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Quality Assurance by D. H. Stamatis

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439
Appendix I
Typical Detailed Expectation List of
a Site Assessment by the Customer
to the Suppliers Facility
Depending on the organization and type of product, the following two cat-
egories are of importance and the supplier must be able to document that it
has completed the expectation. The two types are (1) planning for manufac-
turing process capability and (2) demonstration of manufacturing capability.
The items that we have identied here are only examples and may be used
as applicable. Obviously, more items may be added as needed. For service
organizations, this list may be modied to reect the specic requirements
that the customer needs and wants.
Planning for Manufacturing Process Capability
The supplier should demonstrate and have documented records of the
following:
Quality procedures based on some standard. Here we use the ISO/
TS16949.
An active quality operating system (QOS).
Supplier’s quality system is third-party certied to ISO/TS 16949
requirements.
Supplier’s environmental system is certied to ISO 14001.
Supplier’s quality manual contains processes for all areas of the
site assessment. The quality manual is updated as needed to
drive statistically valid continual improvements in the supplier’s
quality system. Supplier’s senior management team, including
representatives from manufacturing, quality, engineering, and
human resources, perform these reviews. The reviews have to
be documented.
Nonconformances identied in internal audits are not repeated.
Supplier has a documented process to identify and regularly
update customer expectations, objectives, and requirements.
440 Appendix I
Supplier has a documented process to identify and regularly
update internal expectations, objectives, and requirements.
Supplier has a documented process to translate internal and external
expectations, objectives, and requirements into QOS measurables.
Supplier has a documented process to assign targets and objec-
tives to each QOS measurable.
Supplier has a documented process to assign chosen measur-
ables to appropriate management levels for review, follow-up,
and improvements.
Supplier utilizes action plans to drive statistically valid contin-
ual improvement of chosen metrics. These are tracked at QOS
review meetings.
Supplier’s management team holds monthly QOS performance
review meetings with representatives from manufacturing, qual-
ity, engineering, and human resources. Improvement actions
are taken by cross-functional teams that include all levels of the
organization.
QOS reviews include a review of all applicable customer’s and
supplier’s key process metrics.
Metrics monitoring customer satisfaction that are related to sup-
plier manufacturing are understood and tracked.
Failure mode and effect analysis (FMEA)/control plans
All customer parts have documented design and process failure
mode and effects analysis (DFMEA, PFMEA), and design control
plans (or DCPs). There is a robust process in place for developing
these documents.
FMEAs are reviewed annually or as issues arise. A Pareto is used
to focus on (1) severity and (2) the product of severity and occur-
rence, and (3) to identify high RPNs in order to prioritize actions
to drive improvements. All error detection areas are reviewed
and, where feasible, plans exist to move to error prevention
devices (e.g., poke-yoke).
Suppliers, in cooperation with their customers, have identied
critical characteristics (CCs), signicant characteristics (SCs), and
high-impact characteristics (HICs) on their PFMEAs and DCPs
for every customer part or family of customer parts.
Supplier works with customer to establish nal agreement of SCs
and HICs. Suppliers obtain specic agreement from customer for
any parts not having SCs or HICs.
Supplier ensures that all print dimensions and callout notes on
the engineering drawing are always met through DCPs, work
instructions, job setup instructions, and receiving inspection.

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