VDA_6.3_EN_Yellow_Volume_22-05-16.pdf - 第87页

85 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-spe…

P6.3.2 Do the employees know what responsibilities and authority they have

regarding the monitoring of product and process quality?

Minimum requirements relevant for assessment

Examples for implementation

The employees’ responsibilities, duties and author-

ity are described and implemented.

The employees know the consequences of incor-

rect execution of work. The tasks/functions of the

product are known. It is also known what happens

when they are no longer guaranteed.

Employees receive regular information on the cur-

rent standard of quality achieved and are informed

about customer complaints.

The requirements also apply to temporary employ-

ees.

• Work/inspection instructions

• Job descriptions

• Setup release, first piece in-

spection, last piece inspec-

tion

• Authority to stop and start

the process

• Escalation protocol

• Product training

• Product safety/product liabil-

ity training

P6.3.3 Are the necessary personnel resources available?

Minimum requirements relevant for assessment

Examples for implementation

There is a staff schedule for all shifts. The staff

schedule takes into account the required number of

qualified employees.

Rules exist for supporting areas that are not contin-

ually in use (e.g. laboratory, measurement room).

Fluctuations in customer orders and workforce ab-

sences (e.g. illness, holidays, training) are taken

into account in the staff schedule.

The requirements also apply to temporary employ-

ees.

• Shift plan

• Evidence of qualifications

• Qualification matrix

• documented absence man-

agement rules

• Staff schedule

• Mentors

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