CAPA plan and effectiveness check
Turn a root cause into a CAPA plan: link it to its source (deviation, OOS, audit, complaint or trend), pick example corrective and preventive actions for the root-cause category, give each an owner, a target date and a measurable effectiveness check, then record the effectiveness check when it is due. The tool flags weak CAPA, such as retraining-only plans or checks with no timeline.
CAPA plan
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Source
Why this matters
CAPA is one of the four elements of a pharmaceutical quality system. Corrective and preventive actions should result from investigations of deviations, complaints, audit findings, trends and similar sources, and their effectiveness should be evaluated.
Source: ICH Q10 Pharmaceutical Quality System (2008)Actions
Effectiveness plan
Why this matters
Each CAPA needs a measurable effectiveness criterion (what will be checked, how, and when). "Training completed" shows the action was done, not that it worked.
Good practice / example in-house approach — follow your SOP.CAPA text and export
CAPA effectiveness check
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Effectiveness check
Export
Frequently asked questions
How does the CAPA suggester work?
It maps the root-cause category (Man, Machine, Method, Material, Measurement, Environment) to example corrective and preventive actions from a phrase library. Tap one to add it, then edit it so it fits your situation.
What makes an effectiveness check measurable?
It says what will be checked, how much and by when — for example “no recurrence of the same deviation in the next 10 batches”. “Training completed” shows the action was done, not that it worked, so the tool flags it.
Why does it warn when all actions are training?
Retraining alone rarely prevents recurrence. The tool asks for at least one system, procedure or design action.
What is the 30-day closure rule?
Many sites aim to close deviations or CAPA within a set time such as 30 days unless an extension is justified. That is an example in-house criterion, not a regulatory requirement; follow your own SOP.
Can I record the effectiveness check later?
Yes. Save the session to a file or leave it in this browser, then open the “Effectiveness check” tab when the check is due. The CAPA number and criterion are carried forward.
Related guides on pharmaguideline.net
- CAPA in Pharma: Complete Guide to Root Cause and Effectiveness
- CAPA Process: 15 Step-by-Step Instructions for Pharma QA
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