Professional Documents
Culture Documents
All holders must be on the Master List in the Global External Document Control system. It is
important that the document is not redistributed or reproduced. If additional people need copies,
please direct them to the system to obtain the copy and be placed on the Master List of holders.
Please ensure this document is not placed on a shared drive. All external documents are to be
maintained and controlled through our Global External Document Control system.
Process Audit
Copyright 2016 by
Overall production:
Henrich Druck + Medien GmbH
60528 Frankfurt am Main, Schwanheimer Stra(l,e 110
Exclusion of Liability
Copyright
This publication including all its parts is protected by copyright. Any use
outside the strict limits of copyright law, is not permissible without the consent
of VOA-QMC and is liable to prosecution. This applies in particular to copying,
translation, microfilming and the storing or processing in electronic systems.
Trans lations
This publication will also be issued in other languages. The current status
must be requested from VOA QMC.
3
4
Preface
Technical progress, customer expectations and new production technologies
lead to increasing demands in the entire chain of customer and supplier pro-
cesses. This continually poses the quality management of companies with
new and challenging tasks. It is necessary to ensure that robust processes
are in place and secure throughout the manufacturing and supply chain.
The process audit following VOA 6.3 is an important and well established
method for the analysis of processes. The process audit exhibits a high effec-
tiveness through the evaluation of the real performance of the processes on
site, by examining the interfaces and the supporting functions in the project
and serial phase.
After a first edition was published in 1998 a complete revision was made in
2010. With the 2016 ed ition our collective experience has been used to up-
date and optimise the volume.
The process standard VOA 6.3 contains the current questionnaire and evalu-
ation criteria and additionally the requirements for the qualification of process
auditors and the preparation and implementation of process audits.
The process audit following VOA 6.3 is part of the VOA strategy "Quality
standard for the German automotive industry" (VDA6.x Volumes).
5
There is agreement between automobile manufacturers and suppliers on the
execution of audits in accordance with this publication.
We thank the organisations involved and their employees for their contribu-
tions to the preparation of the revised VOA 6.3 volume.
Adam Opel AG
Audi AG
Benteler Automobiltechnik GmbH
BMW AG
Borg Warner Ludwigsburg GmbH
Continental AG
Daimler AG
Harman Becker GmbH
Knorr-Bremse Systeme fur Nutzfahrzeuge GmbH
Magna International Europe AG
MAN Truck & Bus AG
Otto Fuchs KG
Dr. Ing. h.c. F. Porsche AG
Robert Bosch GmbH
Rollax GmbH & Co. KG
Schaeffler AG
Volkswagen AG
ZF Friedrichshafen AG
Our thanks go also to all who have given us suggestions in the preparation
and improvement of this publication.
Berlin, 2016
6
Contents
Preface 5
1 Introduction 11
4 Audit process 23
4.1 Audit programme 23
4.2 Audit request 26
4.3 Audit preparation 29
4.4 Conducting the audit 35
4.5 Evaluation 39
4.6 Presentation of results 42
4.7 Follow up and closure 46
7
6 Evaluating a process audit for material products 55
6.1 Evaluation of the individual questions 55
6.2 Detailed evaluation and downgrading rules 57
6.3 Overall level of compliance and downgrading rules 59
6.4 Evaluation of product groups 61
6.5 Using the questionnaire (Process elements P2 to P7) 63
7 Questionnaire 65
7.1 Overview questionnaire 65
7.2 Project management (P2) 71
7 .3 Planning the product and process development (P3) 75
7.4 Implementation of the product and process development (P4) 80
7.5 Supplier management (P5) 86
7.6 Process analysis production (P6) 92
7. 7 Customer care/customer satisfaction/service (P7) 11 5
8
10 Best practice/lesson learned 178
10.1 Example of a supplier self-assessment 178
10.2 Knowledge database 182
12 Downloads 197
9
10
1 Introduction
The well established Audit Standard VOA 6.3 from 2010 has been completely
revised. With the 2016 edition our collective experience has been utilised to
update and optimise the volume.
The interaction of the process audit standard VOA 6.3 with other VOA publi-
cations, especially ,,Maturity Level Assurance for New Parts (MLA)" und ,,Ro-
bust Production Processes (RPP)", has been strengthened. In this volume the
requirements are given for process specific content. Thus the distinction be-
tween process and system audits is made clearer.
Furthermore the questionnaire has been revised both in content and struc-
ture. The interface between hardware and software in products with embed-
ded software has been included. However, for a detailed evaluation of soft-
ware development other methods are to be used (Automotive SPICE, CMM I).
The content of the process audit for services has also been revised.
The ca lculation of results has been adjusted. All questions are now weighed
equally. The generic approach has been deleted. The classification system
using A, B and C and the reliable downgrading rules have been retained.
Due to the revision, the current edition does not allow audit results from the
previous VOA 6.3 from 2010 to be directly transferred into calculations from
the edition presented here.
Within this volume, the requirements for the qualification of process auditors
are given in more detail. Different requirements for internal and external pro-
cess auditors are given. The qualification of auditors regarding this audit
standard is set out. Focus is also given to the actual implementation of the
audit.
Assessment questions in the areas of sustainable development, compliance
with social standards, environmental protection and conservation of re-
sources are not contained in the questionnaire. For these areas there are
special monitoring methods as well as legal and normative directives. How-
ever, if the auditor observes obvious points that are contrary to the require-
ments of this process audit standard and/or have a negative impact on the
product characteristics, these should be documented and included in the
evaluation.
11
The other volumes of the VOA series and the AIAG manuals are given as a
reference in a matrix that relates to the questionnaire.
Current information and the latest status of the VOA publications can be
found on the VOA QMC website.
12
2 Instructions for use
After SOP the process audit can be used for i.a. the regular monitoring of the
serial production and event orientated fai lure analysis and elimination.
The use of the individual process elements in the project phase can vary in
content and implementation period between internal and/or external applica-
tions.
13
Fig. 2.1 shows possible use of the individual process elements within the con-
text of a specific project.
' IJ1.P., .
14
The process element P4 can be scheduled at a later time to analyse and
evaluate (X3) the implementation of the planning activities in accordance with
process element P3.
I The breakdown of the process elements offers the possibility to assess the
!
I planning activities as well as the implementation/realisation. The application
of the process elements P2 to P4 is utilised for early identification of maturity
I
level and process risks from the contracting stage to SOP and thus supports
1
I the process optimisation from the project phase onwards.
i
'
The process elements P5 to P7 (X4 ) are ideally applied at SOP analo-
gous/according to maturity level ML 6 from VDA-MLA.
As part of the serial production process elements P5 to P7 (X5 ) can be used
for the regular monitoring of the serial process or to support an event-based
reactive process analysis.
In principle, each user/organisation has the right to align the use of the pro-
cess elements to meet their needs during the product development and pro-
duction.
15
2.3 Classification process audit - Potential analysis
As can be seen from figure 2.2, an analysis of potential (P1) can be carried
out before a contract is awarded. The questionnaire, with a reduced scope,
can be used to assess potential suppliers who may be suitable as serial pro-
duction suppliers. Because these are potential suppliers the audit, when nec-
essary must be based on other processes/products which should be compa-
rable with the product to be supplied.
Aw•rd of SOP
Contract
• •
Offor Pre selection
•
Product Customer
Processing ol Suppliers: Senal
Proc:e s Serv,ce
(Contract Potent,al Production
Development (Aft"' Sales)
Rev,ew) Analysis
16
2.4 Identification of process risks (risk analysis)
In a process audit, the effect of the individual processes on the product is
decisive and the assessment must therefore be made from the standpoint of
the product risks involved. For this reason, the potential risks within the
process must be determined as early as the preparations for the audit (see
also section 4.3), so that they may be assessed adequately in the process
audit itself.
An example of the turtle model using process element P6 is shown below, but
the model can be used for all process elements.
• How does the process work (work content, workflow, methods, pro-
cess, instructions - see questionnaire sub-element P6.2)?
17
• What means are employed to carry out the process (material re-
sources such as machines, tools, test equipment, facilities, other
equipment- see questionnaire sub-element P6.4)?
18
3 Requirements for process auditors
Specialised knowledge
Professional experience
19
3.1.2 Supplier auditor
Specialised knowledge
Professional experience
Specialised knowledge
20
• Auditor qualifications (negotiation, conflict management, audit proce-
dure)
Professional experience
21
3.2 Code of conduct for auditors
• Process auditors must at all times behave in a way that does not en-
danger the image and reputation of their own organisation.
• Process auditors must not accept assignments that they cannot carry
out properly because of lack of knowledge.
22
4 Audit process
This section describes the procedure for the implementation of internal and
external audits.
Audit programme
Follow up
and closure
I
1·: ' "
Audit programme
. .
. ... Evaluatron . .:.·
Objective
Audits are planned in accordance with their priority and the organisations internal require-
ments. Qualified auditors are used to achieve the objective.
23
Responsibility
The person responsible for the audit programme draws up an audit schedule
for a defined period.
Description
The need for audits is determined and prioritised by the person responsible for the audit
programme. From this, this person works with the audit customer (and, where appropri-
ate, the organisation to be audited) to set out the following details regarding the audit:
• Main focus of the audit
• When the audit is to be scheduled (e.g. calendar week, month, quarter)
• Aud it scope
• Details of the auditors, in particular the technical experts
In addition to technical qualifications and the necessary neutrality, the choice of auditors
should also take language skills and and inter-cultural aspects into account.
A technical expert could be needed to assess process-specific questions beyond the com-
petence of the process auditor. This technical expert need not necessarily be a VOA pro-
cess auditor. In conclusion, the audit programme is approved by the respective manage-
ment.
Method/documentation
Audit programme
• Event-driven audit
Rolling adjustments
• Current audit pro-
need to the audit programme gramme
as new requirements • Updated resource
emerge
planning
Objective
As a result of continuous adjustment the audit programme is kept current (e.g. addition of
event-driven audits).
24
Responsibility
The person responsible for the audit programme continually adjusts the audit schedule
and plans resources accordingly.
Description
Method/documentation
25
4.2 Audit request
Audit programme
• :. • # •
.. Evaluation
.......
Objective
The requirements of the audit customer are set out in a precisely detailed audit request.
Examples of requirements:
• Determine/assess/approve the current status
• Analyse/estimate risks
• Qualify/encourage/improve
• Check the effectiveness of actions from a previous audit
• Escalation
The audit request is coordinated between all parties involved in the audit.
Responsibility
Person responsible for the audit programme with the support of the customer.
I
:_• thod/doc umentat;on
26
Input Process step Output
Objective
Draw up an audit request with all the information required for a structured implementation
of the audit
Responsibi lity
The audit customer, with support from the person responsible for the audit programme
27
Description
The following factors are for example to be taken into account in an audit request:
• Reason for the audit e.g. new supplier, complaints, evaluation of status
• Audit objective Assessment, process release, status check, etc.
• Audit type Internal/external audit, potential analysis, special audit
• Audit location internal, external
• Audit team (provisional) Auditor, technical experts
• Audit scope Processes, products, manufacturing locations, inter-
faces, outsourced processes
• Customer Person responsible for the audit programme,
management, person responsible for the product
• Audit date Desired date, audit period, shifts
• Date of the contract
• Comments Background information
• Essential documents Test specifications, contracts, important agreements,
(cost stipulations etc.)
• History Complaints, rejects, delivery performance,
project status
Method/documentation
28
4.3 Audit preparation
Audit programme
-4.. , • • ,· ,. '!
'·,
Prc!H~IUl!.llll
Audit 111qUC!it
or msults
l , ',~~I
·~ ' ·~
Objective
Responsibility
The lead auditor specifies the final audit team and organises the audit with the team.
Description
The audit team is appointed on the basis of the audit request, any other relevant infor-
mation and by the schedule in the audit programme.
In addition to the personal suitability of the auditors and any technical experts (see section
3.2: "Code of conduct for auditors") the qualifications for the auditor must be taken into
account, especially technical knowledge. A technical expert should be provided to assess
process-specific questions beyond the competence of the process auditor. This technical
expert need not necessarily be a VOA process auditor.
29
Method/Documentation
Objective
The audit team obtains all the information required to limit the scope and plan the audit.
Responsibility
Audit team with the support of the customer and the organisation to be audited.
Description
The information collected for the audit must be able to describe the process as well as
the interplay and interfaces between processes. The following documents can be taken
into account:
Organisational charts, process flow chart, control plans (internal audit), FMEAs (internal
audit), standards, specifications, customer specific requirements, target requirements (e.g.
PPM), process descriptions, quality control charts, audit results, action plan from last audit,
results of supplier quality assessments (quality performance), complaints, layouts, project
plans etc.
Method/Documentation:
30
Input Process step Output
Objective
The process is li mited and broken down into process steps which can be aud ited. The fo-
cus points for the audit are determined.
I
Responsibility
Audit team
31
Description
The first stage in narrowing down the process is to identify the starting and finishing
points of process. The second step is to break down the process into separate
operations in such a way that they can be assessed as separate entities. It is essential to
specify the responsibilities involved to ensure that the findings at each process/process
step are properly addressed.
The breakdown of the process can be based on existing documentation (e.g., process
flow chart) or it must be carried out by the audit team.
The process risk estimation for the isolated process must be based on the information
which is gathered.
The auditor sets main focus points for the audit in the areas where he/she expects the
greatest potential risk for product and process. One method of detecting potential risks is
the "turtle" model (see figure 2.3).
The following investigations can be carried out, depending on the audit request and the
potential risks which have been identified:
32
--- --------' I I I I
'- - - - - - - - - _,
ln terf Int rfa ce
Before the audit (and particularly in the case of extern al audits) it is essen-
tial that the auditors have access to all relevant information. The participa-
tion of other personnel must be agreed upon. Any restrictions should be
clarified in advance.
• Audit request
Draw up check lists • Audit plan
• Process limits and audit plan and • Checklists
coordinate these
• Process steps
with the organisation
• Audit focus
Objective
The specific checklists are set based on the coordinated audit request.
I
Responsibility
Audit tea m
33
Description
From the information obtained and the organisation's own knowledge database (see
section 10.2), the audit team extends and completes the minimum requirements
covering assessments set out in the VOA 6.3 audit questionnaire.
If any item cannot logically be assigned to an existing question, further questions can be
added. However, this means that the results will no longer necessarily be comparable. In
such cases the assessment matrix will need to be adapted.
