Sie sind auf Seite 1von 25

Quality Assurance Process Audit

Internal audit according to VDA 6.3


Auditor Checklist Revision 1 dated 02/99 Page
1

No. Assessment element

A Product Development Process


Product Development (Design)
M1 Product Development Planning
M1.1 Are the customer requirements available?
Are drawings, standards, specifications and customer requirements
available?
Was the required logistics concept taken into account?

Are the technical delivery conditions and test specifications clearly


defined? How is the (contract) review documented?

Are there product quality agreements, ppm targets?


Are important product/process characteristics described?

Are customer ordering documents including parts lists/deadlines available?


(usually not relevant for automotive divisions UBK)

Were applicable laws and legal standards considered?


Were recycling plans and environmental aspects considered?

Are there quality management and/or organizational requirements? Were


they considered?

M1.2 Is a product development plan available and


are the targets maintained?
Does it contain the customer requirements?

Were cost targets considered?

Are deadlines defined for planning/purchasing release, design freeze, pre-


production, start of mass production (e.g. general deadline schedule and
detailed project deadline schedules)?

Was a capacity analysis performed?


Are quality targets defined and are they tracked? (cost see above)

Is recurring information to management planned (e.g. QB's, reviews,


releases)?

Are simultaneous engineering teams (SET) used?

M1.3 Are the resources for the realization of the


product development planned?
Have customer requirements been considered?
Is the personnel adequately qualified? Is additional training necessary?

Are processing times taken into account?


Are suitable buildings available (for making test and prototype samples)?

Are suitable tools and equipment available?

Is the laboratory and test equipment suitable and available?

Is CAD, CAM and CAE used to a suitable extent?


Quality Assurance Process Audit
Internal audit according to VDA 6.3
Auditor Checklist Revision 1 dated 02/99 Page
2

No. Assessment element

M1.4 Have the product requirements been


determined and considered?
Have customer requirements and market expectations been adequately
considered?

Has an internal specification been developed from the customer


specification which was agreed to?

Are the requirements compatible with the company's targets?

Has the design goal robust design/capable processes been considered?


How is available know-how used; for example, are there design rules?

Are regular customer/supplier discussions planned?

Have important characteristics and legal requirements been considered?

Have functional dimensions, installation dimensions and materials been


determined and defined?

M1.5 Has the feasibility been determined based on


the available requirements?
Has the feasibility of the design been determined?

Can the quality requirements be maintained?


Can the process equipment be made and the capacity requirements met?

Can the applicable standards, rules and laws be complied with?

Can the environmental compatibility requirements be met?

Can the deadlines and overall time schedule be met?

Can the cost target be met?

M1.6 Are the neccessary personnel and technical


conditions for the project process
planned/available?
Are the project management and the project planning team, and their
responsibilities, defined?

Are communications means available (e.g. data transfer via networks)?

Is communication to and from the customer during the planning phase


possible (regulare meetings, conferences)?

M2 Realizing Product Development


M2.1 Is the design FMEA raised and are
improvements measures established?
Have customer requirements/specifications been considered?

Have function, safety, reliability, serviceability and other important factors


been considered?

Have environmental aspects been considered?

Are all relevant departments involved?

Are test results considered?

Have product-specific actions from the process FMEA been considered?


Quality Assurance Process Audit
Internal audit according to VDA 6.3
Auditor Checklist Revision 1 dated 02/99 Page
3

No. Assessment element

M2.2 Is the design FMEA updated in the project


process and are established measures
realized?
Have customer requirements been considered?

Have important parameters/characteristics and legal requirements been


considered?

Have function, installation dimensions and material been considered?

Have environmental aspects been considered?

Has internal and external shipping been considered?

Have product-specific actions from the process FMEA been considered?

M2.3 Is a quality plan prepared?


Are significant characteristics defined and identified?

Are test sequence plans made for the prototype phase and for the pre-
production phase?

Are the necessary equipment and supplies available?

Was advanced planning of the necessary measurement equipment


performed, and is timely availability ensured?

Are tests at suitable stages of the product development planned?

Were the acceptance criteria (customer specification) employed?

