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ISO 13485 internal audit checklist
An ISO 13485 internal audit is a medical device maker's own check that its quality management system works as ISO 13485 and its procedures say. It is done at planned intervals, by auditors who do not audit their own work. This ISO 13485 internal audit checklist has 38 questions on clauses 4 to 8 of ISO 13485:2016, in plain words, each with what to look at. Beside each question is the FDA QMSR section that brings the clause in: since February 2, 2026, 21 CFR Part 820 incorporates ISO 13485:2016 by reference, and adds a few requirements of its own on records (820.35), labeling and packaging (820.45) and UDI, tracking, reporting and corrections (820.10(b)). A production floor tab checks what an auditor sees at a station: the device history record complete to the current step, the current work instruction, operators trained before the task, nonconforming product segregated, and open NCRs and CAPAs moving. Every question is graded OK, Minor, Major, Critical or N/A. It supports internal audits beside your quality system; it is not a certification or MDSAP audit and does not make a plant compliant.
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Audit details, the five grades, and clause 4 to 6 questions, each with its clause, QMSR section, what to look at, a grade and a finding column.38 questions, clauses 4 to 8QMSR section beside eachProduction floor tabFive grades with days to fixFindings logScore by clauseWorked catheter line auditPDF, Excel and Word
When to use it
When to use an ISO 13485 internal audit checklist
- For the internal audits in your audit program, clause by clause or process by process, so the whole system is covered over the cycle.
- Before a certification, surveillance or MDSAP audit, or an FDA inspection under the QMSR, to find gaps while there is time.
- After a complaint trend, a field action or a run of NCRs on one line, to see whether the process behind it is working.
- To train new internal auditors on what to look for at a station and how to trace from the floor back into the system.
How to fill it in
- 1
Plan from the audit program
Pick the clauses and processes due, weighted by importance and past results, and an auditor who does not work in the area.
- 2
Start on the floor
Use the production floor tab first: one row per station, against the lot running. What you see at the station tells you which records to pull.
- 3
Trace back into the system
From each station, trace to the procedure, the training record, the validation report, the calibration record and any open NCR or CAPA.
- 4
Grade with the evidence
Grade each question and write what you sampled: lot numbers, gauge IDs, record numbers. Name the clause and, where it adds something, the QMSR section.
- 5
Hold product questions first
A finding that touches released or running product, such as a validated process outside its range, goes to quality the same day for containment.
- 6
Close in the CAPA system
Agree findings in the closing meeting, give each an owner and a due date, and send systemic ones into CAPA. Verify effectiveness before closing.
On the floor
Start at the station, then trace back into the system
The order this checklist suggests, shown with the example's major finding.
- 1Floor
See it at the station
Pouch sealer at station 4 set to 182 °C. - 2System
Trace it back
The validation report says 185 to 195 °C; three lots sealed since Monday. - 3Product first
Hold and test
The three lots held and seal strength tested; NCR opened. - 4CAPA
Fix how it happened
Find out how a validated setting changed without control.
ISO 13485 and the FDA QMSR
Where the QMSR adds to ISO 13485
21 CFR 820.10(a) brings in ISO 13485 as a whole. These are the places where the regulation adds something of its own, checked against the eCFR. Named, not quoted.
| ISO 13485 clause | QMSR section | What it adds |
|---|---|---|
| 4.2.5 records, with 8.2.2 complaints and 7.5.4 servicing | 820.35(a), (b) | Set details to record for investigated complaints and for servicing. |
| 7.5.1, 7.5.8, 7.5.9 | 820.35(c) | The UDI recorded for each device or batch. |
| 7.5.1 control of production | 820.45 | Labeling and packaging examined for accuracy before release and inspected before use, to prevent mix-ups. |
| 7.5.8 identification | 820.10(b)(1) | UDI assigned under part 830. |
| 7.5.9.1 traceability | 820.10(b)(2) | Tracking under part 821, where it applies. |
| 8.2.3 reporting | 820.10(b)(3) | Reportable complaints notified to FDA under part 803. |
| 7.2.3, 8.2.3, 8.3.3 advisory notices | 820.10(b)(4) | Handled under part 806 (corrections and removals). |
| 7.3 design and development | 820.10(c) | Required for class II and III devices and some class I devices. |
4.2.5 records, with 8.2.2 complaints and 7.5.4 servicing
- QMSR section
- 820.35(a), (b)
- What it adds
- Set details to record for investigated complaints and for servicing.
7.5.1, 7.5.8, 7.5.9
- QMSR section
- 820.35(c)
- What it adds
- The UDI recorded for each device or batch.
7.5.1 control of production
- QMSR section
- 820.45
- What it adds
- Labeling and packaging examined for accuracy before release and inspected before use, to prevent mix-ups.
7.5.8 identification
- QMSR section
- 820.10(b)(1)
- What it adds
- UDI assigned under part 830.
7.5.9.1 traceability
- QMSR section
- 820.10(b)(2)
- What it adds
- Tracking under part 821, where it applies.
8.2.3 reporting
- QMSR section
- 820.10(b)(3)
- What it adds
- Reportable complaints notified to FDA under part 803.
7.2.3, 8.2.3, 8.3.3 advisory notices
- QMSR section
- 820.10(b)(4)
- What it adds
- Handled under part 806 (corrections and removals).
