The inspection-prep moment
Picture the VP Quality in the month before a PMS-focused inspection or audit. Procedures exist, but complaint trends, public signal checks, CAPA screens, risk-file notes, and management-review evidence trails are scattered.
The first move is not to declare whether the signal raises safety, compliance, reportability, equivalence, or exposure questions. The useful move is to map the evidence, name missing links, and prepare reviewer-owned gap decisions.
PMS inspection gap checklist
| Gap layer | Question to answer |
|---|---|
| Source checks | Which public recall, alert, regulator, or database sources were checked and when? |
| Internal records | Which complaint, CAPA, risk, supplier, service, clinical, labeling, or management-review records connect to the signal? |
| Evidence thread | Can a reviewer follow trigger, source, record, owner, rationale, and next action? |
| Owner | Who closes the gap and who reviews the decision? |
| Boundary | Which conclusions remain with qualified reviewers? |
What good looks like
The result should be a gap checklist the inspection-prep team can use before the next review meeting. It should show fewer slides and more evidence trails: source checked, record found, gap named, owner assigned, due date set, and reviewer decision still open.
If the first pass finds many gaps, that is useful. It means the workflow found the places where procedure language and actual evidence are not yet connected.
Source ledger
What it can tell you
Public FDA recall and early-alert records that can create monitoring and inspection-preparation questions.
What it cannot decide
Whether one company's PMS system, complaint handling, CAPA process, or risk file is inspection-ready.
What it can tell you
Canadian public recall and safety-alert records that may frame postmarket evidence questions.
What it cannot decide
A company's Canadian PMS sufficiency, importer duty, distributor duty, or field-action decision.
What it can tell you
European medical-device sector resources and public context that can frame EU postmarket evidence questions.
What it cannot decide
Whether a manufacturer's PMS, PMCF, vigilance, clinical, or conformity evidence is sufficient.
Frequently asked questions
Does this make the PMS file inspection-ready?
No. It organizes the evidence gaps and review questions. Inspection readiness, compliance status, and final quality-system decisions remain with qualified owners.
What is the first useful output?
A PMS inspection gap checklist with public source links, internal record references, owner assignments, missing evidence, due dates, and review questions.
Need PMS inspection gaps turned into an evidence checklist?
Send the product family, audit question, and current evidence list. We can scope a source-backed gap checklist for qualified review.
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