 2 1
Printed in the United States of America
@§ Printed on acid-free recycled paper
Published by:
ASQC
611 East Wisconsin Avenue
Milwaukee, Wisconsin 532()2

...

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 ANSI/ASq::, Q9OO4-1-1994

Contents
Page

Scope " .................••...•.............••.•...•............. , ..•... , ... , .....•

2 :Norrnathe reti:rences .............•.•..••.•...•.•.••••..................................

3 Definitions ...••..•.••..•.••.•.•.••.••••••.•...•..•.••..•••...•................••....

4 Management responsibility. . . . . • . . • • . . . . . • . . • . • . • • . • • • • . . • . . • . • . . . . . . . . . . . . . • . . . . . . . . . . . . 2

5 Quality-system eleo1ents .•.. . • • . . . • • . • • • • • • • . • . • • . . . . . . • • . • . . . . • . . . • . . . • . . . . . . • . . . . . • . • . 5

6 Financial considerations of quality systenlS •••••••••••.•.••••••.••.•••.....•.....•.•.•.••.••.• ' 1

7 Quality in marketing . . . • . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

8 Quality in specification and design • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • . • • . • . . • . . • . . . . . • • . . . • • . • .• 8

9 Quality in purchasing • . • . • . • • . . • • • . • . . • • • • . . • • • . • • . . . . . • • • • • • . • . • . . . . . . . . . . . . . . . . . . • . .. 11

10 Qualityof~ .......•.............••.•.....••..•..........•............•......... 12

11 Conllol of JXOCeSSeS. • • • • • • • . • • • • • • • • . • • • • • • • • • • . . • • . • • • . • • • • . • . . • . • • . • . • . . . . . • . • • . . • • •. 13

12 PIoduct ~ri.fication .....................•..•.......................................... , 15

13 COnbtiof~,~g,and~equqxnent .•..............•..•......................... 15

14 ContIul.ofnonconfonningpoduct ......................... " . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 16

15 CorrectNeaction................................................ . . . . . . . . . . . . . . . . . . . . .. 17

16 ~octionactivities .•.•.•.•...••••.••••...•••...•••••............•........•....• , .. , 17

17 Quality tecOrds. . • • • • . • . • . • • . • • • • • • • . . • • • • • • • • • . • . • . • • . . . • • • • • • . . . • . . . . . . . . . . . • • . • . . .• 18

18 IUsonnel........................................................................... 19

19 Product safuty. . • . . • • • . • • . . . . . • . • • • • • • . • • • • • • • • . . . . • • . . • . . . . . • . . . . . . . . . . . • . . . . . • • • • . •. 20

20 tBe <i statisticallTlethods . • . . . • . • • . • • . • • • • • • • • • . • • . • . . . • . . . . • . . . . . . . . . . . . . . . . . . . . . . . . . . .. 20

Annex
A Bibliography......................................................................... 21

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 Foreword
(This Forev.urd is not a part of American National Standard Quality Management and Quality System Elemenl.5-
Guidelines.)

This American National Standard corresponds to the International Standard ISO 9004-1: 1994. The initial five ISO 9000
series standards, ISO 9000, ISO 9001, ISO 9002, ISO 9003, and ISO 9004, when pubfubed in the United StaLes as
American National Standards in 1987, were designated as ANSV~ Q90 through ANSl/AS(X. 094 respectively. The
lhe 1987 standards in their 1994 international revisions are now designated ISO 9000-1, ISO 9001, ISO 9002, ISO 9003,
and ISO 9004-1 respectively. Their pubLication as American National Standards are oow designated ANSI/ASQ!2 Q9000-
1-1994. ANSI/ASQC Q9OO1-1994. ANSI/ASQC Q9OO2-1994. ANSI/ASQC Q9003-1994. and ANSI/ASQC Q9OO4-1-
1994 respectively. This new numbering system is intended to emphasize the word-for-v.urd correspondence of the
Internati:>nal and American National Standards.
ISO (the International Organization for Standardization) is a \\Uldwide federation of national standards bodies (ISO
member bodies). The \\Ork of pretming Int.ernationaJ Standards is normally carried out through ISO technical commil-
tees. Each member body interested in a subject for which a technical canmiUee has been establimed has the right to be
represented on that committee. International organizations. goYeI1Ullenlal and nongmemmental, in liaison with ISO. also
take (mt in the v.a'k. ISO collaborates closdy with the International Electrotechnical Canmission (IEC) on all matters of
electrot.echnical standardiz.aOOn. The American National Standards In&itute (ANSI) is the U.S. mOOlber body of ISO.
ASI:Y2 is the U.S. member of ANSI responsible for quality management and related Slandards.
Users should note that all ANSI/ASQC standards undergo revision from time to time. In the case of International
Standards adopted as American National Standards, the revisWJn timing is influenced by the international revision timing.
Reference herein to any other standard implies the latest American NatiJnal Standard revision ~ otherwise stated.
Comments concerning this standard are welcome. They should be sent 10 the sponsor of the standard, American Society
for Quality Control. 611 East Wisconsin Avenue, P.O. Box 3005. Milwaukee, WI 53201-3005, clo Standards
Administratot

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 Introduction
0.1 GENERAL
ANSI/ASCX: Q9OO4-1-1994 and all the International Standards in the ISO 9000 family are generic and independent of
any specific indrutty or economic sectoc Col1ectivdy they provide guidance for quality management and modds for qual-
ity assurance.
The International Standards in the ISO 9000 family describe what eiemenlS quality systems should encom{mS, but not
how a specific organization sbould implement these eJemenlS. Because the needs of organizations vary, it is not the pur-
pose IX these IntemationaI Standards or the corresponding Amezican National Standards to enforce unifunnity of quality
systems. The design and implementation of a quality &)'Stem will be influenced by the particuJar oojectiws, products,
~, and individual Jr.ldices of the cxganization.

A {Ximary concern of any organization shadd be the quality of ilS prodocts. (See 3.5 tOr the definition of "prodoct" which
inclooes service.)
In order to be suc~, an organizaOOn should offer prodocts that:
a) meet a v.ell-defined need, use, ()(" purpose;
b) satisfy customers' expectations;
c) comply with applicable standards and specificaoons;
d) COOlply with requirements of society (see 3.3);
e) reflect environmental needs;
f) are made available at competitive prices;
g) are provided economically.

0..2 ORGANIZATIONAL GOALS

In order to meet its objectives. the organization should ensure that the technical, administrative, and human fuctors affect-
ing the quality of its products will be under control, whether hardware, software, processed materials, or servD:s. All such
contml should be oriented Dwanls the reduction, eliminatioo, and, most importantly, preventbn of quality oonconlbnnities.
A quality ~m should be devcloped and implemented for the purpose of accomplishing the objectives set out in the orga-
nization's quality pOOcy.
Each element (or requirement) in a quality system varies in importance from one type of activity to another and from one
prodoct to anothe[
In order to oc~ maximum effectiveness and to satisfy customer expectations. it is essential that the quality system be
awroPriate to the type of activity and to the product being offered.

0.3 MEETING CUSTOMER/ORGANIZATION NEEDS AND EXPECTATIONS

A quality system bas t\m interrelated aspects, as fblIows.
a} The customer's needs and expectations
For the customer. there is a need fur confidence in the ability of the organization to deli..er the desired quality as well
as the consistent maintenance of that quality.
b) The organization's needs and interests
For the organizaoon. there is a business need to attain and to maintain the desired quality at an optimum cost; the ful-
fillment of this aspect is related to the planned and efficient utilization of the. technological. human, and material
resources available to the organization.

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 ANSI/ASQC Q9OO4-1-1994

Each of the abo\e aspects of a quality sy&em requires objective evidence in !he form of infurmatioo and data concerning
the quality of the system and the quality of the organization's prodocts.

0.4 BENEFITS, COSTS, AND RISKS

Benefit, cost, and risIc considerations have great importance for both !he organization and c~met These coosidera1i>ns
are inherent aspects of most prodocts. The possible effects and ramifications of these considerations are given in a to c.
a) Benefit considerations
R>r the cu.stan~ consideration has to be gi\en to reduced costs, irnprmed fitness fur use, increased satisfaction, and
growth in confidence.
Rlr the organization, consideration has to be given to increased JrOfitability and market share.
b) Cost considerations
Rlr the CmtomeI; consideration has to be given to safety, acquisition CO~ operating. mainteclance. downtime and repair
costs, and poosi~ disposal costs..
Rlr the organi2atiJn, consideration has to be given to costs due 10 marketing and design deficiencies. including unsat-
isfactory product. re\\Qfk, repair, replacement, reJXOCeSSing, loss of production, warranties, and field repW:
c) Risk considerations
R>r the customel; consideration has to be given to risks such as those penaining to the heaI!h and safety of people, dis-
satisfuction with product. availability, marketing claims, and ~ of confidence.
Rlr the ~tion, consideration has to be given to risks related to deficient products which lead to loss of image or
reputation, loss of market. complaints, claims. liability, and waste of human and financial resources.

0.5 CONCLUSIONS
An effecti\e quality system shoold be designed to satisfy customer needs and expectations while serving 10 protect the
organization's interests. A well-structured quality ~ is a valuable management resource in the optimization and
contrcl of quality in relation to benefit, cost, and risk considerations.

