Quality Audits

Periodic audits assure adherence to our quality systems. Internal Quality System audits are performed by the Quality Assurance staff and by other trained personnel under the guidance of Quality Assurance. Results of audits are reported to the Assistant Director of Quality, the appropriate Vice President, the Company President, and the operating units involved. It is the responsibility of those units to develop corrective actions, to correct deficiencies and to present evidence of correction. Vendor audits are performed by Quality Assurance staff on an as needed basis. Other Quality System effectiveness checks are

made by department managers and senior management, through periodic review of product complaints, non-conforming material tracking / trending and material review board meeting minutes.

To ensure that the Quality System is effective and relevant, it is reviewed annually by the Senior Management Team, the Asst. Director of Quality, the Regulatory Affairs Specialist and other managers, as appropriate. The agenda for the meeting will be written by Quality Assurance based upon audit results and other outstanding issues related to Quality Systems and product quality. Minutes from the meetings shall be distributed to those present at the meeting as well as any designated attendees that are absent from the meeting. A copy of the agenda and meeting minutes will be maintained on file in Quality Assurance.

Related Procedures:

Corporate:

• Management Quality Systems Review Procedure 
• Quality Meetings 
• FCA Inspection Procedure 
• Internal Audit Procedure 
• Corrective and Preventive Action