A Quality Checklist is a good tool to use any time of the year. In many companies the daily operations take precedence over the Quality System maintenance, thus causing a gap in the Quality System. A good checklist can help you to focus on quality items that are often overlooked.    

  1. Review training records to ensure 100% compliance with current requirements.
  2. Conduct an annual review of your SOPs and Plans (Validation Plans, Quality Plans, etc.)
  3. Review the outstanding CAPAs in your system.  For CAPAs open longer than 30 days, document recent progress and the reason the CAPA is still open.
  4. Review your Approved Supplier List (ASL) to be sure that (1) the list is current and accurate, (2) all vendors are in good standing or have an improvement plan, and (3) You have secured secondary vendors for critical materials and processes.
  5. Review your complaint (and customer feedback) files to ensure that records are properly closed and the documentation is complete.
  6. Communicate with your Regulatory Affairs department on any pending updates to the U.S. FDA or other agencies.
  7. Update your organizational chart. Many organizational changes occur at the end of the year so make sure your organizational chart is updated with the latest company structure.
  8. Clean up your facility.  Remove empty storage containers, broken production equipment, and all expired materials and labeling.  Clean up your facility now to ensure a fresh start in the new year!


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