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7/29/2019 cl_27_01_011e_vda6_2
1/40
No.: CL_27_01_011e Edition: 09/2006 Page 1 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
CH ECK LI ST
VDA 6.2( i n co n for m i t y w i t h t h e 2n d ed i t i on 2004 )
This check list must neither be copied nor reproduced,it remains a QA copyright.
Copyright 2005, byQua l it y Aus t r i a Trainings-, Zertifizierungs- und Begutachtungs GmbH
Pur pose o f use
Self assessment Date:
Pre-audit Date:
Certification audit Date:
Surveillance audit Date:
Extension audit Date:
Subsequent audit Date:
Date:
Organ iza t i on
Name
Address
Postal Code, town/city
Certified area
Area of activity
Contact person
Phone/fax
A u d i t o r t e am
1. Auditor (auditmanager):
Signature:
2. Auditor: Signature:
Observer: Signature:
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CH ECK L I ST
V D A 6 . 2
No.: CL_27_01_011e Edition: 09/2006 Page 2 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Table of Contents:
Notes:........................................................................................................................ 5
Processes and components in ISO 9001:2000........................................................... 6
Standard-ogramm .................................................................................................... 6
Management process ................................................................................................. 9
Obligation of management (provision of resources) ................................................. 10
Quality management system .................................................................................... 11
Document Control..................................................................................................... 13
Quality records control.............................................................................................. 15
Training, competence, awareness............................................................................ 17
Internal audit............................................................................................................. 19
Corrective measures ............................................Fehler! Textmarke nicht definiert.
Preventive actions .................................................................................................... 23
Improvement process ............................................................................................... 25
Customer-related processes..................................................................................... 27
Development ............................................................................................................ 29
Production / service provision................................................................................... 31
Planning of the product implementation ................................................................... 32
Management of the resources (infrastructure, working environment.)...................... 33
Procurement............................................................................................................. 35
Measuring and test equipment monitoring................................................................ 37
Measuring, analysis and improvement ..................................................................... 38
Process assessment according to the VDA 6.2 ............................................... 39
(Summary taking account of the objectives) .................................................. 39
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CH ECK L I ST
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No.: CL_27_01_011e Edition: 09/2006 Page 3 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
1 . Fo rew ordThis audit question catalogue is to be used in principle for the carrying out ofcertification or surveillance audits. It requires the application of fundamental
knowledge of the VDA 6.2 requirements on the part of the user, since points of focusonly are referred to and the individual case application must always be taken intoaccount. This check list is based on the general QA check list forISO 9001:2000. The focal points / cross references are inserted crosswise to the VDA6.2 additional requirements for each of the flow charts / questions - the ISO9001:2000 basis has largely been retained.
2. App l i ca t ion o f th e QA check l i s t
The questions in this checklist are directed to the professional auditor, who evaluatesand documents the compliance with the standards requirements and the body ofregulations. The results of the audit are verified in detail in this manner. This
verification contains notes concerning the documents that have been examinedtogether with precise identification and all appraisals in reference to theimplementation of the QM system, i.e. the description of random samples.
This QA check list can be applied by all QA customers for carrying out internal auditsin the course of the preparation for certification or annual audits.
The current customer specific requirements / expectations from the QM system arefirst of all to be found out and these are to be adequately taken into account in theaudit planning according to the terms of the ISO 9001:2000 requirements providingthe basis, or the specific requirements of VDA 6.2 (also see the QA forms /registration documentation). Taking the requirements form the process model into
account the focal points listed in the following in particular are to be harmonized inthe audit planning:
a.)Identification of the processes determined by the organization based on theagreed customer requirements, the QM system documentation and everyadditional item of information presented by the organization.
b.)Analysis of processes in accordance with the criteria
Products and/or services for the customer
Risks for the customer
Interfaces (inputs / results)
Identification of process groups for economic and effective audits
c.)The classification of audit activities according to priority and taking account of:
Problems for re-checking from earlier audits (external and internal)
Customer complaints
The creation of value input of the auditing organization
d.)The completion of the audit program including the sequences / process steps,time management, interview partners and the application of rules forrecognition by the VDA-QMC.
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CH ECK L I ST
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No.: CL_27_01_011e Edition: 09/2006 Page 4 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
The following reference process structure / chart (page 5) and the form covering themost important / processes / corporate goals (page 6) is to be used as the basis forthe audit planning / application of the QA check list. In this respect potentialinteractions / interfaces are to be given particular attention.
The planning of the scope of the audit must continue to be in conformity with thecertification specifications from VDA 6 (or the QA Automotive Guidelines) in therelevant current editions. The coordinated procedure must also be taken into accountin the course of the registration. Should the prerequisites have changed for thecertification or surveillance audits (the number of employees in the company /expansion of the scope) then the procedure must be carried out in accordance withthe guideline.
The audit manager only sets up a check list for a certification. The appraisals made bythe entire audit team are collected in this list. In suitable locations reference is madeto any additionally added pages (e.g. the auditing of various non-independentlocations / extended workbenches etc.); - these insertions are to be comprehensibleto the audit manager and must be clearly marked.
Following a positive conclusion of the certification / renewal audit the auditdocumentation is to be attached in accordance with the VDA-QMC requirements forthe issuing of certificates.
Poss ib le non -con fo rm i t i es a re to be es tab l i shed unde r obse rva t i on / re fe renc ing w i th rega rd to the measu res reco rd tha t i s to be comp i l ed . An
app l i ca t i on fo r the i ssu ing o f a ce r t i f i ca te i s on l y poss ib l e a f te r thesuccess fu l conc lus ion o f the p rocess ing fo r a l l t he requ i remen ts i n th i srespect .
3. Eva lua t ion sys tem at ics
Upon customers request an evaluation according to the new VDA 6.2 evaluationsystematics can be carried out (this is always done in QA).
In addition to the effectiveness analysis performed up until now, a risk assessment isalso taken into account.
In addition to 100% compliance with the ISO 9001:2000 questions, a score of at least8 is to be achieved for the 13 processes to qualify for the issuing of a VDA 6.2
certificate supplement.
Further details on evaluation can be seen on page 39 of this check list.
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CH ECK L I ST
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No.: CL_27_01_011e Edition: 09/2006 Page 5 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Notes :
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CH ECK L I ST
V D A 6 . 2
No.: CL_27_01_011e Edition: 09/2006 Page 6 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Processes and components in ISO 9001:2000
Standard-ogramm Strengths/weaknesses + -P*
WW*Standard points
Short name
4.1 General requirements
4.2.1 General4.2.2 Quality Management Handbook
4.2.3 Controlling of documents
4.2.4 Controlling of quality records
5.1 Management obligations
5.2 Customer orientation
5.3 Quality policy
5.4.1 Quality objectives
5.4.2 Planning of the quality management system
5.6.1 General information
5.6.2 Inputs for the evaluation
5.6.3 Results of the evaluation
5.5.1 Responsibility and authority
5.5.2 Authorized representative of top management
5.5.3 Internal communication
6.1 Provision of resources
6.2.1 General information
6.2.2 Capability, awareness and training
6.3 Infrastructure
6.4 Working environment
8.1 General information
8.2.1 Customer satisfaction
8.2.2 Internal audit
8.2.3 Monitoring and measuring of processes
8.2.4 Monitoring and measuring of the product
8.3 Control of non -conforming products
8.4 Data analysis
8.5.1 Continuous improvement
8.5.2 Corrective measures
8.5.3 Preventive measures
7.1 Planning and product implementation
7.2.1 Establishing the requirements reg the product
7.2.2 Evaluating the requirements reg. the product
7.2.3 Communication with the customer
7.3.1 Development planning
7.3.2 Development inputs
7.3.3 Development results
7.3.4 Development evaluation
7.3.5 Development verification
7.3.6 Development validation
7.3.7 Controlling of development changes
7.4.1 Procurement process
7.4.2 Procurement data
7.4.3 Verification of procured products7.5.1 Controlling of the product/service provision
7.5.2 Validation of the product/service provision
7.5.3 Identification marking and traceability
7.5.4 Customer property
7.5.5 Product maintenance
7.6 Control of monitoring and measurement
Key
*P = Priority, *WW = Interaction, = Processes, = Components, = Components relating to a process
4. Quality Management System
Documentation requirements
6. Managementof Resources
Capability,awarenessand
training
Infrastructure
Working-
environment
7. Product implementation
Customer-related processes
Development
Production /services provision
ID. /traceab.
