VDA

Quality Management 1
in the Automobil Industry

Quality Evidence

Guidelines for the Documentation and Archiving

of Quality Requirements and Quality Records

2nd completely revised edition 1998/1

Quality Evidence
Guidelines for the Documentation and Archiving of Quality
Requirements and Quality Records

2nd completely revised edition1998/1

Verband der Automobilindustrie e.V. (VDA)

Exclusion of Liability

The volumes of the VDA document series "Quality Management in the Auto-
motive Industry" represent recommendations that may be used by every-
one. Those who apply these documents must in each practical case take
care of their correct application.

They are considered to represent the actual state of the art at the date of
their individual edition. By applying the VDA Recommendations nobody shall
escape his obligations for his own doings. Insofar, everyone is acting at his
own risk. Any liability of the VDA and of those having contributed to the VDA
Recommendations shall be excluded.

Everyone who finds any incorrectness in the application of the VDA

Recommendations or any possibility of an incorrect interpretation is reque-
sted to inform the VDA accordingly without delay, in order to be able to eli-
minate possible defects.

Copyright Protection

The documents including all their parts have been protected by copyright.
Any utilization beyond the stringent limits of the statutory copyright is not
permitted without approval by the VDA and may be subject to prosecution.
This applies above all to copies, translations, microfilm reproductions, and
the storage and processing in electronic systems.

ISSN 0943-9412

Copyright 1997 by
Verband der Automobilindustrie e.V. (VDA)
Qualitätsmanagement Center (QMC)
D-60325 Frankfurt am Main, Lindenstraße 5

Overall production:
Druckerei Henrich GmbH
D-60528 Frankfurt am Main, Schwanheimer Straße 110
Printed on chlorous-free bleached paper

2
Preface

In view of the permanently increasing quality requirements, quality im-

provement of products manufactured by the automobile industry, vehicles
as well as their components, but also services will gain more and more
importance. The Verband der Automobilindustrie (VDA) has initiated the
establishment of a working group, in order to create one of many pre-
requisites, not only to maintain the quality level that has actually been rea-
ched, but to be able to increase it even further - and this in an economically
reasonable scope -; this group should re-consider the subject of ”duty of
documentation” from today’s view and define the results thereof in a revised
2nd edition of Volume 1 of the VDA series of documents "Quality
Management in the Automobile Industry". The duty of filing documents that
today exists only partially, has been designated by the short term "duty of
documentation" and has become the determining element in Volume 1
”Parts to be documented by automobile manufacturers and their suppliers”
which was established in 1973. In addition, there has been the intent to
increase the safety of certain parts, the so-called safety parts, by obtaining a
documentation of e.g. test results through the use of the D marking. The
2nd revised edition however deals mainly with the true reason for the filing
of documents, the demonstration of proof.

It can be seen today, that no quality improvement can be reached by filing

quality documents and specifically with the related archiving procedure. The
quality standard that was achieved is documented only. Nevertheless, a
company may want to or will have to demonstrate proof for various reasons
(audit, recall, product liability, requirements from public authorities), that its
quality management system is functioning and that only those products are
manufactured which comply with all requirements. Documents play an
important role with regard to this procedure of demonstrating proof.
Therefore, this subject is treated with priority in the present paper.

This paper should be understood as guideline, i.e. each entrepreneur must

define himself:
• how he will comply with the requirements of his customers,
• how he will assure quality,
• how he will describe it,
• how he will deal with requirements of public authorities,
• how he will assure the efficiency of the measures planned by him,
and
• to which extent he will protect himself against which problems.

3
This 2nd edition is addressed to management representatives, in order to
provide them with information, why they must take care of the management
of documents, as well as to planning representatives, to give them an
overview on what must be considered, in order to have documents that are
suited for the demonstration of proof under economical aspects.

We are grateful to the companies involved and to their representatives for

having contributed to compile this volume. Contributions were made by the
following companies:

Adam Opel AG
Audi AG
Becker Automotive Systems GmbH
BMW AG
Dr.-Ing.h.c.F.Porsche AG
Fichtel & Sachs AG
Ford-Werke AG
Freudenberg Dichtungs- und Schwingungstechnik KG
Hella KG Hueck & Co
ITT Automotive Europe GmbH
MAN Nutzfahrzeuge AG
Daimler-Benz AG
PIERBURG AG
Robert Bosch GmbH
TRW Fahrwerksysteme GmbH & Co. KG
Volkswagen AG
WABCO Fahrzeugbremsen
ZF Friedrichshafen AG

We are also grateful to all those who have given us hints for the elaboration
and for improvements.

The present 2nd, complete and revised edition was approved in 1997 by the
”Quality Management”committee of the VDA.

Frankfurt/Main, May 1997

VERBAND DER AUTOMOBILINDUSTRIE E. V. (VDA)

4
Table of Contents Page

Preface 3

1 Introduction 7

2 Definition of Terms 9

3 Reasons for the Demonstration of Proof 15

3.1 Quality Control 15
3.2 Economical Considerations 16
3.3 Laws, Contracts, Standards, Association Rules 16
3.4 Product Liability, Penal Law, and Due Care 18
3.4.1 Product Liability 18
3.4.2 Penal Law 19
3.4.3 Responsibilities and Due Care 20

4 Documents for the Demonstration of Proof 23

4.1 Task of the Demonstration of Proof 23
4.2 Nature of Documents 23
4.3 Object of the Demonstration of Proof and Related Types
of Documents 24
4.4 Allocation of Reasons of Proof and Types of Documents 27

5 Archiving 28
5.1 Regular Archiving 28
5.2 Special Archiving 31
5.3 Time of Use and of Archiving 31

6 Practical Instructions for Implementation 35

6.1 Selection of Documents with Special Archiving (DwSpA) 35
6.1.1 General 35
6.1.2 Selection of Documents 36
6.1.3 Economical Considerations 40
6.2 Marking of Documents and Equipment 42
6.2.1 Marking of DwSpA 42
6.2.2 Marking of Products and Product Equipment 46

5
6.3 Examples for Documents Proving Compliance
With Quality Requirements 47
6.4 Possibilities of File Backup in EDP Applications 48
6.5 Selection Procedure for DwSpA 50
6.5.1 Procedure of Selecting DwSpA 50
6.5.2 Criteria for the Specification of Special Archiving 52
6.5.3 Checklists for the Treatment of Products With DwSpA 53
6.6 Traceability 55

ANNEX 56

1 Abstracts and Comments Regarding Laws, Contracts,

Standards, and Association Requirements 56
1.1 Requirements from Laws and Contracts 56
1.1.1 Requirements on Operational Safety 56
1.1.2 Requirements on Documentation 58
1.2 Requirements from Standards and Orders from Public
Authorities, and from Associations 60

2 Schematic Overviews 62

VDA Series of Publications Fehler! Textmarke nicht definiert.

Quality Management in the Automobile Industry
Fehler! Textmarke nicht definiert.

6
1 Introduction

Today, the major competitive factors are deliberate customer orientation as

well as quick implementation of all customer requests and customer
expectations regarding marketable products and services together with a
continuously reduced number of complaints.

By using a philosophy of comprehensive quality management the respon-

sibility for the quality of products and services has been extended to all
areas of the corporation, in order to achieve these goals. Everyone in
Marketing, Engineering, Production Planning, Manufacturing, in Service etc.
will contribute with his quality awareness and his work to maintaining and
even further improving the corporate goal "high quality standard of products
and services". Another corporate goal consists of course of manufacturing
products and of providing services in an economical way too.

One prerequisite for achieving these goals is a comprehensive quality

management system, by which all corporate processes have been defined
and related responsibilities have been defined and clearly explained, by
which the implementation has been supervised, introduced processes have
been controlled, and measures of improvement have been introduced, if
applicable.

Besides the requirements for the control and improvement of the processes,
customers, legislation, and standards may require, among others, that proof
of the quality requirements and the quality standard achieved is demon-
strated at a certain point in time. One prerequisite for such a proof will be
given by the definition and documentation of the quality requirements.
Another prerequisite consists of the documentation of the compliance of
these quality requirements in quality records. Both have in common, that all
documentation regarding the demonstration of proof must be complete and
unambiguous.

The capabilities and goals that are required by the processes will be des-
cribed in documents during the planning phase, e.g. in the QM plan (see
VDA Volume 4.3). A manufacturing process for example will be described in
manufacturing plans, control plans, and inspection plans. Test results will
show, if these specifications have been met.

In total, all documents represent material that is required by the manage-

ment for the control of the corporation - independent of all legal, contractual
or normative requirements.

7
In case of proofs prescribed by law and agreed upon by contract there is no
alternative regarding the contents of the documentation and the archiving.
Only the type and form of archiving may vary under consideration of the
specifications. Examples are: Complete product documentation, inspection
results of individual characteristics, condensed inspection results, results
from audits, results from product reviews etc..

Besides, there is a series of opportunities for the so-called "voluntary" archi-

ving. The scope of voluntary archiving should be planned carefully and kept
within certain limits.

In addition, the quality status of the products achieved and the processes
utilized for their manufacture must be observed also, when defining the pro-
cedure for example for the proof of the specified requirements and their
compliance. It is therefore practical to develop and introduce procedures
and courses of action which will allow a reduction of expenditure for the
demonstration of proof, when increasing the quality status of products and
services.

This may mean, for example, that an inspection of the product at the end of
a process may not be required, but that it is sufficient if one can prove, that
the process was under control and was capable at the time of the manu-
facture of the product.

The present Volume has been based on the idea, that for the above named
reasons, today the application of quality methods is part of the state of the
art, and that the availability of their documentation is necessary within a
certain period of time. Among these quality methods are for example those
summarized under the term of statistical process control (SPC), such as the
keeping of quality control charts or collective non-conformity charts and also
charts for process supervision and the compilation of master sample
reports.

These tools for quality assurance in production will be supported by supple-

mentary methods of preventive quality assurance. Among those you will find
among others the Failure Mode and Effect Analysis (FMEA), the statistical
planning of experiments (Design of Experiments, DOE), Quality Function
Deployment (QFD) etc., just to name a few important tools.

If documents are referred to in this Volume, then those documents are

meant which play a major role in quality management. But since quality is a
characteristic that affects all parts of a corporation, the difference to be
made between general documents and quality documents is not important.

8
2 Definition of Terms

The VDA series of documents is meant to be a supportive means, a tool

and guideline. This must be understood by the partners with regard to the
meaning of the terms used. Therefore, this paragraph describes several
important terms for the introduction to this subject matter. Here, definitions
from ackknowledged institutions such as DIN or DGQ willl be disregarded.
They can be found e.g. in DIN EN ISO 8402, DIN 55 350, and DGQ
Publication 11-4.