In agreement with the audited organisation, the audit team sets out the audit plan, which
will contain the following as a minimum:
• Participants
• Names of the auditors
• Audited organisation/functional unit
• Duration of the audit 7 the time required for documenting each audit step must be
taken into account (for example, 10 minutes for documentation for every hour of the
audit)
• Audit locations
• Process steps/product groups
Breaks in production (lunch-breaks, etc.) must be taken into account when drawing up
the audit plan, as well as the use of foreign languages, inter-cultural aspects, changes in
shifts and transfer times. In agreement with the auditor and the audited organisation on
site changes are possible .
. The planning of the audit duration and capacity depends on the process element to be au-
dited, the structure of the organisation, the location, the complexity of the products and
process, the risk and the process chain with the associated process step.
A partial audit with limited scope may be considered. In this case, it can be used to distin-
guish the identification of the audit results (as described in the example in section 6.3).
A special audit may be used in particular for weak point analysis, complaints, project flow
problems, repeated defects etc.
The use of this flexible and efficient method ensures the results reflect the assessed pro-
cess elements.
Method/documentation:
34
4.4 Conducting the audit
Audit programme
Initiate immediate
Opening discussion to Carry out audit
action if the audit
communicate the audit according to audit
detects crucial
objectives and schedule plan, using checklists
problems
Objective
Important points of the audit process are set in the opening discussion.
Responsibility
Lead auditor
35
Description
The opening discussion takes place with the management of the organisation to be
audited. The objectives of the audit are presented, together with the extent of the audit
and the audit criteria. The audit plan is confirmed and the audit leader explains briefly the
planned audit activities.
The time schedule is checked, any necessary corrections are made and the time for the
closing discussion is determined.
The units/processes to be audited can be presented by those responsible. The auditors
introduce themselves and explain their roles in the audit. The contact personnel between
the audit team and the organisation to be audited are specified.
The process of reporting and the assessment procedure is presented. Reference is
made to the confidentiality of the information and results obtained. The organisation to
be audited confirms the availability of the necessary facilities (rooms, printer, etc.) for the
audit team. In the event that personal protective equipment is necessary, this is clarified
in advance.
I: _•lhod/documentaUon
Objective
The quality standard is documented and verified taking account of the audit plan and the
situation on site
I Responsibility
Audit team
36
Description
The auditor analyses whether the audited division implements the general specifications of
the organisation, the requirements of standards, the customer requirements and legal and
regulatory obligations. The analysis is carried out by asking questions and making spot
checks based on the chronological sequence of activities within the process, using the ques-
tionnaire and any checklists which have been specifically drawn up. The auditor is required
to ask open questions (see "Audit pyramid" in section 6.5).
Based on concrete cases and evidence the auditor must investigate the suitability and
effectiveness of the processes. Technical facilities (equipment, tools, test equipment,
parts storage etc.) are checked through direct inspection and evaluated if they are
suitable and in good condition. As a general rule, the discussion moves from general
questions to concrete, detailed questioning.
The auditor carries out spot checks on the implementation of instructions and
requirements relating to the products and processes, by examining appropriate
documents and records. Findings relevant for the results are noted.
Employees on-site must be brought into the audit by questioning and their responses
verified by inspection of the QM documentation.
Any audit deviations must be communicated directly on the spot with the relevant
personnel.
The audit team should meet periodically, exchange information, assess the progress of
the audit and (if necessary) reallocate the distribution of tasks within the team.
Information regarding the progress and status of the audit can be given periodically to
the audited organisation or those responsible.
The audit plan must be verified regularly by the audit team regarding the time schedule
and modified if necessary in agreement with the audited organisation.
Audit termination
An audit can be terminated at the discretion of the audit team, for example on the
following grounds:
• Refusal to provide necessary information during the audit
• Clear infringements of the law
• Active hinderance to the auditor
• Refusal to allow access to areas relevant to the audit, despite previous agreement
• Deficient preparations for the audit by the organisation
• Presentation of obviously false information
The termination of an audit must be justified by stating the reasons. Audit findings up to
the point when the audit is broken off must be documented.
The audited organisation decides about the implementation of a new audit.
37
Method/documentation
-- -
Input Process step Output
Objectives
To prevent the further spread of serious failures (customer complaints, vehicle break-
downs, loss of function, safety-critical components, critical characteristics, etc.).
Responsibility
The lead auditor is responsible for demanding immediate measures in the occurrence of
serious failures.
Description
Facts which identify a serious risk must be pointed out to the organisation without delay,
so that appropriate, immediate action can be taken.
If serious failures occur that pose a risk for the product and process quality, the audited
organisation must define immediate actions to be used as a safeguard.
Method/documentation
38
4.5 Evaluation
Audit programme
Preparation •• Presentation
of ro11ults
..
Evaluation in
Deci sion about
accordance with the
follow up audit
evaluation scheme
• Findings • Findings
• Aud it evidence Evaluation in • Quantitative assess-
• Evaluation scheme accordance with the
evaluation scheme
ment
• Individual questions
from the checklists
Objective
The quantitative assessment reflects the quality capabi lity status of the process under
consideration. The comparab ility of the audit results is ensured and changes in regard to
previous audits are noted in the sense of a continuous improvement process.
Responsibi lity
39
Description
Based on the findings of the audit the audit team evaluates the individual questions as
described in the assessment procedure in section 6.1. The basis for the evaluation is
whether or not the relevant requirements are achieved and the risks involved.
If a question is not evaluated (n. e.) a reason for this must be stated.
The assessments of the individual questions lead to the overall audit assessment. To
distinguish the scope of the audit the identification given in section 6.3 can be utilised.
This allows the audit results to be compared.
Method/documentation
Objective
The decision about a follow up audit is taken on the basis of the findings.
Responsibility
Lead auditor
40
Description
Under what circumstances a repeat audit is necessary must be specified. Rules for a
repeat audit can be:
• Not reaching a defined level of compliance
• Risks associated with a critical process
• Not achieving required results (zero points) for one or more questions marked(*)
• Red traffic light at potential analysis
1 This repeat audit must be carried out within a specified timeframe. With in this timeframe
the audited organisation must introduce actions to eliminate the deviations effectively.
I In the case of a repeat audit, th is must be carried out to the same extent as the previous
audit. A reduction of the audit scope to just a review of the effectiveness of introduced
measures is not allowed.
I
I
Method/documentaUon
Audit report
41
4.6 Presentation of results
Audit programme
Objective
The audit report is an accurate, concise and clear record of the audit.
Responsibility
42
Description
The audit report is drawn up jointly within the auditor team. It consists of:
• Cover sheet
• Audit findings with regard to the documents which have been inspected
• Explanations regarding the assessment scheme
• Process descriptions, if appropriate
The cover sheet contains the following information:
• Audit procedure
• Fundamental internal and external requirements
• Details of the organisation and processes which have been audited, including
products and customer requirements which have been evaluated
• Audit result
• Summary of the findings
• Must be included: main deviation areas and need for action
• Can be included: positive findings and potential for improvement
• Time schedule for the action plan
Method/documentation
43
Objective
In the final discussion the audited organisation and its representatives are presented with
a report. This report focuses on:
• Notification of the audit results and the audit findings, when necessary with explana-
tions.
• Specifying the next steps, such as dates for defining the corrective actions (action
plan), or arranging a repeat audit if necessary.
The audit report must not contain other findings to what were given at the final discussion.
Responsibility
Description
Method/documentation
44
Input Process step Output
Objective
By signing the audit report by the lead auditor and the responsible persons of the audited
organisation, the audit report is recognized , approved and confirmed .
IResponsibility
Lead auditor
I :~scriplion
Method/documentation
45
4. 7 Follow up and closure
Audit programme
Objective
To a reasonable degree, causes, actions, responsibilities and completion dates are allo-
cated to the findings.
Responsibility
Description
The action plan must be drawn up within a time fra me coo rdinated with the audit team. It
contains all the activities involved, stating responsibilities and completion dates and is
designed to permanently eliminate the deficiencies in the process.
Method/documentation
46
Input Process step Output
Objective
I Responsibility
Audit team
Description
The audit team checks the action plan for plausibility and decides if the actions are
appropriate for eliminating the deficiencies (a check on documents). Here the focus
should be on the permanence of the actions taken, so that repeat failures are prevented.
Even when the action plan is considered plausible by the auditor, the audited
organisation remains responsible for the efficiency of the actions taken.
If there is any lack of clarity or disagreement, the auditor will call for improvements to the
plan. If no response is received the auditor can launch an appropriate escalation
procedure.
Note
in particular in the case of supplier audits the usual escalation procedures should be ap-
plied if action plans are not provided, or are withheld or are not plausible. However,
these escalation procedures should have been agreed upon with the supplier as part of
the contract before the audit takes place.
I Method/documentat;on
Action plan
47
Input Process step Output I
I
Objective
Closure of the control loop covering the implementation of actions with an effectiveness
check
Responsibility
Description
The audited organisation is responsible for implementing the corrective actions and the
person responsible for the process must monitor the implementation . Checking the
effectiveness of the actions agreed upon is carried out primarily by the person
responsible for the process.
Confirmation of the effectiveness of the actions which have been taken is documented in
a dated note in the action plan by the person responsible for the process.
This person also informs the auditor, and when necessary, the monitoring organisation
of the effectiveness of the corrective action.
Possible follow on actions if the effectiveness of the actions is not confirmed are:
• Escalation procedure
• Definition of further actions
• Problem analysis
48
Method/documentation
• Sampling
• Product audit
• Process audit
• Capability studies on machinery and process
• Intermediate status/extent of completion
• Examination of the relevant metrics before and after implementing the actions (ppm
statistics; compliance level of the objective; reject patterns)
49
50
5 Potential analysis (P1)
5.2 Requirements
Because no contractual relationship exists between the customer and the ap-
plicant (possible supplier) during the enquiry and quotation stages, there
should be an agreement made regarding confidentiality and access permission.
5.3 Preparation
51
5.4 Operational sequence of a potential analysis
The following diagram (figure 5. 1) shows the operational sequence of a po-
tential analysis. The evalu ation questions in the P1 analysis are selected from
the process elements P2 to P?. An overview of the questions is given in sec-
tion 7. 1.
If suppliers are in-house, a process analysis can be carried out using a sim ilar
product and/or component produced for another manufacturer/customer. The
analysis is performed by using the VOA 6.3 potential analysis evaluation
questionnaire and if necessary, with the use of further specialised inform ation
A separate evaluation is required for the potential analysis because the
objective here is less to arrive at a classification in percentage terms and
more to decide on "su itable" or "not suitable".
Award of contract
*
Unknown Feedback to Create questions The audit team Process evaluation Prognosis Clarify the provision of
supplier supplier ( request using the should be made based on a similar Recommendation internal resources
any necessary knowledge data· up of experts in process or product (customer)
Unknown
additional base (for product the following (another customer) Veto
facility e.g. taking part in a
information) and process areas:
Report supplier development
Unknown requirements) or • quality programme
technology for development Presentation of
• development
of requirement results
• procurement Clarify the provision of
specifications
external resources
• logistics
(Supplier)
If necessary addition of
necessary resources in the
nomination documents
(e.g. construction of
necessary infrastructure)
End of auditor
_ _r_esponsibility · - -'
52
If a question is not evaluated (shown as n. e.), a reason for this must be stat-
ed. A maximum of 3 questions may be marked n. e. It should be noted that
the comparability of results and the mutual acceptance of audit results from
other parties may no longer apply.
The assessment is marked, using the traffic light system of "red", "yellow" or
"green" (see below).
Interpretation of results
I I=
Green Fully approved potential supplier (applicant)
The supplier has the potential to meet the customer's requirements to the
extent required and may be considered for awarding a contract.
A contract award (nomination) for the project, component or product group by
the customer is possible without restriction .
53
Yellow =Conditionally approved supplier
Only a conditional approval for a contract award can be given. In some cases
the supplier needs support from the customer to implement the requirements
of the project. Under certain conditions a limited approval for a contract may
be given (quantity reduction, smaller series, .. . )
An award (nomination) is possible, but is linked to defined conditions:
The conditions to minimize the risk may be:
54
5.6 Follow up activities after contract award
The results of the potential analysis are used as input when planning the se-
lection of methods or method applications (e.g. process audit for release of
location, VDA-MLA).
A validation of the quality capacity in terms of a release for serial production
can only be given though a PPA-process which corresponds to the analysed
customer scope. To achieve this, a process audit can be held at the same
time as a process release.
55
The following table serves as a guideline for the appropriate allocation o1
points for the evaluation of the questions:
56
If there are several findings for the assessment of a single question, the indi-
vidual assessment which is the highest risk is decisive for the assessment of
the respective question.
The auditor may require immediate actions depending on the risk of the find-
ings.
If a question is not evaluated (n. e.), the reason for this must be stated. At
least 2/ 3 of the questions for each evaluated process element, sub-element or
process step must be evaluated. To ensure comparability the entire list of
questions from the VDA 6.3 process element should be covered in full.
If non-conformities from previous audits are repeated, the lack of implementa-
tion of corrective actions can also be regarded as a deviation: e.g. "cause
analysis", "implementation of measures", "meeting customer requirements".
Evaluation of the process elements and the sub-elements from P6 and the
individual process steps.
Process element
The compliance E Pn of a process element (P2, P3, ... , P7) is calculated as:
Total points awarded for the relevant questions
EPn[o/o] =- - - - - - - - - - - - - - - - - - - -
Total possible points for the relevant questions
57
Exception : When more than one result is given for a question
In process elements P3, P4 (separate results for product and process devel-
opment) and P6 (results for each process step), several results for one ques-
tion may be given. In this case the arithmetic mean of all results for the ques-
tion must be calculated first. In calculations following this step, the average is
rounded to two decimal places.
These averages are used in place of "total points" when calculating the level
of compliance of a process element.
For each question only 10 points may be awarded for the total possible
points - regardless of the number of results per question.
Sub-elements of P6
In the process element P6 the following sub-elements are evaluated:
Eu1 Process input
Eu2 Process management
Eu3 Personnel resources
Eu4 Material resources
Eus Efficiency
Eu6 Process output
Eu? Transport, handling of parts
The calculation of the sub-elements is carried out in the same manner as the
process elements using the exception: more than one result is given for a
question .
58
Total p oints awarded for the P6 questions for this process step
Er. [%] =
Total p ossible p oints for the P6 questions for this process step
For the process elements P3 and P4 separate evaluations for product devel-
opment (Ep3 Product) or fo r process development (Ep3 Process) can be made.
For the calculation of the overall result of all process elements (e.g. P2 to P?)
the mea n values of the respective questions in section P3 and/or P4 are used.
The downgrading ru les are applied to the entire process element P3 and/or
P4 Uoint assessment of produ ct and process development).
If during the audit individual process elements from the questionnaire are
used, the result is calculated based only on the evaluated process elements.