Customerproperty
Protection ValidationSpecification/input
Product/service
Planning
Procurement
Testequipment
Generalrequirements
(processmanagement)
Provisionofresources
Personnelresources
5. Responsibility of the management
Obligation
ofthe
Mana
gement
P
olicy
ta
rgets
planning
review
Responsibility
Ofrepresentative
appointedby
Mana
gement
Cus
tomer
orientation
Internal
Comm
unication
Quality
management
handbook
Documentcontrol
Steeringofnotes
taken
8. Measurement, analysis andimprovement
Analysis ofdata
Customersatisfaction
Process-
m
easurement
a
ndmonitoring
Product
measurement
and
i
i
Internalaudits
Controlling
of non-conforming
products
Preventivemeasures
Improvem
entmeasures
Correctivemeasures
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CH ECK L I ST
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No.: CL_27_01_011e Edition: 09/2006 Page 7 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Protocol / notes: Discussionpartner:
Vision :
Mission :
Pol icy:
Stra teg ies:
Projects:
Programs:
Methods:
Tools:
Processes :
Key processes:
Key parameters:
Funct ions / responsib i l i t ies :
Roles:
The m os t impor t an tkey da ta :
Aud i t ob j ect i ves :
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CH ECK L I ST
V D A 6 . 2
No.: CL_27_01_011e Edition: 09/2006 Page 8 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Processes and componen t s i n t he I SO 9001 :200 0 sys tem and i n VDA 6 .2
Chap te r / c ross-
re fe renceVDA 6.2 Documen t
second ed i t i on 2 004
Additional requirements / focal pointsVDA 6.2 compared with
ISO 9001:2000
sections 5.1, 5.3, 5.4and 5.5
Is a clear definition of the structureand process organization given?
Are all interest partners taken intoreasonable account?
Section 5.1
Section 5.7
Does top management take upissues such as:
o the business plano business resultso comparable performance
internal / external datao employee satisfactiono customer satisfaction
and deal with them in an integratedmanner?
Are aspects such as product liability, therecognition of risks, hazards at theworkplace given reasonable account?
Section 5.1.1. Are there business plans containing
all the following aspects:o cost aspectso sales aspectso overall corporate aspectso development aspectso process and quality aspects
taking account of time data and ofthe customer and employee
expectations?
Section 5.1.2.
Section 5.2 /5.5
Is the efficiency of all valuecreation and support processesevaluated by top management?
Is there a process for establishingcustomer requirements, -(customer representative) havemeasurable targets beenestablished for this?
Section 5.4.1.and 5.6.1 - 4
Have measurable and achievablequality targets (continuously) beenestablished?
Performance of the qualitymanagement system (monitoring ofthe Q- targets / evaluation of thequality related internal / externallosses (periodic tracking)
Section 5.5 Information flow, transparency, -
monitoring of effectiveness Improvement process general.
Goals
PlanningSub-targets
Meansprocessesproducts/services
Customersatisfaction
auditsprocessesproducts
services /system
Update factsand figures
facts
Evaluation ofthe service
System-modificationImprovement
Vision / mission statement
Strategy
Implementation underconsideration of
requirements
Measurementsurveillancecorrectionavoidance
Analysissequential, parallel,
periodic checks
Review
Management
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CH ECK L I ST
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No.: CL_27_01_011e Edition: 09/2006 Page 9 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Protocol / notes: Discussionpartner:
Management processAudit objectives:
Observations/references:
Deviations from standards (number of theimprovement measures protocol):
Notes, recommendations:
J N
5.3 Qua l i t y po l icy
Does the top management ensure that the quality policy:
5.3-01 is Suitable for the purposes of theorganization?
5.3-02 contains an obligation for the fulfillment of therequirements and for the continuous improvement of theeffectiveness of the quality management system?
5.3-03 offers a framework for the establishing andevaluation of the quality objectives?
5.3-04 is distributed and understood within theorganization?
5.3-05 is evaluated in terms of its continuingsuitability for the purpose required?
5.4 Plann ing
5 .4 .1 Qua l i t y ob ject ives
5.4.1-01 Does the top management ensure that thequality targets have been established for the relevantfunctional areas and levels, including those that arerequired for the fulfillment of the requirements forproducts?
5.4.1-02 Are the quality targets measurable andconsistent with the quality policy?
5.4 .2 Plann ing o f the qua l i t y m anagement system
Does the top management ensure that:
5.4.2-01 The planning of the quality managementsystem is done in a manner so as to fulfill thespecifications given in section 4.1 and to achieve thequality objectives?
5.4.2-02 The functionality of the quality managementsystem is maintained, when changes to the qualitymanagement system are planned and implemented?
5.6 Management rev iew
5.6.1 General
5.6.1-01 Does the top management evaluate the
quality management system of the organization atplanned intervals in order to ensure its continuingsuitability, applicability and effectiveness?
5.6.1-02 Does this review of the evaluation ofpossibilities for improvements and the changerequirement for the quality management system alsoinclude the quality policy and the quality objectives?
5.6.1-03 Are the notes made concerning themanagement review adhered to?
5.6 .2 Inpu t fo r eva lua t ion
Does the input for the management review contain informationabout the following issues:
5.6.2-01 Results of audits?
5.6.2-02 Feedback from customers?
5.6.2-03 Process performance and product conformity?
5.6.2-04 The status of preventive and correctivemeasures?
5.6.2-05 Measures to be taken as a consequence ofpreceding management evaluations?
5.6.2-06 Planned changes that could have an effect onthe quality management system?
5.6.2-07 Recommendations for improvements?
5.6 .3 Resu l ts o f the management rev iew
Doe the results contain all the decisions and measures from thereview on the following issues:
5.6.3-01 Improvement of the effectiveness of thequality management systems and its processes?
5.6.3-02 Product improvement in regard to customerrequirements?
5.6.3-03 Resources requirements?
Please note: Requirement in accordance with the QA generalterms and conditions and/or EN 45012
Are compla in ts also dealt with and documented in thescope of this evaluation in regard to the QM system?
AA
AA
AA
AA
AA
AA
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CH ECK L I ST
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No.: CL_27_01_011e Edition: 09/2006 Page 10 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Protocol/ notes: Discussion partner:
Obligation of the management (provision of resources)
Audit objectives:Observations/references:
Deviations from standards (number of theimprovement measures protocol):
Notes, recommendations:
J N
5.1 O b l iga t ions o f managem ent
5.1-01 Can top management prove fulfillment of itsobligation in regard to the development andimplementation of the quality management system?
Can it prove that the effectiveness of the QMS is beingcontinuously improved in that:
5.1-02 The organization is actually conveying thesignificance of fulfillment of customer requirementsand the statutory authority requirements?
5.1-03 The establishment of quality policy?
5.1-04 Assuring that quality objectives have beenestablished?
5.1-05 Management reviews have been carried outand the availability of resources assured?
5.2 Cus tom er o r ien ta t ion
5.2-01 Has top management assured that the issue
of customer requirements has been communicatedand fulfilled with the objective of increasingcustomer satisfaction?
5.5 Respons ib i l i t y , au thor i t y and commu nica t ion
5 .5 .1 Respons ib i l i t y and au thor i t y
5.5.1-01 Top management assures that dieresponsibilities and authorities and their interactionswithin the organization have been defined and havebeen made known?
5.5 .2 Representa t i ve o f t he t op m anagement
Has top management appointed a member, whoindependent of all other responsibilities, has responsibilityand authority including the following points:
5.5.2-01 to ensure that the required processes areintroduced, implemented and maintained for thequality management system?
