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80 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 an…

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

P6.2.3* Are special characteristics controlled in production?

Minimum requirements relevant for assessment

Examples for implementation

Special product characteristics specified by the cus-

tomer and the organization as well as defined pro-

cess parameters are marked in the production con-

trol plan and systematically monitored.

Records of non-compliances and corrective actions

are maintained. Non-compliances affecting the

characteristics of the product must be approved by

the customer.

Records regarding special characteristics are avail-

able. The duration and type of archiving of these

records are specified and meet the customer’s re-

quirements.

• Drawings

• Labeling indicating the cus-

tomer-specific special char-

acteristics, e.g.: D/TLD, DS,

DZ, R, S, F

• Process FMEA

• Production control plan

• SPC evaluations

• Quality control charts

• Proofs of capability

• Proof of inspection process

capability

• Inspection results

• Process parameter records

P6.2.4* Are non-approved and/or defective parts controlled?

Minimum requirements relevant for assessment

Examples for implementation

Suspect parts and defective parts must be sepa-

rated, labeled, recorded or (when necessary) safely

removed from the production process.

These parts must either be directly marked or

marked on their container.

Authorized personnel decide on the further use of

potentially defective products.

The scope (including inspection and release) of

permissible rework is described in work instruc-

tions.

Quarantine stores and quarantine areas must be

clearly labeled. Accidental or unauthorized use of

restricted parts must be excluded.

• Labeling indicating the prod-

uct status

• defined scrap/rework-sta-

tions in production

• Quarantine stores and quar-

antine areas, clearance ar-

eas

• Documentation regarding re-

jects, rework and repair

• Authorizations