This is the post-market aspect of compliance management. A product must be monitored even after it's launched; complaints must be evaluated, risks identified must be reported to the authorities, and the product must be recalled if necessary.
Scope
Complaint and incident log: A single database for collecting customer complaints, service records, field reports, and injury notifications.
Trend analysis: Pattern detection beyond individual complaints. A single complaint might be noise; three complaints belonging to the same component are a signal.
Risk assessment: Comparing the severity of the event to the current risk assessment and determining whether the notification threshold has been exceeded.
Notification to the authority: When a risk is identified, timely notification must be made to the relevant authority in a standard format.
Scope definition: Identifying the affected batch, series, and production date range. The better the traceability, the narrower the scope of the recall.
Compiling the recipient list: Identifying which customer, retailer, and channel received the affected products from shipping records.
Recall process: Standard notification text, direct consumer communication, return and compensation process, tracking of collected amount.
Root cause and corrective action: Identifying the cause, implementing design or supplier-side corrections, and verifying their effectiveness.
Effectiveness measurement: Measuring how many products have been affected by the recall; changing the communication method if it's insufficient.
The key capability: being able to answer the question, "Which products did the problematic lot of this component end up in, and to whom were those products sold?" within hours . This capability transforms a recall from a portfolio-wide disaster into a controlled operation involving a few hundred products. The answer doesn't come from a system established at the time of the recall, but from traceability already present in the product and shipment data.