Quality System Assessment and Records - FY12
- 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
- Complete FY2011 interim contracts (one of three closed)
- Issue FY2012 interim contracts (simplified acquisition)
- Generate new 5-year audit support contract
- Issue Task Orders once base contract in place
- Perform product audits (on-going)
- Site Audits FY2011: 21 opened, 61 closed
- Site Audits FY2012: 37 opened, 16 closed (to date)
- Product Audits FY2011: 132 opened, 140 closed
- Product Audits FY2012: 76 opened, 58 closed (to date)
- Approval Holder quality systems and products continue to meet standard or approval revoked.
- Approval Holders assure quality and reliability of respirators.
- Workers have stronger assurance of respiratory functionality.