A lifecycle, not a search cycle
A PSUR summarises what happened to your device in the field over a period: complaints, incidents, trends, CAPAs and what you concluded. If every event already lives in QES, writing it is a filter and a review. If not, it is a search.
Two ways to reach PSUR day
Same device, same period, same events. The difference is where the information lived while the events were happening.
The search cycle disconnected
- Events are found after the fact, from wherever people happened to write them down.
- The emailed “swapped the cable, all good” calls are invisible, so they never reach the PSUR.
- Counts, dates and CAPA status are rebuilt by hand and reconciled between sources.
- No one can say for certain the list is complete.
The lifecycle QES
- Each stage records what the PSUR will later ask for, at the moment it happens.
- Every event is in one place, including the ones that were fixed on the phone.
- Counts, trends and CAPA status come from the records, not from memory.
- Completeness is built in: if it happened, it has a ticket.
of field events like the sensor call end as an email. In the search cycle they never reach the PSUR, so complaints are under-reported. That is exactly the kind of gap an auditor looks for.
Which stage feeds which PSUR section
Pick a step to see what it puts into the PSUR. Dashed circles are inputs that come from outside QES.
| PSUR section | 1 · Report | 2 · Triage | 3 · Investigate | 4 · Assign | 5 · Track & Outcome | Outside QES |
|---|---|---|---|---|---|---|
| Complaints & non-serious incidentsHow many, what kind, where | ||||||
| Serious incidents & FSCAsIncluding “none”, with the reason | ||||||
| TrendsRepeats, clusters, rising rates | ||||||
| Risk & benefit-risk reviewDid anything change the risk picture? | ||||||
| Corrective & preventive actionsRoot cause, owners, status, effectiveness | ||||||
| Conclusions & actions takenWhat changed because of the period | ||||||
| Units sold & people exposedThe denominator for every rate | Sales & distribution records | |||||
| PMCF, literature, similar devicesEvidence from beyond your own field data | PMCF plan, literature review |
- Every PSUR section that describes field experience is fed by at least one QES step.
- Only the denominator (units sold, people exposed) and external evidence (PMCF, literature) come from elsewhere.
The sensor event, as the PSUR shows it
This is the same event from Part 1. Each line is taken from a QES record; the tag shows which stage wrote it.
Complaints and non-serious incidents
Two reports of the sensor failing to connect to the device, at two sites. Report At the second site, three cables were reported as failed; all three were later found to work normally. Report Both are counted here because their origin is field feedback, even though the confirmed type is a deviation. Assign
Serious incidents and field safety corrective actions
None in the period. The connection event was judged not to be an adverse event at triage, with the rationale recorded. Triage Its type was suspected as a deviation at triage and confirmed at assignment. Assign
Trends
The two reports were linked at triage as one event with a shared cause, because the reported cable faults could not be reproduced elsewhere. Triage
Risk review
A formal risk assessment was judged not required at initial assessment, with the reason documented. Investigate The root cause found later did not change that judgement. Track & Outcome
Corrective and preventive actions
| CAPA | Root cause | Actions | Status |
|---|---|---|---|
| Sensor USB-C connection Assign | Insufficient solder paste on one side of the USB-C connector at chip install; connection works in one cable orientation only. Investigate | Supplier issue raised; replacement sensors to affected sites; production SOPs revised; final test checks both cable orientations; testers trained. Assign | Closed, effectiveness checked Track |
Illustrative extract for training. Section names follow a typical PSUR structure; use the template your regulator or notified body expects.
The questions your reviewer will ask
Whoever reads your PSUR will test it with questions like these. Here is where the answer comes from in each world.
| Question | Search cycle | Lifecycle (QES) |
|---|---|---|
| How many complaints did you receive in the period? | Count emails and spreadsheet rows, then hope nothing was missed | Filter QES events by date and device |
| Were any of them serious incidents? | Re-read each one and decide now, months later | Reportability and its rationale were recorded at triage, Step 2 |
| Did you see any trends? | Only if one person happened to remember both calls | Linked events from triage show the cluster |
| What was the root cause, and who was involved? | Find the supplier email thread | Root cause (Step 3) and the supplier action (Step 4) sit on the event |
| Did your corrective actions work? | Ask production whether the SOP was updated | SOP version, training records and closure evidence attached at Step 5 |
