MIL-PRF-38535K
APPENDIX A
A.4.9.3.4 Audit follow-up. All audit reports shall be filed and maintained by the quality organization. The quality
organization shall establish a procedure to follow up on all audit deficiencies to assure that the corrective actions
have been implemented in a timely manner. A system (e.g., Management Review) shall also be established to
review the acceptability and timeliness of all corrective actions and to determine if any deficiencies have repeated
since the last required self-audit. If any deficiencies have occurred two or more times in the predetermined time
period, additional corrective actions shall be taken to assure immediate correction of the problem and the qualifying
activity (QA) shall be notified. The self-audit team shall perform a follow-up verification within 6 months of corrective
actions covering all deficiencies found during the QA audit and annual self-audit to assure corrective actions are
adequate and maintained.
A.4.9.3.5 Audit schedules and intervals. The original audit interval shall be established with a schedule by the
quality organization but in no case exceed 1 year for each area, unless authorized by the qualifying activity (QA). A
self-audit shall be conducted and corrective actions completed prior to the initial QA audit. Changes to the audit
schedule, due to being consistently above or below average performance on the self-audit, shall require approval of
the QA.
A.4.9.3.6 Self-audit report. The self-audit report shall be signed by the quality assurance representative
responsible for the quality assurance program's overall success or failure. The manufacturer shall make available to
the qualifying activity, during audits, the self-audit report, deficiencies, and corrective actions taken. This report shall
include a summary report of self-audit results categorized by deficiency type (e.g., nonconformance to specification
requirement(s), occurrences affecting product reliability, recurring deficiencies).
A.4.9.3.7 Self-audit areas. The self-audit shall be performed to assure conformance to the checklist and
specification in at least the following areas:
Calibration and preventive maintenance
Fabrication
Deionized (DI) water controls
Training
Assembly operations
Electrical test
Test methods
Failure analysis
Qualification/QCI system
Document control
Environmental control
Incoming inspection
Inventory control and traceability
ESD handling control program
Design change control
Statistical process control, as applicable
Third party subcontractors (see note)
NOTE 1: The QA approval of a subcontractor second and third party facility does not alleviate the manufacturer of
validating product specific requirement.
NOTE 2: The self-audit shall include any activities performed by a subcontractor, and shall ensure full compliance
by the subcontractor to this appendix and the device specification or drawing. Any deviations or questionable
areas shall be brought to the attention of the qualifying activity. QA approval of subcontracted second party
facilities may be used to satisfy the subcontractor audit requirement.
A.4.9.3.8 Self-audit checklist. The audit checklist shall be prepared by the quality organization and maintained
under document control. The checklist shall assure that the quality assurance system is adequate and followed by all
personnel in each area.
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ACTEL [ Actel Corporation ]
