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All CAPA questions

Question 11 of 20 Intermediate Practical

How do you write a CAPA action that is specific and verifiable?

Short answer

Name the cause it addresses, the exact change, the owner, the due date and the evidence that will prove it was done and worked. Prefer actions that change the design of the task or equipment over reminders and retraining, because design changes keep working when attention slips.

Why

Many CAPAs fail before they start because the action is vague, such as "improve awareness of line clearance." Nobody can tell when it is done or whether it worked. FDA quality systems guidance expects the selected action to be taken within a defined timeframe and its effectiveness to be evaluated, which is impossible without a specific action. A good action states which cause it targets, what will change, who owns it, when it is due, and what evidence will show completion and effect.

The second test is strength. The UK Health and Safety Executive explains that slips and lapses happen in familiar tasks and cannot be eliminated by training, while improved design can reduce them. Critiques of root cause analysis in healthcare note that investigations often settle for weaker administrative fixes such as reminders, while poorly designed actions can even cause harm.

So an action that adds an interlock, removes a look-alike material from the area or simplifies a form usually beats one that adds a signature or a training session. Training is right when the cause is genuinely missing knowledge. For example, "Add a barcode check of the label roll against the batch record before the labeler can start, owner engineering, due 30 June, evidence a validated interlock and zero label mix-ups in 50 lots" is specific, strong and verifiable.

A strong answer covers

  • Linked to a specific cause
  • Exact change, owner and due date
  • Completion and effectiveness evidence defined
  • Design changes preferred over reminders
  • Training only when knowledge is the gap

Common mistakes

  • Writing actions like raise awareness or reinforce expectations.
  • Defaulting to retraining for slips and lapses that training cannot prevent.
  • Leaving out how completion and effectiveness will be evidenced.