7.3 design and development
- QMSR section
- 820.10(c)
- What it adds
- Required for class II and III devices and some class I devices.
The 38 questions
What to audit, clause by clause, with the QMSR section
Each question starts with its ISO 13485 clause and the FDA QMSR section that brings it in or adds to it, asks one question in plain words and says what to look at. The last group is the production floor tab, one row per station. On the sheet each one is graded OK, Minor, Major, Critical or N/A.
Clause 4: quality management system
Processes, QMS software, files, documents and records
- 14.1; QMSR 820.10(a): Are the QMS processes, their order and how they interact set out, with outsourced processes and their controls identified? Look at: the process map; one supplier that does a process for you, and how it is controlled.
- 24.1.6; QMSR 820.10(a): Is software used in the QMS (eQMS, ERP, test software) validated for its use before first use and after changes, in proportion to its risk? Look at: the list of QMS software and one validation record.
- 34.2.3; QMSR 820.10(a): Does each device type or family have a medical device file with its description, labeling, specifications and production procedures? Look at: the file for the device running today.
- 44.2.4; QMSR 820.10(a): Are documents approved before issue, is the current version the one in use, and are obsolete copies kept out of use? Look at: two documents at a station against the document list.
- 54.2.5; QMSR 820.35: Are records legible, retrievable and kept for the set period, and do complaint and servicing records hold the extra details the QMSR lists? Look at: retrieve one record from two years ago; one complaint record.
Clause 5: management responsibility
Policy, objectives, roles and management review
- 65.3, 5.4.1; QMSR 820.10(a): Are the quality policy and measurable quality objectives set, and do people in the area know the ones that apply to them? Look at: objectives on the area board; ask two people.
- 75.5.1, 5.5.2; QMSR 820.10(a): Are responsibilities and authorities defined and written, with a management representative named? Look at: the organization chart and two job descriptions.
- 85.6; QMSR 820.10(a): Is management review held at planned intervals with the inputs the standard lists (audits, feedback, complaints, CAPA, process and product monitoring) and recorded decisions? Look at: the last review's minutes and its actions.
Clause 6: resource management
People, infrastructure, work environment and contamination
- 96.2; QMSR 820.10(a): Are competence needs set for each job that affects quality, is training given before the task, and is its effectiveness checked? Look at: the line's training matrix against who is working today.
- 106.3; QMSR 820.10(a): Are buildings, equipment, utilities and supporting software maintained to written requirements, with records? Look at: maintenance records for one production machine.
- 116.4.1; QMSR 820.10(a): Are work environment requirements (temperature, humidity, cleanliness, clothing) written and monitored where they can affect the product? Look at: the cleanroom or work area monitoring log.
- 126.4.2; QMSR 820.10(a): Are contamination controls in place for the work environment, people and product, including particulate and microbial contamination where it matters? Look at: the contamination control procedure and the cleanroom records.
Clause 7: planning, customer requirements, design and purchasing
7.1 to 7.4
- 137.1; QMSR 820.10(a): Is product realization planned, with risk management applied and recorded across it? Look at: the risk file for the product running today.
- 147.2.1, 7.2.2; QMSR 820.10(a): Are customer and regulatory requirements reviewed before an order or change is accepted? Look at: one order review record.
- 157.3; QMSR 820.10(c): Where design controls apply, are design plans, inputs, outputs, reviews, verification, validation, transfer and changes recorded? Look at: the design records for one recent change.
- 167.4.1; QMSR 820.10(a): Are suppliers evaluated and chosen on criteria in proportion to risk, then monitored and re-evaluated? Look at: the approved supplier list and one supplier's file.
- 177.4.3; QMSR 820.10(a): Is purchased product verified before use (inspection, certificate or other means), as its risk calls for? Look at: receiving inspection records for one lot.
Clause 7: production and service provision
7.5 and 7.6
- 187.5.1; QMSR 820.45: Is production run under controlled conditions, with labeling and packaging examined before release and inspected before use to stop mix-ups? Look at: the line; the labeling inspection record.
- 197.5.2; QMSR 820.10(a): Where product must be cleaned or kept clean, is that done and recorded as specified? Look at: the product cleaning procedure and its record.
- 207.5.6; QMSR 820.10(a): Are processes whose output cannot be fully checked afterward (sealing, welding, molding, sterilization) validated, with criteria for revalidation? Look at: the validation report for one sealing or welding process, and its settings at the machine.
- 217.5.8; QMSR 820.10(b)(1): Is product identified at every stage, with its inspection status shown, and is a UDI assigned as part 830 requires? Look at: labels on work in progress and finished goods.
- 227.5.9; QMSR 820.10(b)(2), 820.35(c): Can a lot be traced from its components to its customers, with the UDI recorded for each device or batch? Look at: trace one finished lot back to its component lots.
- 237.5.11; QMSR 820.10(a): Is product protected from damage and contamination in handling, packaging and storage, and is shelf life controlled? Look at: storage conditions and shelf life labels.
- 247.6; QMSR 820.10(a): Is measuring equipment calibrated, identified and protected from adjustment, and is product assessed when a gauge is found out of tolerance? Look at: three gauges at a station; one out-of-tolerance record.
