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HomeGlossaryJidoka
Manufacturing · The complete guide

Jidoka: Autonomation and Built-in Quality Explained

In short

Understand Toyota’s automation with a human touch and how to translate abnormality detection into practical stop-and-fix decisions in regulated manufacturing.

4,127 words · ~19 min read
Jidoka: an operator in hairnet, mask, glasses and gloves checks a stop alert on a tablet after the tablet press andon light halts the line
Jidoka stops the process at an abnormality so people fix the cause before more defects are made.
On this page
  1. 01What jidoka means: autonomation and built-in quality
  2. 02Toyota origins: why jidoka and just-in-time belong together
  3. 03Manual and automated jidoka versus neighbouring production concepts
  4. 04The four steps: detect, stop, correct and prevent
  5. 05Andon: make the abnormality visible and summon help
  6. 06Regulated manufacturing: map product, jurisdiction and decision authority
  7. 07Three worked cases: packaging, filling and manual assembly
  8. 08Integration and recovery: preserve the event across systems
  9. 09Make an operator’s decision to stop work safe
  10. 10Measure response, exposure and recurrence without hiding problems
  11. 11Seven implementation mistakes and their corresponding controls
  12. 12Implementation checklist: demonstrate readiness with an event rehearsal
On this page · 12 sections
  1. 1What jidoka means: autonomation and built-in quality
  2. 2Toyota origins: why jidoka and just-in-time belong together
  3. 3Manual and automated jidoka versus neighbouring production concepts
  4. 4The four steps: detect, stop, correct and prevent
  5. 5Andon: make the abnormality visible and summon help
  6. 6Regulated manufacturing: map product, jurisdiction and decision authority
  7. 7Three worked cases: packaging, filling and manual assembly
  8. 8Integration and recovery: preserve the event across systems
  9. 9Make an operator’s decision to stop work safe
  10. 10Measure response, exposure and recurrence without hiding problems
  11. 11Seven implementation mistakes and their corresponding controls
  12. 12Implementation checklist: demonstrate readiness with an event rehearsal
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01What jidoka means: autonomation and built-in quality

Jidoka is the Toyota Production System principle of building quality into processes by detecting abnormalities and stopping work, either automatically or through an operator’s intervention. In Toyota’s explanation of jidoka, the abnormality may concern a machine or equipment, product quality, or a work delay. The concept therefore reaches beyond machines that stop when they break: it connects recognition of an abnormal condition with a response in the process.

The English label used here is autonomation. For readers asking what jidoka means in Japanese, Toyota loosely translates it as “automation with a human touch.” That is an explanation of the production concept, not a literal Japanese etymology. Toyota describes the human element as adding human wisdom to automation: equipment can detect an abnormality and stop automatically, or an operator can stop the line.

Toyota connects built-in quality with clearly detecting abnormalities and preventing their recurrence. It also connects the ability to stop on an abnormality with removing the need for people simply to watch machines. These are related aims: detection should make a problem actionable, while improvement should address why it happened. The connection to kaizen is therefore part of Toyota’s explanation, rather than an optional addition to more automation.

For practical application, treat built-in quality as a relationship between detection and operational response. The presence of a sensor, camera or inspection station alone does not establish that relationship. Ask what abnormal condition it recognises and what happens when that condition is found. Put that connection into standard work, so the intended response is explicit rather than assumed.

The manufacturing examples in this article are proposed operating designs that illustrate the principle. They are not promises of defect-free production or detection of every possible abnormality.

02Toyota origins: why jidoka and just-in-time belong together

In Toyota’s account of TPS origins, Sakichi Toyoda’s automatic loom did more than mechanize handwork: it incorporated the capability to make judgments into the machine itself. Toyota identifies this as the origin of jidoka. The important historical connection is therefore not automation alone, but automation able to distinguish a condition that calls for intervention.

Toyota attributes development of the just-in-time concept to Kiichiro Toyoda. It describes this second TPS pillar as synchronizing production processes by making only what is needed, when it is needed, and in the amount needed. The two pillars address different operating questions:

  • Jidoka: has an abnormal condition occurred that calls for stopping rather than continuing production?
  • Just-in-time: what does the next process need, when does it need it, and how much should be made?

Read together, they connect response to abnormalities with coordinated flow. Neither should be treated as ensuring the other: a synchronized process can still encounter abnormalities, while stopping for a problem does not itself synchronize production.