M2.4 Are the required releases/qualifications


records available at the respective times?

Has product testing been performed (e.g. installation tests, functional tests,
endurance tests, environmental simulation tests)?

Have individual prototype parts and pre-production parts (hardware) been


tested and released?

Are manufacturing and test equipment, and measuring and test equipment
in the sample shop, included in the release process?

M2.5 Are the required resources available?


Have the sample shop capacity and processing times been considered?

Is the personnel qualified for their tasks?

Note: If M1 and M2 are rated during the audit, then the following questions
can be ignored, since they are considered in question M1.3.

If M2 is used itself (without M1) then the following questions should be


considered:

Are suitable buildings available?

Are suitable tools and equipment available?

Is the laboratory and test equipment suitable and available?

Is CAD, CAM and CAE used to a suitable extent?


Quality Assurance Process Audit
Internal audit according to VDA 6.3
Auditor Checklist Revision 1 dated 02/99 Page
4

No. Assessment element

M3 Process Development Planning


M3.1 Are the product requirements available?
Is the current specification available?

Are the currently valid drawings and test specifications available? (For
projects in an early phase: are current customer or development
documents available (e.g. drawings, specifications) and how is
updating/exchange of documents ensured?)

Which standards or legal regulations are applicable (e.g. DIN, Bosch Norm,
…)? Is the current edition available?

Are packaging requirements known (e.g. one-way or returnable packaging,


special inserts or labeling)?

How are product-related quality agreements (e.g. ppm upper limits) made
known, and how are they achieved?

Are special characteristics (important, significant, critical) agreed upon and


identified in the documentation?

Are dangerous materials used?


Are results from environmental compatibility/recycling tests available?
Which special actions does this result in?

M3.2 Is a process development plan available and


are the targets maintained?
Are activities for process planning defined and dated (e.g. general deadline
schedule, project deadline schedule)?

Do the deadlines correspond to the newest overall project deadline


schedule (e.g. QB/review, release deadlines, pre-production, SOP,
component release/availability)?

Have costs been determined (investment calculation with material,


production area, equipment, … costs)?

Is time allotted for


-checking available production capacity, writing the (equipment)
specification
-procuring and releasing equipment (including tooling/measuring
equipment/software)
-preparing manufacturing and process documentation
-procuring packaging

-starting Production
-training personnel

M3.3 Are the resources for th realization of serial


production planned?
Has a capacity analysis been performed, and a comparison of predicted
sales volume (VPS) to the technical equipment capacity (TEK)?

Is this analysis used to determine the equipment (including laboratory


equipment, measuring and test equipment), production area, personnel, etc.
needed, and if necessary, is an investment request made?

Is an order specification made for new equipment? (including requirements


for power/cycle time/% up-time, machine capability, maintenance, legal
requirements, deadlines, acceptance criteria, ...)

Is enough returnable packaging/containers planned or available, including


corresponding areas for storage and for use in production?
Quality Assurance Process Audit
Internal audit according to VDA 6.3
Auditor Checklist Revision 1 dated 02/99 Page
5

No. Assessment element

Are planning tools such as CA-tools or standardized planning processes


(diagrams, checklists, …) available, and are they used?
Quality Assurance Process Audit
Internal audit according to VDA 6.3
Auditor Checklist Revision 1 dated 02/99 Page
6

No. Assessment element

M3.4 Have the process requirements been


determined and considered?
Is production planning personnel involved in the use of quality management
methods (e.g. QFD, DOE, …) at an early stage of product development, in
order to ensure that previous process experience and requirements are
considered?

How is experience from comparable equipment/tooling/measuring


equipment analyzed and used when planning new equipment, to ensure that
it is suitable from the start?

Are the departments for work and test station design involved in the
planning process, and how are the layout suggestions and requirements
implemented?

How are special handling, packaging, storage and labeling requirements for
materials, components and finished products determined, and how is
compliance with these requirements ensured (e.g. dangerous materials,
limited storage time, ESD protection, clean

M3.5 Are the necessary personnel and technical


preconditions for the project process
planned/available?
Is there a project team with clearly defined responsibilities (e.g.
responsibility for process planning/implementation, if necessary sub- teams
or partial teams as part of the overall project)?