Clause 8: measurement, analysis and improvement
Feedback, complaints, audits, nonconforming product and CAPA
- 258.2.1; QMSR 820.10(a): Is feedback from production and post-production gathered and fed into risk management? Look at: the feedback procedure and one trend from it.
- 268.2.2; QMSR 820.35(a): Are complaints recorded, evaluated and investigated, with the reason recorded when no investigation is done? Look at: two complaint files.
- 278.2.3; QMSR 820.10(b)(3): Are complaints that meet reporting criteria reported to the regulator, to FDA under part 803 in the US? Look at: the reportability decision on one complaint.
- 288.2.4; QMSR 820.10(a): Are internal audits planned by importance and past results, done by auditors who do not audit their own work, and followed up? Look at: the audit program and the last audit's actions.
- 298.2.6; QMSR 820.10(a): Is product checked at the planned stages, with evidence of acceptance and the name of the person who released it? Look at: the final inspection record of one lot.
- 308.3; QMSR 820.10(b)(4): Is nonconforming product identified, recorded, segregated and dispositioned by authorized people, with concessions justified? Look at: the hold area and the NCR log.
- 318.4; QMSR 820.10(a): Are data from feedback, product conformity, process trends, suppliers and audits analyzed? Look at: the last data analysis report.
- 328.5.2; QMSR 820.10(a): Does corrective action find and act on the cause, check that the action does not harm the device's safety or performance, and verify that it worked? Look at: two closed CAPAs.
- 338.5.3; QMSR 820.10(a): Is preventive action taken on potential problems found in trends? Look at: one preventive action and what started it.
Production floor: station checks
Walk the line; one row per station visited
- 347.5.1; QMSR 820.10(a): Is the production record (the device history record) for the lot running complete up to the current step, signed at the time? Look at: the record at the station.
- 354.2.4; QMSR 820.10(a): Is the work instruction at the station the current approved version for the product running? Look at: its revision against the document list.
- 366.2; QMSR 820.10(a): Was each operator trained and signed off on this task before doing it? Look at: names on the record against training sign-off dates.
- 378.3; QMSR 820.10(a): Is nonconforming product tagged and kept in a marked hold area, not on the line? Look at: rejects at the station.
- 388.5.2; QMSR 820.10(a): Is each open NCR or CAPA for this line linked to its cause, with an owner and a due date that is being met? Look at: the line's open NCRs and CAPAs.
A filled-in example
Illustrative, not a benchmarkAn example: an internal audit of a made-up contract manufacturer's catheter assembly and pouch-sealing line in an ISO 7 room (illustrative, the same as the Excel example sheet and page 7 of the PDF). The customer owns the design and reports complaints to the regulator.
The example audit, graded
- OK: 32 questions
- Minor: 3 questions
- Major: 1 question
- N/A: 2 questions
Score = OK ÷ (OK + Minor + Major + Critical)
38 questions, 2 N/A left out
- 32 ÷ 36= 88.9%
Score88.9%
38 questions: 32 OK, 3 minor, 1 major, 0 critical and 2 not applicable. Score 32 of 36 graded, 88.9 percent.
- 38 questions: 2 N/A (7.3 design, owned by the customer; 8.2.3 reporting, done by the customer as legal manufacturer), so 36 graded.
- 1 Major (7.5.6): the pouch sealer at station 4 was set to 182 °C against a validated range of 185 to 195 °C, with three lots sealed since the setting changed. Lots held and seal strength tested; NCR and CAPA opened.
- 3 Minor: an old work instruction revision at station 2, replaced on the spot; a new operator who started a task two days before her sign-off; a pull tester 3 days past its calibration date, checked in tolerance the same day.
- 32 OK, no Critical.
Score = 32 ÷ 36 = 88.9%. The Major is a product question first: hold and test the three lots, then find out how a validated setting was changed without control.
Common mistakes
Auditing clause numbers, not the floor
Reading procedures clause by clause in an office misses the station with the old work instruction. Start on the floor and trace back.
Auditing your own area
ISO 13485 asks that auditors do not audit their own work. In a small site, swap areas or bring in an auditor from a sister site.
Forgetting what the QMSR adds
Under the QMSR, ISO 13485 is the base, but records, labeling, UDI and reporting carry extra FDA requirements. Check them where they apply.
Treating a validation finding as paperwork
A validated process running outside its range is a product question. Contain first, then investigate the change.
Closing CAPAs without an effectiveness check
Clause 8.5.2 asks you to verify the action worked. Closing on completion brings the same finding back next audit.
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FAQ
ISO 13485 internal audit checklist: common questions
A medical device maker's own audit of its quality management system against ISO 13485 and its procedures, at planned intervals, by auditors who do not audit their own work. Findings feed corrective action and management review. It is required by clause 8.2.4.
At planned intervals set by your audit program, weighted by how important each process is and what earlier audits found. A common pattern is to cover every clause and process at least once a year, with high-risk processes such as sterilization or sealing audited more often.
Since February 2, 2026, the QMSR (21 CFR 820) incorporates ISO 13485:2016 by reference, so its internal audit clause applies to US device makers through the regulation. The QMSR also adds its own requirements on records, labeling and packaging, UDI and reporting, which an internal audit should cover.