Just-in-time also does not mean zero inventory. Toyota expressly describes minimum parts stocks, withdrawal by the next process, and replenishment by the preceding process. The distinction is between stocking to support that replenishment loop and assuming that all stock must disappear. For related flow concepts, see kanban and value stream mapping.

03Manual and automated jidoka versus neighbouring production concepts

Performing work automatically is not the same as building jidoka into it. Toyota distinguishes automation from the added capability to detect an abnormality and stop. Its description also includes an operator pulling a stop cord: a fully automated line is not necessary to illustrate jidoka.

The comparison below separates functions within Toyota’s account; equipment-initiated and operator-initiated are descriptive labels, not separate Toyota production systems.

ConceptMain functionTrigger or actionRelationship to jidoka.
Automated workPerform work previously done by handMachine carries out the operationAutomation alone does not establish abnormality detection and stopping.
Equipment-initiated jidokaDetect an abnormality and stopEquipment detects the abnormality and stops automaticallyBuilds the stopping capability into equipment.
Operator-initiated jidokaEnable a human-initiated stopOperator pulls the stop cordApplies human judgment without requiring automatic detection.
AndonCommunicate an abnormalityDisplay lights when equipment stops or a cord is pulledSignals the problem within the broader jidoka principle.
Just-in-timeSynchronize production processesMake only what is needed, when needed, in the amount neededCoordinates flow rather than detecting abnormalities.

Andon is therefore the communication element, not a synonym for jidoka; how the signal works and who owns the response is covered in the andon section below.

Toyota's account puts manual understanding first: the work is done correctly by hand and improved through kaizen before detection is built into machines. Buying automation does not supply that understanding.

04The four steps: detect, stop, correct and prevent

Use detect, stop, correct and prevent recurrence as a practical operating model—not a numbered framework quoted from Toyota. The steps below are proposed design choices: define them for the operation before relying on them during an event.

  1. Detect: Define the abnormal condition before evaluating an observation. Specify the operation, what is observed, the measurement units where applicable, and the decision criterion. For a filling check, that means naming the fill operation, measured net mass in grams, and the applicable acceptance rule—not merely recording “weight alarm.”
  2. Stop: Specify the boundary interrupted: the operation itself, material transfer, or the next handoff. Identify affected material by lot, container or unit, location and event reference. Where material is pooled, consider how bin-level lot genealogy supports identification across that boundary.
  3. Correct: Record the immediate action that removes the observed condition and the check demonstrating that result. Keep this separate from investigating why the condition occurred; restoring an acceptable observation does not, by itself, explain its cause.
  4. Prevent recurrence: Link the proposed change to the identified cause. Define an effectiveness check with an observation period or production exposure, a measure, and a success criterion. If the cause remains uncertain, record that uncertainty rather than treating a plausible change as proven prevention.

The accompanying workflow expands those four parts into operational handoffs. These event states are proposed labels, not universal requirements.

Event stateHandoff evidence or question
DetectedObservation and criterion recorded; does the stop rule apply?
StoppedInterrupted boundary confirmed; affected material identified.
Under assessmentExtent, immediate correction and investigation needs assessed.
CorrectedAction recorded; repeat check meets its criterion.
Ready for a restart decisionRestart evidence assembled; unresolved actions and restrictions visible.

Readiness is a handoff, not permission to restart. Decision authority is addressed in the regulated-manufacturing section; recurrence-prevention work has its own effectiveness evaluation.

From abnormality to controlled restart
  1. 1
    DetectCapture the abnormal condition and its process context.
  2. 2
    StopApply the defined stop or hold at the affected operation.
  3. 3
    SignalShow where help is needed and assign a responder.
  4. 4
    ContainIdentify potentially affected material and prevent unintended use.
  5. 5
    InvestigateAssess the cause and document the proposed correction.
  6. 6
    Authorise RestartAn authorised person checks readiness and records the restart decision.
  7. 7
    Prevent recurrenceEvaluate the corrective change against the original abnormal condition.
Illustrative workflow; actual stop boundaries and decision roles belong in the site procedure.

05Andon: make the abnormality visible and summon help

In Toyota’s description of andon, the problem display board lights when equipment stops, notifying workers of the abnormality. Toyota also describes a line without equipment: pulling the stop cord lights the andon so workers can call the person in charge.

For an illustrative implementation, treat the andon signal as a request for a specific response. Keep its message concise:

  • Location: line, station or equipment identifier.
  • Abnormality category: equipment, quality or work delay.
  • Event time: when the abnormality was detected.
  • Requested assistance: the skill or decision needed.

