Created protocols for and conducted IQ, OQ and PQ for Medical Device manufacturing equipment

Posted by Bob Duffy on April 3, 2017 in Manufacturing Projects

Challenge

Client needed new controlled process to expand their existing manufacturing capabilities.

Actions

• Investigated process and options for automated equipment.
• Investigated process parameters and options for process control tests and test equipment.
• Developed process parameters for initial implementation.
• Wrote and executed IQ, OQ and PQ protocols and Manufacturing and Test Procedures.
• Wrote Test Reports and Change Orders to release Test Reports, Manufacturing and Test Procedures and Equipment documents.

Result

Client successfully added the new controlled process to their existing manufacturing capabilities.