Quality Assurance - std30200022

DOE-STD-3020-97

6.0

QUALITY ASSURANCE

6.1

Manufacturer's Quality Assurance Program, Procedures, and

Documentation

Filters shall be manufactured and shipped under a quality assurance

program meeting the essential 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

medium used in the completed filter. All tests and inspections shall be

conducted in accordance with documented manufacturer's procedures, and

the results shall be traceable to specific lots of completed filters. The results

of penetration and resistance tests specified in Section 6.2 of this standard

shall be documented and identified by serial number for each individual filter

unit. Nonconformances with the above items and documentation of

problems and their resolution shall be addressed in the manufacturer's QA

Plan.

Qualification. Filter manufacturers shall be required to show

6.1.1

evidence that HEPA filters meet the test requirements of Sections

6.1.3 to 6.1.5 of this standard.

Qualifications testing must be performed and certified by an

independent test laboratory.

Requalification is required every five years.

If a filter fails any or all of the qualifications tests, the test organization

shall first notify the manufacturer, and provide the manufacturer the

opportunity to review test methods and results prior, to removing the

filter model from the QPL. (or similar qualifications list) and issuing

notice thereof.