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 ANSI/Asr:t:. Q9OO4-1-1994

QUALITY MANAGEMENT AND

QUALITY SYSTEM ELEMENTS-GUIDELINES

1 SCOPE ANSI/~ Q9OO4-1-1994. At the time of putiicatioo,

ANS1/~ Q9004-1-1994 provides guidance on qual- the editions indicated were valid. All standards are subject
ity management and quality-~ dements. to revision, and parties to agreements based on
ANSIJ~ Q9OO4-1-1994 are encouraged to investi-
The quality-system elements are suitable for use in the gate the possibility of applying the most recent editions
dewlopment and implementation of a comprehenshe and of the standards indicated below. Members of IEC and
effeclhe in-house quality sy&em, with a view D ensuring ISO maintain registers of currently valid International
customer ~tion. Standards.
ANSl/ASOC Q9OO4-1-1994 i'> not intended ilr contrac- ANSIJASQC Q9OOO-1-1994, Quality Management and
tual, regulatu"y, or certificatim use. Consequently, it is not QuaUty Assurance Standard3-Guidelines for SeleClion
a guideline fur the implementing of ANSIIASQC Q900 1. and Use.
ANSI/ASQC Q9002-1994. and ANSl/ASQC Q9003-
1994. ISO 9000-2 shoold be used fur that purpose. ISO 8402:1994, Quality management and quality asslU-
ance-Vocabulary.
The selection of appropriate elements contained in this
part of ANSl/ASQC Q9004-1-1994 and the extent to
which these elements are adopted and awlied by an orga- 3 DEFINITIONS
nization depends upon factors such as the marlret being This revisi>n of ANSIJ~ Q94-1981 has imprmed the
served, nature of the prodOCI. production processes, and harmonization of terminology with other American
c\lStOOler and consumer needs. National Standards in the ANSIJASQC Q9000 series and
with other International Standards in the ISO 9000 family.
References in ANSI/ASOC Q9OO4-1-1994 to a "product" 'JaNe 1 mows the supply-chain terminology used in these
silould be interpreted as awlicable to the generic product
American National Standards.
categories of hardware. software. processed materials or
service (in accordance with the definition of "product" in Thus. the term "subcontractor" is used rather than the
ISO 8402). term "supplia"" in ANSIJASQ!:, Q9OO4-1-1994 to a\Uid
confusion with the meaning of the term "supplier" in
NOTES ANSIJASQC Q9OOO-1-1994 and ANSIJASQC Q9001-
For further guidance. see ISO 9004-2 and ISO 9004-3. 1994. See ANSIJASQC Q9OOO-1-1994 fur a fuller expla-
2 For inftrmati~ references, see annex A. nation of the 00sis for usage of these letms.
For the purposes of ANSl/ASQC 09004-1-1994, the
1 NORMATIVE REFERENCES definitions g~ in ISO 8402 apply.
The following standards contain provisions which, For the convenience of users of ANSl/ASQC Q9OO4-1-
through reference in this text, constitute provisions of 1994. the fuUowing definitions are quoted from ISO 84m.

ANSl/ASQC Q9OOO-1-1994

ANSIIASQC Q9OO1-1-1994
Subsuppliet ...
Table 1 - Relationships of organizations in the supply chain
supplier
or organization
-.. customer

ANSIIASQC Q9OO2-1994 Suboontra::1or suwfier ~ cusWmer

ANSIJASQC Q9003-1994 ----
ANSIIASQC Q9OO4-1-1994 Subcontra::tor -.. organization ~ cUSlOmer

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 ANSl/ASc:y::, Q9OO4-1-1994

3.1 organizatioo: Company, corporation, firm, enter- NOI'ES

prise, or institution, or Jmt thereof, whethex incorporated 11 A product may include service, hardware, processed
or not. public or private, that has its own functions and materials, software, or a combination thereof.
administration.
12 A product can be tangible (e.g., assemblies or
processed materials) or intangible (e.g., knowledge
3.2 customer: Recipient of a product provided by the
or concepts), or a COOlbination thereof.
suwfier.
13 A product can be intended (e.g., offering 10 cus-
NOTES tomers) or unintended (e.g., pollutant or unwanted
3 In a contractual situation, the customer is called the effects).
"purchaseL"I)
4 The customer may be, for examJie. the ultimate c0n- 3.6 service: Result generated by activities at the interfuce
sumer, \JSeI; beneficiary, or purchaset between the supplier and the customer and by supplier
internal activities 10 meet the custooler needs.
5 The customer can be either ~ or internal 10 the
organization. NOTES
14 The supplier or the cUSlOOler may be represented at
3.3 requirements or society: Obligations resulting fium the interface by peoonnel or equipmenL
laws, regulations. rules, codes, statutes, and other consid- 15 CUstomer activities at the interface with the supplier
erations. may be essential 10 the secvice deli\ery.
NOTES 16 Delivery (X' use of tangible products may fOrm part of
6 "Other considerations" include protection of the envi- the service deli-.ery.
ronment, health. sarety, security. and conservation of 17 A service may be linked with the manufocture and
energy and natural ~. supply of tangible product.
7 All requirements of society should be taken into
account when defining the requirements for quality. " MANAGEMENT RESPONSmILITY
8 Requirements of society include jurisdicoonal and reg-
4.1 General
ulatory requirements. These may vary from one juris-
diction 10 anothet. The responsibility for and commitment 10 a quality pOOcy
beJong'> to the highest levcl of management Quality man-
3.4 quality plao: Document setting out the specific agement encan~ all activities of the 0Yerall manage-
quality practm. resoun:es, and sequence of activities rel- ment function that determine the quality policy,
evant 10 a particular prodoct, project, or contm:t objecti~, and responsibilities, and implement them by
means such as quality planning, quality contml, quality
NOTES assurance, and quality improvement within the quality
9 A quality plan usually makes reference 10 the parts ri ~m.
the quality manual awJ.icabIe to the specific case.
10 Depending on the scope of the plan, a qualifier may 4.2 Quality policy
be used, fur example, quality assurance plan, quality The management of an organization should define and
management plan. document its quality pol9. This policy fbould be con-
sistent with other policies within the organization.
3.5 product: Result of activities or proce&'>eS. Management sftould take all necessary measures 10 ensure
that its quality policy is understood, implemented, and
reviewed at all Ievcls of the organization.

4.3 Quality objectives

1) The recommended hannonized term is "customer" as
shown in Thble 1 of ANSl/ASQC 09004-1-1994. The 4.3.1 Management should document objectives and com-
tenn "purchasec" was used in ANSI/ASQC 091-1987, mitments pertaining 10 key elements of quality, such as fit-
ANSI/ASc:y::, Q92-1987, and ANSI/ASQC 093-1987. ness for use, performance, safety, and dependability.

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 ANSIJASCX- Q9OO4-1-1994

4.3.2 The calculation and evaluation of C<Ns associated e) prodoction, or provision of services;
with all quality elements and objectM:s lbouId always be f) verification:
an important consideration. with the objective of mini-
g) packaging and storage;
mizing quality I~.
h) sales and distribution;
4.3.3 Appropriate levels of management should docu- i) installation and coounissioning;
ment specific quality objectives consistent with quality j) technical assistance and servicing;
pdicy as wcll as other objectives of the organization.
k) after sales;
4.4 Quality system I) disposal or recycling at the end of useful life.
NOTE 18 Figure 1 ghes a schematic representation of
4.4.1 A quality systan ~ the organi7ational mdure, pr0- the typical life<ycle phases of a product
cedures, processes, and resources needed to implement
quality management 5.1.2 In the context of interacting activities within an
organization, marketing and design should be emphasized
4.4.2 The organization's management should develop, as especially important fur
establish, and implement a quality system to accomplish
the stated policies and objecthes. -determining and defining customer needs, expectations.
and other product requirements, and
4.4.3 The quality system should be structured and -providing the concepts (including supporting data) fOr
adapted to the organization's particuJar type of business producing a product to documented specifications at opti-
and should take into occount the apprqxiate elements out- mwn cost.
lined in M'lSl/ASQC Q9OO4-1-1994.
5.2 STRUCTURE OF THE QUALITY SYSTEM
4.4.4 The quality system should fWlCtion in such a man-
ner as to provide conJidence that 5.2.1 General
a) the system is understood. implemented.. maintained, Input from the mam:t sOOuld be used to imprme new and
and effective; existing products and to improve the quality system.
b) the products actually do satisfy customer needs and Management is ultimately responsible fur establishing the
expectafuns; quality pdicy and for decisions concerning the initiation,
c) the needs of both society and the environment have development. implementation, and maintenance of the
been addressed; quality system.
d) emphasis is placed on prOOlem )re\Ul000 rather than
dependence on detection after occurrence. 5.2.2 Responsibility and authority
Activities contributing to quality. whether directly or indi-
5 QUALITY-SYSTEM ELEMENTS rectly, mould be defined and documented. and the follow-
ing acOOns taken.
5.1 Extent of application a) General and specific quality-related responsibilities
should be ~y d~.
5.1.1 The quality system typically applies to, and inter-
b) ResponsIbility and authOOty delegated to each octivity
acts with, all activities pertinent to the quality c:l a prod-
contributing to quality should be clearly established.
uct. It will in'ldve all phases in the 1ife..cycle rl a fI'Oduct
Responsibility, organizatiooal freedom, and authority
and processes, fran initial ilentification c1 market needs
to act should be sufficient to attain the assigned quality
to final satisfuction of requirements. "£Ypical phases are:
objecthes with the desired efficency.
a) marlceting and madret research;
c) Interface control and coordinaOOn measures between
b) prodoct design and c\evelq)ment; di.fkrent octivities should be defined.
c) process planning and development; d) In organizing a well-structured and effective quality
d) purchasing; ~m, emphasis should be placed on the identificalion

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 ANSI/ASQC Q90<»-1-1994

Purchasing
After sales

1YPicallifix}de
phases of a product
Thclmical assistance
and servi:ing

Installation and - _ _ "-

commisroning

Verification

SaIes and distribution

Pockaging and storage

Figure 1 - Main activities having an impact 00 quality

of potential or octual quality JXOOlems and the implemen- d) inspection, test. and examination equipment;
tation of preventive or corrective action (see clauses 14 e) instrumentation and computer software.
and 15).
Management shouki determine the level of competence.
5.2.3 Organizational structure experience. and training necessary to ensure the capability
Functions related to the quality system should be clearly of personnel (see clause 18).
established within the overall organizational structure. Management shwld identify quality-related factors affect-
The lines of authority and communication should be ing market position and objectives relative to products.
defined. processes. or asoocialed services. in order to aI.Iocate orga-
nizaoon resources on a planned and timely basis.
5.2.4 Resources and persoooel
Management should identify resource requirements. and Programs and schedules covering these resources and
prcNide sufficient and appropriate resources essential to skills should be consistent with the organizaOOn's merall
the implementation of the quality pdicy and the achieve- objecti~.
ment of quality objectives. fur ewnple. these resources
can lncIlXIe:
5.2.5 Operational procedures
a) human resources and specialjred 00lls;
The quality system mould be organized in soch a way that
b) design and development equipment; adequate and continuous control is exercised over all
c) manufacturing equipment; activities affecting quality.

