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Are test sequence plans made for the prototype phase and for the pre-
production phase?
Has product testing been performed (e.g. installation tests, functional tests,
endurance tests, environmental simulation tests)?
Are manufacturing and test equipment, and measuring and test equipment
in the sample shop, included in the release process?
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.
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?
How are product-related quality agreements (e.g. ppm upper limits) made
known, and how are they achieved?
-starting Production
-training personnel
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
Are reporting paths and cycle times (who reports what to whom) defined
and known to all team members?
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 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
Are changes implemented on time, and are they documented in the FMEA in
an understandable manner?
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?)?
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)?
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
Has the required process capability been analyzed and fulfilled? If it is not
fulfilled: are the necessary additional quality assurance activities defined
and implemented?
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?
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 the test methods, test procedures and test frequencies agreed?
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?
M5.8
Are input materials/internal residues delivered
and stored according to their purpose?
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 is responsible for furnishing, storing and labelling parts at the work
stations?
Does the personnel have the necessary qualification records (e.g. forklift
driver's license, welding certificate, vision test, hearing test, etc.)?
How are employees involved in CIP and workshops, and are quality topics
covered (is there an overview of the topics)?
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
Do the feeder devices and product conveyor devices affect the product
quality, and how are these maintained?
Are test equipment capability analyses performed for the equipment used?
Is there proof of calibration for the measurement equipment used (e.g. test
sticker)?
Are the control plan, work sequence plan, and manufacturing specifications
available and complied with?
Are test and quality specifications available and complied with?
Is there a checklist for the initial release and for re-releasing, is it complete,
and is it being used?
M6.2.7
Are the required corrective actions carried out
on schedule and checked for effectiveness?
Are parts forwarded with suitable transport means to defined storage areas
without, or with minimal, intermediate storage?
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 containers for scrap, rework, set-up parts and recyclable materials
labelled?
How are corrective actions defined from the results of reliability testing?
Does this lead to corrective actions, and are the control plan, process FMEA
etc. updated if necessary?
Are only products which have been tested good shipped to the customer?
Are the resources and reaction time for sorting activities planned and
implemented (e.g. for 100% checks of inventory, possible rework)?
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)?
Does the personnel have the necessary qualification records (e.g. records
of product training, seminars on quality techniques)?