Worked Example: A Complete CAPA From Complaint to Closure

Fictional worked example. The company, people, device and numbers below are invented to show how one CAPA moves through linked records in our templates. It is not a customer case study.

Short answer: a CAPA is only as good as the chain of records behind it. This example follows one complaint through the complaint log, a nonconformance report, a root cause analysis, a CAPA record, a procedure change, training, and an effectiveness check, showing what each record contains and how they reference each other.

The situation

Northbay Wound Products (fictional), 40 people, makes sterile foam wound dressings and is certified to ISO 13485:2016. A hospital customer reports that two pouches from lot 24-117 had open seals on one edge.

1. Complaint log entry (CL-2026-031)

Received 3 March 2026, by email, from hospital procurement
Description 2 of 50 pouches in one box found with incomplete seal on the long edge before use. No patient involvement.
Reportability Assessed against MDR and vigilance criteria: no death or serious injury, and the defect was detectable before use. Not reportable. Rationale recorded, reviewed by RA.
Investigation needed? Yes: sterile barrier failure. Linked to NCR-2026-044.

2. Nonconformance report (NCR-2026-044)

Scope check Retained samples from lot 24-117 inspected: 3 of 200 with seal width below 6 mm specification. Lots 24-116 and 24-118 inspected: no defects.
Containment Remaining stock of lot 24-117 quarantined; customer offered replacement; 112 boxes recalled from two distributors as a precaution.
Disposition Lot 24-117 scrapped. Escalated to CAPA-2026-009 because the cause was not known.

3. Root cause analysis (5 Whys, recorded on the RCA form)

  1. Why were seals incomplete? Seal bar temperature was 12 °C below the validated range for part of the shift.
  2. Why? The heater controller was replaced during maintenance the day before.
  3. Why wasn't the temperature caught? The replacement controller was not verified against the validated settings before restart.
  4. Why not? The maintenance work order had no step requiring revalidation or verification after replacing parts on a validated process.
  5. Why? The equipment maintenance procedure did not link to the process validation procedure.

Root cause: no control requiring verification of validated process parameters after maintenance on validated equipment. Not “operator error”: the operator followed the procedure as written.

4. CAPA record (CAPA-2026-009)

Corrective actions (a) Revise the maintenance procedure to require a parameter check against the validation report before restart; (b) add a “validated equipment” flag to the asset register; (c) add a release hold on the first lot after maintenance until seal strength results are in.
Owners and dates (a) Maintenance lead, 20 March; (b) QA, 20 March; (c) Production manager, 27 March
Risk file Sterile barrier failure hazard reviewed in the risk management file; probability estimate unchanged after controls, new control added and traceability updated.
Impact check Corrective actions checked for adverse effect on regulatory compliance and device safety: none.

5. Change control and training

Maintenance procedure revised from rev C to rev D under document control (change request DCR-2026-018), approved by QA and the maintenance lead, effective 18 March. Four maintenance technicians and two line leads trained on rev D on 19 March; training effectiveness checked by observing the next two maintenance restarts.

6. Effectiveness check (planned at CAPA opening, done 90 days later)

Criteria set in advance Zero seal-width failures in the first lot after each maintenance event for 3 months; every maintenance restart on validated equipment has a completed parameter check.
Evidence 7 maintenance events on validated equipment, 7 completed parameter checks; first-lot seal tests all within specification; no related complaints.
Result Effective. CAPA closed 24 June 2026 by QA manager. Trend included in the next management review.

What this shows

  • Every record points to the next: complaint to NCR to CAPA to change request to training to effectiveness check.
  • The root cause is a system gap, so the fix is a system change, not “retrain the operator”.
  • Effectiveness criteria are defined when the CAPA opens, not invented at closure.
  • The risk file is updated, which ISO 13485 and ISO 14971 both expect.

The templates behind it

The complaint log, NCR, RCA form, CAPA log and effectiveness check form are in the ISO 13485 CAPA and Nonconformance Kit and the Complaint Handling, PMS and Vigilance Kit, and all of them are in the Complete QMS Kit. For ISO 9001, the same flow uses the nonconformity and corrective action records in the ISO 9001:2026 Complete QMS Kit. Start with the free CAPA initiation checklist.