This is a ready-to-use plan for a scored mock inspection. Replace every <<FILL: ...>> placeholder with your specifics, set your document numbers and dates, and route it through your normal document control. A worked filled specimen follows. Verify each cited reference against the current source before you rely on it. This content is educational and general, not regulatory advice.
Document control header
| Field | Entry |
|---|---|
| Document title | Mock Inspection Plan, <<FILL: area / product>> |
| Document number | <<FILL: PLAN-ID, e.g. MIP-2026-03>> |
| Version | <<FILL: version>> |
| Effective date | <<FILL: effective date>> |
| Program owner | <<FILL: role, e.g. Inspection Readiness Lead>> |
1. Purpose and readiness hypothesis
Run a planned, scored rehearsal of a <<FILL: PAI / routine GMP / for-cause / GCP>> inspection to find the gaps a real investigator would find, before one arrives. State the hypothesis being tested, for example: “We believe <<FILL: data integrity controls in the QC lab>> would not survive an inspection; prove or disprove it.”
2. Scope
| Dimension | Decision |
|---|---|
| Systems in scope | <<FILL: any of Quality, Facilities/Equipment, Materials, Production, Packaging/Labeling, Laboratory>> |
| Depth | <<FILL: full multi-day / targeted half-day>> |
| Style | <<FILL: announced to management, unannounced to bench>> |
| Posture | <<FILL: PAI product-specific / routine surveillance>> |
| Areas | <<FILL: rooms, lines, systems>> |
| Records window | <<FILL: date range>> |
| Out of scope | <<FILL: explicitly excluded areas>> |
Tie each in-scope area to a documented trigger or risk (a pending application, open deviations, repeat CAPAs, an OOS cluster, time since last inspection, current citation trends). A scope that could describe any site on any day is not a scope.
3. Regulatory basis and scoring model
State the inspection model you score against. For drug GMP, the FDA systems-based model (Quality, Facilities and Equipment, Materials, Production, Packaging and Labeling, Laboratory Control) from the Compliance Program Guidance Manual 7356.002; in the EU, EudraLex Volume 4 and the PIC/S approach. Score severity with the PIC/S critical/major/other definitions and separately estimate the likely FDA 483 observation and NAI/VAI/OAI classification.
4. Roles and assignments
| Role | Played by | Name |
|---|---|---|
| Mock inspector(s) | External consultant or cross-site staff (not the area owner) | <<FILL>> |
| Front room lead / host | Site QA lead | <<FILL>> |
| SME presenters | Process, lab, validation, IT owners | <<FILL>> |
| Scribe | QA associate | <<FILL>> |
| Back room lead | Experienced QA | <<FILL>> |
| Runners / retrievers | QA, document control | <<FILL>> |
| Observers / evaluators | QA management, trainers | <<FILL>> |
| Program owner | Inspection readiness lead | <<FILL>> |
The mock inspector should not run the area being inspected; the back room should be staffed by the people who will staff the real back room.
5. Persona and threads
Define at least one inspector persona and brief the mock inspector to play it consistently.
| Persona dimension | Choice |
|---|---|
| Focus area | <<FILL: data integrity hawk / contamination-control / investigations skeptic / computerized-systems>> |
| Questioning style | <<FILL: thread-puller / document-driven / floor-walker>> |
| Pace and pressure | <<FILL: patient and quiet / fast and demanding>> |
Pre-define the threads to pull, for example: batch record to deviation to CAPA (effectiveness verified?) to OOS (root cause proven or assumed?) to instrument calibration and audit trail to analyst training record. Do not script SME answers; the point is to see what they actually say.
