VDA
Qualitätsmanagement
in the Automotive Industry
Quality Part 1
System Audit
Based on DIN EN ISO 9001 and DIN EN ISO 9004, Part 1
Table of contents
Exclusion of Liability
This VDA volume takes into account state of the art technology, current at
the time of issue. Implementation of VDA recommendations excludes no
one from responsibility for their own actions. In this respect everyone acts at
their own risk. The VDA and those involved in VDA recommendations shall
bear no liability.
Referenced standards
The quotations from standards identified with their DIN number and date of
publication are reproduced with the permission of the DIN Deutsches Institut
für Normung e.V. The version with the latest issue date, available from the
publishers Beuth Verlag GmbH, 10772 Berlin, is definitive for the use of the
standard.
Copyright
This publication is protected by copyright. Any use outside the strict limits of
copyright law is not permissible without the consent of the VDA and is liable
to prosecution. This applies particularly to copying, translations, microfilming
and the storage or processing in electronic systems.
Translations
This publication will also be issued in other languages. The current status
must be requested from VDA-QMC.
3
ISSN 0943-9412
Copyright 1998 by
4
th
Foreword to the 4 Edition
Quality assurance has a new dimension today - it covers and integrates all
divisions of the company in it’s vertical and horizontal structures (cross-
sectional function).
This VDA Volume 6 very quickly received a good response both outside the
industry and on an international level. Practical experience has shown that
this publication is not only suitable for the preparation of internal audits, but
also represents an excellent aid for preparation of a certification.
The practical experience of auditors led to the volume being revised and
defined in more precise terms as a second edition (12/92). This simplified
handling and a uniform assessment method was achieved.
The new edition of the standard series DIN EN ISO 9000 (Edition 8/94)
made revision of the second edition necessary.
rd
The 3 Edition also includes requirements from the guidelines EAQF/94
(France) and QS-9000/95 (America). This allows comparison of the audit
results. Furthermore, certification notes were incorporated.
5
th
In the 4 Edition further corrections and up-dates were included. Comments
from the users and the auditor’s symposia were considered (see Para.
12.1). The audited organization is now referred to as „the company“
throughout the questionnaire.
The element Z1, so far only required for companies with international busi-
ness activities, now has to be considered generally during audits/certifica-
tion.
DIN EN ISO 9001 (Edition 8/94) was used as the basis for the Quality
system audit which describes a comprehensive system of industrial quality
management with its elements. Questions were formulated from the
requirements profile of this standard relating to the explanation of a quality
management system, together with specific requirements from DIN EN ISO
9004 (Edition 8/94) and supplemented with the practical experience of the
automotive industry. In contrast to the standard which treats the same
subject matter partially in various places and varying depth the ques-
tionnaire in this publication normally contains the subject matter only once in
order to, as far as possible, avoid the repetitions contained in the standard.
- M Company Management
- P Product and Process.
Since the company management and the lower management levels have a
decisive influence on the definition, implementation and monitoring of quality
assurance, it’s incorporation is the fundamental requirement of the
standard. This is expressed in the structure of the questionnaire and is
taken into account in the questions accordingly. The questions are therefore
to be answered by the person responsible for the particular division of the
company.
6
This VDA Volume represents a supplement to those volumes already pub-
lished and serves the evaluation of quality management systems under
comparable conditions. It is intended to help identify weaknesses, to remedy
them through corrective actions and thereby continually improve the com-
pany's productivity.
The aim of this work is to unify the necessary audits in order to reduce the
working expenditure for the auditor as well as for those to be audited. Car
manufacturers and suppliers agree to mutually recognize, as far as
possible, audits carried out on the basis of this uniform questionnaire and
evaluation system for rationalization reasons. Recognition of the system-
related audit allows concentration on more specific product- and process-
related audits.
7
We thank those companies involved and their employees for their work in
drawing up these guidelines:
Thanks also to all those who offered suggestions for improvement and
those companies represented in the editorial circle.
8
Contents Page
1 INTRODUCTION 13
4 DEFINITIONS 27
4.1 General terms according to DIN EN ISO 8402/1995 (Extract) 27
#.1.1 Unit 27
#.1.2 Process 27
#.1.3 Procedure 27
#.1.4 Product 28
#.1.5 Service 28
#.1.7 Organization 28
#.1.8 Organizational structure 28
#.1.9 Customer 29
#.1.10 Supplier 29
4.2 Quality-related Definitions according to
DIN EN ISO 8402/1995 (Extract) 29
#.2.3 Quality Requirements 29
#.2.15 Inspection and Testing 30
#.2.17 Verification 30
#.2.18 Validation 30
#.2.19 Evidence 30
9
4.3 Definitions for Quality Systems according to
DIN EN ISO 8402/1995 (Extract) 31
#.3.1 Quality Policy 31
#.3.6 Quality System 31
#.3.12 Quality Manual 31
4.4 Definitions for Tools and Techniques according
to DIN EN ISO 8402/1995 (Extract) 32
#.4.9 Quality Audit 32
#.4.10 Quality Audit Findings 32
#.4.14 Corrective Action 33
4.5 Additional Terms (Definitions for the present volume) 33
4.5.1 System 33
4.5.2 Method 33
4.5.3 Serial Production 33
4.5.4 Quality Procedures 34
4.5.5 Work Instructions (Inspection and Testing Instructions) 34
10
11 Purchasing 117
12 Control of Customer-Supplied Product 125
13 Product Identification and Traceability
(Process Control, Inspection and Test Status) 129
14 Process Control 137
15 Inspection and Testing (Product Verification) 147
16 Control of Inspection, Measuring and Test Equipment 153
17 Control of Nonconforming Product 159
18 Corrective and Preventive Action 163
19 Handling, Storage, Packaging, Preservation and Delivery 169
20 Control of Quality Records 175
21 Servicing, (After Sales, Post-production Activities) 181
22 Statistical Methods 187
9 LITERATURE 199
9.1 VDA-Series "Quality Management in the
Automotive Industry": 199
12 APPENDIX 207
th rd
12.1 Changes of the 4 Edition compared to the 3 Edition 207
12.2 Comparison Tables 210
12.2.1 Comparison Matrix VDA 6.1 / DIN EN ISO 900194 210
12.2.2 Comparison Matrix DIN EN ISO 900494 / VDA6.1 214
11
12
1 Introduction
Management must prove that due diligence has been shown in all areas of
the business, from planning to design, procurement, production, sales and
user information through to the observation of a product's market position.
This applies especially in the event of a claim for damages.
It is not only sensible, but essential that all quality management activities be
planned, implemented and combined in a quality system. Only a well
planned and purposefully selected quality system gives business partners,
authorities and, increasingly, insurers confidence in the business's ability to
comply with quality requirements.
The original understanding of quality, mainly shaped by the product, and the
associated duties of quality management have changed in recent years and
include new additional content and dimensions.
* Note: The terms "Quality Management“, „Quality System" and "Quality Manual", according
to DIN EN ISO 8402 replace the earlier used terms "Quality Assurance“, „Quality
Assurance System" and "Quality Assurance Manual".
13
- Definition and monitoring of quality-related costs
- Consideration of product safety and product liability
- Involving all employees in the responsibility for quality
These duties are covered in part M of the questionnaire with respect to the
quality management system.
Through the evaluation of the quality system with the help of the question-
naire, the customer is given a general view of the supplier's ability to deliver
products and services which meet his quality requirements.
The purpose of this volume is to define an agreed general procedure for the
uniform evaluation of a defined quality system. In this way, the working
expenditure required for further quality system audits, for example, by other
customers, can be reduced.
The result of the evaluation shall show the audited company where his
quality system meets the requirements and in which elements improve-
ments are necessary.
The audit result is signed by the auditor and the audited company. The
audited company confirms with it’s signature that the identified result has
been discussed with him. He is free to provide his own response.
Information acquired during the performance of the audit is, other than for
the use of the audit itself, to be handled confidentially.
Following written release by the auditing company, or respectively, the certi-
fication body, in the appropriate field of the coversheet of the quality system
audit, the audited company is free to present the audit result to other
customers.
This VDA Volume 6, Part 1 is the basis for internal quality system
st nd
audits (1 Party), customer/supplier audits (2 Party) and for audits
with VDA 6.1 Certificate Supplement through VDA approved
rd
certification bodies (3 Party).
14
2 Quality system according to the DIN EN ISO 9000 Series
Users of this standard are enabled to select from the presented basis of
elements according to extent, depth and overall requirements of the
business in order to be able to completely fulfill the tasks of their own
company-specific quality system.
15
2.2 Quality Assurance Model
(according to the introduction to DIN EN ISO 9001)
The scope and depth of the quality system may depend on the type of pro-
ducts to be supplied, the applied technology and the size of the evaluated
company.
The following paragraphs are taken from the national foreword and the
introduction of DIN EN ISO 9001: 1994-08. There it is appropriately stated:
1) According to DIN EN ISO 8402, 1.4 may include product as well as services.
16
The following alternative models for quality assurance described in three
international standards represent three differing forms of "the functional or
organizational quality capability" which are suitable for use in contracts
between two partners (see Chapter 5: Cross-Reference List of Section
Numbers)
17
3 Quality System Audit
3.1 General
- management responsibility
- quality system
- internal quality audits
- training/personnel
- financial considerations to quality systems
- product safety
- corporate strategy
18
If the quality system of a company, on the occasion of a system audit, has
been found to be satisfactory in accordance Paragraph 3.3, then a periodic
quality system audit is to be carried out at appropriately defined intervals.
The relevant elements and corresponding questions for the evaluation of the
quality system of a company are to be defined. The elements 08, 12 and 21
can, under special circumstances, be completely/ partly omitted. Comments
regarding this are given with the relevant elements.
st nd
During internal quality audits (1 Party) and customer audits (2 Party)
further quality elements and questions may also be added. Furthermore,
elements of a quality system may be adapted, deleted (in exceptional
cases) or extended to meet company or product-specific needs. Additional
questions to the quality system must be communicated to the company/
organization to be audited beforehand.
rd
During certification audits (3 Party) additional requirements can only be
added if they form part of the quality system of the company to be audited.
In this case, their compliance and effectiveness are to be assessed. The
point rating according to VDA 6 Part 1, Paragraph 3.3.1 is not applicable.
Individual questions can only be omitted if they are unusual or not able to be
evaluated for the company size or branch. In cases of doubt, clarification
with the customer is sensible.
19
questions with an *. Non compliance with these requirements has
particular influence on the overall rating or awarding of a VDA 6.1
Certificate Supplement (see 3.3.3 and 3.3.4).
The auditor evaluates the definition and effectiveness of the quality mana-
gement activities in complying with the respective requirements by initially
determining:
20
According to the following table, answers to the questions lead to a rating for
each relevant question. This rating can result in 0, 4, 6, ,8 or 10 points per
question. Thereby, the following point rating is valid for each question:
Proven effective in
practice yes yes mainly *) no
Point score 10 8 6 4 0
Rating
21
Calculation of element ratings:
For the two parts of the audit, M (management) and P (product and pro-
cess), the individual levels of compliance CM and CP are calculated. They
are established by calculating the average value of the levels of compliance
for the relevant evaluated quality elements
CM + 2 * CP
CTOT = ——————— [%].
3
The rating system may also be applied if further elements or questions are
added or if elements or questions are omitted. If additional questions relate
to product, services or applied process technology, it may then be neces-
sary to adapt the point and rating system accordingly.
22
Note on the formula for CTOT*
The formula arises from the following consideration:
On condition that the 7 quality elements concerning management and the 16 quality elements
concerning product and process (from Chapter 6) are equally weighted in CTOT
Then:
7 * CM + 16 * CP
CTOT = ———————— = 0,30 * CM + 0,70 * CP
23
should be calculated.
In order to retain a simple formula and also to give more weight to the Part M quality ele-
ments, the committee defined the formula for CTOT as presented above (no mathematical
background). The elements of CM are therefore more heavily weighted by a factor of 0.33/
0.30 = 1,1.
Thereby the elements of management, as an essential part of quality assurance, are treated
with more importance in the quality rating system.
* CTOT is referred to as E
GES in the original German version
nd
3.3.3 Rating during Customer/Supplier Audits (2 Party)
*) Notes
1. Companies audited and having received an overall level of compliance exceeding 90% (or
respectively 80 %) but which have a level of compliance for one or more elements of less
than 75% will have their rating dropped from A to AB (or respectively AB to B), as
appropriate.
2. If a question marked with * which has particular influence on product and process or which
can lead to a failure of the quality system is graded with less than 8 points then the
company being audited is to be downgraded from A to AB or from AB to B.
3. If a question not marked with * is graded with 0 points, then the audited company is to be
downgraded from A to AB.
4.Downgrading according to 1, 2) or 3) above may be applied only once.
5. Downgrading are to be justified in a commentary sheet.
23
rd
3.3.4 Awarding of the VDA 6.1 Certificate Supplement (3 Party):
Exception:
2. Follow-up /Re-audit
A follow-up audit is not possible if more than one question marked with *
is rated with 0 points (Status : failed)
A re-audit is only possible at the earliest after 90 days. The same rules
apply as for a follow-up audit.
24
3.4 Summary of Results
The results of the quality system audit of Part M (management) and Part P
(product and process) are to be presented as shown in the sample forms
(Chapter 8). The results of each element will be entered on the sheet
"Summary of Results".
In the course of a close out meeting regarding the quality system audit, the
auditor informs the audited company's management which nonconforman-
ces are present and to what extent corrective actions are necessary. These
will be presented in an summary sheet "Nonconformances/Corrective
Actions". After completion of the quality system audit, the auditor raises an
audit repot and establishes a time schedule with the audited company for
the corrective actions (see sample forms – Chapter 8). If necessary, a
follow-up audit date is agreed.
The result of the quality system audit, presented as shown in the main
paragraphs 3.4 and 3.5 above, serves the management of the audited com-
pany as a basis for corrective actions. It is the duty of the audited company
to work out and implement an improvement program. This has to be
communicated to the lead auditor responsible for heading the audit. The
auditor decides on the basis of the presented improvement program to what
extent a follow-up audit is carried out.
A VDA 6.1 certificate can only be awarded if the overall rating achieved is A
(see 3.3.3). A precondition for this is that the auditor is registered as a Lead
Auditor with the VDA. The representative of the certifying body applies for
the VDA 6.1 certificate from the VDA at the request of the company being
audited.
