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SOTIF Analysis Template (ISO 21448)

ISO 21448 SOTIF file: ODD, acceptance criteria, functional insufficiencies, triggering conditions, V&V targets, known and unknown scenarios

ISO & Tuân thủĐầy đủISO 21448:2022sotifanalysis
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Cách dùng: Use it when a driver assistance or automated driving function relies on sensing or perception and you must show it is safe even without faults. Fill the specification and acceptance criteria first, then search systematically for triggering conditions. The main pitfall is a validation target with no stated confidence level or representativeness argument.

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SOTIF Analysis: [Function or system name]

The safety of the intended functionality (SOTIF) analysis for one vehicle function that relies on sensing, perception, prediction or decision algorithms, structured on ISO 21448:2022 (Road vehicles, Safety of the intended functionality, first edition, June 2022). SOTIF covers hazards that arise when the function works exactly as designed but the design is not good enough for the situation: a camera that cannot see in low sun, a classifier that has never met a certain object, a driver who misreads what the system will do. Faults of the E/E system are the subject of ISO 26262; cybersecurity threats belong to ISO/SAE 21434. This file holds the specification, the hazard evaluation, the triggering conditions and functional insufficiencies, the modifications, the verification and validation strategy, the evaluation of known and unknown scenarios, the release argument and the field monitoring plan. Replace every [bracketed] value and every row marked Example. This is a documentation format, not regulatory, type-approval or legal advice: check the current official texts and involve a qualified safety assessor.

Document control

FieldValue
Document ID[SOTIF-NNN]
Function[Name, version, vehicle programme]
Automation level[For example SAE J3016 level 0 warning, level 1 or level 2 assistance]
Related item definition and HARA[HARA-NNN]
Software and calibration baseline[Release tag, perception model version]
Version[0.1]
Status[Draft / In review / Approved]
Owner[@sotif-lead]
Last updatedYYYY-MM-DD
Classification[Internal / Confidential]

Approvals

RoleNameDecisionDate
SOTIF lead[@name][Approved]YYYY-MM-DD
Functional safety manager[@name][Approved]YYYY-MM-DD
Independent assessor[@name][Reviewed]YYYY-MM-DD
Programme or release owner[@name][Approved]YYYY-MM-DD

Revision history

VersionDateAuthorChange summary
0.1YYYY-MM-DD[@name]First draft: specification and hazard evaluation
0.5YYYY-MM-DD[@name]Example: Triggering condition analysis and V&V strategy added
1.0YYYY-MM-DD[@name]Example: Release argument approved for start of production

Contents

  1. Scope and relationship to other safety work (cl. 4)
  2. Specification and design (cl. 5)
  3. Hazard identification, evaluation and acceptance criteria (cl. 6)
  4. Functional insufficiencies and triggering conditions (cl. 7)
  5. Functional modifications (cl. 8)
  6. Verification and validation strategy (cl. 9)
  7. Evaluation of known scenarios (cl. 10)
  8. Evaluation of unknown scenarios (cl. 11)
  9. Evaluation of the achievement of the SOTIF and release (cl. 12)
  10. Operation phase activities (cl. 13)
  11. Traceability matrix
  12. Glossary and references

0. Scope and relationship to other safety work (cl. 4)

The analysis covers hazardous behaviour of the function that results from limits of its specification or of its performance, and from reasonably foreseeable misuse by the driver or other road users. It does not cover random hardware faults or systematic faults of the E/E implementation; those stay in the ISO 26262 work products. Where a hazard can arise both from a fault and from a performance limit, record it in both analyses and cross-reference the IDs.