Which process elements have been used in the evaluation must be made
clear in the audit report.
59
Example P5/P6/P7
If the process elements P5, P6, P7 are evaluated (e.g. auditing of serial pro-
duction) then the result is ca lculated as follows:
Total points awarded for all evaluated questions from
P5, P6 and P7 (Eps ,EP6 and Ep7)
EG(P5P6P7) [%] =
Total possible points from these questions
Example P4
If only process element P4 is evaluated (e.g. audit at the time of handing over
the project to seria l production) then the result is calculated as follows:
Total points awarded for all evaluated questions from P4 (Ep4)
EG(P4) [%] =
Total possible points from these questions
The designation EG(P5P6P7) and EG(P4) are used to easily identify the process ele-
ments evaluated.
60
Rules for downgrading
The following rules for downgrading are to be used and documented in the
audit report:
• At least one process element (P2 to P7) or process step (E1 to En) is
evaluated with a level of compliance Ep or En < 80%.
• A level of compliance Eu1 to Eu? in one of the sub-elements of P6
is< 80%.
• At least one *-Question is rated with 4 points.
• At least one question from the process audit is rated with O points.
• At least one process element (P2 to P7) or process step (E 1 bis En) is
evaluated with a level of compliance Ep or En < 70%.
• At least one *-Question is rated with O points.
Similarly, when applying the downgrading rules (process element, sub-
element or process step), the individually ca lculated results EPn, Eun and En
are rounded to the nearest percentage point.
61
Product group Possible process steps I
Note: To evaluate process steps, additional process requirements are generated from
the organisation internal knowledge database (see section 10.2).
In the evaluation matrix (see section 9.1: Assessment forms: Process audit
for material products) the relevant process steps are allocated to the product
group being evaluated.
The overall level of compliance for each product group EG(PGn) is calculated as
follows:
++Explanations of "points obtained" and "possible points" see section 6.2: Exception.
When evaluating product groups, the downgrading rules are applied specifi-
cally to the product group concerned.
62
6.5 Using the questionnaire
(Process elements P2 to P7}
The questionnaire is one of the main tools for the auditor. Depending on the
phase of the product life-cycle (see section 2.1) the auditor selects the rele-
vant process elements for the audit. Additional specific requirements can be
added to the questions depending on the product/process risks identified.
The questions can be used for processes, both for material products and for
consumable materials.
• Questions
63
$
...$)
§'
-:::5
""?:
& Assessment questions
~~ Closed question Assessed by
' answered? the Auditor
Yes I No
Audit questions
On site
Open questions
64
7 Questionnaire
Potential Transport/
Analysis** Handling
of Parts
P2 Project management
2.3 Is there a project plan and has this been agreed with
X
the customer?
3.3 Are the activities for the product and process develop-
ment planned in detail?
65
Potential Transport/
Analysis** Handling
of Parts
' ' '
P4 Implementation of the product and process
development
4.1* Are the actions from the product and process develop-
X
ment plans implemented?
4.4* Are the required approvals and releases for the product
X
and process development available?
67
Pot ential Trans po rt/
Ana lys is** Handling
of Parts
6.4.1* Can the prod uct-specific req uireme nts from the cus-
X
tomer be met with the manufacturing equipment?
6.4.4 Are the work and inspection stations appropriate for the
X
needs?
68
Potential Transport/
An alysis** Handling
of Parts
69
Potential Transport/
Analysis** Handling
of Parts
70
7.2 Project management (P2)
The project organisation meets the customer re- • Composition of the project
quirements. team
71
P2.2 Are all resources required for the project implementation planned and
available and are changes shown? .
P2.3
'
ls·there a project plan and has this
.
been agreed with the customor?
"
'
The project plan meets the specific customer re- • Project plan with milestones
quirements.
• Specific customer require-
All internal and customer defined milestones are fully ments regarding technologies
incorporated in the project plan. and/or product groups
A review is carried out at the milestones defined in • Customer's project plan
the project plan to check that all planned activities
• Customer's deadlines
are carried out and that the level of maturity required
is achieved. • Customer's milestones
If a statutory authorisation procedure for a product is • Customer's targets (meas-
specifically required, the duration of this procedure is urements within the individual
included in the project plan. milestones)
In-house communication is ensured when changes • Milestone assessments (re-
are made to the project plan. Changes made to the views)
project plan which affect the customer are coordinat-
• QM plan (e.g. from VOA MLA
ed with the customer.
or APQP)
The critical path is generated from the project plan
• Country specific certification
and takes account of critical delivery items.
requirements (ECE, SAE,
Detailed quality-related project activities must be part DOT, CCC, ...)
of the project plan. This may be in a separate docu-
ment (QM Plan) that is referred to from the project • Legal and regulatory approv-
plan. The plans must take prototypes and pre-launch als process of critical systems
parts into account. (electroplating, paint, ... )
72
P2.4 Is the advanced product quality planning implemented within the project ,
and monitored for compliance?
P2.5* Are the procurement activities of the project implemented and monitored
for compliance?
The activities have to ensure that only approved and • Make or buy decisions
quality-capable suppliers are used in production.
• Supplier selection criteria
The level of activity depends on the risk classification
• Supplier development plan
of procured scope of supplies.
• List of suppliers for the pro-
These include the supplier selection and award crite-
ject
ria, award amount and delivery target date.
The transfer of customer requirements in the supply • List of approved suppliers
chain is ensured . • Risk appraisal of each sup-
The activities also include customer required suppli- plier
ers (directed suppliers) as stated within the agree- • Quality agreement for di-
ment rected suppliers
The suppliers for facilities, machinery, tools, test and • Component classification
measurement systems as well as services are inte-
grated. • Suppliers for services such
as development, laboratories
The appointment of suppliers must be traceable and maintenance etc.
through appropriate documentation.
Dates for the assignment, supplier milestones and
release have been laid down in the plan and coord i-
nated with the overall schedule and the progress is
monitored.
73
P2.6* Is change management within the project ensured by the project
organisation?
The escalation process in the project meets the spe- • Time periods for escalation
cific customer requirements. depending on the risk have
An escalation model (risk management) must be been agreed upon
available for deviations in the project affecting the • Contact personnel/decision
overall schedule. Project risks are identified, as- makers in the escalation pro-
sessed and reduced through appropriate measures. cess are defined
The criteria for escalation are defined, responsibilities • Escalation criteria and paths
and authorities are regulated and measures derived of communication are defined
when deviations occur.
• Protocols of milestone reviews
If risks have been identified in technologies, suppliers including measures
or supplied countries, these risks have to be consid-
ered within the escalation management.
74
7.3 Planning the product and process
development (P3)
' ' , I •
Process Element P3: Planning the product and process development :
~ ·~ ~~e·:.m
Minimum requirements relevant for assessment Examples for implementation
The organisation must take into account and use re- • QM specific requirements
quirements on the product and the process known • Quality agreements
from previous experience.
• Requirements for documenta-
Special characteristics must be identified on the ba-
tion
sis of their own requirements, customer require-
ments, legal requirements, manufacturing technology • Logistics requirements (JIT,
and characteristics that arise from the purpose/use of JIS, on consignment)
the product. • Schedules, technical delivery
The quality requirements from the customer for the conditions
product and the process must be available. • Access to portals/information
Inquiry and contract documents are checked for platform in the internet
completeness. • Definition of responsibilities
If customer requirements cannot be fulfilled the cus- for suppliers (e.g. qualifica-
tomer must be notified or deviations "allowed"/ap- tion, sample submissions,
proved by the customer (if the contract has been approval, testing ... ).
awarded).
• Test regulations
Customer requirements regarding the selection of
• Catalogue of characteris-
suppliers or purchased materials must be document-
tics/boundary samples for
ed.
decorative surfaces
Quality agreements with directed suppliers are avail-
• Experience with previous pro-
able.
jects
75
Process Element P3 : Planning the product and process development
• ProducUprocess characteris-
tics
• Order documents with item
lists and schedules
• Legislation/regulations
• Environmental aspects, recy-
cling requirements
• Proof of capabi lity
Product development
• Specifications, technical
drawings, special characteris-
tics
Process development
• Suitability of facilities, tools
and test and inspection
equipment
• Layout of work and test facili-
ties
• Handling, packaging, storage
and identification
76
P3.2* Is the feasibility comprehensively evaluated according to the product and
process requirements?
' '
P3.3 Are the activities for the product and process development planned in
detail?
78
'f1"""'1t'!•" ~~ "~,ll'l'J 'i"'" I>., .., j . I> • • •a..> , .!,\11"',_.,.+.~ '' ,..,p-r• "'U •', '[If r- 1' "'"<' 1 ,,Ii 1 •" '
. · ·,Ar_
e,tthe activ,!~i~~ ~1a~~,ed,.~or c~s~~mcr c~~ci~u'"sto~it, :.· . 1 • ·:.. ••• •• _j
satisfaction/customer service an~,Jield failure .analysis?,, ·J· ~ , , ~~-.;:,- .. ·, :· .;1ij
idiJDt.tJll.t~IU.iJ ~• ',f,W,!~lil',f1.'ii-.t\"::r.1 !:J..~,i11;,,.fi~~J;; .··~,, .. ..,',~'fa,,<»,, :.r.,.:,I
The customer requirements for the supply of parts Product/process development
across the product life cycle are taken into account in
• Training plan
the planning.
• Qualification matrix
Concepts to continually ensure series supply includ-
ing a contingency plan are provided in the planning • Investment planning
phase. Process development
A fallback concept is provided for product and pro- • Inspection planning for
cess innovation. standard and stress testing
The analysis process for 0-km and field complaints is
• Triggering criteria are defined
planned for delivery. The customer requirements are
taken into account for field failure analysis. • NTF process
When introducing new technologies and products, • Concept for the supply of
employee training and the creation of the necessary spare parts
infrastructure are provided also in customer service. • Contingency plans
79
7.4 Implementation of the product and process development
(P4)
'
Process Element P4: Implementation of the product and process development
P4.1 * Are the actions from the product and process development plans
implemented?
80
I
P4.2 Are personnel resources available and are they qualified to ensure the start
of serial production? ,
I
I
P4.3 Are the material resources available and suitable to ensure the start of I
serial production?
I
I
81
Outsourced processes must be considered. • Capacity before series start
The resources must be available with a suitable lead (initial stock)
time before the start of customer's serial production. • Supporting processes for ex-
ample from logistics und IT
P4.4* Are the required approvals and releases for the product and process
development available?
82
I p4.4• - Are the required approvals and releases for the product and process
development available?
• Capacity studies
• Tool approvals
i, ·~·"·.7. ·11t\, r: ~- · ..i+.t!t!• ,_ ·- :-..,u1t1c•f,1<111~., '!lb\ ..-.·N, -~l!! 11.·,· l")',,.1uw. , ,........ ~,:~-"}
, ., ·.'), ,•,~.:i''·lllll'f'.
:.;P_4.5 .· Are Jht?,:r,~~u.!a_ c~uring ~')~,if~P,~~ti~n.SJ?.e.clf!~~t,!?ns d,erive~ :!r.orri ttif. .: -;-.1:·
11·, "' product and ·process development and ·are.theyiimplemonted?.. · ·• .~ · ·. ~. ·'.
~ •,.•.,,.,.. ......_,._1,+.,o;•"'° -, ,..._. :r.,.~·.c :r.lil*,~"~'7'!' ,'.'ri'~:-.wi''~f-:--V . ~-t~at·'·:!1.~·litl....,.#1:
The manufacturing and inspection specifications con- Product development
tain all characteristics from the product and process
• Risk analysis (FMEA, FTA
development (including special characteristics).
etc.)
These must take into account all the components,
assemblies, subassemblies, parts, software and ma- • Control plan (prototypes pre-
terials including the processes for manufacturing of launch)
the products. Process development
Results of the risk analysis are considered. • Risk analysis
The specifications include information for product (FMEA, FTA etc.)
control, manufacturing process control, methods and • Control plan (pre-series, se-
reaction plans and corrective actions. ries)
Product audits, layout inspection and functional test-
• Product audit plan
ing are defined.
• Inspection instruction
The specifications must be available for all phases:
prototype phase (if required by the customer), pre- • Reaction plan
launch and series phase. • Layout inspection and fu nc-
tional testing planning
• Series release (first and last
piece)
• In-line inspections
· P4:6 . ' Is a p~rf~·rmance test ca~ried .~ut u~d~r seri~s co~ditions for tho se~i~~ .. · 11
• . release? . · · , +. · 1,
>1
,~',. ' . ., . . ' . ,·, .~,.11 .... .,,~
83
P4.6 Is a performance test carried out under series conditions for the series
release?
• Work/inspection instructions
• Packaging requirements
• Process validation
The customer requirements for the supply of parts during Process Development
the product lifecycle are established in the processes.
• Evidence of training
The planned processes for the continuous series supply
• Qualification matrix
including safety margins for emergencies are available.
• Existence of infrastructure and
The analysis process for 0-km and field complaints is es-
test equipment
tablished for the scope of delivery. The customer re-
quirements for field failure analysis are taken into ac- • Service agreements with exter-
count. nal analysis sites
The requirements for the analysis capability at the site • Equipment for standard and
have been agreed with the customer. stress tests
If external sites are used for analysis, the interfaces are • Triggering criteria are defined
defined and evidence of the presence of the required
• NTF process
equipment and capacity is available.
New technologies and products are also taken into ac- • Concept to ensure supply of
count in customer support. spare parts
The employees designated for these processes are quali- • Contingency plans
fied. The infrastructure is available.
84
P4.8* Is there a controlled method for the product handover from development
to serial production?
A process exists for transferring work results from the Product/process development
project to the production.
• Customer requirements
For products with embedded software, the results of
the development (including the intermediate results
• Handover protocols/
checklists with handover cri-
and their documentation) are documented.
teria
Prerequisite for project delivery is a successful inter-
nal PPA process. Prerequisite for a series delivery • Acceptance reports
85
7.5 Supplier management (PS)
In serial production it must be ensured that only ap- • Defined and documented cri-
proved suppliers are used. An evaluation of suppliers teria are used for supplier se-
using defined criteria for the qualification capability lection
must be available.
