NC-CAPA Question Title * 1. Date Date / Time Date Question Title * 2. Name of Reporter Question Title * 3. Short description of the problem, error or audit finding * Question Title * 4. Affected Area CERT OPS EXAMDEV QMS PROFDEV Question Title * 5. Source of Finding? * Complaint Communication Issue Customer Contact Notification from Vendor Internal Audit External Audit Vendor Error Self-identified Website Question Title * 6. Attach supporting documents, e.g. emails, audit findings or documents describing the problem Question Title * 7. Attach supporting documents, e.g. emails, audit findings or documents describing the problem Question Title * 8. What type of error, problem, audit finding, or nonconformity occurred? * Does not meet intended use Does not meet requirements Did not follow the process or procedure Current version of procedure not used or available Customer error or customer not properly informed Incomplete record Incorrect information used/provided Product does not meet specifications Training Product, Process or Service Quality Vendor error Inadvertent error Test Publication Errors Other anomaly Question Title * 9. Potential Root Cause (what caused the error, problem or audit finding) * EXT: external error, vendor, customer PRO: Documented process or procedure not accurate or clear INC: Incorrect information used or received CUST: Customer complaint ERR: Inadvertent human error SPEC: Does not meet specifications or requirements UNSPEC: Cause of error/problem not determined Question Title * 10. Type of action taken to correct the error, problem or audit finding * Immediate correction (what was done to immediately correct the error/problem/audit finding) Corrective action (long term action to prevent error/problem/audit finding from recurring) Preventive Action (action(s) taken to prevent the occurrence of potential error/problem/audit finding) Improvement (action(s) taken to improve the process or procedure) Question Title * 11. Briefly describe what else needs to be done to correct the error, problem or audit finding, a date for completion, and the responsible person(s) * Question Title * 12. Attach supporting documentation for corrective action Question Title * 13. Attach supporting documentation for corrective action Question Title * 14. Quality Assurance Check Resolved and Closed Pending investigation Done