Define acknowledgement as acceptance of response ownership: a named responder has taken responsibility for attending to the event. It is not evidence that the condition has been corrected. Keep acknowledgement and correction as distinct states in the local response method.

Set the escalation path in standard work. The initial responder assesses the condition within their competence and authority. If they cannot resolve it, they pass the event to the relevant technical specialist or authorised quality decision-maker, identifying the unresolved question and assistance required. Have the receiving person explicitly accept ownership so the request does not become an unassigned handoff. This proposed interface does not depend on a particular display, colour scheme or application.

06Regulated manufacturing: map product, jurisdiction and decision authority

Use this proposed worksheet for each abnormality. For every jurisdiction–product row, ask: which product classification, manufacturing activity and intended market govern this event? Check the current applicable text for scope before assigning obligations; the product labels below are starting points, not classification decisions.

  • Binding law or regulation: identify applicable provisions and tie each required review element to its own exact provision.
  • Regulator guidance: assess relevant recommendations separately from binding requirements.
  • Toyota’s production philosophy: use as operating inspiration, not regulatory authority.
  • Proposed site operating controls: label investigation prompts and evidence fields as local design choices.
  • Software support: specify desired recordkeeping and routing separately; do not delegate approval authority to software.
Worksheet fieldQuestion to answer for this abnormalityWho records it
Product classificationIs the affected product a drug, dietary supplement, food, medical device, chemical or another class in the intended market? The classification decides which binding text applies.Quality or regulatory affairs
Manufacturing activityWhich operation stopped (filling, blending, packing, assembly, reaction) and which product attribute could the abnormality have affected: identity, quantity, process condition or labelling?Area lead with the operator
Intended marketWhere will the material be supplied? A lot destined for several markets needs each market's provisions checked, not just the site's home rules.Regulatory affairs
Applicable provisionWhich exact section of current binding text governs the record or review for this product and activity? Cite the section, not a general regulation name.Quality
Guidance statusIs there regulator guidance for the activity, and is it final or draft? Guidance informs the approach but is not binding law.Quality
Decision ownerWho is authorised to decide disposition or release of material made around the stop, and who is separately authorised to restart equipment?Named in the site's quality procedures

For each row, also ask what material could be involved and which decision needs supporting evidence. Proposed evidence fields include affected identifiers, event boundaries and observations linked to the batch record through production context tagging. These are assessment prompts, not a universal regulatory checklist.

In this illustrative design, permission to restart equipment is separate from disposition or release of held product. Record each decision and its supporting evidence separately. Both decisions remain with the authorised people identified in site procedures; a restart does not itself clear held material.

07Three worked cases: packaging, filling and manual assembly

These hypothetical cases use local criteria to illustrate stop-and-fix reasoning, not regulatory requirements. Apply the decision authority described above; each observation opens an investigation rather than settling the product’s status.

Hypothetical case 1: Pharmaceutical packaging

  • Local criterion: Assume each bottle’s label identity must match the identity specified in the packaging instruction. The line runs continuously at 120 bottles per minute.
  • Abnormal observation: A label identity mismatch is found. There are 45 seconds between the last demonstrated acceptable identity check and the stop.
  • Immediate response: Stop packaging, retain the mismatched sample and identify output potentially involved. The initial time-window calculation is 120 × 45 ÷ 60 = 90 bottles. This assumes uninterrupted flow and excludes any additional in-process inventory.
  • Evidence question: Which bottles correspond to that interval, and what do label samples, check records and physical counts establish? Ninety bottles is an initial assessment quantity, not proof that every bottle is defective or that earlier bottles are unaffected. Include conveyor or accumulation inventory separately when defining the assessment boundary.
  • Unresolved decision: Authorised reviewers still need to determine the affected population, its disposition and the conditions for restarting; the time-window arithmetic alone settles none of these.

Hypothetical case 2: Supplement filling

  • Local criterion: Assume a nominal 500 g net fill and a locally selected illustrative action band of 498–502 g. These values are example settings, not legal tolerances.
  • Abnormal observation: A measured result is 497 g: 498 − 497 = 1 g below the lower action boundary.
  • Immediate response: Pause filling under the example’s local response rule. Identify the product, batch, sampled container and potentially involved output. Preserve the original result rather than replacing it with a later passing measurement.
  • Evidence question: Does the result represent net contents? Assess tare handling, balance condition and the measurement method, then investigate the filling condition. A fill-weight check and net-versus-gross reconciliation address different parts of that question.
  • Unresolved decision: The observed shortfall triggers assessment; it does not establish the cause or scope. A restart decision remains pending identification of the material involved, assessment of the measurement and investigation of the condition.

