Writing Good SOPs & SOP Documentation
The methodology I use to turn a messy process into a clear, auditable SOP, and keep improving it.
A good SOP is not paperwork for its own sake. It's the fastest way to make a process safe, repeatable and easy to train. Here is how I build them.
My 7-step SOP cycle
- Full job review & time studyI walk the whole job end to end, interview the people doing it, and time each step to see where the minutes actually go.
- Material & supporting studiesA material study (what moves, where and how much) plus motion, ergonomics, safety/hazard, quality/defect and equipment utilization studies.
- Compile the reportEverything goes into one report: current state, data, risks, and the biggest opportunities ranked by impact.
- AuditI audit the current process against the report, GMP expectations and your state rules to confirm the gaps are real.
- Build the optimized workflow & SOPsRedesign the workflow, then write clear SOPs for it with the people who will use them.
- Re-audit & redo time studiesAfter rollout I audit again and repeat the time studies to prove the change worked, and fix what didn't.
- Continuous improvementSOPs are living documents. I push continuous development: scheduled reviews, feedback loops and KPI tracking.
AnatomyWhat every SOP should contain
| Section | What goes in it |
|---|---|
| Header | Title, SOP number, version, effective date, owner, approver |
| Purpose | Why the SOP exists, in one or two sentences |
| Scope | Which process, area, equipment and people it covers, and what it does not |
| Roles & responsibilities | Who performs, who verifies, who approves |
| PPE & safety | Required PPE, hazards, references to safety documents |
| Materials & equipment | What is needed, with IDs where relevant |
| Procedure steps | Numbered, one action per step, written for the person doing it |
| Acceptance criteria | How you know the step or output is right |
| Deviations | What to do and who to tell when something goes off-script |
| Records | Which forms/logs are completed |
| Revision history | Version, date, change summary, approver |
| Training sign-off | Trainee, trainer, date, signature |
GMP document control & record-keeping best practices
- One controlled master copy; obsolete versions removed from the floor and archived.
- Every change goes through review and approval, with a reason recorded.
- Unique document numbers and version numbers on every page.
- Records completed in real time, in permanent ink or a validated system; errors corrected with a single line, initials and date (never erased).
- Training on the new version before it takes effect, with sign-offs kept.
- Defined retention periods per your state rules.
- Periodic review dates set and tracked.
Free blank SOP template
A clean starting point with all the sections above. Download it as Word (.docx) or PDF.
Related: Running an Extraction Facility (maintenance, KPIs, failed tests) and safety & compliance.
Questions
What should an SOP include?
Purpose, scope, roles and responsibilities, required PPE, numbered steps, acceptance criteria, how to handle deviations, revision control with version history, and training sign-offs.
How often should SOPs be reviewed?
On a fixed schedule (many labs choose annually) and whenever equipment, regulations or the process change, or after a deviation shows the SOP is unclear.
What is GMP document control?
A system that makes sure only current, approved versions of documents are in use, changes are reviewed and approved, old versions are archived, and records are complete, legible and traceable.
What is a time study?
A structured measurement of how long each step of a job takes, used to find waste, balance workloads and confirm improvements.
Need SOPs written or audited?
I run workflow audits, time studies and GMP mock audits for licensed labs.
Ready when you areGet a closed loop expert in your lab
Setup, repairs, upgrades, diamond programs or a GMP mock audit. I travel and live on site at licensed facilities.