• Evidence of a qualification
An analysis of the quality performance of existing programme for suppliers who
suppliers has to be considered. did not meet the selection cri-
Risks in the supply chain have been identified, eval- teria
uated and reduced using suitable measures (contin- • Evaluation of the quality ca-
gency strategy). pability (QM-System, Pro-
cess) for example self-
assessment, audit resu lts,
supplier certificates
• Results of the potential anal-
ysis
Can also be used for:
86
The communication of customer requ irements must • Transmission of requ ire-
be regulated and traceable. ments, tolerances, time
Customer requirements also include requirements schedule, process releases,
from technical drawings, components, software or releases, complaints etc. with
component specifications, from QM agreements and ensuring change manage-
other valid standards. ment
Target agreements have been made with all suppli- • Measurable targets for quali-
ers throughout the supply chain for products and ty, delivery quantity (batch-
processes and have been agreed upon and imple- es), punctuality, for example
mented. to: reduce the ppm rates with-
Supplier output must be checked and evaluated with- in the 0-failure strategy
in defined periods. • QM agreements including es-
If deviations occur actions must be agreed upon and calation mechanisms
their implementation including deadlines is to be • Avoidance of extra tours
monitored.
• Reduction of rejects
• Reduction of the work in pro-
gress
87
P5.4* Are the necessary releases available for purchased products
and services?
• Qualification tests/reports
• Model releases
88
P5.5* Is the agreed upon quality of the purchased products and services
ensured?
89
Incoming materials and loading equipment must be • Packing
stored in accordance with their release status so that
• Inventory control
they cannot be damaged or mixed.
• Labelling (traceability/test sta-
For materials that could be damaged by temperature,
tus/work sequence/use sta-
humidity, vibration, etc. and affect the quality of the
tus)
final product, the transport and storage conditions
must be defined and evidence shown. • Quarantine stores; quarantine
areas
Terms of transport should be determined for critical
incoming materials. • FIFO
"Suspect"/quarantined products must be stored se- • Batch-related use
curely to prevent unauthorised access to them.
• Shelf life requirements
FIFO and batch traceability are to be ensured when
• Climatic conditions
the materials and goods are further processed.
• Protection against dam-
Material stock figures in the inventory control agree
age/contamination/corrosion
with the quantities actually in stock.
Storage conditions conform to the product require- • Order and cleanliness
ments. • Precautions to prevent mix-
ing/mistakes
• Remaining quantities from
production
90
A description must be given of what responsibili- • Product/specifications/customer
ties, tasks and authority the employees have in requirements
their relevant work areas (e.g. for incoming in-
• Knowledge about product fea-
spection, complaint processing, supplier man-
tures and production process for
agement, supplier audit).
the individual parts of modules
Qualification requirements must be determined
• Standards/legislation
for each employee in relation to their tasks and
qualifications carried out accordingly. • Packaging requirements
Knowledge of previous complaints is available • Assessment methods (e.g. au-
when appropriate for purchased products and dits, statistics)
services.
• Quality procedures (e.g. 80-
method, cause/effect diagram)
• Complaints and corrective action
• Job/function descriptions
• Qualification matrix
• Foreign languages
• Qualification of supplier auditors
91
7.6 Process analysis production (P6)
P6.1.1 Has the project been transferred from development to serial production and
is a reliable start guaranteed?
The project transfer to serial production has been • Project status reports
carried out. If necessary, unresolved issues are fol-
• Transfer reports
lowed up on and implemented on schedule. The re-
sponsibilities for the entire handover process are • Milestone reports
regulated and acknowledged. • Defined actions with imple-
A complete production process and product release mentation schedule
(PPA) including the documentation required must
• Process FMEA and actions
take place before the first production shipment.
• Product FMEA and actions
Measures are taken to secure the launch of produc-
tion. • Production release report
The updating and further development of the risk • Machine and process capa-
analysis (e.g. process FMENproduct FMEA) is en- bility examination
sured. • Measurement capability
Tools, test and measuring equipment are available in
• Capability of measurement
the necessary quantities.
process
• Production test/performance
test and evidence
• Transport planning process
• PPA documents including
customer release and refer-
ence sample
• Non-conformity permission
when necessary
• Released software standard
92
P6.1.2 Are the necessary quantities/production batch sizes of incoming materials
available at the agreed upon time and at the correct storage location/
work-station?
The correct product (incoming material, part, compo- • Sufficient and appropriate
nent etc.) must be provided to the agreed quality, in transport facilities
the correct quantity and the correct packing, with the
• Defined storage points
correct documentation, at the agreed time and at the
agreed place. Parts/components must be available at • KANSAN
defined storage areas/work-stations. • Just in time/just in sequence
At the workplace, parts and materials are provided as
• Inventory control
needed, taking into account the order quantity/lot
size (for example, KANBAN, Just in time, FIFO). Up- • Change status
stream processes are taken into account. • Exchange of information to
After order completion, the return of unneeded parts the return of unnecessary
(surplus) including their quantity is regulated. components/surplus
• Inventory
• Production levels tailored to
the customer's requirements
• Special requirements for
components and containers
(e.g. ESD-protection for elec-
tronic components, residue)
93
,, • ' • .. ' • ·- • • • "'!"• ~. ''<' • • - ~ • ' •• , ,
P6.1.3 Are incoming materials stored appropriately and are the moans of ..1
transp.o~packing facilities suitable for tho special characteristics of the · 1
in~o-~(~9 mato~i~.ls? , , · , .' ~lj
Packaging requirements must be consistently taken • Stock quantities
into accounUimplemented (also in the production
• Storage conditions
stages).
• Released special and stand-
During manufacture and internal transport and also
ard transport containers
when being transported to and from service compa-
nies, suitable transport units must be used to protect • Packaging requirements
the products from damage and contamination.
• In-house transport containers
Store areas/work-stations/containers must be appro-
• Protection against damage
priate for the tidiness and cleanliness required for
the parts/products. Clean ing cycles are defined and • Positioning of parts in the
monitored. workplace
94
Released incoming materials must be clearly identi- • Customer specifications
fied and recognizable. The release status must be
• Customer requirements for
identifiable and the release identification on bun-
labelling and tracing
dles/batches/load containers/parts must be defined.
• Legal requirements, product
It must be ensured that only released materials/parts
liability legislation
are forwarded to production/the next process stage
and used. • Identification of replacement
parts
The traceability of the units produced must be en-
sured within a reasonable framework (e.g., documen- • Process for the release of
tation, batch installation). parts/materials
Depending on the product risk, traceability must be • Identification of released
guaranteed across the entire process chain, from parts/materials (stickers, la-
sub-supplier to the customer. bels, issue slips, ... )
Customer identification and traceability requirements • Records of approvals
must be taken into account.
• Traceability system/concept
Legal and regulatory requirements are taken into ac-
• Documentation of conces-
count.
sions (number, duration, type
Test results of characteristics with special require- of identification, ... )
ments for documentation and arch iving are recorded
accordingly.
95
P6.1.5* Are changes to the product or process in the course of serial production
tracked and documented?
Change management, meaning from the change re- • Trigger matrix in accordance
quest to the implementation, must be clearly docu- with VOA Volume 2
mented. Responsibilities must be regulated. • Change release by the organ-
According to customer requirements changes to the isation and the customer (e.g.
product and process are to be agreed upon, ap- feasibility, interface to com-
proved and released by the customer (including ponents, effect on costs and
software changes). If necessary a new PPA must be schedules)
carried out. Documentation of change status must be
• Information about changes is
fully traceable.
passed onto process devel-
It must be ensured that, at all times, the correct de- opment, production areas,
sign level of the incoming materials or software is stores or to sub-suppliers
used and the correct design level of the fin ished
• The level of implementation
product is manufactured and shipped to the custom-
of the change is tracked
er.
(overview with status)
• Documented change record
(part life history)
• Update of documentation in-
volved (e.g. technical draw-
ings, instructions)
• Updates of the FMEA (Prod-
uct and Process)
• Verification and validation of
changes including documen-
tation
• Controlled introduction of
changes and modified prod-
ucts/parts
• Layout production before ma-
jor changes or relocations
which require a production
stop. Lead times from changes
(e.g. customer requirements)
• Change levels of
test/inspection equipment,
gauges, tools and technical
drawings
• Parameter changes
• Software
96
Process element P6 : Process analysis production
P6.2.1 Are the requirements of the control plan complete and have they been
effectively implemented?
The production and test documents are complete • Evidence of machine and
and available and based on the control plan. Inspec- process capability
tion characteristics, facilities, methods, test frequen-
• Process parameters and tol-
cies, test cycles, layout inspections and functional
erances (pressure, tempera-
testing must be defined .
tures, times, speeds ect.)
Access to these documents must be available at all
• Inspection specifications
times.
(special characteristics, at-
Process parameters influencing product characteris- tributive characteristics,
tics/quality must be fully stated. Tolerances must be measurement equipment,
given for process parameters and inspection charac- methods, test frequency)
teristics.
• Data regarding ma-
The control limits in process control charts are de- chines/tools/auxiliary aids
fined, identifiable and plausible. (identification numbers)
Deviations and actions taken regarding process re- • Guidelines regarding meas-
quirements and inspection characteristics are to be urement fixtures/reference
documented. points
Required measures (reaction plan) for process dis- • Work instructions (including
turbances are known and initiated and documented reworking)
by the responsible employees.
• Inspection instructions
For products with specific requirements on the manu-
facturing process the appropriate data about ma- • Specific requirements on the
chinery/tools/resources must be noted in the control manufacturing technology,
plan and/or the manufacturing and inspection docu- e.g. sampling relevant as-
ments. signment of machines and
plants
Cond itions governing rework are specified and se-
cured within the process (parts identification; re-
checking/inspection etc.).
97
The production repeat release is the order-related • Release of a batch
approval for production start-up.
• Release of reworked parts
Criteria for triggering a production repeat release
• . First piece release/first part
must be defined e.g. after an interruption of produc-
release
tion.
• Tooling diagrams/reference
A repeat release is necessary for product and pro-
parts/installation parts (e.g.
cess and must be carried out and documented by
defect identification)
authorised employees using acceptance criteria. De-
viations and measures taken are to be documented. • Possible triggering criteria for
A repeat release inspection must be carried out using a repeat release:
clear inspection instructions (quantity and method). o Production interruption
(e.g. night time in two
If production is continued after collection of samples,
parts should be isolated until the samples are ap- shift operations, tool
proved. changes, materi-
al/batch/product change)
At the time of release the necessary reference and
tolerance samples must be available. o Repair, tool change
o Setting data
98
P6.2.4* Are non-approved and/or defective parts managed ?
Non-approved parts and defective parts (scrap and • Labelling of scrap, rework,
rework parts) must be separated and recorded or reference and setting parts
when necessary safely removed from the production
• Labelling of conta iners for
process.
scrap, rework and setting
These parts are to be either directly marked or parts
marked on their container.
• Defined scrap/rework-
Reworking criteria including testing are defined, stations in production
known and implemented .
• Storage areas for blocked
Storage areas for blocked stock and restricted areas stock and restricted areas
must be clearly labelled . Accidenta l use of restricted
parts must be excluded . • Records of rework and scrap
99
,, ~ • ' ' f •• • j , '
~P6 ..~~5 . :is Jhe flow of materials and parts secure~ agaJnst mixing/wrong items?
...
A mix of materials or the use of wrong materials, • Material and parts flow
software or components must be ruled out.
• Product/process FMEA
Appropriate measures and checks must be taken to
• Poka Yoke actions
ensure the early detection and ejection of incorrectly
installed items. Associated topics and actions must • Checks and tests in produc-
be included and examined in the risk analysis (pro- tion facilities
cess FMEA and, if appropriate, in the product
• Parts identification
FMEA).
• Identification of work, inspec-
The process and/or inspection status of parts must
tion and usage status
be clearly visible.
• Batch identification, traceabil-
The reuse of residual quantities, separated parts,
ity of the installation of batch-
reworked parts, reusable parts from product audits,
es or the production of batch-
inspected items etc. must be clearly defined (includ-
es
ing regulations for traceability).
• Removal of invalid labelling
Regulations for reintroducing parts of outsourced
processes (e.g. sorting service) must be available. • Working papers with master
data for parts/production
• Design status
• Material flow analysis
• Value stream
• Regulations for reworking
100
Process element P6: Process analysis production
101
Employees receive regular information on the current • Process control (interpreta-
standard of quality reached, both internally and with tion of control charts)
the customer (complaints).
• Authority to stop and start the
The requ irements apply to both internal and external process
temporary employees.
• Order and cleanliness
• Repair and maintenance is
carried out or when neces-
sary, arranged for
• Parts supply/storage
• Provision and adjustment of
test/measuring equipment is
carried out or when neces-
sary, arranged for
• Training about the product
• Quality information (tar-
get/actual values)
• Product safety/product liabil-
ity trainings
102
..~ - ~ ' ~ ' ~ -· ' - ~ ~ .,.,. ti
,t.r,.ocess element P6. : ~roces~ analysis proc;:luction i
ijr 6.4
~ ··
' ~h~\me·ari~~~lre .used
Material resolirces·· : .
impleme_n.t the· process?
'
to
,
1·
.. , ~ ,, _. .. , ' " I ' ! t, ~..! ~ •1/',,-'W :, 1 , 1 I , , • , I
P6.4.1 * Can the product-specific requirements from the customer be met with the
manufacturing equipment?
Evidence must be shown that the processes are im- • Evidence of machine/process
plemented in accordance with the customer re- capability for special charac-
quirements using the existing production facilities teristics or process-
and that the resulting products meet the customer determining parameters (e.g.
specifications. pressure, time, temperature)
The production facilities, machinery and equipment • Output/production capacities
must be able to comply with the specified tolerances
• Warning at deviations from
for the respective product and process characteris-
limit specifica-
tics.
tions/parameters (e.g. an
Process capability must be determined for selected alarm, lamp, automatic shut-
product and process characteristics and their per- down, unloading)
formance verified.
• Feed and removal systems
The process capability must meet the customer re-
• Capability of replacement
quirements. For long term process capability the
tools
minimum requirement of Cpk ;:: 1,33 must be met. In
the case of significant characteristics where no ca- • Reproducibility of gauges, fix-
pability level can be proven, 100% inspection is re- tures etc.
quired.
• Cleanliness requirements
Layout and cond ition of the equipment, tools, fixtures
and handling facilities meet the requirements under
real production conditions.
103
'.). ' • '!' I •• '' I • I \~, ' •' ' ~~· ~,,_ •' jil)!llf ~
104
P6.4.3* Can the quality requirements be effectively monitored with the measurement
and test facilities in use?
105
Tools, equipment and test equipment (including • Stored protected against
gauges) must be stored and managed properly. This damage
also applies for tools, equipment and test equipment
• Cleanliness and tidiness
not in use or not yet released.
• Defined storage location
All tools, equipment and test equipment are identified
with their current status and all changes are docu- • Environmental influences
mented (change history).
