MIL-PRF-38535K
3.4.1.5 Manufacturer self-validation. The manufacturer shall perform a self-validation to determine compliance to the QM
plan (see appendix G).
3.4.1.6 Change management system. The manufacturer shall have a system for change management. This system shall
include a process to monitor internal changes and the assessment of those changes as to the impact to customers. The
manufacturer shall analyze the impact of major changes and its effects on previously approved modifications of test (see
J.3.12). An appropriate customer notification methodology shall be in place.
3.4.1.7 Deficiencies and concerns. Deficiencies and concerns shall be noted by the validation team during an exit critique
and shall be followed up with a written report. The microcircuit manufacturer shall not receive a letter of certification until all
certification requirements are met.
3.4.1.8 Letter of certification. After validation, the QA shall issue a letter of certification to the manufacturer, which shall
include all certified site(s).
3.4.2 QML qualification requirements. Integrated circuits (ICs) furnished under this specification shall be products which are
authorized by the QA for listing on the QML. Qualification testing shall be performed in accordance with the agreed upon
qualification plan (see appendix H).
3.4.2.1 Qualification extension. When a basic plant desires to qualify a device or process flow that includes an offshore
site, application for certification and qualification may be extended with QA approval under the following conditions:
a. Control and approval of the design, fab, assembly and test operations by the manufacturer’s TRB is required along
with periodic self-assessments of the offshore sites. The manufacturer’s TRB shall review all screening and TCI tests
to determine whether they should be performed exclusively in the offshore site or reserved for the basic plant in order
to assure quality and reliability. The manufacturer’s TRB assessment shall be made available to the QA for review or
approval as appropriate.
b. QA certification of the offshore site is required. For classes Q, V, Y, N and T products all operations, sites, and plants
shall be QA certified however, this certification may be issued through the manufacturer’s TRB with QA approval.
Validation of these offshore operations is also required. For assembly site(s) an initial site shall be certified and
qualified by the QA. Additional assembly sites shall be assessed subsequent to the initial validation.
c. All devices assembled in the offshore assembly site shall have a country of origin marking (see 3.6.5) reflecting the
assembly site. In addition, a unique code shall be marked on each device to assure traceability to the assembly
site(s).
d. All operations, flows, quality control procedures and test standards at the offshore site shall be under the control of the
manufacturer’s TRB. Alternately, the manufacturer shall establish a procedure for maintaining oversight of the
offshore facility. All such operations, flows, procedures and test standards shall be baselined by the manufacturer’s
TRB and the offshore site at all times.
e. The QA reserves the right to audit the offshore site(s) with a minimum notice. The basic plant site shall be responsible
to facilitate all QA site assessments. Any refusal to allow such a site assessment may result in an immediate
de-certification and QML removal.
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ACTEL [ Actel Corporation ]
