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Procedure Anatomy

Reference for qms-procedure-writer · 58 lines

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

Which document type?

TypeAnswersAudienceLengthExample
Policy / manualWhy and what the system isEveryone, auditors1-15 pagesQuality manual
Procedure (QP)Who does what, when, across functionsProcess owners, supervisors2-6 pagesControl of nonconforming product
Work instruction (WI)How to do one task at one stationOperators1-2 pages, picturesTorque the flange bolts
Form / record (QF)Evidence it was doneWhoever completes it1 pageNCR form

Rule of thumb: if a step crosses departments it belongs in a procedure; if it is done by one person at one place it belongs in a work instruction. ISO 9001:2015 mandates no procedures: write one where its absence would cause inconsistent results (4.4.2, 7.5.1 b).

Sections

SectionContentTip
HeaderID, title, revision, owner, approver, effective dateControlled under document control
1 PurposeOne or two sentences: the risk it controls"Prevent nonconforming parts reaching customers"
2 ScopeWhere it applies and where it does not; ISO clausesName sites, product lines, exceptions
3 ResponsibilitiesRACI table from the stepsOne accountable owner
4 DefinitionsOnly terms a new employee would not knowMRB, concession, quarantine
5 ProcedureNumbered steps: actor - action - timing - record5-20 steps; flowchart for branches
6 RecordsName, retention, location, ownerTies to 7.5.3 retention
7 ReferencesOther procedures, WIs, forms, standardsDocument numbers, not titles only
8 Revision historyRev, date, change, authorSay what changed, not "updated"

Step format

text
<n>. **<Role>** - <verb> <object> <criterion/timing>. Record: <form>.
3. **Quality engineer** - Decide disposition within 2 working days of the NCR. Record: QF-07 section B.

Branches: write the decision as its own step with both outcomes, or use a swim-lane flowchart with one lane per role:

text
4. **Quality engineer** - If the disposition is use-as-is or repair, request a customer concession (QF-07B)
   before release; otherwise go to step 5.

Common procedures in a manufacturing QMS

ProcedureClausesKey records
Control of documented information7.5Document register, change requests
Contract review8.2Order review checklist
Purchasing and supplier control8.4ASL, supplier evaluations, POs
Production control and release8.5, 8.6Travellers, inspection reports, CoC
Calibration7.1.5Calibration register, certificates
Nonconforming product8.7NCRs, concessions
Corrective action10.2CAPA records
Internal audit9.2Programme, reports
Management review9.3Minutes
Training and competence7.2Competence matrix, training records
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