Are reporting paths and cycle times (who reports what to whom) defined
and known to all team members?

Are the communication interfaces to the customer (personnel and technical)


defined (e.g. sales, development, … CAD data transfer)?
Are the Bosch-internal requirements/directives available, and are they
complied with (e.g. during data exchange)?

Are documents available for estimating the number of personnel needed?

Are documents available for estimating the technical feasibility (e.g.


difficulty, equipment for planning, installing process equipment: CAD,
machine construction, …)?

Is the technical capacity available (e.g. degree of use of machines and


equipment), or are the orders confirmed?

M3.6 Is the process FMEA raised and are the


improvement measures established?
Do all relevant departments (e.g. production planners, manufacturing
personnel, development, quality assurance) participate in performing the
process FMEA?

Are technical specifications complied with (e.g. test specification, drawings,


special characteristics (customer requirements) with special symbols, etc.)?

Have all manufacturing stages and process steps been considered in the
FMEA?
Is follow-up on comments from the design FMEA concerning manufacturing
activities performed?

Have environmental influences (e.g. temperature, vibration) and


environmental protection aspects been considered?

How have suppliers been involved (can be rated in M5):


Are suppliers informed of the function and of potential risks/defects in
components (e.g. from the design FMEA)?
Is the supplier familiar with the process FMEA and process capability
measures?
Quality Assurance Process Audit
Internal audit according to VDA 6.3
Auditor Checklist Revision 1 dated 02/99 Page
7

No. Assessment element

Have internal and external shipping risks, and (if required) traceability risks
been considered?
Quality Assurance Process Audit
Internal audit according to VDA 6.3
Auditor Checklist Revision 1 dated 02/99 Page
8

No. Assessment element

M4 Realizing Process Development


M4.1 Is the process FMEA updated when
amendments are made during the project
process and are the established measures
implemented?
Is the FMEA updated for changes of components, the finished product or
processes, and are all process steps analyzed regarding possible changes
or additions?
Are affected suppliers involved?

Are changes implemented on time, and are they documented in the FMEA in
an understandable manner?

Are changes and updates of the FMEA clearly understandable (FMEA


change history/resum?)?

M4.2 Is a quality plan prepared?


Note:
Quality plan for equipment planning and implementation activities see
above in questions M3.2/3.3. The following questions deal with SOP and
mass production.

Is there a control plan (see QSP0403)?


If pre-production or pilot series were manufactured: is there a
corresponding pre-production control plan?

Is the control plan in agreement with other manufacturing documents (e.g.


work flow plan, drawings, manufacturing and test/work station instructions),
or is it clear that the documents have been verified to agree with each
other?

Is there a corresponding process layout/flow chart?

Are special characteristics (important, significant, critical) identified in the


PQP (control plan)?

Does the PQP or its supplemental documents include information on


ensuring the capability of equipment (cyclical tests of proper and capable
function)?

Are actions defined in the process FMEA included in the PQP and
implemented?

Is the control plan updated when process changes or additions are made
(e.g. due to additional CIP or defect prevention activities), and can the
changes and modifications be clearly traced (PQP change history/resum?)?

M4.3 Are the required release/qualification records


available at the respective times?
Has an acceptance qualification release according to the specification for
equipment (machines, equipment, tooling, measurement equipment) been
performed and documented (including corresponding machine and
measurement system capabilities)?

Are there deadlines for items still open, and are they finished according to
the schedule?

Are all of the purchased parts, materials and operating supplies for mass
production available (i.e. has the initial sampling been successfully
completed)?

Are reliability tests according to the test specification performed and


completed on time?
Are additional tests (of finished products, components, materials)
planned/performed/completed (e.g. installation tests, environmental tests,
driving tests)?
Quality Assurance Process Audit
Internal audit according to VDA 6.3
Auditor Checklist Revision 1 dated 02/99 Page
9

No. Assessment element

How has the logistic concept been validated (e.g. shipping tests, are the
results documented and have corrective actions been introduced, if
necessary)?
Quality Assurance Process Audit
Internal audit according to VDA 6.3
Auditor Checklist Revision 1 dated 02/99 Page
10

No. Assessment element

M4.4 Is a pre-production carried out under serial


conditions for the serial release?
Is an initial series production with the necessary number of parts
performed, analyzed and documented, together with possibly needed
corrective actions?

