MIL-PRF-38535K
APPENDIX A
d. Initial documentation and subsequent changes in design, materials, or processing (see A.4.8.1.2.4) (5-year
record retention).
e. Equipment calibrations (see A.4.8.1.2.5) (see ANSI/NCSL Z540.3 for records).
f. Process, utility, and material controls (see A.4.8.1.2.6) (1-year record retention).
g. Product lot identification (see A.4.8.1.2.7) (5-year record retention).
h. Product traceability (see A.4.8.1.2.8) (5-year record retention).
i. Self-audit report (see A.4.9.3.6) (4-year retention).
Note: Altered records shall not be considered acceptable data unless documented instructions are followed which
shall include:
j. For changed data:
(1) Identification of individual making new entry.
(2) Maintain identity of all original data entries (white out is not permitted).
(3) Justification and date noted for change and verification by a second party (QA shall verify screening,
qualification and quality conformance inspection records) when change affects lot jeopardy (e.g., lot
originally considered to be rejected is changed to pass status).
k. For transferred data to new test record:
(1) Identification of individual transferring data.
(2) All original record entries shall be transferred.
(3) New test record entries shall be verified against the original test record by a second party.
l. Computerized records are optional provided they clearly and objectively indicate that all the requirements, of
the specified device class, of this appendix have been met. The computerized records for traceability,
screening and quality control inspection shall be readily accessible and available to Government personnel for
review and an appropriate electronic/hard copy provided when required. The requirements below shall be
met.
(1) Entry verification:
(a) Each individual making shall be uniquely identified.
(b) All manually entered data shall be verified at the time of entry by the same operator.
(c) All accepted transactions (e.g., entered data) shall be identified by time/date or date/entry
sequence to protect against "out of sequence" entries. No recorded transactions shall be deleted
or changed.
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ACTEL [ Actel Corporation ]
