This is a working checklist. An author runs it against a draft before routing for review, and an independent reviewer runs it again before approval. Mark each item Yes, No, or N/A, and record the evidence or location. Any No is a defect to fix before the SOP advances. A filled specimen follows so you can see how a completed checklist reads. This checklist does not replace your document control SOP; it is a readiness gate that sits on top of it.
Document control header
| Field | Entry |
|---|---|
| SOP under review | <<FILL: SOP-ID and title>> |
| Draft version | <<FILL: e.g. 0.3 draft>> |
| Author / process owner | <<FILL: role and name>> |
| Checklist completed by | <<FILL: role and name>> |
| Date | <<FILL: date>> |
| Stage | Author self-check / Independent review (circle one) |
How to use this checklist
Run it twice. First the author runs it as a self-check before sending the draft for review; this catches the obvious gaps cheaply. Then an independent reviewer, ideally including someone who will actually use the SOP, runs it again. The most valuable single item is the dry run (section E): a real user performs or simulates the task with only the SOP in hand, and every hesitation is logged as a defect. Skipping the dry run is the most common reason an approved SOP turns out to be unfollowable.
A. Right instrument and altitude
| # | Check | Yes / No / N/A | Evidence or note |
|---|---|---|---|
| A1 | The activity genuinely needs an SOP, not a policy, a work instruction, a protocol, or a one-time work order. | <<FILL>> | |
| A2 | The document is at one altitude, it is not trying to be policy, procedure, and work instruction at once. | <<FILL>> | |
| A3 | Where step-level mechanics for one machine or task are needed, they are in a subordinate work instruction, not bloating this SOP. | <<FILL>> |
B. Header, control, and framing sections
| # | Check | Yes / No / N/A | Evidence or note |
|---|---|---|---|
| B1 | Header or footer carries document number, title, version, effective date, and “page x of y” on every page. | <<FILL>> | |
| B2 | Purpose states the outcome the procedure assures, it does not just restate the title. | <<FILL>> | |
| B3 | Scope states both what is covered and what is explicitly excluded, with what governs the exclusions. | <<FILL>> | |
| B4 | Responsibilities name roles, not individuals; every listed role appears in the steps. | <<FILL>> | |
| B5 | Every actor that appears in the steps is listed in responsibilities (no unnamed actors). | <<FILL>> | |
| B6 | Definitions cover the load-bearing terms and acronyms; no obvious terms over-defined, no critical term undefined. | <<FILL>> | |
| B7 | References list only documents actually used; no dead links to superseded documents. | <<FILL>> | |
| B8 | Materials and equipment section lets the user gather everything before starting (or states “None”). | <<FILL>> | |
| B9 | Safety and environmental controls are specific to the actual steps, not generic boilerplate. | <<FILL>> |
C. The procedure section (where SOPs live or die)
| # | Check | Yes / No / N/A | Evidence or note |
|---|---|---|---|
| C1 | Each step is one action, in the active voice, with one named role as the actor. | <<FILL>> | |
| C2 | Every acceptance criterion (value, range, condition) is stated inside the step that needs it, not buried elsewhere. | <<FILL>> | |
| C3 | Every decision point is written as an explicit if/then with a defined path for each outcome. | <<FILL>> | |
| C4 | Every failure path is defined: what to record, when to stop, when to raise a deviation, and who to notify. | <<FILL>> | |
| C5 | Steps are numbered so they can be cited precisely (for example “repeat 5.3 to 5.6”). | <<FILL>> | |
| C6 | One term is used for one thing throughout; terminology is consistent with the forms and references. | <<FILL>> | |
| C7 | No vague qualifiers at critical steps (“periodically”, “as appropriate”, “sufficient”, “if necessary”). | <<FILL>> | |
| C8 | Detail is right-sized to the criticality and the trained competence of the user. | <<FILL>> | |
| C9 | Every recording action is tied to the time of performance (contemporaneous). | <<FILL>> |
D. Records and forms
| # | Check | Yes / No / N/A | Evidence or note |
|---|---|---|---|
| D1 | Every form or template the SOP references exists under document control, with a version. | <<FILL>> | |
| D2 | The form fields capture exactly what the steps require (form and SOP designed together). | <<FILL>> | |
| D3 | The records section states what is generated, where it is stored, and how long it is retained. | <<FILL>> | |
| D4 | Records are designed to be attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available (ALCOA+). | <<FILL>> |