Is initial sampling performed and documented according to customer


requirements (e.g. PPAP)?

Has the required process capability been analyzed and fulfilled? If it is not
fulfilled: are the necessary additional quality assurance activities defined
and implemented?

Is delivery performed according to the packaging parts list?

Have general parts flow requirements (e.g. FIFO, labeling, …) been


considered?

Is the personnel trained, and is the necessary documentation of this


training available?

M4.5 Are the production and inspection documents


available and complete?
Are the manufacturing and test documents controlled copies, or how can
the personnel check whether they have the current and valid version (e.g.
with a master list on the computer network)?

Are all of the required/planned process, test and manufacturing instructions


(test specifications indicating the characteristic, test method, test
frequency, test equipment) available and up-to-date?

Are all of the required set-up instructions for current machine/process


parameters available (e.g. quantities for pressure, temperature, time, speed,
machine program, …), and are the permissible tolerances indicated?

Have set-up charts been prepared for replaceable tooling and fixtures, and
are they being used?
Are operating manuals available if needed?

Are all of the SPC charts specified in the control plan, including the
necessary test information, in place, and are they being used?

Are manufacturing defects (also from final testing) systematically registered


and analyzed? Are the responsibilities defined?

Are clear maintenance specifications available (indicating the activity,


frequency of performance and responsibility), and is performance of this
activity documented?

M4.6 Are the required resources available?


Has the capacity (as planned, see question M3.3) been installed?
If there are capacity problems: are actions defined and are they being
completed according to schedule?

Has a capacity analysis been performed, and a comparison of predicted


sales volume (VPS) to the technical equipment capacity (TEK)? Have sub-
assemblies and purchasing of materials and components been included in
the analysis?

Is this used to determine the equipment needed (including laboratory


equipment, measuring and test equipment), production area, personnel,
etc., and if necessary, was an investment request filled out?

Is an order specification made for new equipment? (including requirements


for power/cycle time/% up-time, machine capability, maintenance, legal
requirements, deadlines, acceptance criteria, ...)
Quality Assurance Process Audit
Internal audit according to VDA 6.3
Auditor Checklist Revision 1 dated 02/99 Page
11

No. Assessment element

Is enough returnable packaging/containers planned or available, including


corresponding areas for storage and for use in production?
Quality Assurance Process Audit
Internal audit according to VDA 6.3
Auditor Checklist Revision 1 dated 02/99 Page
12

No. Assessment element

B Serial Production
M5 Suppliers/Input Material
M5.1 Are only approved quality capable suppliers
used?
Is there a formal release of all relevant suppliers?

Are there meetings with suppliers and regular contacts?

Is a quality capability assessment performed (self assessment, audit from


other customers, certificate)?

Is the quality of delivered products rated (quality, cost, service)?

M5.2 Is the agreed quality of the purchased parts


guaranteed?
Is there adequate test equipment (laboratory and measurement equipment)?

Are there internal/external tests?

Are there customer-supplied gages or fixtures? Are they included in the


calibration system? Are they according to the latest revision level?

Are drawings/order specifications/specifications according to the latest


revision level?

Are there quality assurance agreements (general delivery agreements,


quality assurance agreements, ship-to-stock agreements, specific
requirements for the components, ramp-up schedule, quality assessment of
new parts)?

Are the test methods, test procedures and test frequencies agreed?

Are the most commonly occuring defects analyzed?

Is there proof of capability?

M5.3 Is the quality performance evaluated and are


corrective actions introduced when there are
deviations from the requirements?

Are there meeting minutes for quality meetings?

Are agreed improvement programs tracked?

Are there test and measurement records for corrected/modified


components?

Are there special support programs for problem suppliers?

M5.4 Are target agreements for continual


improvement of products and process made
and implementaded with the suppliers?

