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qms-procedure-writer

Write and review ISO 9001 quality management system procedures and work instructions that people can follow and auditors can verify: purpose, scope, RACI responsibilities, definitions, numbered actor-action-timing steps, records with retention, references and revision history. Generates a procedure in Markdown from a JSON process description (with a RACI table built from the steps) and lints existing procedures for missing sections, vague wording (as needed, periodically, promptly, etc.), passive steps with no actor, should/may ambiguity, records without retention, overlong steps and missing time limits. Covers when to write a procedure vs a work instruction vs a form, and common manufacturing QMS procedures (document control, contract review, purchasing, calibration, nonconforming product, corrective action, internal audit, management review). Use when drafting an SOP or QP, tidying a procedure before an audit, or after a finding that a procedure is not followed.

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

A procedure is good when a new employee can follow it, every step has an owner and a time limit, and every piece of evidence has a named record. scripts/procedure_scaffold.py turns a step list into a complete procedure with a RACI table; scripts/procedure_lint.py finds the wording that makes procedures unauditable.

Trigger Conditions

Activate this skill when the user:

  • Needs a QMS procedure, SOP or work instruction written
  • Wants an existing procedure reviewed before an audit
  • Has an audit finding "procedure not followed" or "procedure does not reflect practice"
  • Asks "do we need a procedure for X?" or "procedure or work instruction?"

Workflow

text
1. DECIDE   -> procedure (cross-functional) or work instruction (one task, one station)? (procedure-anatomy.md)
2. WALK     -> walk the process with the people who do it; list who does what, when, and what is recorded
3. SPEC     -> write spec.json: id, title, owner, purpose, scope, clauses, steps (actor, action, record), records
4. DRAFT    -> python scripts/procedure_scaffold.py spec.json > QP-07.md
5. LINT     -> python scripts/procedure_lint.py QP-07.md   (fix every high and medium finding)
6. VALIDATE -> the people who do the work read it; does it match what they do?
7. RELEASE  -> approve and issue under document control; train; audit it within 3-6 months

Step Format

text
3. **Quality engineer** - Decide disposition within 2 working days of the NCR. Record: QF-07 section B.

Role, verb, object, criterion or time limit, record. Branches become their own decision steps. Section list, document hierarchy and a table of common manufacturing procedures with their records: procedure-anatomy.md.

Lint Codes (procedure_lint.py)

CodeSeverityProblemFix
PR001highMissing purpose, scope, responsibilities, procedure or records sectionAdd the section
PR002mediumVague wordingReplace with a frequency, quantity, role or deadline
PR003mediumPassive step with no actorPut the role first
PR004mediumshould / may / could in a stepmust, or state the condition
PR005mediumRecords without retentionAdd retention and location
PR006lowStep over 40 wordsSplit
PR007lowNo revision/approval blockAdd header table
PR008lowNo time limits anywhereAdd "within ..." / "before ..."
PR009lowMore than 25 stepsMove task detail to work instructions
text
PR003 [medium] line 7: passive step with no actor: 'Nonconforming parts are identified and segregated.'
PR002 [medium] line 9: vague 'promptly': say who, how often, how much or by when

Vague-to-specific and passive-to-active rewrite tables: plain-language-rules.md.

Output Format

Deliver:

  1. The procedure in Markdown with header, the eight sections and a RACI table.
  2. Lint result - procedure_lint.py with no high or medium findings left (or each one justified).
  3. Open questions - anything the walk-through could not confirm (timings, retention, approvers).
  4. Related documents - work instructions and forms the procedure references that still need writing.

Scripts

bash
python scripts/procedure_scaffold.py spec.json > QP-07.md

Spec keys: id, title, owner, purpose, scope, clauses, definitions, steps (actor, action, record, consulted, informed), records (name, retention, location), references. Exit codes: 0 written, 1 a step lacks an actor or action, 2 read/JSON error.

bash
python scripts/procedure_lint.py QP-07.md
python scripts/procedure_lint.py WI-10.txt --json

Exit codes: 0 no high findings, 1 high findings (missing sections), 2 read error.

Additional Resources

FileContent
procedure-anatomy.mdDocument hierarchy, procedure vs work instruction, sections, step format, common QMS procedures
plain-language-rules.mdSeven writing rules, vague -> specific and passive -> active tables, readability checks
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