If one term has several meanings, then the meaning which has been printed
in bold in the following explanations shall be used as standard in this
Volume.

Demonstration of Proof

There are several reasons, why you want to prove, that the quality has been
or can be reached as planned in accordance with the defined requirements.
In general, documented quality requirements and the related inspection
results (quality documents) are required, in order to demonstrate this proof.
But this proof can also be shown by the demonstration or representation of
the process that has been intended to be the one leading to quality, or by a
marking on the product showing that the product has undergone defined
tests successfully.

Also, not all requirements can be defined in a document - i.e. on paper or in

an electronic way -, for example, characteristics that can technically not be
completely described, which will then be defined by a master sample.

On the other hand, defined requirements cannot be tested 100 % (destruc-

tive testing!) and can therefore not be registered either. In this case the
safety of the related manufacturing processes may be tested and registe-
red.

9
 requirements not
defined by documents Compliance with the
Requirement

requirements without
requirements no records proof by dokuments
defined by and not test
documents record on tests
or on process
parameters

Non-compliance leading
to rejects/reworking

Records for use as proof of

compliance with the requirements
(different period of archiving)

Figure 2-1: Demonstration of proof for compliance with the require-

ments

The demonstration of proof may become necessary for various conditions

of interest:

• the corporate management wants to be sure, that the QM system is

functioning
• someone responsible wants to know, how sure he can be, that the
requirements of a product can be met
• a public authority may require proof as part of a public permission
• proof may be required to weaken an allegation (negligence, wrongful
intent) raised by legislation or public authorities
• the customer (buyer of the product) may request that proof should be
demonstrated (compliance with contract).

The proof itself may be as varying as it may be comprehensive. You may

demonstrate proof pertaining to

- a product (e.g. product audit on the final product or inspection

of the quality of one characteristic)
- a process (e.g. process audit)
- a system (e.g. auditing, certification).

10
 (Quality-Related) Documents

Quality Requirement Documents Quality Records

Documented QM Procedures Important Control Records

QM manual Minutes of meetings

Documented procedures QM system audit results
Manufacturing plans QM system certificates
Inspection procedure description
Directives
Standards
Project descriptions (in the sense of a
documented working procedure)

Product Specifications Important Product Records

Drawing Inspection results

List of specifications Test reports
Technical delivery requirements Product audit results
Purchase agreement Warranty statistics
Bills of material Product certificates
Inspection procedures

Subject to ongoing changes Must not be changed

Figure 2-2: Itemization of the types of quality-related documents

Therefore, the demonstration of proof is the activity, by which the attempt is

made to prove at hand of a documentation, that a performance (product or
service) rendered complies with the requirements. Major elements in this
regard are documents.

Documents

As shown in Figure 2-2, there are two completely different types of docu-
ments. One type of documents largely describes requirements of processes
and products, the second type represents the records of the results regar-
ding activities and inspections, i.e. the records of the review of the com-
pliance of these requirements. Both types are called ”document” in this
paper.

11
 The use of
documents for

control purposes a demonstration of proof the description

· of(e.g.technical processes
control chart)
· based on requirements of inter-
nal rules (e.g. administrative
· of(e.g.products
drawing)
· of(e.g.procedures procedures, initil sample report)
· of(e.g.procedures
system audit)
· toexpenditure
reduce product recall flow diagram)

Verwendungszweck wird in
· to(e.g.meetsafety
legal requirements
regulation) The purpose of application
diesem Band nicht primär
behandelt
· forductrelief purposes in cases of pro-
liability ans penal proceedings)
is not primarily covered
by this volume

Documents Documents
with regular treatment with special treatment

There are not external requirements for these These documents are subject to external
documents regarding formal criteria, contents, requirements regarding
and preservation. In this regard, internal company - period of archiving
definitions are provided. - conditions of safekeeping
- authenticity of documents
- other requitements (e.g. information, training)

Figure 2-3: Interrelation between demonstration of proof and docu-

ments

On the other hand, documents are used for various purposes, e.g. to control
an operation, for the demonstration of proof, or to describe conditions or
products. In this regard it is not necessarily required to establish different
documents. In many cases, the same documents may be used for several
purposes. The interrelations are explained in Figure 2-3.

Documents that stand a legal review are designated here as true docu-
ments, all other common documents as non-true documents.

12
Documentation

In this relation, documentation is used as "compilation of documents" as

well as in the sense of "descriptive evidence" (synonym for demonstration of
proof). In various papers the terms "demonstration" or "disclosure" are also
being used. It is likely, that any uniform use of the term cannot be assured.

To Document

This term should be used in the sense of "creating documents". This inclu-
des for example:

- compilation of product specification

- compilation of manufacturing plan
- recording of test results
- creating a delivery note
- creating a training certificate.

But to document will also be used in the sense of "demonstrating proof, that
...". In the more familiar language ”to document” is very often used for
"preserving". This interpretation should not be used.

Documents with Special Archiving

Documents with special archiving (DwSpA) are documents defined by the

corporation (see general Paragraph 6.1) and subject to a special archiving
procedure (for the marking of DwSpA see general Paragraph 6.2).

Product

Besides the proper final product, representing a technical component,

product also means the result of any activity, e.g. of planning, design, sales
negotiations or training regarding the individual products: Manufacturing
plan, drawing, purchase agreement, training certificate etc..

Period of Safekeeping

The period of safekeeping is the time span from the moment of creation of a
document to the moment of its destruction. It includes the time of use and of
keeping on archives of the document.

13
Period of Use

The period of use of a document is the time span during which the docu-
ment is used for quality control purposes (see Figure 5-1 and 5-2). For
example, an inspection plan will be used for quality control as long as the
product is being manufactured and inspected according to an inspection
procedure derived from this inspection plan. The period of use of the old
invalid inspection plan will end upon a modification. The old invalid inspec-
tion plan will be kept on archives too.

Period of Archiving

The period of archiving is the time after the end of use of the document.
This time span depends on the reason for the demonstration of proof, for
which the documents are required. A more detailed explanation can be
found in general Paragraph 5.3.

Duration, Term, and Time

The designations duration, term, and time are almost used as synonyms
while relating to safekeeping, use, and archiving. In case of duration, the
focus is more on the length of time, and in case of term, the focus is more
on the end of the period of time.

14
3 Reasons for the Demonstration of Proof

3.1 Quality Control

The goal of a corporation is among others, to manufacture products in an

economical way and to render services in accordance with the quality
requirements. For conducting the related necessary quality control, docu-
ments will be required, showing the quality requirements and the degree of
their compliance. This means that a great variety of documents must be
established and be kept on archives accordingly for the manufacture of pro-
ducts and the rendering of services, as well as for the implementation of the
processses required. These documents established in view of achieving the
corporate goal represent a multitude of documents, when compared to
those requested in laws and contracts.

Mainly, these documentations are a result from the requirements of DIN EN

ISO 9000 and following already.

Here are some examples of reasons for establishing documents:

• Control of quality within the QM system / process control

- Corrective measures
- Management review
- Progress development of the QM system
- Limitation and traceablility of non-conformities and of their
possible consequences on all levels and in all sectors including
the suppliers.
• Proof of qualification for quality audits
• Transfer of the know-how gained to new processes and products.

15
3.2 Economical Considerations

Economical considerations which are exceeding the pure control of the ope-
ration may be a reason for documentation too, e.g.:

• in the event of a recall from the field, or to minimize the scope and
thus the expenditure at the automobile manufacturer by limiting the
non-conformity to the products actually involved as precisely as
possible
• in cases of liability and warranty claims by proving the condition of the
product quality actually delivered
• in view of obtaining a more favorable rate at the liability insurer
• in the event of a transfer of the know-how gained to new processes
and products.

3.3 Laws, Contracts, Standards, Association Rules

A considerable number of laws, contracts, standards, and association rules

include the definitions of requirements with regard to the type of quality of
products and with regard to procedures during their manufacture, the
compliance of which must be proven too, if applicable.

Laws include the description of requirements relating to products (vehicles),

that are participating in motor vehicle traffic. These include among others
definitions of the prerequisites for type approval and manufacture. The
minimum rules for the safety of manufacture are described in these laws as
general requirements, and the extent of demonstration of proof has not
been defined. For these reasons, a risk evaluation of the corresponding
overall process will always be required too, in order to define the scope of
documentation.

To give assistance for decisions in this regard, some of the most important
requirements that were applicable at the time of printing have been named
and interpreted. The following is a summary overview.

16
These laws include for example:
• Road Traffic Homologation Law, Germany, StVZO § 30
• Law on Liability for Defective Products, ProdHaftG dated 01 January
1990
• General Noise Emission Directive, 70/157/EEC
• General Exhaust Emission Directive 70/220/EEC
• General Directive 70/156/EEC in the version 92/53/EEC, Par. 10
Annex X, Initial evaluation
• Federal Motor Vehicle Agency (”KBA”) ”Anforderungskatalog zur
Begründung der Herstellereigenschaft” (manufacturers qualification
requirements) dated August 1993
• US Safety Regulations, Federal Motor Vehicle Safety Standards
(FMVSS)
• US Environmental Protection Regulation, (Title 40, Chapter 1)
Environmental Protection Agency, Subchapter C - Air programs.
• National Traffic and Motor Vehicle Safety Act of 1966, Issue 1082,
revised through 31 October 1988
• Australian Motor Vehicle Certification Board, Conformity of Pro-
duction-Manual-Circular 0-13-1.

In addition, customers require in contracts the compliance with standards

and association definitions on quality management also. In this case, they
must not only be considered as recommendations, but as contractual
requirements. The same applies to the observation of the scientific and
technical state of the art also.

Related examples are:

• Standards on Quality Management according to DIN EN ISO 9000
and following
• Association Definitions Quality Management, such as VDA
Volume 6.1, EAQF94, FIEV, AVSQ, QS 9000
• Military Requirements on Quality Management AQAP 100 and follo-
wing
• German Industry Association (BDI)/Government Standard Agree-
ment, Annex X, Par. 1 of Article 10 of the Council Directive
92/53/EEC
• VDA Recommendations of 15 AUG 1995 ”Allgemeine Gechäftsbe-
inungen für den Bezug von Produktionsmaterial und Ersatzteilen, die
für das Automobil bestimmt sind” (General business terms and
conditions for the procurement of production material and spare parts
intended for automobiles).

17
3.4 Product Liability, Penal Law, and Due Care

It may be practical or necessary also during the course of handling or in

view of a rejection of product liability claims to be able to prove, that the pro-
cedure as anticipated/requested in the appropriate laws have been adhered
to during the manufacture of the related product. The most important
content of the corresponding laws is explained in the following, in order to
be able to select the suitable documents.