Are workshops (interdisciplinary work teams) performed?

Are measurable targets for quality, price and service defined?


…Reduction of the amount of testing, while at the same time increasing
process capability
…Reduction of scrap (internal/external)
…Reduction of in-process inventory
…Increasing customer satisfaction
Quality Assurance Process Audit
Internal audit according to VDA 6.3
Auditor Checklist Revision 1 dated 02/99 Page
13

No. Assessment element

M5.5 Are the required releases for the delivered


serial products available and the required
improvements measures implemented?

Are there production model releases (by authorities)? Are there test
releases? Are these releases up-to-date?
Are there initial sample reports according to VDA or comparable standards?

Has capability been proven for important characteristics?

Are safety data sheets and EC guidelines complied with?

Has the reliability been analyzed?

Are there requalification test reports, and do these result in improvement


activities?

M5.6 Are the procedures agreed with the customer,


regarding customer-supplied products,
maintained?
Customer-supplied products can be:
services, tooling, test equipment, packaging, products.

Are there agreements on handling and on the procedure for customer-


supplied products with quality defects (rework, guarantee)?

How does control, verification, storage, shipping, and maintenance of


quality and characteristics occur?

What information paths exist for deficit or lost products?

Is the quality documented (quality status, quality history)?

M5.7 Are the stock levels of input material matched


to production needs?
Which customer requirements exist, and how are they implemented?

Which inventory system is used (KANBAN, Just in Time), and how is it


implemented?

Are storage costs and inventory costs tracked?

Are there emergency strategies for material shortages?


How is the FIFO principle implemented? …during initial addition to stock,
….when returning items to stock?
Quality Assurance Process Audit
Internal audit according to VDA 6.3
Auditor Checklist Revision 1 dated 02/99 Page
14

No. Assessment element

M5.8
Are input materials/internal residues delivered
and stored according to their purpose?

Are packaging requirements defined (type, size, material) defined and


complied with?

Does the inventory management system support FIFO?

Are component/finished product-specific requirements for orderliness and


cleanliness defined and maintained? (Mix-ups?)

Are the climatic conditions for storage defined and maintained?

Are components/finished products protected from damage? Are


requirements for orderliness and cleanliness defined and maintained?

Are labeling requirements defined and maintained (traceability, test status,


process step, use status)?
Is there a containment storage area for bad parts or parts on hold, and is it
used? Who is responsible for it?

M5.9 Is the personnel qualified for the respective


tasks?
Are there qualification records for specific tasks?

Are special qualifications/knowledge needed to perform some tasks? Is


there proof of this (e.g. for forklift drivers, x-ray testers, etc.)
Quality Assurance Process Audit
Internal audit according to VDA 6.3
Auditor Checklist Revision 1 dated 02/99 Page
15

No. Assessment element

M6 Production
M6.1 Personnel/Qualification
M6.1.1 Are the employees given responsibility and
authority for the monitoring the
product/process quality?
Who performs the process release?

Who tests the first piece off the line?


Who performs the necessary tests (are they done by production personnel
themselves)?
Who fills out the SPC cards?
Who evaluates and analyzes?

Who is authorized to put products on hold?

Who works on improvement projects (involvement in CIP, etc.)?

M6.1.2 Are the employees given responsibility and


authority for the production equipment and
environment?
Does production personnel perform repairs and preventive maintenance
themselves, and are there records of this?

Who is responsible for furnishing, storing and labelling parts at the work
stations?

Who is responsible for using and functional adjustment of the necessary


test and measurement equipment?
Is the production personnel responsible for orderliness and cleanliness of
the work stations?

M6.1.3 Are the employees suitable to perform the


required tasks and is their qualification
maintained?
Does production personnel have proof of initial
instruction/training/qualification for the process?
…for mistakes that can occur?

How was the personnel informed of on-the-job safety and environmental


aspects?
How was the personnel informed of how to handle components which
require "special retention of records"?

Does the personnel have the necessary qualification records (e.g. forklift
driver's license, welding certificate, vision test, hearing test, etc.)?

