Night Shift Deviation: What Now?
Choose an immediate response to a potential process deviation that preserves evidence and quality unit review.
GMP DECISION A transient endpoint alarm occurred during a batch. The process can continue physically, but the deviation status and product impact are not yet understood. What should the supervisor do first? Pause at the next safe hold point, preserve alarm and batch evidence, notify QA, and open or initiate the deviation process. Strong. This protects the batch and the investigation. It does not overreact by scrapping the lot, but it recognizes that quality impact and procedural compliance need documented review before release. Continue processing because the alarm cleared and final blend moisture met specification. Weak. Passing one downstream check…
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