3.4.1 Product Liability

The general rule is, that evidence must be shown, that all legal require-
ments imposed and those of due care have been met, e.g. that the scientific
and technical state of the art has been met, or that all obligations of selec-
tion, supervision, and organization have been met.

Depending upon the case, e.g. in the event of a private or commercial

damage, with or without compensation for pain and suffering or combi-
nations thereof, different claim bases may be used against manufacturer
and supplier by the plaintiff, parallel and as supportive element: Liability
depending on wrongful doing (Liability in tort according to § 823, BGB - Civil
Code) or liability independent of wrongful doing (Liability law for defective
products, ”ProdHaftG”- Product Liability Law).

On liability it must further be distinguished between the aspects of private

law and penal law. In the event of private liability claims, the focus will
mostly be on the legal entity (company), whereas liability in penal law cases
is always related to a natural person (individual person).

For more detailed relations, see schematic overviews in the Annex.

18
Liability Depending on Wrongful Doing (Liability in tort according to
§ 823-BGB - Civil Code)

Every employee in the company must, according to his/her area of duty and
responsibility, meet his/her obligations of due care. Based on the tortious
general clause of § 823 Subpar. 1 BGB - Civil Law, the following applies:

"... those, who illegally cause injury to the life, body, health, freedom,
property or to any other right of others in an intentional or negligent
way, are liable to those others for replacing the damage resulting
thereof".

This means, that everyone must behave in such a way, that there will
be no illegal causes for any injury to any person or any objects of a
third party within the area of his/her control. Everyone must take the
required and sufficient measures within the scope of his/her possibili-
ties and reasonableness, in order to avoid any hazards to those
rights. In case of intentional or negligent infliction of this obligation,
the injured party has the right for compensation of his/her damages.

The shifting of the burden of proof in product liability cases which is in

general implemented by legislation represents a relief to the plaintiff with the
consequence, that the defendent must prove his "innocence" (see decision
of the BGH - Federal Supreme Court dated 26 NOV 1968 on the fowl pest).

Liability that is Independent of Wrongful Doing (Liability law for defective

products, ”ProdHaftG”)

The shifting of the burden of proof has become the principle within EU
product liability. Here, as opposed to the liability in tort, no fault is anticipated
any more, and the plaintiff must deliver a prima facie evidence only, i.e. the
relation between his damage and the non-conformity of the product. § 1,
Subpar. 4 of the product liability law explains:

"... the manufacturer shall carry the burden of proof in those cases,
where it is in dispute if the obligation for damage compensation has been
excluded".

This means, that the plaintiff carries the burden of prima facie evidence
only with regard to the cause and its effect on the damage.

19
3.4.2 Penal Law

The penal law always applies, when personal injuries or deaths were cau-
sed due to negligence. The product responsibility by the penal law always
means that the individual employee will have to answer personally for his
own doings. Therefore, several persons may be responsible by penal law for
one and the same damage. Product responsibility includes the liability for
positive (=active) doing as well as for non-action (=default). The prosecution
by penal law is based on the responsibility for the source of the hazard, that
has been created by bringing the product into service.

The product responsibility by the penal law means in general the liability for
damages caused by conduct on purpose and by negligence. Conduct on
purpose may be given, when a manufacturer does not respond after having
recognized sources of hazard. Negligence may be given in case of violation
of an existing obligation to exercise due care and where a cause-and-effect
condition exists between the violation of duty and the damage occurred, as
well as in cases, where the damage could subjectively have been foreseen
and avoided.

The measures for due care in case of a violation of duty have been
determined by technical regulations, by the state of the art, and finally by the
expectations of service of the product users. The inherent residual risk that
must be considered in an individual case (so-called permissible risk) will
also be determined by the expectations of service.

3.4.3 Responsibilities and Due Care

The manufacturer’s duties and responsibilities for the corporation are based
on the common laws, such as the product liability law, and by the state of
the art of technology. The general responsibility of the corporate manage-
ment, the responsibility of the managing directors of the corporate divisions,
and the responsibility of the management representatives as well as the
distribution of responsibilities between manufacturers and suppliers must be
described and established on a general regulatory basis.

20
Principle of General Responsibility and General Competence

The principle of general responsibility and general competence is applicable

to the Board or the Corporate Management respectively, independently of
any explicit interdepartmental distribution. This responsibility includes all
initial obligations of due care (obligations of selection, supervision, and
organization).

Organizational Structure

In general, the corporation must be organized according to the state of the

art of technology (see product liability law ”ProdHaftG”). The tasks and
responsibilities must be clearly defined and described in an organizational
structure.

The subject of liability of the vicarious agent has been described in

§ 831 BGB (Civil Law): Corresponding rights and obligations may be trans-
ferrable under certain circumstances within the scope of responsibility of
substitution.

Personal Responsibility of Employees

The personal responsibility may be shown as a responsibility of conduct of

those, having caused the non-conformity directly within the operation.
Everyone involved in engineering, design, manufacturing and sales and
marketing is responsible for the correct (=defect-free) implementation of his
tasks.

General Obligations of Due Care

Jurisdiction is requesting from manufacturers, that they apply the necessary

due care according to the state of the art of technology in engineering,
design, manufacturing, sales and marketing, and in product review. Due
care is requested to the extent that is reasonably required to avoid non-con-
formities that would lead to a damage during the just use of the product.
"Just" in this regard means, that the foreseeable or even common misuse of
a product must be included in the considerations also.

Negligence is given, when the necessary due care has been omitted in
service operation, i.e. when the objective mandatory due care has not been
observed.

21
Due Care Obligations of the Operation

Due to the interlinking of tasks in the corporation as an organizational unit,

those responsibilities are also overlapping, which develop from interior and
inter-company task sharing and the interdepartmental areas of responsi-
bility, and interrelations resulting thereof. The so-called secondary obliga-
tions are deducted from this structure of responsibilities, in most cases
meaning obligations with regard to clarification of subject matters, conduc-
ting requests, and giving instructions.

Many issues which appear as mere practical decisions under productivity

aspects may have an objectively legal content too, when considered under
pure technical and business management aspects. Therefore, decisions on
subject matters and on organization which are suitable and reasonable
under productivity aspects may be legally incorrect (”defective”). In the event
of a personal injury caused thereof (or that has not been avoided ”in breach
of duty”), this may result in a co-responsibility of the managment repre-
sentatives based on penal law.

22
4 Documents for the Demonstration of Proof

4.1 Task of the Demonstration of Proof

The demonstration of proof has been intended for the presentation of

definitions and results of a quality management system in a corporation in
front of internal and external departments and individuals. Internal depart-
ments and individuals are for example those, who specify and further
develop the quality management system, who control and supervise quality,
or who deduct other measures thereof. External departments and indivi-
duals are those, who certify the QM systems, or customers, suppliers,
homologation authorities, insurers, legislators, courts, etc..

Typically, documents are used for the presentation of definitions and results;
definitions are described in quality requirement documents and results are
described in quality records (see Figure 2-2). Therefore, they must include
complete, unambiguous, distinct, and allocatable information about what
should be proven.

4.2 Nature of Documents

The nature of the documents originates from the purpose, for which they
have been intended (Figure 4-1). In general, distinction must be made
between common documents (non-true documents) and those that stand a
legal review (true documents).

A common (non-true) document includes at least:

- the date of creation or recording

- the modification status
- the individual(s) responsible for the content
- the name of the inspector or of the one determining the recorded
result
- their signature(s)
- The allocation to the delivered product lots, projects, manufac-
turing lots, production periods etc..

23
A true document (standing legal review) must, in addition to those of the
common document, meet at least all the following criteria:

• they must be original documents (no condensed ones established

later) or microfilm reproductions of the original documents or elec-
tronic documents on a data carrier, and
• proof must be shown of who in the company had the knowledge of
the document (e.g. distribution list), and
• proof must have beeen given of the precautionary measures that
exclude any falsification and mixing of the documents during the
entire administration procedure, and
• its statements must be unambiguous.

But in this regard, a true document must not meet the conditions of a docu-
ment in the legal sense (i.e. executed and signed by hand writing).

4.3 Object of the Demonstration of Proof and Related

Types of Documents

The documents may show as object of the demonstration of proof

• the QM system
• the process quality in the production and product manufacturing
process as well as in all other processes
• the product quality of the final product and the quality of the results
from e.g. engineering and planning work

as well as all other processes (Figure 4-1).

24
 Object of
Demonstration of Proof
QM System Process Quality Product*-Quality general
e.g. in: e.g. in: type
- QM manual - Sales - Specification (non-true
Type
- Documented - Design - Drawing documents)
procedures - Testing - Test report of
- Documented - Planning - Manufacturing plan docu-
working - Preparation - Plant layout true
procedures - Procurement - Products documents
ments
- Manufacturing - Support
- Service
* Product here means the product of any activity

Figure 4-1: Object of the demonstration of proof and type of

documents.

QM System as Object of the Demonstration of Proof:

Companies with an established QM system that meets the definitions of DIN

EN ISO 9000 and following, VDA 6.1 or the like, do have an appropriate
systematic procedure, if strict application is implemented. Based on the
corporate objectives as well as on the organizational structures and
procedures, the structural of functions and responsibilities of the entire
process chain is described. The documentation system is systematically
described by the QM Manual, the documented procedures, and the working
and inspection procedures for the worker level. The interfaces between the
different levels and the responsibilities must be established clearly and be
traceable. The implementation may for example be documented in the
results of QM system audits.

25
Process Quality as Object of the Demonstration of Proof:

Process quality may be proven by quality-related documents and records

which demonstrate compliance of the specifications of the QM system.
These are for example:

- Results from process and product audit

- Requirement, planning, and proof of employee qualification
- Inherent residual risk figures from analyses, e.g. product and
process FMEA
- Proofs for the processing of corrective measures
- Release documents for process qualification.

For the proof of quality of the manufacturing process the following will
additionally be required if applicable, e.g.:

- SPC control charts

- Proofs of process capability, e.g. cpk values
- Failure rates, collective non-conformity charts
- Registrations of process parameters.

Product Quality as Object of the Demonstration of Proof:

Product quality here means the product resulting from any activity. Any
product quality will be proven by documents, showing the compliance with
the specifications. These are for example:

- Results from product audits

- Inspection results of any kind
- Software structural diagrams
- Delivery notes, ordering calls
- Results from meetings (minutes)
- Internal and external customer complaints
- Inherent residual risk figures from analyses, e.g. product and
process FMEA
- Design review compared to standards, normalization specifi-
cations, and internal as well as external requirements.