5.5.2-02 That top management is reported to onthe performance of the quality management system
along with each necessity for improvement?5.5.2-03 that awareness about customerrequirements is promoted and assured throughoutthe entire organization?
5 . 5 .3 I n t e r n a l c o m m u n i c a t i o n
5.5.3-01 Does top management assure thatsuitable processes for communication are introducedthroughout the organization and that acommunication about the effectiveness of the qualitymanagement system takes place?
6.1 P rov is ion o f resources
Does the organization determine the resources and providethem for:
6.1-01 Implementing the quality managementsystem and for continuously improving itseffectiveness
6.1-02 Increasing customer satisfaction through
fulfillment of the customer requirements?
AA
AA
AA
AA
AA
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CH ECK L I ST
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No.: CL_27_01_011e Edition: 09/2006 Page 11 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Protocol/ notes: Discussionpartner:
Quality management systemAudit objectives:
Observations/references:
Deviations from standards (number of theimprovement measures protocol):
Notes, recommendations:
J N
4 Q ua l i t y management sys tem
4.1 Genera l requ i remen ts
4.1-01 Has the organization built up, documented,realized and maintained a quality managementsystem and continuously improved its effectiveness?
4.1-02 Are the processes required for the qualitymanagement system and its application in the entireorganization (also for outsourced services / keywordinterfaces) recognizable?
4.1-03 Has the sequence for and interaction of theprocesses been established?
4.1-04 Have the required criteria and methods beenestablished for assuring the effective implementationand steering of these processes?
4.1-05 Has the availability of resources andinformation been assured that are required for theimplementation and monitoring of these processes?
4.1-06 Are these processes monitored, measured,and analyzed?
4.1-07 Have the required measures beenestablished in order to achieve the planned resultstogether with a constant improvement of theseprocesses?
4 . 2 D o c u m e n t a t i o n r e q u i r e m e n t s
4.2.1 General
Does the documentation for the quality managementsystem contain:
4.2.1-01 a documented quality policy and qualityobjectives?
4.2.1-02 a quality management handbook?
4.2.1-03 documented procedures that are requiredby this international standard?
4.2.1-04 documents that are required by theorganization for assuring the effective planning,implementation and controlling of all its processes?
4.2.1-05 The quality notes specified by thisinternational standard?
EXPLANATORY NOTE 1:
When the designation "documented procedure" is used,
this means that the relevant procedure is defined,
documented, realized and maintained.EXPLANATORY NOTE 2:
The extent and scope of the quality management system
documentation can be different from organization to
organization as a result of:a) the size of the organization and the ty pe of its activities,
b) the complexity and the interaction of the processes, and
c) the capabilities of the personnel.EXPLANATORY NOTE 3:
The documentation can be implemented in any form or
type of medium.
4.2 .2 Qua l i t y Management Hand book
Does the Quality Management Handbook contain:
4.2.2-01 the application area of the qualitymanagement system including the details about andreasons for every exclusion?
4.2.2-02 the documented procedures created forthe quality management system or indicators to it?
4.2.2-03 a description of the interaction ofprocesses in the quality management system?
AA
AA
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CH ECK L I ST
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No.: CL_27_01_011e Edition: 09/2006 Page 12 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Processes and comp onen ts i n t he I SO 9001 :2000 system and in I SO
/ TS 1 6 9 4 9
Chap te r / c ross-
re fe renceVDA 6.2 Documen t
second ed i t i on 2 004
Additional requirements / focalpoints
VDA 6.2 compared withISO 9001:2000
Section 4.2.3.1 Is the timely evaluation /
distribution / implementation incompliance with the customerscheduling assured?
Have all changes beenconsistently documented?
Is there a clear presentation of
all documents? Is exclusion of abuse ensured?
Publishupdate
withdrawremovedestroy
file original
Creating, maintaining
Identifying,marking,
cataloguing
Checkingreleasing
Publishupdate
Withdrawremovedestroy
Changecheck
release
Document control
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No.: CL_27_01_011e Edition: 09/2006 Page 13 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Protocol / notes: Discussionpartner:
Document controlAudit objectives:
Observations/references:
Deviations from standards (number of theimprovement measures protocol):
Notes, recommendations:
J N
4.2 .3 Documen t Cont ro l
4.2.3-01 Are the documents required by the qualitymanagement system controlled?
4.2.3-02 Quality notes represent a specialdocument type. Are they controlled in accordancewith the specifications in section 4.2.4?
Does a documented procedure exist for establishing therequired control measures in order:
4.2.3-03 to approve the documents prior to theirpublication in respect to their adequacy?
4.2.3-04 to evaluate documents, update them onrequirement and approve them anew?
4.2.3-05 to ensure that the changes along with thecurrent editing status of the documents are
marked?4.2.3-06 to ensure that the valid versions ofrelevant documents are available at the appropriatepoints of use?
4.2.3-07 to ensure that the documents are legibleand easily recognized?
4.2.3-08 to ensure that those documents ofexternal origin are marked and that theirdistribution is controlled?
4.2.3-09 to prevent the unintentional use ofoutdated documents and to mark them in anappropriate manner, in the event that they have tobe preserved for any reason?
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No.: CL_27_01_011e Edition: 09/2006 Page 14 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Processes and componen t s i n the I SO 9001 :2000 sys tem and i n I SO / TS1 6 9 4 9
Chap te r / c ross-re fe rence
VDA 6.2 Documen tsecond ed i t i on 2 004
Additional requirements / focal pointsVDA 6.2 compared with
ISO 9001:2000
Section: 4.2.4.1 Does the control of the recordscomply with statutory, authorityand customer requirements?
Are aspects taken into accountsuch as:
o protection against fire, watero archiving media (files, micro-film,
computer).o if necessary additional security
files (double archiving, safetycopy etc.)
Destroy
Creatingcollecting
putting in orderidentifying
cataloguing
Releasingdistributing
Storingsecuring
Define retentiontimes
Protectkeep
Control of quality records
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No.: CL_27_01_011e Edition: 09/2006 Page 15 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Protocol / notes: Discussionpartner:
Control of quality records
Audit objectives:
Observations/references:
Deviations from standards (number of theimprovement measures protocol):
Notes, recommendations:
J N
4.2 .4 Cont ro l o f qua l i t y records
4.2.4-01 Are quality records produced andmaintained in order to provide verification ofconformity with the requirements and establish theeffective functioning of the quality managementsystem?
4.2.4-02 Are quality records kept legible, easilyrecognizable and easy to find?
4.2.4-03 Does a documented procedure exist forestablishing the controlling measures that areessential for the marking, keeping, protection, quickaccessibility, the maintenance deadline forpreserving quality records and the right of disposalover quality records?
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No.: CL_27_01_011e Edition: 09/2006 Page 16 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Processes and componen t s i n the I SO 9001 :2000 sys tem and i n I SO / TS1 6 9 4 9
Chap te r / c ross-
re fe rence
VDA 6.2 Documen tsecond ed i t i on 2 004
Additional requirements / focal pointsVDA 6.2 compared with
ISO 9001:2000
Section 6.2.1.
Section 6.2.1.1.
Are measures for training, qualificationand motivation of the employeesplanned and implemented at all levelsin all areas and is the implementationevaluated?
Is the qualification of the employeesestablished in appropriate requirement
profiles, job descriptions, functional orprocess descriptions? Has a sustained improvement in
management / managementbehaviour been achieved (keywordemployee attitude survey)
Section 6.2.2.
Section 6.2.2.1
Section 6.2.2.2/3
Are there procedures for:o Attracting new employeeso Job familiarization/instructiono Regular employee discussions
with comparison of targetachievement
o Regular establishing of thepersonnel and functionrelated training requirements
of all employees? Is there an adequate employee
training given at the workplace?Keywords to this:
o New / changed workprocesses
o Effects of faults / non-fulfilment on the customer
Establishing of employee motivation(continuous improvement ofenvironment / innovation).
