Free CAPA form template
A corrective and preventive action form in Word that follows a CAPA from its source to the effectiveness check, with the fields auditors and inspectors look for. No email needed.
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Free to use and adapt in your organisation. No email address needed. Add your own document number and version, and approve the form under your document control before use.
- Word (.docx)
CAPA form
Source, problem, containment, risk, root cause, action plan, effectiveness check, plan approval and closure.
What this template is for
A CAPA (corrective and preventive action) record shows how a problem was understood, which actions removed its cause and whether those actions worked. ISO 9001, ISO 13485 and ICH Q10 all describe this loop, and in an audit the CAPA record is where it is either visible or missing.
This form keeps one CAPA on one record: the source and problem, containment, risk, root cause, an action plan with owners and dates, the effectiveness check and the approvals. Grey guidance text explains each field and can be deleted before you issue the form.
Requirements it supports
How to fill it in
- 1
Link the source
Record where the CAPA comes from (deviation, complaint, audit finding, investigation or trend) and the source record numbers, so a reviewer can follow the trail in both directions.
- 2
Describe the problem and its extent
State what happened or could happen, where, when, how it was detected and which products, batches or systems are affected. Facts and record numbers, not conclusions.
- 3
Record containment separately
Corrections such as quarantine or rework go in the containment section. They deal with the immediate problem; the corrective action deals with its cause.
- 4
Assess the risk
Rate the impact on product quality, safety, compliance, other products or sites and the validated state. The risk level decides how deep the investigation goes and how fast actions must close.
- 5
State the root cause and its evidence
Write one clear root cause statement, tick its category and reference the evidence. Use the root cause analysis template pack when the investigation needs more room.
- 6
Plan actions with one owner each
Mark each action corrective or preventive, and give it one owner, a due date and the evidence that will prove it is done. Note the change control, document revisions or training it triggers.
- 7
Define the effectiveness check before you implement
Set a measurable criterion, the data to review and the date, for example zero recurrences in the next 20 batches. Record the result before QA closes the CAPA.
Common mistakes inspectors flag
Effectiveness never verified
CAPAs closed as soon as the actions are done, without checking that the problem stopped. Missing or weak effectiveness checks are among the gaps auditors find most often.
Corrections recorded as corrective actions
Reworking or rejecting the affected batch fixes the batch, not the cause. A CAPA with only corrections will see the problem again.
Retraining as the default action
Retraining without a root cause that points to training, or without fixing the procedure that confused people, rarely prevents recurrence.
Due dates moved without a reason
Actions extended again and again with no documented justification or risk assessment for the delay.
Records that do not reference each other
Deviations, investigations, CAPAs and change controls without links make it impossible to show that the loop was closed.
Do this in QFacts
A template works until the records pile up. QFacts keeps these records in one eQMS with workflows, electronic signatures and an audit trail. Try it for 14 days, no credit card needed.
- Link each CAPA to the investigation that found the root cause.
- Give every action an owner and a due date.
- Check efficacy before a CAPA can be closed.
- Keep every step in an audit trail that cannot be edited or deleted, with role-based access.
Frequently asked questions
What is the difference between a corrective and a preventive action?
A corrective action removes the cause of a problem that has happened, so it does not recur. A preventive action removes the cause of a potential problem before it happens, for example applying a fix to similar equipment that has not failed yet. The form marks each action C or P.
What is the difference between a correction and a corrective action?
A correction deals with the nonconformity itself, such as reworking or rejecting a batch. A corrective action deals with its cause. The form records them in separate sections.
How do I write a CAPA effectiveness check?
Before implementing the actions, define a measurable criterion, the data source and a time window, for example no labelling deviations of the same type in the next three months, verified by trend review. Record the result, and open a new or extended CAPA if the check fails.
Does every deviation need a CAPA?
Not necessarily. Most procedures require a CAPA when the investigation finds a cause that needs action to prevent recurrence, or when the risk is significant. Define the criteria in your deviation procedure and apply them consistently.
Is this CAPA form free?
Yes. Download the Word file without an email address and adapt it to your own procedures.
More free templates
- Root cause analysis template pack
Investigation report, 5 Whys worksheet and fishbone (Ishikawa) diagram, with worked examples.
- Free change control form template
Change request, impact assessment across eleven areas, classification, implementation plan and approvals.
- Free training matrix template for Excel
Excel training matrix with retraining due dates, a skills matrix with competence levels and a training log.
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