VDA_6.3_EN_Yellow_Volume_.pdf.pdf - 第75页

73 Minimum requirements relevant for assessment Examples for implementation The responsibilities, tasks and authority the em- ployees have in their relevant work areas must be specified. The employees are qualified in ac…

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P5.6 Are incoming goods delivered and stored appropriately?
Minimum requirements relevant for assessment
Examples for implementation
Primary materials and load carriers must be stored
in accordance with their release status so that they
cannot be damaged or mixed.
For materials that could be damaged by tempera-
ture, humidity, vibration, etc. and affect the quality
of the final product, the transport and storage con-
ditions must be defined and evidence shown.
“Suspicious”/quarantined materials must be clearly
labeled protected against unauthorized access.
FIFO/FEFO (shelf-life requirements) and batch
traceability must be ensured when the materials
are further processed. This equally applies to resid-
ual quantities.
Material stock figures in the warehouse manage-
ment system match the quantities actually in stock.
The storage conditions fulfill the product require-
ments.
Packaging
Labeling (traceability/inspec-
tion status/use status)
Quarantine stores; quaran-
tine areas
Batch-related use
Climatic conditions
Protection against dam-
age/contamination/corrosion
Order and cleanliness
Precautions to prevent mix-
ing/mistakes
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Minimum requirements relevant for assessment
Examples for implementation
The responsibilities, tasks and authority the em-
ployees have in their relevant work areas must be
specified.
The employees are qualified in accordance with the
job profile.
Qualification requirements must be determined in
relation to the tasks, and qualifications must be
planned and carried out accordingly.
Knowledge of previous complaints (including cor-
rective actions) is available for purchased products
and services.
Knowledge of specifications,
product characteristics, cus-
tomer requirements and pro-
duction processes
Standards
Statutory and regulatory re-
quirements
Packaging requirements
Quality procedures
Job description / description
of tasks and function
Qualification matrix
Qualification of supplier audi-
tors
P5.7 Are personnel qualified for their respective tasks and are responsibilities
defined?
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7.6 Production process analysis (P6)
Process element P6: Production process analysis
P6.1 What goes into the process?
Process input
P6.1.1 Has the project been handed over from development to series
production and is a reliable start guaranteed?
Minimum requirements relevant for assessment
Examples for implementation
The project handover to series production has been
documented according to the specified criteria.
The responsibilities for the entire handover process
are specified and acknowledged. Unresolved is-
sues are followed up on, and the necessary
measures are implemented on schedule.
A complete production process and product release
(PPA) including the documentation required must
take place before the first production shipment.
Measures to secure the production start-up have
been implemented on the basis of a risk analysis.
Tools, transport and series packaging, inspection
and measuring equipment are available in the nec-
essary quantities.
Analysis options for failure analysis are available
The product software corresponds to the latest re-
lease versions.
Handover reports
Defined measures and im-
plementation schedule
Production release report
Releases for all plant compo-
nents and tools in 6.1.2
PPA documents, including
customer approval and refer-
ence parts regarding the
PPA procedure
Waivers
Released software versions
Examples for securing the
production start-up:
Higher inspection frequency,
additional inspections, Resi-
dent,
Safe launch concept