Section 6.3
Section 6.3.1.
Are all activities traceable to terms ofmaintenance / improvement of theinfrastructure?
Have all the criteria for a fulfilment ofthe services according to requirementsbeen established (e.g. ergonomics,quality, schedules, costs)
Are there emergency plans?
Section 6.4
Section 6.4.1.
Has it been assured that all therequirements from planning for theworking environment have beenmaintained in relation to the provisionof the service?
Do the works, the environment complywith the statutory requirements inrespect to safety, order, and hygiene?
Analysis ofrequirement
abilitiesgaps
Planningbudgetingselectionof offers
Coordinationimplementation
Evaluatinguse
Checkingneeds coverage
Resources, training, competence,awareness
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No.: CL_27_01_011e Edition: 09/2006 Page 17 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Protocol / notes: Discussionpartner:
Training, competence, awarenessAudit objectives:
Observations/references:
Deviations from standards (number of theimprovement measures protocol):
Notes, recommendations:
J N
6.2 P ersonne l resources
4.2.1 General
6.2.1-01 Is the personnel that is involved inactivities that influence the product quality capableas a result of reasonable training, instruction,abilities and experience?
6.2 .2 Capab i l i t y , awaren ess and t ra in ing
6.2.2-01 Does the organization establish thenecessary capabilities of the personnel involved inactivities that influence the product quality?
6.2.2-02 Does the organization take care ofcoverage for this need for training or does it resortto other measures?
6.2.2-03 Does it assess the effectiveness of themeasures resorted to?
6.2.2-04 Does it ensure that the personnel is awareof the significance and importance of its activitiesand does it know that it is contributing to theachievement of quality objectives?
6.2.2-05 Does it maintain suitable notes andrecords on instruction, training, skills andexperience?
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No.: CL_27_01_011e Edition: 09/2006 Page 18 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Processes and componen t s i n the I SO 9001 :2000 sys tem and i n I SO / TS1 6 9 4 9
Chap te r / c ross-re fe rence
VDA 6.2 Documen t
second ed i t i on 2 004
Additional requirements / focal pointsVDA 6.2 compared with
ISO 9001:2000
Section 8.2.2.1 Does the system audit your QM systemin accordance with the VDA 6.2specifications, along with all other QMsystem requirements (taking account
of customer specific specifications)?
Section 8.2.2.2 Is each service process audited in
order to establish its effectiveness?
Section 8.2.2.3
Do the internal audits take account ofall the service processes listed in thehandbook and are these audited in anadequate manner?
Is there an annual plan for the carryingout of audits?
Does the internal audit planning takeinto account at least:
o auditing issueso reference documentso processes to be auditedo audit sequenceo questions complex (check list)o scheduleso audit team (contact partners)o reporting and distribution
Section 8.2.2.4
Are all the auditors sufficientlyqualified in accordance with thecustomer / industry requirements /(also see Basic Requirements fromVDA 6 )
Are all the auditors trained in regard tothe requirements of methods, qualitytechniques, standards etc?
Do the auditors comply with therequirements in terms of personalcharacteristics (also see ISO 19011see Basic Requirements for Auditors)?
Analysis of therequirement and the
frequency
Definition of theareaprocessespersons
Planningselection of the
auditorsmethods and
means
Realizationcoordination
conformity comparisoncompiling
improvement potential
Establish and implementfollow-up activities
Internal audit
Reporting
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No.: CL_27_01_011e Edition: 09/2006 Page 19 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Protocol / notes: Discussionpartner:
Internal auditAudit objectives:
Observations/references:
Deviations from standards (number of theimprovement measures protocol):
Notes, recommendations:
J N
8 . 2 .2 I n t e r n a l a u d i t (according to ISO 9001:2000)
Does the organization carry out internal audits at plannedintervals to establish whether the quality managementsystem:
8.2.2-01 fulfils the planned rules of thisinternational standard and the requirements on thequality management system as established by theorganization?
8.2.2-02 is effectively realized and maintained?
8.2.2-03 Is an audit program created in which thesignificance of the processes to be audited and theareas as well as the results of earlier audits aretaken into account?
8.2.2-04 Are the audit criteria, the extent of theaudit, the audit frequency and the audit methoddefined?
8.2.2-05 Does the selection of auditors and thecarrying out of the audits ensure the objectivity andimpartiality of the audit process?
8.2.2-06 Is it assured that the auditors are notauditing their own activities?
8.2.2-07 Are the responsibilities and requirementsfor the planning and implementation of auditstogether with reporting on their results and thekeeping of record notes established in adocumented procedure?
8.2.2-08 Has the management responsible beenassured for the area to be audited so that measuresfor dealing with faults and their causes that havebeen recognized can be taken without delay?
8.2.2-09 Do the follow-up measures containprovisions for the verification of these measuresand for reporting on the verification?
AA
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No.: CL_27_01_011e Edition: 09/2006 Page 20 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Processes and componen t s i n the I SO 9001 :2000 sys tem and i n I SO / TS1 6 9 4 9
Chap te r / c ross-
re fe renceVDA 6.2 Documen t
second ed i t i on 2004
Additional requirements / focal pointsVDA 6.2 compared with
ISO 9001:2000
Section 8.5.2.1
Are appropriate methods for solvingproblems systematically applied bythe organization in order to do awaywith the basic causes (e.g. 8 Steps, 5Steps, 5 M or similar)?
Are deeper root causes established by
these methods, in particular in regardto quality and problems withcustomer satisfaction (inclusion ofthose involved in the process such asservice providers and servicereceivers / record documents coveringthis)?
Are problem solving methodsspecified by the customer applied?
Section 8.5.2.2
Is the knowledge gained fromproblems also taken into account insimilar cases / processes on apreventive basis?
Are processes that promote customeroriented thinking and acting and ruleout repetitions of faults established?
Are appropriate techniques used,e.g.:
o working in a control cycle(PDCA)
o working according to cycleplans, check lists or similar
o risk analyses (FMEA)
Section 8.5.2.3
Are services analyzed about whichcustomers have complained?
Is the analysis of data for internal andexternal complaints a purposeful /planned procedure with the objectiveof systematically excluding the causesof faults?
Is the time for diagnostics (analysis ofcauses of faults / derivation ofmeasures / checking of effectiveness)recorded and minimized?
Are the record notes on this available?
Selectweight
evaluateexisting
problems
Analysecauses
Defineand implement
measures
Check the effectivenessof these
measures
Corrective measures
Defineintroduce
implement andevaluate
follow-up measures
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No.: CL_27_01_011e Edition: 09/2006 Page 21 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Protocol / notes: Discussionpartner:
Corrective measures
Audit objectives:
Observations/references:
Deviations from standards (number of the improvementmeasures protocol):
Notes, recommendations:
J N
8.5.2
8.5.2-01 Have corrective measures been made fordealing with the causes of faults to preventreoccurrence?
8.5.2-02 Corrective measures must be appropriateto the effects of the faults that have occurred. Isthis the case?
Does an introduced documented procedure exist toestablish specifications for the:
8.5.2-03 Evaluation of faults (including customercomplaints)?
8.5.2-04 Establishing the causes of faults?
8.5.2-05 Assessment of the requirement for action,
to prevent the renewed occurrence of faults?
8.5.2-06 Establishing and realization of therequired measures?
8.5.2-07 Recording of the results of the measuresintroduced?
8.5.2-08 Evaluation of the corrective measurestaken?
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No.: CL_27_01_011e Edition: 09/2006 Page 22 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Processes and componen t s i n the I SO 9001 :2000 sys tem and i n I SO / TS1 6 9 4 9
Chap te r / c ross-re fe rence
VDA 6.2 Documen tsecond ed i t i on 2 004
Additional requirements / focal pointsVDA 6.2 compared with
ISO 9001:2000
Basic requirements forthe
automobile industry
are to be taken intoaccount
Question a systematic procedurerun-up for risk analysis.