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 ANSI/AS(l2 Q9OO4-1-1994

The quality sy&em should emphasize pre\mtive actions 5.3.2.1 The primary purpose of a quality manual is to
that IOOid occurrence or Jl"Oblems, while mainlaining the define an outline structure of the quality system while
ability to respond to and correct failures. should they serving as a permanent reference in the implementation
occut and maintenance of that system.
Documented operational procedures coordinating cJifter- 5.3.2.3 Documented procedures should be established lOr
ent activities with respect to an effective quality system making changes, modifications. revisions. or additions to
should be de\ek)ped, ~, and mainlai.ned to imIkment the contents ct a quality manual.
the quality policy and objectives. These documented pr0-
cedures should specify the objectives and perfunnance of 5.3.2.4 Supporting the quality manual are documented
the various activities having an impact on quality (see quality-system procedures (e.g., design, purchasing, and
Figure I). process work instructions). These docwnented JroCedures
All documented procedures should be stated simply. can take various forms, depending on
unambiguously. and understandably. and should indicate -the size of the OI'gaIlization,
meth>ds to be used and criteria to be satisfied. -the specific nature of the activity, and.
-the intended scope and structure of the quality manual.
5.2.6 Configuration maoagement
Documented procedures may awly to one or more parts
The quality system should include documented proce-
of the organization.
dwes for configuration management to the extent appr0-
priate. This discipline is initiated early in the design phase 5.3.3 Quality plans
and continues through the whole life-cycle of a JrOOucllt
assists in the operation and control of design, develop- For any product or process. management should ensure
that documented quality plans are prepared and main-
ment, production, and use of a product, and gives man-
agement visibility of the state of documentation and tained. These sIl>uld be consistent with all other require-
product during its life-time. ments of the organization's quality system. and should
ensure that specified requirements roc a product, project.
Configuration management can include: configuration or contract are met. A quality plan may be a part of a
identification. configuration control. con1igUI3tion status larger oYernll plan. A quality plan is particularly neces-
accounting. and configuration audit It relates to several sary for a new product or process. or when there is signif·
of the activities described in ANSI/ASQC Q9OO4-1- icant change to an existing product or process.
1994.
Quality plans sflould define:
5.3 Documentation of the quality system a) the qiJality objectives to be attained (e.g .• characteris·
tics or specifications. unifonnity, effecti\elleSS. aesthet-
5.3.1 Quality policies and procedures ics, cycle time, cost. natural resources. utilization,
All the elements, requirements, and provisOOs adopted by yield, and dependability);
an organization for its quality system should be docu- b) the sIepS in the processes that constitute the operating
mented in a systematic. oo1erly, and understandable man- pactice of the a-ganization (a flowchart or similar dia-
ner in the fOrm of pdicies and procedW'eS. However; care gram can be used 10 demonstrate the elements of the
sbould be taken to limit documentation to the extent per- process);
tinent to the applicafun.
c) the specific alkx:ation Of responsibilities, authority, and
The quality system shoold include adequate provisKxt b resources during the dilIerent phases of the project;
the proper identification. distribution. collection. and d) the specific documented JXOCedures and instru::tions to
or
maintenance all quality documents. beapJiied;
5.3.2 QuaUty-system documentation e) suitable testing, inspection. examination, and audit ~
grams at ap(I'Opriate stages (e.g., design and de\dop-
5.3.2.1 The typical form of the main document used to ment);
demonstrate or describe a documented quality system is a f) a documented procedure for changes and modifica-
"quality manual." For further guidance. see ISO 10013. tions in a quality plan as projects proceed;

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g) a method for measuring the achie\ement of the quality a) organizational structures;

objectives; b) administrative, operational. and quality-system proce-
h) other actions necessary to meet the objecthes. dures;
Quality plans may be incllKled or referenced in the qual- c) pefflOIlllel, equipment, and malerial resources;
ity manual, as awropriate. d) \Wrlc areas, operaOOns, and processes;
Th fucilitate achiewment of the objectives of a quality e) products being produced (to establish the degree of
plan, documented operational control as described in conformance 10 standards and specifications);
ANSl/ASQC Q9OO4-1-1994 should be used. f) documentaoon. reports, and record keeping.

5.3.4 Quality records

Personna conducting audits of quality-system elements
should be independent of those having direct respoDSlbili-
Quality records, including charts pertaining to design, ties fur the specific activities or areas being aOOited. An
inspeclion, testing, surwy, aIXlit, re~w, or related results, audit plan should be prepued and documented to incllKle
should be maintained as important evidence to demon- the items listed in a to f.
strate conformance to specified requirements and the
e1fecthe operation of the quality system (see clause 17).
5.4.4 Audit reporting
5.4 Auditing the quality system Audit observations, conclusions, and agreements on
timely oorrective acOOn should be recorded and submitted
5.4.1 General for awropriate oclion by the management responsible fur
Audits should be planned and carried out k> detennine if the area audited, and commwt.icated tOr the infutmation of
the activities and related results of the organization's qual- management with aeculM'l responsibility fur quality.
ity system comply with planned arrangements, and to The following items should be covered in the audit
determine the effecti\eness of the quality ~. All de- report:
ments should be internally aOOited and evaluated on a reg-
a) all examples of noncon1brmities or deticiencies;
ular basis, considering the status and importance of the
activity to be audited. For this purpose, an appropriate b) apprc¢ate and timely corrective action.
audit program !Muld be estaliished and implemented by
the organization's management 5.4.5 Follow-up actioD
Implementation and effecti\eness of correcti~ actions
5.4.2 Audit program
resulting from previous audits should be assessed and
The audit program should COYer. documented.
a) planning and scheduling the specific activities and
NOTE 19 For further guidance on quality auditing.
areas to be audited;
qualifications of auditors and management of audit pr0-
b) assignment of peroonnd with appropriate qllalific;ni>ns grams, see ANSI/ASQ!:. QlOOll-l-l994, ANSl/~
to oonduct audits; Q10011-2-1994, and ANSI/ASQC QlOOll-3-1994.
c) documented procedures for carrying oot aOOits, includ-
ing recording and reporting the results of the quality 5.5 REVIEW AND EVALUATION OF THE
audit and reaching agreement on timely corrective QUALITY SYSTEM .
acoons OIl the deficiencies found dming the audit.
The OI'g3Jlization's management should provide for inde-
Apart ftom planned and systematic audits, other factors pendent review and evaluation of the quality system at
neressitatfug audits can be organizational changes. market defined interVdls. The reviews of the quality policy and
feedback, nonconformity reports, and surveys. objecti\eS sboold be carried out by top management, and
the review of supporting activities should be carried oot
5.4.3 Extent 0( audits by management with executive responsibilitie for quality
Objecti~ evaluations of quality-system activities by com- and other appropriate members of managem<2lt, utilizing
petent personnel should include the following ~ or competent independent personnel as decided on by the
areas: management.

