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§ 71.121 Internal inspection.
The licensee, certificate holder, and applicant for a CoC shall
establish and execute a program for inspection of activities affecting
quality by or for the organization performing the activity, to verify
conformance with the documented instructions, procedures, and drawings
for accomplishing the activity. The inspection must be performed by
individuals other than those who performed the activity being
inspected. Examination, measurements, or tests of material or products
processed must be performed for each work operation where necessary to
assure quality. If direct inspection of processed material or products
is not carried out, indirect control by monitoring processing methods,
equipment, and personnel must be provided. Both inspection and process
monitoring must be provided when quality control is inadequate without
both. If mandatory inspection hold points, which require witnessing or
inspecting by the licensee's designated representative and beyond which
work should not proceed without the consent of its designated
representative, are required, the specific hold points must be
indicated in appropriate documents.
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