What is CAPA?
CAPA (Corrective and Preventive Action) is the part of a quality management system that turns problems into lasting improvements. Inputs come from complaints, nonconformances, deviations, audits, trends and supplier issues. Each CAPA is investigated to its root cause, fixed with actions that remove that cause, and closed only when there is evidence the fix worked. For medical device, pharmaceutical and other regulated manufacturers, CAPA is one of the most inspected processes.
- Correction: fixes the nonconforming product or situation now.
- Corrective action: eliminates the cause of a detected nonconformity to prevent recurrence.
- Preventive action: eliminates the cause of a potential nonconformity to prevent occurrence, for example on similar products.
The CAPA process, step by step
- Initiation. Describe the issue with facts, rate its risk to set the priority, and contain it.
- Investigation. Find and verify the root cause with a method suited to the risk: 5 Whys, fishbone, fault tree or a full 8D.
- Action plan. Plan corrective and preventive actions with owners and due dates, and assess the impact of changes.
- Implementation. Complete the actions and keep evidence (changed procedures, training records, validation).
- Effectiveness check. Verify against the criteria set in advance, after enough time or volume.
- Closure. Review and approve the record; reopen the investigation if the actions were not effective.
CAPA example
Trend monitoring shows seal strength on a sterile pouch sealer falling 18% in three months, with three results below specification. Severity 4 × occurrence 3 gives a risk of 12: medium priority, with 60 days to close. Affected lots are quarantined and re-tested (correction). The investigation finds the sealer temperature controller drifted 9 °C low, undetected by a 12-month calibration interval and no daily temperature check. Corrective actions replace the controller, add a daily check and shorten the calibration interval; a preventive action reviews the intervals of all critical heat-process equipment. The CAPA will be effective when 30 consecutive lots meet specification with a seal strength Cpk of at least 1.33, which you can check with the process capability tool.
What auditors look for in a CAPA
- Risk-based depth: a documented rationale for the priority and the level of investigation.
- A real root cause: not "human error" or "operator retrained" without asking why the system allowed the error.
- Actions linked to causes: every root cause has an action, and every action addresses a cause.
- Timeliness: actions completed on time, or extensions justified.
- Effectiveness evidence: measurable criteria, defined in advance and verified before closure.
- Trending: CAPA data reviewed in management review to spot systemic issues.
How to use this CAPA tool
- Open the CAPA. Enter the title, number, owner, type, source, opening date and product or process.
- Describe and rate. Describe the issue, rate severity and occurrence to set the priority and target closure date, and record the containment.
- Investigate. Choose the method, record the verified root cause and its category.
- Plan the actions. Add corrections, corrective and preventive actions with owners and due dates. Overdue actions are flagged.
- Check effectiveness. Define measurable effectiveness criteria, then record the result and verdict when the check is due.
- Close and export. Record who approved the closure and when, then export the CAPA record to PDF or Excel.
Frequently asked questions
What is CAPA?
CAPA stands for Corrective and Preventive Action. It is the quality system process that investigates problems, eliminates their root causes and verifies that the actions worked. Corrective actions remove the cause of an existing nonconformity; preventive actions remove the cause of a potential one.
What is the difference between a correction and a corrective action?
A correction fixes the immediate problem (rework, scrap, re-label, quarantine). A corrective action removes the root cause so the problem does not happen again. A CAPA usually needs both: the correction contains the issue, the corrective action prevents recurrence.
Which regulations require CAPA?
CAPA is required by FDA 21 CFR 820 (QMSR, which incorporates ISO 13485:2016), ISO 13485 clauses 8.5.2 and 8.5.3, EU GMP Chapter 1, ICH Q10 and others. ISO 9001:2015 requires corrective action (clause 10.2) and replaces preventive action with risk-based thinking.
What is a CAPA effectiveness check?
An effectiveness check verifies, with objective evidence, that the actions eliminated the problem without creating new ones. Define the criteria when you plan the actions (for example "no recurrence in the next 30 lots and Cpk ≥ 1.33"), then check after enough time or volume has passed. CAPAs closed without effectiveness evidence are a frequent FDA 483 observation.
How is CAPA priority set?
Most companies rate risk, typically severity × likelihood, and set the investigation depth and closure target by priority. This tool uses a 5 × 5 rating: 15 or more is high priority, 8 to 14 medium, below 8 low, with default closure targets of 30, 60 and 90 days that you can change.
What are the steps of the CAPA process?
Initiation (describe the issue, assess risk, contain), investigation (find the root cause), action plan, implementation, effectiveness check and closure. The roadmap in the tool follows these six stages and updates their status from the content of the record.