Updated PFMEA to support manufacturing startup on new Medical Device

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

Challenge

Client needed PFMEA updated and process Risk Control measures defined for Design Transfer and manufacturing startup on new Medical Device.

Actions

• Create manufacturing process flowchart for device.
• Updated PFMEA to define potential process failures that would affect device meeting specifications.
• Defined process Risk Control measures to reduce residual risks to acceptable levels.

Result

Client was able to implement process Risk Control measures to ensure produced devices meet specifications.