(For further examples on this seecontract verification / project handling/ FMEA)
Identifyingweightingevaluating
possible, butnot yet existent
problems / risks
Considerpotential causes
Define andimplementpreventiveactivities
Verifying whether risks havebeen reduced
Preventive measures
Defineintroduce
implementevaluate
follow-up activities
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No.: CL_27_01_011e Edition: 09/2006 Page 23 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Protocol / notes: Discussionpartner:
Preventive actionAudit objectives:
Observations/references:
Deviations from standards (number of theimprovement measures protocol):
Notes, recommendations:
J N
8.5 .3 P revent i ve measures
8.5.3-01 Have preventive measures for dealingwith the causes of potential faults been defined toprevent these from occurring?
8.5.3-02 Preventive measures must be appropriateto the effects of the potential problems that haveoccurred. Is this the case?
Does an introduced documented procedure exist toestablish specifications for the:
8.5.3-03 Establishing of potential faults and theircauses?
8.5.3-04 Assessment of the requirement for action,to prevent the renewed occurrence of faults?
8.5.3-05 Establishing and realization of therequired measures?
8.5.3-06 Recording of the results of the measuresintroduced?
8.5.3-07 Evaluation of the preventive measurestaken?
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No.: CL_27_01_011e Edition: 09/2006 Page 24 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Processes and componen t s i n the I SO 9001 :2000 sys tem and i n I SO / TS1 6 9 4 9
Chap te r / c ross-
re fe renceVDA 6.2 Documen t
second ed i t i on 2 004
Additional requirements / focal pointsVDA 6.2 compared with
ISO 9001:2000
Section 8.5.1.1
Is the service improvementconstantly aligned to reducingthe quality fluctuations?
o Improvement of thequality level for services
o Optimizing of processeso Risk analysis for the
service provisiono Increasing efficiency
(costs reduction forprocesses, increasingcustomer value)
o Improving customersupport and customerrelations
Section 8.5.1.1
Have steps and activities such ase.g.:
o Systematic diagnosis and
implementation of theknowledge that has beenobtained (inclusion ofthose concerned,optimizing)
o Establishing ofresponsibilities andauthorities
o Selection of improvementprojects according toestablished criteria
o Monitoring of theseparate improvementprojects
o Results evaluation(customer value,economy, comparisonwith objective targets)
o Use of reporting systems,benchmarks, audits,customer reports
been taken into account?
Defining theimprovement potential
of the system,the processes,the products,the services,
the communication,the information,
and setting priorities
Considering targetsand makingthem binding
Planning, implementingand monitoring
activities
Verification of achievementof objectives
Improvement process
Defineintroduceimplementevaluate
follow-up activities
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No.: CL_27_01_011e Edition: 09/2006 Page 25 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Protocol / notes: Discussionpartner:
Improvement process
Audit objectives:
Observations/references:
Deviations from standards (number of the improvementmeasures protocol):
Notes, recommendations:
J N
8.5 .1 Cont inuous improvement
8.5.1-01 Is the effectiveness of the qualitymanagement system continuously improvedthrough the application of quality policy, qualityobjectives, audit results, data analysis, correctionand preventive measures plus managementevaluation?
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No.: CL_27_01_011e Edition: 09/2006 Page 26 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Processes and componen t s i n the I SO 9001 :2000 sys tem and i n I SO / TS1 6 9 4 9
Chapt er / c ross-reference
VDA 6.2
Documentsecond edi t ion
2 0 0 4
Additional requirements / focal pointsVDA 6.2 compared with
ISO 9001:2000
Section 7.1
Is quality planning done across alldepartments?
Does the quality future planning includeconcepts for avoiding faults?
Are the processes / activities described in anappropriate manner, - as e.g.:
o establishing and marking of the
significant characteristics of theservice
o provision of equipment, processes andcontrolling measures
o updating of processes and equipmento timely, forward looking provision of
measuring techniques and methodso testing of purposeful positions for
service implementationo clarification of acceptance criteriao monitoring of changes including
verification and validation
Section 7.2.1
Has a check been made prior to the provisionof the service, which applicable specifications,standards and drawings are to be taken intoaccount?
Section7.2.1.1.
Is there a process for market research as thebasis for the development / provision ofservices?
Is it a management task to monitor theseprocesses in regard to their effectiveness?
Section 7.2.2.1
Has the extent of the service to be providedbeen adequately clarified?
o clarification of the extent of theservice and its feasibility
o limiting of the expected costs in theprovision of the service
o defining the quality requirements
Section 7.2.3.1
Can a systematic market development bedocumented?
Are advertising claims fulfilled in a manner thatcan be verified?
Is the effectiveness evaluated? Is a Corporate Identity maintained?
Section 7.2.3.2
Is the acceptance of and affect on/through thecustomer observed through the entire period ofthe warranty/guarantee?
Is the knowledge gained in this made of use ofin the sense of the KVP?
Requirements
Analysisidentification
comparison
Evaluation of suitabilityfor implementation and
feasibility
Chancesrisks
standardsfactors of influence
Analysis of thefeedback
Customer related processes
External / internalcommunication
interactivesequential
parallelproactivereactive
Follow-up activity
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No.: CL_27_01_011e Edition: 09/2006 Page 27 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Protocol / notes: Discussionpartner:
Customer-related processes
Audit objectives:
Observations/references:
Deviations from standards (number of theimprovement measures protocol):
Notes, recommendations:
J N
7.2 Custom er re la ted p rocesses
7.2 .1 Es tab l i sh ing t he spec i f i ca t ions in regard t o t he
p r o d u c t
Does the organization establish the following:7.2.1-01 The requirements established by thecustomer including the requirements in respect todelivery and activities after delivery?
7.2.1-02 Those specifications that have not beengiven by the customer, but which are essential forthe defined or the known and intended use?
7.2.1-03 Statutory and authority specifications inrespect to the product?
7.2.1-04 All further requirements established bythe organization?
7.2 .1 Es tab l i sh ing t he spec i f i ca t ions in regard t o t he
p r o d u c t
7.2.2-01 Does the organization evaluate thespecifications in regard to the product?
7.2.2-02 Is this evaluation made before a deliveryobligation to the customer arises (e.g. delivery ofoffers, acceptance of contracts or orders,acceptance of contractual or order changes)?
Does it ensure:
7.2.2-03 That the specifications made on theproduct are defined?
7.2.2-04 That the differences between thespecifications in the contract or order and thespecifications as these were previously formulatedhave been disposed of?
7.2.2-05 That the organization is in a position tofulfil the defined specifications?
7.2.2-06 That records are made of the evaluationresults and their follow-up measures?
7.2.2-07 That the customer requirements prior toacceptance are confirmed by the organization whenthe customer has not previously presenteddocumented specifications?
7.2.2-08 Does the organization ensure whenproduct requirements change that the re levantdocuments are also changed and that theresponsible personnel are made aware of thechanged specifications?
EXPLANATORY NOTE: In a nu mb er of cases e.g. In ter net
sales, a form al evaluation of each separate order is not
practicable. Instead of this, the evaluation can refer to
relevant product informat ion such as catalogues or
advertising material for example.
7.2 .3 Communica t ion w i t h t he cus tomer
Does the organization have effective regulations forcommunication with the customer that have beenestablished to cover the following points and have thesebeen implemented:
7.2.3-01 Product information?
7.2.3-02 Inquiries, contracts or order processingincluding changes?
7.2.3-03 Feedback from the customer includingcustomer complaints?
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No.: CL_27_01_011e Edition: 09/2006 Page 28 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Processes and componen t s i n the I SO 9001 :2000 sys tem and i n I SO / TS1 6 9 4 9
Chap te r / c ross-re fe rence
VDA 6.2 Documen tsecond ed i t i on 2004
Additional requirements / focalpoints
VDA 6.2 compared withISO 9001:2000
Section 7.3.1.
Is an inter-departmentalapproach assured?
Have special characteristics andtheir monitoring been established
within the scope of the projectplanning?
