MIL-PRF-38535K
APPENDIX A
(2) Control procedures for lot history records:
(a) Lot histories may be modified only by additions (e.g., original entries plus corrective addenda).
(b) All corrective addenda shall meet all the requirements of A.4.8.1.2 i.
(c) Only limited designated operators shall be able to access lot history computer records for corrective
addenda. Documented security procedures shall be followed to assure that limited access is
maintained (e.g., restricted terminals, passwords, etc.).
(d) A quality assurance representative shall verify screening, qualification, and quality conformance
inspection records when corrective addenda affect lot jeopardy.
(3) Control of computerized lot history records:
(a) All computer lot history records shall have an accurate tape or equivalent backup generated prior to
lot shipment. Within 3 months of lot shipment, the backup record shall be transferred to a secure
location to be archived.
(b) These archived tapes or equivalent media shall be kept for a minimum of 5 years.
A.4.8.1.2.1 Personnel training and testing. Records shall cover the nature of training or testing given, the date
thereof by week and length in hours, and the group(s) of personnel given work training and testing. Records are
required only for product-related training and testing as distinguished from safety, first aid, etc.
A.4.8.1.2.1.1 Training of operators and inspectors. All critical processes and production inspection shall be
performed by personnel who have been trained by the manufacturer to perform their assignment task in accordance
with manufacturer's in-house standards, including a formal training (e.g., classroom or on the job training supervised
by a certified trainer) and test procedure to assure the proficiency of each individual. Each individual shall be
retested or retrained at the end of a designated period or when personnel performance indicates poor proficiency.
Personnel shall not be used in critical processes or inspections until the required level of proficiency has been
demonstrated.
A.4.8.1.2.2 Inspection operations. Records of inspection operations shall cover the tests or inspections made, the
materials group (lot, batch, etc.) inspected, the controlling documentation, the date of completion of inspection, the
amount of material tested, and acceptance, rejection, or other final disposition of the material.
A.4.8.1.2.3 Failure and defect reports and analyses. Records of failed or defective devices shall cover the source
from which each device was received, the test or operation during which failure occurred or defects were observed,
and prior testing or screening history of the device, the date of receipt, and the disposition of the device. Records of
failure and defect analyses shall cover the nature of the reported failure or defect (failure or defect mode), verification
of the failure or defect, the nature of any device discrepancies which were found during analysis (failure or defect
mechanism), assignment of the failure-activating cause if possible, the date of completion of the analysis,
identification of the group performing the analysis, disposition of the device after analysis, and the distribution of the
record. The record shall also treat the relationship of observed failure or defect modes in related lots or devices and,
where applicable, corrective action taken as a result of the findings.
A.4.8.1.2.4 Initial documentation and subsequent changes in design, materials, or processing. Records shall
cover the initial documentation and all changes with the date upon which each change in design, materials, or
processing becomes effective for devices intended to be submitted for quality conformance inspection under this
specification, the documents authorizing and implementing the change, and identification of the first production and
quality conformance inspection lot(s) (as applicable) within which product incorporating the change is included shall
be maintained when the change requires notification of the qualifying activity (see A.3.4.2).
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ACTEL [ Actel Corporation ]
