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Plain-Language Rules for Procedures

Reference for qms-procedure-writer · 43 lines

Manufacturing & Industrial Operations / Quality Management & ISO 9001v1.0.0Updated OCT 25 20262 references2 scripts

Auditors check that people follow the procedure as written. Every vague phrase is a place where two people do different things, and every passive step is a place where nobody does it.

Seven rules

  1. Actor first. Every step names a role: "The inspector tags..." not "Parts are tagged...".
  2. One action per step. Over 40 words means two steps.
  3. Measurable timing. "Within 2 working days", "before the first part is run", "at every shift start".
  4. Obligation words. Use imperative or "must"; reserve "may" for real options and say when.
  5. Name the record. "Record the result on QF-12" makes the evidence auditable.
  6. Use the words people use on the floor. If they say "red tag", write "red tag" (define it once).
  7. No "etc." Lists in procedures must be complete; if they cannot be, refer to a controlled list.

Vague -> specific

VagueSpecific
as needed / as appropriatewhen the gauge reading is outside the green zone
periodically / regularlyevery 4 hours, at shift start, monthly
promptly / as soon as possiblewithin 1 hour, before the next lot starts
relevant personnel / concerned departmentthe production supervisor and the quality engineer
adequate / suitable trainingcompletion of WI-10 training and 3 supervised runs signed off
records are keptthe inspector files QF-12 in the job folder; retained 10 years
should informmust inform (or: may inform if ..., otherwise ...)
and/orsay which combinations are allowed

Passive -> active

Passive (no actor)Active
The first piece is approved.The setter measures the first piece and the inspector approves it on QF-03.
Nonconforming parts are segregated.The operator moves nonconforming parts to the red quarantine bin.
The NCR is closed.The quality engineer closes the NCR after the disposition is complete.

Readability checks

  • A new employee can follow it without asking anyone.
  • Every step that produces evidence names the record.
  • Steps match what people actually do (walk the process with the operator before approval).
  • Run procedure_lint.py until it reports no medium findings.
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