The awarding of a VDA 6.1 certificate may also be carried out under
consideration of existing certificates according to DIN EN ISO 9001/9002 or
QS 9000 with supplementary auditing (see VDA Volume 6).
The certificate is valid for 3 years after the date of issue.
25
VERBAND DER
VDA AUTOMOBILINDUSTRIE E. V.
VDA 6.1-URKUNDE
Unternehemen:
Betriebsteil:
Produktgruppe/n:
_________________________
Firma / Unterschrift des Bevollmächtigten VDA-Stempel
Lead-Auditor(en): __________________
_________________________________
26
4 Definitions
#.1.1 Unit
#.1.2 Process
A set of interactive resources and activities which transform inputs into out-
puts.
#.1.3 Procedure
27
#.1.4 Product
Note 1: The term product may include a service (1.5), hardware, processed materials,
software or combinations thereof.
Note 2: A product can be tangible (e.g. assemblies or processed materials) or
intangible (e.g. knowledge or concepts) or a combination thereof.
Note 3: A product can be intended (e.g. offered product to customers (1.9)) or
unintended (e.g. pollutants or unwanted effects).
#.1.5 Service
The result generated at the interface between the supplier (1.10) and the
customer (1.9), as well as by internal activities of the supplier (1.10) to meet
the customer needs.
#.1.7 Organization
28
#.1.9 Customer
#.1.10 Supplier
The organization (1.7) which provides a product (1.4) to the customer (1.9).
Note 1: In a contractual situation, the supplier may be called the "contractor" (1.12).
Note 2: A supplier may be, for example, the producer, distributor, importer, assembler
or service organization.
Note 3: The supplier can be either external or internal.
Note 1: It is essential that quality requirements fully reflect the established and given
needs of the customer.
Note 2: The term "requirement" includes market-based, contractual, as well as internal
requirements of a company (1.7). They may be developed, defined and
updated in the various planning phases.
Note 3: Established quantitative requirements of the characteristics include e.g.
nominal values, ratings, limit deviations and tolerances.
Note 4: The quality requirements should be expressed in functional conditions and be
documented.
29
#.2.15 Inspection and Testing
#.2.17 Verification
#.2.18 Validation
Note 1: In design and development, validation concerns the process (1.2) of exa-
mining a product (1.4) to determine its conformity (2.9) with the needs of the
user.
Note 2: Validation is normally performed on the end product under defined operating
conditions. It may be necessary at an earlier stage.
Note 3: The term "validated" is used to describe the corresponding status.
Note 4: Multiple validations can be carried out, if different applications are intended.
#.2.19 Evidence
30
4.3 Definitions for Quality Systems according to DIN EN ISO
8402/1995 (Extract)
Note: The quality policy is an element of the corporate policy and is approved by the
management.
Note 1: The quality system should be as comprehensive as required to meet the quali-
ty objectives.
Note 2: The quality system of a company (1.7) is aimed primarily at satisfying the
internal needs of the company. It is more extensive then the requirements of a
single customer (1.9) who only evaluates the part of the quality system
relevant (to him).
Note 3: For contractual or other obligatory purposes of quality assessment (4.6), de-
monstration of the implementation of defined quality system elements may be
required.
A document stating the quality policy (3.1) and describing the quality system
(3.6) of an organization (1.7).
Note 1: A quality manual may relate to the entire company activity or just parts of it.
Title and purpose of the manual reflect the scope of application.
Note 2: A quality manual normally contains or refers at least to:
a) he quality policy;
b) the responsibilities and authorities (jurisdiction), as well as the interrelations
personnel who manage, perform, assess or evaluate quality-related acti-
vities;
31
c) the procedures (1.3) of the quality system (3.6) and corresponding in-
structions;
d) a stipulation for reviewing, revision and administration of the manual.
Note 3: A quality manual may differ in comprehensiveness and format in order to
refelct the needs of a company. It may consist of more then one document.
Depending on the purpose of the manual, a title may be used such as „Quality
assurance manual“ .
Note 1: The quality audit is typically applied, but is not limited to a quality system (3.6)
or elements thereof, processes (1.2) or products (1.4) (including services
(1.5)). Such quality audits are often called "System Audit", "Process Audit",
"Product Audit" or "Service Audit".
Note 2: Quality audits are carried out by persons who have no direct responsibility in
the area to be audited, however, preferably they should be working together
with the relevant personnel.
Note 3: One purpose of a quality audit is to evaluate the need for improvement or
corrective action (4.14). A quality audit should not be confused with the
activities of quality monitoring (4.7) or reviewing (2.15) which are carried out
for process control or material receiving.
Note 4: Quality audits may be carried out for internal or external purposes.
32
#.4.14 Corrective Action
Note 1: Corrective actions can bring about changes in e.g. procedures (1.3) and
systems to achieve quality improvement at any stage of the quality cycle (4.1).
Note 2: One has to differentiate between a "correction" and a "corrective action":
- A " correction" concerns a repair (4.18), a rework (4.19) or an adjustment
and refers to the treatment of an existing nonconformity;
- A " corrective action" refers to the elimination of the cause of the noncon-
formity.
4.5.1 System
4.5.2 Method
33
4.5.4 Quality Procedures
Quality procedures are specific instructions that are required in order to fulfil
given quality-related activities. They are to be put into force by signature.
34
5 Cross-reference List of Paragraph Numbers for Correspon-
ding Topics (according to DIN EN ISO 9000-1, Appendix D,
1994-08)
35
6 Structure and Number of Questions per Quality Element
Page No. of
questions
M Management
01 Management Responsibility 39 6
DIN EN ISO 9001, Section 4.1
DIN EN ISO 9004-1, Section 4
02 Quality System 47 6
DIN EN ISO 9001 Section 4.2
DIN EN ISO 9004-1, Section 5
03 Internal Audits 57 4
DIN EN ISO 9001, Section 4.17
DIN EN ISO 9004-1, Section 5
04 Training, Personnel 63 7
DIN EN ISO 9001, Section 4.18
DIN EN ISO 9004-1, Section 18
05 Financial Considerations of Quality Systems 71 4
DIN EN ISO 9004-1, Section 6
06 Product Safety 75 4
DIN EN ISO 9004-1, Section 19
Z1 Company Strategy 81 5
Subtotal of questions in section M 36
36
Page No. of
questions
P Product and Process
07 Contract Review, Quality in Marketing 77 5
9001, Section 4.3 / 9004-1, Section 7
08 Design Control (Product Design) 83 7
9001, Section 4.4 / 9004-1, Section 8
09 Process Planning (Process Design) 91 7
9001, Section 4.4 / 9004-1, Section 8
10 Document and Data Control 99 4
9001, Section 4.5 / 9004-1, Section 17.3
11 Purchasing 105 7
9001, Section 4.6 / 9004-1, Section 9
12 Control of Customer Supplied Product. 113 4
9001, Section 4.
13 Product Identification and Traceability (Process 117 7
Control, Inspection and Test Status)
9001, Section 4.8 (4.9, 4.11, 4.12)/9004-1, Section11
14 Process Control 125 7
9001, Section 4.9 / 9004-1, Section 10
15 Inspection and Testing (Product Verification) 133 6
9001, Section 4.10 / 9004-1, Section 12
16 Control of Inspection Measuring and Test Equipment. 139 5
9001, Section 4.11 / 9004-1, Section 13
17 Control of Nonconforming product 145 4
9001, Section 4.13 / 9004-1, Section 14
18 Corrective and Preventive action 149 4
9001, Section 4.14 / 9004-1, Section 15
19 Handling, Storage, Packaging, Preservation and 155 6
Delivery
9001, Section 4.15 / 9004-1, Section 16
20 Control of Quality Records 159 4
9001, Section 4.16 / 9004-1, Section 17.2
21 Servicing, (After Sales and Post-production Activities) 163 5
9001, Section 4.19 / 9004-1, Section 16
22 Statistical Techniques 167 6
9001, Section 4.20 / 9004-1, Section 20
Sub-total of questions in section P 89
Total of all questions 125
37
7 Quality System Audit Questionnaire
For every quality element the general requirements are described in an in-
troduction, the subject in its context is briefly explained and the questions
are stated..
In addition, reference is made to other applicable VDA Volumes which are
to be considered during the realization of the quality system. Equal proce-
dures and processes are permitted.
Questions on the quality system which have a special influence on the
product or process or may lead to the failure of the quality system are mar-
ked with an *.
Each question is structures as follows:
1. The Question
2. Definition
Where required, the terms used in the question are defined according to the
relevant standard and the standard or an extract thereof is cited. The source
is stated respectively.
Explanation of terms
Where required, the terms used in the question are explained, if no defini-
tion is given, to provide a better understanding.
3. Requirements/Explanations
Note: For each applicable question, the auditor has to evaluate the definition nad
effectiveness of the quality measures.
38
Part M: Company Management
01 Management Responsibility
DIN EN ISO 9001, Section 4.1
DIN EN ISO 9004-1, Section 4, 5
Reference
DIN EN ISO
9001 9004-1
01.1 Has the quality policy been defined by mana- 4.1.1 4.2
* gement and has it been made known to all
levels?
01.2 Have quality objectives been defined within 4.1.1 4.3.1
* the scope of corporate planning and the
quality policy and are the results monitored?
01.3 Is a continuous improvement process part of -- --
* the quality policy?
01.4 Have the necessary resources been provided 4.1.2.2 5.2.4
by the company management?
01.5 Has a management representative been 4.1.2.1 5.2.2
* assigned and are his duties, authorities and 4.1.2.3 5.2.3
responsibilities defined?
01.6 Does management regularly evaluate the 4.1.3 5.5
* effectiveness of the quality system?
39
01.1* Has the quality policy been defined by management and has
it been made known to all levels?
Definition:
Note: The quality policy forms one element of the corporate policy and is approved by
management.
Requirements/Explanation:
The quality policy must be formulated in such a way that it can be under-
stood, implemented and applied by employees at all levels The principles of
the quality policy are to be described in a quality manual or an equivalent
document (see Question 02.1).
- notices
- memoranda
- organizational guidelines and instructions
- informative presentations about the quality policy.
The quality objectives of the company are established from the quality policy
(see Question 01.2) which are authoritative for the organization of the
company and which incorporate the expectations of the customer(s).
40
01.2* Have quality objectives been defined within the scope of cor-
porate planning and the quality policy and are the results
monitored?
Explanation of terms:
Requirements/Explanation:
Objectives for quality within the scope of the quality policy might be, for
example:
a) Corporate-wide objectives
• Fulfillment of the general company requirements (laws, regulations,
directives)
• Improving market acceptance
• Making profit
• Ensuring the continued existence of the company
• Continuous quality improvement (see Question 01.3).
b) Product-related objectives
• Scrap-/ failure rates (%)
• Supplier delivery quality (ppm)
• Improving product quality
• Improving process capability (Cpk)
• Improving reliability
• Environmental tolerance.
c) Customer-related objectives
• Shortening of order processing time (inquiries, orders etc.)
(difference in days)
• Improving customer satisfaction (e.g. reducing the number of customer
complaints change %)
• Reduction in the reaction time when dealing with complaints (difference
in days)
• Improving delivery reliability (on-time performance).
41
d) Higher objectives
• Reducing costs but not to the detriment of quality
• Advance quality planning (see Question 02.5)
• Increasing improvement suggestion activities (methods, equipment,
operations etc.)
• Calculating and evaluating the costs assigned to all quality elements in
order to minimize any loss of quality
• Monitoring the effectiveness of corrective actions on the basis of audit
results
• Quality of the development of products and processes (time, imple-
menation, practicability, feasibility etc.)
• Quality system upgrade from ISO 9001/2 to VDA 6.1. Further develop-
ment towards TQM, EQA etc.
42
01.3* Is a continuous improvement process part of the quality
policy?
Requirements/Explanation:
Improvement programs for the operating units and for the commercial and
technical functional units of a company must be introduced and maintained.
The methods cited elsewhere (see Questions 04.2 and 04.5) must be used
here.
Items for improvement include, for example:
- Reducing non-value-adding activities (e.g. rework, repairs)
- Simplification of processes/Optimization of production
methods.
- Minimization of waste
- Reducing unplanned down-time of machines
- Shortening setting-up and tool change times
- Increasing service life/cycle times of products and equipment
- Improving the ease of repair of products and equipment
- Reducing water, air and energy expenditures
- Optimization of activity times
- Improved handling in all areas
Note: Connections to Question 01.2 are possible. The working methods applied can
be selected on a company-specific basis.
43
01.4* Have the necessary resources been provided by the company
management?
Requirements/Explanation:
So that the quality system can operate effectively, the company manage-
ment has the task of providing the financial and personnel resources
needed to fulfil the requirements in the quality elements. These include, for
example:
The effectiveness and efficiency of the quality system depends on the pro-
vision of the necessary resources for the realization of the quality policy and
the quality objectives.
Note: This question cannot be finally evaluated until the entire quality system has
become transparent as a result of the audit and until it has been ascertained
that all necessary resources are available.
44
01.5* Has a management representative been assigned and are his
duties, authorities and responsibilities defined?
Explanation of terms:
Requirements/Explanation:
Note: The representative may at the same time be responsible for the organizational
functions "quality department", "quality assurance", "quality management„ etc.
45
01.6* Does management regularly evaluate the effectiveness of the
quality system?
Definition:
Requirements/Explanation:
Company management must periodically (at least once each year) assess
and satisfy itself about the effectiveness of the established quality system.
The aim of this assessment is to achieve a continuous optimization and
adaptation to changed conditions (market, technology etc.). This can be
done by collecting and evaluating the following information, for example:
The review is carried out by comparing the findings with the objecti-
ves of the quality policy and usually results in preventive and correc-
tive actions.
46
02 Quality System
DIN EN ISO 9001, Section 4.2
DIN EN ISO 9004-1, Section 5
Reference
DIN EN ISO
9001 9004-1
47
02.1* Is the quality system described in a quality manual or an
equivalent document?
Definition:
A document stating the quality policy and describing the quality manage-
ment system of an organization. (see Paragraph 4.3 #3.12).