Hypothetical case 3: Manual medical-device assembly

  • Local criterion: Assume the kit instruction specifies six components before handoff to the next operation.
  • Abnormal observation: The operator observes five. Six minus five equals one missing component.
  • Immediate response: The operator stops the handoff, keeps the kit identifiable and requests assistance. This is built-in quality through an operator’s observation and action.
  • Evidence question: Which component is absent? Compare the kit with the instruction and examine whether the discrepancy concerns this kit alone or other kits prepared together.
  • Unresolved decision: The responsible person must determine the correction and checks needed before handoff resumes. Adding one component resolves the count only; it does not establish that the component identities are correct.

08Integration and recovery: preserve the event across systems

The following proposed logical design keeps the stop event, the affected material and the assessment connected across systems. It is a design pattern, not a regulatory record set. Allocate responsibilities across MES and SCADA integration and MES–QMS integration so the stop and its assessment remain connected.

Logical recordProposed responsibility and links
Equipment eventReport the stop, abnormality, equipment identity and stable event identifier.
Production recordLink that identifier to the operation and affected material identities.
Quality recordLink assessment, supporting evidence and authorised human decisions to that identifier.
Effectiveness evaluationLink follow-up observations and the evaluator’s conclusion to the original event.

Keep occurrence time separate from each receiving system’s receipt time. Preserve source identity and sequence information where available; delayed transmission must not silently redefine production order. Flag uncertain ordering for review rather than treating arrival order as fact.

Proposed recovery tests

  • Duplicate messages: resend the same message; confirm it links to the existing event rather than creating a second independent event.
  • Out-of-order delivery: deliver an assessment before the stop message; retain it for reconciliation without inventing sequence.
  • Communication loss: disconnect the interface; confirm the documented fallback preserves local event and material identification.
  • Interrupted transfer: interrupt transmission midway; confirm incomplete content is flagged and retry does not duplicate accepted content.

For offline work, document who maintains the local log, assigns unique local identifiers and reconciles them after restoration. Reconciliation should expose missing or conflicting entries. Restored connectivity alone is not a restart instruction; retain the designated human restart decision.

Records connecting the abnormality to its resolution

Process Rule

Defines the condition evaluated.

  • rule_id
  • rule_version
  • process_step_id
  • abnormality_criterion
  • stop_scope

Abnormality Event

Records the observed abnormality.

  • event_id
  • rule_id
  • rule_version
  • observed_at
  • observed_value
  • observed_unit

Affected Material

Links material to containment.

  • containment_id
  • event_id
  • lot_id
  • held_quantity
  • quantity_unit

Human Decision

Identifies the accountable human decision.

  • decision_id
  • event_id
  • decision_type
  • decided_by
  • decided_at
  • decision_reason

Effectiveness Check

Connects corrective change with evaluation.

  • check_id
  • event_id
  • change_reference
  • acceptance_criterion
  • evidence_reference
Illustrative logical records for event traceability; field names describe a proposed design, not product features.

09Make an operator’s decision to stop work safe

Toyota’s account of jidoka connects operator-initiated stops with developing people who think independently and implement kaizen. A proposed local leadership approach is to make raising a concern usable, not merely permitted.

  • Operator: initiate the stop and describe what was seen, where, and how certain they are.
  • Shift lead: respond as defined in the andon escalation path.
  • Technical support: investigate within the relevant engineering or quality remit.
  • Named escalation owner: take unresolved uncertainty to the authorised decision-maker.

For example, an operator stops packaging after seeing what appears to be a mismatched label. Inspection finds the correct label; glare caused the concern. The supervisor should assess whether the observation was plausible and clearly communicated, and whether the response addressed it—not treat the absence of a confirmed defect as misconduct.

Put these roles in standard work. Rehearse the actual call route, including an unavailable shift lead, and ask the receiving person to confirm ownership. A “stop the line” slogan alone does not exercise that handoff.

10Measure response, exposure and recurrence without hiding problems

Use this proposed local scorecard to distinguish response speed, potentially affected material and repeat abnormalities. Record timestamp differences in seconds using a common clock; missing timestamps remain unknown, not zero.