M6.1.4 Is there a personnel plan with a replacement


ruling?
Are there qualification records (soldering certificate, etc.) for performing the
necessary process steps?

Is there a qualification matrix?

Are work station analyses/time studies (e.g. MTM, REFA) performed?

M6.1.5 Are instruments to increase employee


motivation effectively implemented?
Are employees aware of the current quality level?
Is this information up-to-date?

How are employees involved in CIP and workshops, and are quality topics
covered (is there an overview of the topics)?

Who is responsible for updating the shop floor display areas?


Quality Assurance Process Audit
Internal audit according to VDA 6.3
Auditor Checklist Revision 1 dated 02/99 Page
16

No. Assessment element

Is there an employee suggestion program? Is it actively used?

How are employee suggestions at the shop floor level processed? Is there
feedback to the employees?
Quality Assurance Process Audit
Internal audit according to VDA 6.3
Auditor Checklist Revision 1 dated 02/99 Page
17

No. Assessment element

M6.2 Production Material/Equipment


M6.2.1 Are the product-specific quality
requirements fulfilled with the
production equipment/tools?
Were machine and process capability studies performed for manufacturing
equipment and tooling, and are they capable?

How are the process and component parameters controlled?

Is there an in-process warning when the process is out of tolerance (e.g.


lamp, horn, shut-down, etc.), and is its correct function regularly tested?

Do the feeder devices and product conveyor devices affect the product
quality, and how are these maintained?

Does the repair and maintenance status of tooling/equipment/machines


affect the quality of manufactured parts?

M6.2.2 Can the quality requirements be monitored


effectively during serial production with the
implemented inspection, measuring and test
equipment?
Does this process step manufacture characteristics affecting reliability,
function or corrosion?

Are these items monitored during product audit tests?

Is the measurement accuracy of the test equipment used adequate (test


equipment capability)?

Are test equipment capability analyses performed for the equipment used?

How is the necessary data registered and analyzed?

Is there proof of calibration for the measurement equipment used (e.g. test
sticker)?

If test equipment is found to be defective or damaged, what is the procedure


for this situation, and how are possible effects on finished products
evaluated and, if necessary, the required actions defined (e.g. informing
customers, retrieving products)?

M6.2.3 Are the work and inspection stations


appropriate to the needs?
Ergonomics, lighting, orderliness and cleanliness, environmental
protection, surroundings/handling of components, on-the-job safety

M6.2.4 Are the relevant details in the production and


inspection documents complete and
maintained?
Are the process parameters available and complete?
Is the data for machines/tooling/fixtures (tool and machine number) named
in, for example, the work sequence plan, control plan, test instruction?

Are test characteristics, equipment, methods, and frequencies defined and


complied with?

Are the control plan, work sequence plan, and manufacturing specifications
available and complied with?
Are test and quality specifications available and complied with?

Are control limits specified in SPC cards?


Quality Assurance Process Audit
Internal audit according to VDA 6.3
Auditor Checklist Revision 1 dated 02/99 Page
18

No. Assessment element

Are operating instructions available?

Is information on recent problems available and known?


Quality Assurance Process Audit
Internal audit according to VDA 6.3
Auditor Checklist Revision 1 dated 02/99 Page
19

No. Assessment element

M6.2.5 Are the necessary auxiliary means available


for adjustments?
Are set-up plans (set-up data, programs, etc.) and product-specific
changeover plans available?

Are there set-up fixtures and comparison devices available?

Are flexible tooling change fixtures used?

Are there test and limit samples available and in use?

M6.2.6 Is an approval for production starts issued and


are adjustments details, as well as deviations
recorded?
Is there a procedure for initial release and for re-releasing production, and is
it specified when this is necessary?

Is there a checklist for the initial release and for re-releasing, is it complete,
and is it being used?

How, where and by whom is documentation done?

M6.2.7
Are the required corrective actions carried out
on schedule and checked for effectiveness?

Are activities defined in the process FMEA implemented?

Are additional activities due to corrective actions implemented?

Are improvements from audits implemented, and is their effectiveness


checked?

Is there feedback of information to the source/machine operator?