Requirements/Explanation:
- Organizational structure
- Names of responsible individuals
- Implementation process for all activities affecting quality in the
company.
The manual must display the approval of the company management, the
validity date and the revision status. Responsibility for it’s updating, revision
service and the distribution list must be defined. The main purpose of a
quality manual is to define the structure of the quality system and, at the
same time, to serve as a permanent reference for the implementation and
maintenance of this system.
48
02.2 Does the quality system encompass all areas, levels and
employees of the company?
Definition:
Requirements/Explanation:
The quality system extends to all phases of the life cycle of a product
(DIN EN ISO 9004-1 Paragraph 5.1) and all value-adding processes invol-
ved. It’s interacting functions are a precondition for the continuous com-
pliance with the requirements of customers, legislators and society.
49
02.3* Are there documented procedures defining duties, responsi-
bilities and authority levels for quality activities?
Explanation of terms:
Requirements/Explanation:
which come into effect when signed. Hereby, it must be ensured that duties
are clearly defined with the necessary independence to fulfill stipulated
requirements. This requires a definition as to who, for example:
50
02.4* Is there a cross-functional project management established
which includes the quality planning process?
Explanation of terms:
„Project management“ is defined as the management of activities across
several departments within a company, aimed at the realization of a particu-
lar project (e.g. introduction of a new product [see Question 08.1], a new
process, start of a series [see Element 14]). This task begins as early as
possible and encompasses the concept/design phase, the manufacturing
process, through to product utilization and disposal. It includes, among other
things, quality planning (see Question 02.5) and the quality plan (see
Question 02.6).
Requirements/Explanation:
Project flow charts with the main details, among other things for the mana-
gement of a project, must be raised and developed at a very early stage.
Here, the joint activities include:
- raising the specification
- concept / design,
- development
- production
- utilization
- disposal
51
02.5* Is there a quality planning process for the necessary measu-
res and procedures for fulfilling quality requirements?
Definition:
Quality planning (acc. to DIN EN ISO 8402/3.3): activities that establish the
objectives and quality requirements, as well as the requirements for the
application of the elements of the quality system.
Requirements/Explanation:
Quality planning must take into account the tasks and deadlines stipulated
by the customer and must contain specially defined methods.
Interdisciplinary teams must be used for the activities to be carried out (e.g.
Product Development, Process Planning, Quality, Marketing).
52
The quality planning phases for new products are:
53
Activities include, for example,:
02.6* Are there quality plans resulting form the quality planning
process?
Definition:
Note 1: A quality plan normally refers to those parts of the quality manual which apply in
a specific case.
Note 2: An alternative description, e.g. "quality assurance plan" can be used, depending
on the area of application of the plan.
Requirements/Explanation:
54
The quality plan must normally be drawn up for the following 3 phases:
• Prototype phase
• Pre-series phase
• Series phase
Comprehensive documentation of the product and process characte-
ristics, the process control measures, the inspections and tests and
measuring systems which must be observed during series produc-
tion.
When quality plans are drawn up, a distinction is made between various
versions. These are related to tangible products in
a) plans for a part manufacturing process with, for example, the following
content:
• Part name
• Process plan (manufacture / inspection / storage)
• Process stages (working steps)
• Work instructions
• Identification of the quality-relevant characteristics which have to be
monitored during production.
• Process monitoring
- Process description
- Monitoring methods (quality control charts, automatic recor-
dings etc.)
- Responsibilities (operator inspection, quality inspection etc.)
- Inspection instructions
• Inspection
- Parameters
- Geometric/material/functional characteristics
• Documentation,
55
b) plans for a finished product with, for example, the following content:
including
If required, the quality plan must be agreed upon with the customer.
Quality plans are living documents and must be reviewed and updated if:
56
03 Internal Quality Audits
DIN EN ISO 9001, Section 4.17
DIN EN ISO 9004-1, Section 5
Reference
DIN EN ISO
9001 9004-1
03.1 Are the personnel (auditors) who perform internal quality 4.17 5.5
* audits qualified and independent of the areas being
audited?
03.2 Are all elements of the quality system regularly subjected 4.17 5.4
* to internal audits and evaluated according to an audit 5.5
plan?
03.3 Do deviations lead to corrective actions and are these 4.17 5.4.5
* documented?
03.4 Are the demands placed on products and processes - 5.4.3
* audited and evaluated internally on the basis of an audit
plan?
57
03.1 * Ist das Personal (Auditoren) für die Durchführung von inter-
03.1* Are the personnel (auditors) who perform internal
quality audits qualified and independent of the areas being
audited?
Definition:
Quality auditor (according to DIN EN ISO 8402/4.11):
Person qualified to perform quality audits.
Explanation of terms:
"Quality auditors" (see DIN ISO 10011, Part 2) must be impartial and free
from any influences which might affect their objectivity.
Personnel tasked with carrying out audits must be independent of the areas
on which they are reporting. They must not come from the organizational
unit to be audited.
Requirements/Explanation:
Auditors must be qualified to manage and perform internal quality audits.
The required qualification profile must be defined. Depending on the type of
audit and size of the company , the following aspects are particularly
relevant:
• Qualification in accordance with DIN ISO 10011-2 and training in
accordance with EOQ or equivalent guidelines. Evidence of training
can also be supplied through internal training courses.
• Knowledge and understanding of the standards which might form the
basis for audits of quality systems (DIN EN ISO 9000 - 9004, VDA
Volume 6, Part 1)
• Evidence about the methods of grading through investigation,
interview, evaluation and reporting (e.g. auditor training in accordance
with VDA 6.1)
• Skills that are essential for the management of a quality audit, such
as planning, organization, communication and leadership
• Experience in quality management and quality techniques
• Personal characteristics, such as, e.g. integrity, good judgement,
analytical ability, open-mindedness
• Upholding of relevant qualifications with certificates.
58
03.2* Are all elements of the quality system regularly subjected to
internal audits and evaluated according to an audit plan?
Explanation of terms:
The different types of audits with scheduled dates and the areas to be
audited have to be defined in an „audit plan“ (according to DIN ISO 10011-
1). This auditing is the systematic review of all quality elements with regard
to their effectiveness, compliance with the requirements and their topicality.
Requirements/Explanation:
Individual quality elements or parts thereof can also be inspected and eva-
luated at different times. All quality elements, in all areas, and at all com-
pany sites must be audited within 3 years.
59
03.3* Do deviations lead to corrective actions and are these docu-
mented?
Definition:
Requirements/Explanation
a) Deviations
- Non-compliance with a requirement of a standard
- Instructions are not suitable to achieve the objective
- Activity does not correspond to the instructions
- Instructions not actually implemented
c) Remedial measures
d) Responsibilities/deadlines
e) Effectiveness check
f) Reporting
60
03.4* Are the demands placed on products and processes audited
and evaluated internally on the basis of an audit plan?
Explanation of terms:
A "process audit" serves to check whether the product complies with the
quality requirements and that the process is mastered and capable.
Requirements/Explanation
Audit plans must be defined for products and processes and must include
the following information:
- Audit aim
- Reference documents
- Products/processes to be audited
- Audit sequence
- Questionnaire/checklist
- Deadlines
- Auditors
- Reporting with distribution list
- Pursuit of corrective measures
61
62
04 Training
DIN EN ISO 9001, Section 4.18
DIN EN ISO 9004-1, Section 18
Reference
DIN EN ISO
9001 9004-1
63
04.1 Are training requirements regularly determined on an indivi-
dual and function-related basis and is a differentiated training
program for all levels of the company derived from this?
Explanation of terms:
"Training program" means the determination of the entire training needs and
the derived measures in all areas of the company.
Requirements/Explanation:
All employees at all levels who carry out activities which affect quality must
be included. Requirement profiles must be defined on a function-related
basis. The training and further training activities must be summarized on an
individual basis. The summary should clearly show completed and still-open
training measures, and the qualification status must be clearly recognizable.
64
04.2 Does the training program also include actions for further
training in quality techniques?
Requirements/Explanation:
- risk analyses
- design of experiments
- test and measurement technology
- capability studies
- statistical process control
- quality control chart system
- system, process and product audit
- supplier evaluation
- problem solving techniques
- evaluation procedures.
65
04.3 Are top management and other management staff included in
the vocational training program?
Requirements/Explanation:
- Quality objectives
- Quality management / TQM
- Quality development
- Quality related costs
- Quality information
- Tools and methods of quality assurance
- Product safety
66
04.4* Are there introduction and instruction programs for new and
transferred employees and for the introduction of new or
modified processes, business procedures etc.?
Explanation of terms:
Requirements/Explanation:
Special attention should be paid to the selection and training of new per-
sonnel, workers on temporary contracts, workers on loan and personnel
entrusted with new duties.
67
04.5* Do employees possess the formal qualification for their
activities?
Explanation of terms:
Requirements/Explanation:
For auditors who carry out external quality audits, records for the following
are to be provided:
68
Evidence must be provided for development and testing activities, for
example:
Explanation of terms:
Requirements/Explanation:
- Improvement suggestions
- Quality circles
- Zero defect programs
- Poster campaigns, competitions
- Training, information meetings
- Awards
- Workshops.
The quality and performance capabilities of a company are not only depen-
dent on the technical and organizational capabilities and the business re-
sources, but far more so, on the qualification and readiness of employees to
perform well.
69
04.7* Do clear and understandable representations of the achieved
quality compared to the set objectives exist in the company?
Requirements/Explanation:
70
05 Financial Considerations to Quality Systems
DIN EN ISO 9004-1, Section 6
Reference
DIN EN ISO
9001 9004-1
71
05.1 Is there a procedure for financial reporting of the effective-
ness of the quality system?
Requirements/Explanation:
There are various methods for collecting, analyzing and displaying financial
data about the quality elements.
The financial reporting methods used depend on the individual structure of
each company and it’s organizational units, it’s activities and the maturity of
the quality system.
Traditional methods do not exclude the use of others, or their adaptation
and/or combination.
The appropriate procedure, method and cost structure (see Questions 05.2
to 05.4) must be defined (e.g. with instructions, distribution list, cost center
and cost plan and a summary of all financial outlays for the company
management).
Methods of financial reporting on activities in the quality system include, for
example:
• Quality-related costs
- Fault prevention
- Inspection and testing
- Internal and external faults
Note: Detailed information is only the subject of internal audits. Only the existence of
the procedure must be proven to an external auditor.
The company has the task of recording, analyzing and outlining on a cause-
related and time-related basis the financial figures which illustrate the
effectiveness of the quality system. It must also introduce and monitor the
effectiveness of improvement and preventive measures.
72
05.2* Does regular financial reporting and evaluation by the
persons responsible take place?
Explanation of terms:
Financial reports on quality-related activities should be compiled and eva-
luated regularly by the persons responsible. Improvements and objectives
can be derived from this.
Requirements/Explanation:
The reports must relate clearly to business parameters, such as sales,
turnover or value-added figures, in order to provide a realistic view the
company. Characteristic parameters and measured values must be in line
with target values. Trends and potential areas for improvement must be
identifiable. Quality and cost targets and improvement measures must be
defined for the subsequent period.
05.3* Is there evidence about internal losses as a result of unac-
ceptable quality (nonconformity)?
Explanation of terms:
„Internal losses“ are losses before delivery as a result of unacceptable qua-
lity. They may arise from reduced work efficiency caused by rework, poor
ergonomics etc. They also include nonconformity costs resulting from the
non-fulfillment of quality requirements by a product prior to delivery (e.g.
repeated performance of a service, renewed production, rework, re-inspec-
tion and testing, rejects).
Requirements/Explanation:
These costs/expenditures include, for example:
- Rejects
- Rework
- Quantity deviation
- Value reduction
- Unplanned sorting action
- Re-inspection and testing
- Investigation of the problem
- Down-time caused by failures
- Development targets not achieved.
Key cost items must be shown with their causes, in a time-, production- and
product-related manner.
73
05.4* Is there evidence about external losses as a result of unac-
ceptable quality (nonconformity)?
Explanation of terms:
„External losses“ are tangible and intangible losses which are identified as
resulting from unacceptable quality.
Tangible losses are nonconformity costs which result from the non-
fulfillment of quality requirements by a product after delivery (e.g. sorting,
rework and repair, warranty performances and return shipments, direct
costs and compensation, costs of product recalls, product liability costs).
Typical intangible losses include, for example, lost future sales as a result of
customer dissatisfaction.
Requirements/Explanation:
- Loss of image
- Loss of customers due to dissatisfaction.
Key cost items must be shown with their causes, in a time-, production- and
product-related manner.
74
06 Product Safety
DIN EN ISO 9004-1 Section 19
Reference
DIN EN ISO
9001 9004-1
75
06.1 Are the principles of product liability known throughout the
company?
Definition:
Product liability (according to DIN EN ISO 8402/2.12):
A generic term used to describe the onus on a producer or others to make
restitution for loss related to personal injury, property damage or other harm
caused by a product.
Note: The legal and financial implications of product liability may vary from one
jurisdiction to another.
Requirements/Explanation:
Indications concerning the knowledge of the principles of product liability
can be, amongst others, evidence of:
- Instruction and qualification of responsible individuals
- Legal services (internal / external)
- Product liability insurance
- Observation of science and technology
Product safety deficiencies can lead to liability claims against the company.
Therefore, the company employees, particularly the management per-
sonnel, in accordance with their activities, must have appropriate knowledge
of the principles of product liability.
Principles of product liability are (amongst others):
- Liability dependent on blame (characterized by the reversal of
the burden of proof. i.e. the burden of proof lies with the
defendant)
- Liability independent of blame (new product liability law), liability
for direct damages and consequential damages caused by a
defect
- It must be demonstrated that the manufacturing process
(design, manufacturing and testing) is "state of the art" - simply
complying with the applicable standards is not sufficient
- Responsibilities must be defined in writing
- Inspection and testing documentation with archiving
- Traceability must be ensured (limitation of damages)
- Warning of possible risks when the product is put into action by
the user.
76
06 .2 Is there a procedure to define and identify products and spe-
cial characteristics, for which special documented evidence
of the quality is required?
Explanation of terms:
Requirements/Explanation:
77
A retention period of 15 years (differences specified by the customer must
be taken into account) is also valid after discontinuation of production (for
further instructions, see VDA Volume 1).
The company obligates itself with the order confirmation to follow the
appropriate procedure, if agreed.
