1. Notify the supervisor or QA staff promptly (within 24 hours) after discovering a problem or nonconformity, or deviating from an SOP, batch record, or test method.
2. Draft a clear, complete problem definition.
3. Assess patient safety and product effect (the QA or medical affairs department will make the final determination).
4. Follow company SOPs and fill out forms completely.
5. Describe the immediate actions taken.
6. List all possible causes.
7. Create a timeline or chronology.
8. Look for any prior occurrences.
9. Look for changes or differences.
10. Identify whether other systems, products, rooms, equipment, or raw materials may be affected.
11. Brainstorm root causes. Always look for at least two causes, in the form of preexisting conditions and actions (or catalysts).
12. Create an investigation plan and carry out the investigation (most should be done within 30 days). Assign an individual and a due date to each item. Handle any problem concerning distributed product quickly.
13. Ask questions that will help get to the bottom of the problem (who, what, when, where, why, and how).
14. After analyzing the data, narrow the root causes, brainstorm, and select the best possible solutions. When proposing a CAPA item, also suggest a way to measure its effectiveness.
15. Create a corrective action plan that corrects the immediate problem and prevents it or something similar from occurring again. Get a signed agreement and a due date from everyone responsible for completing a CAPA item.
16. Document well. Use interim reports for any investigations going past 30 days.
17. Follow up on all CAPA actions.
18. Measure the effectiveness of the action. Check the data sources that helped identify the problem to see whether the problem is recurring.
19. Get the investigation plan and CAPA completion approved by QA and other necessary departments.
20. Communicate the results to everyone involved at all company sites.