The above-mentioned specifications, according to which inspections are

conducted are of course considered to be documents that are necessary for
the demonstration of proof. (see Figure 2-2).

26
4.4 Allocation of Reasons of Proof and Types of Docu-
ments

The allocation of the types of documents described in the general Para-

graph 4.3 regarding the different reasons for the demonstration of proof
described in Par. 2 results in the subsequent detailed determination matrix
for types of documents (Figure 4-2).

QM System Process Quality Product Quality

Demonstration of Proof true non-true true non-true true non-true
document document document document document document

Internal Requirements
- Process control X X X
- Management review X X X
- Certification X X X
- QM certificates X X X

Economical Consideratios
- Efficient control of operations X X
- Localization of defective batches X X
in case of recall X X
- Relief in case of general X X
warranty claims

Legal Requirements
- Proof of design conformity X X X
- Proof of product conformity X X

Product Liability, Penal Law

- Relief in CASE of liability claims X X X
- Relief in CASE of penal X X X
prosecution

Figure 4-2: Determination matrix for types of documents

27
5 Archiving

Archiving means the systematic registration, ordering, keeping and admini-

stration of the documents.

The documents can be divided into two groups:

• Documents with regular archiving and

• Documents with Special Archiving (DwSpA).

Documents with regular archiving are intended for the proof of requirements
related to the QM system and for the proving of compliance of the product
with the quality requirements within a certain period of time. This certain
period of time will be deducted from the normal business operation.

DwSpA (i.e. documents having a longer archiving period compared to "regu-

lar" archiving) will be the result for example from legal definitions, con-
tractual agreements or from inter-company specifications (for reasons for
the demonstration of proof see Par. 3, and for the selection of suitable
documents see general Par. 6.1).

5.1 Regular Archiving

In view of archiving, one must in general distinguish between original docu-

ments and documents created by electronic data storage. The latter must in
many cases be designated as "original documents" also, e.g. when they
exist in electronic files only.

In general, original documents are paper documents (e.g. forms filled out by
hand, EDP printouts, printouts from measuring and test equipment). Here,
he most simple way of archiving is the filing of originals. In addition, there is
the possibility to keep the original data on microfilm or on an electronic
storage medium.

28
Requirements Regarding Archives Locations

Archives locations should provide sufficient assurance by protecting against

fire and/or water as well as against unauthorized access, and should
prevent from document alteration by appropriate backup measures.

An external service provider may also be used for archiving.

EDP Operation and Its Specific Requirements

Additional criteria must be observed, when archiving electronically stored

data. First, one should decide, which data must be available online and
offline, depending on the volume of the data and the existing hardware. In a
corporation having appropriate hardware, online archiving should be
preferred, e.g. by optical disk drive. In this regard, those systems should
possibly be applied which do not allow any subsequent alterations (e.g.
WORM: write once, read many).

With regard to the type of storage, the manufacturers recommendations on

the durability of storage media should be observed. One must take care of
refreshing the stored data in time (see also general Par. 6.4).

Basically, the decision about the necessity of the online access should be
made under economical aspects and under consideration of the frequency
of access to the documents that are kept on archives.

Organization of Archiving

The procedures and responsibilities introduced for archiving in a company

should be defined in a documented procedure. These documented
procedures should at least include information about

- which documents shall be kept on archives

- who is in charge of the storage
- who will refresh the data if applicable and how this will be done
- where the archives will be kept
- who has access
- how proof will be shown of the efficiency of the archiving system
(auditing).

29
The departments responsible in the corporation should be informed about
which documents qualify for archiving, about who is responsible for the
keeping of the documents and where they are kept. In this regard, the
question of access authorization must also be clarified and considered, so
that the individuals with autorization to read cannot alter the data that were
stored on archives.

Instructions for data backup in EDP operation are given in general Para-
graph 6.4.

The QM elements of DIN EN ISO 9001 4.5 "Control of Documents and

Data" and 4.16 "Quality Records" must be observed together with element
4.8 ”Identification and Traceability".

The type of file has a considerable effect on the access time to the
documents. But short search times and thus quick access will in general
require increased expenditure for archiving. Therefore, the economical
expenditure should be estimated by a cost/profit analysis. The major item in
this regard are the search criteria (e.g. the probability, that a document on
archives will be used only once), from which the type of marking, regi-
stration and storage will be deducted. For practical reasons, this structure
should be kept in an archiving plan.

After expiration of the archiving period the stored documents may be

destroyed. The frequency of such action depends on the size of the
archives and on the space available. It must be considered, that the records
may include corporate confidential data. It must therefore be assured by
appropriate measures (e.g. paper shredder), that the destroyed documents
and data have been protected against unauthorized access.

Economy

The space required for archiving may be considerably reduced by

electronically created documents, microfilm procedures or by the transfer of
original documents to electronic (magnetic/optical) storage systems.

30
5.2 Special Archiving

In addition to the statements given in general Paragraph 5.1 for the regular
archiving, the longer archiving period and the safer storage conditions if
applicable shall apply to documents with special archiving (DwSpA).

Proof must be shown (e.g. in a product liability case) for true documents
(see general Paragraph 4.2), that they were not altered or exchanged during
their entire archiving period, or that individual documents were not de-
stroyed. An inter-company regulation must be used to control this by appro-
priate documented procedures including the entire archiving system and the
regular proof of the efficiency of the system. In this regard, careful conside-
ration must be given to the fact, that such alterations are avoided by the
type of archiving organization.

5.3 Time of Use and of Archiving

During the lifetime of a document one must distinguish between the time of
use and the time of archiving. The time of use is the time, during which the
document in service is being used. Once the document is not required any
more, i.e. after the end of use the document will be stored on archives. Now,
the time of archiving begins (see Figure 5-1 and 5-2).

The archiving begins for example

• for a quality requirement document (specification document), after it
was modified and as the use of the new version begins
• for a quality record, after it is not required any more in service opera-
tion.

During both periods the document will be preserved - in most cases in a

different way -, and this is called the time of safekeeping. The time of safe-
keeping begins with the creation and ends with the destruction of the docu-
ment.

It must absolutely be observed with regard to the time of archiving, that this
time does in most cases not begin with the creation of a document, but with
its expiration e.g. by modification of the quality requirement document or by
the termination of its use.

Any quality requirement document that has expired should be marked

accordingly.

31
 ^Safekeeping Period

Time of Usage Time of Archiving

Compilation End of use Destruction

of document of document of document

Change od document =
set-up of new document

Safekeeping Period

Quality
Requirement Time of Usage Time of Archiving
Documents
Destruction
of document

Figure 5-1: Safekeeping period of quality requirement documents

Safekeeping Period
Begin of the
validity of
the related Time of Time of Archiving
Q requirement Usage
document
Compilation Destruction
of a Q record of a Q record

Compilation .... Destruction .....

Safekeeping Period

Usage Archiving

Quality Compilation .... Destruction .....

Record
Safekeeping Period

Usage Archiving

Figure 5-2: Safekeeping period of quality records

32
 Type of document Time of archiving

Quality Documents from the engineering Begins with the delivery of the last
requirement phase and quality requirements product, which has been described
document from the production phase of the in these documents, or after com-
object of delivery (e.g. documented pletion of the modification of a
QM procedures, product specifi- document, e.g. due to change of
cations). engineering status

Quality record Records from the production phase Begins with the delivery of the
of the object of delivery product, to which the recordings
regarding the product and the
related process belong
Records from the production phase Begins after termination of the
of spare parts upon expiration of production of the spare part
series production

Figure 5-3: Begin of the time of archiving

A difference in the definition of the time of archiving between products of the

actual series production and spare parts, even after expiration of the series
production exists insofar only, that the time for storage of spare parts
between their manufacture and delivery must be added to the time of
archiving (see Figures 5-2 and 5-3).

There are no generally applicable guidelines or regulations for the time of

archiving of documents.

When determining the time of archiving of documents from "normal busi-

ness operation", one will use the internal requirements as guidelines, and
the necessity for demonstrating an efficient QM system. Normally, shosrter
times of archiving are sufficient for such documents, such as approximately
2 to 3 years. This period of time is sufficient, e.g. to prove the efficiency of
the QM system.

Customer requirements too must often be considered for the time of

archiving of documents. Therefore, quality agreements for example can be
determined on a common basis with regard to which documents should be
preserved on archives for how long.

33
For DwSpA a time of archiving of at least 15 years is being recommended
for the following reasons:
• The average vehicle lifetime has been extended over the last years. It
must be assumed, that after 15 years only, the majority of the
vehicles will be withdrawn from service in traffic.
• As a result from the product liability law, the time of archiving is at
least 10 years (statute of limitations). 3 years must be added for the
period for objection of the plaintiff upon occurrence of the damage.

A specific aspect must be observed with ”wear-out parts” (e.g. brake linings
and tires), which have a shorter lifecycle than the vehicle. It does not make
much sense for these parts, which will be at least exchanged once during
the lifetime of the vehicle, to define a time of archiving for the related
documents that has the same length of time as the documetns for the
vehicle. But this way of consideration cannot be applicable to the engi-
neering documents of the wear-out parts.

It may furthermore be practical to review, if a standardization to 15 years

would be reasonable on the grounds of rationalization and to avoid pro-
blems with marking (mixing up) in view of a requested time of archiving
between 2 and 15 years.

34
6 Practical Instructions for Implementation

6.1 Selection of Documents with Special Archiving

(DwSpA)

6.1.1 General

Not all reasons for a demonstration of proof will require the definition of a
”special” archiving, this means a preservation that exceeds the regular,
typical period of safekeeping in a business operation. Therefore, a selection
must be made, and a marking of those documents may be required if
applicable, which have been selected for a special archiving (see Fig. 6-1).

A corresponding selection and the

separate treatment of DwSpA can be
avoided, when - in case of the pre-
Documents, data sence of appropriate prerequisites - the
and Q records
compiled
decision will be made, to generally treat
within the documents all documents as DwSpA and keep
company required for
demonstration
them on archives in accordance with
of proof the longest time required. The modern
DmSpA
technical methods of electronic data
recording and storage allow more and
more that this consideration will be
realistic, at least for the compo-nents of
a complete system.

Figure 6-1: Volume of documents

35
6.1.2 Selection of Documents

It can basically be assumed, that there are two types of DwSpA:

• legally prescribed ones and/or those agreed upon by contract

• those, defined by the corporation in their own interest ("voluntarily").

Any discussion about the documentation and archiving of the legally

prescribed characteristics or those agreed upon by contract is unnecessary.
These characteristics have been defined and cannot be discussed within
the scope of this paper. They may be defined in the manufacturer’s data
sheet of specifications for the vehicle if applicable, and the suppliers may be
informed about the corresponding specifications for their individual pro-
duct/system.