Explanation of terms:
"Product Risks" are safety risks that are involved in the product fulfilling it’s
own function. Furthermore, this also refers to the risks that a component
brings to a complete assembly.
Requirements/Explanation:
78
06.4 Do emergency plans and procedures for containing noncon-
forming products exist?
Explanation of terms:
Requirements/Explanation:
79
80
Z1 Corporate Strategy
Reference
DIN EN ISO
9001 9004-1
81
Z1.1 Is there a strategic business plan in the company which
contains aspects relating to costs, sales, quality etc.?
Definition of terms:
Requirements / explanation:
a) Cost aspects
- Finance and cost planning (investments, personnel and
material costs)
- Cost targets
d) Development aspects
- Development and trial projects
- Product analyses of competition results
82
All aspects should:
Z1.2 Are there methods to measure business results and are they
used regularly in order to introduce improvements?
Definition of terms:
The "business result" expresses what the company achieves with respect to
it’s planned performance.
Requirements/Explanation:
- Profit − Capital
- Cash flow − Liquidity
- Turnover − Dividends
- Value added shareholders − Long-term value for
(shareholder value)
In practice, these values are shown partly as absolute values and partly as
ratios per capital unit or per employee.
83
Cycle times such as:
- Innovation time
- Time until the profit threshold is reached
- Stock turnover frequency
The measured variables are orientated towards the company strategy and
to the corporate aims and plans. They contain measured variables which
enable the internal economy and effectiveness to be recognized and which
are decisive for continued corporate success.
Note: Only the existing system must be evaluated, not the absolute values /
amounts themselves.
Requirements/Explanation:
The evaluation, analysis and use of company-wide performance data in
comparison with the data of competitors or other companies through
benchmarking must give information on, for example:
- Productivity
- Economy
- Quality situation
- Efficiency
Trends in the data and information should be compared with the progress
made towards the company's overall targets and converted into useable
information for the purpose of:
- development of priorities for the rapid solving of customer-
related problems
- determining the important customer-related trends and inter-
relationships in order to make a review of the company's
situation, decision-making policies and long-term planning
possible.
Note: 1. Only the existing system must be evaluated, not the absolute
values/ amounts themselves.
2. This question can be omitted for companies (particularly small
companies) which do not operate on international markets.
84
Z1.4* Is there a procedure which enables customer satisfaction to
be measured and changes to be detected?
Requirements/Explanation:
- Method application
- Recognition frequency
- Data evaluation and representation
- Interpretation of trends
- Responsibility
- Distribution list
Note: Only the existing system must be evaluated, not the absolute values/ amounts
themselves.
85
Z1.5 Is employee satisfaction in the company one of the principles
of management and is it maintained on a continuous basis?
Definition of terms:
Requirements/Explanation:
Note: Only the existing system must be evaluated, not the absolute values/
amounts/results themselves.
86
Part P: Product and Process
The marketing function should take priority when defining the qua-
lity requirements of the product. They determine the requirements
for a product, the market demand and the customer requirements.
Reference
DIN EN ISO
9001 9004-1
87
07.1 Has a function ‘marketing’ been incorporated into the opera-
tional organization?
Definition:
Requirements/Explanations:
88
07.2 * Are inquiries, quotations, contracts/orders checked for com-
pleteness and feasibility and approved?
Definition:
Contract Review (according to DIN EN ISO 8402/3.10):
Systematic activities carried out by the supplier prior to signing the contract
to ensure that the quality requirements are adequately defined, free from
ambiguities, documented and can be realized by the supplier.
Requirements/Explanations:
Prior to the submittal of a quotation or the acceptance of a contract/order
the contract documents (specifications, drawings, requirement specifica-
tions, standards, quality agreements, logistical stipulations etc.) must be
checked for completeness.
Hereby it must be ensured that, e.g.:
- requirements are complete, appropriate and documented
- agreement exist for verbally placed orders prior to acceptance
- ambiguities and deviations are clarified early.
For this a system must be in place in which all responsible functions of the
company and its organizational units (e.g. sales, development, production,
production preparation, quality department and material management) con-
firm that they are able to fulfill customer requirements. The interfaces to the
customer are to be defined.
The contract review includes, for example:
- a defined sequence of events in the quality manual/procedures (flow
chart)
- Approval ruling prior to submittal of quotation to the customer (form
with approval by the responsible organizational units)
- Review of contract documents, among others, for:
• clarity of the individual requirements
• inconsistency of individual requirements
• missing of individual requirements
• given deadlines.
89
07.3 Are technical and commercial costs ascertained when pre-
paring a quotation?
Definition:
In a quotation a customer (the market) is offered a product for purchase or it
is provided to him as property or for use.
Products can be tangible or non-tangible.
Requirements/Explanations:
For a quotation, all decisive cost elements must be established and taken
into consideration. The costs are compiled by the responsible divisions and
are incorporated into the overall calculation.
The individual cost elements contain, for example:
- development costs
- material costs
- investments (including hardware/software)
- costs for quality measures
- transportation costs
- packaging costs
- value-added portions/calculated profit
- overheads (administration and marketing cost)
Note: The procedures in practice must be proven to the auditor, rather than the
absolute values.
Definition:
Quality requirement (see Para. 4.2/#.2.3)
Requirements/Explanations:
The quality requirements for a product must be documented, defined and
thereby the customer’s requirements completely taken into account. All
relevant functional/organizational units are to be included in these
sequences.
90
The quality requirements (of the customer) are described, for example, in:
- Specifications
- Quality agreements
- Drawings
- Performance specifications
- Standards
- Purchasing conditions
- Order documents.
Special requirements with regard to type, scope and structure of the quality
system are to be agreed separately.
07.5 Is a procedure available that ensures the early and clear noti-
fication of all product specifications to all areas involved?
Definition:
The entirety of the customer requirements concerning the supplies and ser-
vices of the supplier.
91
Performance Specification (according to DIN 69905):
All the realization requirements worked out by the supplier based on the
implementation of the requirements specification.
How and with what the requirements are to be realized is defined in the
performance specification.
Requirements/Explanations:
92
08 Design Control, (Product Design and Development)
DIN EN ISO 9001, Section 4.4
DIN EN ISO 9004-1, Section 8
The quality element design control also called the quality at inter-
pretation and design describes the quality-ensuring tasks in the
area of product design and development. These should take care
of the transferal of the customer needs from the requirements spe-
cification into a performance specification and technical specifi-
cations for products and prepare for a timely realization in confor-
mance with customer requirements. The provision of resources
for, e.g.: personnel, equipment, trials is a precondition for product
development.
Note: 1. This element is to be evaluated except when design responsibilities
are contractually defined. It is not applicable when a completed
product design is adopted.
2. VDA Volume 3, Volume 4 Part 1, 2 and 3 are also applicable to this
element.
Bezug
DIN EN ISO
9001 9004-1
08.1 Does an appropriate product development 4.4.1, 8.1,
* plan for a new product exist? .2,.4,.5 8.2
8.10
08.2 Is it ensured that all product requirements can 4.4.4 8.2.4
be realized? 8.4.2a
und b
08.3 Are product trials planned during the develop- 4.4.7 8.3,
ment and pre-series phase? 4.4.8 8.5
08.4 Are procedures and methods available to 4.4.6 8.2.3
* carry out a quality evaluation of designs, 8.3
design models and pre-series products in 8.4.2
accordance with the particular project phase?
08.5 Are all responsible functions involved in the re- 4.4.8, 8.6,
lease of the product design and its realization? .3, .5 8.7
08.6 Is the result of the product design and 4.4.5 8.6,
development documented in specifications? 8.8
08.7 Are the experiences of product design and 4.4.3 8.9
development experiences of products docu- 4.4.5
mented and are they available to other areas?
93
08.1* Does an appropriate product development plan for a new
product exist?
Requirements/Explanations:
For the product development plan current milestone plans, network plans
etc. with detailed plans must be produced which show all activities from
placement (design and development) through to start of series. The syste-
matic processing of the planned tasks (project planning) must be guaran-
teed. A person responsible for the project and all involved areas with their
tasks must be name (see Question 02.4). Central monitoring of the project’s
progress must be guaranteed (specified/actual comparison). Monitoring
must cover the compliance with all given targets such as, e.g.:
- deadlines
- product qualifications
- costs.
94
08.2 Is it ensured that all product requirements can be realized?
Definition:
"Quality Requirements" (see also definition in Para. 4.2/ #.2.3) are des-
cribed, e.g. in:
- laws, ordinances, etc.
- general standards, guidelines, specifications
- special standards or requirements specifications (these may
contain special inspection and test instructions also for hard-
ware and software).
Requirements/Explanations:
95
08.3 Are product trials planned during the development and pre-
series phase?
Requirements/Explanations:
The trial conditions for the product are to be determined and agreed with the
customer.
The product trials may also be performed by an external body (e.g. indepen-
dent inspection agencies, customers). The competence of external bodies
must be proven; if required, accredited bodies are to be used.
- assembly trials
- functional testing
- durability testing
- environmental simulation testing.
96
08.4 * Are procedures and methods available to carry out a quality
evaluation of designs, design models and pre-series pro-
ducts in accordance with the particular project phase?
Requirements/Explanations:
"Design" Phase
97
"Production prior to series start“ phase (see also Quality Element 09):
- Process analyses
- Process optimization
- Process review
- Compliance with specification limits.
Note: Procedure for release of series production see Question 14.2 (Product) and
Question 09.5 (Process).
Requirements/Explanations:
Release is based on the evaluation of the feasibility of the design by, among
others, development, sales, purchasing, production, quality assurance, to-
gether with the customer (Project launch meeting). It represents the appro-
val that the design may be realized.
98
08.6 Is the result of the product design and development docu-
mented in specifications?
Definition:
Requirements/Explanations:
For products that are not clearly specified in the customer's drawings ("as
delivered", "as per manufacturer's choice", “without information on inspec-
tion and test instructions“ etc.), the corresponding information in the com-
pany’s detailed drawings and the finished part drawings must be completed.
Furthermore, the narrowing of tolerances on the customer's drawings might
be necessary. Company specifications must cover the requirements speci-
fied by the customer.
99
08.7 Are the experiences of product design and development
experiences of products documented and are they available
to other areas?
Requirements/Explanations:
- design manuals
- data bases for design FMEA
- product life cycles with, for example, product optimization/
improvements, adaptation through modified/improved produc-
tion procedures
- documentation of test results
- corresponding reports on materials and procedures.
100
09 Process Planning (Process Development)
DIN EN ISO 9001, Sections 4.4, 4.9
DIN EN ISO 9004-1, Section 8
Reference
DIN EN ISO
9001 9004-1
09.1 Does an appropriate process development plan for (4.4.1, (8.1, 8.2
* new/modified products exist? .2, .4, .5) 8.10)
09.2 Are production, assembly and maintenance pro- (4.9 (10.1.1)
cesses and the material flow planned according to Abs.1
quality aspects and are process control require- 4.9a)
ments defined?
09.3 Is it ensured that all product requirements are met (4.3.2c) (8.2.4
by the process? 8.4.2a /b)
09.4 Are procedures and methods available to carry out (4.4.6) (8.2.3 8.3
* a quality evaluation of processes and procedures in 8.4.2)
accordance with the respective project phases?
09.5 Are all responsible functions involved in the release (4.4.8, (8.6, 8.7)
of processes and procedures? .3, .5)
09.6 Is the result of process planning/development docu- (4.4.5) (8.6, 8.8)
mented in process specifications/ procedures?
09.7 Are the experiences from process planning and (4.4.3 (8.9)
development documented and are they available to 4.4.5)
all relevant areas?
101
09.1 * Does an appropriate process development plan for new/
modified products exist?
Requirements/Explanations:
For the process development plan, current milestone plans, network plans
etc. with detailed plans must be produced which show all activities from
placement (development) to series start. The personnel and finance resour-
ces are also to be considered in the development plan. The systematic
processing of the planned tasks (project planning) must be guaranteed. A
project manager and all involved areas with their tasks must be named.
Central monitoring of the project’s progress must be ensured (specified/
actual comparison). Monitoring must cover compliance with all stated
targets such as, e.g.:
- Deadlines
- Process Qualifications
- Costs.
- Production planning
- Equipment/tool design and construction
- Procurement (of products, materials, components) from
suppliers
- Operating equipment construction
- External developments
- Purchasing and the procurement of production and manufac-
turing equipment
- Updating the process development plan.
102
09.2 Are production, assembly and maintenance processes and
the material flow planned according to quality aspects and
are process control requirements defined?
Definition:
Process control
Process control is a quality control where the observed unit (tangible or non-
tangible object of an observation) is a process.
Requirements/Explanations:
103
To achieve and maintain controlled processes, it is also necessary to carry
out a systematic planning for, e.g.:
- material control
- release of equipment for production, assembly and
maintenance
- approval of procedures and work instructions
- quality plans
- computer software
- documentation requirements
09.3 Is it ensured that all product requirements are met by the pro-
cess?
Definition:
104
Requirements/Explanations:
Tasks for suppliers are also to be included in the review. Overall responsi-
bility remains with the company. In cases of noncompliance, comprehensive
measures are to be taken.
The process requirements must take into account the bases and results of
the contract review (compare Questions 07.2 to 07.4).
105
09.4 * Are procedures and methods available to carry out a quality
evaluation of processes and procedures in accordance with
the respective project phases?
Requirements/Explanations:
The method of quality evaluation for processes is applied to ensure that all
quality-relevant findings from the various phases of product development
can be realized.
• ensure that the best possible and most comprehensive picture of the
desired quality of the new product is produced by involving and systema-
tically questionning all affected functional areas,
• identify potential weak spots early through the appropriately timed appli-
cation corresponding to each project phase and initiate the introduce of
corrective actions
• guarantee and clarify the implementation of corrective actions (e.g.
results from FMEA, fatigue test, field trial and assembly test)
• document all important results of the quality assurance activities during
the development of a new process/procedure
• include the practical preliminary planning for the quality of the series and
purchasing.
