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Cleanroom audit checklist
A cleanroom audit checklist is the list of checks that shows a cleanroom is used the way it was designed and qualified. That means pressures held, people gowned and qualified, materials brought in the right way, cleaning and monitoring done to plan, and tests current. This one has 33 checks split by how often they run. The each-shift checks cover pressure differentials, alarms, doors and airlocks, gowning, people and materials. The weekly checks cover the cleaning log, disinfectant rotation and the monitoring results. The per-plan checks cover ISO 14644-1 classification, filter integrity tests, airflow and recovery tests. The system checks cover change control, excursions and training. Each check says what to look at and is graded OK, Minor, Major, Critical or N/A. The PDF adds a gowning order to watch an entry against, a blank differential pressure log and a worked week of readings with one excursion. Limits are always yours: write your validated limits on the log, never a number from a template. It supports internal audits beside your quality system; it is not a classification test.
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Audit details, the five grades, and the each-shift checks on pressure, alarms, doors, gowning and people, with a grade and a finding column.33 checks by frequencyEach shift, weekly, per planFive grades with days to fixGowning orderDifferential pressure logFindings logExcel flags out-of-limit readingsWorked week of readingsPDF, Excel and Word
When to use it
When to use a cleanroom audit checklist
- Every shift, for the short each-shift checks: pressures, alarms, doors, one watched gowning entry, materials coming in.
- Once a week, when the cleaning log, disinfectant rotation and monitoring results are reviewed against the plan.
- When your monitoring plan says a classification, filter, airflow or recovery test is due, to check the report is on file.
- After an excursion, a change to the room or its air handling, or maintenance inside the room, before the room goes back into use.
How to fill it in
- 1
Write your limits first
Copy each room pair's validated low and high pressure limits, and the room's temperature and humidity ranges, onto the log before the first reading. They come from your design and qualification, not from this template.
- 2
Run each group at its own frequency
Each-shift checks at the start of every shift, weekly checks on a fixed day, per-plan checks when the plan says they are due, system checks with the quality team. One sheet covers all four, so nothing falls between them.
- 3
Watch a gowning entry from outside
Once a shift, watch one person gown through the window, against the posted order. Do not go in to watch: an extra person in the gowning room changes what you are checking.
- 4
Grade and write the finding
Grade each check OK, Minor, Major, Critical or N/A. Write each finding with the room, the time and what you saw: 'door 2 wedged with a cart at 12:40', not 'doors not OK'.
- 5
Act on an excursion before you write it up
A reading outside your limits is an excursion. Close the door or stop entries first, then recheck, record it and raise it with quality, who judge the effect on product.
- 6
Close findings with a check
Log every finding with an owner and a due date. Start the next audit by checking last time's open findings, and close each one only when someone has seen the fix work.
On the floor
When a reading is outside your limits
The order this template uses for an excursion, with the example's Tuesday reading as the case: act first, then record, then fix the cause.
- 1Each shift
Read the gauges
Every room pair against the limits copied onto the pressure log. - 2Decision
Inside the limits?
- Yes:
- log it and go on
- No:
- next step, now
- 3Minutes
Act first
Close the door, stop entries, read again. In the example: back to 15 Pa at 12:44. - 4Same day
Check the product
Particle count in the room; hold open work until quality reviews it. - 5Change control
Record and fix the cause
Excursion record, then the lasting fix: a cart bay, an 'airlock clear' check, a shorter alarm delay.