This may be different with the DwSpA, which are being defined by the indi-
vidual company based on their own interest. Therefore, in this paragraph
the procedure for the selection of such documents only should be treated.

Here it is practical to undertake economical considerations about what will

be the advantage, a company may have from special archiving. In most
cases of these considerations the idea of being afraid of any tortious liability
or product liability, or the argument of a less costly recall action play quite a
role. For both cases a DwSpA may be helpful. But the cases that one may
be afraid of should not occur in a company with a really functioning QM
system. Recall actions and product liability cases can be avoided by
preventive measures, sometimes by reactive quality measures too, and not
by a functioning archiving system. It is extremely diffcult to select those
parts or characteristics for a special archiving, on which non-conformities
that may occur eventually will lead to such problems. Therefore, only the
overall corporate strategy on how to deal with product design, process
control, traceablility etc. can be of decisive importance. Therefore, we
emphasize this practical recommendation:

The examples named in this brochure should in no case be used, in

order to have them hastily applied in suitable cases. They represent
hints only in view of the determination on how to possibly proceed in
a special case that applies to the related company only.

36
To minimize the expenditure of archiving as much as possible when
determining DwSpA, a careful risk analysis will be required in the product
and process development phase, according to which the measures and
characteristics that must specifically be documented will be identified. This
includes for example those characteristics that have, after individual risk
assessment, a considerable influence on vehicle safety or on the
compliance with legal specifications (e.g. emission limits). According to the
general understanding, the following subassemblies and components will
among others have to be included in this regard,

- the brake system

- the steering system and wheel suspension
- the fuel supply and mixture formation system
- the engine management system
- the exhaust control system
- the noise emission system
- the illumination system,

because a functional failure of one component of these systems will repre-

sent a very high risk potential to the vehicle occupants or to the environment
respectively.

But those subassemblies and systems should be included in the analyses

also, on which functional non-conformities are of considerable importance to
the driver ”only” (e.g. immobilization), because unexpected functional inter-
ruptions under certain realistic driving conditions may indeed be dangerous
to the driver and may be the cause for a recall action.

Documents for the QM System

Besides the special archiving of proofs of product and process quality, it

may also be required in some cases to be able to demonstrate even after a
long period of time, how the procedures were organized and who at the time
was responsible for them. For a demonstration of proof for example accor-
ding to general Paragraph 3.3 and 3.4 mainly the documents relating to the
structure of responsibility and certain documented procedures may apply,
e.g. those intended to demonstrate, which quality tools had to be applied at
which time and by whom.

37
Documents of the Product Development Phase

By using documents demonstrating the risk analysis of the product, e.g.

system FMEA for product and process (see VDA 4.2) it will be possible to
show proof, that a complete analysis of all product characteristics, speci-
fically of those with very high non-conformity importance has been demon-
strated, and that all risk-related conditions have been eliminated. The
related test reports and alternative test methods (vehicle tests, finite-
element studies, bench tests, prototype tests, fleet tests etc.) may prove,
that the occurrence of any functional failure was practically not to be
expected (where bench tests using a limited number of test specimen as
proof are in general not sufficient).

To avoid inherent residual risks that would require the definition of DwSpA,
all risks should be minimized carefully during the design and planning
phase, and it should be checked, if the design as selected can be manu-
factured with the anticipated manufacturing methods while meeting process
capability. requirements

Another reason for special archiving is in certain cases based on the

necessity to demonstrate proof of the product-related quality requirements
and of the processes used for testing and manufacturing. For this purpose,
specific product-related quality requirement documents (specification docu-
ments) may be used, from the definition of the engineering concept to the
specifications for the Service. If this is required, documents from this
category may be used for the demonstration of proof, e.g. for

- Engineering projects (specification data sheet)

- Specifications for product design (drawings)
- Production and inspection procedures (QM plan, manufacturing
and inspection plans, process data)
- Limit values for quality inspections.

Documents of the Process Development Phase

As in the product development phase, demonstration of proof is also

possible in the process development phase by using those documents
demonstrating the risk analysis of the processes (e.g. process system
FMEA), that a complete analysis of all process-related risks, specifically of
those having a very high non-conformity importance, has been conducted,
specifically of those having a high non-conformity importance, and that all
conditions that include any risks have been eliminated. It can de shown at
hand of the corresponding process development reports (e.g. the correlation

38
process/product characteristic, test results with statistical test plans), that
the occurrence of a product failure due to process non-conformities has
practically been excluded. In such cases, the specification of process and
product quality records as DwSpA may not be required for example.

Documents in Production

In manufacturing it may become necessary to demonstrate proof of those

procedures and processes that were used for the manufacture of the
product at a later point in time. The corresponding documents will then have
to be specified as DwSpA. But more important are those records that
document an actual condition at a certain point in time. These records will
be established once and will not be modified any more thereafter.

On one hand, records may be used to demonstrate proof of the results from
activities, such as

- system audits (to prove the functioning of the QM system)

- supervision of inspection equipment
- training measures,

on the other hand to demonstrate proof of the qualification (degree of

compliance with the quality requirement) of a limited volume of products,
such as

- results from testing

- release records
- process data registration
- process control charts
- inspection results
- results from product audits
- initiated and completed corrective measures.

Such records are specifically suited in those cases, where proof must be
demonstrated, that the products delivered have met the specified quality
requirements. In this case, it must absolutely be assured, that the
documents can be allocated to the product volumes, to which they apply
(see Par. 6.2.2).

But it should be critically reviewed in each case if it is necessary to treat the

measuring values of all manufactured products with special archiving.
Often, the demonstration of the product quality must be conducted by proof
of process self-control too (e.g. by process control charts). On the other

39
hand, it is often not sufficient or not necessary at all to demonstrate proof of
functional quality on delivery, but proof of other quality characteristics may
be required (e.g. with regard to dependability).

To minimize the expenditure, a condensed statistical review and the

application of control charts may be considered too (not applicable to 100%
inspections with selective procedure) instead of documenting each product
individually. Or, it may be sufficient to prove, instead of a documentation of
all OK results, that the inspection system and its supervision (e.g. by
random sample testing and/or by audits) are mandatorily assuring, that the
products have run through a precisely defined and documented inspection
procedure, while adhering to the limit values (e.g. automatic application of a
permanent marking onto the product in case of OK results). In contrast, it
will not be sufficient, to document the deviations only.

6.1.3 Economical Considerations

The most efficient and cost-saving method as well as the minimum

expenditure possible should be used in any kind of documentation. But in
this regard, limits are given for example by specifications from legislation or
customers. But the basic rule is, that the expenditure for specific archiving
can be influenced considerably by the careful selection of DwSpA. Also, it
should be reviewed in regular intervals if the definition is still justified.

The following includes other instructions on this subject matter, without

being complete:

• In the entire chain of production from the sub-supplier to the manu-

facturer the documentation should be coordinated with regard to
minimum expenditure and in view of avoiding any duplicate documen-
tation (each required characteristic should be documented only once).

• For specific archiving, no specific documents should be created, but

already existing material should be used.

40
 • If the definition of the DwSpA is within the product manufacturer’s
freedom of decisionmaking (no requirement from laws or from custo-
mers), then additional considerations are permissible. In this regard,
two extreme positions may be possible:

1. Besides the legally prescribed archiving, no additional archiving

will be conducted besides the legally prescribed special archiving.
Thus, there will be no extra costs for archiving. This procedure
may be acceptable, depending upon the effects of possible func-
tional non-conformities on the delivered products.
2. ”Everything” will be treated by special archiving. Despite the maxi-
mum costs in this case, assurance has not been given, that the
characteristic or the part having caused the damage was in com-
pliance with the specifications at the time of manufacture in a par-
ticular case.

The decision on how to proceed must be made by each company on its own
under the consideration of the risk (see also Par. 6.5.2). Here are some
more hints in this regard:

• By applying preventive QM measures(e.g. sturdy design, controlled

and capable processes) the probability of a case of interruption can
be minimized to such an extent, that the risk of a non-existing docu-
mentation may become acceptable. This can be supported by the use
of preventive QM methods, e.g. by the FMEA (see VDA 4.2). It must
be observed in this regard, that for example early failures during
testing are considered as non-conformity, and that appropriate
response is being undertaken.

• Special consideration should be given to the documentation of modi-

fications, since they represent a special risk potential.

- The customer may change the product or use it differently, without

informing about such changes (this means for example interface
description as DwSpA).

- process changes may at the beginning not be recognized as being

relevant, but will lead to problems later. This means for example,
that equipment logs must always be kept with extreme precision,
and be treated as DwSpA, in order to allow localizations at a later
point in time.

41
 - the quality delivered parts may vary considerably, and deviations
may be recognized too late, due to the skip lot method for
example.

• If in the course of deliveries proof of compliance with specifications

has been demonstrated by quality assurance agreements only, then
carefully judgement is required on who is liable in the event of a
damage.

• The completeness and truth of content of all records that have been
compiled should be reviewed again and again for plausibility. Audits
may be helpful in this regard.

• For special archiving, not as many characteristics as possible, but as

few as necessary should be selected.

• The extent of the entrepreneur’s acceptable risk should be calculated,

depending upon the probability of occurence, the type or damage and
ist amount. Examples for the consequences of missing or insufficient
documentation are:

- the scope of recall actions cannot be limited any more

- no relief is possible in case of formal proceedings (e.g. in court)
- increased insurance rates
- no insurance possible

6.2 Marking of Documents and Equipment

6.2.1 Marking of DwSpA

All documents and records should always be marked with a date and show
the issuing/recording party, and the modification status too if applicable. The
allocation of any record to certain manufacturing periods, batches, deliveries
etc., or to the scope of application of the documents should be possible
(traceability).

There are no standardized specifications for the marking of documents that

are subject to special archiving, and/or of the quality characteristics or
activities to be documented, that were indicated on the documents. But it
has been strongly recommended to the companies/users, to define uniform

42
procedures (in-house standards) and to apply them throughout the process.
Customer marking requirements relating to the archiving of documents
should be included in this in-house standard as much as possible.

The following includes some proven types of marking as examples:

Individual Marking of Documents

The definition of a certain space on the document has been recommended

in case documents and records will be marked. In case of preprinted forms
or standard layouts, a certain space should be provided for this purpose.
This space will then be filled out with the corresponding marking or it may
remain empty.

In order to assure its recognizability, a minimum size, larger than the

surrounding text, should be defined for the marking Also, the copying capa-
bility of the document should be considered, any exclusive color marking for
example is not suitable.