• “Design“ Phase:
- Risk analyses (e.g. Failure Mode and Effects Analysis, Fault Tree
Analysis) (compare VDA Volume 4, Part 1 and 2)
- Design of Experiments (statistical test methodology, e.g. according to
Taguchi, Shainin)
106
• “Production prior to series start“ Phase:
- Process analyses
• Causes of dispersions
• Appropriate inspection and test methods, e.g. fault tree
analysis, test methodology, cause/effects diagram
- process optimization
- process review
- compliance with specification limits
Requirements/Explanations:
The release is based on the evaluation of the producibility of the design and,
beside others, through development, sales, purchasing, production, quality
assurance, together with the customer. It represents the approval that the
design may be realized.
107
09.6 Is the result of process planning/development documented in
process specifications/ procedures?
Definition:
Requirements/Explanations:
- description of process
- process parameters
- important product and process characteristics
- inspection and test plans and work plans/instructions
108
09.7 Are the experiences from process planning and development
documented and are they available to all relevant areas?
Requirements/Explanations:
109
110
10 Document and Data Control
DIN EN ISO 9001, Section 4.5
DIN EN ISO 9004-1, Section 17
Reference
DIN EN ISO
9001 9004-1
111
10.1* Are the responsibilities and procedures for the identification,
maintenance, review and approval of the documents defined?
Definition:
“Identification" serves the clear relation to events, processes or products.
"Maintenance" encompasses the revision service and archiving whereby the
ability to retrieve records must be guaranteed.
"Review" includes, beside others, the comparison and translation between
internal and customer specifications, as well as the formal and contextual
review of documents.
"Release" is the approval given by the responsible departments.
Requirements/Explanations:
The processes are to be comprehensively laid out from the customer to the
company integrating all relevant internal departments. For the following
documents, procedures and responsibilities are to be defined:
Affected are, for example:
- documents for contract review
- specifications
- drawings
- formulations
- standards, regulations, internal standards
- inspection and test instructions
- inspection and test plans, control plans, inspection and test
instructions
- work instructions
- work procedures, measuring programs
- quality plans
- quality procedures
- quality manual
- procedures for quality verification
- reference samples
- trial procedures.
Documents must be available with the valid revision status to all involved
organizational units. Special identification instructions from customers are to
be followed
A clear presentation of all types of documents is useful.
112
10.2 Is there a distribution and maintenance system with revision
service available for the documents?
Requirements/Explanations:
- distribution, availability
- completeness (reference documents)
- safeguarding the latest revision status (current revision status)
- approval of changes
- method of identifying changes in the document
- invalidation.
The regulations relating to the approval and distribution system must des-
cribe a process which ensures that the correct documents are available at
the correct time, in the correct place and that a confusion with invalid
documents is excluded.
113
10.3 Is it defined, where, how and for how long the documents are
to be archived?
Requirements/Explanations:
- retention period
- filing system
- filing location.
The retention time (archiving) must also be in line with, amongst other
things, requirements of laws, general guidelines, customers and product
liability aspects (see VDA Volume 1).
114
10.4 Is the timely introduction and control of external documents
ensured?
Requirements/Explanations:
The company must set up a procedure which ensures that all external
documents such as, e.g., standards, specifications, documented procedu-
res and their revisions are reviewed, distributed or introduced at the appro-
priate time. Records of this must be kept in the same way as for internal
documents. Summary of the external documents at a central location is
possible.
Requirements/Explanations:
Immediately after new documents are received, the invalid documents must
be recalled and destroyed by the person responsible.
115
116
11 Purchasing
DIN EN ISO 9001, Section 4.6
DIN EN ISO 9004-1, Section 9
Note: 1. VDA Volume 2, 6 Part 1, 6 Part 3 and 6 Part 4 are also applicable.
2. This element may also be applied to internal customer/supplier
relationships.
Reference
DIN EN ISO
9001 9004-1
117
11.1 Are the quality requirements on the products and services
clearly and completely specified in the order documents for
suppliers?
Requirements/Explanations:
The company must agree these specifications with the supplier. Prior to re-
lease of the order documents, these must be checked for clarity and com-
pleteness. Specifications passed on to suppliers may exceed the quality
requirements of the companies’ customers, but must at least contain all
these requirements on which the supplier has an influence or which affect
him.
This also includes visits of the companies’ customers at his suppliers, if this
is contractually agreed.
When purchasing tools and capital goods the following must be considered
and defined, beside others:
118
11.2* Are the evaluation and selection of suppliers defined?
Requirements/Explanations:
(Such system audits also serve as a support for the supplier in setting up
his quality system. They also serve the purpose of system consultancy.)
- product audits
- first sample testing (compare Question 11.3)
- quality assessments of capital goods (compare Question 14.2)
Special care is to be paid to the selection of suppliers for products with spe-
cial characteristics, the documentation of which requires special archiving.
119
11.3 Are sample tests for purchased products defined?
Definition:
First samples are products and materials which have been completely
manufactured with standard equipment under series conditions.
Requirements/Explanations:
- geometry
- material (special attention to hazardous material)
- function
- reliability.
First sampling provides evidence that the supplier is able to fulfil the re-
quired specifications with the applied procedures and equipment. The first
120
samples give the company important evidence on the quality of the series to
be expected. A release of the first samples by the inspector does not relieve
the supplier of the responsibility for the series of these products.
Note: Depending on the application purpose, there are various types of samples. In
many branches other designations are used instead of "first sample" such as,
for example, "First lot", "First delivery". The above requirements apply in
corresponding form to all sample types.
Definition:
Requirements/Explanations:
121
11.5 Do agreements with the suppliers regarding the method and
responsibilities for quality inspections exist?
Requirements/Explanations:
Where necessary, the company has to set up clear agreements with its
suppliers, regarding e.g.:
Requirements/Explanations:
When the supplier provides quality records (e.g. test certificates according
to DIN EN 10204/3.1b), then control tests are to be performed periodically.
The characteristics to be shown on the quality records are to be agreed.
The certificate must be based on tests carried out on goods ready for
delivery.
If it has been agreed with the supplier that product inspections are only
carried out at his premises, then the company has to satisfy itself as to the
proper execution at the supplier. The visits shall be carried out depending
on the quality capability of the supplier and on the importance of the
product. The company must demonstrate this by means of visit reports.
122
A clear identification of the identity of the delivery lots and a differentiation of
released and non-released lots is to be carried out. The material receiving
system must bar goods that have not been released. In the event of use of
the delivered product prior to the completion of inspection, a procedure
(special concession) must be implemented (traceability).
Definition:
Requirements/Explanations:
123
124
12 Control of Customer-Supplied Product
DIN EN ISO 9001, Section 4.7
Products sold by the customer to the company are not the subject
of this quality element as the normal customer/supplier relation-
ship applies.
Reference
DIN EN ISO
9001 9004-1
125
12.1 Do agreements with the customer on quality measures for
customer-supplied products exist?
Definition:
Requirements/Explanations:
Where no agreements exist, the company can only take quality responsi-
bility for his value- added activities (compare Question 12.2).
Requirements/Explanations:
In the event that no special agreements with the customer have been made,
a documented procedure must define responsibilities for at least the
following measures:
126
12.3 Is a procedure defined for reporting nonconformities or
losses of customer-supplied products to the customer?
Requirements/Explanations:
When nonconforming products are delivered or when products are lost the
customer must be informed of the following, for example:
- Delivery condition/damage
- Incorrect delivery
- Quantity deviation/lost goods
- malfunction
- Deterioration of quality during processing
- Rework.
Definition:
The documentation describes the quality history of customer-supplied pro-
ducts. It provides a summary of the quality situation during a particular
period.
Requirements/Explanations:
The delivery quality of customer-supplied products can have a significant
influence on further processing. Deviations from defined quality characte-
ristics are, for example, to be:
- documented upon receipt
- recorded within the area of the production process
- recorded in the case of a product ready for dispatch
- assigned to the delivery lot
- stored for a defined period.
The recordings showing the type of deviation may be carried out, for
example, in:
- nonconformity tally cards
- quality control charts
- Statistics.
127
128
13 Product Identification and Traceability (Process Control,
Inspection and Test Status)
DIN EN ISO 9001, Section 4.9, (4.8, 4.11, 4.12)
DIN EN ISO 9004-1 Section 11
Note: To complete this element, Sections 11.2 and 11.7 from DIN EN
ISO 9004-1 are additionally discussed here.
Reference
DIN EN ISO
9001 9004-1
129
13.1 Is the identification of products for internal processes
defined?
Definition:
Requirements/Explanations:
The system shall ensure that products are unambiguously identified in every
stage of the material flow, also with regard to their operational state,
inspection and testing and modification status in order to avoid mix-ups. For
products with a limited storage life, the storage limitation must also be
identified.
The relation to the lot or batch must be traceable. The corresponding work
instructions must be available at site.
Note: 1. The identification system used by the company must allow the clear relation
to the customer’s drawing with revision index at the interface to the
customer (dispatch).
2. Identification for traceability, see Question 13.6
130
13.2 Is the fulfillment of the quality requirements on the product
ensured through process control measures?
Definition:
“Process control measures“ include, among others, all inspections and tests
accompanying the process in the complete production sequence used for
controlling.
Requirements/Explanations:
Inspections and tests accompanying the process must be carried out so that
timely detection of deviations is guaranteed. This allows the timely intro-
duction of corrective actions and prevents further processing of defective
materials.
The documentation must also contain the results from manual and/or auto-
matic 100 % inspections. In the case of an automated 100 % inspection, a
recording of inspected and rejected products must be carried out.
131
13.3 Are process parameters recorded and deviations including
corrective actions reported?
Definition:
Requirements/Explanations:
- Pressure
- Temperature
- Time
- Torque
- Distance
- Electric current
- Voltage
- Frequency
- Humidity
- Velocity.
132
13.4 Are production as well as inspection, measuring and test
equipment appropriately stored and protected during inter-
ruptions in use?
Requirements/Explanations:
Production and inspection and test equipment must be appropriately stored
and protected from damage and dirt so that the performance capability is
not affected. This also applies to computers and data storage media.
Tools specifically linked to parts and inspection and test equipment must be
related to a defined release or revision status of the related product. The
revision status must be securely attached to the production mean or, e.g.,
must be included in the file for production means.
In the production means store, the tool crib etc. the difference between tools
ready for production and those still to be inspected and reconditioned must
be identifiable (release status).
Mix-ups lead to nonconforming production, complaints, rework costs,
additional set-up costs etc. This can only be excluded through a clear
process organization.
Requirements/Explanations:
Products must be given an inspection status after each process step
(except for interlacing) which shows whether the products have been
inspected, which quality inspections have been carried out and whether or
not they meet the quality requirements (see Question 13.1). Hereby
customer requirements must be considered.
The sequence organization, with responsibilities, must be defined. This
applies particularly where operator inspection is practiced.
This is intended to ensure that only those products which have been
released in accordance with the work instructions and which are usable
reach the next operational stage or dispatch.
Where the identification of products is not possible or economically
justifiable the type of identification must be agreed and proven.
133
13.6 Is the known product data traceable from dispatch to material
receiving?
Definition:
Requirements/Explanations:
134
The FIFO principle must be followed in all production areas (material
receiving, in-process, delivery and external stores) (for example through
transient or electronically controlled stores with storage date as a sorting
criteria, etc.). Instructions must be available at the individual work stations.
A clear date identification on the material traveler cards is required,
especially for reserved and fixed storage areas and products with a
expiration date.
The individual production lots and batches are to be identified and kept
sepaate. The identification applies to all areas of the company (material
receiving, production, stores, etc.) up to the point of use. Identification is
placed directly on the parts and/or on the containers/ packaging (compare
Question 13.1).
135
13.7 * Is there a procedure available for the re-release to serial
production?
Definition:
Requirements/Explanations:
Note: The release of the serial production for products manufactured for the first
time is evaluated in Question 14.2.
136
14 Process Control
DIN EN ISO 9001, Section 4.9
DIN EN ISO 9004-1, Section 10
Remark: Activities which are necessary for restart of series production are
treated under Question 13.7
Reference
DIN EN ISO
9001 9004-1
14.1 Are capability studies carried out on new/over- 4.9b 10.1.1
hauled machines (plants) and also on new/
modified products?
14.2 Are the conditions for a release to series pro- 4.9 10.1.1
* duction for new and modified products/proc- c, d, e
esses regulated and are they agreed with the
customer)?
14.3 Is the monitoring and control (regulation) of 4.9d 10.1.2
the relevant process parameters and product 10.2
characteristics ensured?
14.4 Does a tool management and a planned 4.9g 11.3
maintenance/servicing for equipment and
tools exist?
14.5 Are the requirements on special processes 4.9 11.4
defined? Abs.2,3 Abs.3
14.6 Are the environmental conditions which influ- 4.9b 10.3
ence product and process controlled? 4.11.2g
14.7 Is the effectiveness of production processes - -
evaluated with suitable methods?
137
14.1 Are capability studies carried out on new/overhauled
machines (plants) and also on new/modified products?
Definition:
Machine Capability
Process Capability
Requirements/Explanations:
The characteristics and method for performing the capability study are to be
defined.
Machine Capability
138
Under specific conditions, capability studies must be repeated in coordi-
nation with the customer, e.g., for:
In capability studies the machine with tools and, if applicable, integrated test
and control equipment is to be treated as a unit. The short term distribution
must have a capability characteristic number of at least cmk 1.67. If devia-
tions occur corrective actions must be determined and a new capability
study is to be carried out after these actions have been implemented.
Process capability
All characteristic values must generally lie within the tolerance range. The
characteristics important to product quality must be defined and agreed with
the customer. If process capability cannot be proven for important
characteristics measures must be defined. These can be, for example:
139
For cost and risk reasons, a 100% inspection requires process optimization.
In the case of non-capable processes, the 100% inspection is the only
procedure for sorting out defective products and introducing fault analysis
and corrective actions. Thereby, all actions should have the aim to conti-
nually improve the processes within the scope of a zero-failure strategy.
14.2 * Are the conditions for a release to series production for new
and modified products/processes regulated and are they
agreed with the customer)?
Requirements/Explanations:
For release to series production (see Definition, Section 4.5.3) all production
factors must be available. Only the consideration of all production factors
ensures the problem-free start of series. When determining capacities all
production factors must be considered. Bottlenecks lead to quality
impairments and additionally to exceeding of costs and deadlines.