How often each check runs
Each shift, weekly, per plan: what gets checked when
The frequencies this template sets. Your environmental monitoring plan and SOPs decide yours; where they say more often, follow them.
| Frequency | What is checked | Who usually does it | Record |
|---|---|---|---|
| Each shift | Pressure differentials, alarms, doors and airlocks, temperature and humidity, one watched gowning entry, materials and equipment in the room | Shift lead or cleanroom operator | Pressure log, gowning observation, this checklist |
| Weekly | Cleaning log against the schedule, disinfectant rotation and made-up solutions, particle and viable monitoring done and reviewed, trend review | Area supervisor with quality | Cleaning log, monitoring data, signed trend review |
| Per plan | ISO 14644-1 classification, filter integrity, airflow, recovery and smoke tests, instrument calibration, plan review | Quality or engineering, with trained testers | Test reports, calibration register |
| Any time | Change control, maintenance release, excursion handling, training and gowning requalification | Quality team | Change, maintenance, excursion and training records |
Each shift
- What is checked
- Pressure differentials, alarms, doors and airlocks, temperature and humidity, one watched gowning entry, materials and equipment in the room
- Who usually does it
- Shift lead or cleanroom operator
- Record
- Pressure log, gowning observation, this checklist
Weekly
- What is checked
- Cleaning log against the schedule, disinfectant rotation and made-up solutions, particle and viable monitoring done and reviewed, trend review
- Who usually does it
- Area supervisor with quality
- Record
- Cleaning log, monitoring data, signed trend review
Per plan
- What is checked
- ISO 14644-1 classification, filter integrity, airflow, recovery and smoke tests, instrument calibration, plan review
- Who usually does it
- Quality or engineering, with trained testers
- Record
- Test reports, calibration register
Any time
- What is checked
- Change control, maintenance release, excursion handling, training and gowning requalification
- Who usually does it
- Quality team
- Record
- Change, maintenance, excursion and training records
The 33 checks
What to check in a cleanroom, by how often
Each check starts with its topic, asks one question and says what to look at. On the sheet each one gets a grade (OK, Minor, Major, Critical or N/A), the finding and an owner. Limits are always your own validated limits.
Each shift: pressure, alarms and doors
Before work starts and at every shift change
- 1Pressure: Is every room pair's differential pressure inside your validated range, and written on the log with the time and initials? Look at: the gauges or monitoring screen against the log; any reading sitting at the edge of the range.
- 2Alarms: Has every pressure, particle, temperature or humidity alarm since the last shift been acknowledged, explained and recorded? Look at: the alarm history on the monitoring system; who acknowledged each one and what they wrote.
- 3Doors: Do the airlock interlocks let only one door open at a time, and is no door wedged, taped or held open? Look at: try each interlock; door closers; marks on the floor where carts wait in doorways.
- 4Temperature and humidity: Are room temperature and relative humidity inside the ranges set for the room? Look at: the room displays against the log for this shift.
- 5Room status: Does the sign at each room's entrance show its true status (in use, cleaned, out of service)? Look at: the status board against what is happening inside.
Each shift: gowning and people
One observed entry per shift, plus a look at the room
- 6Gowning: Does everyone entering follow the posted gowning order, and is one entry each shift watched and recorded? Look at: an entry seen through the gowning room window; the observation record.
- 7Qualification: Is everyone in the room on the current list of people qualified to gown for this grade? Look at: names on the entry log against the gowning qualification list and its expiry dates.
- 8Garments: Are garments the right type and size for the grade, within their use or sterility date, with no tears or open seams? Look at: garment labels, packs on the shelf, one garment at the end of a shift.
- 9Personal items: Are jewelry, makeup, phones, paper and food kept out as your gowning procedure says? Look at: the pre-entry sign; pockets of coats left in the gowning room.
- 10Behavior: Do people move slowly, keep gloved hands off their face and off critical surfaces, and is the head count within the posted maximum? Look at: five minutes of watching; the head count against the sign.
Each shift: materials and equipment
How things come in, and what is in the room
- 11Transfer: Do materials come in only through the pass-through or material airlock, wiped or unwrapped as the transfer procedure says? Look at: one transfer in progress; the agent and wipe used; the outer wrap left outside.
- 12Pass-throughs: Are pass-through doors interlocked or opened one at a time, and is the hatch clean inside? Look at: open each side in turn; the floor and corners of the hatch.
- 13Paper and cardboard: Is cardboard kept out, and are records inside kept on cleanroom paper or a tablet? Look at: corners, under benches, the bins.