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Reviews should coosilt of well-~tured and comprehen- Such measurement and reporting can provide a means for
she evaluations which inchxJe: identifying inefficient activities, and initiating internal
a) results from internal audits centred on various ele- improvement octivities.
ments of the quality system (see 5.4.3); By reporting quality-system activities and effectiveness in
b) the <mrall effectiveness in satisfying the guidance of financial terms, management will receoo
the results in a
ANSl/ASQC Q9004-1-1994 and the organization's common businC$language from all dqmtments.
~ quality pdicy and objectives;
c) considerations fur updating the quality symn in rela- 6.2 Approaches to financial reporting of quality-
tion to changes brought about by new technologies, system activities
quality concepts. market strategies, and social or envi-
6.2.1 General
ronmental conditions.
Some organizations find it useful to report the financial
Observations, conclusions, and recanmendafuns ~hed benefits using systematic quality financial reporting
as a result of review and evaluation should be documented procedures.
fur necessary action.
The awooch(es) to financial reporting selected and used
5.6 Quality improvement by particular organizations will be dependent upoo. their
When implementing a quality system, the management of individual structures, their octivities, and the maturity of
an organization shoold ensure that the system will fucili- their quality ~ms.
tate and proolote continuous quality improYt'Jllent
6.2.2 Approaches
Quality improvement refers to the actions laken through-
There are various approoches to gathering, rcesenting, and
out the organization to increase the effectiveness and effi-
analyzing the dements of financial data. The awrooches
ciency of activities and processes to provide added benefits
given in a to c have been futmd to be useful, but do na
to both the organization and its customers.
aclude others, or adaptations or oornbinaOOns of them.
In creating an environment for quality improvement. a) Quality-costing approach
consideration should be given to: This approach addresses quality-related costs, which
a) encouraging and sustaining a supportive style of man- are broadly divided into those arising from internal
agement; operations and external activit.es.
b) promoting values. attitudes, and behavior that roster Cost elements for internal operations are analyzed
improvement; according to the PAP (prevention, appraisal, failure)
c) setting clear quaIity-imprmement goals; costing model.
d) encouraging effective communicafun and leamwork; Prevention and appraisal costs are considered as invest-
ments, whik failure costs are considered as losses. The
e) recognizing successes and achievements;
components of the co&s are:
1) tIaining and educating fur improvement
1) prevention: efforts to prevent fhllures;
NOTE 20 Further guidance is given in ISO 9004-4. 2) appraisal: testing, inspection, and examination to
assess whether requirements (or quality are being
6 FINANCIAL CONSIDERATIONS OF QUALITY fulfilled;
SYSTEMS
3) internal fuilure: costs resulting fron a product fhll-
6.1 General ing to meet the quality requirements prior to deliv-
It is impoctant that the effectiveness of a quality system be ery (e.g., re-performing a service, reprocessing.
measured in financial tenus. TIle impact of an effective rework, retest, scrap);
quality system upon the organization's profit and loss 4) external fuilure: costs resulting fron a prodoct fhll-
statement can be highly significant, particularly by ing to meet the quality requirements afta: delivery
improvement of operations, resulting in reduced losses (e.g .• product maintenance and repair. warranties
due 10 error and by making a contribution to customer and returns, direct costs and allowances. product
satisfacOOn. recall COSIS,liability ~).

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b) Process-cost approach products inva.\e several generic product categories. The

This approa:.:h analyzes the COS(S of confurmily and the marketing function should:
costs r:i. nonconformity for any process, both ot which a) determine the need fur a prodoct;
can be the source of savings. These are defined as:
b) define the madcet demand and ~ so that product
1) cost of conformity: cost to fulfill all of the stated grade. quantity. price. and timing can be detennined;
and implied needs of customers in the absence of
c) determine specific customer requirements. or review
failure of the emting process;
general market needs; actions include assessment of
2) cost of nonoonformity: cost incurred due to Iililure any unstated expectations or biases held by customers;
of the existing process.
d) communicate all customer requirements within the
c) Quality-loss approach organization;
This approoch fucuses 00 internal and ~ losses
e) enslIre that all reJevant ~ functbns agree that
due to poor quality and identifies tangil:ie and intangi-
they ha~ the ~ k> meet customer requirements.
ble loss types. Typical external intangible mes are
loss of future sales due to customer dissatisfaction.
7.1 Defining product specification
'JYpical internal inlangible losses arise from kJwer wade
efficiency due to rework, poor ergonomics, missed The marketing function mould provide the organization
opportunities, etc. Thngible losses are internal and with a formal statement or outline of product require-
external f.rllure costs. ments. Specific customer and general marlcet require-
ments and expectations should be translated into a
preliminary set of specifications as the basis fur subse-
6.3 Reporting
quent design work. Among the elements that may be
The financial reporting of quality ~tivities should be reg- included are the fcilowing requirements:
ularly provided to and monitored by management, and be
related to other business measures such as "sales," a) performance characteristics (e.g .• environmental and
''ttu"tlcM7.'' or "<dded value" in on1er to provide fur a real-
usage conditions and dependability);
m, entrqreneuriaJ b) sensory characteristics (e.g •• style, ~ t&te, 9llell);
-evaluation of the adequacy and effectiveness of the c) installation, arrangement layoot or fit;
quality system, d) applicable standards and statutory regulations;
-identilicatDn of OOditional areas requiring atlftltDo and e) llICkaging;
inqJ"<r.ement, and f) quality \erification and/or assurance.
--estaNisfunent of quality and cost objecfues for the fol-
lowing perm 7.3 Customer feedback information
The elements of financial quality reports are in many The marketing function 5hou1d establish an infonnation-
cases already available in the organization, but in other monitoring and feedback system on a continuous basis.
forms. Their reporting as a financial qualily report can All infurmatkxl. pertinent to the custaners' use of and sat-.
require regrouping of individual elements from other isfacoon with the quality of a product should be analyzed,
reports. collated, interpreted, \'erified. and reported in accordance
with OOcumented procedures. Such infonnailin will help
!o determine the nature and extent of product problems in
7 QUALITY IN MARKETING
relation to CUSOOler experience and expectations. In addi-
tion, the feedback infurnlatiOo can lead to management
7.1 Marketing requirements acfun resulting in product im~t or to new product
The marketing function should establish adequately offerings (see also 8.8, 8.9. clause IS, and 16.6).
defined and documented requirements for the quality of
the prodOCL Particularly at this early Uge in the product 3 QUALITY IN SPECIFICATION AND DESIGN
llfe-cycJe. it is important to consider the requirements lOr
all the elements of the total product, whether hardware. 3.1 Contribution or specification and design to quality
software, processed materials, or services. In fact, all The specificatioo and design function ~d provUe lor the
products involve some element of service, and many translatioo cl custaner needs into technical specitications

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«x materials, products, and ~ 'l'lm should n:sult in 8.3 Product testing and measurement
a (IOduct that proviIes customer satisfa:;OOn at an ~. The methods of measurement and test. and the accep-
able price that gives a satisfactory financial return br the tance criteria applied to evaluate the product and
organiz3tion. The specification and design smlId be soch processes during both the design and production phases,
that the product is produciNe, \erifia1ie. and contrdlable !Mu1d be specified. These should indude the following:
under the JXOpOSed production. insIallation. oommission-
a) performance target values, tolerances, and attribute
ing. or ~ oonditions.
features;
8.2 Design planning and objectives (defining the b) acceptance criteria;
project) c) test and measurement methods, equipment. and com-
puter software (see clause 13).
8.2.1 Management 910uJd prepare plans that define dIe
responsibility for each design and de\'clopment activity 8.4 Design review
inside and/or ootside the organization. and ensure that all
those who oontribute to design are aware of their respon- 8.4.1 General
sibilities in relation to the full scope of the prQjecl At the conclusion of eoch phase of design development. a
tOnnal, documented, systematic, and critical revX:w of the
8.2.2 In its delegation of responsibilires and authority iJc design results should be planned and conducted. This
quality, management should ensure that design functions mould be distinguished from a IIOject progress meeting.
provide clear and definithe technical data fur JXOCUreI1lenl, Participants at each design review should include repre-
the execution of v.OOc. and \erificatioo of confunnaoce of sentati\e8 of all functions affecting quality, as apptq)riate
products and ~ to specification requirements. to the phase being reviewed. The design review should
identify and anticipate problem areas and inadequacies.
8.2.3 Management should establish time-phased design and initiate corrective actions to ensure that the final
programs with holdpoints SW£OPriate to the nature of the design and supporting data meet custooler requirements.
product and process. The extent of each Pmse. and the
position of the holdpoints at which evaluations of the 8.4.2 Elements or design reviews
prodoct Ol'the proce&'l will take place, can depend upon
~ elements. such as
As ~iate to the design phase and product. the ele-
ments outlined in a to c srould be oonsidered.
-the product's application,
a) Items pertaining to customer needs and satisfaction
-its design complexity.
1) comparison of customer needs expressed in the
-the extent of innovation and technology being intro- product specification with technical specifications
duced.and fOr mataiaIs, puducts, and processes;
-the degree of standanlization and similarity with pa& 2) validation of the design through prototype tests;
pro...en designs.
3) ability to perfOrm under expected condifuns of use
and environment;
8.2.4 In addition to customer needs. consideration !Muld
be given to the requirements relating to safety. environ- 4)unintended uses and misuses;
mental. and other regulations. including items in the orga- 5)satety and enviromnental comJXltibility;
nization's quality policy which may go be}Iond existing 6) compliance with regUlatory requirements, national
statutory requirements (see also 3.3). and International Standards, and organization
practices;
8.2.5 The design should unambigUOl.lSly and adequately
7) oomIXUisons with ccmpetitM! designs;
define characteristics important to quality, such as the
acceptance criteria. Both fitness for purpose and safe- 8) oom}Xlrison with similar designs. especially analysis
guards against misuse moold be considered. Product def· of the hi<itory of internal and external problems to
inition can also include dependability and serviceability a\Od repeating problems.
through a reasonable life expectancy, including benign b) Items pertaining to product specification
failure and safe disposability. as appropriate. 1) dependability and serviceability requirements;

