MIL-PRF-19500P
APPENDIX D
D.3.15 Handling, storage, packaging, and delivery.
D.3.15.1 Security of completed devices. Marked devices which have passed all screening and conformance
requirements shall be retained in a secure area prior to shipment delivery. Device inventory shall be controlled by
device type, lot identification code, quantity, product assurance level, and transaction date. This requirement applies
to both the manufacturer and the distributor(s).
D.3.15.2 Electrostatic discharge sensitive (ESDS) program. The manufacturer of ESDS class 0, 1A, 1B, 1C, and
class 2 devices shall institute an ESDS program commensurate with the product classification. The product
classification shall be as indicated in appendix E. The requirements of JESD-625 apply but may be tailored for
establishing an ESDS program. Justification for the tailoring shall be made available to the qualifying activity for
approval upon request.
D.3.16 Quality records. A system shall be in place to track all quality records, including but not limited to the
results of all qualification, screening, conformance tests (attributes and variable data as applicable) and inspections,
any required failure analysis, subcontractor records, internal quality audit results, training, and management reviews.
The retention period for each type of quality records shall be a minimum of 10 years based on lot date code. Quality
records shall be available for review and maintained in an organized manner. Quality records may be retained using
paper hard copy or suitable electronic medium. If electronic records are used, the manufacturer shall establish
appropriate procedures to ensure the security of such records from loss or alteration. Corrections to "hard copy"
quality records shall be made by "lining out" the incorrect entry with a single line (maintaining the legibility of original
data) and inserting the correct entry immediately adjacent to the "lined out" entry. The operator making the change
shall initial by the "lined out" entry. Erasures, mark overs, and "white out" are not permitted on any quality record.
For electronic records, the manufacturer shall establish procedures for making corrections to quality records such that
the original record, the date of the change, and the person making the change are clearly identifiable. Quality records
of any type and data of any type shall be sent to the qualifying activity or preparing activity upon request.
D.3.17 Internal quality audits.
D.3.17.1 Internal audit program. The manufacturer shall establish an independent internal audit program which
shall be included in the quality system. The internal audit program shall assess compliance with all MIL-PRF-19500
requirements(processes and quality systems) and shall identify key review areas, their frequency of audit, and
corrective actions shall be resolved through the corrective action system (see D.3.16).
D.3.17.1.1 Internal audit checklist. The internal audit checklist shall assure that the quality system is adequate and
followed by all personnel in each area.
D.3.17.1.2 Subcontractor Audits. All subcontractors are to be audited by the certified manufacturer (or by DLA
Land and Maritime) annually, to have an available checklist of the audit, a list of any concerns, and corrective actions
available to the qualifying activity for review. This does not apply to facilities with DLA Land and Maritime lab
suitability. All certified manufacturers shall demonstrate effective control of relevant contracted services as approved
by the qualifying activity.
D.3.17.2 Audit schedules and frequencies. The audit frequency shall in no case exceed 1 year for each area
unless authorized by the qualifying activity. An internal audit shall be conducted and corrective actions completed
prior to the initial qualifying activity audit. The qualifying activity may modify the frequency of the internal audit(s) or
require additional inspection based on the effectiveness of the manufacturer's internal audit program, and
assessment of the internal audit findings.
D.3.17.3 Auditors. The designated auditors shall be independent from the area being audited. If the use of an
independent auditor is not practical, a second individual should be assigned to participate in the audit or review the
results. Auditors shall be trained in the area to be audited, in the applicable military specification requirements and
provided with an appropriate checklist for annotating deficiencies. Prior to the audit, the assigned auditor(s) shall
review the previous internal audit results to assure corrective actions have been implemented and are effective.
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