CAPA Quality Loop Cards
Recall which quality framework to use for risk anticipation, root-cause analysis, and improvement testing.
Quality loop selector Which framework fits the moment? Before, after, improve Match the tool to the question, not the seriousness of the meeting. Use FMEA when... You are designing or revising a process and need to prioritize failure modes before they occur. Examples: decentralized visits, IP shipping, imaging workflow. Use Five Whys when... A problem has occurred and you need an evidence-based, controllable root cause. Stop when the cause points to a process control you can change. Use PDCA when... You have a suspected improvement and need to test whether it works before scaling. Always include a measure and decision…
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