- 14Equipment labels: Does every piece of equipment show a clean status label and, where needed, a calibration or maintenance label in date? Look at: labels on balances, carts, fixtures and tools.
- 15Waste: Is waste bagged and taken out by the planned route, not left to build up? Look at: the bins, the waste route and the time of the last removal.
Weekly: cleaning and monitoring records
Records checked against the plan
- 16Cleaning log: Is every scheduled clean signed for, with the agent, its strength or lot, and the contact time? Look at: last week's cleaning log against the cleaning schedule.
- 17Disinfectant rotation: Is the agent in use the one your rotation plan calls for this week, including any periodic sporicide your plan sets? Look at: the plan, the bottle labels and the log.
- 18Made-up solutions: Is every made-up disinfectant labeled with name, strength, date made and expiry, and used within that date? Look at: bottles and buckets in use.
- 19Cleaning tools: Are mops, wipes and buckets kept for this grade only, stored dry and replaced on schedule? Look at: where they are stored, their color coding and wear.
- 20Particle counts: Were the airborne particle counts in your monitoring plan taken at the planned points and times, and is each excursion investigated? Look at: the counter's data or printouts against the plan.
- 21Viable monitoring: Where your plan calls for them, were settle plates, contact plates, air samples or glove prints taken and their results reviewed? Look at: the sample log, results and trend chart.
- 22Trend review: Has someone reviewed the week's pressure, particle and environmental data for drift, not only single excursions? Look at: the signed review and any action that came from it.
Per plan: certification and tests
At the intervals your monitoring plan sets
- 23Classification: Is each room's ISO 14644-1 classification current, with the report on file and the next date planned? Look at: the last classification report and its date against your plan.
- 24Filters: Has every HEPA filter had its integrity (leak) test to plan, and passed or been repaired and retested? Look at: the test report for each filter in the room, by filter ID.
- 25Airflow: Are air velocity or air change rates tested to plan and inside the design values? Look at: the test report; changes since it, such as new equipment or a moved return grille.
- 26Recovery and smoke tests: Where your plan or the room's grade calls for them, are recovery tests and airflow visualization done and on file? Look at: the reports and their dates.
- 27Instruments: Are pressure gauges, sensors and particle counters calibrated and in date? Look at: the calibration labels and the calibration register.
- 28Monitoring plan: Was the monitoring plan reviewed after the last change to the room, the process or the results trend? Look at: the plan's revision date against those changes.
System: changes, excursions and training
Any time; usually with the quality team
- 29Change control: Were changes to the room, its air handling or its use approved before they were made, with any retest done? Look at: change records from the last 6 months; the room as it is today.
- 30Maintenance: Is maintenance inside the room planned, then followed by cleaning and, where needed, a retest before the room goes back into use? Look at: the last two maintenance jobs and how the room was released.
- 31Excursions: Is each out-of-limit result investigated, its effect on product judged, and closed with an action? Look at: the last three excursions from start to close.
- 32Training: Are operators, cleaners and maintenance staff trained in cleanroom behavior, cleaning and gowning, with records? Look at: training records for three people seen in the room today.
- 33Gowning requalification: Is gowning qualification repeated at the interval your procedure sets, and does anyone who fails retrain before going back in? Look at: requalification dates; one failed attempt and what followed.
A filled-in example
Illustrative, not a benchmarkAn example: one week of differential pressure readings in a made-up catheter assembly suite with an ISO 7 assembly room, an ISO 8 gowning room and an ISO 8 packing room, read at 07:00 and 12:40 each day (illustrative, the same as the Excel example sheet and page 7 of the PDF). The limits are the made-up plant's own validated limits.