Have appropriate methods andtools been used in the planningphase (e.g.: FMEA)?
Section 7.3.2.1
Have all thecharacteristics/requirements forthe product development beenestablished, documented andevaluated?
o customer demandso contract document
specificationso agreed delivery obligationso taking into account of
previous experience (marketresearch, competition,supplier feedback,...)
o Have targets beenestablished for the productquality/servicelife/reliability/shelf life etc.been established? Is there atime management and costoverview for this?
Section 7.3.2.2
Are all the requirements for theproduction process developmentknown?
Have the special characteristicsbeen established (customerrequirement or internal)?
Section 7.3.3.1 Are the results of the service
process development available?
Section 7.3.4.1
Is the development ofappropriate evaluationsperformed in established phases?
Section 7.3.7
Have processes andresponsibilities for changes beensuitably established?
Section 7.3.8
Is there a procedure for thechecking and release aftercompletion of the servicepreparation?
Ideasanalysingcustomerwishes
internal / external
Specification
Decisionplanning
project design
Development
Design/developmen
t
Design/Reviews
Verification
Validation
Designresults
development
results
Design/develop
mentchanges
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No.: CL_27_01_011e Edition: 09/2006 Page 29 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Protocol/ notes: Discussionpartner:
Deve lopmen t
Audit objectives:
Observations/references:
Deviations from standards (number of theimprovement measures protocol):
Notes, recommendations:
J N7.3 Deve l opment
7 .3 .1 Deve lopment p l ann i ng
7.3.1-01 Does the organization plan and control thedevelopment of the product?
7.3.1-02 Are a reasonable evaluation, verification andvalidation and the responsibilities and authorities fordevelopment established in the development planning anddevelopment phase for each development phase?
7.3.1-03 Does the organization manage and control theinterfaces between the different groups involved in thedevelopment groups, in order to assure an effectivecommunication and a clear allocation of the responsibility?
7.3.1-04 Is the result of the planning updated with thecontinuing development insofar as this i s appropriate?
7.3 .2 Deve l opment i nput s
7.3.2-01 Are inputs in regard to the product requirementsestablished and recorded?
Do these contain:
7.3.2-02 Functional and performance requirements?
7.3.2-03 Appropriate statutory and authority requirements?7.3.2-04 Where applicable, information derived from earliersimilar developments?
7.3.2-05 Other specifications important for the development?
7.3.2-06 Are these inputs evaluated on the basis of theirappropriateness?
7.3.2-07 Are the specifications complete, clear and free fromcontradictions?
7.3 .3 Deve l opment r esu l t s
7.3.3-01 Are the development results provided in a formwhich make their verification possible over and against thedevelopment inputs, and are they subject to approval beforerelease?
Is it ensured that:
7.3.3-02 the development results fulfil the developmentspecifications?
7.3.3-03 reasonable information levels for the procurement,production and provision of service are prepared?
7.3.3-04 Acceptance criteria for the product are contained orreference made to them?
7.3.3-05 Those characteristics of the product are establishedthat are essential for a safe use and the intended the purpose?
7.3 .4 Deve l opment eva l ua t i on
Are systematic reviews carried out in suitable phases in order to:
7.3.4-01 Assess the suitability of the development results forthe fulfilment of the specifications?
7.3.4-02 To recognize all problems and to suggest necessarymeasures?
7.3.4-03 Do the participants of reviews of this kind includerepresentatives of the functional areas that are affected by theevaluated development phase or the evaluated developmentphases.
7.3.4-04 Are notes taken about the results of the reviews andabout essential measures?
7.3 .5 Deve l opment v er i f i ca t i on
7.3.5-01 Is a verification is carried out in order to assure thatthe development results fulfil the development specifications?
7.3.5-02 Are notes taken about the results of the verificationand about essential measures?
7.3 .6 Deve l opment va l i da t i on
7.3.6-01 Has a development validation been carried out inaccordance with the planned regulations (see 7.3.1), to ensurethat the resulting product is in a position to fulfil thespecifications for the defined or the known intended use?
7.3.6-02 Has the validation been completed where possiblebefore the delivery or the introduction of the products?
7.3.6-03 Are notes taken about the results of the reviews andabout essential measures?
7.3 .7 Steer i ng o f deve l opment changes
7.3.7-01 Are development changes marked and recorded?
7.3.7-02 Are changes evaluated, verified and validated andalso approved before their introduction insofar as it is reasonableto do so?
7.3.7-03 Does the evaluation of the development changesinclude the assessment of the effects of the changes on thecomponents and the delivered products?
7.3.7-04 Are notes taken about the results of the reviews andabout essential measures?
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No.: CL_27_01_011e Edition: 09/2006 Page 30 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Processes and componen t s i n the I SO 9001 :2000 sys tem and i n I SO / TS
1 6 9 4 9
Chap te r / c ross-re fe rence
VDA 6.2 Documen tsecond ed i t i on 2 004
Additional requirements / focal pointsVDA 6.2 compared with
ISO 9001:2000
Section 7.5.1.1.
Is there a steering plan for theprovision of the service?
o indicators for quality steering?o testing and treatment of
customer propertyo defined characteristicso
information requestedo immediate measures for Q-problems
Section 7.5.1.2 Are there appropriate process- /
procedural instructions for thecompletion of the contract?
Section 7.5.1.3 Are all the working instructions
required up-to-date and available atthe workplaces?
Section 7.5.1.4 Are the requirements for servicing /
maintenance of tools fulfilled toterms of the requirement(availability / planned maintenance
/ key equipment / resources /qualification etc.)?
Section 7.5.1.5
Is there a coordination and scheduleplanning for the provision of theservice?
Are agreements with the customeravailable and are these taken intoaccount?
Section 7.5.1.7 Is there a process in respect to
feedback from the customer?
Section 7.5.1.8 Is there a real process for service
and customer support?
Section 7.5.2 Are all production and service
processes validated?
Section 7.5.3 Is the entire service traceable at all
times (participating employees /records)?
Section 7.5.4.1
Are the requirements for theproducts / tools that have beenprovided (customer property)fulfilled?
Section 7.5.5.1
Is the state of the warehousechecked at reasonable plannedintervals?
Are the FIFO requirements fulfilled
and are the storage areas optimallyused?
Specifications
Planningavailability of:informationinstructionscheck lists
measuring testequipmentresources
Implementationsteering
controlling
Resultproduct /service
Production / provision of service
Validation
Protectionofthe
Products/sevices
Identification
undtaceability
Custom
erproperty
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No.: CL_27_01_011e Edition: 09/2006 Page 31 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Protocols/ notes: Discussionpartner:
Production / service provision
Audit objectives:
Observations/references:
Deviations from standards (number of theimprovement measures protocol):
Notes, recommendations:
J N
7.5 P roduc t i on and serv i ce prov i s i on
7.5 .1 Cont ro l l i ng t h e produc t i on and t he serv i ces prov i s i on
7.5.1-01 Is the production and the services provision in theplanned form and is it implemented under controllableconditions?
Do the controllable conditions contain where appropriate:
7.5.1-02 The availability of data describing thecharacteristics of the product?
7.5.1-03 The availability of the working instructions?
7.5.1-04 The use of suitable equipment?
7.5.1-05 The availability and use of monitoring andmeasuring equipment?
7.5.1-06 The implementation of monitoring andmeasurements?
7.5.1-07 The implementing of release and delivery activitiesand activities subsequent to the delivery?
7.5 .2 Va l ida t i on o f t he produc t i on and serv i ce prov i s i onprocesses
7.5.2-01 Are all the production and service provisionprocesses validated, whose the results cannot be verified bythe following monitoring or measurement?
7.5.2-02 Does this also apply to all processes where theinadequacy of was first seen only after either the product hadgone into use or the service had been provided?
7.5.2-03 Does this validation demonstrate the capability ofthese processes for the achievement of the planned results?
Have regulations been established for these processes insofar as this i srelevant, containing:
7.5.2-04 Established criteria for the evaluation and approvalof the processes?