• Status identification
Storage is provided where the equipment is protect-
• Identification showing cus-
ed against damage and environmental effects.
tomer's property, prod-
Cleanliness and tidiness are ensured .
ucts/tools/devices provided
The issue and use of this equipment is controlled on loan
and documented.
• Defined release status and
change level
• Storage and retrieval ma-
chines/equipment for
transport and storage etc.
• Reference component/setup
parts (e.g. error test pieces)
106
Minimum requirements relevant for assessment Examples for implementation
107
• ,; ' -1, l' l',, ~: I • ~,, ' ,, ~ ~ } ,' • 1 1 '
108
P6.5.3* In the case of deviations from product and process requirements, are the
ca uses analysed and the corrective acti ons checked for effectiveness ?
109
The audit programmes for process and product au- Product and process audit
dits are available and implemented. Customer re-
• Specifications
quirements are taken into account.
• Special characteristics
The process and product audits carried out are suit-
able to identify specific risks and weak points and • Audit programme for product
implement corrective action. and process audits including
scheduled and event-based
A root cause analysis is carried out w hen deviations
audits
occur. Corrective actions are derived, their imple-
mentation is monitored and the effectiveness is veri- • Frequency of audits
fied. • Audit requirements
Product audits are periodically carried out and docu-
• Aud it results, audit reports
mented. Scope of the audit is the end product and
where necessary intermediate products. In the prod- • Aud itor qualification
uct audit specified characteristics are examined and Process audit
tested according to defined specifications.
• Process parameter/capability
Non-conformities that affect the properties of the de-
livered product are communicated to the customer. Product audit
• Labelling, packaging
• Capacity of the test equip-
ment
• Software version
110
Process element P6: Process analysis production
16;t'.1ir· p9'jJhe,·<1.~~t\tWef~~o~1t.~~~J~.~~·~hf~.!.~~.~,~~~·~;nei~~.a:n.~a·~~-they · , 1
'., ',/ ,: systemat1cally 1d1rect~1.t 0Jhemext process step? ·,;'.:,:,~, Jf ., · ,.·: ... 1; , ·. /· r.i: .·
·i. ,.
,t.-.i''.'.::ll!:llli/~.:1,TJF,;;;:~ ,1;1'mU~:!.::~ 7.:~/n · ·: ":'.r':.;.:t\'i::;··;,~;¥.~f,t~,.:. ~~~: ,,;'},~ '.. ·: 1'.·':,:i· · !, i ··
Minimum requirements relevant for assessment Examples for implementation
111
,1 P6.6.2 Are products/components stored in an ap~~opriate manner and are
transport facilitios/packing arrangements suitable for tho special
I
characteristics of the products/components?
112
11."", •-41" .,~·. ""'' µ·~~ .. ,,,,,
.1. • •I l• I
.,. •\l't"I'
.'P6.6.3 . Aro the necessary records/releases retained?
. ._ ' ~ • .. ~ 4 I
.. ,
>~ - -
~":" , •.,. ... , I"."
0 •
,uc,
', ' •
.r
• •
" , ,· /
,.,.,
1,. , , •
~·
~1,¢:;, 1
'' • • ; '
't\;"'
;·
•
.. '"""·~·~
••
' ·
, .. ~
:1,,.
11 3
P6.6.4* Are the customer requirements met at the delivery of the fin al product?
The customer specific requirements of the final prod- • Quality agreements with the
uct (delivery reliability, quality goals, quality perfor- customer
mance etc.) are known and monitored.
• Customer specific require-
If deviations occur, corrective actions are defined and ments
implemented.
• Customer requirements for
Final products are shipped in accordance with the the identification of special
customer requirements. characteristics
The handling of supplied products is regulated and • Shipping audit
implemented.
• Storage/recall pro-
Customers should be informed of delivery stops cessing/parts supply/sh ipping
wh ich affect them and further procedure should be
coordinated with them. • Target agreements
11 4
7.7 Customer care/customer satisfaction/service (P7)
,: P7.1
', ' ' ~
Are all requirements related to QM·System, product and process fulfilled?
I ' -' '• ' ; , .. ~ •' '1 1•j
~ i., "•• .....-.,. ~.:i,t,.. .t -· ,_.;,o.,,,1,,~i
,
.... .i..
• •
l,l.i. JkA. • 1 ,i_. { , .. M • .__.J.:...;.1,/ a.--.
•
....
• •
-~a....:,-.ll~.-k
" , ' •
o ~~ •
.......
4
.M >
,
c:.... ~I ..........
' 1 )
~., ~....... ....!......1
' '
J
The internal and customer specific requirements on • Quality agreements with the
the quality management system are fulfilled. customer
Layout inspection and a functional testing checks are • Concept for layout inspec-
carried out according to the customer requirements. tions and functional testing
The customer requirements for the supply of spare e.g. carried out product au-
parts during and after the production phase must be dits, function tests, endurance
implemented. tests
Customer requirements for the return of parts and • Inclusion of suppliers for the
their recycling must be implemented. supply of spare parts
• Supply guarantee after serial
production
• Certification of the QM sys-
tem
~ ' - :'
P7.2 Is customer service guaranteed? · :,
, lf , J, ~ r. I
11 5
P7.3* Is the supply of parts guaranteed?
Contingency concepts and concepts to ensure sup- • Contingency plans (e.g. for
plies are available and up to date. Not only internal alternative production, sup-
processes but also the processes of suppliers are to pliers, transport)
be considered.
• Capacity and reaction time
Procedures must be in place which guarantees that for sorting actions
the organisation informs the customer immediately
• Use of external capacity
when supply shortages are detected. The information
must include the expected duration and extent of the • Communication regarding
shortages, the reason and the actions which have supply shortages
been taken.
• Regu lations covering authori-
ty to make deci-
sions/escalation paths when
introducing special actions
• Blocking of parts
116
I P7.4* If there are deviations fro m quality req uirements or complaint s, are failure
analyses carried out and corrective actions implemented effectively?
I
A complaint process that meets the customer re- • Process for processing com-
quirements (e.g. 80) is used for 0-km and field com- plaints
plaints.
• 80 process
Procedures for failure analysis are defined. The nec-
• Internal/external analysis fa-
essary personnel and material resources are availa-
ci lities (laboratories, test and
ble to ensure punctual processing. The customer has
inspection facilities, person-
to be informed when deviations to the agreed upon
nel)
time limits occur.
• Use of problem solving meth-
In the case of field complaints a failure analysis is to
ods
be carried out according to customer requ irements
(e.g. VOA Volume Field Failure Analysis). • Performance tests
• Flow of information to the
customer in the case of devi-
ations
• Knowledge store, lessons
learned
• Quality control loop
• FMEA
• Access to the necessary re-
lease documents (e.g. PPA)
11 7
It must be determined which responsibilities, duties • Organisational chart
and authorisations each employee has in their re-
• Evidence of knowledge of the
spective area of responsibility.
product/specifications/
Training needs must be determined individually and customer requirements
implemented for each person, depending on their
• Standards/legislation (product
tasks.
liability)
The employees know the product and the conse-
• Processing/use
quences of faulty workmanship for the supply of parts
and the quality of the final product. • Failure analysis
• Evaluation methods (e.g. au-
dits, statistics)
• Quality techniques (e.g. Pare-
to, 80 Method, cause and ef-
fect diagram, Ishikawa)
• Foreign language skills
118
8 Process audit services
2.2 Are all resources required to carry out the project planned and available and are
changes reported?
2.3 Is there a project plan and has this been coordinated with the customer?
2.4 Are all relevant advanced quality planning activities of the project implemented
and monitored regularly for compliance?
2.5* Are the procurement activities of the project implemented and monitored regular-
ly for compliance?
2.6* Is change management within the project ensured by the project organisation?
.,
""·'
., 03
1'· • .
Planning service development
.,.,."'.,. - ' • "'''''''"' '' ~ ..•• -. ~1"':
' ~ - '1 -. ,JI''''"""'"''
' "
_t .
, .. '"I , 1 ' <I"""!
··,
·., 7~[~ .... ~.~
',1, ..,
'' ' ;,, • \ • ~ • ~ '1
" · .... /, . '.i,taC~,u.:
3.1 Are the requirements for the development of the service available?
3.2* Is the feasibility comprehensively evaluated accord ing to the service require-
ments?
3.3 Are the activities for the development of th e service/service process planned in
detail and coordinated with the customer?
119
"
04 Implementation of the service development
4.1* Are the actions which were defined in the development plan for the service im-
plemented?
f-·
4.2* Are personnel resources available and qualified to ensure customer require-
ments?
4.3 Are material resources available and suitable to ensure customer requirements?
4.4* Are the required approvals and releases for the service/service development
available?*
4.5 Are the service specifications derived from the product and process development
and are they implemented?
4.6 Is a performance test for the developed service defined and performed to ensure
the service will perform under the required conditions?
4.7* Is there a controlled method for the project handover from development to provi-
sion of service?
--
05 Procurement management
5.1* Are only approved and quality-capable suppliers/external service provider used?
5.2 Are customer requirements taken into account in the supply/service chain?
5.3* Are supplier target agreements/external service provider target agreements im-
plemented with regard to the scope of supply/services?
5.6 Are personnel qualified for their respective tasks and are responsibilities de-
fined?
120
06 Providing the service
i ·' •· ~
'' '.; ·
~11', ,'
,,, '"<i' ·'s ,,
Whailgoe~
,l,,1'\
, ," , ', " •
nto) he,process?
,.!J'•rt,jt_'
,,, • ' :'\,,, '
J~,~
''?t •s.,~,-,~-:~•,1~fM\fl
~1t,t··· ;,,I,..•
• -'
1,,,.. Id!.,.. :; '•{"".
_.,,j
I '< ,1•· « ' ' 'f·•< ·Jt ,', f \',, ;·, ,'"
,~-=11g1-,,·ts'i.;r I
""°']i
~,11,..-'\•1,1
,;,~ti• ,i..,
! ~;,
..,·ff·•• .YJ_r~C~SS:lnput
a..,.l\tl~ . •J~I ,•'.... 1!11:"(··::iili.til;i;,1,/·,._.,-
..,~tt.-'\Ju.... t, .••.. ~"~·~' . ',.-: , .1$·:;r ~,
6.1.1* Has the project been transferred from development to the provision of service
and is a reliable start of service provision guaranteed?
6.1.2* Are the necessary materials for providing the service available at the agreed up-
on time, in the right quantity and at the right location?
-
6.1.3* Are incoming materials necessary to provide the service stored appropriately and
are the means of transporUpacking facilities suitable for the special properties of
the incoming materials?
6.1 .4 Are changes to the service made during the provision of the service tracked and
documented?
•,"f~-~,
( 6.2· 1
4
,
f. ;_ {I' '": Jo ,
·, Are.au·procosses.necessary~
,i.-..i1\ ,,. ,;~ ~~•«J•i::11J.J.!f},;.\J,,i,,ffi ••'1.i,
j' '' ' J •1,;, \ "'' liF..",:r..W .M.'fi '~: 'Iii""""' r~ r 1.. ,{i"'
1
6.2.1* Are the requirements of the service control plan complete and has it been effec-
tively implemented?
6.2.2 Are specific requirements (special characteristics) controlled during the provision
of service?
6.2.3* Are non-conforming services identified and are appropriate measures taken
(immediate measures and corrective actions)?
6.3.1* Are the employees able to fulfil their given tasks to provide the service?
6.3.2 Do the employees know their responsibilities and authority in carrying out and
monitoring of the service quality?
121
6.4.1 * Can the specific requirements from the customer for the provision of the service
be met with the equipment used?
6.4.3* Can the quality requirements of the service be effectively monitored with the
measurement and test facilities in use?
6.4.4* Are the work-stations for the provision of the service appropriate for the needs?
6.5.2 Is quality and process data about the service collected in a way that allows analy-
sis?
6.5.3* In the case of deviations from the service requirements and provision of the ser-
vice, are the causes analysed and the corrective actions checked for effective-
ness?
6.5.4 Are service requirements and provision of the service audited regularly?
6.6.1 * Are the necessary records concerning the service provided retained?
122
I -
1.. , 1.._... , • •• ,. lftu i. l • .• 1- "'·' Toi.;~ [t]. ··-"'I ~---··...·-
7.1 Are all requirements related to QM-System, service and service process fulfilled?
7.4* If there are deviations/complaints, are failure analyses carried out and corrective
actions implemented effectively?
7.5 Are personnel qualified for the various tasks and are responsibilities defined?
123
8.2 Project management (02)
The project organisation meets the customer re- • Composition of the project
quirements. team
124
Resource planning takes account of the customer's • Evidence of resource plan-
requirements, based on the contract covering the ning (taking other projects in-
project. to account)
Resource planning for project members is estab- • Resource planning for
lished and implemented. The staff workload has to equipment (e.g. development
be considered. tests)
Review and where necessary adjustment of resource
planning is carried out when changes occur (dates,
scope of services provided ... ). This applies to
changes that are triggered by the customer as well
as internal changes or supplier changes.
The critical path is given special consideration within
the resource planning.
The necessary project budget for personnel and
equipment is planned and released.
Changes in the project organisation (interface with
customer) are reported.
125
The project plan meets the specific customer re- • Project plan with milestones
quirements.
• Specific customer require-
All internal and customer defined milestones are fully ments regarding provision of
incorporated in the project plan and are monitored services
and updated as necessary.
• Customer's project plan
In-house communication is ensured when changes
• Customer's deadlines
are made to the project plan. Changes made to the
project plan which affect the customer are coordinat- • Customer's milestones
ed with the customer.
• Customer's targets (meas-
The critical path is generated from the project plan urements within the individual
and takes account of required procurement items. milestones)
The project plan must include detailed activities to • QM Plan
ensure the quality of the service provided. Detailed
plans may be in a separate document (QM Plan) re-
ferred to in the project plan.
The project plan must include the detailed activities
concerning procurement. Detailed plans may be in a
separate document referred to in the project plan.
126
Do the relevant advanced quality planning activities • Project plan
of the project meet the specific customer require-
• Customer milestones
ments.
• Milestone evaluation (review)
Is a review of the milestones identified within the pro-
ject plan carried out? Are all planned activities im- • Customer requirements in re-
plemented and is the required maturity level reached. gard to quality plans
Verification and validation of the service require- • Customer specifications
ments are contained within the plan.
• Requirements specification
The planning also addresses critical service provision manual
(internal and external services).
The plan is regularly monitored for compliance and
for target achievement.
127
D2.5* Are the procurement activities of ;he project implemented and monitored I
regularly for compliance?