In case of new definitions or modifications the letter ”A” like for special
Archiving should be used for such markings as well as the use of one or
several of the symbols indicated below.

The marking with the letter ”D” as often used so far should support the
awareness to demonstrate, that this represents a different type of
”documentation” than understood by the term ”duty of documentation” so far
(see Preface and Introduction). The ”D parts” as defined already according
to VDA Volume Band 1, 1st edition, may be used as ”D parts” in the future.
But it has been recommended, to introduce the procedure described in this
brochure at least with the new products, and to review the old ”D parts” and
conduct the changeover if applicable.

43
 The criteria marked
by this sign "A"
A * *
are subject to
special archiving
Document
with special
archiving

Checked:: ..................
A A Date: ..........................

Number of Number of
criteria criteria

Figure 6-2: Examples for markings

Marking of Characteristics

As described on the documents marked above, several manufacturing

steps, activities, inspections, quality characteristics etc. have been listed,
the execution, results and data of which must not all be kept on special
archives (e.g. on bills of materials, drawings, documented procedures,
inspection procedures etc.). Therefore, those quality and process charac-
teristics, procedures etc., intended for registration as DwSpA should have a
specific marking. In this regard, the numbering of the characteristics with
special archiving by running order on the document is a practical solution.

The following symbols are recommended for such markings:

*Characteristic*

Ax Characteristic (x =running numbering order)

(A) Characteristic
____________

Characteristic

44
Such a structure of a marked document and of the marked characteristics
or reference documents contained therein may also be necessary in several
steps. But basically, all documents marked that way should have a special
archiving.

Archiving Plan for DwSpA

Also, the compilation of an ”archiving plan” for a product has been recom-
mended as an alternative or as supplement to the marking of documents,
i.e., a list containing all characteristics, process parameters, procedures,
paperwork etc. that are DwSpA (e.g. quality requirement documents) or
that should become a DwSpA (e.g. quality records). It is practical for this
plan to include the definition of archiving responsibility, filing location and
medium. This archiving plan should be part of the bill of material of the pro-
duct.

The QM plan is also specifically suited for this definition.

Decision Criteria for the Type of Marking

The advantages and disadvantages of the individual marking or of the docu-

mentation plan have been compiled as an example in Figure 6-3 below. As
an optimum, both procedures may be used in practice.

Documentation Plan Individual Marking

Individual document cannot be identified - Individual document can imme- diately +

as DwSpA be identified as DwSpA
Schematic overview of all DwSpA for a +
product
Facilitates planning as a whole for a + Increased expenditure -
product
Alle information on one document + Additional information is neverthe-less -
required (e.g. regarding type, location,
and responsibility of filing)
Additional expenditure -

Fig. 6-3: Types of marking + = adv./ - =disadv.

45
6.2.2 Marking of Products and Product Equipment

In general it is not required and not practical either, to mark the product itself
or the packing or transport unit respectively, containig such products, in
order to indicate, that this is a product having DwSpA. This information does
not mean anything to those receiving the product, such information
represents an unnecessary expenditure only. If DwSpA pertaining to goods
are delivered to the customer, it is recommended that they are handed out
to the customer separately.

It is important in any case, to allocate the DwSpA to the delivery lots, deli-
very periods, marking of manufacturing date or the like of the corresponding
products in a suitable manner.

But it has been strongly recommended to mark the products (as far as tech-
nically feasible) and/or the packing units with regard to:

• Part number (identification of product) and

• Allocation to a certain manufacturing period, e.g. by:
- manufacturing date
- batch relation
- shift designation
- modification status
- running number (serial number).

This marking is required, in order to allow the interrelation between the

products and the corresponding DwSpA (traceability).

In general it is not required to mark the machinery and equipment (hard-

ware) on site that produce quality characteristics, proof of which must be
conducted with special archiving. If special specifications and/or personnel
qualifications have to be observed with regard to the operation and the actu-
ation of this equipment, then this should be defined for practical reasons in
the appropriate documented procedures and work plans (= DwSpA), and
compliance should be proven (= DwSpA). The specific archiving of these
proofs, such as analysis of machine capability, test equipment capability,
process capability, maintenance, calibration of test equipment, training of
personnel etc. does not depend on the marking of the corresponding
hardware.

46
6.3 Examples for Documents Proving Compliance With
Quality Requirements

Steps of Quality-Related Documents Steps of Quality-Related Documents

Process Process
Sales and Market analysis Tool Measuring records
Marketing Contracts Supervision
List of specifications
Preventive Maintenance records
Maintenance
Product Project release
Development List of specified functions Receiving Inspection certificates
Drawings Inspection Q documentation at the supplier
Bill of materials Results from Receiving
Results from design reviews Releases
Test results
Liste of standards used Intermediate Control charts (SPC)
System / design FMEA Inspection Quality supervision charts
External test results Checklists
Instruction of personnel Pareto analyses
Single value records
Qualification of Qualification procedures plans Statistical evaluations
-Subassemblies Checklists
-Final products Inspection and test results Final Inspection Results from individual inspection
Release reports Summary of inspection results
Statistical evaluations
Validation Test reports from practice Limit value samples
Qualifications of Qualification procedures plans Proof of current supervision of
Purchased parts Initial sample reports (VDA 2) inspection equipment
Individual release reports Check- Audits Audit reports and lists of measures
lists on pro- duct, process, and system
Process Process FMEA (VDA 4.2) audits (VDA 6)
Development Qualification Proof of compliance with
Process procedures plan
Process data sheet of Personnel requirement pro-files according to
Manufacturing plan position specifications
Inspection plan
Training Training planning
Documented work/inspection
Particiaptioin certificates
procedures
Schulungsnachweise
Process Machine capability analysis Proof of periodic instruction at
Evaluation Process capability analysis workplace
(VDA 4.1)
Supervision of Records regarding inspection
Process release
Inspection equipment supervision
Customer Design release Equipment Inspection equipment analyses
Release Initial sample test report (VDA 2) Documentation of referenceability
to master equipment devices
Process Control Control charts (SPC)
Process data records Corrective Special releases
Inspection results Measures Catalogue of corrective measures
Minutes on corrective measures 8D reports

Figure 6-4: Examples for the documents on the steps of process

47
Figure 6-4 shows at hand of an example the quality requirement documents
and records that may serve as proof of compliance with quality
requirements and with the correct function of the QM system.

Remark: Special archiving of all named documents and material is not

required at all. The selection will be conducted in appropriate
accordance with the individual product and the reason for the
demonstration of proof.

6.4 Possibilities of File Backup in EDP Applications

File backup should be conducted, when a new working procedure on the

document may cause a data loss at the latest.

• Backup procedures should be conducted in regular time intervals

during registration of data, in order to avoid data loss, (e.g. operation-
related file backup: Data should be stored upon completion of each
individual operation, or be transferred to the central EDP Host).

• Recently established documents/files should generally be secured by

backup before being printed out.

• Never overwrite a preceding backup copy with a new backup copy.

• Always keep backup copy separate from the original. It has therefore
been recommended, to use two alternating storage medium sets for
the backup copies.

There are different storage possibilities for file backup, depending on the
type of hardware equipment and the scope of data to be secured:

- Diskette
- Exchangeable hard disk
- Digital audio tape (DAT)
- Streamer tape
- Exchangeable optical disk.

48
File backup in network systems is commonly executed automatically by a
server. This periodic file backup is in general not sufficient in networks with
large flow of data. The ”data reflection” system has been recommended in
such cases. The information to be secured are continuously stored parallel
to each other on two independent storage media. Thus, the second storage
medium may be used in the event of a failure of one storage medium..

In the PC area today, the streamer is the most commonly used means of file
backup besides the diskette. Increasing usage has also been observed with
CD-ROM, where the writing is executed on an optical basis, and the data
cannot be altered any more.

Another aspect that has often been neglected is the lifetime of the data
carrier. Two criteria must be observed, in order to assure the readability of
the stored information during the entire period of archiving:

1. Electronic storage media undergo a quality loss over the time.

2. The hardware and software required for the reading of the data
must be available during the anticipated archiving period.

With regard to data service life, you should follow the recommendations of
the storage medium manufacturers. The stored data must be transferred in
time (refreshed) to a new storage medium if required (safe data service life
shorter than anticipated archiving period).

In addition, the future readability of the information stored on electronic

storage media must be secured in case of a change of hardware and soft-
ware. The corresponding equipment must either be kept available in the
future or, a transfer of the data under loss hazard must be conducted to
storage media that are readable by the new equipment. If one decides for
the old equipment it must be observed, that any failure of the old equipment
includes the hazard of loss of readability of these stored files. It has there-
fore been recommended for this case, to keep the appropriate hardware
and software equipment available in several numbers.

When archiving electronically stored data and information, the specific

storage conditions for the storage media (e.g. protection from magnetic
fields) must be considered besides the regular requirements regarding
rooms for archiving. In cases of doubt, the recommendations of the storage
media manufacturers may be helpful.

49
6.5 Selection Procedure for DwSpA

6.5.1 Procedure of Selecting DwSpA

A systematic, process-oriented procedure may be helpful for the selection of

DwSpA. Figures 6-5 and 6-6 represent an appropriate procedure.

Product

Do
Yes
specific laws
and regulations
exist?
No
Do
Yes
customer or
consumer require-
ments exist?

No

Conduct risk analysis

No
Does
no special residual risk exist?
archiving Special documantation
required?
Yes

Define safety-critical
function or criterion
to be documented

Clearly define
quality requirements
Have
requirements
been sufficiently
No defined??

Yes
1

Figure 6-5: Flow chart for the selection of DwSpA, Part 1

50
 1

No Is record of
inspection results
sufficient?

Yes
No Document
process parameters
additionally or Define location and
alternatively? scope of inspection

Yes
No Document Define prozesses Yes
engineering procedures that determine Can measuring
and results additionally a Q criterion data be collected
or alternatively? statistically?
Determine type
No of evaluation
Define Special
measures Determine, which docu-
Yes ments of process de-
scription and/or which
records of process Determine type of
Determine DwSpA parameters are DwSpa.
of Engineering quality record

Yes Definition of marking for

Traceability - Individual products or
required? - Batches or
- Production periods etc.
No

Compile/Add list of DwSpA and/or

mark individual documents

Define responsibility,
duration, and archiving

Figure 6-6: Flow chart for the selection of DwSpA, Part 2

51
6.5.2 Criteria for the Specification of Special Archiving

In cases where special archiving has not been prescribed externally (by
regulations, laws, customers), the risk of a damage that may cause a recall
and/or product liability claims can be estimated by using an FMEA-type
evaluation of various criteria, as shown at hand of Figure 6-7 as an
example. This may be used to deduct the necessity for special archiving of
certain characteristic figures and/or procedures.
Criterion A Criterion B Criterion C
Degree of Safety Probability of Occurrence Probability of Discovery of
Reduction of Non-Conformities Non-Conformities
1 low 1 low 1 high
No or low reduction Design/manufacturing Non-conformity has been
process corresponds to a discovered during
status, for which no/an manufacturing process.
insignificant number of
problems are known
2 medium 2 medium 2 medium
Safety reduction. Accident Design/manufacturing Probability exists, that the
cannot generally be process corresponds to a non-conformity will be
excluded. status, for which non- discovered during the
conformities cannot be manufacturing process
excluded.
3 high 3 high 3 low
Failure will most likely lead Design/manufacturing It is almost unlikely, that
to accident with personal process is new, no the non-conformity will be
injuries experience yet so far discovered during the
manufacturing process.