140
- Product qualification review
• Acceptance criteria
• Functional performance
- First sample with first sample inspection report (VDA Volume 2)
• geometric
• material
• functional
• visual
- Production release
• provisional
• final
The conditions for a release and the type of documentation (e.g. checklist)
must be defined. It is useful and in certain cases (e.g. modified/relocated
processes) it is necessary to agree the release conditions (series and
modifications) with the customer in advance. This includes, among other
things, the production process and product approval procedure (PPA)
(compare VDA Volume 2) and the procedures/methods prior to start of
series (compare VDA Volume 4, Part 1, 2 and 3).
141
14.3 Is the monitoring and control (regulation) of the relevant
process parameters and product characteristics ensured?
Requirements/Explanations:
Documentation must also contain and justify every change to the defined
production parameters. A change to the production parameter may require
a new process capability study.
142
14.4 Does a tool management and a planned maintenance/ser-
vicing for equipment
Explanation of term:
Definition:
Note: This serves to ensure the continuing quality capability of the process and may
also include computer and software.
Requirements/Explanations:
143
Based on a risk analysis a minimum amount of spare parts must be kept in
stock for bottleneck machines and equipment.
Definition:
“Special processes“ are processes the results of which can only be verified
(checked) on the product at a later time or not at all.
Requirements/Explanations:
- Characteristics
- Parameters
- Sequences
- Targets.
The control and monitoring of the processes must correspond to the pro-
cess situation. Personnel assigned for these processes must be appropria-
tely qualified and trained. The unambiguous allocation of the documentation
for processes, equipment and personnel must be given.
144
14.6 Are the environmental conditions which influence product
and process controlled?
Requirements/Explanations:
The environmental conditions must be tailored to the work contents and
products in order to prevent contamination, damage and mix-ups. Products
with "special visual requirements" have to fulfill special requirements.
Criteria are, e.g.:
- definition of the responsibilities for order and cleanliness
- clean, intact transport and operating equipment
- clean, well-illuminated workplaces and inspection places
- clear identification systems (e.g. escape routes)
- clear, ordered, if possible synchronous material flow
- appropriate disposal containers
- appropriate room and storage conditions.
Order and cleanliness have a significant influence on the work result. Where
possible, descriptions of the standards should be available.
Requirements/Explanations:
The production process must be continually monitored for deviations from
requirements and possible improvement potential.
Personnel active in the process must be involved in the evaluation so that
their experiences are taken into account. Recognized improvement possi-
bilities must be implemented without delay according to a plan to be defined.
Potential methods are, e.g:
- process audit (compare Question 03.4)
- CIP (compare Question 01.3)
- Quality circle (compare Question 04.6)
145
146
15 Inspection and Testing (Product Verification)
DIN EN ISO 9001, Section 4.10
DIN EN ISO 9004-1, Section 12
Reference
DIN EN ISO
9001 9004-1
147
15.1 Are all inspection activities covered in control plans with
inspection instructions?
Explanation of Terms:
The "control plan" is a product-related representation of all quality inspec-
tions, with reference to inspection instructions, from incoming goods through
to delivery.
Requirements/Explanation:
All inspections (including destructive testing) during the construction pro-
cess of a product must be recorded in control plans and these plans must
be kept available on site. The control plans must include, among other
things:
- specific parts data (part number, designation)
- quality characteristics at the relevant process stage
- reference to supplementary process descriptions
- reference to supplementary inspection descriptions/inspection
instructions
- references to decision possibilities (release, place on hold,
rework).
If inspections are carried out externally, the same regulations apply. The
company must regularly satisfy itself of the correctness of the operations
performed. When required by the customer, accredited laboratory facilities
are to be used.
A single inspection control plan can apply to a group or family of parts which
are manufactured using the same process and the same equipment.
When drawing up control plans, different information is used and obtained
from, e.g. :
- Process plan
- System-/Product-/Process-FMEA
- Special characteristics which were agreed upon
- Knowledge obtained from similar parts / processes
- Knowledge obtained from the development phases
- Other analytical techniques (optimization methods, QFD,
DOE).
The inspection control plan must be in line with the quality management
plan. It can also be included within the quality management plan.
148
15.2 Are the quality inspections in the process and the appropriate
methods/techniques defined in inspection instructions?
Requirements/Explanation:
149
15.3 Are the defined quality records maintained for all incoming
products?
Requirements/Explanation:
It has to be ensured, that only released products are submitted for further
processing.
In order to fulfill the obligation to show due care and attention, periodic
cross-checks and repeated inspections and tests must be performed.
150
15.4 Are the defined quality records maintained during the pro-
cesses/working stages?
Requirements/Explanation:
151
15.5* Are the defined quality records maintained on the end product?
Requirements/Explanation:
The inspections must be carried out in accordance with the inspection
control plan and inspection instructions. Refer to Question 15.4 for further
requirements/explanation.
The defined evidence must be provided for repeat inspections (rework).
Quality evidence also includes, for example, results from
- final inspections and tests
- functional inspections (under conditions of use)
- acceptance tests
- product audits
- reliability testing.
Note: It must be guaranteed that all inspections and tests are carried out before the
goods are dispatched to the customer. Special agreements must be made, if
this does not apply.
Requirements/Explanation:
Periodic inspections and tests should also be defined in the control plan or
quality management plan; the results are to be documented.
These periodic inspections and tests should prove that all quality require-
ments of the product are fulfilled. The type and scope of these inspections
go beyond the normal inspections and tests during production.
They can be performed at different times for differing requirements.
"Periodic inspections" are inspections, for example, such as:
- long term tests (weathering, ozone, corrosion testing)
- re-qualification tests
- durability tests
Records about verification checks on products which are delivered with
quality evidence conforming to DIN EN 10204 are included in the periodic
inspections.
Repeated inspections, performed as and when required, can also become
necessary and be carried out for a limited period as a result of special
findings, e.g. from serial inspections.
152
16 Control of Inspection, Measuring and Test Equipment
DIN EN ISO 9001, Section 4.11
DIN EN ISO 9004-1, Section 13
Prior to the use of inspection and test equipment (measuring and tes-
ting equipment, including software and gauges), it has to be ensured
that the equipment is suitable for the foreseen purpose, for example,
through equipment capability evidence and comparison measure-
ments.
The control of the inspection and test equipment in all areas is a basic
requirement to ensure the necessary confidence in the accuracy of
measuring results and subsequent decisions made based on those
results.
Through control of the inspection, measuring and test equipment, the
regular calibration of the equipment and thereby the traceability of
measured results to national standards is guaranteed. This procedure
corresponds with „recognized rules of technology", as defined and
required in relevant national and international regulations, standards,
official specifications and contractual agreements.
The accuracy of the results from a piece of equipment, evidenced in
it’s documentation, is of particular importance as inaccurate
measurements could lead not only to nonconformance of an "assured
characteristic", but could also present a risk when testing quality and
safety-relevant characteristics.
Reference
DIN EN ISO
9001 9004-1
16.1 Is there a procedure for the approval, identifi- 4.11.1 13.1
* cation, calibration, control and maintenance of 4.11.2 13.2
inspection and test equipment? b - e, -i
16.2 Is the adherence (traceability) of inspection and 4.11.2b 13.2b
test equipment to the requirements of national
and international standards regulated?
16.3 Are only pieces of inspection and test equipment 4.11.2a 13.2b
used that have a sufficiently low measurement
uncertainty?
16.4 Is there a procedure defined to record the (4.11.2a) 13.1
inspection and test equipment capability?
16.5 Are corrective actions defined following the 4.11.2 f 13.4
detection of defective and damaged inspection
and test equipment?
153
16.1* Is there a procedure for the approval, identification, calibration.
control and maintenance of inspection and test equipment?
Requirements/Explanation:
The control of all inspection and test equipment in all areas, e.g. in develop-
ment, tool making, maintenance, production, assembly, quality and custo-
mer services, must be guaranteed in order to provide confidence in deci-
sions and actions based on the measured results of tests and inspections.
Inspection and test equipment must be approved for use and calibrated
regularly in order to guarantee it’s accuracy throughout it’s entire service life.
The control must cover, among other things:
- standard inspection and test equipment of all kinds
- gauges
- measuring instruments
- sensors
- measurement recorders
- special test equipment and the corresponding software.
In addition, devices, inspection and test records, comparison references
and process monitoring instruments which might influence the quality of a
product or a process must be controlled in the same way.
The system for controlling equipment must be described in a documented
procedure or similar, including the following, for example:
- initial inspection and approval for use of new test equipment
- identification system
- recording of the equipment in a supply source record/approval list
- inspection instructions for the testing/calibration of inspection
and test equipment with defined inspection intervals and
documentation (see VDI / VDE / DGQ Guideline 2618 for
„Inspection instructions for the control of inspection and test
equipment")
- internal/external control body
- reference standards, master gauges
- control of test equipment used by customer services
- control of supplied inspection and test equipment with clear
regulation in the contract permitting it’s use
- definition of the testing/calibration intervals dependent on the
wear and tear and frequency of use
- examination of the equipment following changes, damage, and
suspicion of false indications
- maintenance of inspection, measuring and test equipment.
154
Gauges linked to specific parts must be able to be clearly cross-referenced
to the subject numbers of the parts, as well as their current revision status in
order to prevent confusion.
The test and calibration intervals depend on the frequency of use and must
be evident from the files or directly on the equipment itself. Actual calibration
and measurement values are to be documented (including initial calibration
values prior to first use). The results provide additional information about
wear and tear and the likely time the inspection and test equipment will
become obsolete.
Access to technical data and records about inspection, measuring and test
equipment has to be provided, when required by the customer.
Definition:
155
Traceability according to DIN EN ISO 10012 Part 1:
The property of a result of a measurement whereby it can be related to
appropriate measurement standards, generally international or national
standards, through an unbroken chain of comparisons.
Requirements/Explanation:
Complete evidence of the traceability to the next highest level of adherence
(e.g. Deutscher Kalibrierdienst [DKD], Physikalisch-Technische Bundesan-
stalt [PTB], equivalent national organization, research facilities or manufac-
turer’s standard) with validity certificates must be furnished.
Traceability forms part of ensuring the correctness and precision of mea-
surements and is legally regulated. In the case of measuring devices and
material measures, calibration is necessary. Calibration takes place against
a standard.
The uninterrupted chain goes in rising form (calibration hierarchy) from the
used standard, to the reference standard, via the national standard through
to the primary standard.
16.3 Are only pieces of inspection and test equipment used that
have a sufficiently low measurement uncertainty.
Definition:
Uncertainty of measurement (according to DIN EN ISO 10012 Part 1/3.b):
Result of the evaluation aimed at characterizing the range within which the
true value of a measure is estimated to lie, generally with a given likelihood.
Note: The measurement uncertainty is frequently incorrectly described, contrary to
the standard, as accuracy.
Requirements/Explanation:
Testing equipment must be selected so that the characteristics to be tested
can be measured with an acceptable level of uncertainty, which must be
known.
The highest permissible measuring uncertainty is dependent on the
process/product specification and the inspection instructions of the
customer. These factors and the corresponding surrounding conditions (e.g.
temperature, humidity) must be taken into account when selecting the
necessary inspection and test equipment.
156
16.4 Is there a procedure defined to record the inspection and test
equipment capability?
Explanation of Terms:
The "capability of inspection and test equipment" is determined from the
measurement uncertainty of the inspection and test equipment in relation to
the tolerance of the characteristic to be measured.
Requirements/Explanation:
The capability study of inspection and test equipment is to be proven on the
basis of the statistical evaluation of ranges of measurements. This may be
done by calculation or graphically (correlation diagram). Special customer
requirements must also be considered here, as far as possible and other
procedures are to be agreed, if necessary.
The inspection and test equipment capability is determined using the
repeatability or comparability of measurements, with the help of the range
method or the mean value and range method under consideration of the
chance variance (95/97, 5/99%).
The result of the study is not only determined by the test equipment itself,
but also through other influences, for example:
- composition of the tested products
- operator
- measurement records
- holding devices
- surrounding conditions.
The necessity for evidence of the capability of inspection and test equip-
ment is dependent on:
- the measurement uncertainty of the inspection and test equip-
ment
- the complexity of the inspection and test equipment
- the use of interlocking inspection and test equipment/methods.
This applies especially to complex inspection and test equipment such as:
- measuring machines
- multi-point measuring devices
- measuring equipment for statistical recording
- test equipment for electrical quantities.
Note: When technical modifications are made to products, the inspection and test
equipment capability must, if necessary, be reassessed.
157
16.5 Are corrective actions defined following the detection of
defective and damaged inspection and test equipment?
Requirements/Explanation:
When it is determined that inspection and test processes are no longer con-
trolled or the inspection and test equipment can no longer maintain it’s
highest permissible level of measurement uncertainty or is damaged,
corrective actions are required .
- rework,
- re-testing
- complete rejection
- informing the customer.
158
17 Control of Nonconforming Product
DIN EN ISO 9001, Section 4.13
DIN EN ISO 9004-1 Section 14
Reference
DIN EN ISO
9001 9004-1
159
17.1* Are there procedures for the handling of nonconforming
units?
Requirements/Explanation:
- rework
- acceptance with or without repair, on the basis of a concession
- downgrade for another use
- rejection
- scrap.
The processes addressed here must describe all activities which are carried
out in conjunction with the control of nonconforming products in order to
remedy faults. This must also include units which are suspected of being
nonconforming. This can necessitate an inspection of other products which
have been developed and manufactured using the same process and/or of
preceding lots of the same product.
160
17.2 Is the agreement of the customer obtained, prior to shipment
of products which deviate from the specification?
Definition:
Requirements/Explanation:
The internal and external concession procedure until the agreed delivery to
the customer (internal/external) must be defined.
The deviation from the specification must be presented in detail to the cus-
tomer and documented. If necessary, the products must be identified and
the approved, as well as the dispatched quantity is to be recorded.
Products deviating from the specification - even where the deviation does
not appear critical to the company - may only be shipped if the customer
has given his agreement. This procedure, if necessary including the validity
period of the concession, must be documented.
Requirements/Explanation
For any required rework, the working and inspection steps, together with the
associated production and testing equipment, must be defined. Qualified
staff must be used. The performance of the orderly work is to be monitored
and documented.
Note: The responsibilities for the initiation and monitoring of corrective actions are
evaluated in Question 18.1.