Is there an inter-disciplinary flow of information between shifts and


production areas, and does it function well?

How are internal/external complaints processed, corrective actions


implemented and tracked (e.g. product resum?, list of corrective actions)?

Do internal customer questionnaire responses lead to corrective actions,


and are they implemented?
Quality Assurance Process Audit
Internal audit according to VDA 6.3
Auditor Checklist Revision 1 dated 02/99 Page
20

No. Assessment element

M6.3 Transport/Parts Handling/Storage/Packaging


M6.3.1 Are the quantities/production lot sizes
matched to the requirements and are they
purposefully forwarded to the next station?

Are parts forwarded with suitable transport means to defined storage areas
without, or with minimal, intermediate storage?

Are process logistics controlled (KANBAN, Just in Time, FIFO)?

Is product identification for different change revision levels defined?

How is forwarding of good/rework/scrap parts identified, and how is the


return of parts no longer needed defined?

How are quantities determined and analyzed?

M6.3.2 Are the products/components appropriately


stored and are the transport means/packaging
equipment tuned to the special properties of
the product/components?

Can information on in-stock and available stock quantities be retrieved?

Are components protected from damage?

Is the component positioning suitable for safe handling?

Are the storage areas and containers clean and orderly? Overfilled?

Are the specified storage times monitored (maximum and minimum storage
times, specified intermediate storage time)?

Are the components protected from environmental and climatic influences?

M6.3.3 Are rejects, rework and adjustment parts, as


well as internal residues strictly separared and
identified?

Is there a containment storage area for bad parts or parts on hold?

Are containers for scrap, rework, set-up parts and recyclable materials
labelled?

Are defective parts and defect characteristics identified?

Are there defined reject and rework stations?

M6.3.4 Is the material and parts flow secured against


mix ups/exchanges by mistake and traceability
guaranteed?
Are there enough containers and components, suitably and clearly
identified?

Is the processing status or test status apparent, if necessary?

Are lots identified, if necessary?

Is the expiration date/maximum storage time adhered to, if necessary?

Are invalid labels removed?


Quality Assurance Process Audit
Internal audit according to VDA 6.3
Auditor Checklist Revision 1 dated 02/99 Page
21

No. Assessment element

M6.3.5 Are tools, equipment and inspection,


measuring and test equipment stored
correctly?

Do the storage conditions protect the equipment from damage?

Are the storage conditions in line with orderliness and cleanliness


requirements?

Are the storage locations defined?

Is the procedure for issuing defined?

Is the storage location protected from damaging environmental influences?

Is stored equipment identified?

Is the release and change revision level status of tools/equipment/test


equipment identified/indicated?
Quality Assurance Process Audit
Internal audit according to VDA 6.3
Auditor Checklist Revision 1 dated 02/99 Page
22

No. Assessment element

M6.4 Fault analysis/Correction/Continual Improvement


M6.4.1 Are the quality and process data recorded
complete and ready to be evaluated?

Are SPC cards/control cards/tracking cards used?

Are they filled out as specified?

Is process data automatically recorded?

Are process disruptions recognized, and if necessary are corrective actions


(action plan) initiated and documented?

M6.4.2 Are the quality and process dada statistically


analyzed and are improvement program
derived from this?
Is process capability determined (cpk-value)?
Is defect type and frequency recorded, analyzed and are corrective actions
defined?
Are defect costs recorded according to the correct source of the costs
(number of scrap, rework and replacement parts), and are corrective actions
defined?

Are process parameters analyzed?

What is the reaction to messages about products on hold/sorting activities?

Are deviations from standard cycle times recognized?

How are corrective actions defined from the results of reliability testing?

M6.4.3 Are the causes of product and process


nonconformities analyzed and the corrective
actions checked for their effectiveness?

Which methods are used to perform cause analysis? Is the 8D method


used?

Does this lead to corrective actions, and are the control plan, process FMEA
etc. updated if necessary?

Is the effectiveness of corrective actions monitored?

M6.4.4 Are process and products regularly audited?

Which type of audits are performed?

Is the improvement potential identified in audits used for additional process


improvement?

