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Site Audits are another tool used as part of the NPPTL post-certification quality assurance verification.  Site Audits are conducted at all approval holder locations, including subcontractors, regardless of whether or not the NIOSH approved product is currently being marketed.  They occur every 1-2 year (depending on the type of unit).  Often they are conducted by a contract representative for NIOSH, but at times NIOSH personnel conduct them.  The approval holder’s manufacturing process and quality assurance system is evaluated against Federal Regulation 42 CFR Part 84 and the quality control system in place at the facility.