File 16: Post-market monitoring and complaints
After launch: complaints, signals, registers and the judgement about when a signal becomes an action.
The file guide
Working guides in this file
16A post-market monitoring plan for a product family: one page that covers a whole range, not just one product A product family monitoring plan covers shared components, suppliers and uses across a range, with a single log, a single review rhythm and family level triggers, so a signal in one variant is checked against its siblings before it is judged isolated. 16Accident and incident reporting duties: what to report, to whom, and how quickly, in general terms Accident and incident reporting means telling the relevant authority and others in the chain promptly when a product causes or may cause serious harm, with the facts known at the time, and updating the report as more is learned, rather than waiting for a complete investigation. 16An internal product safety complaints register that a small team can actually keep A complaints register works when it is product based, uses customer words, groups by batch and failure, and is reviewed regularly, so it becomes a pattern finding tool rather than a filing cabinet for refunds. 16Closing the loop after a safety investigation: telling customers, fixing the cause, and proving the fix worked Closing the loop means completing the investigation, communicating the outcome to those affected, changing the cause, and verifying that the change worked, rather than filing the investigation as soon as a decision is made. 16Deciding when a signal becomes an action: severity, repetition, batch and use judged together A signal becomes an action when severity, repetition, batch concentration or a clear cause together outweigh the cost of waiting, and the decision should be recorded with its reasoning even when the decision is to watch and wait. 16Escalating a safety signal to a decision: who decides, how fast, and what happens if they disagree Escalation works when every handler knows the trigger, the person and the timeframe, so a serious or repeated signal reaches a decision maker the same day instead of waiting for a weekly meeting. 16Handling customer complaints about safety: listening well, preserving evidence, and answering honestly Safety complaints need a different handling from ordinary complaints: listen without arguing, preserve the product and its details, log the safety words exactly, and give a clear next step rather than a quick refund that erases the evidence. 16Incident trend analysis for small sellers: spotting a pattern in a handful of reports Trend analysis for small sellers means grouping a small number of reports by product, batch, failure words and time, and looking for concentration that stands out against the background, without needing statistics a small team cannot run. 16Keeping monitoring records: what to file, how to organise it, and how long to keep it useful Monitoring records work when they are organised by product and batch, contain decisions as well as reports, and can be found quickly by someone who did not create them, long after the original team has moved on. 16Monitoring regulatory alerts and Safety Gate: turning other sellers alerts into checks on your own products Monitoring regulatory alerts means checking Safety Gate and authority notices regularly for products like yours, and asking whether the same component, supplier or failure could affect your range, before an authority asks you. 16Monitoring reviews and online feedback for safety signals: reading between the stars to find a hazard Review monitoring means reading reviews, questions and social mentions for safety words, grouping them by product and batch, and treating vague language seriously, since customers rarely use the word safety when they describe a hazard. 16Monitoring safety signals from test labs: what a lab report, a retest and a failed sample can tell you after sale Lab signals after sale include failed retests, batch variations, supplier test discrepancies and customer returned sample results, and each should be logged, grouped and judged like any other safety signal. 16Post-market monitoring and supplier audits: using what you learn after sale to check the factory, not only the product Supplier audits after sale should be driven by monitoring signals, focusing on the component, process or change behind a pattern, rather than repeating a generic factory checklist that misses the actual cause. 16Post-market monitoring explained for sellers who have never run a monitoring routine Post-market monitoring is the routine of collecting, grouping and reviewing information about products already sold, so problems are spotted from patterns in complaints and returns rather than from a single dramatic incident. 16Post-market monitoring for marketplace sellers: complaints, reviews and takedowns across platforms you do not control Marketplace monitoring means gathering complaints, reviews, returns and platform notices across every marketplace you sell on, into one product log, so a pattern spread across platforms is visible despite each platform showing only its own slice. 16Post-market monitoring for small sellers: a routine that fits a team of one or two Small seller monitoring works when it is tiny, regular and product based: one log, one weekly review, and one rule for escalating a serious report or a repeated pattern, without software a small team will not maintain. 16Working with suppliers after a safety signal: evidence, deadlines and joint fixes without blame or delay Working with suppliers after a signal means sharing grouped evidence promptly, agreeing a joint investigation and a deadline, and verifying the fix together, while keeping sales decisions in the seller hands until the fix is proven.