The activities have to ensure that only approved and • Make or buy decisions
quality-capable suppliers/external service provider
• External service provider se-
are used in the serial production phase.
lection criteria
The level of activity depends on the risk classification
• External service provider de-
of procured supplies.
velopment plan
These include the supplier/external service provider
• List of external service pro-
selection and award scope, award amount and target
vider for the project
date for the award.
• List of approved external ser-
The transfer of customer requirements in the supply
vice provider
chain/service chain is ensured.
The activities also include customer directed suppli- • Risk classification of each ex-
ers/external service providers as stated within the ternal service provider
agreement.
The suppliers for facilities, machinery, tools, test and
measurement systems and services are integrated .
The appointment of suppliers/external service pro-
viders must be appropriately documented and trace-
able.
Dates for the assignment, milestones (supplier and
external service provider) and approval have been
!aid down in the plan and coordinated with the overall
schedule.
The progress of the activities is monitored.
128
I D2.6* Is change management within the project ensured by the project
org anisation ?
' ..
02. 7 Is there an escalation process established and is this effectively
implemented?
The escalation process in the project meets the spe- • Time periods for escalation
cific customer requirements. depending on the risk have
An escalation model (risk management) must be been agreed upon
available for deviations in the project affecting the • Contact personnel/decision
overall schedule. makers in the escalation pro-
The criteria for escalation are defined, responsibilities cess are defined
and authorities are regulated and measures are tak- • Escalation criteria and paths
en when deviations occur. of commun ication are defined
If specific risks have been identified in technologies, • Protocols of milestone re-
suppliers/external service provider and supplied views including measu res
countries, these risks should be considered within
the escalation management.
129
8.3 Planning of the service development (D3)
• • J '
A process for identifying all requirements for the pro- • Inquiry documents
vision of service including responsibilities is regulat-
• Contract documents
ed.
• Requirement specifications
All customer requirements, statutory and regulatory
requirements and other requirements of interested • Service level agreement
parties have been identified and documented.
• Customer requirements
The organisation must use previous experience and
• Legal and regulatory re-
take into account known requirements for the provi-
quirements
sion of service.
• Purchasing conditions
Special characteristics are identified and taken into
account. • QM specific requirements
There is an agreement with the customer regarding • Quality agreements
the approval procedure for the approval of the devel-
• Requirements for documenta-
oped service.
tion
If customer requirements cannot be fulfilled coordina-
• Logistics requirements (JIT,
tion takes place with the customer. The results de-
JIS, on consignment)
termined are documented.
• Schedules, technical delivery
The conditions needed to fulfil the customer require-
conditions
ments have been determined and allowed for.
• Access to portals (custom-
Identified needs are clear, understandable and verifi-
er/supplier) information plat-
able.
form in the internet
The effect that changes in the requirements have on
• Definition of responsibi lities
the service provided is checked (risk management).
for supplier/external service
The procedure for dealing with non-conforming ser- provider together with the
vices is coordinated with the customer. customer (e.g. qualification,
approval, testing ... ) as part of
the quality agreement
• Experience from previous
projects
• Environmental aspects, recy-
cling requirements
130
D3.2* Is the feasibility comprehensively evaluated according to the service
req uirements?
All activities from the contract award to the provision • Overall schedule and process
of service are planned, documented (project plan, development plan
milestone plan) and agreed upon with the customer.
• Customer requirements
The progress of the activities is monitored regularly.
• Customer schedule
Action is taken when necessary.
• Lead times
The identified requirements are checked regularly for
completion/feasibility. • Regular status checks on the
progress of the development
The development of the service process includes a
(reviews)
risk analysis and the resu lting measures.
The steps necessary for release meet the customer • Project plans for investment
requirements or internal specifications. Deadlines items (facilities and equip-
have been set for all release criteria. The results of ment)
the respective release are documented.
Services provided from external service providers are
part of the project planning.
131
03.4 Are tho resources necessary to provide the service available?
132
8.4 Implementation of the service development (04)
D4.1 * Are the actions which were defined in the development plan for the service
implemented?
133
04.2* Are personnel resources available and qualified to ensure customer
requirements?
I
i
A general staff plan must be available. • Customer requirements
Personnel must be qualified for the relevant tasks. • Requirements profile for the
This also applies to the staff of external service pro- relevant positions
viders. Appropriate certification must be available.
• Determination of the need for
Needs assessments will be carried out regularly dur- training
ing service development with regard to possible
• Evidence of training
emerging bottlenecks and additional requirements.
• Knowledge of methods and
Personnel resources are planned and personnel are
qualified in accordance with the project plan. foreign languages
Service processes that have been outsourced have • Appropriate behaviour for the
also been considered. quality of service
134
D4.4* Are the required approvals and releases for the service/service
development available?
135
D4.6 Is a performance test for the developed service defined and performed to
ensure the service will perform under the required conditions ..
..
A performance test of the service must be carried out • Packaging requirements
in order to assess all factors and influences at the
• Customer requirements
appropriate time and make any necessary correc-
tions. • Determination of minimum
quantities (intended produc-
A performance test has provided evidence that the
tion rate and flexibility as
quality capability of the entire provision of service is
agreed upon)
given under the agreed upon cond itions.
• Process capability study
• Measurement capability
• Suitability of the equipment
and infrastructure (test re-
ports)
• Personnel concept for serial
production
• Work/inspection instructions
• Service tests according to
customer schedule
136
D4. 7* Is there a controlled method for the project handover from development
to provision of service?
The personnel resources required to provide the ser- • A method has been deter-
vice are available in accordance with the planning mined to carry out fai lure
and are qualified. analysis and to introduce cor-
rective actions
The material resources include buildings, test facili-
ties, laboratory facilities, equipment, facilities, etc. • Metrics such as OEE, re-
These are available and have been released. jects, ...
Measures to safeguard the initial provision of service • Experience from the ongoing
are specified and introduced when necessary. project
137
8.5 Procurement management (05)
It must be ensured that only approved suppli- • Defined and documented cri-
ers/external service providers are used. teria are used for selection of
An evaluation of the qualification capability of the suppliers/external service
supplier/external service provider using specified cri- providers.
teria must be available. • Evidence of a qualification
An analysis of the quality performance of existing programme for suppli-
suppliers/external service providers has to be con- ers/external service providers
sidered. who did not meet the selec-
tion criteria
Risks in the supply chain/service chain have been
identified and assessed and appropriate measures • Evaluation of the quality ca-
for their reduction have been implemented (e.g. con- pability (QM-System, Pro-
tingency strategy). cess) for example self-
assessment, audit results,
supplier/external service pro-
vider certificates
138
The communication of customer requirements for • Transmission of require-
suppliers/external service providers (see D3.1) must ments, time schedule, ap-
be regulated and traceable. provals, complaints etc. with
Likewise, change management has to be consid- ensuring change manage-
ered . ment
Target agreements have been made with all suppli- • Measurable targets for quality,
ers/external service providers throughout the supply delivery quantity, punctuality
c;hain/service chain for products and processes.
• QM agreements including es-
These agreements have been verified and imple-
calation mechanisms
mented.
• Service level agreement
Supplier/external service provider performance must
be checked and evaluated within a defined period.
If deviations occur actions must be agreed upon and
their implementation including deadlines is to be
monitored.
To ensure meeting their target agreements, suppli-
ers/external service providers must consider events
such as a disruption in the supply of energy, labour
shortages etc. within their risk analysis and develop
contingency plans to cover these theoretical events.
139
D5.4* Are the necessary releases available for purchased services?
D5.5* Is the agreed upon quality of purchased products and services ensured ?
spect to the differences in the scope of procured ser- • ppm evaluations, 80 reports
vices.
• Agreement and tracking of
Supplier/external service provider audits are to be improvement programmes
planned and carried out based on the risk given by a
deviation in the quality of procured services.
• Test possibilities (internal and
external laboratories and test
Test and measuring equipment for the procured ser- facilities
vice are available in the required number, they are
stored in an orderly manner and associated work-
• Gauges/fixtures
stations are laid out appropriately (e.g. damage, con- • Technical drawings/ordering
tamination, climate control, lighting, order, and clean- and packaging require-
liness). ments/specifications
• Test certificates
140
A description must be given of what responsibilities, • Product specifications/
tasks and authority the employees have in their rele- customer requirements
vant task areas (e.g. for complaint processing, pro-
• Knowledge about service fea-
cess monitoring of suppliers/external service provid-
tures
ers).
• Standards/legislation
Qualification requirements must be determined for
each employee in relation to their tasks and qualifica- • Assessment methods (e.g.
tions carried out accordingly. audits, statistics)
Knowledge of previous complaints is available when • Quality procedures (e.g. 80-
appropriate for purchased products and services. method, cause and effect
diagram
• Complaints and corrective ac-
tion
• Job/function descriptions
• Qualification matrix
• Foreign languages
• Qualification of supplier
auditors
141
8.6 Providing the service (D6)
D6. 1.1* Has the project been transferred from development to the provision of
service and is a reliable start of service provision guaranteed?
Based on the risk assessment, measures for the safe • Service level agreement
provision of the service are planned and implement- • Released software standard
ed.
• QM plan
A process for the further development of the FMEA is
defined and regulated.
In order to monitor the effectiveness of the service
process, control mechanisms/systems must be intro-
duced.
Where necessary, tools, test and measuring equip-
ment are available in the necessary quantities.
142
D6.1.2* Are the necessary materials for providing the service available at the
agreed upon time, in the right quantity and at the right location?
The correct material must be provided to the agreed • Sufficient and appropriate
quality, in the correct quantity and with the correct storage facilities
documentation, at the agreed time and at the agreed
location where the service wi ll be provided.
• Defined storage points
The stock inventory in the system is the same as the • KAN BAN
143
-
-1- -- -------------
0 6.1 .3* Are incoming materials necessary to provide the servic e stored
appropriately and are the means of transport/packing facilities suitable for
the special properties of the incoming materials ?
144
06.1 .4 Are changes to the service made during the provision of the service
tracked and documented?
. .
Change management from the change request to • Change release by the ser-
implementation must be clearly documented and re- vice provider and the cus-
sponsibilities must be regulated. tomer (e.g. feasibility, inter-
faces, effect on costs and
Changes that impact on customer requirements and
schedules)
expectations must be coordinated, approved and
approved by the customer. If necessary a new ser- • Information about changes is
vice agreement must be made. This includes both passed onto service devel-
the actual service as well as the process for the pro- opment, the location where
vision of service. the service is carried out and
Changes/documentation of change status must be all sub-suppliers involved with
fully traceable. providing the service
• The level of implementation
of the change is tracked
(overview with status)
• Documented change record
including updated service
agreement
• Updates of the FMEA (Ser-
vice and process for provision
of service)
• Verification and validation of
changes including documen-
tation
• Controlled introduction of
changes or changes to ser-
vices
• Change history
• Lead times for service
changes (e.g. customer spec-
ifications)
• Change status of test equip-
ment, tools and materials that
are needed to provide the
service
• Changes to software
145
Process element 06: Providing the service
I
06.2 Are all processes necessary to provide the service determined?
D6.2.1 * Are the requirements of the service control plan complete and has it been
effectively implemented?
The documentation for the provision of the service is • Parameters, indicators and if
complete and available and is based on the service necessary tolerances
control plan.
• Special characteristics of the
Access to the documents must be possible at all service
times.
• Data regarding ma-
Characteristics of the service, materials and methods chines/tools/materials neces-
used to provide the service must be defined. sary to provide the service
Compliance with the internal/external requirements • Instructions on providing the
must be ensured. service
The service/service product must be clearly identifia- • Parameters for measuring the
ble or marked. quality of the service
Any mixing or confusion of information/data, soft- • Specific requirements regard-
ware, materials and components must be excluded. ing the behaviour of service
Indicators or parameters that influence the quality of providers
the service must be fully documented.
• Work instructions
When possible, tolerances in relation to indicators or
• Process descriptions
parameters for controlling the provision of services
are specified .
Deviations to the service control plan and corrective
actions taken must be documented.
Required measures (reaction plan) for disturbances
in the provision of service are specified.
Services with specific requirements (special charac-
teristics) for the performance of the service provider
must be taken into account in the service control
plan.
146
Special characteristics that significantly affect the • Service FMEA
provision of the service are noted and systematically
• Process FMEA
monitored.
• Service level agreement
In the case of deviation in regard to special charac-
teristics immediate action is taken and this is docu- • Special characteristics of the
mented. service
If it is not possible to meet the requirements of the • Special characteristics relat-
special characteristics the customer must be notified ed to the performance of the
and changes agreed upon. service provider
When special characteristics are related to the per-
formance of the service being provided, direct feed-
back discussions between the service provider, the
service provider management and when necessary
the customer, are to be carried out to ensure neces-
sary measures are agreed upon and initiated.
D6.2.3* Are non-conforming services identified and are appropriate measures tak-
en (immediate measures and corrective actions)?
147
Process element 06: Providing the service
D6.3.1* Are the employees able to fulfil their given tasks to provide the service?
The requirements also apply to external temporary • Training about the service be-
employees. ing provided
148
'o6.3.2 ·oo ,th~ ;~~loyees know th~!~.'~~sp·~~sibilitl~s· and a~tho;i't~ ·i~ ·carrying out
.v,. a.nd m~nit.~ri!19. of t~e so.~ ice quali~y_? , . "' 1
,y; ., 't'/ f' JI, , '"l.11.. .,. o.•, • _., ,~ 1 ~ ...... -'!. ,J .,,.. , • , '111
The requirements also apply to internal and external • Repair and maintenance is
temporary employees. carried out/arranged for if
necessary
• Provision and adjustment of
test/measuring equipment is
carried out/arranged for if
necessary
• Training about the service
• Service quality information
(target/actual values)
• Trainings relevant for appli-
cable legal require-
ments/regulatory require-
ments
149
The required number of qualified employees is avail- • Shift plan
able during the agreed upon time of service provi-
• Evidence of qualifications
sion. Employee qualifications need to be considered
(qualification matrix)
when scheduling staff (e.g. qualification matrix).
• Documented absence man-
Fluctuations in the assignment of the provision of
agement rules
services and through staff absences (e.g. illness,
holidays, training) are taken into account in the • Workforce scheduling
schedule.
The requirements apply to internal, external and
temporary employees.
150
Process element 06: Providing the service
06.4.1* Can the specific requirements from the customer for the provision of the
service be met with the equipment used?
It must be shown that the service processes are im- • Proof of machine/process ca-
plemented in accordance with the customer require- pability for special require-
ments using the existing production facilities. Further men ts
it must be shown that the resulting services meet the
customer specifications.
• Cleanliness requirements
151
Maintenance activities (maintenance, inspection and • Availability/use of the appro-
repair) are determined and implemented for all instal- priate technical documents
lations, equipment and machines.
