This is a ready-to-use record for preparing a subject matter expert (SME) before an inspection. A poorly prepared SME is one of the most common sources of inspection trouble, and unlike a missing record, a bad SME answer cannot be quietly corrected later. This form covers two things: whether the SME actually knows their systems and procedures, and how they answer under pressure, scored against the listen, clarify, answer, stop pattern. Replace every <<FILL: ...>> placeholder, run it as part of your mock inspection program, and turn every weak area into a coaching action with an owner. A filled specimen follows. This content is educational reference, not legal or regulatory advice; adapt it to your quality system.
Header
| Field | Entry |
|---|---|
| Record number | <<FILL: FORM-ID>> |
| SME name / role | <<FILL>> |
| Area / systems owned | <<FILL: e.g. QC chromatography, LIMS>> |
| Preparation session date | <<FILL>> |
| Prepared / assessed by | <<FILL: inspection readiness lead / QA>> |
| Anticipated inspection | <<FILL: PAI / routine / for-cause / mock>> |
Part 1, Knowledge readiness
The SME should be able to speak to each of these without looking it up. Mark Ready, Gap, or N/A.
| # | The SME can, without notes | R/G/NA | Note |
|---|---|---|---|
| K1 | Describe each system in their area: what it does, how it is validated, and its current validated state | <<FILL>> | <<FILL>> |
| K2 | State what the audit trail captures and when it was last reviewed | <<FILL>> | |
| K3 | State who has access and administrator rights, and how that is controlled | <<FILL>> | |
| K4 | Walk through the relevant SOPs from memory of intent, not word for word | <<FILL>> | |
| K5 | Walk a sample from receipt to reported result (or the equivalent process flow) | <<FILL>> | |
| K6 | Show, live in the system, the last audit trail review and the last few investigations | <<FILL>> | |
| K7 | Explain how the system clock is controlled and known correct | <<FILL>> |
Part 2, Behavior under questioning
The content can be right and the delivery still create risk. Coach and score the habits.
| # | Behavior | Observed (good / needs work) | Note |
|---|---|---|---|
| B1 | Listens to the whole question before answering | <<FILL>> | <<FILL>> |
| B2 | Clarifies scope when a question is ambiguous | <<FILL>> | |
| B3 | Answers the specific question, in plain language | <<FILL>> | |
| B4 | Stops; does not fill silence or volunteer new topics | <<FILL>> | |
| B5 | Says “I do not know, I will find out” rather than guessing | <<FILL>> | |
| B6 | Offers a supporting document when one exists | <<FILL>> |
Part 3, Mock-interview question bank
Ask each. Record the answer quality and whether it opened an unnecessary new thread. These mirror the openers investigators actually use.
| # | Question | Answer quality (1-5) | Opened a new thread? | Note |
|---|---|---|---|---|
| Q1 | Walk me through the lifecycle of a sample from receipt to reported result | <<FILL>> | <<FILL: Y/N>> | <<FILL>> |
| Q2 | How is this system validated, and where is the validation summary? | <<FILL>> | ||
| Q3 | Who has administrator rights to this system, and how is that controlled? | <<FILL>> | ||
| Q4 | Show me the last time the audit trail was reviewed | <<FILL>> | ||
| Q5 | How do you know the system clock is correct? | <<FILL>> | ||
| Q6 | What happens when an analyst makes an entry error in a batch record? | <<FILL>> | ||
| Q7 | How do you decide whether a deviation is major or minor? | <<FILL>> | ||
| Q8 | Walk me through your last OOS that confirmed | <<FILL>> | ||
| Q9 | Who can change integration parameters, and what is logged when they do? | <<FILL>> | ||
| Q10 | How do you ensure a contractor follows your procedures? | <<FILL>> |
Score guide: 5 = accurate, complete to the question, backed by a record, opened no new thread; 3 = correct but volunteered extra or hesitated; 1 = wrong, guessed, or opened a significant new thread.
Coaching action list
| Action | Source item | Owner | Due | Status |
|---|---|---|---|---|
<<FILL>> | <<FILL: e.g. K6, Q8>> | <<FILL>> | <<FILL>> | <<FILL>> |
Acceptance criteria
- Every Part 1 item is Ready or a justified N/A before the inspection window; each Gap has a coaching action.
- Behavior items B1 to B6 are observed as good, or coached with a re-check.
- No mock question scores below 3 without a coaching action and a re-run.
- The record is signed and the coaching actions are tracked to closure.
Signoff
| Role | Name | Signature | Date |
|---|---|---|---|
| SME | <<FILL>> | ||
| Assessor (readiness lead / QA) | <<FILL>> |
References
FDA Data Integrity and Compliance With Drug CGMP, Questions and Answers (2018). FD&C Act section 704 (inspection authority). ICH Q10 (pharmaceutical quality system, for roles and knowledge management).
Confirm the current version of each reference before use.
Filled specimen
A partial completed record for an example QC chromatography SME. Illustrative only.
| # | Question | Answer quality (1-5) | Opened a new thread? | Note |
|---|---|---|---|---|
| Q4 | Show me the last audit trail review | 5 | N | Opened the CDS, showed the signed review from last week |
| Q8 | Walk me through your last OOS that confirmed | 4 | N | Accurate, but hesitated locating the investigation number |
| Q9 | Who can change integration parameters, and what is logged? | 2 | Y | Volunteered a past period of “heavy reintegration when the method was drifting” |
On Q9 the SME gave a correct core answer but then opened a new thread, an unprompted mention of a period of heavy reintegration, that an investigator would immediately pull on. The coaching action: rehearse the listen-clarify-answer-stop pattern so the answer ends at “integration parameters can be changed by the analyst and reviewer roles; every change is captured in the audit trail with old value, new value, user, time, and reason,” backed by showing the access list, and then stops. Re-run scored 5.
Common inspection findings this record helps prevent
- An SME who cannot show, live, that the audit trail was reviewed or that a system is validated.
- An SME who volunteers a new problem the investigator had not asked about, expanding the inspection.
- An SME who guesses at an answer the records later contradict, which reads as evasion or incompetence.
- An SME who has to find and read the SOP during the inspection instead of demonstrating command of it.
How to adapt this record
- Replace the question bank with the openers most likely in your area (add sterility, aseptic, or chain-of-identity questions as relevant).
- Run it inside the mock inspection program, not as a memo the week before.
- Re-run any question that scored below 3 after coaching, and record the improved score.
- Track coaching actions to closure before the anticipated inspection window.