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Z) permissible tolerances and comparison with models and/or actual production samples. The amount
process capabilities; and degree of testing (see 8.3) mould be related to the
3) product acceptance criteria; identified risks. Independent evaluation can be used. as
appropriate, to verify original calculations, provide alter-
4) installability, ease of assembly. storage needs,
nati~ calculations, or perform tests. A number of samples
shelf-lite. and disposability;
mould be examined by tests and/or inspection to provide
5) benign failure and fail-safe cham::terutics; adequate statistical confidence in the results. The tests
6) aesthetic specificatbns and acceptance criteria; should include the ftilowing octivities:
7) failure mode and effect analysis, and fault tree a) evaluation of performance. dwability, safety, reliability,
analysis; and maintainability under expected storage and ~­
8) ability to diagnose and correct problems; tional conditions;
9) labeling. warnings. identification, traceability b) inspections to verify that all design features conform to
requiremenlS, and user instructions; defined user needs and that all authorized design
changes have been accomplished and recorded;
10) review and use of standard puts.
c) validation of computer systems and software.
e) Items pertaining to process specification
1) ability to produ::e product conforming to the design. The results of all tests and ewluations should be docu-
including special process needs, mechanization, mented regularly throughout the qualification tem-qcle.
automation, assembly, and installation of compo- Review of test results should include nonconformity and
nents; failure analysis.
2) capability to inspect and test the design, including
special inspection and test requirements; 8.6 Final design review and production release
3) specification of materials. components, and SUD- The final design shooId be revie\Wrl and the resuIts appr0-
assemlXies. including appnwed supplies and subcon- priately documented in specifications and drawings;
ttactors as well as availability; which then fbnn the design baseline. Where apprqxiate,
4) ~, handling, storage, and shelf-life require- this should include a description cI initial test units and
ments, especially safety factors relating to incooIing any modifications made to e<nect deficiencies identified
and outgoing items. during the qualification test programmes. The total docu-
ment package that defines the design bascline (output)
8.4.3 Design verification should require approwl at appropriate levels of manage-
All designs sOOuld be \erified to ensure that product spec- ment affected by or contributing to the product. This
ifications are fulfilled (see 7.2). In addition to design approval constitu~ the production release and signifies
review, design verification should include one or I1lOle of that the design can be realized.
the following methods:
a) performing alternative ca1cuJati>ns, made k> ¥erify the 8.7 Market-readiness review
correctness of the original caJcuJatOOs and analyses; A determination should be made as to whether the orga-
b) testing and demonstrations (e.g., by model or pr0to- nization has the capability to deliver the new or
type tesfS); if this method is adqted, the test programs redesigned product. Depending upon the type of product.
should be clearly defined and the re&Jlts documented; the review can COYer the Wowing points:
c) independent verification, to verify the correctness c:J a) availability and adequacy of installation, operation,
the original calculations and/a- OCher design activities. maintenance, and reprir manuals;
b) emtence of ooequate distribution and CI$)R1eC afrer-
8.5 Design qualifICation and validation sales servk:e;
The design process ~d provide periJdic evaluaOOn cI c) training of field personnel;
the design at significant stag~. Soch evaluatiln can take d) availability of S(Xlre parts;
the ronn of analytical methods, such as FMBA (failure
mode and effect analysis), fault tree analysis, or risk e) field trials;
assessment, as well as inspection and test of pIOtotype t) satisfactory oompletion of qualification tests;

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g) physical inspecfun of early production units and their activities should be planned and controlled by docu-
p1Ckaging and labeling; mented procedures. Purchased services such as testing,
h) evidence of process capability to meet specification on calibration, and subcontracted ~ should also be
production equipment included. A close working relationship and feedbacksys-
tern should be estaNished with each subcontrnclot In this
8.8 Design-change control way. continual quality imp1'OYelllellts can be maintained
and disputes avoided or settled quiddy. This dooe WOIking
The quality sy&em lMuld include docurnmted pocedures
reJationsbip and feedback system will benefit both ~.
filr coolniling the rek:ase. change. ahi use <t documenlS that
deane the deSgn input and the <Je:ggn 00scline (output). and The quality ~ for purchasing should include the tbl-
filr authaizing the receswy Y.Qlk ~ be perlbrmed 10 imPe- lowing elements as a minimum:
men! changes and rrofificatioos that can affect ll'Oduct dur- a) The applicable issue of specifications, drawings, pur-
ing its entire life·<:>de. including changes in sdtware and chase documents and other technical data (see 9.2);
service instructions. The procedures should provide for
b) sdectiJn of qualified subcontractors (see 9.3);
v.uhl<> IleCe$3I'}' appuvaIs. specified points and times fa-
implementing changes, removing obsolete drawings and c) agreement on quality assurance (see 9.4);
specificaticns fum v.OOc: areas, and \elificathn that changes d) agreement on \erificatiJn methods (see 9.5);
are made at the appointed times and }iaces. These pr0ce- e} provisions for settlement of disputes (see 9.6);
dures shooId handle ernerg;:ocy changes necessary to p:-mmt
f) receiving inspection procedures (see 9.7);
production or delivery of nonconforming product.
ConsideraOOn should be &M:o t) instituting fmnal design g) receiving controls (see 9.7);
reviews and validati>n testing when the magnittxIe, canpIex- h) receiving quality rerords (see 9.8).
tty, or rut 8&'iOCiated with the change warrant soch actioos.
9.2 Requirements for specifications. drawings, and
8.9 Design requanrlCation purchase documents
Periodic evaluation of product should be perfonned in The successful purchase of supplies begins with a clear
Older to ensure that the design is still valid. This shou1d definition of the requirements. U!ually these requirements
include a review of customer needs and technical specifi- are contained in contract specifications, drawings. and
cati:>ns in the light of field experiences. field performance purchase documents which are provided to the subcon-
suneys, or new techndogy and techniques. The evalua- ttactoc
tion mould also consider process modifications. The qual-
ity system should ensure that any production and field The purchasing activity should develop documented pr0-
experience indicating the need fur design change is fed cedures to ensure that the requirements for the supplies
back for analysis. Care should be taken that design are clearly defined, cooununicated, and, most imJn1antly,
changes do not cause degradation of product quality fur are completely understood by the subcontractor. These
example, and that proposed changes are evaluated fur methods may include documented procedures for the
their impact on all product characteristics in the original preparation of specifications, ~, and purchase doc-
product specification. umenlS, meetings with subcontractors prior to the release
of the purchase document. and other octivities apprqlriate
8.10 Configuration management in design for the supplies being procured.
This discipline may be initialed once the requirements Purchasing documents should contain data clearly
have been defined. but is most useful dwing the design descnbing the product ordered. Typical elements are as
phase. It continues through the whole life-cycle of a follows:
prodoct (see 5.2.6). a) precise identi1ication of type. ~, and pJe;
b) inspection instructions and applicable issue of specifi-
9 QUALITY IN PURCHASING
cations;
9.1 General c) quality-system standard to be applied.

Purchases become JllI1 of the organization's product and Purchasing documents should be revie\\ro and approved
directly affect the quality of its product All purchasing fur accurocy and compietene$ prior to release.

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9.3 Selection of acceptable subcontractors with subcontractors. Provisions should exist for dealing
Each subcontractor should ha\e a demonstrated capability with routine and nonroutine matters.
to furnish product which meets all the requirements of the A very important aspect of these systems and ~ures
specifications. drawings, and plU'Chase documents. is the provision of improved communication channels
The methods of establishing this capiliility can include, between the organization and the subcontractor on mat-
but are not limited to, any combinaOOn of the following: ters affecting quality.
a) on-site evaluation of subcontractor's C3plbility and/or
quality system; 9.7 Receiving inspection planning and control

b) evaluation of prodoct samJies;

Appropriate measures should be established to ensure that
received materials are properly controUed. These pr0ce-
c) Jmt history with similar products; dures sOOuid indude quarantine areas or other apprqriue
d) test results of similar products; methods to prevent unintended use or installation of non-
e) puliished experience of other users. oonfurming materials (see 14.3).
The extent to which receiving inspection will be per-
9.4 Agreement on quality assurance IDrmed should be carefully planned The charactermcs to
The organization should d~ a clear agreement with be inspected should be based on the cruciality of the
subcontractors fur the assurance of prodll::t suwfied. This product The capability of the subcontractor should also
can be achieved by one or more of the falowing: be considered, taking into account the fucm listed in 9.3.
a) reliance on subcontractor's quality system; The level of inspecOOn should be selected so as to balance
the rusts of inspection against the consequences of inade-
b) submission of specified inspection/test data and quate inspection.
proces8«>ntni records with shipments;
c) 100% inspec~g by the subcontractoc; It is also neceswy to ensure, before the incoming product
arri'JeS, that all the n~ tools, gauges. meters, instru-
d) lot acceptance inspection/testing by sampling by the
ments, and equipment are available and properly cali-
subcontractor; brated. Personnel should be ooequately trained.
e) implementation of a fonna} quality system by the sub-
contractor as specified by the organization; in certain 9.8 Quality records related to purchasiog
cases, a formal quality-assurance model may be
imdved (see ANSJ/ASQC Q9001-1994. ANSJ/ASQ!::. Appropriate quality records related to product received
should be maintained. This will mstIl'e the availability of
Q9OO2-1994, and ANSJ/~ Q9003-1994 for fur-
historical data to assess subcontractor perlormance and
ther infOrmafun);
quality trends.
1) periodic evaluafun of subcontractor quality practices
by the organizatX>n or by a third party; In addition, it may be useful. and in certain instances
g) in-Ix>use receiving inspectiJn or sorting. essential, to maintain records of lot identification tOr the
purposes of lr.K:eability.
9.5 Agreement on verifICation methods
10 QUALITY OF PROCESSES
A clear agreement mould be deveJoped with the subcon-
tractor on the methods by which confurmance to require- 10.1 Planning for proce5S control
ments will be \erified. Such agreements may also inclWe
the exchange of ~Wn and test data with the aim of 10.1.1 Planning of processes should ensure that these
furthering quality impnnements. Reaching agreement can
proceed under controlled cooditioos in the specified man-
minimize difOCuIties in the interpretatDt of requirements ner and sequence. Controlled conditions include BpprqlCi-
as well as inspection, ~ or sampling methods. ate controls for materials, approved production,
instaLlation. and servicing equipment, documented proce-
9.6 Provisions for settlement of disputes dures or quality plans, computer software, reference stan-
Systems and procedures should be established by which dards/codes, suitable approval of processes and personnel,
settlement of disputes regarding quality can be reached ~ well as associated 9JPPlies, util.iW, and environments.