• Maintenance plan and
Maintenance activities that have been carried out maintenance tasks
(scheduled and unplanned) are documented and an-
• Weak-point analysis
alysed for improvement measures.
• Preventative tool exchange
A process for the analysis and optimization of down-
programme for units subject
time, machine utilization is implemented effectively.
to increased wear and tear
The key processes and critical machines are identi-
• Storage and retrieval ma-
fied and appropriate maintenance activities (preven-
chines/equipment for
tative or prospective maintenance) are carried out in
transport and storage etc.
terms of a risk-based maintenance programme. The
availability of replacement parts must be ensured. • Availability of spare parts at
production facilities producing
Resources needed to carry out necessary mainte-
key products
nance measures are available.
Tools undergo a tool management which includes • Adherence to the prescribed
the following: maintenance intervals
152
06.4.3* Can the quality requirements of the service be effectively monitored with
the measurement and test facilities in use?
Test and measuring equipment used are suitable for • Service level agreement
the planned purpose and handling of service provi-
sion. They are included in the service level agree- • Accuracy of inspection
equipment/capability of test
ment.
equipment
Capability studies confirm the suitability of the test
and measuring equipment employed. • Proof of the capability of in-
spection processes
There is an identification system for the periodic con-
trol of inspection, measuring and test equipment. • Data collection and its inter-
pretability
Administration of this equipment is based on the
identification. • Evidence of the calibration of
inspection equipment
A process for the periodic monitoring of test and
measuring equipment is installed and implemented • Comparison of test equip-
(responsibility for collection and return is defined). ment/measurement process-
This process also takes into account the calibration es with the customer (e.g. in-
of process-integrated measurement technology with !er-laboratory comparisons)
an influence on the product characteristics.
• Inspection plate
Auxiliary equipment for measuring and test equip-
ment that have an influence the measurement result • Test procedures for behav-
iour-based services (e.g.
are monitored in the same way.
sales test, service test)
Testing of behaviour related requirements for ser-
vices is carried out using appropriate testing methods
(e.g. sales test, service test etc.).
06.4.4* Are workplaces for the provision of the service appropriate for the needs?
• Work safety
153
Tools, equipment, test equipment (including gauges) • Storage free from damage
must be stored and managed properly. This also ap-
• Cleanliness and tidiness
plies for tools, equipment and test equipment not in
use or not yet released. • Defined storage location
All tools, equipment and test equipment are identified • Environmental influences
with their current status and all changes are docu-
• Status identification
mented (change history).
• Identification showing cus-
Storage is provided where the equipment is protected
tomer's property, prod-
against damage and environmental effects. Cleanli-
ucts/tools/devices provided
ness and tidiness are ensured.
on loan
The issue and use of th is equipment is controlled and
• Defined release status and
documented.
change level
• Storage and retrieval ma-
chines/equipment for
transport and storage etc.
154
Process element 06: Providing the service
06.5 How effective is the process for the provision of the service being
carried out?
Effectiveness. efficiency, waste avoidance
Process-specific targets are defined for the provision • Availability of facilities and
of the service. The targets are defined, monitored equipment
and results are communicated.
• Process indicators
Target requirements are coordinated and achievable;
0 Services provided
they are guaranteed to be up to date.
0 Services per unit of time
Customer requirements are taken into account when
setting targets. 0 Quality of service
155
r• . . . .. . . . . . . . . .
.··' 06.5.2 · ,.,.
Is' quallty
.
and iprocess data about...the service collected in a way that
·. . ~llows analysis? ,
!• • '• -
I ~ ' ' l r f 1' ~ ' t..&,, < >.~ •• ~ •' I 't ,'t
156
0 6.5.3* In the case of deviations from the serv ice requirements and
provision of the service, are the causes analysed and the corrective actions
checked for effectiveness?
157
Audit programmes for service processes and service Service and service process
audits are available and implemented. Customer re- audit
quirements are taken into account.
• Specifications
Testing of behaviour related requirements for ser-
• Special characteristics
vices is carried out (e.g. sales test, service test etc.)
and verified. • Audit programme for services
and service process audits
The service process and service audits carried out
including scheduled and
are su itable to identify specific risks and weak points
event-based audits
and implement corrective actions.
• Aud it frequency
When deviations occur a root cause analysis is car-
ried out. Corrective actions are derived, their imple- • Audit requirements
mentation is monitored and the effectiveness is veri-
• Audit results, audit reports
fied.
• Auditor qualification
Service audits are periodically carried out (if possible
after the provision of service) and documented. In the Service process audit
service audit specified characteristics are examined • Process parameter for ser-
and tested according to previously defined specifica- vices
tions.
Service audit
Non-conformities that affect the properties of the ser-
vice are communicated to the customer. • Labelling, packaging
• Capacity of th e test equip-
ment
• Software version
• Sales and service testing
158
Process element 06: Providing the service
D6.6.1* Are the necessary records concerning the service provided retained?
The scope of the records that are used to document • Customer specifications
the provision of service are specified.
• Special characteristics
Traceability (agreed with the customer) must be en-
sured. • Specifications for archiv-
ing/customer requirements
The acceptance of the service by the customer or for archiving (e.g. EDP, pa-
subsequent services must be determined. per, fire protection, legibility)
If the terms of the service level agreement cannot be • Parts history
fully met the required reduction of services must be
coordinated with the customer. • Documentation in the case of
reduced services
Appropriate documented information has to be avail-
able. The documentation includes the relevant time • Compliance
period and/or the number of affected services.
For archiving requirements and duration, regulatory,
internal and customer requirements are taken into
account.
159
The customer specific requirements in relation to the • Service level agreement with
service provided are known and monitored. If devia- the customer
tions occur, corrective actions are defined and im-
plemented.
• Customer specific require-
ments
Services are delivered according to customer re-
quirements to the customer (service to the customer
• Customer requi rements for
special characteristics of the
etc.).
service
If services are stopped the customer must be in-
formed immediately and further procedure is to be • Delivery reliability
• Storage/recall pro-
cessing/parts supply/shipping
• Target agreements
160
8.7 Customer care/customer satisfaction/service (D7)
' 07 .1 Are all requirements related to QM-System , service and service process
fulfilled? ··
,.
Minimum requirements relevant for assessment Examples for implementation
The internal and customer specific requirements on • Quality agreements with the
the quality system are fulfilled. customer
The customer requirements must be implemented in • Inclusion of supplier/external
the service development phase and during the provi- service providers
sion of service.
• Certification of th e QM sys-
Customer satisfaction is determined by regular anal- tem
ysis, measures are derived and implemented.
161
07.3 Is the provision of service guaranteed?
Concepts including securing service are available • Contingency plans (e.g., for
and up to date. These concepts also cover emergen- alternative services, external
cy situations. service providers, packaging,
Not only internal processes but also processes of transport)
suppliers/external service providers must be consid- • Use of external capacity
ered.
• Communication regarding
Procedures must be in place which guarantees that supply shortages
the organisation informs the customer immediately
• Regulations covering authori-
when shortages in the provision of services are de-
ty to make deci-
tected.
I The information must include the expected duration sions/escalation paths when
introducing special actions
I and extent of the shortages in the provision of ser-
vices, the reasons and the actions which have been
taken.
162
D7.4* If there are deviations/complaints are failure analys s car ied ut and
orrective actions implemented effectively?
163
It must be determined which responsibilities, duties • Organisational chart
and authorisations each employee has in their re-
• Evidence of knowledge of the
spective area of responsibility.
producUspecifications/
Training needs must be determined individually and customer requirements
implemented for each person, depending on their
• Standards/legislation (product
tasks.
liability)
The employees have knowledge of the service and
• Processing/use
understand the consequences of a defective service
to the customer. • Failure analysis
• Evaluation methods (e.g. au-
dits, statistics)
• Quality techniques (e.g. Pare-
to, 80 Method, cause and ef-
fect diagram, Ishikawa)
• Foreign language skills
164
8.8 Application and evaluation of process audit for services
The use of the questionnaire for a process audit for servi ces is ca rried out in
accordance with section 6. 1 of the questionnaire for materi al products.
++The term "mainly" means that the relevant requirements are met in most instances and
no special risks have been identified .
165
The following table illustrates the appropriate allocation of points for the eval-
uation of the questions for services:
I Points
l
Evaluation of the performance of the individual requirements
6 The process does not I The service is faulty or Requirements are par-
always meet the defined disturbs the customer tially met; significant de-
requirements. This has processes. This can be viations
an impact on the cus- corrected with additional
tomer or following pro- work
cess steps
4 The process does not The service is not con- Requirements insuffi-
meet the defined re- form or disturbs the cus- ciently met; major devia-
quirements and has a tamer processes. This tions
significant impact on the cannot be completely
customer or following corrected with additional
process steps work/expense
0 The process is not ca- Full failure of the service Requirements are not
pable of ensuring com- provider. The require- fulfilled
pliance with the defined ments of the service are
requirements not met
If there are several findings for the assessment of a single question, the indi-
vidual assessment which is the highest risk is decisive for the assessment of
the respective question.
The auditor may require immediate actions depending on the risk of the find-
ings.
166
If a question is not evaluated (n. e. ), a reason for this must be stated. At least
2/3 of the questions for each evaluated process element, sub-element or pro-
cess step must be evaluated. To ensure comparability the entire list of ques-
tions from the VOA 6.3 process element should be covered in fu ll.
If non-conformities from previous audits are repeated, the lack of implementa-
tion of corrective action can also be regarded as a deviation : e.g. "cause
analysis", "implementation of measures", "meeting customer req uirements".
Process element
The level of compliance Eon of a process element (02, 0 3, ... , 07) is ca lcu-
lated as:
In process element 06 several process steps for each question may produce
multiple results. In this case the arithmetic mean of all results for the question
must be calculated. In ca lculations following this step, the average is rounded
to two decimal places.
These averag es are used in place of "total points" when calculating the level
of compliance of a process element.
For each question only 10 points may be award ed for the total possible
points - rega rdless of the number of results per question.
167
Sub-elements of D6
Eus Efficiency
The questions from 06 are used for the evaluation of the individual process
steps. All questions from 06 can be answered in each process step. The per-
formance level E0 of each process step can be calcu lated as follows:
Total points awarded for the D6 questions for this process step
En[%]=
Total possible points for the D6 questions for this process step
168
8.8.3 Overall level of performance
If during the audit individual process elements from the questionnaire are
used, the result is calculated based only on the evaluated process elements.
Which process elements have been used in the evaluation must be made
clear in the audit report.
169
Level of compliance for partial audits
The following rules for downgrading are to be used and documented in the
audit report:
• At least one question from the Process audit is rated with O points.
• At least one process element (02 to 07) or process step (E 1 bis En) is
evaluated with a level of compliance E8 or EG(Dn) or En from < 70%.
170
Audit report VOA 6.3 Evaluation of quality capability
c.o c.o
~
Supplier:
Location:
Audit request: Department: Order No.:
..,"O )>
0
en
Audit Reason:
(")
en
(?)
(?)
en en
Evaluated process ektmont:
Evalu-.ttion lrde1t I EG {%I Rat~
Summary of the audit carried out: en en
I IEG ·~·'""':!; n. e. n.e. D)
3(?)
-
P2, P3, P4, P5, P6, P7
-
Evaluated product group: C: :,
-
e•• Q.
e•• ;:.:
e•• 0..,
E PN During the audit the following significant findings were identified: ..,0 3
--
C!ass.l:wliun scale. A= 90 - 100% qLalily capable; 8>=80- <90% oomJilionanyquality capable; C = 0 - <
80% not quality capab:e 3D) en
Further action:
..,
"C
0
Q.
Audtt team: Audit Organization:
! '~r.(>( l.l:r<,u<1,1;r>t
->.
--.J
->.
.;
.; 1~
·r :i: · il
,iJ
-~
."I··.
f' ,"I "'i H' ·1' 1·,J 11,1 :·'j·1 !~
1
j • -i .
~ ;.I' i,
"' ; ,.
1
_i
1
: ·:
.. J C I
ii' •i .< :' ,J '! 1
1·1 1r1·1 t·l
,, 1·1 ,: •I 1,!
1
1'. .J
•n, 1·~' i ' I
'
Cj
I J •.. , ~
·l]
,1,1 i,l ITT
_·_· (•
l;j ,.
r,
""1 ·
. ..
'
"(~
;: ~J
!1
'~
,;~ :-;
I
a! ,I . ,[ i
H ·-I
,I
<(
0
> F1,LJ
.
'~
~,
'
' ! ;,g
1;:i
.;
'1
172
- ----· - -·· - --·-- --------·--·------ -~------··--- -- ·· ·---·-- ----
!
~-
Filled_!n by the auditor In the questionnaire Filled in by tho audited area
---y-------..
0.-tion
'0<onn Audil R..aon(•l
""
2.1 Please rate! 0
__ 2.2_ · ______Please rate! _______
Please rate!
------- --- - - -· · ···· - - _ _ o0 --- - --- ---- - - - ·--------
_ 2..3
2.4
--- ·--
Please rale! --o-·-
. 0 ~
____ 2.5 _ --···-------·· Please raie!____________________
0 •
2.6 ·- _ ··-·- -··- Please.rate! ____····--·-- ·-·- -····
2.7 Please rate! ··o·~- --
PJ Plonn4ng U. product and pr«as devoloprnenl
3. 1 Product Please rate! O
3. 1 " Process Please rate! · · 0 "
3.2 Product Please rate! O
3.2 Process Please·rate! - - - 0
3.3 Product Please rate! 0
3.3 - PrOcess Please rate! - -- - - - - - 0 •
3.4 Product Please rate!
- 3.4 Pi-ocess Please rate!
__ 3.5 __ .....Produc_t Please rate! · - - -- -
P,.-.P,ocluet. -
Project X 0
' YELLOW
0
a.:........;
0
n.e
36
---
>>n.e. ev aluated
Process description:
en
(1)
-
-
(1)
0- · -·
-
::J ~
::J
::J D,)
Project Y 0 0 0 36 >>n .e. ev al uat ed e!. ::J
., D,)
Project Z 0 0 0 36 >>n.e. ev aluated (1) -
4<
en
-~;~..,,~=~~
Risk assessment:
-·
en
-
BAtret:~. ~ ; or.1s l"IOI. DOS!,;be.
,-
YELLOW Conoltonlt1 t.ppfv.eJ: N::ln'Jr;a'.Jl'l ' "' ....A10!tol'W/ p::=.ble.
_....!
"'C
-
Fu2y appr0'o90~. f\lofT'ma1on~~l*: Potential assessment:
..Jo.
