Use Five Whys Without Blaming the Coordinator
Apply Five Whys to find a process-level cause for a recurring protocol deviation.
Third missed safety-lab window: the pattern matters more than the person who touched the last visit. Five Whys works when every why is evidence-based and leads toward a controllable process cause for CAPA. Start with the event Avoid blame stop Choose CAPA Apply to a new deviation Step 1: define the event The event is a missed week-12 safety lab window for the third subject in six weeks. Define the problem in event language before explaining it. Step 2: follow evidence, not assumptions The visit was scheduled using a CTMS calculator that disagreed with the protocol window language. Strong why-chains…
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