An internal audit is your own check of your system. An MDSAP audit is one audit, by a recognized auditing organization, that several regulators accept. Internal audits prepare you for it, and the MDSAP auditor will look at your internal audit program.
At each station: the production record for the lot is complete to the current step, the work instruction is the current approved version, each operator was trained before the task, nonconforming product is tagged and held apart, and open NCRs and CAPAs for the line are moving.
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- Pest control inspection checklistA pest control walk-round for a food plant, with a log of traps and stations and action levels for each type of device.
- Cleanroom audit checklist33 cleanroom checks split by how often they run (each shift, weekly, per plan, system), a gowning order to watch against, a differential pressure log and a findings log, with a worked week of readings.
- GMP audit checklist for drug manufacturing42 self-inspection checks ordered by the subparts of 21 CFR 211, each with its section, the matching EU GMP chapter and whether it is seen on the floor or in records, graded critical, major or minor, with a worked audit of a packaging line.
- Line clearance checklist28 line clearance checks in six sections (area, equipment, materials, printed materials, documents, coder and vision settings), cleared by the operator and verified by a second person, with a printed-materials reconciliation and a worked example that does not balance.
- ISO 22716 GMP audit checklist for cosmetics25 cosmetic GMP checks following the sections of ISO 22716, split into a floor walk (people, premises, equipment, materials, production) and system checks (lab, out of specification, deviations, complaints, change control, audits, documents), with a worked audit of a filling line.
- SSOP template: sanitation standard operating procedureOne sanitation SOP sheet per area or machine (steps, chemical, contact time, PPE, lockout, owner), a 23-check pre-op inspection and a verification log for visual, ATP and micro checks.
- SQF internal audit checklist for food manufacturing54 questions in the two parts of the SQF manufacturing code (system elements and GMP), each group mapped to BRCGS and FSSC 22000, graded Conforms to Critical, with findings, a score and a yearly plan.
- Injection molding defects chart16 molding defects with causes by machine, material, mold and method, first checks, and an Excel defect log with a Pareto.
- ESD audit checklist29 checks for an ESD protected area, with daily tests split from periodic verification, a measurement log and a worked audit.
- 1-1-90 method worksheetOne page: score areas 1 to 5, write the pain point with a before and target number, check days 30, 60 and 90, and plan the next three areas.
- Leader standard work templateA team leader's daily, weekly and monthly routine with a box per day, follow-ups and a weekly review.
- Supervisor leader standard work templateA supervisor's daily, weekly and monthly routine with a box per day, an escalation log and a weekly review.
- Production manager leader standard work templateA production or value stream manager's routine by day, week and month, with an escalation log and a weekly review.
- Plant manager leader standard work templateA plant manager's short routine by day, week and month, with an escalation log and a weekly review.
- Autonomous maintenance (CILR) checklist20 clean, inspect, lubricate and retighten checks with a box per day, an abnormality log and sign-off.
- A3 problem solving templateThe standard seven-box A3 from background to follow-up, with a filled-in worked example. PDF and Excel.
- PDCA templateOne improvement cycle on one page: plan, do, check against the goal, then standardize or adjust. PDF and Excel.
- 5 Whys templateA problem statement, a why chain that can branch, evidence for every answer, root causes and countermeasures that are checked.
- 5W1H templateWho, what, when, where, why and how: a problem statement built from checked facts, and an action plan with nothing left open.
- Skills matrix templatePeople by tasks on a 0 to 4 scale, coverage and gaps per task and shift, and a training plan that closes them.
- Standard work sheet templateTakt time, each element's manual, machine and walk time on a time chart, key points and standard WIP.
- One point lesson (OPL) templateOne topic on one page: wrong way and right way pictures, checkable key points, the standard it belongs to and a sign-off record.
- SMED changeover worksheetChangeover steps with times, internal or external, what can move, ideas and before/after totals.
- Kaizen event charter templateProblem, goal, scope in and out, boundaries, metrics from baseline to target, team and roles, and sign-off before day one.
- RACI matrix template17 kaizen project tasks by 10 roles, with R, A, C, I drop-downs and a check for one accountable per task.
- Shift handover templateSafety, production against plan, holds, downtime events, materials and people, and the open actions the next shift takes over.
- Shift schedule packTen shift patterns defined exactly, each with a 28-day calendar, hours worked out from the cycle and a US 40-hour check, plus an Excel roster.
- Kanban card templateSix production and six withdrawal kanban cards to print and cut out, with loop sizing and a card register.
- Idea suggestion formA one-page idea form with the supervisor's answer and points, and an idea log that tracks days to answer.
- Just Do It (JDI) card templateSix Just Do It cards per sheet for quick fixes, with the rules for what counts and a log of every card.
- Quick kaizen templateOne page for a small improvement: before and after, the cause, the countermeasure, the results and whether the standard changed.
- Time study sheetTime each element over 10 cycles and work out the average, lowest repeatable and standard time. Excel does the sums.
- Spaghetti diagram templateSquared paper to trace every trip, a trip log that turns grid squares into feet, meters and walking time, and a before and after comparison.
- OEE tracking sheetOne row per shift for a week. The Excel version works out availability, performance, quality and OEE and charts the week.
- Near miss report formA two-page near miss report from the first report to closure, and an Excel log with status and days open.
