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170 Part III: Inspection and Test
1. Attitude. This includes developing a genuine concern for the product
and for the customer, as well as fostering a positive self-image of the
inspection function. To a significant extent, attitude is affected by
the leadership of management and supervisory staff.
2. Knowledge. This includes not only knowledge directly related to the
inspection function, but also of the various production processes,
materials, equipment, procedures, and so on.
3. Skills. This refers to mastering the performance of the technical
activities that are part of the inspector’s job.
3. PRODUCT TRACEABILITY
Identify methods to trace products and
materials such as age control, shelf life, and
first-in first-out (FIFO). (Application)
Part III.C.3
Body of Knowledge III.C.3
Traceability is an explicit part of the ISO 9000 and ISO/TS 16949 standards. See
paragraph 7.5.3 in ANSI/ISO/ASQ Q9001-2001, for example. Traceability is like the
pedigree of a dog or the provenance of a painting. It allows one to find out about
the past history of any item. Commodity products such as nuts and bolts have
limited needs for traceability. Complex products such as automobiles must have
multiple paths to trace back through many levels and many different sources. Sensitive
material such as pharmaceuticals and food products must be traceable at all
times. Even in the case of nuts and bolts, however, wise manufacturers will keep
different lots segregated and identified as long as it is economically possible.
The ISO 9000 standard requires product identification and traceability, where
appropriate, for the recall of nonconforming product, hazardous product, or product
in conflict with laws, regulations, or statutes. Product identification must be
provided when required by a customer. Properly identified items must have a
unique number and be able to be tracked by their location in the process. Differences
between items and lots must be distinguishable.
The place to start with traceability, that is, the ability to preserve the identity
of the product and its origins, is when the process is first designed. Today, appropriate
software and database designs are available. Training of workers may be
required in order to create the proper climate and means to accomplish this. Frank
M. Gryna (1988) listed four reasons why traceability is needed:
1. To assure that only materials and components of adequate quality enter
the final product, for example, sterility of drug materials, adequate
metallurgical composition, and heat treatment of structural components.
2. To assure positive identification to avoid the mix-up of products that
otherwise look alike.