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Validation can make a device launch a sure thing

For custom injection molder Mack Molding, process validation has taken on greater importance as the company has gained in experience and market share in the medical device industry. The reasons are obvious: Validations can take years. Creeping elegance can take over. Product launches can be stopped in their tracks. When implemented correctly, however, process validation can improve launch success and minimize product recalls.

PlasticsToday Staff

August 24, 2011

1 Min Read
Validation can make a device launch a sure thing

Bryan Campbell, plant manager at Mack Molding's headquarters facility in Arlington, VT, penned an article on the topic for our sister publication MDDI (Medical Device and Diagnostic Industry). Campbell argues, "When used carefully, process validation is an invaluable tool for manufacturer.

The bottom line for any quality system (QS) is that it must ensure products are manufactured to the OEM's satisfaction. The OEM's requirements, or product specifications, drive process development and define the process parameters. To ensure that the process can be repeated successfully over the long term, it must be validated. This can be simple if the OEM works with its contract manufacturer (CM) to develop and doggedly follow an advanced quality plan, form a cross-functional project team, and provide regular input."

In the article, available here, he discusses and explains:

  • The Importance of Validation

  • Assembling the Right Team

  • Developing the Plan

  • Installation Qualification

  • Operational Qualification, Process Qualification and Best Practices.

As Campbell notes, looking beyond the manufacturing efficiencies and the statistical confidence that will result, validation data can be used by OEMs to develop the next generation of products. As in so many product launches, "the key to success rests on a collaborative partnership between the OEM and the CM. Clearly articulated, well-timed, authoritative communication must be the rule, not the exception."

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