Can establish a root cause that survives challenge, distinguish correction from corrective action, and define an effectiveness criterion before the action closes — so that recurrence, not closure rate, is what the CAPA system is judged on.
A published entry in the SPEQ competency map. It records what it means, how it is assessed, and — deliberately — what it does not indicate.
COMPETENCY-INVESTIGATION-AND-CAPA-EFFECTIVENESS · WORKING · v1.0.0 · PUBLISHED
Orientation only. SPEQ does not assess whether a practitioner can perform this work; the level describes what the competency is about, not an attainment SPEQ has verified.
Indicates orientation only. It is not a qualification, license, or certification, and does not replace employer training, supervision, or professional judgment.
WHAT IT LOOKS LIKE · 6
- Establishes what happened before deciding why, and separates the two in the record.
- Pursues a cause until the answer explains every feature of the event, rather than stopping at the first plausible one.
- Scales the investigation and the action to the risk, and can justify both directions — including deciding a small event needs no corrective action.
- Distinguishes correction, corrective action and preventive action, and does not record a repair as a corrective action.
- Defines effectiveness checks that could show the action failed, and acts when one does.
- Extends a confirmed cause to other products, lines and sites where the same cause could operate.
HOW IT IS DEMONSTRATED AT WORK
Read the investigation against its own evidence: does the stated cause account for the timing, the scope and the fact that it had not happened before? Then look at the effectiveness check — whether it was capable of detecting recurrence, whether it ran, and what happened when one failed. An organisation in which no effectiveness check has ever failed is not checking effectiveness.
WHERE IT IS COMMONLY WEAK
Human error as a root cause is the classic failure, and it is a description of the event rather than an explanation: the useful question is what made the error available. Retraining as the sole action is its companion. The subtler pattern is a house cause — one category that fits most events and directs attention nowhere — and effectiveness checks written to be passed, measured over a window too short for the failure to recur.
WHAT TEACHES IT · 2
- CAREER PATHWAYQuality Assurance — career pathway
- TOPICQuality Risk Management (ICH Q9)
WHAT EXERCISES IT · 0
Nothing exercises this yet. 13 scenarios are published and none is linked to this entry — we would rather say so than point you at the closest one.
See what your own record shows against this entry — and what it does not.
Where you stand →WORK TOWARD THIS
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