This is a ready-to-use report for a completed mock inspection. Replace every <<FILL: ...>> placeholder with your specifics, write it within days while memory is fresh, and route it through your normal review. A worked filled specimen follows. This content is educational and general, not regulatory advice.
Document control header
| Field | Entry |
|---|---|
| Report title | Mock Inspection Report, <<FILL: area / product>> |
| Report number | <<FILL: MIR-ID, e.g. MIR-2026-03>> |
| Mock dates | <<FILL: dates>> |
| Plan reference | <<FILL: MIP-ID>> |
| Author | <<FILL: program owner>> |
1. Executive summary
State the overall readiness assessment, the headline gaps, and a clear statement of the likely outcome if a real inspection happened today. Two or three sentences a leader can act on, for example: “If inspected today, the lab would likely receive a 483 with a data-integrity observation driven by <<FILL>>; <<FILL: N>> critical/major gaps need closure before <<FILL: date>>.”
2. Scope as executed
| Item | Planned | As executed |
|---|---|---|
| Systems / areas | <<FILL>> | <<FILL>> |
| Record window | <<FILL>> | <<FILL>> |
| Not covered | <<FILL>> | <<FILL>> |
State plainly what was not covered. A green result in an uncovered area is not a result.
3. Findings register (scored)
| Finding | System | Description (specific) | Severity | Likely real outcome | Basis |
|---|---|---|---|---|---|
<<FILL: MF-01>> | <<FILL>> | <<FILL: specific, dated, referenced>> | <<FILL: Critical/Major/Minor>> | <<FILL: likely 483 / note / coaching>> | <<FILL: regulation / SOP>> |
<<FILL: MF-02>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
Order by severity. Each finding is specific enough to act on, with a cited basis.
4. Systemic themes
Group findings into patterns. Three minor findings about uncontrolled documents in three areas is one major systemic finding about document control, not three minor ones. Regulators think in patterns; the report should too.
| Theme | Contributing findings | Systemic severity |
|---|---|---|
<<FILL: document control>> | <<FILL: MF-04, MF-07, MF-09>> | <<FILL: Major>> |
5. Positive observations
What was strong. This tells management where not to over-invest remediation effort and keeps the program from being purely punitive.
<<FILL: e.g. back-room retrieval times consistently under 12 minutes>>
6. Behavioral observations
Front-room and back-room performance that rarely fits the findings table but matters.
| Observation | Detail |
|---|---|
| Front-room over-answering | <<FILL: who, when, what was volunteered>> |
| Unknown-answer handling | <<FILL: did SMEs say "I will confirm" or guess>> |
| Story consistency | <<FILL: did two SMEs describe the same process differently>> |
| Back-room retrieval time | <<FILL: median and worst case>> |
| Document screening | <<FILL: were weak records caught before they went forward>> |
7. CAPA seed list
Each critical and major finding mapped to a proposed action, owner, and priority. These convert to tracked CAPAs (see the remediation tracker below).
| Finding | Proposed corrective action | Owner | Priority |
|---|---|---|---|
<<FILL: MF-01>> | <<FILL: root-cause-level action>> | <<FILL: named person>> | <<FILL: High>> |
8. Remediation tracker (to be maintained to closure)
| Finding | CAPA ID | Root cause | Action | Owner | Due | Status | Effectiveness check |
|---|---|---|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | Open | <<FILL>> |
9. Acceptance criteria for remediation
Every critical and major finding has a named owner, a real due date, a root-cause-level action, and a defined effectiveness check, and the open list is reported in management review until closed. If findings live and die in this report, you ran an event, not a program.
10. References
FDA Compliance Program Guidance Manual 7356.002 (systems-based model). PIC/S deficiency classification; EudraLex Volume 4; ICH Q10. 21 CFR 211.192 (investigations), 211.22 (quality unit).
Confirm the current version of each reference before issue.
11. Approvals
| Role | Name | Signature | Date |
|---|---|---|---|
| Author (Program owner) | <<FILL>> | ||
| Reviewer (QA Head) | <<FILL>> |
Filled specimen
A completed findings register and behavioral section for an example lab-focused mock. Values are illustrative.
Executive summary: If inspected today, the QC lab would likely receive a 483 with a data-integrity observation. Two critical and two major gaps need closure before the expected pre-approval inspection window. Back-room performance was strong; front-room over-answering and one inconsistent process description are coaching priorities.
| Finding | System | Description | Severity | Likely real outcome | Basis |
|---|---|---|---|---|---|
| MF-01 | Laboratory | Audit trail for a chromatography sequence unreviewed for 8 weeks; one aborted run (seq 23-0412, 2026-04-14) not investigated | Critical | Likely 483; data integrity theme | 21 CFR 211.194; audit trail review expectation |
| MF-02 | Quality | CAPA for a repeat deviation closed without documented effectiveness check | Major | Likely 483 | 21 CFR 211.192; ICH Q10 |
| MF-03 | Production | Operator described a step differently than the batch record sequence | Major | Possible 483 | 21 CFR 211.100; procedure not followed |
| MF-04 | Materials | Two sampling tools without current calibration stickers in a sample room | Minor | Note, 483 if pattern | 21 CFR 211.160(b)(4) |
Behavioral: back-room retrieval median 9 minutes (worst case 32 on an OOS file); the back room correctly held a thin OOS investigation before it reached the front room; one SME volunteered scope on an open-ended question; “I will confirm and come back” was used well by two of four SMEs.
MF-01 and MF-03 are behavior and data-integrity problems a binder review would have missed; only the floor walk and the thread-pull surfaced them.
Common reporting failures this template prevents
- A flat list of observations with no severity, so management cannot triage.
- Findings with no cited basis or no specific detail (“lab looked disorganized”).
- No systemic-theme view, so three symptoms of one problem read as three small issues.
- No behavioral section, so the front-room and back-room gaps go unrecorded.
- No CAPA conversion, so the same gaps are open at the real inspection.
How to adapt this report
- Set your report number and plan reference in the header.
- Write within days of the mock; a report three weeks late has lost most of its value.
- Convert every critical and major finding into your real CAPA system and report the open list in management review.
- Keep positive and behavioral observations; they steer effort and rehearse the human dynamics.
- Confirm every reference in section 10 against the current published version before issue.