161
17.4 Is there a procedure for the identification of recurrent non-
conformities?
Explanation of Terms:
Requirements/Explanation:
The procedure must describe the activities regarding further analyses and
corrective actions. The evaluation should consider internally and externally
encountered nonconformities, for example, by means of:
162
18 Corrective and Preventive Action
DIN EN ISO 9001, Section 4.14
DIN EN ISO 9004-1 Section 15
- Development evaluations
- Analyses of potential nonconformity possibilities
- Quality inspections and audits
- Reports on process nonconformities
- Feedback from the market
- Service reports
- Customer complaints
- Management reviews (see Question 01.6).
Reference
DIN EN ISO
9001 9004-1
18.1 Are the responsibilities for the initiation and 4.14.1 15.2
* monitoring of corrective actions clearly 4.14.2
defined?
18.2 Are there procedures to estimate potential 4.14.3 15.6
nonconformity risks and to implement corres-
ponding preventive actions?
18.3 Are there procedures for the analysis of non- 4.14.2 15.4
conformity causes? b 15.5
18.4 Are there procedures to prevent recurrent 4.14.2 15.7
* nonconformities? d 15.8
163
18.1* Are the responsibilities for the initiation and monitoring of
corrective actions clearly defined?
Definition:
Requirements/Explanation:
The responsibility and authority for the initiation of corrective actions must
be defined. Responsible persons must be also defined for the coordination,
recording and monitoring of corrective actions. The monitoring activity inclu-
des both the performance of the remedial action and the check of it’s
effectiveness.
164
18.2 Are there procedures to estimate potential nonconformity
risks and to implement corresponding preventive actions?
Explanation of Terms:
- process costs
- quality-related costs,
- performance, functional capability and safety of the product,
- customer satisfaction.
Requirements/Explanation:
Risk analyses, for example, form the basis for the optimization of and
changes to:
- specifications
- operations
- test and manufacturing equipment
- instructions.
165
18.3 Are there procedures for the analysis of nonconformity
causes?
Requirements/Explanation:
When a quality problem occurs, the actual root cause must be determined
by analysis before corrective actions are planned. Often the root cause is
not obvious; which necessitates a thorough analysis of, for example,:
166
18.4* Are there procedures to prevent recurrent nonconformities?
Explanation of Terms:
Requirements/Explanation:
167
168
19 Handling, Storage, Packaging, Preservation and Delivery
DIN EN ISO 9001, Section 4.15
DIN EN ISO 9004-1 Section 16
Reference
DIN EN ISO
9001 9004-1
169
19.1 Are there instructions for the handling of products?
Explanation of Terms:
Requirements/Explanation:
The instructions must contain orderly planning and control for incoming
materials, their further processing, and for end products up to the point of
use by the final customer. The methods and responsibilities must be defined
for, e.g.:
170
19.2 Is the packing and identification process prior to delivery
defined and monitored?
Requirements/Explanation:
- initial packing
- final packaging / repackaging for shipment container
- identification,
171
19.3 Is it ensured that damage or deterioration in quality during
storage and transport is prevented?
Requirements/Explanation:
- condition of containers
- cleaning and preservation
- filling of containers
- methods of transport (temperature, vibrations, etc.)
- protective measures for products and personnel
- effects of humidity
- padding
- secure fixing
- collective packaging
- instructions for handling (e.g. assembly, delivery).
Requirements/Explanation:
172
19.5 Is the identification of products during transport and storage
ensured?
Requirements/Explanation:
It must be ensured that products are identifiable at all times during transport
and storage. Customer requirements must be taken into account.
Explanation of Terms:
Requirements/Explanation:
173
174
20 Control of Quality Records
DIN EN ISO 9001, Section 4.16
DIN EN ISO 9004-1, Section 17
Note: For this element VDA Volume 1 and 7 are also valid.
Reference
DIN EN ISO
9001 9004-1
175
20.1 Are procedures and responsibilities defined for the identifi-
cation, review and approval of quality records?
Explanation of Terms:
Requirements/Explanation:
176
20.2 Are there procedures and responsibilities defined for the eva-
luation and distribution of quality records?
Explanation of Terms:
Requirements/Explanation:
The quality records of the supplier and customer must be incorporated into
this process.
177
20.3 Is it defined where, how and for how long quality records are
retained?
Explanation of Terms:
"Retained" refers to the filing and archiving of records, whereby it must be
guaranteed that all documents are retrievable.
Requirements/Explanation:
This requires instruction about e.g.:
- retention period
- filing system
- filing location.
Thereby the following, for example must be considered:
- protection against fire, water etc.
- storage media (files, microfilm, DP storage)
- if necessary, additional back-up files (e.g. double archiving,
security copy etc).
Retaining quality records is necessary in order to be able to prove, even at a
later date that the quality system, the process and the product fulfilled all the
quality requirements for that particular period.
The retention (or archiving) period must be defined, among other things, on
the basis of the requirements of legislation, general guidelines, customers
and product liability aspects (see VDA Volume 1).
Minimum requirements for the archiving period are:
- one year after product discontinuation: Product/ process
releases, Tool inspection reports, Purchase contracts and
supplements to them etc.
- two years: Records on quality performance (quality control
charts), Inspection results, ppm lists etc.
- three years: Reports for the (top) management, Records to
internal quality audits, management reviews etc.
- longer: documents requiring special archiving (DWSpA) (See
VDA Volume 1)
The destruction of quality records after defined archiving period has to be
ruled.
Note: 1) For a listing of quality records, see Question 20.1
2) Copies of records concerning discontinued products which are required for
approval of the new products must be archived referenced to these new
products.
3) See Question 06.2
178
20.4 Is the manner in which quality records are made accessible
to the customer defined, if this has been contractually
agreed?
Requirements/Explanation:
179
180
21 Servicing, (After Sales, Post-production Activities)
DIN EN ISO 9001, Section 4.19
DIN EN ISO 9004-1 Section 16, (7)
Note: If only the Question 21.3 is relevant for the evaluation of this element,
then this question can also be considered and evaluated as an
additional question 18.5 under Element 18. In this case the individual
evaluation of Element 21 is no longer applicable.
Reference
DIN EN ISO
9001 9004-1
181
21.1 Is the preparation of operation and assambly instruction
defined and are these clear and understood?
Requirements/Explanation:
Note: Regarding products within the automotive industry, this question applies
primarily to companies active in the accessory business sector. The necessity
of this question is to be agreed upon in individual cases.
Requirements/Explanation:
The procedure for this must be defined and, if necessary, agreed with
customers that further process delivered products. Thereby, not only the
warranty period but also the entire utilization period should be taken into
account (e.g. also long-term evaluations).
Every company must be aware of how it’s products behave in use. The
activities undertaken by the company, in order to obtain information about
the quality of it’s products in use, must be evidenced.
182
This includes for example:
An early warning system must be agreed and built up between the company
and the customer. This should include, e.g.:
The information must be available to, among others, the following organi-
zational units:
- Development
- Work planning
- Production
- Quality management.
183
21.3 Is there a procedure to analyze product nonconformities
during use, as well as to implement and monitor corrective
actions?
Requirements/Explanation:
The results of the analysis of the nonconformity and the corrective actions
must be informed to the customer and, if necessary, to the development
department.
Note: The procedure for the above is to be defined with the customer.
184
21.4 Is the customer service function included in the information
flow system?
Explanation of Terms:
Requirements/Explanation:
- identified responsibilities
- discussion notes
- check lists
- meeting reports
- travel reports.
185
21.5 Is there a procedure for maintenance activities, if these are
agreed?
Requirements/Explanation:
The following must also be taken into account, among other things,
- special tools
- inspection measuring and testing equipment
- work instructions for commissioning
- administration of spare parts
186
22 Statistical Methods
DIN EN ISO 9001, Section 4.20
DIN EN ISO 9004-1 Section 20
Reference
DIN EN ISO
9001 9004-1
187
22.1 Are the possibilities for using statistical methods determined
and is their use planned?
Requirements/Explanation:
The need for statistical methods to determine, monitor and examine
process and product within the process chain must be defined.
It is to be defined, dependent on the results of the risk analysis (e.g. FMEA),
which processes and characteristics have to be tested and evaluated and
with which methods.
The appropriate method must be defined and used for the particular
application.
Statistical methods allow the user to assess processes taking into account
economic aspects within the process chain.
Statistical methods are planned within the framework of project planning in
the form of a advanced quality plan (quality planning).
The results of the statistical evaluation must be considered within the scope
of quality improvement programs.
Wherever possible and economically viable, the statistical evaluation of pro-
cess parameters must be given precedence over the evaluation of quality
results on products.
Requirements/Explanation:
Typical methods are e.g.:
- Design of Experiments / analysis of influencing variables
- variance and regression analysis
- significance studies
- calculation of failure probability
- FMEA
- failure tree analysis
- system optimization.
Statistical methods must be used both for product and process development
in testing, design and model construction.
188
22.3 Are statistical methods used for the evaluation of quality
inspections on deliveries?
Requirements/Explanation:
The evaluation of quality evidence for deliveries also forms part of this.
22.4 Are statistical methods used for process optimization and for
process control?
Requirements/Explanation:
189
22.5 Are statistical methods used for the evaluation of quality test
at final inspection?
Requirements/Explanation:
Requirements/Explanation:
190
8 Forms for the Quality System Audit - tangible products -
The use of forms to correctly carry out the quality system audit is advan-
tageous because they enable the results to be gathered quickly, rationally
and clearly for all parties involved. The forms shown below show examples
of possibilities.
The set of forms: Quality system audit for material products in accordance
with VDA 6.1 consisting of :
Assessment documents
Overall assessment of the quality system
Overall grading
Summary of results
Summary of the assessed questions
Corrective actions
Corrective actions - summary
DIN A4, block of 10 sets, 5 pages each set.
Reference sources:
Druckerei Henrich
D-60528 Frankfurt am Main, Schwanheimer Str. 110
(0 69)67 80 06-0
(0 69)67 80 06-30
191
VDA 6, Part 1- Quality System Audit
Overall Evaluation of the Quality System
of the Company
Customer/Certification body
Area/Works Location
Auditor
Report No. of System Audit:
Audit-period: starting ending
Audited/Certified Company
Area / Works Location
Audited Products / Product groups
Address
Contact person
Result
Signature of audited/certified
company/Date Signature Auditor(s) / Date
................................................. .................................................
.................................................
Signature/Date
192
VDA 6, Part 1- Quality System Overall Compliance
nd
- Only for Customer / Supplier Audits (2 Party)
Customer: Supplier:
Report No. of System Audit: Date:
Ranking:
System evaluation:
193
VDA 6, Part 1 - Quality System Audit: Summary of Results
194
VDA 6, Part 1- Quality System Audit: Summary of Evaluated questions
Customer / Audited/Certified
Certification body: company:
Report N°. of System Audit: Date:
Certificate N°.: DIN EN ISO:
Valid to:
195
VDA 6, Part 1- Quality System Audit: Remarks on Status
Customer / Audited/Certified
Certification body: company:
196
VDA 6,Part 1- Quality System Audit: Corrective Actions
197
VDA 6, Part 1- Quality System Audit: Corrective action - Summary
Customer / Audited/Certified
Certification body: Company:
Report N°. of System Audit: Date:
further
VDA
Element J F M A M J J A S O D Infor-
No. mation on
page No.
Part M: Management
01 Management Responsibility
02 Quality System
03 Internal Audits
04 Training, Personnel
05 Fin. consideration on Q.-System.
06 Product Safety
Z1 Company Strategy
Part P: Product and Process
07 Contract Review, Quality in
Marketing
08 Design Control (Product design)
09 Process Planning,(Process dev.)
10 Document and Data Control
11 Purchasing
12 Control of custom-supplied Prod.
13 Identification, Traceability, etc..
14 Process Control
15 Inspection + Test (Product testing)
16 Control of Insp.+Test Equipment
17 Control of non-conforming Prod.
18 Corrective + Preventive Actions.
19 Handling., Storage, Pack., etc.
20 Control of Quality records
21 Servicing (Post-Production Activity)
22 Statistical Methods
198
9 Literature
199
9.2 Masing, Walter (Hrsg.),
Handbuch des Qualitätsmanagement, 3. Auflage, 1994
200
9.13 DIN EN ISO 9003 (08/94)
Qualitätssicherungssysteme; Modell zur Darlegung der Qualitäts-
sicherung bei der Endprüfung
201
9.24 VDI/VDE/DGQ-Richtlinie 2619:
Prüfplanung
References
202
10 Agreement with Industrial Associations
10.1 Introduction
Deutscher Schraubenverband e. V
Hagen (German Association of Fasteners)
203
• Verband der Deutschen Federnindustrie (VDFI)
Hagen (Association of the German Spring Industry)
- Fachvereinigung Präzisionsrohrwerke e. V.
(Association of Precision Tube Works)
204
AGREEMENT
on mutual recognition
PSA Peugeot Citroën, Renault, FIEV and Verband der Automobilindustrie (VDA)
The car manufacturers PSA PEU- ment of this procedure. It forms the
GEOT CITROËN and RENAULT basis for evaluating the quality
evaluate the quality capability of capability of their own suppliers.
their suppliers according to a pro-
The German car and component
cedure that is described in the
manufacturers, members of the
publication
VDA (Verband der Automobilindu-
„REFERENTIEL D’EVALUATION strie e.V. Association of the
D’APTITUDE QUALITÉ FOUR- German Automotive Industry) have
NISSEURS“ established an audit procedure for
the evaluation of the quality sys-
(Evaluation of the quality capability tems of their suppliers that is des-
of suppliers) cribed in Volume 6 of the series
Edition 94, based on the standard „QUALITÄTSMANAGEMENT IN
series EN29000. DER AUTOMOBILINDUSTRIE –
The French component manufac- QUALIÄTSSICHERUNGSSYSTE
turers, members of the FIEV MAUDIT“
(Fédération des Industries des
and which is also based on the
Equipements pour Véhicules),
standard series EN 29000.
have participated in the develop-
In an effort to raise the efficiency when auditing quality systems and after
establishing the comparability of both evaluation procedures
• The car manufacturers PSA • The car and component manu-
PEUGEOT CITROËN and facturers of the VDA on the
RENAULT, as well as the com- other side
ponent manufacturers of the
FIEV on the one side and
have decided
TO MUTUALLY RECOGNIZE AUDITS WHICH HAVE BEEN CARRIED
OUT BY ONE OF THE CONTRACT PARTNERS FOLLOWING ONE OF
THE ABOVE PROCEDURES AND THEIR RESULTS.