- Safety observation card templateFour behavior-based safety cards per sheet, with safe and at-risk checks, the conversation and a tally sheet.
- Job safety analysis (JSA) templateJob steps, hazards, risk scored before and after the controls, the hierarchy of controls, PPE and sign-off.
- Risk assessment matrix template (5×5)A color-coded 5 × 5 severity and likelihood matrix, a scoring guide and a risk register.
- Incident investigation report templateFacts and a sourced timeline, causes at three levels, actions by the hierarchy of controls, a US recordkeeping screen and a closure check.
- Incident report templateThe first report, filled in the same shift: what happened, people, injury or damage, treatment, a US recordkeeping screen, actions and an Excel incident log.
- Toolbox talk templateA record of a short safety talk: topic, key points, questions raised, actions and an attendee sign-in sheet.
- Lockout/tagout (LOTO) procedure templateA machine-specific LOTO procedure: energy sources and isolation points, the steps from shutdown to restart, and the annual review.
- Preventive maintenance checklist templateA PM checklist per machine with readings and sign-off, and a PM schedule that works out the next due date.
- Equipment downtime log (MTTR and MTBF)A breakdown and downtime log, with MTTR, MTBF and downtime by machine and cause worked out in Excel.
- Environmental aspects and impacts registerAn ISO 14001-style register of aspects and impacts, with significance scoring, legal requirements, controls and owners.
- Manufacturing process instruction (MPI) templateOperation steps with parameters, tools, quality checks, safety and a photo each, plus revision history and approval.
- Engineering process instruction (EPI) templateScope, parameters and limits, equipment and materials, validation steps, acceptance criteria, change history and approvals.
- Training sign-off sheetAn attendance and sign-off record where each person signs they understood, with a competence check and an Excel log.
- Learning curve and ramp-up workbookBoth learning curve models side by side, a fit from your own observed hours, batch hours, the unit that reaches standard and a weekly ramp plan.
- Operator staffing calculatorTakt, work content, the operators a line needs, a check of your station plan and the roster with absence cover, from your own demand and element times.
- On-the-job training (OJT) checklistThe training record for one trainee on one job: the four TWI steps signed, every try judged, qualified when your rule is met, then tapering follow-up checks.
- New hire onboarding checklist (manufacturing)29 onboarding items from before day 1 to the 90-day review, with owners, dates and review notes.
- Competency assessment formThe one-person assessment behind a skills matrix rating: each task rated 0 to 4 from evidence, checked, with a training plan for every gap.
- Cross-training plan templateWho is learning which task, from and to which level, by when, and how many are qualified on each task.
- Absenteeism tracker templateA monthly attendance grid with codes, absence rate by person and team, and an optional Bradford factor.
- Engineering change request (ECR) formAn ECR form with the change, what it touches, risk and approvals, and an Excel log that tracks each change to done.
- Process flow diagram templateA squared sheet to draw the flow with a symbol key, and a step table that counts operations, moves, checks, waits and storage.
- Lubrication schedule templateEvery lube point with lubricant, method, amount, frequency and who, with next due dates and a monthly sign-off record.
- TPM tag logEvery abnormality tag with type, who fixes it, priority and dates, with days open and counts by type and week.
- Autonomous maintenance step auditCriteria for each of the seven autonomous maintenance steps, scored 0 to 2, with the step result and the decision to move on.
- Inventory cycle count sheetA blind count sheet with variance and tolerance, an ABC count schedule and record accuracy, worked out in Excel.
- Hour-by-hour production boardHourly plan against actual with running totals and the reason for each miss, plus a shift summary by reason.
- Cost savings trackerA savings log with hard and soft savings, payback and Finance's sign-off, plus a glide path against the year's target.
- CapEx request formA capital request with options, costs, benefits, payback and NPV, and the approval levels the amount needs.
- Standard cost variance workbookEight standard cost variances from your standards and actuals, favorable or unfavorable, proved against actual cost, with the questions to ask on the floor.
- Cost-benefit analysis templateUp to three options side by side with costs, hard and soft benefits, payback, NPV and the benefit-cost ratio.
- Cost of poor quality (COPQ) worksheetCost of quality by prevention, appraisal, internal and external failure, with COPQ as a share of sales.
- Receiving logA dock receiving log with quantities, damage, QC holds and putaway, plus a discrepancy report and dock-to-stock time.
- Warehouse safety inspection checklistThirty warehouse safety checks from aisles to fire exits, marked OK or Not OK, with an action for every finding.
- Pallet racking inspection checklistRack checks per aisle with a green, amber and red damage rating, and a damage log with repair dates.
- Material shortage logEvery part short with its need date, line impact, ETA and escalation, and counts by reason and supplier.
- Ergonomic risk assessment checklistScreen a task for 21 ergonomic risk factors, score how long each lasts, and rank tasks so the worst get controls first.
- Work order template for maintenanceA work order template for maintenance: one form per job from request to handback, and a log of response, completion and backlog by priority.
- Six big losses worksheetWhere a machine's planned time goes: the six big losses in minutes, ranked, with A, P, Q and OEE worked out.
- Andon response logEvery andon call with response and fix times, flags against your targets, and counts by type and station.
- Changeover checklist25 checks for every changeover, a record of planned and actual times, and a log of changeover time against target.