7.5.2-05 Approval of the equipment and the qualification ofthe personnel?
7.5.2-06 Use of specific methods and processes?
7.5.2-07 Requirements for records?
7.5.2-08 Renewed validation?
7.5 .3 Mark i ng and t r aceab i l it y
7.5.3-01 Is marking of the products with suitable meansduring the entire product realization performed insofar as thisis reasonable?
7.5.3-02 Is a marking made of the product status in respectto the monitoring and measurement requirements?
7.5.3-03 Is a clear marking of the product steered andrecorded when traceability is demanded?
EXPLANATORY NOTE: In some industrial branches configurationmanagement is a means for m arking and traceabili ty.
7.5 .4 Proper t y o f t h e cus tomer
7.5.4-01 Does the organization handle customer propertycarefully for as long as it is within the controlling orbit of theorganization or while it is used by it?
7.5.4-02 Does the organization mark, verify and protect thecustomer property that is entrusted to it for use or forinclusion in the product?
7.5.4-03 Are cases of loss, damage or otherwise non-suitability for use in respect to customer property reported tothe customer and are records maintained of thi s?
EXPLANATORY NOTE: Custom er prop erty can also includ eintellectual property.
7.5 .5 P roduc t ma i n tenance
7.5.5-01 Is the conformity of the product maintained duringthe internal processing and delivery to the specified locationas foreseen?
7.5.5-02 Does this maintenance include marking, handling,packing, storage and protection?
7.5.5-03 Does this maintenance apply in an analoguemanner for the components of a product?
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V D A 6 . 2
No.: CL_27_01_011e Edition: 09/2006 Page 32 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Protocol / notes: Discussionpartner:
Planning of the product implementationAudit objectives:
Observations/references:
Deviations from standards (number of theimprovement measures protocol):
Notes, recommendations:
J N
7 . 1 P l an n i n g o f t h e p r o d u c t i m p l e m e n t a t i o n
7.1-01 Does the organization plan and develop theprocesses that are required for the productimplementation?
7.1-02 Is the planning of product implementation inharmony with the requirements of the other qualitymanagement system processes?
Does the organization establish the following in theproduct implementation, insofar as this is reasonable:
7.1-03 Quality objectives and requirements fromthe product?
7.1-04 The necessity of introducing processes,creating and compiling documents and the productspecific making available of resources?
7.1-05 The required product specific verification,validation, monitoring and testing activities as wellas the product acceptance criteria?
7.1-06 The records required to demonstrate that theimplementation processes and the resulting productscomply with the specifications?
7.1-07 Are the results of this planning available in aform suited to the organization operating methods?
EXPLANATORY NOTE 1: A docum ent that establishes
both the processes of the quality management system
(including the product implementation processes) and the
resources that are to be used for a specific product, project
or for a specific contract, can be nam ed quality
management plan.
EXPLANATORY NOTE 2: The organ ization may apply
the requirements given in Section 7.3 also on the
development of product realization pro cesses.
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V D A 6 . 2
No.: CL_27_01_011e Edition: 09/2006 Page 33 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Protocol / notes: Discussionpartner:
Management of the resources (infrastructure, workingenvironment.)Audit objectives:
Observations/references:
Deviations from standards (number of theimprovement measures protocol):
Notes, recommendations:
J N
6 . 3 I n f r a s t r u c t u r e
6.3-01 Does the organization establish, prepare andmaintain the infrastructure that is required toachieve conformity with the product requirements?
The infrastructure includes e.g.:
buildings, workplace and t he supply facilities connected to
them, process equipment, both hardware and software, as
well as supporting services such as transport or
communications.
6 . 4 W o r k i n g e n v i r o n m e n t
6.4-01 Does the organization establish, manage andsteer the working environment that is required toachieve conformity with the product requirements?
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V D A 6 . 2
No.: CL_27_01_011e Edition: 09/2006 Page 34 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Processes and componen t s i n the I SO 9001 :2000 sys tem and i n I SO / TS1 6 9 4 9
Chap te r / c ross- re fe rence
VDA 6.2 Documen t
second ed i t i on 2 004
Additional requirements / focal pointsVDA 6.2 compared with
ISO 9001:2000
Section 7.4.1.
Do all the products, materials andservices procured comply with therelevant applicable officialregulations?
Section 7.4.1.2
Does the supplier QM system
comply with automobile industryrequirements and is there at leasta valid (accredited) ISO9001:2000 certificate available?
Section 7.4.1.3
Has it been ensured that theorganization uses only supplysources that have been approvedby the customer, insofar as thishas been contractually agreed?
Section 7.4.2
Have all the details relevant tothe procuring of the products /services been coordinated withsuppliers / sub-contractors?
Section 7.4.3.1
Is the supply quality adequatelymonitored?
o receipt and evaluation ofstatistical data
o goods arrivals testso evaluation / auditing of
supplierso other methods coordinated
with the customer
Section 7.4.3.2
Is the supplier service monitoredaccording to appropriateindicators (product quality,delivery performance, additionalfreight costs)?
Specifications
Selectionmarket analysis
Selection ofexistingand newsuppiers
Implementingcontracting
contract set-upperipheral
requirements
Procurement
Evaluation
re-evaluationwith suitablemethods andinstruments
Procuremen
tinformation
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No.: CL_27_01_011e Edition: 09/2006 Page 35 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Protocol / notes: Discussionpartner:
Procurement
Audit objectives:
Observations/references:
Deviations from standards (number of the improvementmeasures protocol):
Notes, recommendations:
Y N
7.4 Procuremen t
7 .4 .1 The procurement p r ocess
7.4.1-01 Does the organization ensure that theproducts procured fulfill the procurementspecifications as defined?
7.4.1-02 Does the type and extent of themonitoring applied to the supplier and the productprocured, depend on the influence of the productprocured on the subsequent productimplementation or on the end product?
7.4.1-03 Does the organization assess suppliers onthe basis of their capabilities for supplying productsthat are compliant with the specifications of the
organization?7.4.1-04 Does it select suppliers on this basis?
7.4.1-05 Do criteria exist for selection, assessmentand re-assessment?
7.4.1-06 Are records kept about the results of theassessments and with regard to essentialmeasures?
7.4 .2 Procurem ent da ta
7.4.2-01 Do procurement data describe the productthat is to be procured?
Do these contain insofar as reasonable:
7.4.2-02 Requirements for approval of products,procedures, processes and equipment?
7.4.2-03 Requirements on the qualification ofpersonnel?
7.4.2-04 Specifications for the quality managementsystem?
7.4.2-05 Does the organization assure the
suitability of the procurement requirementspecifications prior to informing the supplier aboutthem?
7.4 .3 V er i f i ca t i on o f p rocur ed produc t s
7.4.3.-01 Are the specified tests or other activitiesby means of which it is ensured that the procuredproduct fulfils the defined procurementspecifications both established and realized?
7.4.3.-02 Does the organization establish theintended verification measures and the methods forthe release of the product in the procurement datawhen either the organization itself or the customerintends to carry out verification activities at thesuppliers premises?
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No.: CL_27_01_011e Edition: 09/2006 Page 36 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Processes and componen t s i n the I SO 9001 :2000 sys tem and i n I SO / TS
1 6 9 4 9
Chap te r / c ross- re fe rence
VDA 6.2 Documen tsecond ed i t i on 2 004
Additional requirements / focal pointsVDA 6.2 compared with
ISO 9001:2000
Section 7.6.1.
Is all calibration, testing,measuring equipment that isrequired for verification ofconformity monitored?
Proof of at least the following has to
be made: Marking of the measuringequipment including traceabilityto the Calibration andMeasurement Standard.
Re-processing on the basis ofdevelopment and constructionalchanges.
All measured values outside ofthe specification that are foundduring calibration or verification.
Evaluation of the effects of thedefective state
Confirmation of compliance with
the specification after thecalibration or verification and
Reporting to the customer ondelivery and/or installation ofproducts suspects of beingdefective or materials or in thecase of services suspected ofbeing faulty.