Assembly (ISO 7) to gowning room (ISO 8): the week's 10 readings against the 10 Pa low limit
- Mon 07:00: 15 Pa
- Mon 12:40: 14 Pa
- Tue 07:00: 15 Pa
- Tue 12:40: 7 Pa
- Wed 07:00: 14 Pa
- Wed 12:40: 15 Pa
- Thu 07:00: 16 Pa
- Thu 12:40: 15 Pa
- Fri 07:00: 14 Pa
- Fri 12:40: 15 Pa
Readings in pascals, Monday to Friday at 07:00 and 12:40: 15, 14, 15, 7, 14, 15, 16, 15, 14, 15. All are at or above the 10 Pa low limit except Tuesday 12:40, which read 7 Pa. The other two room pairs stayed in range all week. 29 of 30 readings in range.
- 3 room pairs, 10 readings each: 30 readings. Limits: assembly to gowning 10 to 25 Pa, gowning room to corridor 5 to 20 Pa, packing room to corridor 5 to 20 Pa.
- Tuesday 12:40: assembly to gowning read 7 Pa, under its 10 Pa low limit. The gowning room read 13 Pa at the same time, its highest of the week: the sign of an open door between the two.
- Found: a cart left in the airlock was holding the inner door open; the monitoring trend showed it open from 12:18. Door closed at 12:41, back to 15 Pa at 12:44.
- Particle count in assembly at 12:50 was inside the room's limits. Open subassemblies on bench 2 were held until quality reviewed them, then released.
- Lasting fix: a marked cart bay outside the airlock, 'airlock clear' added to the each-shift door check, and a shorter door-open alarm delay under change control.
29 of 30 readings in range = 96.7%, with 1 excursion of about 23 minutes. The number to track month to month is excursions and how long each lasted, not the percentage.
Common mistakes
Limits copied from a website
A pressure, particle or temperature limit only means something if it comes from your room's design and qualification. Write your validated limits on the log; a number from a template is not one.
Logging a reading without acting on it
A low reading written neatly on the log and left is a common gap. Out of limits means act now: close the door, stop entries, recheck, then record and raise it.
Watching gowning from inside
Standing in the gowning room to check gowning adds a person, a body of air and a distraction. Watch through the window or a camera, against the posted order.
Mixing up classification and monitoring
A current classification report does not show the room is in control today; the monitoring does. Check both, at their own frequencies.
Closing an excursion without the product question
Every excursion needs someone from quality to decide what it meant for the product in the room at the time, and to write that down.
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Free tools
Guides
- Cleanroom gowning audit (app template)
- Cleanroom pressure differential check (app template)
- ISO 13485 internal audit checklist
- GMP audit checklist for drug manufacturing
- Training sign-off sheet
- Lean for medical device manufacturing
- Lean for pharmaceutical manufacturing
- Competency Management: who is qualified for every job
FAQ
Cleanroom audit checklist: common questions
Checks at four frequencies: each shift (pressure differentials, alarms, doors and airlocks, a watched gowning entry, materials in), weekly (cleaning log, disinfectant rotation, monitoring results and trends), per plan (ISO 14644-1 classification, filter integrity, airflow and recovery tests, calibration) and system checks (change control, excursions, training). This one has 33, each with what to look at.
A common order is top to bottom: shoe covers at the step-over bench, hair cover, face mask, hood, coverall, boot covers, eyewear, then gloves last, finished with a mirror check. Your gowning SOP for each grade sets the actual order and garments, and the checklist checks people follow it.
Rooms with continuous monitoring are watched all the time, with alarms; the checklist adds a recorded check of the readings and alarm history at the start of every shift. Rooms without it are read and logged at the frequency your monitoring plan sets, often at least once per shift. Use your own validated limits.
ISO 14644-1 sets the cleanliness classes, ISO 1 to ISO 9, by airborne particle concentration and says how to test a room against its class. ISO 14644-2 covers monitoring the room afterwards to show it stays in control. Classification is a periodic test; monitoring is ongoing.
No. It supports internal audits beside your quality system and your environmental monitoring program. Compliance with ISO 14644, EU GMP Annex 1 or FDA rules comes from your design, qualification, procedures and records, judged by your own quality team and your auditors.
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- 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.