Are audit reports sent to the responsible managers?

Are employees informed of the audit results and of possibly necessary


improvement activities?

M6.4.5 Are the procduct and process subject to


continual improvement?
Which process-specific CIP activities are performed (costs, scrap, rework,
increasing process capability, changeover time optimization, equipment up-
time, reducing process time, reducing storage time)?

M6.4.6 Are the target parameters available for the


product and process and is their compliance
monitored?
Quality Assurance Process Audit
Internal audit according to VDA 6.3
Auditor Checklist Revision 1 dated 02/99 Page
23

No. Assessment element

Which process-specific targets have been defined (quantity produced,


quality indicators such as defect rates, audit results, process times, defect
costs, process indicators such as cpk)?
Quality Assurance Process Audit
Internal audit according to VDA 6.3
Auditor Checklist Revision 1 dated 02/99 Page
24

No. Assessment element

M7 Customer Service, Customer Satisfaction, Service


M7.1 Are the customer requirements fulfilled at
delivery?
Were quality assurance agreements made with customers?

Is the customers' supplier rating system known?

Are customer requirements audited (e.g. dock audit)? Is product put on


hold if necessary, is the customer informed?

Are endurance tests performed according to the test specification?

In case of delivery stops, is it clearly defined who will inform the


departments storage/delivery planning/component supply/shipping, and the
customer if necessary?

Are only products which have been tested good shipped to the customer?

Is the suitability of test and measurement equipment controlled? Is


customer-owned test and measurement equipment used?

Has the customer agreed to the test methods?

Are only valid specifications used?

M7.2 Is the customer service guaranteed?


Is customer service responsibility defined? Do customer evaluations lead
to improvement activities, and is their effectiveness checked?

Is the customer service personnel knowledgeable of product operating


conditions and product problems?

Are new customer requirements implemented?

Are improvement activities, resulting from customer complaints or


evaluations, communicated to the customer?

Are changes (e.g. product and process changes, production relocations -


also at suppliers) reported to the customer?

Is initial and repeated sampling agreed with the customer?

Are customers informed of nonconformities?


Quality Assurance Process Audit
Internal audit according to VDA 6.3
Auditor Checklist Revision 1 dated 02/99 Page
25

No. Assessment element

M7.3 Are the complaints quickly reacted to and the


supply of parts secured?
Is the supply of parts and meeting of delivery deadlines ensured?

Are deviations from delivery requirements recognized and reported, and


which corrective actions are initiated?

Are emergency plans used when delivery bottlenecks occur?

Are the resources and reaction time for sorting activities planned and
implemented (e.g. for 100% checks of inventory, possible rework)?

Is it ensured that non-predictable changes of equipment, special operating


supplies and tooling will not cause a delivery bottleneck or delivery stop?

Are external resources used (e.g. requests for temporary manpower, service
companies)?

Is there a data back-up (emergency) system used for the possibility that the
the computer system data transfer fails (if the customer has an electronic
system of data transfer for early reporting of deliveries to the supplier)?

Is the supplier's production planning oriented toward customer orders (e.g.


daily/weekly comparison of orders with the customer)?
Is there a procedure for reporting delivery bottlenecks to management?

Is there a procedure for reporting delivery bottlenecks to management?

M7.4 Are fault analysis carried out when there are


deviations from the quality requirements and
are improvement measures implemented? Are internal/external defect characteristics analyzed (e.g. Pareto analysis,
laboratory, test equipment, personnel), improvement actions implemented
and their effectiveness checked? Are all relevant departments
(internal/external) involved?

Are sampling nonconformities/specifications reworked?


Are problem-solving methods (e.g. 8D report) used?

M7.5 Is the personnel qualified for each task?


Is the personnel qualified for their tasks (for example):
customer service, product testing, storage and transportation, shipping and
defect analysis?

Is the personnel knowledgeable of (for example):


-products/specifications/special customer requirements
-standards/laws
-processing/use
-quality techniques (e.g. 8D method, cause/effect diagram)
-foreign languages?

Does the personnel have the necessary qualification records (e.g. records
of product training, seminars on quality techniques)?