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The operation of processes should be specified to the nec- 10.2 Process capability
essary extent by documented work instructions. Processes should be verified as being capalie of producing
Process-capabiIity studies sbould be conducted to deter- product in accordance with specifications. Operations
mine the potential effectiven~ of a ~ (see 10.2). associated with p:oduct or process characteristics that can
have a significant effect OIl product quality should be iden-
Common practices that can be beneficially applied tified Appropriate control should be estaliisbed to ensure
throughout the organization should be documented and that these characteristics remain within the specification.
referenced in all apprqxiale procedures and instrucOOos. <r that apptq)fiate modifications or changes are made.
These should describe the criteria for determining satis-
factory work completion and conformity to specification \erification of processes should include material, equip-
and standards of good ~. 'MJrkmanship crite- ment, computer ~tem and software. procedures. and
ria sOOuld be stipulated in the clearest practical manner by pezsonnel.
written standards. photogrnphs. illustrations. and/or repre-
sentative samples. 10.3 Supplies, utilities and environment
Where important to product quality characteristics, auxil-
10.1.2 Verification of the quality status of a hardware iary materials and utilities. such as water, compressed air,
prodoct, process. ooftware. processed material, service, or electrical power, and chemicals used for processing.
environment should be considered at important points in should be controlled and verified periodically to ensure
the p:oduction sequence to minimize effects of errors and uniformity of effect on the process. Where environmenlal
to maximize yields. The use of control charts and statisti- conditions. such as temperature. humidity and cleanliness.
cal samIiing procedures and pJans are examples of tech- are important to product quaIi1y, apptqriate limits should
niques employed to facilitate process control (see also be specified, conlrdled, and verified.
12.2).
10.4 Handling
10.1.3 Monitoring and contra of processes should re1ate The handling of JXOduct requires proper planning. contrd,
directly to finimed product specifications or to an internal and a documented system for incoming, in-process, and
requirement. as apprqxiale. H verification of the proce&<; final product; this applies not only during delivery but up
variables through some measurement procedure is not to the time of being put into use.
physically or econootically practical or feasible, then \eIi-
The methods of handling of product should provide for
ficatioo will have to depend primarily on verificaOOn of
the correct selection and use of suitable pillets. contain-
final product characteristics. In all cases, relationships
ers, con\e)US, and vehicles to pre.ent damage ordeterio-
between in-~ controls, their specificat.ions, and final
ration due to vibration, shock abrasion, corrosion.
product specifications should be developed. communi-
temperature. or any other conditions occurring during the
cated to the pexsonnel concerned, and then documented.
production or delivery processes.

10.1.4 All in-process and final verifications should be

11 CONTROL OF PROCESSES
planned and specified. Documented test and inspection
procedures should be maintained for each quaIi1y charac-
teristic to be checked. These should include the specific 11.1 General
equipment to perform such checks and tests, and the spec- Product quality should be ~ in each phase of the
ified requirements and ~ criteria. life-cyde (see 5.1.1).

10.1.5 The appropriate methods of cleaning and pre- 11.2 Material control, traceability, and identiracation
serving, and the details of packing, including moisture
elimination, cushioning. bkx:king. and crating. should be 11.2.1 Material control
established and maintained in documented }XOCedures. All materials and parts should conform to specified
requirements before being introduced into a process.
10.1.6 Efforts to develop new methods for improving However. in determining the amount and nature of receiv-
process quality sOOuJ.d be encouraged. ing inspection nece&<my. consideration should be giwn to

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cost impact and the effect that substandard material quaI- Process variables should be monitored, controlled, and
ity will ha~ on JXOduction flow. ~rified at appropriate frequencies to assure:

In-process product. including lhat in in-pIOCeS') ~tory a) the accuracy and variability of equipment used;
stockrooms, should be appropriately stored, segregated, b) the skill, capability, and knowledge of operators;
handled, and JRServed to maintain its suitability. Special c) the accuracy of measurement results and data used to
consideration should be gi\en to shelf-life and deteriora- control the process;
tion control, including asse<;sment of product in Wlck at
d) process environment and other factors affucting quality,
awroIJriate intervals. (For final product storage, see 16.1.) soch as time, temperature, and pressure;
11.2.2 Traceability e) appropriate documentation of proce$ variables, equip-
Where traceability of product is important, appropriate ment, and personnel
identification should be maintained throughout the [n some cases, for example where process deficiencies
process, (rom receipt and during all stages of prodocWn, may becoole apJment only after the product is in use, the
demery, and installation, to ensure trareability to original results of processes cannot be directly ~ by subse-
material identification and verification status (see 11.7 quent inspection or test of the product itself. Such
and 14.2). processes require prequaliJication (validation) to ensure
process capability and control of all critical variables
11.2.3 Identification during process q>eration.
The marking and labeling of materials shoold be legible,
durable and in accordance wilh specifications. Materials
should be uniquely identified from the time of initial n.5 Documentation
receipt, to delivery and installatioo at the final deSination. Documentation should be controlled as specified by the
The identification should be in accordance with docu· quality system (see 5.3 and 17.3).
mented procedures, and should be recorded. This should
enable a ptrticular product to be identified in the ewnl
that a recall or special inspection becomes necessary. 11.6 Process-change control
Those responsible for authorization of process cbanges
11.3 Equipment control and maintenance should be clearly designated and, where necessary, cus-
All equipment, including fixed machinery, jigs. fixtures, tomer approval should be sought. As wilh design changes,
toding, templates, patterns, and gauges, shoo1d be pnmd all changes In production tooling or equipment. materials,
fur accuracy JXior to use. Special attention should be prid or processes should be documented. The implementation
to canputers used in contrdIing processes, and especially shoold be COYered by defined procedures.
the maintenance of the related software (see 13.1). A product should be evaluated after any change to ~r­
Equipment !iloold be appropriately stored and adequately ify that the change instituted had the desired effect upon
protected between use, and ~rified or recaIibrated at product quality. Any changes in the relationship
appr<lIXiate intervals to ensure lhat the requirements con- between process and product characteristics resulting
cerning accuracy (trueness and precision) are ful6lled. from the change should be documented and appropri.
ately communicated.
A program of preventive maintenance should be estab-
lished to ensure continued process capability. Special
attention sbouId be given to equipment characteristics that 11.7 Control of verification status
contribute to product quality. \Uification status of JXOduct output shouId be identified.
Such identification should be suitable means, such as
1L4 Process-control management stamps, tags, notations, a inspection reoon:Is that accom-
Processes which are lmportant to product quality should IllllY the product, or by computer entries or physical loca-
be planned, approved, monitored, and controlled. tion. The identification should distinguish among
Particular consideration should be given to product unverified, conforming, or nonconforming product. It
characteristics which cannot be easily or economically !ttoold also identify the organi.zaOOnal unit responsiHe fur
measured. and those requiring special skills. \erification.

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IL8 Control of nonconforming product b) Product-quality auditing of sample units selected as

Provision should be made for the identification and control re(l'eSentathe of comJieted lots may be eithec continu-
of all noocooforming products and materia1s (see clause ous or periodic.
14). Acceptance inspection and product-quality auditing may
be used to provide rapid feedback for corrective action of
12 PRODUCT VERIFICATION product, process, or the quality system. Nonconforming
product should be reported and reviewed, removed, or
12.1 Incoming materials and parts segregated, and repaired, accepted with or without con-
The method used to ensure quality ci. purthased materi- cession, reY.Urked, regraded, or scrapped (see clause 14).
als, component JXlI1S and assemblies that are reccived into RepUred and/or rewodred products sbould be reinspected
the puduction facility will depend on the importance d or retested
the item to quality, the state of control and infurmation No product should be dispatched until all the activities
available from the subcontractoc. and impact on costs (see specified in the quality plan or documented procedures
clause 9, in (XU1icular 9.7 and 9.8). have been satisfactorily completed and the as90Ciated data
and documentation are available and authorized.
12.2 In-process verifICation
Verification, typically by inspections or tests, should be 13 CONTROL OF INSPECTION, MEASURING,
considered at appropriate points in the ~ to verify AND TEST EQUIPMENT
conformity. Location and frequency will depend on the
importance of the characteristics and ease rl verificatm 13.1 Measurement control
during processing. In general, ..m.tication lh>uld be Irukle Contra shoold be maintained <M::r all measuring systems
as close as possible to the point d realizatDl rl the char- used in the ~ent, production, installation, and ser-
acteristic. vicing of product to provide confidence in decisions or
actions based on measurement data. Control should be
Verifications for hardware products may include the
exercised over gauges. instruments. sensors, special test
following:
equipment, and re1ated test software. In OOdition, manu-
a) set-up and first-piece inspectX>n; fucturing jigs, fixtures such as test hardware, comparative
b) inspections or tests by machine operntar, references, and ~ instrumentation that can affect the
c) automatic inspection or ~ specified characteristics d a product or process sflould be
suitably contmlled (see 11.3).
d) fixed inspection stations at intervals throughout the
process; Documented procedures Iibould be established to monitor
e) monitoring ~ operaOOns by patniling inspecfnrs. and maintain the measurement ~ irself in a rutte of
statistical control, including equipment, procedures, and
Product &ilou1d not be released for further use until it bas operalor skills. Inspection, measuring. and test equip-
been \erified in accordance with the quality pan, except ment, including test software, sbouJd be used in conjullC-
under positive recall procedures. tion with documented procedures to ensure that
measurement uncertainty is known and is consistent with
12.3 Finished product verification the required measurement capability. Appropriate action
1b augment inspections and tests made during process- should be taken when accuracy is not adequate 10 measure
ing, two forms of verification of finished product are properly the process and product.
available. Either or both of the following may be used, as
appropriate. 13.2 Elements or control
a) Acceptance inspecfuns or tests may be used to ensure The procedures for control. of inspection. measuring. and
that finished product confurms to the specified require- test equipment and test methods should include, as
ments. Reference may be made to the pun;hase order appropriate:
to \erify that the product to be shipped agrees in type a) suitable specification and selection, including range.
and quantity. Examples include 100% inspection of accuracy, and robustness, under specified environmen-
items, lot sampling, and continuous sampling. tal conditions;