6. Schedule (day plan)
| Time | Activity |
|---|---|
<<FILL>> | Pre-brief (private): persona, scope, threads, document path, scribe and log set up |
<<FILL>> | Opening meeting: persona states scope, requests standard opening documents |
<<FILL>> | Tour of in-scope areas: watch operators, ask open questions |
<<FILL>> | System and record review: pull records, pull threads, back room runs |
<<FILL>> | Daily wrap (private): consolidate, classify severity, set next threads |
<<FILL>> | Closing meeting: read out findings; front room practices receiving them |
7. Scoring method
| Severity | PIC/S-style definition | Likely real outcome |
|---|---|---|
| Critical | Produces or significantly risks a product harmful to the patient, or involves fraud or data integrity falsification | Likely 483; possible OAI |
| Major | Significant departure from GMP, or a non-critical deficiency that is part of a pattern | Likely 483; VAI |
| Minor / other | A departure that is neither critical nor major | Note; possible 483 if pattern |
Every finding needs a specific description, a severity tied to a definition, a cited basis (regulation, standard, or SOP), and a defensible link to a likely real-world consequence. “Lab looked disorganized” is not a finding.
8. Reporting and CAPA conversion
Each critical and major finding converts to a tracked corrective action in the same CAPA system used for real deviations and audit findings, with a named owner, a real due date, a root-cause-level action, and a defined effectiveness check. Minor findings go to a tracked action list. Open mock findings are reported in management review. Findings that live and die in a PDF are the most common program failure.
9. Confidentiality and tone
State, in writing and at the opening, that findings drive improvement, not individual discipline, so people answer honestly. Keep behavioral coaching separate from individual discipline. This paragraph determines whether you get a real result or a defensive one.
10. Acceptance criteria for the plan
A competent QA person not involved could read this plan, run the mock, score it the same way, and produce a report that maps to real citation severity. Scope names the systems, areas, record window, and exclusions, and ties each in-scope area to a documented risk.
11. References
FDA Compliance Program Guidance Manual 7356.002, Drug Manufacturing Inspections (systems-based model). EudraLex Volume 4, EU GMP guide; PIC/S inspection approach and deficiency classification. ICH Q10, Pharmaceutical Quality System; 21 CFR 211.22, 211.180(e)/(f).
Confirm the current version of each reference before issue.
12. Revision history
| Version | Date | Author | Summary of change |
|---|---|---|---|
<<FILL: 1.0>> | <<FILL: date>> | <<FILL: author>> | Initial issue. |
13. Approvals
| Role | Name | Signature | Date |
|---|---|---|---|
| Author | <<FILL>> | ||
| Reviewer (QA) | <<FILL>> | ||
| Approver (Quality Head) | <<FILL>> |
Filled specimen
Scope and persona completed for an example two-day, lab-focused PAI simulation. Values are illustrative.
| Dimension | Decision |
|---|---|
| Systems in scope | Quality + Laboratory Control |
| Depth | Two days, lab-focused |
| Style | Announced to management, unannounced to bench |
| Posture | PAI simulation for product X |
| Areas | QC HPLC lab, stability, sample management |
| Records window | Last 18 months |
| Out of scope | Microbiology lab (separate mock planned) |
Readiness hypothesis: chromatography audit-trail review would not survive an inspection. Persona: data integrity hawk, thread-puller, patient and quiet. Primary thread: a stability batch record to its deviation to the CAPA (effectiveness verified?) to the OOS (root cause proven?) to the HPLC calibration and run audit trail to the analyst training record.
The “out of scope” line is doing real work here: a green result does not mean microbiology is ready, and the plan says so.
Common inspection-program failures this plan prevents
- The friendly mock: an insider inspector who steers around known weak spots.
- A binder-only mock that never walks the floor or watches behavior.
- A flat list of observations with no severity, so management cannot triage.
- A back room that was never rehearsed, so retrieval is slow in the real event.
- Findings that die in a PDF with no CAPA conversion or owner.
- A scope that re-tests the strong area and never the messy one.
How to adapt this plan
- Set your document number, posture, and readiness hypothesis in the header and section 1.
- Fill scope (section 2) from evidence: open deviations, repeat CAPAs, current citation trends, time since last inspection.
- Cast the mock inspector from outside the area, and staff the back room with the real back-room team.
- Pre-define your threads (section 5) against your actual records.
- Wire section 8 into your real CAPA system and management review, not a side spreadsheet.
- Confirm every reference in section 11 against the current published version before issue.