Figure 6-7: Selection criteria for DwSpA

The determined number combination can for example be allocated to a

statement in a table (Figure 6-8), showing that in this case special archiving
must be considered. In general, the combinations that are not shown do not
lead to the necessity of special archiving.
Criterion Criterion Criterion Special archiving to
A B C be considered
2 2 2 yes
all other combinations yes
which contain number 3

Figure 6-8: Decision criteria

This allocation can represent examples only, that should be modified for
specific company reasons and on a case-by-case basis.

52
6.5.3 Checklists for the Treatment of Products With DwSpA

The following checklists for the treatment of products and characteristics

anticipated for specification of DwSpA (Figure 6-9 and 6.10) represent
proposals that must be adapted for specific company reasons and on a
case-by-case basis.

Run- Requirement Com-

ning pleted
No. Yes No

1 Definition of specification is clear and can be tested

2 Set-up of a documentation plan (possibly as alternative to 3 through 5)
3 Marking of bill of material as DwSpA
4 Marking of drawing as DwSpA
5 Marking on the drawing of the characteristics to be documented
6 Conduct FMEA
7 Marking as DwSpA of the manufacturing plans and the
processes/process parameters to be documented
8 Plan manufacturing processes such, that the quality requirements to
be documented can be met safely (process capability)
9 Establish QM plan
10 Marking as DwSpA of the inspection plans and inspections included
therein, the results of which must be documented
11 Definition of inspection equipment, by which the characteristics are
registered with sufficient safety of inspection (capability of inspection
equipment)
12 Definition of the frequency of inspection (under consideration of the
manufacturing safety) with statistical safety such, that compliance with
the limit values can be proven over the entire manufacturing period.
13 Set-up of specifications for type and scope of supervision of manu-
facturing equipment and of the part-related setting figures.
14 Assurance of employee instruction at the wotkplace
15 Establish initial sample test report for dimensions, function, material
16 Assurance of permanent supervision of the inspection equipment and
devices
17 Specification of organizational measures assuring the separation of
parts on which non-conformities have been discovered
18 Specification of documentation procedure for corrective measures
19 Define, which documents should treated for archiving in which way
(DwSpA)

53
 Run- Requirement Com-
ning pleted
No. Yes No

20 Check, if the documents selected for special archiving comply with the
specified reqirements regarding the demonstration of proof
21 Permanent checking of the documentation regarding its correct
execution (audit)
22 Assure, that design or manufacturing modifications regarding
characteristics to be documented will automatically be subject to the
procedure specified in this checklist
23 Define product reviews

Figure 6-9: Checklist for the treatment of products with DwSpA

- in-house production

Com-
Run- Requirement
pleted
ning
Yes No
No.
1 Inclusion of supplier in decisionmaking to specify the necessity and
scope of the documentation (information on product application,
legislatory situation, safety relevance etc.)
2 Definition of clear and inspectable specifications for the supplier
3 Marking of the documents as DwSpA, also at the supplier, e.g. drawing,
bill of material, documentation plan
4 Marking of the characteristics to be documented on the documents
5 Supplier evaluation under specific consideration of their capability to
manufacture safely those products requiring DwSpA, and to conduct the
documentation correctly in accordance with VDA Volume 1
6 Provide supplier confirmation, that he will comply with the requirements
regarding product and documentation
7 Planning of assurance of the quality delivered. E.g.: Receiving inspec-
tion, proof of process capability by the supplier, plant certificate with lot-
related measuring results
8 Specification of measures for identification and traceability (customer
and supplier jointly)
9 Supplier information about product liability risk
10 Agreement on other requirements

Figure 6-10: Checklist for the treatment of products with DwSpA -

purchased items

54
6.6 Traceability

The expenditure for special archiving in order to assure the traceability is

practical and economical for all involved, only if the traceability has been
assured over the entire chain of production from the sub-supplier to the
supplier and the manufacturer and further to the sale of the vehicle, see
Figure 6-11.

Elements of Step of Characteristic Allocation Records

the Chain of Process to Be Pursued Criteria
Production
Initial supplier Manufacture of composition of Batch number Plant inspection
steel alloy, certificate
crack-free
structure,
texture
Parts Manufacture of Surface Batch number, Process data
manufacturer rack hardness, Manufacturing Ispection results
strength, lot
crack-free
structure
Supplier, Manufacture of Test results, Manufacturing Design data,
Module supplier, steering gear functional lot, Inspection
System supplier values, Manufacturing resulls Vehilce
functional safety date, type plate
criteria Idividual part
number
Automobile Installation in Functional VIN Sales
manufacturer vehicle safety documents

Figure 6-11: Schematic overview of traceability - Example: Steering gear

55
ANNEX

1 Abstracts and Comments Regarding Laws, Contracts,

Standards, and Association Requirements

As described in Par. 3, the reasons for a demonstration of proof are often

founded in laws and contracts, which in turn refer to some extent to other
standards and association requirements. To give support for decisionmak-
ing in this regard, below are some of the most important requirements inclu-
ding wording and interpretation, that have been applicable at the time of
printing.

1.1 Requirements from Laws and Contracts

1.1.1 Requirements on Operational Safety

Laws are describing requirements relating to motor vehicles that are parti-
cipating in road traffic. They include among others the definition of liability
for non-conformities and consequential damage, and minimum rules for
type approval and manufacture. In general, the minimum rules for the
manufacturing safety are described in these laws as general requirements,
and their precise scope regarding demonstration of proof has not been
defined. For these reasons, precise definitions will always require a risk eva-
luation of the entire corresponding process too.

Among these laws is for example the German Road Traffic Homologation
Law (”StVZO”), § 30:

”(1) Mot or vehicles must be designed and equipped in such a way, that
1. during their common use in road traffic nobody will be damaged or, more
than unavoidable incur any hazard,be impeded or annoyed,
2. the occupants will be protected as much as possible, specifically in
accidents against injuries, and that the extent and the consequences of
injuries remain minimal as much as possible.
(2) Vehicles must be designed and maintained with regard to road protection.
(a) Vehicle components that are important for road traffic or operational safety
and that can easily be used up or damaged, must be such that they can be
checked in a simple manner and easily be exchanged."

56
The requirements of the ”StVZO” apply above all to products that have been
brought into road service for the first time. In this regard, the manufacturer is
responsible for the condition of a defect-free product. His responsibility is
based on the laws, among others on the Product Liability Law or the Civil
Law (BGB § 823) in general. These laws describe the liability of the
manufacturer for damages that any user or third party may incur, due to
insufficient safety of use of the product, e.g in § 1 Subpar. 1 ”ProdHaftG”
dated 01 January 1990:

”In case of the death of a person, in case of injury to his/her health or in case of property
damage, due to a defect of the product, the manufacturer shall be liable for compensation
of the damage resulting thereof to the injured party ....”.

In Europe, minimum rules have been defined for type approval for com-
pliance by the manufacturer, e.g. by the General 70/156/EEC, version
92/53/EEC, Par. 10, Annex X, Initial evaluation, Section 1.1 through 1.3:

”Before granting a type approval, the approving authority of a member state will verify if
the necessary measures have been observed and if procedures are available, to assure
an efficient control of compliance of the manufactured components, systems, independent
technical units or vehicles with the approved type in each case.”

Other motor vehicle requirements in the national legislation worldwide are

defined for example in the USA in:

• US safety regulations: FMVSS (Federal Motor Vehicle Safety

Standards), based on the National Traffic and Motor Vehicle Safety
Act of 1966, issued by the National Highway Traffic Safety Admini-
stration in the USA. These regulatioins include for example the admi-
nistrative rules and requirements regarding the entire vehicle, in ana-
logy to the above-mentioned EU Directives.

• Die US environmental protection regulations (Title 40, Chapter 1)

Environmental Protection Agency, Subchapter C: Air Programs. They
include e.g. the administrative rules and requirements for emissions:
Part 86 - Control of air pollution from new and in-use motor vehicles.

57
1.1.2 Requirements on Documentation

For Europe, minimum rules to be met by the manufactuarer have been

defined for example in the General Directive 70/156/EEC, version
92/53/EEC, Par. 10, Annex X Section 2.1 through 2.3.3:

”Each vehicle, system, component or each technical unit which has been approved based
on this directive or on an individual directive must be designed in such a way, that it is in
conformity with the approved type and that the regulations of the present directive or of an
individual directive are met, which are included in the complete list in Annex IV or in
Annex XI. The approving authority of a member state granting a type approval, verifies in
coordination with the manufacturer with regard to any approval, that suitable precautionary
measures have been taken and that written test procedures exist, in order to be able to
conduct tests in defined intervals or suitable reviews including the tests, which may be
defined in individual directives, in order to assure continued conformity with the approved
type. It is above all the duty of the holder of an approval to assure, that test results
are recorded and that the records and the related material remains available over a
period of time to be agreed with the approving authority. This period should not
exceed 10 years.”

For the USA appropriate regulations for the demonstration of conformity of

production with the type approval are included in the National Traffic and
Motor Vehicle Safety Act of 1966, Issue 1082, revised until 31 October
1988, Section 1, Paragraph 112 (b), Sheet 23:

”Each motor vehicle manufacturer must keep such material on files and compile such
reports that can reasonably be requested by the Department, in order to allow the
Department to determine if a manufacturer has acted in compliance with this Section or
with any regulations, administrative rules including the orders published therein....”.

For Australia for example, the Australian Motor Vehicle Certification Board,
Conformity of Production-Manual-Circular 0-13-1, Item 2 is applicable to the
conformity of production with the type approval:

”Each manufacturer must provide measures for quality assurance, among others:

d) specific controls for safety-critical parts

(f) control procedures for the documentation:

During Conformity of Production (COP) reviews, i.e. the review of the products with regard
to conformity of the manufactured products with the individually approved product, the
manufacturer must demonstrate proof at hand of documents and quality records”.

