This is a ready-to-use RACI matrix for running a health authority inspection. It assigns, for each activity, who is Responsible (does the work), Accountable (owns the outcome, one per row), Consulted (gives input), and Informed (kept aware). Confusion about who does what is itself a common cause of a poor inspection, so fill this in by name before an inspection, not during one. Replace every <<FILL: ...>> placeholder and route it through your normal document control. A filled specimen follows. The roles and the front-room/back-room model are explained in inspection readiness.
How to read this matrix
- R, Responsible: performs the activity. There can be more than one.
- A, Accountable: owns the result and signs off. Exactly one per row.
- C, Consulted: provides input before or during the activity (two-way).
- I, Informed: told of the outcome (one-way).
Assign a named person and a named backup to every role. Inspections do not pause for sick days, and a single point of failure in a named role is a readiness gap.
Role key (adapt to your organization)
| Code | Role |
|---|---|
| SH | Site head / senior management |
| HOST | Inspection lead / front-room host (often QA head) |
| SCR | Scribe |
| SME | Subject matter expert (per topic) |
| BRC | Back-room coordinator |
| DOC | Document control / records staff |
| RUN | Runner |
| QA | Quality / regulatory leadership |
| IT | IT / system administrator |
The matrix (blank)
Enter R / A / C / I in each cell for your organization. A blank cell means the role is not involved in that activity.
Before the inspection
| Activity | SH | HOST | SCR | SME | BRC | DOC | QA | IT |
|---|---|---|---|---|---|---|---|---|
| Maintain state of control (audits, periodic review, audit-trail review) | A | C | R | R | R | R | ||
| Run mock inspection and remediate gaps | C | A | R | R | R | C | ||
| Assign and drill front-room / back-room roles | I | A | R | R | R | R | C | C |
| Stage document packages for recent lots | C | R | A | R | C | C | ||
| Brief management on opening/closing and commitments | A | R | C |
During the inspection
| Activity | SH | HOST | SCR | SME | BRC | DOC | QA | IT |
|---|---|---|---|---|---|---|---|---|
| Opening and closing meetings | A | R | I | I | C | |||
| Single point of contact with the investigator | A | C | C | |||||
| Answer technical questions in scope | C | A | I | C | ||||
| Capture contemporaneous scribe notes | C | A | I | I | ||||
| Run the request log and back-room flow | I | C | A | R | I | |||
| Retrieve, QA-check, and provide records (two copies) | C | C | R | A | R | |||
| Live system walkthrough at the keyboard | I | A | C | C | ||||
| Daily debrief and overnight staging | C | A | C | C | R | C | R | C |
After the inspection
| Activity | SH | HOST | SCR | SME | BRC | DOC | QA | IT |
|---|---|---|---|---|---|---|---|---|
| Reconstruct what was observed from log + scribe notes | C | R | C | R | C | A | ||
| Preliminary root cause on disclosed findings | I | C | R | A | C | |||
| Confirm verbal commitments are recorded accurately | A | R | C | C | R | |||
| Draft and submit the written response | I | C | R | C | A | C | ||
| Track commitments to closure | I | I | R | A | C |
Acceptance criteria
- Every row has exactly one A; where no separate R is shown, the accountable role also performs the activity (it is A and R).
- Every role has a named person and a named backup.
- The host is A for contact with the investigator but is not A for answering SME questions (the SME owns their own answers).
- The scribe owns the notes (A, and R where they also take them) and has no duty to answer the investigator.
- Records provided to the front room are A-owned by document control with QA as R for the completeness check, so nothing reaches the investigator unchecked.
- Post-inspection response is A-owned by QA, with SMEs R for the technical content.
Filled specimen
An illustrative slice, filled with example names, for the “during the inspection” phase. Replace with your own people.
| Activity | Accountable (name) | Responsible (name) | Consulted | Informed |
|---|---|---|---|---|
| Single point of contact with the investigator | R. Gomez (QA Head) | R. Gomez | Site QA lead | Back room |
| Answer technical questions, CDS | A. Patel (Sr Analyst) | A. Patel | QC Manager | QA |
| Capture contemporaneous scribe notes | J. Okafor (QA Specialist) | J. Okafor | Host | QA, back room |
| Retrieve and QA-check records | L. Fernandez (Doc Control) | L. Fernandez + doc team | QA reviewer | Host |
| Daily debrief and overnight staging | R. Gomez (QA Head) | Back-room coordinator | SMEs on open items | Site head |
In this example the host owns contact but not the technical answers; the analyst owns the CDS answers; the scribe owns only the notes; and document control owns record retrieval with a QA completeness check before anything goes to the front room. Each row has one clear owner, which is the whole point of doing this before the inspector arrives.
Common coordination failures this matrix prevents
- The host answers every technical question, so the investigator concludes the operators cannot answer for themselves or that the narrative is being managed.
- Records reach the front room without a QA completeness check because no one owned that step.
- The scribe is also expected to answer questions, so the notes suffer.
- No named backup for a key SME, and the inspection stalls when that person is out.
- Verbal commitments made in the room are never captured, and the written response then contradicts what was said.
- The back room drifts from logistics into coaching or screening, which reads as obstruction rather than readiness.
How to adapt this matrix
- Replace the role key with your actual titles, and add roles (for example a communications or legal liaison) if your organization uses them.
- Confirm each A is a single accountable owner and each role has a named backup.
- Align this matrix with your inspection-management SOP so the two never disagree on who owns a step.
- Review and re-assign names before every inspection and after any reorganization.