What's in your Manufacturing Readiness Review ?
Posted by Bob Evans on Wed, Oct 12, 2011 @ 03:47 PM
Successful medical product design follows a proven process that complies with the applicable regulatory standards. ISO 13485 requires that a comprehensive management system be established and maintained to monitor and control/mitigate risks from product inception through design transfer and into production, referred to by the FDA as Total Product Life Cycle (TPLC). There are various stage gate reviews during the TPLC with the Manufacturing Readiness Review being the final gate for the design transfer to production.
At the point of design transfer to a manufacturing/production environment, many if not all of the identified risks will have been eliminated or mitigated (i.e. by design, process control, labeling). The design history file is complete with supportive verification testing data and the documentation to procure, fabricate, tool, build, and test has been released in support of a production lot build. But ... are you ready ?
A manufacturing readiness review is a key tool of a proven process that provides the insight to determine whether the output of the design process coupled with the manufacturing, supply chain, and quality team preparedness meet all the requirements to move to a production manufacturing environment.
Moving through this gate without completing all the elements could cause costly engineering changes, rework and product recalls in the future. Moving too slowly through this gate could cause product launch delays and potentional erosion of market share. This is why a well planned and executed product development process with meaningful product design stage gates/reviews which culminate in a manufacturing readiness review lead to a smooth design transfer to production.
Come to the MPO Symposium 2011 in Waltham, MA on the 19th of October and talk with Ron Jellison, KMC Systems VP of Business Development, about your Manufacturing Readiness Review. Ron will be leading a roundtable discussion at lunch and participating as a panelist in the "Building the bridge between OEM design and outsourced manufacturing."
