What the template covers
The distinction is the whole point of this workbook. The How to use tab centres on SOP versus work instruction, why the best instructions are written at the workstation, and the failure modes: bundled steps, missing acceptance criteria, happy-path-only instructions, photos that drifted out of date. The Work Instruction tab is the skeleton: header, before-you-start, task steps, escalation. The Worked Example tab completes it as a label-reel change on a generic packaging line; use it to judge the altitude a step should sit at.
- Header — title, ID and version, effective date, parent SOP, owner, approver, and what this version changed
- Before you start — preconditions, tools and materials, task-specific safety
- Numbered task steps — one action per row, starting with the verb
- An acceptance criterion for every step — what the operator should see if it went right
- A photo/diagram placeholder per step, and an escalation row that names the trigger and the role
Work instruction vs SOP — the distinction is the point
An SOP describes a process: who does what, when, and in what order. A work instruction describes one task from that process: how, step by step, at the level of hands on the equipment. If the reader needs to know which button, which setting, which direction — it belongs here. If they need to know who and when — it belongs in the SOP. Mixing the two levels is how sites end up with forty-page SOPs nobody reads and workstation folklore nobody wrote down.
Keep the two linked: every work instruction names its parent SOP in the header, and the SOP references its work instructions instead of absorbing them. That way a task-level change — a new reel type, a moved control — revises one small document, not the whole procedure.
Writing one that survives contact with the workstation
The best work instructions are written with the person who does the task, at the workstation — not at a desk from memory. Walk the task, write what actually happens, then test the draft by having someone else follow it verbatim: every place they hesitate or ask a question is a step that needs rewriting. The acceptance-criterion column enforces the other half of the discipline — for each step, what should the operator see if it went right? A criterion that just restates the instruction is not a criterion.
A work instruction is a controlled document like any other — ID and version, approved before use, current at the point of use; ISO 13485:2016 clause 4.2 (documentation requirements) covers how such documents are controlled, and no standard mandates a work instruction format. It is also what operator training hangs off: our training matrix template covers tracking who is trained on which document, and the SOP management glossary entry covers the document lifecycle around both. Inspectors do not read work instructions at a desk; they stand at the station and watch someone follow them.
