VDA_6.3_EN_Yellow_Volume_22-05-16.pdf - 第88页

86 P6.4.2 Is the maintenance of the manufacturing equipment and tools controlled? Minimum requirements relevant for assessment Examples for implementation Preventive and/or predictive maintenance activities (maintenance,…

Process element P6: Production process analysis

P 6.4 What material resources are used to implement the process?

Material resources

P6.4.1* Is the manufacturing equipment suitable to meet the customer’s prod-

uct-specific requirements?

Minimum requirements relevant for assessment

Examples for implementa-

tion

It must be demonstrated that the processes are im-

plemented in accordance with the customer re-

quirements using the existing production facilities,

and that the resulting products meet the customer

specifications.

The production facilities, machines and plants must

be able to comply with the specified tolerances for

the respective product and process characteristics.

Parameters and software that influence the process

are protected against unauthorized access.

Process capability must be determined for selected

product and process characteristics, and proof of

capability must be provided.

The process capability must meet internal require-

ments as well as customer requirements. The mini-

mum requirement for process capability is Cpk ≥

1.33. In case of characteristics where a certain ca-

pability is required but proof of capability cannot be

obtained, 100% inspection is required.

• Proof of machine/process

capability

• Monitoring of key process

parameters (e.g. pressure,

time, temperature)

• Capability of replacement

tools

• Feed and removal systems

• Reproducibility of gages, fix-

tures etc.

• Cleanliness requirements

• Configuration management,

ensuring provision of soft-

ware in accordance with the

unique identifier, software in-

tegrity (build number, hash

key)

P6.4.2 Is the maintenance of the manufacturing equipment and tools

controlled?

Minimum requirements relevant for assessment

Examples for implementation

Preventive and/or predictive maintenance activities

(maintenance, inspection and repair) are defined

and implemented for all installations, equipment,

machines and tools based on the risk.

Scheduled and unscheduled maintenance activities

that have been carried out are documented and an-

alyzed with regard to potential improvement

measures.

Resources needed to carry out necessary mainte-

nance activities are available.

A process for the analysis and optimization of

down-time, machine utilization and tool life is imple-

mented effectively.

The availability of replacement parts is ensured.

Tools undergo tool management which includes the

following:

• Tool history including all changes and tool life

• Operational status

• Labeling of tools

These requirements also apply to external service

providers.

• Production-related logistical

equipment, such as forklift

trucks

• Maintenance and servicing

schedules

• TPM Total Productive

Maintenance

• Key processes and bottle-

neck machines

• Technical documentation

provided by the manufac-

turer

• Preventative tool exchange

programs for units subject to

increased wear

• Tool operation sheet

• Operational status of tools,

e.g. operational, not opera-

tional

• Labeling of tools, e.g. prop-

erty of the customer, tool no.,

index

P6.4.3* Can compliance with quality requirements be effectively monitored with

the measuring and inspection equipment in use?

Minimum requirements relevant for assessment

Examples for implementation

The inspection equipment and measuring systems

used are suitable for the intended purpose and han-

dling in production. They are included in the pro-

duction control plan.

Confirmed results of capability studies are available

for the inspection equipment and measuring sys-

tems used.

Inspection and measuring equipment is labeled.

The validity status is monitored.

A process for periodic monitoring of inspection

equipment and measuring systems is established

and implemented.

In case of non-conformity, an assessment of poten-

tial risks in relation to the process, the product and

the customer is carried out. Measures have been

defined and are implemented effectively.

Auxiliary equipment for inspection equipment and

measuring systems that have an influence on the

measurement result are monitored in the same

way.

• Measuring system analysis

• Test process capability

• Replacement measuring

equipment

• Software integrity check

• Calibration status (inspection

sticker, barcode, engraving,

etc.)

• Reference parts