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b) initial calibrafun prior to first use in order to validate are to pre~t the customer from inad\el1ently receiving
the required accuracy (accuracy and precision); the nonconforming product and to avoid the unnecessary
software and procedures controlling automatic test costs of further processing nonconforming product The
equipment should also be tested; steps outlined in 14.2 to 14.7 should be taken as soon as
c) perXxtic recall foe adjustment, re~ and recalibratiln, indications occur that materials, components, or com·
considering the manufacturer's specification, the pleted product do not, or may not, confonn to the speci-
results of prioc calibration. and the method and extent fied requirements.
of use, to maintain the required accuracy in use;
14.1 IdentirlCation
d) documentary evidence ro.ering unique identification
of instruments, frequency of recahoratiln, calibration Suspected nonconforming items or locs should be imme-
status. and procedures for recall, handling, preserva- diately identified and the occurrence(s) recorded.
tion, and storage, adjustment, repair, calibraOOn, instal- Provision should be made as necessary to examine or
lation, and use; J:ee1taJJline previous kJts.
e) traceability to reference standards of known accuracy
and stability, preferably to nationally or internationally 14.3 Segregation
recognized standards; where such standards do not The nonconforming items should be segregated, when
exist, the basis used for calibration should be docu- practical, from the confbrming items and adequately iden-
mented. tified to })l'erent further unintended use of them until the
apprq:lriate ~mn is decided.
13.3 Subcontractor measurement controls
The control of measuring and test equipment and test 14.4 Review
methods may be extended to all subcontractors. Nonconfbnning product sbould be subjected to review by
designated persons to determine whether it can be
13.4 Corrective actioo accepted with or without repUr by concession, repaired,
Where measuring ~ are fOund to be out of contni, 1'e\\Uked, regraded, <r scrapped. Persons carrying out the
or where inspection, measuring, and test equipment are review should be competent to evaluate the effects of the
found to be out of calibration, apprq:xia1e action is ~­ decision on interchangeability, further~, perfor·
sary. Evaluation should be made to detennine the effects mance, dependability, safety, and aesthetics (see 9.7 and
on completed VtQCk and to what ex.tent rqrocessing. retest- 11.8).
ing, recalibration, or complete rejection may be necessary.
In addition, in\eStigation of cause is important in order to 14.5 Disposition
amid recurrence. This can include review of calibration Disposition of nonconfurnting product should be IaI<:en as
methods and frequency, training, and adequacy of test soon as practicable. A decision to accept such product
equipment shook! be docwnented., together with the reason for doing
so, in authorized waivers, with apprqriate precauilins.
13.5 Outside testing
The facilities of outside organizations may be used for 14.6 Action
inspection, measurement. testing, or calibration to a\tid Action should be taken as soon as possible to prevent
costly duplication or additional ~ent, provided that unintended use or inSlallation of nonconforming product.
the conditions given in 13.2 and 13.4 are satisfied. (For This acOOn can include rcM:w of odIer product designed
further information, see ISO 10012.1.) or processed fdlowing the same procedures as the product
found to be nonconforming, and/or previous lots of the
14 CONTROL OF NONCONFORMING PRODUCT same product.
For ""'IX in progress, correctiw action should be insti-
14.1 General tuted as soon as practical in order to limit the costs of
The steps for dealing with nonconforming product mould repair, reworking, or scrapping. Repaired. reworked,
be established and maintained in documented pucedures. and/or IIl()(ti&d prodoct should be reinspected or relested
The objectives of procedures for nonconformity conlrol to \erify conformance with ~ requirements.

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In addition, it may be ~ to recall completed prod- relationship of cause and effect should be determined.
uct, whether in a finmed product warehouse, in transit to with all potential causes considered. The results of the
distributors, in their stores, or already in use (see 11.2). investigation ~ be recorded.
Recall decisions are affected by considerations of safety,
product liability, and customer satisfaction. 15.5 Analysis of problem
In the analysis ci a quality-related problem. the root cause
14.7 Avoidance of recurrence or causes should be determined before corrective action is
Appropriate steps shoold be taken 10 avoid the recurrence planned. Often the root cause is not obvious. thus requir-
of nonconfonnity (see 15.5 and 15.6). ing cardul analysis of the product specifications and of all
related processes, operations, quality records, servicing
15 CORRECTIVE ACTION reports. and custDmer romplaints. Sratistical methods can
be useful in problem analysis (see clause 20).
15.1 General
Consideration shoold be &hen to establishing a file listing
The implementation of correcme action begins with the nonconformities to help identify those protlems having a
detection of a quality-related problem and inml~ taking common source. contrasted with those that are unique
measures to eliminate or minimize the recurrence of the occurrences.
problem. Corrective action also presupposes the repair,
reworking, recall, or scrapping of um;ttisfadory product. 15.6 Elimination of causes
The need fur action 10 eliminate the cause of nonconfor-
ApproJxiate steps sbould be taken 10 eliminate causes of
mities can originate fran soorces su;;h as:
actual or potential nonconformities. Identification of the
a) audits (internal and/or external); cause or paential causes may result in changes 10 JIOduc-
b) process-nonconfurmity reports: lion. pdcing. service. transit or storage ~, a pod-
c) management reviews: uct specification, and/or revision of the quality system.
d) market feedOOck;
Action should be initiated to a degree appropriate to the
magnitOOe of the problem and to awid the recurrence of
e) custooler complaints. nonconformities.
Specilic actions 10 eliminate the causes of either an exist-
ing oonooofonnity or a poeentiaI nonconformity are given 15.7 Process controls
in steps 15.2 to 15.8. Sufficient contros of ~ and procedures ~ be
implemented to amid recurrence of the problem. When
15.2 Assignment or responsibility Ihe correcti\e ~oon is implemented. its e1Iect shoold be
The responsibility and authority for instituting corrective monitored in ocdet to ensure that desired gools are met
octm sfIoo1d be defined as JIIll of the quality ~ The
coadinaOOn, recmling, and monitaing eX correcthe octm 15.8 Permanent changes
related to all ~ eX lhequality ~ lhJuId be~ Permanent changes resulting from correcti\e action
within the organizafun. The analysis and implementation should be recorded in work instructions. production-
may imdve a variety c:i functions, soch as design, purchas- process documentation, product specifications, and/or the
ing. ~ing. processing. and quality cootld. quality-system documentation. It may also be neceswy to
revise the procedures used 10 detect and eliminate poten-
15.3 Evaluation of importance tial pOOlems.
The significance of a problem affecting quality should be
evaluated in tenns of its potential impoct on such aspects 16 POSTPRODUCTION ACTIVITIES
as processing costs. quality-related costs, performance,
dependability. safuty, and custcmer satisfaction. 16.1 Storage
AwroJriate storage methods shou1d be specified to ensure
15.4 Investigation or possible causes shelf-life and to amid deterioration. Storage conditions
Important variables affecting the C3plbility of the process and the condition of JrOduct in stock should be chedced at
to meet specified requirements sOOuld be identified. The appropriate intervals for compliance with specified

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 ANSJ/ASQC Q9OO4-1-1994

requirements and to detect any m, damage, or deteOOra- made available for review and corrective action in the
tion of product (see also 10.1.5 and 10.4). design. processing. and/or use of the product.
16.2 Delivery 16.6 Market reedback
Provision for protection of the quality of product is impoc- A feedOOck system regarding performance in use should
tant during all phases of delhery. All product, in particu- exist to monitor the quality characteristics of products
lar product with limited shelf-life or requiring special throughout the Iife-cycle. This system can permit the
proteCtion dwing transport or stornge, sbould be identified analysis, on a continuing basis, of the degree to which the
and procedures established, documented. and maintained product satisfies ClNOmer requirements or expectations on
to ensure that deteriorated prodlXt is not Slipped and put quality, including safety and dependability.
into use.
17 QUALITY RECORDS
16.3 Installation
17.1 General
Inst.a1.Iafun procedures. including warning notices, should
The organization should establish and maintain docu-
contribute to proper installations and should be docu-
mented procedures as a means for identification. collec-
mented. They should include provisions which preclude
tion. indexing. access, filing. storage. maintenance.
improper installation or factors degrading the quality, reli-
retrieval. and disposition of pertinent quality records.
ability. safety, and perixmance of any product or material.
RlIicies should be estaI:fuhed concerning availability and
access of records to customers and subcontractors.
16.4 Servicing
Policies concerning documented procedures should also
be established for changes and modifications in various
16.4.1 Special-purpose tools or equipment fur handling
types of documents.
and servicing products dming or after instaI.1ation moutd
have !heir design and function validated. as i:lr any new 17.2 Quality records
prodoct (see 8.5).
The quality system mould require that sufficient records
16.4.2 Inspection. measuring. and ~ equipment used be maintained to demonstrate confonnance to specified
in the field should be cootrdled (see clause 13). requirements and verify effective operation of the quality
system. Analysis of quality records provides an important
16.4.3 Documented procedures and a&'IOciated instroc- input tOr corrective action and impr<J\'emenl The follow-
oons for field assembly and installation, commissioning, ing are examples of the types of quality records, including
operation, administration of spares or parts lists, and ser- charts. requiring control:
vicing of any product should be comprehensive and be -inspection reports,
estattished and SUWlixl in a timely manner. The suitability ~data.
of instructioos for the intended reader should be ~ -qnalificatioo reports.
16.4.4 Adequate logistic back-up, to include technical -validafun reports.
adm, spares or parts supply, and competent servicing, -survey and audit reports,
should be assured. Responsibility should be clearly -material review reports,
assigned and agreed among subcontractors, distributors, -<al.ibratioo data, and .
and customers.
-qua1ity-related cost reports.
16.5 Arter sales Quality records sbouId be retained for a specified time, in
Consideration should be given to the establishment of an such a manner as to be readiIy retrovab1e for analysis, in
early warning system for reporting instances of product order to identify trends in quality measures and the need
failure of shortcomings, to ensure rapid corrective for, and the effectiveness of, correcfue actiJn.
action.
While in storage, quality recools should be protected in
Jnformation on comJWnts, the OCC\Jl'falCe and modes of suitable facilities from damage, loss and deterioration
failure. or any problem encountered in use should be (e.g.• due to envirorunental conditions).

