The inspection-prep moment
Picture the quality assurance manager in an inspection prep meeting before the PMS process walk-through. The team can describe monitoring, but it is harder to show repeatable source checks, owner cadence, and escalation records.
The first move is not to declare whether the signal raises safety, compliance, reportability, equivalence, or exposure questions. The useful move is to map sources, internal records, owners, and review boundaries before the walk-through.
PMS inspection questions checklist
| Inspector question | Evidence to prepare |
|---|---|
| What sources do you monitor? | Public regulator sources, complaint trends, CAPA screens, risk records, service records, and supplier signals. |
| How do signals become records? | Trigger, source link, owner, internal file, rationale, next action, and review date. |
| Who owns escalation? | RA/QA, complaint, CAPA, risk, supplier-quality, clinical, legal, regulatory, or leadership owner. |
| What changed after review? | Record updates, owner actions, management-review inputs, and qualified-review decisions. |
| What remains open? | Missing evidence, unresolved source limits, and decisions not made by this checklist. |
What good looks like
The result should be a checklist a team can use before a PMS process walk-through. It should show fewer slides and more evidence trails: source checked, record found, owner assigned, gap named, and next review trigger captured.
If the first pass finds gaps, that is useful. It shows 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 show whether the team checks external signals consistently.
What it cannot decide
Whether a company's PMS process, complaint handling, CAPA workflow, or risk file is inspection-ready.
What it can tell you
Canadian public recall and safety-alert records that may become part of a monitoring source checklist.
What it cannot decide
Whether a company has met Canadian postmarket duties for one product, importer, or distributor workflow.
What it can tell you
European medical-device sector resources and public context that can frame EU PMS evidence questions.
What it cannot decide
Whether a manufacturer's PMS, PMCF, vigilance, clinical, or conformity evidence is sufficient.
Frequently asked questions
Does this prove the PMS system is inspection-ready?
No. It organizes evidence and review questions. Inspection readiness, compliance status, and final quality-system decisions remain with qualified owners.
What should a manual PMS system show first?
It should show source checks, internal record links, owners, review cadence, escalation triggers, and open reviewer decisions.
Need PMS inspection questions turned into an evidence checklist?
Send the process question, product family, and current evidence list. We can scope a source-backed PMS walk-through checklist for qualified review.
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