Complaints, Recalls, Deviations, and CAPA
This domain tests how a site detects, investigates and responds to product problems: complaint handling, recall classification and execution, deviation and investigation requirements, and corrective and preventive action through to verified effectiveness. Expect questions where a company takes the cheapest visible action.
Complaints
- 211.198 requires written procedures for handling all written and oral complaints and a complaint file containing the complainant's name and address, the nature of the complaint, the product name, strength and lot number, the date received, the investigation findings, the reply and any follow-up.
- The quality unit reviews and investigates complaints; investigation extends to other batches that may be affected.
- Complaint trends are a signal detection tool and feed management review and CAPA.
Recalls
- Recall classes under 21 CFR 7 reflect health hazard: Class I is a reasonable probability of serious adverse health consequences or death; Class II is temporary or medically reversible harm, or a remote probability of serious harm; Class III is unlikely to cause adverse health consequences.
- Recalls have a strategy including depth of recall, public warning where needed, effectiveness checks, and status reports to the agency.
- A firm must not delay a recall in order to complete its investigation. Notify the agency promptly and continue investigating in parallel.
Deviations
- 211.192 requires any unexplained discrepancy or failure of a batch to meet specifications to be thoroughly investigated whether or not the batch has been distributed, with the investigation extended to other batches.
- Deviations are commonly classified by impact on patient safety, product quality and regulatory compliance, which determines the investigation depth and the level of approval.
- Root cause analysis tools include the five whys, Ishikawa diagrams, fault tree analysis and FMEA. The output must be a cause that the actions actually address.
CAPA
- Steps: contain and assess impact, determine root cause, define corrective action for the occurrence and preventive action for potential occurrences elsewhere, assign owners and due dates, implement, verify effectiveness against predefined criteria, then close and trend.
- A CAPA is effective only when data show the problem has not recurred over a defined period. Implementation evidence is not effectiveness.
- Repeat deviations of the same type should trigger a CAPA and escalation to management review.
Worked example
Three bottles from one lot are complained about for chipped tablets. The retain sample shows the same defect, so this is a manufacturing issue. The batch record shows compression force at the upper limit and a new cam track fitted the previous week, corroborated by maintenance records. Corrective action replaces the cam track and requalifies the press; preventive action adds cam track wear inspection to the planned maintenance schedule for all presses; effectiveness is verified over six months of complaint and reject data plus the next three batches. A health hazard evaluation determines whether other lots require recall.
Traps that cost marks
- Closing a complaint as isolated with no investigation or retain sample examination.
- A CAPA whose only action is retraining, with no identified root cause.
- Closing a CAPA at implementation rather than after the effectiveness check.
- Delaying a recall to finish the investigation, or failing to extend the investigation to other lots.