Quality System Assessment and Records - FY11
- Ensure manufacturer compliance with quality system plan.
- 42 CFR 84.40-43, Subpart E - Quality Control
- All Approval Holders
- 3 Private sector auditing firms
- Respirator manufacturers
- Respirator users
- Perform a site audit every 2 years for all Approval Holders
- Perform respirator product audits
- Issue site-audit Task Orders (on-going)
- All Task Orders have been issued under existing contract - all but two closed
- Generate new audit support contract FY2011
- Perform product audits (on-going)
- At least 40 site audits opened in FY09, 68 closed
- At least 39 product audits performed in FY09
- Approval Holder quality systems and products continue to meet standard.
- Approval Holders assure quality and reliability of respirators.
- Workers have stronger assurance of respiratory functionality.