--
The f1ndirgs (conform, nonconform) identified in this report are to be used at own respol'lSibility with cause
(1)
analysis, action definition, action implementation arxl evaluation of effectiveness. This report will be used as the
basis for further I future analysis.
.><,
I -- I ~- 1=:==-j - I
~!f'.Iilll!;[Il'.Il. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . D,)
Further course.Cit action:
n
.,....
0
Aul( team
lead a udllor
A:..dl1or
Ai..t11tor
~tlor
F ..w,ct,on
Audit team
Supplier:
QM
>fl
Flllciiort'
Mar'Uactl.Jlng
DeYelopment
-
3
::r
Ci)
<
'--_-_-_-::~---- ===-=.- 1
. ::., 0
l>
PU"ctosmg ,~ o f actions Effeciiveness review•: I -
~ ~ u p p h e , __ --+-""-'_·_'•- --+-----<
ma11.. 7
P2.2
Ate an resources required for the project implementation planned and
available and are cha es re orted? • n.e.
• n.e.
• n.e.
P2.3 Is there a project plan and has this been agreed with the customer?
• n.e.
• n.e.
• n.e.
P2.4
Is the advanced product quality planning implemented within the project
and monitored for com liance? • n.e.
• n.e.
'• n.e.
P2.5
Are the procurement activities of the project implemented and monitored
for com liance? • n.e.
• n.e.
• n.e.
P2.6
Is change management within the project enslJ'ed by the project
• n.e.
• n.e.
• n.e.
175
Are processes aOO products al.OIied regUBrty?
176
---~·· ------------·------ - ·- ---------~· -----·-· ··-·-·-·· ···-·
Action plan
Supplier: Order:
Location: Copy sheet lo new I Date:
Show all ro•,vs
__ file ····----J
Filled in by the auditor In the questionnaire l !-- filled In by the audited area
Respon·
Findings Reason(•) Mea1ure(1) Date Effectlvity
libility
P2.1 1
P2.1
i---- -- - - -- ---1--- - - -- - - - - - - - - - - j l - - - - -~ r - - - ~ -- - - -
P2.4
P2.4
1---- - -- - - -- - - + - - - - - - - - - -- -- ---lf----~ ~- - - -· i--------
P2.5
P2.5
P2.5
P2.6
P2.6 :r---- .
P2.6
:r===::===-~~~=-~--11 - -
P2.7
P2.7
P2.7
P3.1
*"""9the producl and prOCM&-
-t __ .I
:--- - · ······
P3.1
P3.1
k-~~-- ~ ~t 1f------
Ion of Ille product end procen elev ~ ~ ~ ~ ~ - - - - - ~ ~------·-- ·· · ·• - - - " i - - - - - 1
->,
-....J n.e.
-....J
10 Best practice/lesson learned
The return of the supplier self assessment is an obligation (and where appropriate with attachments). The details are exclusively
related to the actual manufacturing site! Please return the completed form immediately! - please insert additional lines if
Jnecessary
Tel. No. :
Mobile Alone:
If relevant please provide former name of 8reil:
the company:
Languages: German German German
Enalish Enalish Enolish
Spanish Spanish Spanish
French French French
Internet-Hom page:
Address of Manufacturing site: Address of Development Centre :
178
1.3 External Suppliers
Is it planned that important features e.g. functional and quality relevant components for the currently requested Yes I No
project will be purchased from external suppliers? Will external senice suppliers be used for the actual quoted I
project (e.g. machining, assembly, painting)?
Parts/Product Groups Supplier/Company Cert. To % Grade Date
2. Development
2.1 Joint Venture Partner I Know-how cooperation
Company/Contact: I JV-Share (in % ) Cooperation Partners 'I Rnancial Contribution of Partners
I
!Tel. No.: IFax No.:
Which components involve a joint venture or know-how cooperation? Partner:
-- --- -
Which De-..elopment- and Quality Methods are used by the supplier?
---
a) QFD Methods:
b) FMEA (Design FMEA, Process FMEA):
c) DOE Methods:
-----
d) Others:
---
179
2.5 CAD Engineering Systems? Yes No
Does the supplier ha~ CAD Systems?
___
_l!_yys .. what. systems are t ~: ..- -..----- · -----·--·-·------·-------------....,_,_ ........----- ·-·-·- - - - - - - -·-·-..-- ..-,..- ....._..... ....._. ____.. ..,
1.
2.
- ..
------·----- -----
Is there a CAD-Data link?
------------------·----·-----··
If yes. what sort of link is in use?
Does the supplier use simulation methods?
If yes, what are the systems?
1.
2.
·-
3.
i
i
Which endurance test rigs are maintained at the site? available at site?
-
Which measurement and anal),'.Sis eguiement does the sueelier ~ aintain?
- available at site?
-
-- -
180
2.9 Test Facility/Prototyping I Yes I No
Does the s ~ r maintain a test_facility or prototyping on site?
- ..--·--··------· I I
!Which f rototyping_facilities are used internally?
·----------------------
1 3.1 Export
Which components are exported and for which customers? How much is the share for the net value of such products?
Components: Customers: Product Net Value:
3.2 Comments/Attachments
- --------
~-----------------·--------· -------·-----
www.l.da-qmc.de
181
10.2 Knowledge database
Audit results are greatly influenced by the knowledge of the auditor regarding
the product and process being evaluated. Asking relevant questions and
evaluating the answers depends on this knowledge. There are different ways
to build up this knowledge and use it in an audit. This is done for example by:
182
Knowledge database for process auditors - Plastic injection moulded parts
Surface quality
• If visual tests are being carried out rate the workplace (light-
ing etc.).
Dimensional accuracy
183
Knowledge database for process auditors - Stamped and punched parts
• Corrosion protection
• Damage-free surface
Material certificate
Tool design
• Hardened surfaces
Dimensional accuracy
184
11 Definition of terms and glossary
11 .1 Glossary
Term Definition
·---n····-··--·--·--·---
Notes/
References
CAM CAM refers to the IT support for control and Committee for Efficient
Computer aided manufacturing monitoring of production equipment and Production (AWF)
processes.
CAQ CAQ System is the generic term for IT sys- VOA Volume "Standardized
Computer aided Quality Assur- terns that are specifically developed to sup- Process for Handling Cus-
ance port quality management processes. tamers· Complaints"
185
I
Term Definition Notes/
References
Change Management Change management describes the func- VDA ECM (Engineering
tions and processes that are established in Change Management), ISO
an organisation to ensure changes to a 9001 e.g. chapters 8.3.6,
product are controlled and documented. 8.5.6
Control Chart With the help of control charts the perfor- DIN ISO 10004
mance of processes is monitored and sta-
tistically significant non-random deviations
can be detected. Control charts help to
focus on the stability of a process (see con-
trol cycle).
Control Cycle System which continuously compa res its VOA Volume "Robust Pro-
actual value with the desired va lue and can duction Process"
react to implement corrective changes.
186
r
Term I Definition Notes/
I References
Deviation Permit Risk assessment of parts that do not meet VOA Volume 2
the specifications. It is assessed whether
the parts can still be used. The permit al-
lows the use of components that do not
meet all the required steps and release
specifications.
A deviation permit/authorization can be
granted only by authorized personnel and
only in coordination with the customer. The
deviation permit must be attached together
with the action plan for the execution of the
shortcomings of the PPA documentation.
See PPA and deviation permit/ authorisa-
tion.
187
I
Term Definition Notes(
References
- --
DoE The objective of this method is to vary tac- VOA Volume 4;
Design of Experiments tors that influence the process or the sys- VOA Volume 11
tern experimentally to find an optimum (e.g.
optimal combination of injector, mixture etc.
to achieve the most fuel-efficient combus-
tion possible). The basis of the method is
an experimental design using statistical
methods to maximize the use of information
from the experiments carried out.
First Pass Yie ld Percentage of results that are correct in the VOA Volume "Robust Pro-
first process run and do not require rework- duction Process"
ing (corresponds to first-time-through quali-
ty, straight running).
····-- ··--
First time through quality Percentage of results that are correct in the VOA Volume "Robust Pro-
first process run and do not require rework- duction Process"
ing (corresponds to first pass yield, straight
running).
188
··- - ~ ------ - ----·- ----,
Definition Notes/
References
FTA The fault tree analysis is a method for risk VOA Volume 4
Fault Tree Analysis analysis for equipment and systems.
IMDS The IMDS is the material data system of IMDS International Material
International Material Data Sys- the automotive industry. All materials used Data System
tern in the manufacturing of vehicles are col-
lected, maintained, analysed and archived
within the IMDS. Through the use of the
IMDS it is possible to fulfil the requirements
of national and international standards,
legislation and regulations that are required
by automotive manufactures and their sup-
pliers.
Layout Inspection and Func- A layout inspection and a functional testing ISO TS 16949 or IATF
tional testing to applicable customer engineering material 16949
and performance standards, shall be per-
formed for each product as specified in the
control plans, taking into account the appli-
cable customer requirements for material,
function and frequency. Results shall be
available for customer review.
189
I
-
Term
MSA
Measurement System
Analysis
I
I Definition
NTF NTF refers to the fact that a rejected part is VOA Volume "Field Failure
No trouble found analysed (standard test and load test) and Analysis"
no deviations from the specifications are
found. The part is considered OK according
to the findings and the complaint could not
be validated. The cause of the error could
not be identified.
Pareto Analysis Using the Pareto analysis priorities can be VOA Volume4
identified and visualised. In a Pareto analy-
sis the characteristics (e.g. error, defective
components, etc.) are sorted by frequency
or importance.
Poka-Yoke principle System method for preventing mistakes. VOA Volume "Robust Pro-
duction Process"
190
t Term Definition I Notes/
References
' PPAP The purpose of the PPAP is to determine AIAG; VOA Volume 2;
Production Part Approval Pro- whether the product complies with the de- VDA Volume "Maturity
cess sign documents and specification require- Level Assurance for New
ments. Also see: APQP; PPA. Parts"
191
·-·- - -- -
Term Definition Notes!
References
192
Term Definition I Notes/
References
--- - - --
Start of Production The primary goal of the start of production Milling (2008).
phase is to convert a new product from the Start of Production in the
laboratory like conditions to a stable prod- Automotive Industry: Tech-
uct series. This phase begin s as soon as nical changes as a cause
the integration of all product components in or symptom of initial diffi-
prototype is successful and ends with the culties?
ability to produce the desired quality and
quantity (see also SOP).
Straight run Percentage of results that are correct in the VDA Volume "Robust Pro-
first process run and do not require rework- duction Process"
ing (corresponds to first pass yield, first
time through quality).
VOA Maturity Level Assur- Continuous tracking of the maturity level of VDA Volume "Maturity
ance for New Parts new parts in conjunction with an objective Level Assurance for New
assessment of the product and production Parts"
process maturity at agreed times during the
product implementation process.
193
11.2 List of abbreviations
Abbreviation
CAx Computer-aided x
02 Project Management
05 Supplier Management
DIN German Institute for Standardisation (Deutsches lnstitut fur Normung e. V.)
Eon Compliance level of the service process element (02, 03, ... , 07)
194
Abbreviation
IT Information Technology
n. e. Not evaluated
P1 Potential Analysis
P2 Project Management
P5 Supplier Management
195
Some abbreviations are based on terms from the German Volume. These have not been
translated because of their use in the calculations and assessment forms where one
standard abbreviation is necessary. A summary of these abbreviations is given below.
----
r~rev~ation
Eon Compliance level (.~.) of the service (.Q) process element (!1)
196
12 Downloads
Because the presentation of the tables and figures shown in the print form is
limited we have provided you with pdf downloads under the following link:
www.vda-gmc.de/downloads
Login information:
197
13 Overview Matrix
Overview matrix of the references pertaining to the individual questions
of the process elements.
AIAGAPQP X X X X X X X
AIAGNDA FMEA X X
AIAG PPAP X
AIAG MSA
198
For the process elements P3.1 - P3.5
I
Pl.1 P3.2 P3.3 P3.4 P3.5
A IAGAPQP X X X X X
A IAGNDA FMEA X X X
A IAG PPAP
AIAG MSA
199
For the process elements P4.1 - P4.8
., ""., ~•• 1 : ,' ;-11 r,' ,. ,• •' , t,t 1111 'Cf·~ , , f _.,' .. '
~' . .
~ ·~ - · •
.
..
"', "lf< .. ~\' ...,, / 'f~ •~~ ,
"'' I
'
... •
~1 "
: .. ''· ··; · p4:1.' 1 P4.2 , 'P4.3 P4.4, ~ P4.5 •P4.~ '·P4!7 " P4:8'
1,, \
•»"' r. ' •'A ',:, ~ 'Ip''. ,.,. t(:o • ,'tif •::," • ,lf-1i, .._, •, ' , ,,..-.. "'1oo11J•t;~.,.f
1 ·J·~ .tr.M
AIAGAPQP X X X
A!AGNDA FMEA X X X
I
AIAG PPAP X X
AIAG MSA X
200
For the process elements P5.1 • PS.7
K-,- ~J ~
~;: 'i\... • .
'•,
.• ,,-. ,..., , ,
..... ~ ....... t, - , . ,.... tr:,i
t ,,
::r ·~~·'· "'""·.~~"'~ "; r · i'' '·f,+ ·' , '"'.
t, · ; 1:; ,/ '~:- .I ff
·1,· , ~ ;,.i1>i) ?f ._,rr.
,,:·-~it,: •i ~,, PS.\ , ,', PS.2 · /I PS.3 ·,
..... "'A~\ 1.i,:,~1t.,,''6{, ;,.;,,,
, ',
d
. , r. ..,._.,j . . ~ • : ,,
pS.4 ·' • PS.5 . PS.6 ! PS 7
1'i.,, ~~],iJ;, ,,.\ti \I,,\(
J
VDA Volume 1 - Documentation and Archiving of
X
quality requirements and quality records
A IAGAPQP X X
A IAGNDA FMEA X X X
A IAG PPAP X X
201
P6.1.1 P6.1.2 P6.1.3 P6.1.4 P6.1.5
AIAGNOAFMEA X X
AIAG PPAP X X
AIAG MSA
A IAGNDAFMEA X
A IAG PPAP
A IAG MSA
202
For the proces s elements P6.3.1 - P6.4.5
AIAGNOA FMEA X
AIAG PPAP
AIAG MSA X
203
r
~
AIAGNOAFMEA X X X
AIAG PPAP X X
AIAGMSA
AIAGSPC X
AIAG PPAP X X
AIAGNOA FMEA X
204
Quality Management in the Automotive Industry
Available from:
205