10 CFR 71.121 - Internal inspection.

§ 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.

Title 10 published on 19-May-2018 04:00

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 10 CFR Part 71 after this date.

  • 2017-11-15; vol. 82 # 219 - Wednesday, November 15, 2017
    1. 82 FR 52823 - Miscellaneous Corrections
      GPO FDSys XML | Text
      Final rule.
      This rule is effective December 15, 2017. The material incorporated by reference was previously approved by the Director of the Federal Register.
      10 CFR Parts 2, 9, 40, 50, 61, 71, 73, and 110
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