1. Purpose

To establish a consistent process for documenting quality issues, determining root cause, implementing corrective and preventive actions, and verifying that those actions are effective.

2. Scope

Applies to quality issues identified from internal audits, sponsor monitoring visits, regulatory inspections, protocol deviations, privacy or security incidents, staff reports and trend analysis.

3. Responsibilities

• Quality Assurance Specialist: Maintains the CAPA log, facilitates root cause analysis, and tracks actions to closure.
• Action Owner: Executes assigned actions by the agreed target date and supplies objective evidence of completion.
• Quality Assurance Director: Classifies severity, approves CAPA plans, and approves closure after effectiveness verification.
• Department Managers: Provide resources, escalate blockers, and communicate process changes to their teams.

4. Definitions

Correction

An immediate fix applied to the specific instance of a problem.

Corrective action

An action taken to eliminate the root cause so the problem does not recur.

Preventive action

An action taken to prevent occurrence of a similar problem in a process where it has not yet happened.

Effectiveness check

Objective evidence, collected after implementation, confirming that the action achieved its intended result.

5. Procedure

1. Document the issue in the CAPA log within three business days of identification, recording the date discovered, source, study, description and immediate patient-safety or data-integrity impact.
2. Apply and record any immediate correction needed to protect subject safety, data integrity or protected health information.
3. Classify severity as Critical, Major or Minor using the site severity matrix; Critical issues are reported to the Quality Assurance Director and Chief Medical Officer the same business day.
4. Assemble a review team that includes the process owner, an affected staff member and Quality Assurance.
5. Perform root cause analysis using a documented method such as five-whys or a cause-and-effect diagram; do not accept 'human error' as a terminal root cause without identifying the contributing system factor.
6. Define corrective actions that address each root cause, with a single named owner and a target completion date for every action.
7. Assess whether the same cause affects other studies, departments or processes, and define preventive actions for those areas.
8. Determine the training impact and, where required, revise the affected SOP under QA-001 and issue new read-and-understand assignments.
9. Obtain Quality Assurance Director approval of the CAPA plan before implementation begins.
10. Implement the actions and retain objective evidence such as revised documents, training records, screenshots, logs or equipment records.
11. Perform the effectiveness check no earlier than thirty days and no later than ninety days after implementation, using a predefined measurable criterion.
12. Close the CAPA only when every action is complete and the effectiveness check passes; if it fails, reopen the CAPA and return to root cause analysis.
13. Report open and closed CAPAs, including aging, at the monthly quality management review and in the annual quality report.

6. References

• ICH E6(R3) Good Clinical Practice, quality management
• 21 CFR Part 312.50 — Sponsor and investigator responsibilities
• QA-001 SOP Development, Review, Approval & Document Control
• QA-003 Internal Audits & Inspection Readiness
• CON-002 Protocol Deviations & Violations

7. Revision History

• v1.0 · Apr 10, 2020 — Initial issue.
• v2.0 · Feb 19, 2024 — Added severity matrix and mandatory effectiveness checks.
• v2.1 · Nov 03, 2025 — Editorial clarification of CAPA logging timeline.