- Kanban sizing calculatorHow many kanban cards each loop needs, per part, with the change from today's cards and what the loop holds in days.
- Kaizen event trackerEvery kaizen event on one sheet: status, roles, the metric against target, open actions and the 30, 60 and 90 day checks.
- TWI job breakdown sheetThe TWI Job Instruction breakdown of a job into important steps, key points and reasons, with a worked example and the four steps.
- Standard work combination tableOne operator's manual, machine, walk and wait time on a time chart against takt, with machine cycles and a process capacity sheet.
- Lead time worksheetProduction lead time from the inventory waiting at each step, value-added time and process cycle efficiency, plus an order traced from order to delivery.
- Maintenance KPI trackerMTBF, MTTR, availability and PM compliance per asset and month, plant figures from the totals, planned maintenance % and backlog in weeks.
- Daily huddle agendaA 15-minute start-of-shift stand-up in six timed blocks, with yesterday's SQCDP results, today's plan, actions and escalations.
- DMAIC project charter templateThe Define-phase charter on one page: problem and goal, metrics, scope, team and phase dates, with savings and a tollgate checklist.
- Water spider route plan (mizusumashi)A water spider's fixed route: stops with arrival times, what is delivered and collected, route time against the cycle, cart load and a trip log.
- Cost deployment matrixWCM cost deployment on paper and in Excel: loss quantities by process, causal and resultant losses, the cost of each loss, a Pareto and the projects that recover them.
- Equipment criticality analysisAssets scored 1 to 5 on six criteria with your own weights, ranked and sorted into classes A, B and C with a safety override and a suggested maintenance strategy.
- Bottleneck analysis worksheetEffective capacity per station from cycle time, parallel units, availability and yield, the bottleneck, takt and utilization, a queue cross-check and the five focusing steps.
- Fault tree analysis templateA drawing area with the FTA symbols, an event table with probabilities and minimal cut sets, and the gates worked out bottom-up in Excel.
- 5G investigation sheetConfirm the facts before naming a cause: 5W1H, the five G's with 20 prompts, the gap against the principle and the standard, and the countermeasures.
- Yokoten tracker (horizontal deployment)Copy a proven improvement line by line: the source result, each candidate's own before and after, its share of the source's improvement and the standard updated.
- Coaching kata template (improvement kata storyboard)The learner's storyboard (target condition, current condition, obstacles, PDCA cycles) and a fold-over card with the coach's five questions.
- SMART goals templateWrite a goal, test it against the five SMART letters, then track progress toward the target against the time used.
- Nemawashi template (stakeholder plan)Plan the one-to-one conversations before a decision: who to talk to in what order, their concerns, what changed and where they stand.
- Breakdown analysis reportOne equipment breakdown from the stop to the 90-day check, plus a breakdown log with repeat flags, MTBF and MTTR by asset and a Pareto of causes.
- Heijunka box planner (production leveling)Weekly demand turned into containers a day, takt, pitch and slots, a leveled sequence of products and the heijunka box, with a check that the changeovers fit.
- Future state value stream map worksheetThe eight future-state questions worked through in order: takt, pitch, flow, supermarkets, the pacemaker and the mix, with an EPEI check and current against future lead time.
- Value stream plan (VSM action plan)The future-state map cut into loops, each with an objective and a measurable goal, and its kaizen bursts turned into owned, dated projects on a 12-month timeline.
- Kaizen project plan (Gantt chart)One improvement project as a Gantt chart: tasks by phase with owners, predecessors and working days, a 16-week grid, milestones and a status from planned against actual % done.
- Escalation matrix templateWho is called for each type of issue and after how long, with severity rules, contacts and an escalation log.
- Employee recognition program templateDesign a recognition program on one page, then run it: points per action, prizes, budget, a points ledger, a monthly leaderboard and a fairness check by team and shift.
- Lean transformation roadmapA plant-wide lean program on one sheet: six phases with exit criteria, six workstreams by quarter over 24 months, the model line, metrics with baseline and target, cadence and risks.
- Obeya room plannerPlan the walls, owners, cadence, agenda and rules of an obeya, then run the weekly review of KPIs, problems, actions and milestones.
- Paper forms inventory (paperless manufacturing worksheet)Every paper form, checklist and log in one list: hours a month, who acts on it, how long the paper waits, and which forms to move first.
- Continuous improvement software evaluation scorecardCompare CI software vendors: a must-have gate, eight weighted criteria scored 1 to 5, points out of 100 and a rank, with a demo script and reference questions.
- Lean principles assessment templateThe five lean principles as 25 things you can see on one value stream, answered yes, partly or no on a walk, with a score per principle, the next step and a trend over walks.
- Employee engagement survey templateA short anonymous pulse survey for shop floor staff: 14 statements in six drivers, two open questions, results by driver and team, and the actions.
- Hansei reflection sheet (lessons learned)A written look back at one finished project, event or launch: goals against results in numbers, causes rather than blame, lessons to keep or change, and where else they apply.
- Safety cross calendarA month drawn as the green cross, colored each day by the most serious safety event, with totals and days since the last injury.
- Daily kaizen routine boardA team's 10 to 15 minute daily routine at the board: one problem from each person, small fixes with one owner, counted every week.
