The licensee, certificate holder, and applicant for a Certificate of Compliance shall maintain sufficient written records to describe the activities affecting quality. These records must include changes to the quality assurance program as required by §71.106, the instructions, procedures, and drawings required by §71.111 to prescribe quality assurance activities, and closely related specifications such as required qualifications of personnel, procedures, and equipment. The records must include the instructions or procedures that establish a records retention program that is consistent with applicable regulations and designates factors such as duration, location, and assigned responsibility. The licensee, certificate holder, and applicant for a Certificate of Compliance shall retain these records for 3 years beyond the date when the licensee, certificate holder, and applicant for a Certificate of Compliance last engage in the activity for which the quality assurance program was developed. If any portion of the quality assurance program, written procedures or instructions is superseded, the licensee, certificate holder, and applicant for a Certificate of Compliance shall retain the superseded material for 3 years after it is superseded.

[80 FR 34014, June 12, 2015]


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