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17.3 Quality-records control together with the tools and techniques needed for full
The quality system should require that sufficient docu- executive management participation in the operation of
mentation be available to fdlow and demon&1"ate confor- the system. Executi~ management should also be aware
mance to specified requirements and the effective of the criteria avaiJaNe to evaluate the effectiveness of the
operation of the quality system. Pertinent subcontractor system.
documentation should be included. All documentation
~ be legible, dated (including revision dates), clean, 18.1.3 Technical personnel
readily identifiable, retrievable. and maintained in facili- ltaining should be given to the technical personnel to
ties that provide a suitafie environment to minimize dete- enhance their contribution to the success of the quality
rioration or damage and to pre~nt loss. Rooxds may be system. 'fraining should not be restricted to personnel with
in the form of any type of media such as hard ropy, elec- primary quality assignments, bot should include assign-
tronic media, etc. ments such as marketing, purchasing, and proc~ and
In addition. the quality system should pt'OVXIe a method li:r prodoct engineering. Particular attention should be given
defining retfntm times, removing and/<r disposing c:i docu- to training in statistical techniques, such as those listed in
mentation when that docwnmtation has becane outdated. 20.2.
The following are examples of the types of documents
requiring control: 18.1.4 Process supervisors and operating personnel
-drawings, All Jl'OCeSS supervisors and operating personnel should be
trained in the procedures and skills required to perform
-specifications, their ~, i.e.
-inspection procedures and instructions, -dle prq>er operation of instruments, tools and machin-
-4eSt procedw-es, ery they have to use,
-'M>rk instructions, -reading and understanding the documentation
-q>eration sheets, provided.
-quality manual (see 5.3.2), -the reIaOOnship of their duties to quality, and
-quality plans, -safety in the workplace.
-operational ~, and As appropriate. personnel should be certified in their
-quality-~ proced~. skills, such as v.elding. 1laining in basic statistical tech-
niques should also be considered.
18 PERSONNEL
IS.2 Qualification
18.1 Training
The need to require and document qualifications of
18.1.1 General personnel performing certain specialized operations.
processes, tests, or inspections should be evaluated and
The need for training of personnel should be identified.
implemented where necessary, in particular for safety-
and documented procedures for providing that training
related work. The need to assess periodically and/or
mould be estab&hed and maintained. AnJropriate train-
require delJlODSbaOOns of..skills and/or capability should
ing ~d be provided to allle\ds of personnel within the
be addressed. Considerations should also be given to
organization performing activities affecting quality.
apprqriate edocation, training, and experience.
Particular attention should be gi~ to the qllaJificatioos,
selection, and training of newly recruited pemlnnel and
personnel transferred to new assignments. Appropriate IS.3 Motivation
records of training shoold be maintained.
lS.3.1 General
18.1.2 Executive and management personnel Motivation of personnel begins with their understanding
'fraining should be given which will provide executive of the tasks they are expected to perform and how those
management with an understanding of the quality system, tasks support the overall activities. Personnel should be

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 ANSI!ASfY.:, Q9OO4-1-1994

made aware of the advantages of Jl"OpeC job perfonnance d) de\eloping a means of traceability to f::k:ilitate product
at all levels, and of the effects of poor job performance on recall (see 11.2, 14.2 and 14.6);
other people. customer satisfaction, operating costs, and e} considering de\oclopment of an emcrgency plan in case
the ecoOOOlic well-being of the organization. recall of a product becomes necessary.

18.3.2 AppJicability
20 USE OF STATISTICAL METHODS
Efforts to encourage personnel toward quality of perfor-
mance sOOuld be ~ted oot only at prodoction wod<ers,
but aloo at personnel in marketing, design, documentation, ZO.1 Applications
purchasing, inspection, test, packing and shipping, and Identification and correct apJiication of modem statistical
servicing. Management, professimal, and staff personnel methods are important elements to control every phase of
mould be included. the organization's processes. Documented procedures
should be established and maintained for selecting and
18.3.3 QuaUty awareness applying stalistical methods to:
The need for quality should be emphasized through an a) market analysis;
awareness program which can include introduction and b) product design;
elementary programs for new personnel, periodic
c) dependability specification, longevity, and durability
refresher programs ftx' long-standing personnci, provisixl
prediction;
fur personnel to initiate preventhe and correcti-..e actions,
and other procedures. d) process-control and process-caplbility studies;
e) determination of quality levels in sampling plans;
18.3.4 Measuring quality f) data analysis. perfurmanre assessment, and nonconfur-
Where awropriate, objecti-..e and accurate means of mea- mity analysis;
suring quality achie\'ements should be de~. These g) process improvemel1t;
may be publicized to let personnel see for themselves
It) safety evaluation and risk: analysis.
what they, as a group or as individuals, are achieving. This
can encourage them to improve quality. Recognition of
perfOtmance should be provided. 20.2 Statisticallecbniques
Specific statistical methods for establishing, controlling.
19 PRODUCT SAFETY and \erifying ac~ include, but are not limited to, the
Consideration should be given to identifying safety fDllowing:
aspects of prodocts and processes with the aim of enhanc· a) design of experimMts and factorial analysis;
ing safety. Steps can include:
b) analysis of wriance and regression analysis;
a) identifying relevant safety standards in order to make
c} tests of significance;
the formulati>n of JXOOuct specificati.oos more effective;
d) quality-control charts and cuswn techniques;
b) carrying out design evaluation tests and prototype (or
model) testing for safety and documenting the test e) statistical sampling.
results; NOTE 21 Guidance on the International Standanis to be
c) analyzing instructions and warnings to the lJSeI; main- used for the stftistical techniques that are identified may
tenance manuals, and labeling and prornoti>nal mater- be found in [som 13425 and ISO Handbook 3. For
ial in orde1" to minimize mNnteqretation, }m1icularly guidance on dependability applications, reference should
regarding intended use and known hazards; be made to ISO 9000-4 and to IEC publications.

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 ANSI/ASOC. Q9OO4-1-1994

ANNEX A (INFORMATIVE)

BIBLIOGRAPHY

[I] ANSJ/ASQC Q9OOO-1-1994. Quality Managemen/ and Quality Assurance S/andards-GuideUnes/or Selection
and Use.
[2] ANSI/ASQC Q9OO1-1994. Quality System9-Model/or Quality Assurance in Design. Development. Production,
Installation, and Servicing.
[3] ANSIJASQC Q9002-1994, Quality Systems--Model for Quality Assurance in Production, Installation. and
Servicing.
[4J ANSI/ASQC Q9OO3-1994, Quality Syslems-Model/or Quality Assurance in FifU1/ Inspection and Test.
[5] ANSIJASQC QlOOll-l-I994, Guidelines/or Auditing Quality Systenu-Auditing.
[6] ANSI/ASQC QlOOll-2-1994. Guidelines/or Auditing Quality Systems-Qualijication Criteria/or Quality
Systems Auditors.
[7] ANSIJASQC QlOOII-3-1994. Guidelinesfor Auditing Quality Systems-M(1IUlgement of Audit Programs.
[8] ISO 9000-2: 1993. Quality management and quality assurance standarrJs.-.Part 2: Generic guidelines for the
application of ISO 9001, ISO 9002 and ISO 9003.
[91 ISO 9000-3:1991. Quality management and quality assurance standards--Part 3: Guidelinesfor the application
of ISO 9001 to the development. supply and mailllenance of software.
[10] ISO 9000-4:1993, Quality management and quality assurance standards-l'art 4: Guide 10 dependability pro-
gramme managemelll.
(11] ISO 9004-2: 1991. Quality management and quality system elements-Part 2: Guidelines for services.
[12] ISO 9004-3: 1993. Quality management and quality system elements--Part3: Guidelines/or processed materials.
[13] ISO 9004-4: 1993. Quality management and quality system elements-Part 4: Guidelines/or quality improvemenJ.
(14) ISO 100 12-1: 1992. Quality assurance requirements for measuring equipmenl-Part 1: Metrological confirmation
system/or measuring equipment.
[15] ISO 10013:-1), Guidelinesfor developing quality manuals.
[16] ISO Handbook 3:1989. Statistical methods.

1) 10 be published.

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