- Weekly maintenance schedule templateNext week's maintenance jobs, scheduled only when ready, loaded against each craft's hours by day, with schedule compliance and break-ins at week end.
- Operational excellence assessment templateThe ten principles of operational excellence as 30 behaviors and practices you can see, scored 1 to 5 by several people, with the spread, the three lowest principles and an action plan.
- Scrum meeting agenda templateTimed agendas for the five scrum meetings, a sprint planning sheet, a retrospective sheet, and an Excel sprint backlog with a burndown.
- Toyota Production System (TPS) house templateThe TPS house for one plant or value stream: roof, two pillars and foundation, with what you do today, the evidence, a status and the next step for each element.
- EPEI and batch size calculatorHow often each part can come round on a shared machine (EPEI) and how big each batch must be, from demand, cycle times and changeovers, now and after SMED.
- People, process, technology (PPT) assessmentCheck one change before go-live: 18 people, process and technology statements scored 1 to 4 by the people who will use it, the lowest element and the actions.
- Process capacity sheet templateEach machine in a part's routing with manual, auto and tool change time, its capacity per shift, and the step that limits the cell against demand.
- Team charter templateA one-page charter for a standing team: purpose, scope, roles, the KPIs it owns, which decisions it makes itself, norms and cadence.
- Chaku-chaku line plannerPlan a load-load cell: time each machine, load and walk, check that every machine is ready when the operator comes back, compare the cell cycle with takt and size the crew.
- Standard operating procedure (SOP) templateA full SOP in the hierarchical step format, from purpose and scope to the steps, records, revision history and approvals, with review checks and an SOP register.
- Process improvement method selectorEight questions about one problem, an example rule that suggests a method and a matrix of nine methods: when each fits, the usual team and time, and the template to start with.
- Safety pillar 90-day model area planThirteen weeks from the incident pyramid to safety standards on one model area, a KPI board, the day-90 gate and expansion waves.
- Autonomous maintenance 90-day model area planAM steps 0 to 3 on one model machine in 13 weeks, a KPI board, the day-90 gate and expansion waves for months 4 to 12.
- Professional maintenance (PM) 90-day model area planThirteen weeks from breakdown analysis to a running PM calendar on one model machine, a KPI board, the day-90 gate and expansion waves.
- Environment and energy pillar 90-day model area planThirteen weeks from waste and energy maps to area standards on one model area, a KPI board, the day-90 gate and expansion waves.
- Focused improvement 90-day model area planThirteen weeks from the loss Pareto to standardized fixes on one model line, a KPI board, the day-90 gate and expansion waves.
- Logistics and customer service pillar 90-day model area planThirteen weeks from the current-state map to pull on one model value stream, a KPI board, the day-90 gate and expansion waves.
- People development pillar 90-day model area planThirteen weeks from the skills matrix to trained cover on critical tasks in one model area, a KPI board, the day-90 gate and expansion waves.
- Early equipment management 90-day model area planThirteen weeks from lessons on current machines to a tracked start-up on one model equipment project, a KPI board, the day-90 gate and expansion waves.
- Cost deployment pillar 90-day model area planThirteen weeks from the loss map to costed, ranked projects in one model area, a KPI board, the day-90 gate and expansion waves.
- Moving from Excel to one system checklistA 34-point checklist and a file inventory for moving trackers from spreadsheets to one system: keep, move, connect or retire, clean, pilot, run both, retire.
- Prioritization matrix templateScore up to 20 improvement ideas on weighted criteria, rank them, test the ranking with equal weights and place each one on an effort and benefit grid.
- Cost per unit worksheet (manufacturing cost per good unit)One product's cost per good unit by materials, labor, machine and overhead, the gap to target, and which cost lever is worth most a year.
- Digital manufacturing readiness assessmentScore 24 statements on process, technology and people from 0 to 4, check the balance between them and rank the gaps by what matters in your plant.
- Manufacturing KPI dashboard templateWeekly plant numbers in, 14 KPIs out: OEE and its parts, first pass yield, scrap, on-time delivery, recordable rate, cost and absence, each against a target.
- RCM worksheet (failure mode and task selection)Failure modes classed as hidden, safety, operational or non-operational, then a task chosen for each: condition-based, discard, failure-finding, redesign or run to failure.
- Training matrix template with expiry datesPeople by required trainings with expiry dates, OK, due, expired and missing flags, compliance by person and area, cover per training and a renewal list.
- Downtime reason codes template26 starter codes mapped to the six big losses, a log with drop-downs, a Pareto by code and by loss, and a code card for the line.
- Kaizen event preparation checklistEverything that has to be ready before a kaizen event and done after it: 44 items with owners and due dates from 6 weeks before day 1 to 30 days after, five go or no-go gates and a day-by-day agenda.
- Critical spare parts list and stocking levelsAssets ranked by consequence, each part classed and given a stocking policy, and min and max worked out from usage and lead time, with the downtime each stock-out would cost.
- Tier 2 meeting agenda and escalation sheetA 15-minute tier 2 agenda in ten timed blocks, fixed roles and rules, escalation triggers with time limits, and a log that ages every escalation and sends the answer back down.
- Forklift operator training and evaluation recordPer-operator training and evaluation record, a register with three-year due dates and refresher triggers, and a weighted practical evaluation scoresheet.
