VDA_6.3_EN_Yellow_Volume_.pdf.pdf - 第81页

79 Process element P6: Production process analysis P6.2 Are all production processes controlled? Process management P6.2.1 Are the requirements in the production control plan complete and have they been effectively imple…

P6.1.5* Are product or process changes during series production tracked and

documented?

Minimum requirements relevant for assess-

ment

Examples for implementation

Changes to the product and the production pro-

cess are implemented in accordance with the

change management described. Changes to the

product and process are agreed upon with the

customer, approved and released (including soft-

ware changes) in accordance with customer re-

quirements. A PPA must be carried out. The his-

tory of change statuses must be fully traceable.

The correct, released version of the material / soft-

ware must be used.

After changes have been made, it must be

checked whether the risk analyses need to be up-

dated.

• Trigger matrix in accordance

with VDA Volume 2 or cus-

tomer specifications

• Documented release of a

change

• Cross-functional evaluation

prior to changes

• Change history/parts history

(also for software)

• Design and process FMEA

• Operation management in

case of changes

• Pre-production

• Unique software identifier,

software integrity (build num-

ber, hash key)

Process element P6: Production process analysis

P6.2 Are all production processes controlled?

Process management

P6.2.1 Are the requirements in the production control plan complete and have

they been effectively implemented?

Minimum requirements relevant for assess-

ment

Examples for implementation

The production and inspection documents are

complete and are based on the production control

plan.

The data relating to released machinery/tools/aids

must be noted in the production control plan

and/or the manufacturing and inspection docu-

ments.

The documents must be accessible close to the

work-station.

Required measures (reaction plan) for process

disturbances are described in the production con-

trol plan and are implemented and documented.

Process parameters influencing product character-

istics/quality must be fully stated.

Tolerances must be stated for process parameters

and inspection characteristics.

The control limits in process control charts are de-

fined, identifiable and plausible.

Non-conformities and initiated measures regarding

process requirements and inspection characteris-

tics must be documented.

Conditions governing rework are specified, assess

as part of the risk analysis and secured within the

process (parts identification; repeat inspection

etc.).

• Inspection characteristics, in-

spection equipment, inspec-

tion methods, inspection fre-

quencies, inspection cycles

and requalification

• Data regarding ma-

chines/tools/aids (identification

numbers), process parame-

ters and tolerances (pressure,

temperatures, times, speeds

etc.)

• Work instructions (including

reworking)

• Inspection instruction

P6.2.2 Are production processes released?

Minimum requirements relevant for assessment

Examples for implementation

A process-specific release inspection for first

piece/last piece and repeat release was carried out

and documented.

A release is necessary for the product and the pro-

cess and must be carried out and documented by

authorized employees using acceptance criteria.

Non-conformities and initiated measures are docu-

mented.

At the time of release, the necessary reference and

boundary samples must be available.

Criteria for triggering a repeat release must be de-

fined e.g. after an interruption of production.

If production is continued after the collection of in-

spection parts, these products must be accessible

until the inspection parts are released.

• Release of a batch, includ-

ing repeat release

• First piece /last piece and

repeat release

• Tooling diagrams/reference

parts/installation parts (e.g.

defect identification)

• Possible triggering criteria

for a repeat release:

○ Production interruption

(e.g. night time

in two-shift operations,

tool changes, material/

batch/product change)

○ Repair, tool change,

○ changed setting data

• Release of reworked parts