MeasureDefinitionUnitInterpretation limit
Detection-to-stop timeConfirmed stop timestamp minus abnormality detection timestamp.SecondsExcludes the interval before detection; define what confirms a stop.
Signal-to-acknowledgement timeAcknowledgement timestamp minus signal timestamp.SecondsAcknowledgement does not establish arrival, correction or resolution.
Material exposureFor the packaging case above, count packs produced after the last successful check through the confirmed stop.PacksThis proposed boundary identifies potentially affected packs, not proven defects.
Recurrence frequencyMatching recurrence events after correction divided by production cycles subject to the same check during the stated observation period.Events per cycleDefine matching by station, abnormality category and failure mode; inconsistent coding undermines comparison.

The recurrence denominator represents opportunities for the abnormality to recur under comparable detection conditions. Report numerator and denominator together; zero eligible cycles makes the frequency undefined. Keep andon response records aligned with these event definitions.

Treat a lower stop count as ambiguous unless detection opportunities and event classification remain interpretable. Fewer recorded stops alone do not establish better quality. Separate observation from explanation: a change after a kaizen intervention warrants investigating effectiveness, not concluding that the intervention caused it. Set numeric targets locally for the proposed implementation; these definitions supply no Toyota or software performance benchmarks.

11Seven implementation mistakes and their corresponding controls

Use these proposed design controls when reviewing jidoka checks and related mistake-proofing measures. They address implementation risks, not a universal regulatory checklist.

Failure modeHow the design can failProposed control
Unit mismatchA reading and limit use different units but are compared as equivalent.Make intended units and conversion explicit before comparison; retain the original observation and its units.
Premature roundingDisplay rounding silently changes which side of a limit a value occupies.Separate display formatting from the decision comparison; define comparison precision explicitly.
Disappearing transient signalThe indication clears before anyone accepts responsibility.Retain the event after the immediate condition clears, with response ownership still visible.
Unowned shift handoffAn open event loses its responsible person during personnel changes.Record explicit responsibility transfer and acceptance by the incoming owner.
Invisible temporary bypassA disabled check looks like normal operation to the next operator.Display bypass status, owner and permitted scope wherever the affected check is used.
Retroactive rule substitutionA later criterion replaces the basis of the original evaluation.Preserve the original criterion version in the event’s production context; distinguish any subsequent reevaluation.
Erased failed restart attemptAn eventual successful restart overwrites an earlier unsuccessful attempt.Retain each restart attempt and outcome in chronological event history rather than replacing previous results.

12Implementation checklist: demonstrate readiness with an event rehearsal

Use this proposed readiness review as a local design test, not a source-prescribed checklist. For every test, record the named local owner, expected result, observed result, and unresolved action with its assignee.

  1. End-to-end rehearsal — Production owner: introduce one simulated abnormality under controlled conditions. Exercise detection, stopping, material containment, escalation and the authorised restart decision. Ask a reviewer to reconstruct the event, affected material and decision sequence from the resulting records.
  2. Communication interruption — Controls or IT owner: interrupt one communication path. Apply the recovery controls covered above; compare recovered records and notifications with the expected sequence, identifying gaps or duplicates.
  3. Shift handoff — Outgoing and incoming supervisors: transfer the unresolved event using the ownership controls above. Confirm that the incoming owner can identify material status, pending decisions and the next action.
  4. Corrective change — Quality owner: select a completed change and locate its effectiveness evaluation, including the criterion, observations and conclusion—not merely a closed task.

Can the team demonstrate the intended response under both ordinary and exception conditions before extending the design to another operation?

Frequently asked questions

Q.Can jidoka help when an abnormality becomes visible only after a laboratory result arrives?+

Yes—as a practical adaptation, make the laboratory result a trigger for containment rather than pretending detection happened during production. Identify the sampled batch, related material and downstream transfers through [lot genealogy](/glossary/bin-level-lot-genealogy). Route the result into the site’s [out-of-specification handling](/glossary/out-of-spec-handling) process, with authorised personnel deciding investigation scope and disposition. For future runs, assess whether an earlier process signal could provide a useful warning; do not treat that signal as a replacement for the laboratory test without establishing its suitability.