- REBA worksheet (Rapid Entire Body Assessment)Score up to six postures with REBA: body-part drop-downs, Tables A, B and C as lookups, final score and action level, and a before and after comparison.
- Plan for every part (PFEP) templateOne row per part: supplier, pack, container, usage, lead time and locations, with ABC classes, market and line kanban counts and a lineside space check.
- Changeover matrix templateA from-to matrix of changeover minutes with the clean each transition needs (allergen, colour, format), and a weekly planner that totals the order and suggests a shorter one.
- Overhead crane inspection checklist: frequent and periodic34 crane checks tied to OSHA 1910.179: an operator's pre-shift card, frequent and periodic inspections with signed records, a deficiency and tag-out log, and a register of next due dates.
- Maintenance job plan templateOne job planned on one sheet: steps and craft hours, parts checked against stock, tools, lockout and permits, documents, a ready check for the schedule, and technician feedback.
- Video time study filming checklistA pre-shoot checklist and shot log for filming a time study on video: camera, light, people, settings, power and review.
- Reorder point and safety stock sheet (many parts)Safety stock, reorder point, order quantity and an order list for up to 500 parts, worked out from each part's own demand and lead time history.
- TRIR and DART rate trackerMonthly hours, OSHA 300 case counts and near misses in; rolling 12-month TRIR and DART rate, a case budget against your target and a trend chart out.
- Energy use and EnPI trackerMonthly electricity, gas and fuel in one unit, a 12-month regression baseline, expected against actual energy for each month, an EnPI ratio, the running saving and the tests that say whether the model can be trusted.
- FIFO lane sizing sheetThe maximum for a FIFO lane from the stop it must cover, in whole containers, with length, refill and wait checks for up to eight lanes.
- Pugh matrix templateCompare up to 8 concepts with a datum as better, same or worse on up to 12 criteria, flag must-haves, and carry the strongest into a second round.
- Machine guarding inspection sheetA machine register with due dates and a status per machine, 21 checks tied to OSHA 1910.212, .219 and .147, a guard opening check against Table O-10, and an action log.
- Condition monitoring route sheetA route of measuring points with baselines, alert and alarm limits, a check interval from the P-F interval, readings with rising and overdue flags, and an exceptions list worst first.
- Fire extinguisher inspection checklist and logThe 8 monthly checks for each portable extinguisher, plus a log with the hydro test interval from OSHA Table L-1, annual and 6-year due dates and open issues.
- Quad chart templateA project on one page in four boxes: idea and owner, problem, approach, and cost, schedule and result.
- Toolbox talk topics (52 weekly topics)52 weekly toolbox talk topics, each with a one-line key message and a discussion question, and a tracker for the year.
- Loss tree worksheetBreak one big loss number into area, line, machine, loss type and cause, and stop at the cause a team can fix.
- Equipment register templateOne row per asset, with hierarchy, criticality, PM strategy and owner, and a check that flags what is missing.
- Machine history record templateOne record per machine: components and their life, every breakdown and repair with cost, MTBF and MTTR, and a repair-or-extend check.
- Compressed air leak survey logWalk sheet, printable leak tags and a tracker that puts an annual cost on every leak and follows it to a verified fix.
- Project savings validation checklistThe gate between a project's claim and a reported saving: 20 checks, a claims register and a six-month sustainment check.
- Life cycle cost analysis templateCompare up to three machines over ten years: price, energy, upkeep, failures and down time, discounted to present value.
- Equipment design review checklistGate reviews for a new machine before order, before build and before start-up, with a safety buy-off and a problems journal.
- Emergency action plan templateA written emergency plan for a plant: site facts, roles and backups, warden coverage, scenario steps and a drill record.
- Preliminary hazard analysis (PHA) worksheetFind and score the hazards of a new line, machine or process before design is fixed, then choose controls and re-score.
- Risk register templateOne scored list of operational risks with owners, actions and dates, a heat map and a review log.
- Hot work permit templateA hot work permit with a precautions checklist, fire watch record and close-out, plus an Excel permit log.
- Confined space entry permit templateA confined space entry permit with checks, an air test log, an entry log and cancellation, plus an Excel register.
- Energy loss matrix templateSeven types of energy loss by six energy sources with a cost in each cell, an action plan and an idle-period shutdown checklist.
- Management safety tour formA leader's scheduled safety walk: observation form, operator interview, tally, actions, rota and a tour log with a dashboard.
- Hazard prediction worksheetA pre-task worksheet: score what could go wrong at each step of a job, add a countermeasure and score again.
- Chemical inventory and SDS register templateA register of every chemical on site with its hazard class, safety data sheet and label, and a check that incompatible products are kept apart.
- Safety committee meeting minutes templateMinutes for a safety committee: attendance, nine agenda items, an action log that carries open actions forward, and monthly numbers.
- Management of change formA change request and review form for a plant: what changes, the hazard review, approvals, pre-startup review, training and close-out.
- Silica exposure control plan templateA written silica plan for general industry: tasks, controls and housekeeping, plus monitoring, medical surveillance, training and a 31-check plan audit.
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A shift handover sheet, a red tag log, a changeover checklist for one machine: if your team uses it on the floor, ask.