This requires, that the audited company provides the result and audit report
of a preceding audit. Specific elements of the respective partner may be
subject of a supplementing audit.
nine signatures
- End of the agreement –
205
11 Notes on a Certification according to VDA 6.1
Certification audits must only be carried out by „certified VDA 6.1 auditors„
with the corresponding branch expertise.
206
12 Appendix
th rd
12.1 Changes of the 4 Edition compared to the 3 Edition
207
3.7 VDA 6.1 Certificate
The text of the certificate has been changed. The statement of the
level of compliance has been dropped.
7 Questionnaire
Question 01.6: Management review "with all elements" dropped
Question 03.1: Qualification requirements for internal auditors up-
dated. External auditors now defined under 04.5.
Question 04.5 Qualification requirements for external auditors
newly included.
Question 06 The circle of persons to be informed has been
newly formulated.
Question 06.4 Definition for „Emergency Plans„ revised.
Element Z1 Is now generally to be taken into account during
audits/certification.
Question Z1.3 Examples for data have been supplemented.
Question 07.5 Formulation: „early„ has been added.
Question 09.4 Quality evaluation „at least three times„ has been
dropped.
Element 10 VDA Volume 1 has been added as being applicable.
Element 11 „Supplier„ is generally used instead of „Sub-
supplier„. The note was added that the element is
also applicable for internal customer/supplier re-
lationships.
Question 11.6 „inspected“ and „not inspected„ has been re-
placed by „released„ and „not released„.
Question 13.2 „Inspection and test plan„ has been replaced by
„inspection and test instruction„.
Question 13.3 Formulation: „Production parameters of the process“
has been replaced with „process parameters“.
Question 13.4 Formulation: „Manufacturing means„ has been re-
placed by „production means„.
Question 14.1 Explanation to „Process Capability„ added.
Question 14.2 PPA Process according to VDA Volume 2 and
note on process changes added.
208
Question 14.7 Note on applicable methods added.
Question 15.1 „Destructive testing„ added.
Question 15.2 Procedure for rework added.
Question 15.6 „Durability test„ added, „Product audit„ dropped
(compare 03.4).
Element 20 „Quality-relevant records„ changed into „Quality
records„. Note on VDA Volume 1 added.
Question 20.1 Formulation: „maintenance„ has been dropped.
Question 20.3 Definition for DwSpA added (compare VDA 1).
Element 21 Note on procedure when only Question 21.3 is
relevant.
8 Forms
In the form ‚Corrective actions‘ the word „deviations„ has been added.
11 Notes on Certification
This section has been updated. VDA Volume 6, Basics for Quality Audits is
referenced.
12 Appendix
nd rd
The notes on changes made from 2 Edition to the 3 Edition have been
dropped.
209
12.2 Comparison Tables
In the following, the comparison tables to DIN EN ISO 9001 are shown.
210
VDA 6 Subject of the Question DIN EN
ISO 9001
Z1. Corporate Strategy
Z1.1 Business plan on costs, sales, quality etc. --
Z1.2 Measuring methods for business results and CIP use --
Z1.3 Performance data, company-wide / comparison --
Z1.4 Customer satisfaction, measurement and modification --
Z1.5 Personnel satisfaction --
P Product and Process
07. Contract Review / Quality in Marketing 4.3
07.1 Marketing function --
07.2 Contract review 4.3.1, 4.3.2
07.3 Structure quotation --
07.4 Quality requirements of the customer 4.2.3, 4.3.2a,
07.5 Requirements and performance specification known 4.3.2c
08. Design Control 4.4
08.1 Product/process development plan 4.4.1, 4.4.2,
4.4.4, 4.4.5
08.2 Quality requirements fully considered 4.4.4, 4.3.2c
08.3 Product/process trial 4.4.7, 4.4.8
08.4 Management review 4.4.6
08.5 Design approval 4.4.8, 4.4.3,
4.4.5
08.6 Result of design work 4.4.5
08.7 Transfer of development experience 4.4.3, 4.4.5
09 Process Planning (Process Development) 4.4, (4.9)
09.1 Process development Plan for new/modified products 4.4.1, 4.4.2,
4.4.4, 4.4.5
09.2 Production plans, work instructions 4.9 Abs.1,
4.9a
09.3 Quality requirements fully considered 4.4.4, 4.3.2c
09.4 Management review of processes and procedures 4.4.6
09.5 Approval of processes and procedures 4.4.8, 4.4.3,
4.4.5
09.6 Result of process planning and development work 4.4.5
09.7 Transfer of experiences from process planning 4.4.3, 4.4.5
10. Document and Data Control 4.5,
10.1 Quality-relevant documents, responsibility, procedures, .. 4.5.1 to -3
10.2 Approval and revision 4.5.2, 4.5.3
10.3 Archiving 4.3.4
10.4 Appropriately times introduction of customer documents 4.5.2
10.5 Non-use of invalid documents 4.5.3
211
VDA 6 Subject of the Question DIN EN
ISO 9001
11. Purchasing 4.6
11.1 Order documents 4.6.2, 4.6.3,
4.6.4.2
11.2 Supplier selection 4.6.1, 4.6.2a
11.3 Sample test 4.6.1, 4.6.2b
11.4 Supplier quality performance 4.6.1, 4.6.2c
11.5 Agreements on quality inspections 4.6.2b, (4.6.4)
11.6 Material receiving inspection 4.6.4, 4.10.1
11.7 Traceability 4.8
12 Control of customer-supplied Products 4.7
12.1 Agreed quality measures 4.7
12.2 Minimum scope of inspection and testing 4.7
12.3 Reporting of nonconformities 4.7
12.4 Quality history 4.7
13. Process Control/Identification and Traceability/Inspection and Test 4.9, (4.8,
Status 4.11, 4.12,
4.19´6)
13.1 Product identification 4.8, 4.12
13.2 Process control measures 4.9d
13.3 Records of process parameters 4.9 (Para.4)
4.16
13.4 Production means – Storage 4.11.2h
13.5 Quality objective/subsequent process, dispatch 4.12
13.6 Traceability 4.8 (Para.2)
13.7 Release on restart 4.9e
14. Process Control 4.9
14.1 Machine/process capability tests 4.9b
14.2 Production release 4.9c, -d, -e
14.3 Control of relevant process parameters 4.9d, 4.9f
14.4 Maintenance, preventive servicing 4.9g
14.5 Special processes 4.9 Para. 2, 3
14.6 Environmental conditions specified/complied with 4.9b, 4.11.2g
14.7 Evaluation of the effectiveness of production processes --
15. Inspection and Testing 4.10, (4.2.3)
15.1 Inspection and test plans 4.2.3b,-c,-d,-e
15.2 Inspection and test plans and instructions 4.10.1
15.3 Quality evidence for external purchases 4.6.4.1,
4.10.1, 4.10.2
15.4 Quality evidence according to work steps 4.10.1,4.10.3,
4.12
15.5 Quality evidence on the final product 4.10.1, 4.10.4
15.6 Periodic inspections and tests (4.10.1)
212
VDA 6 Subject of the Question DIN EN
ISO 9001
16. Control of Inspection, Measuring and Test Equipment 4.11
16.1 Control and calibration system 4.11.1,4.11.2
b,-c,-d,-e,-g,-i
16.2 Connection to national/international standards 4.11.2b
16.3 Measurement uncertainty of inspection, measuring and test 4.11.2a
equipment
16.4 Inspection, measuring and test equipment capability (4.11.2a)
16.5 Measures to be taken in case of nonconforming inspection, 4.11.2f
measuring and test equipment
17. Control of Nonconforming Products 4.13
17.1 Treatment of nonconforming units 4.13.1, 4.13.2
17.2 Concessions 4.13.2
17.3 Carrying out of corrective actions 4.13.2
17.4 Identification of reoccurring nonconformities 4.14.2a
18. Corrective and Preventive Actions 4.14
18.1 Initiation of corrective actions 4.14.1, 4.14.2
18.2 Estimating the nonconformity risk 4.14.3
18.3 Analysis of the cause of nonconformities 4.14.2b
18.4 Prevention of nonconformity reoccurrence 4.14.2d
19. Handling, Storage, Packaging, Preservation and Delivery 4.15
19.1 Product handling 4.15.1,4.15.2,
4.15.3
19.2 Packaging and identification process 4.15.4
19.3 Prevention of transport damage 4.15.4,4.15.5,
4.15.6
19.4 Correction of packaging errors 4.15.1 with
4.14.1
19.5 Product identification 4.15.4
19.6 Delivery reliability --
20. Control of Quality Records 4.16
20.1 Quality-relevant documents 4.16
20.2 Evaluation of quality records 4.16
20.3 Archiving 4.16, 4.3.4
20.4 Customer access to quality records 4.16
21 Quality in the application phase/Servicing/Customer Service (4.19)
21.1 Users manual and installation instructions (4.19)
21.2 Product observation/Field failure-early warning system --
21.3 Field failure analysis (4.14.2b)
21.4 Customer service information --
21.5 Servicing 4.19
22. Statistical Techniques (at) 4.20
22.1 Method planning 4.20.1
22.2 Development/Trial 4.20
22.3 External sources 4.20
22.4 Process development and control 4.20
22.5 Final inspection 4.20
22.6 Evaluation of field failures 4.20
213
12.2.2 Comparison Matrix DIN EN ISO 900494 / VDA6.1
214
DIN EN Element according to DIN EN ISO 9001 VDA6
ISO 9001
4.5 Document and Data Control 10
.1 General 10.1
.2 Approval and issue of D. & D. 10.1, 10.2,
10.4
.3 Amendments to documents and data 10.2, [07.2 with
introductory
comment], 10.5
4.6 Purchasing 11
.1 General 11.2, 11.3,
11.4
.2a Evaluation of subcontractors 11.1, 11.2
Suitability: evaluate and select
.2b Monitoring: Capabilities and performance 11.3, 11.5
.2c Record corresponding data 11.4
.3 Purchasing information 11.1
.4.1 Inspection of purchased products (Supplier at the subcontractor). [11.5], 11.6
.4.2 Inspection of purchased products [11.1, 11.5],
(Inspection by the customer). 11.6
4.7 Control of Customer-supplied Products 12
4.8 Identification and Traceability of Products (06.3), 11.7,
13.1, 13.6
4.9 Process Control 9, 13, 14
Para.1 Planning of quality-influencing assembly and servicing 9.1, 13.2
a Documented procedures 9.2, 13.2
b Suitable equipment and environmental conditions 9.4, 14.1,
14.6
c Compliance of standards, quality plans, documented procedure. 9.3, 9.5, 14.2
d Matching process parameters 9.5, 13.2,
14.2, 14.3,
(13.4)
e Approval of processes and equipment 9.4, 9.5, 13.7,
14.2,
f Criteria for work performance 9.2, 14.3
g Maintenance 14.4
e Release 9.5, 13.7,
14.2
Para.2,3 Special processes 9.4, 14.5
Para.4 Recordings of quality processes, equipment, personnel 9.6, 9.7, 13.3
215
DIN EN Element according to DIN EN ISO 9001 VDA6
ISO 9001
4.10 Inspection and Testing 15
.1.1 General 11.6, 15.2,
15.3, 15.4,
15.5, (15.6)
.2.1 Receiving inspection and testing 15.3
.2.1 Application after verification 15.3
.2.2 Scope and type of receiving inspection 15.3,
.2.3 Pre-release and concession 15.3
.3 In-process inspection and testing 15.4
.4 Final inspection and testing 15.5
.5 Inspection and test records (Records
always)
4.11 Control of Inspection, Measuring and Test Equipment 16
.1 General 16.1
.2a Determination of control procedure, inspection and testing and 14.2 with
inspection, measuring and test equipment 16.3, (16.4)
.2b Determination and calibration of inspection, measuring and test 16.1, 16.2
equipment
.2c Determination of corresponding procedures 16.1
.2d Identification of calibration status 16.1, 16.4
.2e Archiving of records on calibration 16.1, 20.1
.2f Evaluation and recording of previous measurement results for 16.5
nonconformities on inspection, measuring and test equipment
.2g Environmental conditions for measurements 14.6, 16.1
.2h Handling, protection and storage of inspection, measuring and test 13.4
equipment
.2i Protection of the calibration status 16.1
4.12 Inspection and Test Status 13.1, 15.4
4.13 Control of Nonconforming Products 17
.1 General 17.1
.2 Evaluation and handling of nonconforming products 17.1, 17.2,
17.3
4.14 Corrective and Preventive Action 18
.1 General 18.1, 19.4
.2a Corrective actions, effective treatment of nonconformities 17.4, 18.1
.2b Corrective action – cause of nonconformity in relation to 18.1, 18.3,
production, process, system (21.3)
.2c Corrective action – Determination of... 18.1
.2d Corrective action – Monitoring of their effectiveness 18.1, 18.4
.3 Preventive actions 18.2
4.15 Handling, Storage, Packaging, Preservation and Delivery 19
.1 General 19.1, 19.4
.2 Handling 19.1
.3 Storage 19.1
.4 Packaging 19.2, 19.3,
19.4
.5 Preservation [07.5], 19.3
.6 Delivery [07.5], 19.3
216
DIN EN Element according to DIN EN ISO 9001 VDA6
ISO 9001
4.16 Control of Quality Records 12.3, 20
4.17 Internal Quality Audits 03
Para.1 Documented procedure 03.2
Para.2 Planning of audits and auditors 03.1
Para.3 Recording and distribution of results 03.2
Para.4 Follow-up audits – corrective actions 03.3
4.18 Training 04
4.19 Servicing (21.1 to
21.4),21.5
4.20 Statistical Techniques 22
.1 Determination of demand 21.1, 21.2,
21.3, 21.4
.2 Procedure 21.1, 21.2,
21.3, 21.4
217
Other VDA-FORMS
218
Quality Management in the Automotive Industry
Volume 6 Part 1 Quality System Audit, Basics DIN EN ISO 9001 and
DIN EN ISO 9004
219