Q.How can a continuous chemical process use jidoka without an unsafe abrupt shutdown?+

Treat this as an engineered abnormal-condition response, not a generic instruction to cut power. Have process-safety and operations specialists define the safe response for each condition, including which protective functions must remain active and how potentially affected output will be controlled. Connect [interlock logic](/glossary/interlock-logic) to that reviewed response, and use [alarm rationalization](/glossary/alarm-rationalization) to distinguish operator notification from protective action. The practical aim is to prevent uncontrolled continuation without creating a different hazard through an improvised stop.

Q.What should happen when production and quality personnel disagree about whether a condition is abnormal?+

Use a predefined escalation route rather than settling the question through production pressure or informal voting. As an operating practice, preserve the observation, compare it with the applicable acceptance criteria, and identify who has authority to resolve ambiguity. Put that decision route in standard work and connect it to the [quality assurance process](/glossary/quality-assurance-process). Specify an interim operating and material-control status while the disagreement is reviewed. Record the decision and its reasoning so the next shift does not reopen the same argument.

Q.Should an operator wait for a second failed check before raising an andon?+

Not merely to obtain confirmation. Toyota describes jidoka as [stopping immediately when abnormalities are detected](https://global.toyota/en/company/vision-and-philosophy/production-system/index.html), rather than waiting for another defect. A practical implementation should specify what constitutes a failed check and what response it triggers. If a check is ambiguous, raise the uncertainty through the andon response instead of inventing a two-failure rule at the workstation. Any confirmation step should have a defined purpose and instructions for controlling work while confirmation is pending.

Q.How should a defect first reported by a customer influence the detection rule?+

Use the report to challenge the detection rule, not simply to add another alarm. As an improvement practice, reconstruct the reported failure and ask whether the existing check could detect that failure mode under representative conditions. Examine its location, method and response logic. Consider [poka-yoke](/glossary/poka-yoke) where prevention is feasible, then define an effectiveness check for the change. Keep a reported symptom distinct from a confirmed cause; the complaint should initiate investigation, not predetermine its conclusion.

Q.How can a supplier participate when it does not share the factory’s systems?+

Design a simple notification-and-acknowledgement interface rather than requiring a shared platform. A practical supplier arrangement can specify the abnormality description, affected lot identifiers, shipment status, contact roles and how receipt of the alert is confirmed. Use [attributable recording](/glossary/attributable-recording) so each side can identify who reported what and when. Agree how subsequent corrections and disposition decisions will be communicated. Test the handoff with a hypothetical event, including unavailable contacts, before relying on it during a real disruption.

Q.What can a low-volume workshop do when it has too few events for meaningful trend analysis?+

Start with direct observation and structured examination of individual events rather than forcing a statistical conclusion. A practical [gemba](/glossary/gemba) review can follow the task, identify where an abnormal condition becomes visible, and check whether the operator knows the response. Use safely controlled demonstrations or representative training examples to test recognition and escalation. Record recurring mechanisms qualitatively, while keeping actual defects separate from exercises. Choose improvements against an identified failure mechanism, not an apparently impressive percentage built from very few observations.

Q.How should teams handle abnormal work delays when no defective product has been found?+

Toyota explicitly includes [work delays among jidoka abnormalities](https://global.toyota/en/company/vision-and-philosophy/production-system/index.html); a defect is not the only reason to signal for help. As a practical response, distinguish a missing input, equipment interruption or unclear instruction from ordinary variation in task duration. Use [value stream mapping](/glossary/value-stream-mapping) to examine where work and information wait. Set a locally justified escalation trigger and response owner. Investigate the obstruction without automatically classifying the product as defective or treating the signal as a judgement of operator performance.

Primary sources

  • Toyota: Toyota Production System
Software that covers Jidoka
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Back to glossary
Inside V5
  • → Score your compliance gap — then download the validation pack.
  • → Document control — one version in force, every change signed and explained.
  • → QMS — quality records next to the work they concern.
Regulatory anchors
  • 21 CFR 211.100
  • 21 CFR 211.192
  • ISO 13485:2016 cl. 7.5.1 via 21 CFR 820.10 (QMSR; replaced former 820.70)
  • ISO 13485:2016 cl. 8.2.6 via 21 CFR 820.10 (QMSR; replaced former 820.80)
  • ICH Q10 §3.2.4
  • ICH Q9(R1)
  • EU GMP Annex 1 §4
  • ISO 13485 §8.3
Related terms
  • → Andon
  • → Poka-yoke
  • → Standard Work
  • → Line Clearance
  • → Deviation
  • → CAPA
  • → Kaizen

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V5 Ultimate
Ultimate

Warehouse, quality and manufacturing software for regulated operations.

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