Requirement
Follow-up measures, stock,disposal,
depreciationevaluation of required
activities or products / services
Measuring and testing equipment
Specifications
Procurement
Verification
Stock
Calibration
Calibration
Steering
Withdrawal
Issue
Consistencyofthemeasurementtomeasuringspecifications
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No.: CL_27_01_011e Edition: 09/2006 Page 37 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Protocol / notes: Discussionpartner:
Measuring and test equipment monitoring
Audit objectives:
Observations/references:
Deviations from standards (number of theimprovement measures protocol):
Notes, recommendations:
J N
7.6 Cont ro l l i ng o f mon i t o r ing and measur ing
e q u i p m e n t
7.6-01 Are the monitoring procedures andmeasurements which must be conducted to proofcompliance of the product with the definedrequirements and the required monitoring andmeasuring equipment established?
7.6-02 Have processes been introduced to ensurethat the monitoring and measuring can be carriedout and that this can be done in a manner that iscompatible with the specifications made formonitoring and measuring?
To the extent that valid results are required, is themeasuring equipment:
7.6-03 Calibrated or verified at defined intervalsbefore use?
7.6-04 And can this be done on the basis ofmeasuring standards that are based oninternational or national measuring standards?
7.6-05 When there are no measuring standardsof this kind, is the basis for the calibration orverification recorded?
7.6-06 Is measuring equipment adjusted or re-adjusted if required?
7.6-07 Are they marked so that the calibrationstatus can be recognized?
7.6-08 Are they secured against wrongadjustments that would make the measuring resultinvalid?
7.6-09 Are they protected against damage ordeterioration during handling, maintenance and
storage?7.6-10 Does the organization assess the validityof previous measuring results and are theserecorded when it has been established that themeasuring equipment does not fulfil therequirements.
7.6-11 Are suitable measures being taken inrespect to the measuring equipment and all theproducts affected?
7.6-12 Are notes taken about the results ofcalibration and verification?
7.6-13 When computer software is used formonitoring and measuring compliance with thedefined specifications, is the suitability of thissoftware confirmed as regards the intendedapplication ?
7.6-14 Is this done before the first use and whennecessary later?
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No.: CL_27_01_011e Edition: 09/2006 Page 38 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Protocol / notes: Discussionpartner:
Measur ing , ana lys i s, im provem en t
Audit objectives:Observations/references:
Deviations from standards (number of theimprovement measures protocol):
Notes, recommendations:
J N
8.1 General
Has the organization planned and realized monitoring, measuring,analysis and improvement processes that are required in order to:
8.1-01 Show the product conformity?
8.1-02 To assure the conformity of the quality managementsystem?
8.1-03 To continuously improve the effectiveness of thequality management system?
8.1-04 Does this comprise the establishing of appropriatemethods including statistical methods and the extent of t heirapplication and are the users appropriately qualified?
8.2 Mon i t o r i ng and measur i ng
8.2 .1 Cus tomer sa t i s f act i on8.2.1-01 Is information regarding customer perceptionsmonitored in the question, whether the organization has fulfilledcustomer requirements, as one of the benchmarks for theperformance of the quality management system?
8.2.1-02 Have the methods for obtaining and using thisinformation been defined?
8.2 .3 Mon i t o r i ng and m easur i ng o f p rocesses
8.2.3-01 Are suitable methods for monitoring and, whereappropriate, measuring the processes of the qualitymanagement system applied?
8.2.3-02 Do these methods demonstrate that the processes arein a position to bring about achievement of the planned results?
8.2.3-03 When the planned results are not achieved, arecorrections and corrective measures introduced in order toassure product conformity insofar as this is reasonable?
8.2 .4 Mon i t o r i ng and measur i ng o f t he produ c t
8.2.4-01 Are the characteristics of the product monitored andmeasured, in order to verify the fulfillment of the specificationsin the product?
8.2.4-02 Is this done in suitable phases in the productimplementation process and in compliance with the plannedactivities?
8.2.4-03 Is a proof of conformity carried out with theacceptance criteria?
8.2.4-04 Do these record notes state who is or who are theperson/s responsible for the release of the product?
8.2.4-05 Is a product release and service provision only madeafter the satisfactory completion of all the defined activities,insofar as this is not done otherwise by a responsible body and,
to the extent that this is required, with the permission of thecustomer?
8.3 Cont ro l o f non-conform i ng pr oduc t s
8.3-01 Is it assured that a product that does not fulfill thespecifications is appropriately marked and controlled to ensurethat its unintentional use or its delivery are prevented?
8.3-02 Are the control measures and the responsibilities andauthorities allocated to them for dealing with non-conformingproducts established in a documented procedure?
Are non-conforming products dealt with in one or more of the followingways:
8.3-03 Introduce measures to deal with the established fault?
8.3-04 Approval for use, for release or acceptance afterspecial release by a responsible position and, whereappropriate, by the customer?
8.3-05 Introduce measures to rule out the originally intendeduse or application?
8.3-06 Making record notes of the type of faults and thesubsequent measures resorted to including the special releasesthat have been obtained?
8.3-07 When a non-conforming product has been improved isthis verified once again to demonstrate conformity with the
specifications?
8.3-08 If a non-conforming product is discovered after thedelivery or in use, are measures introduced that are appropriatefor the consequences or the potential consequences?
8.4 Data analysis
8.4-01 Are suitable data established, recorded and analyzedin order to present and assess the suitabili ty and effectivenessof the quality management system where continuousimprovement of the quality management system can be made?
8.4-02 Does this also include data that is obtained frommonitoring and measuring and from other relevant sources?
Does the data analysis supply data about:
8.4-03 Customer satisfaction?
8.4-04 The fulfillment of the specifications for the product?
8.4-05 Process and product characteristics and their trends?
8.4-06 Possibilities for preventive measures?
8.4-07 Suppliers?
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VDA 6.2
No.: CL_27_01_011e Edition: 09/2006 Page 39 of 40
Created by: Perschler Tested by: Kreiter Released by: Perschler
A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,E-mail: [email protected]
Process assessm ent accord ing t o VDA 6 .2
Risk assessment ,
e f fec t i ven ess in
prac t i ce
No r i s k ,
e f fec t i veness
ver i f i ed
Low r i s k ,
e f fec t i veness
la rge l y ve r i f i ed
Sign i f i cant
r i s k ,
e f fec t i veness large ly
ve r i f i ed
H igh r i s k ,
e f fec t i veness
par t i a l l yve r i f i ed
H igh r i s k ,
e f fec t i veness
no t ve r i f i ed
Speci f i cat ion an dver i f i cat i on document a t i on
Complete ly
fu l f i l l ed
Predomina te l y
g iven
Predomina t
e ly g iven
Part l y g iven Given in
f r a g m e n t s
6 / r ed
( m i n o rdev ia t i on )
4 / r ed
( m a j o rdev ia t i on )
0 / r ed
( m a j o rdev ia t i on )
Poin ts assessment to VDA
6 .2Tra f f i c- l i gh t l og i c /
e f fec ts fo r ce r t i f i cat i on
p rocedures
1 0 / Gr e en
(OK)
ce r t i f i ca te
suppor ted
8 / y e ll o w
( N o t e )
ce r t i f i ca te
suppor ted No ce r t i f i ca te supp lement acco rd to VDA6 .2
Evaluated processes Eva lua t i on / resu l t s acco rd ing to VDA 6 .2
Corpora t e s t ra tegy
Management i nc l ud ing
corpo ra te cu l tu re , pe rsonne l/ sa f et y
Process landscape( r esponsib i l i t y f o r
deve lopment and sequence
organ i za t i on )
Management sys tem( a lso QM system )
Con t r o l l i ng ( a l so f i nanc ial
eva lua t i on o f non-qua l i t ycos ts )
Marke t and cus tomerrequ i rem en ts a re de f i ned?
Deve lop se rv i ce (p r oduc t )
Develop serv ice pr oce