Medical device manufacturer

Following a component lot into finished goods

A medical device manufacturer connected component lots, finished production, and verification records so quality could follow the history of a lot from either end.

A finished lot number was only the starting point

For an audit or a quality investigation, the team needed to answer two questions: which component lots went into this finished lot, and what else used one of those same component lots? The answer had to tie back to the production and verification records for the work in question.

Recording material use as part of production

The manufacturer used Pocket-E Flow to associate component lots with finished production as material was consumed. Recording that relationship during the run kept the lot history tied to the work that produced it.

Pocket-E Verify captured the required checks in the workflow. Those records gave quality a way to review the verification history alongside the material history, including when a lot needed to be held for review.

A trace the quality team could follow in both directions

The team could start from a finished lot and look back at its inputs, or start from a component lot and see where it was used. That gave quality a way to gather the records for an audit and identify the production to review when a component was in question.

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