E. Usability dry run
| # | Check | Yes / No / N/A | Evidence or note |
|---|---|---|---|
| E1 | A qualified but new user performed or simulated the task using only this SOP and the referenced forms. | <<FILL>> | |
| E2 | Every place the user hesitated, asked a question, or reached for tribal knowledge was logged as a defect. | <<FILL>> | |
| E3 | All dry-run defects are resolved in the draft (or dispositioned with a reason). | <<FILL>> | |
| E4 | Reading the procedure aloud as if instructing someone adds no missing words; any added word was inserted as a step. | <<FILL>> |
F. Regulatory and lifecycle readiness
| # | Check | Yes / No / N/A | Evidence or note |
|---|---|---|---|
| F1 | The regulation or standard that mandates this activity is identified and the procedure satisfies it. | <<FILL>> | |
| F2 | Each cited regulation, ICH code, USP chapter, or annex was confirmed against its current published version. | <<FILL>> | |
| F3 | Effective date is aligned with training completion (no in-force-but-untrained window, no following a draft). | <<FILL>> | |
| F4 | The change reason and a real revision history entry are prepared (not “updated for clarity”). | <<FILL>> | |
| F5 | The approval routing (author, technical reviewer or SME, QA, management where needed) is set. | <<FILL>> |
Disposition
| Field | Entry |
|---|---|
| Total Yes | <<FILL>> |
| Open defects (any No) | <<FILL: count, with item numbers>> |
| Decision | Ready to route / Return to author (circle one) |
| Completed by (name, signature, date) | <<FILL>> |
Any No must be closed or formally dispositioned before the SOP is routed for approval.
Filled specimen
The following shows the checklist completed for an example draft, a procedure for receiving and quarantining incoming raw material samples. The company, IDs, and notes are illustrative. Only the items that drove a finding are shown filled; the rest were marked Yes.
| Field | Entry |
|---|---|
| SOP under review | SOP-QC-014, Receipt and Quarantine of Incoming Raw Material Samples |
| Draft version | 1.8 draft |
| Author / process owner | QC Supervisor, A. Rao |
| Checklist completed by | QC Reviewer, M. Diaz (independent) |
| Date | 22 June 2026 |
| Stage | Independent review |
| # | Check | Result | Evidence or note |
|---|---|---|---|
| C2 | Acceptance criterion in the step | No | Step 8.4 said “measure the temperature” with no range. Added “acceptance range 2 C to 8 C.” |
| C4 | Failure path defined | No | Step 8.5 had no out-of-range path. Added “stop, retain in quarantine cooler, initiate deviation per SOP-QA-021, notify supervisor and QA.” |
| D1 | Forms under document control | No | The Sample Receipt Log circulated as an unversioned spreadsheet. Brought under control as SOP-QC-014-F1 v1.0. |
| E1 | Dry run performed | Yes | New analyst ran the task with the draft only; two hesitations logged (steps 8.4 and 8.5), both fixed above. |
Disposition: 3 open defects at first pass, all closed in version 1.9 draft. Decision, ready to route. Completed by M. Diaz, signed, 22 June 2026.
In this specimen the checklist caught a missing acceptance range, an undefined failure path, and an uncontrolled form, the three defects most likely to become inspection findings, and the dry run is what surfaced two of them. That is the gate working as intended.
Common inspection findings this checklist prevents
- “Established procedures were not followed”, where the deeper cause was that the procedure was not followable.
- Steps with no defined failure path, where operators improvised and a deviation resulted.
- Critical steps with missing acceptance criteria, making the procedure unauditable.
- Forms referenced by an SOP that are uncontrolled, unversioned, or circulating as spreadsheets.
- Records not captured contemporaneously because the SOP never required it at the point of action.
- Effective date ahead of training, or staff following an unapproved draft.
- Revision history that cannot reconstruct what the procedure required at a past date.
How to adapt this checklist
- Add or remove rows so the checklist matches your own document control SOP’s required sections and numbering.
- Keep the dry run (section E) as a mandatory gate; it is the single highest-value item and the one most often skipped.
- Make a No on any item a hard block to routing, or define which items are advisory versus blocking for your system.
- Attach the completed checklist to the change control record so the readiness evidence travels with the SOP.
- Confirm the regulatory references in any SOP you check against their current published versions before approval.