58
Large customers, such as the Federal Armed Forces or Nato partners,
Postal Services and increasingly freight forwarding companies, car rental
companies etc. are making reference in their contracts to quality assurance
systems according to AQAP 100 and following or DIN EN ISO 9000 and
following. The conclusion of such contracts may be regarded as a require-
ment that goes without saying in a long-term, partner-like cooperation.
Examples for contractual definitions are:

• The German Industry Association (”BDI”) - Governmental Standard

Agreement, e.g. initial evaluation of quality assurance in production
and assembly (corresponds to Annex X, Section 1 regarding
Article 10 of the Council Directive 92/53/EEC). Abstract from Par. 1.3
Quality Records:

”Definition of the required measures, that the quality records and

QA proofs must be compiled correctly in all areas of the company, in
order to protect them against loss.”

• The standard agreement of the Federal Armed Forces (”BWB”),

(Nato requirement regarding an industrial inspection system accor-
ding to AQAP 100 and following). Abstract from Par. 203b Records:

”The contractor must keep records on all conducted tests, which

are used for conformity purposes. The records must include, as far as
required, article designation, lot, type and number of findings, type
and number of non-conformities found, accepted and returned
volume as well as corrective measures conducted. The records must
be stored and be available upon request.”

• VDA Recommendations, dated 15 August 1995 ”General business

terms for the procurement of production material and spare parts,
intended for automobiles”. Abstract from Par. IX.3:

"In case of motor vehicle components with special marking in tech-

nical documents or based on special agreement the supplier must in
addition maintain special records defining, when, in which way,
and by whom the delivered items shall be inspected with regard to
those characteristics that must be documented, and which are the
results from the required quality tests".

59
1.2 Requirements from Standards and Orders from Public
Authorities, and from Associations

Besides the requirements by law, there are those from customers too, that
require compliance by contract with standards and association rules regar-
ding quality management issues. In this case, they cannot only be regarded
as recommendation, but finally as requirements. The same applies to the
observation of the scientific and technical state of the art.

In most cases compliance with standards such as DIN EN ISO 9000 and
following is required. Thus, the compilation of documents among others and
of quality records in view of demonstrating proof of compliance with the
quality requirements and with an efficient functioning of the quality
management system have become a duty. This duty to demonstrate proof
applies in general to all products and processes in manufacturing and when
rendering services..

DIN EN ISO 9001 through 9003, Issue August 1994 prescribes in Para-
graph 4.16 ”Control of Quality Records”:

”The supplier must establish and maintain documented procedures for the marking,
collection, registration, accessibility, filing, storage, updating, and disposal of quality
records".

Before granting a type approval for a motor vehicle or a component, the

approving authority, e. g. the Federal Motor Vehicle Agency will verify, if the
manufacturer applies a quality management system, by which conformity of
production has been assured. This requirement regarding the quality mana-
gement system of the manufacturer and his systems or component supplier
has been defined by the Federal Motor Vehicle Agency in its ”Catalog of
Requirements for the Justification of the Manufacturer’s Capability” dated
August 1993. In this regard, the manufacturer must assure according to
Paragraph II, Subpar. 1.1 through 1.3:

"...that a standardized QA system according to EN 29001 or EN 29002 (or ISO 9001 or

ISO 9002, or actually DIN EN ISO 9001 or 9002 respectively) or another comparable
standard that has been adapted to the requirements is available in the part of the
manufacturing operation working for him. In addition, he must assure and demonstrate
proof of the efficiency of this QA system by appropriate measures..

...that the manufactured products will be inspected with regard to their approval conformity
before bringing them into service by using suitable random sample plans (product inspec-
tions).

60
 ...that the manufacturer presents procedures that assure, that in case of discovery of non-
conformity of products, these products cannot be brought into service operation or that
products used in service operatioin can be recalled again."

Association recommendations, such as the VDA series of publications "QM

rd
in the Automobile Industry", Volume 6, Part 1, 3 edition, ”Quality Manage-
ment System Audit According to DIN EN ISO 9001 and DIN EN ISO 9004”,
are describing QM systems including all elements, and provide support for
interpretation and definition. Many manufacturers in the EU are using this
VDA Volume as their contractual basis. There, this reads as follows:

"The quality management requires the recording of quality-relevant data, in order to

demonstrate compliance with defined quality requirements. Therefore, their identification,
collection, order, distribution, maintenance, and storage must be considered. The ability to
find stored records again, and theior hierarchical order must be assured at all times.

Related quality records from suppliers must be considered in the same way".

In this regard, in VDA Volume 6, Part 1 for example, in QM element 20 the

following questions are found:

• Have responsibilities and procedures beed defined for the collection and checking of
quality records?

• Are there procedures and responsibilities for evaluation and distribution of quality
records?

• Are there definitions on where, how, and how long quality records will be stored?

• Are there definitions on how quality records will be made available to the customer, if
this has been agreed upon by contract?

61
2 Schematic Overviews

The Figures below show the consequences of defective products (Figure

A2-1) and the major differences in liability for consequential damage based
on defective products (Figure A2-2).

Consequences of defective products

on non-legal, above all oflegal nature: Liability

of economical nature
Affecting e.g.
- Sales
- Market position
- Reputation/Kredit
- etc.

Liability based on civil law Liability based on penal law

e.g. due to (in general negligent)
- homicide
- nodily injury
- arson
- explosion damage

Liability based on contract Extracontractual liability

Warranty Liability for conse- Liability based product liability BGB § 823
quential damages on special laws law
Liability for the Caused by faulty e.g. Medical In case of damage In case of
defect-free con- (= intentional or Preparations due to defective damage due to
dition of a legally negligent) violation Act products (even faulty negli-
due performance of contractual without fault) gence of duty
itself, when assu- secondary obli-
red properties gations.
are missing; also
possible: Liability based on
Liability for "positive violation
consequential of contract".
damages. No neg-
ligence required!

Definition of
defect:
"Affecting the Definition of defect:
value or the "Endangering someone's rights"
possible use of (Avoidable) lack of safety
the product".

Figure A2-1: Consequences of defective products

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 Liability bases
Contractual liability - Tortious liability Liability according to the
Liability Liability from positive according to § 823 BGB Product Liability Law
differences violation of contract

Liability prerequisites Violation by default (= inten- Violation by default (= inten- Defective product (default is
tional or by negligence) tional or by negligence) not important!)
Violation of a contractual Violation of the general duty
(secondary) duty of care toward third parties
(i.e. not to violate the rights
of third parties)

and damage caused thereof and damage caused thereof and damage caused thereof

Damage: all direct and indirect All (direct and indirect) All direct and indirect
Damage to be compensated damage, also pure property damage to those rights that damage due to death or
loss have been protected by § personal injury as well as to
823 BGB, including ”private” matters
compensation for pain and
suffering

losses that cannot be Immaterial damage Pure property damage Immaterial damage
compensated (compensation for pain and (compens. for pain and
suffering) suffering); damage to
industrial property, facility
operations or to public
property

Liability of vicarious agent Liability for fault of such Liability only if fault of such Unlimited, because any fault
or employee persons is treated like persons also applies to is not important, but the
liability for own fault business management/ defective-ness of the
employer, i.e., in case of product alone
incorrect selection, instruc-
tion or supervision (§ 831
BGB); such a fault is being
assumed by the law - the
business management must
prove ist innocence

Agreed exemption from Under certain conditions at As with contractual liability Not possible
liability (exclusion or least partially possible (of minor importance in
limitation of liability) wiithin the scope of an practice, since damaging
appropriate agreement with and injured party do in most
the injured party cases not know each other,
and can therefore not
conclude any agreement)

Statute of limitations In case of claims due to 3 years (as of knowledge of 3 years

damage having close the injured party about the Begin of term: When the
relation to insufficient per- damage and of the injuring person entitled acquires
formance (”damage due to party); at the latest: 30 knowledge of damage, of
shortcoming”): 6 months; in years after occurrence of the product defect and of
case of ”more distant” con- the action that caused the the person liable, or when
sequential damage: damage he/she sould necessarily
30 years. Begin of term: have acquired the
Acceptance or delivery of knowledge
performance

Expiration No expiration due to pure No expiration due to pure 10 Jahre years after
elapsed period of time elapsed period of time bringing into service of the
product

Figure A2-2: Schematic Overview on Major Differences in Liability for Consequential

Damage Due to Defective Products

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Forms
FIRST SAMPLE TEST REPORT – new version (1998)
Cover Page, Order No. 0501
Multipart form set, 5 copies (packed of 50 sets)
Test results, Order No. 0502
Multipart form set, 5 copies (packed of 50 sets)
Material Data Sheets, Order No. 0503
Multipart form set, 5 copies (packed of 50 sets)
Tabel to Material Data Sheet, Order No. 0504
Multipart form set, 5 copies (packed of 50 sets)
FIRST SAMPLE TEST REPORT – old version
Cover Page, Order No. 0661
Multipart form set, 5 copies (packed of 50 sets)
Test result, Order No. 0662
Multipart form set, 5 copies (packed of 50 sets)
Outline form for process capability verification, Order No. 0663
Pad of 50 sheets – Minimum order 1 pad
FIRST SAMPLE TEST REPORT – present version
First Sample Test report – Report result, Order No. 0331
Multipart form set, 7 copies (packed of 50 sets)
First Sample Test report – Report result, Order No. 0031
Pad of 100 sheets
SYSTEM-FMEA
DIN A3 format, Pad of 50 sheets – Minimum order 1 pad, Order No. 7422
QUALITY SYSTEM AUDIT (Material products)
Questionnaire (only questions)
DIN A5, Pad of 10 sets à 12 sheets
Evaluation documents
Final evaluation of the quality system
Summary of results
Total grading
Summary of evaluated questions
Individual measures
Corrective Actions-Outline
DIN A4, Pad of 10 sets of 5 sheets
The two pads form a unit and are only offered as a set, Order No. 2500
Order:
DRUCKEREI HENRICH GMBH
Schwanheimer Straße 110, D-60528 Frankfurt
Telephone (069) 35 10 05 - 28, Telefax (069) 35 10 05 - 29

64
Quality Management in the Automotive Industry

The latest revisions of the published VDA volumes regarding ‚Quality

Management in the Automotive Industry (QAI)‘can be found on the internet
under http://www.vda-qmc.de.

Orders can also be made directly from the VDA homepage.

Order:
Verband der Automobilindustrie e.V. (VDA)
Qualitätsmanagement Center (QMC)
Lindenstraße 5, D-60325 Frankfurt
Telefax (0 69) 9 75 07-431

65