Quality Assurance - doe-std-3020-20050019

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.