Page 238 - The Handbook for Quality Management a Complete Guide to Operational Excellence

224 P r o c e s s C o n t r o l Q u a l i t y A u d i t s 225

Finished Goods
The quality plan should include procedures that document the tests or
inspections required prior to the release of product for delivery to the cus-
tomer. The procedures should specify how the inspection and test status
of finished goods will be shown, where the goods will be stored while
awaiting shipment, and proper methods of packaging, handling, and
loading the goods for final delivery.

Lot Traceability
Documented procedures should be prepared to ensure that, when
required, lot traceability is maintained. Traceability is largely a matter of
record-keeping. The system should ensure that the units in the lot and the
lot itself are identified, and the integrity of the lot is maintained (i.e., every
unit that is part of the lot remains in the lot).
Lot traceability is generally required when there is reason to believe
that the unit in question may need to be located at some time in the future.
There are many reasons why this might be necessary, but the primary
reason is that a safety defect might be discovered. The manufacturer
should be able to quick ly communicate with all those who are at risk from
the defect. Items whose failure would cause an unsafe condition to exist
are known as critical compo nents or critical items.

Materials Segregation Practices
The previous sections describe various activities relating to the identifica-
tion of various types of materials, for example, by type of defective, or by
processing sta tus. Once a “special” classification has been made (e.g., mate-
rial to be scrapped or reworked), the procedure specifies how the affected
material will be identified. Next, provision must often be made to physi-
cally remove the material from the normal processing stream. Formal,
written procedures should be developed to describe the control, handling,
and disposition of nonconforming materials to ensure that such materials
are adequately identified and prevented from becoming mixed with
acceptable materials.
The physical control of nonconforming materials varies widely from
firm to firm and by type of problem. Some organizations require that
discrepant-critical components be immediately removed to a locked
storage area and require authorization from designated individuals for
release.

Configuration Control
Configuration control is the systematic evaluation, coordination, approval
or disapproval, and implementation of all approved changes in the con-
figuration of an item after formal establishment of its configuration
identification.

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