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DOE-STD-3020-2005
6. QUALITY ASSURANCE
6.1
Manufacturer's Quality Assurance Program, Procedures, and
Documentation: Filters shall be manufactured under a Quality Assurance Program
which has been evaluated with documented evidence of compliance to the
requirements of ASME NQA-1. Procurement and fabrication activities shall allow
positive identification of the grades of source materials used in construction, and
permit positive identification of the roll (or production run for separatorless filters) of
filter media used in the completed filter. Penetration and resistance production tests
and inspections shall be conducted in accordance with ASME AG-1, FC-5000 or
FK-5000 and with documented manufacturer's procedures. The results shall be
traceable to specific lots of completed filters. Non-conformances with the above
items and documentation of problems and their resolution shall be addressed in the
manufacturer's Quality Assurance Program.
6.1.1
Qualification: Filter manufacturers shall be required to show evidence that
HEPA filters have successfully passed the qualification and requalification
testing in accordance with ASME AG-1. As specified in this Section,
qualification tests are to be performed and certified by an independent test
laboratory as defined in ASME AG-1. Tests performed on a filter
manufacturer's equipment by an independent testing organization are not
acceptable.
A filter design shall be requalified when any change is made to design or
construction or composition of construction materials that could affect filter
performance including normal service and off-normal service. Examples of
changes that require requalification include: composition of filter media,
manufacture of gasket or sealant materials, and materials or methods used to
assemble filter cases.
If a filter fails any or all of the requalification tests, the test organization shall
provide the manufacturer with the test results. The manufacturer shall notify
DOE and the FTF that the filter model failed requalification. DOE shall notify
DOE contractor organizations that the filter model is no longer acceptable for
use in DOE facilities, pending requalification.
In order to reduce costs associated with qualification testing, successful tests
of filters with known material components for filter frames, filter media, cases
and adhesives that have been produced by a single manufacturer, can be used
to qualify filters of similar construction. Similar construction is defined as
manufactured using the same method, material, equipment and processes.
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