TopicCovered hereCovered elsewhereReference
Performance limits of sensors and perceptionYesSections 3 and 6
E/E faults and safety mechanismsISO 26262 safety case[FSC-NNN]
Machine-learning lifecycle (data, training, model assurance)PartlyISO/PAS 8800:2024 work products[AI-SAFETY-NNN]
Cybersecurity threatsISO/SAE 21434 TARAcompliance/automotive-tara
Driver misuse and misunderstanding of the functionYesHuman factors studiesSection 3.3

1. Specification and design (cl. 5)

1.1 Intended functionality

ItemValue
PurposeExample: Reduce the severity of, or avoid, front-to-rear collisions with vehicles, pedestrians and cyclists by warning the driver and braking automatically
Driver roleExample: Driver remains responsible at all times; the function intervenes only when a collision is imminent
Activation and deactivationExample: Active by default above 5 km/h at every ignition cycle; the driver can switch it off in the settings menu
Actuation authorityExample: Partial braking up to 4 m/s^2, full braking up to 9 m/s^2
WarningsExample: Visual and acoustic forward collision warning 1.6 s before predicted impact

1.2 Operational design domain and use conditions

DimensionInside the specificationOutside or degraded
SpeedExample: 5 to 160 km/h for vehicles, 5 to 60 km/h for pedestrians and cyclistsAbove these speeds the function warns only
Road typesExample: All public roadsOff-road, car parks with ramps (reduced performance documented)
LightExample: Daylight, dusk, night with headlampsDirect low sun into the camera
WeatherExample: Dry, light to moderate rainHeavy snow covering the radar fascia
TargetsExample: Passenger cars, trucks, motorcycles, adult and child pedestrians, cyclistsAnimals, debris, crossing trains

1.3 Architecture and known performance limits

ElementRoleKnown limit at design timeSource
Front camera (Example)Object classification, lane geometryDynamic range limited in low sun and tunnel exitsSupplier data sheet [DS-CAM-NNN]
Front radar (Example)Range and relative speedReflections from metal structures above the roadRadar test report [RT-NNN]
Fusion and threat assessment software (Example)Combines tracks, predicts time to collisionPrediction assumes constant acceleration over 1.5 sDesign document [SWAD-NNN]
Brake system interface (Example)Executes deceleration requestBuild-up time 180 ms to full decelerationBrake supplier specification

2. Hazard identification, evaluation and acceptance criteria (cl. 6)

2.1 Hazardous behaviour and hazards

A hazardous behaviour is relevant to SOTIF unless every resulting hazard is either controllable in general by the people involved or would cause no harm. Record the reasoning for that decision in the last column, as it decides whether the hazard enters the rest of the analysis.

IDHazardous behaviour at vehicle levelDriving situationHarmSeverity and controllability rationaleSOTIF-relevant?
HB-01 (Example)Unintended full braking with no obstacleMotorway, following traffic at 120 km/hRear-end collision by following vehicleFollowing driver often cannot react in time, injuries possible; cross-reference the HARA event if also rated thereYes
HB-02 (Example)No braking for a crossing pedestrianUrban road at night, 40 km/hPedestrian injuredDriver relied on the function and reacted lateYes
HB-03 (Example)Late braking for a stationary vehicleRural road, curve exit, 80 km/hFront collisionSpeed reduced but impact remainsYes
HB-04 (Example)Short warning with no obstacleAnyDistractionControllable in general, no brakingNo, recorded for comfort tracking

2.2 Acceptance criteria for residual risk

Set a quantitative or qualitative criterion for each SOTIF-relevant hazardous behaviour. Base it on a stated reference such as the performance of human drivers, field data from comparable functions, or a regulatory expectation, and document the reasoning. The standard does not fix a number; the values below are illustrative.

IDAcceptance criterionBasisValidation target
AC-01 (Example)Unintended braking above 5 m/s^2 occurs at a rate below 1 per 100,000 operating hoursRate judged not to raise rear-end collision risk compared with traffic without the function, from internal accident study [ACC-STUDY-NNN]299,573 h with zero events at 95% confidence (section 5.2)
AC-02 (Example)Pedestrian detection rate at least 95% across the night test catalogue in section 6Consumer test protocols and internal benchmarkKnown scenario catalogue SC-10 to SC-24
AC-03 (Example)No increase of front collisions at curve exits compared with the previous generation in field dataField monitoring baseline [FIELD-NNN]Section 9 indicator KPI-03

3. Functional insufficiencies and triggering conditions (cl. 7)

3.1 Functional insufficiencies

IDTypeInsufficiencyElementLinked hazardous behaviour
FI-01 (Example)Performance insufficiencyRadar confirms an overhead sign gantry as an in-path stationary objectRadar, fusionHB-01
FI-02 (Example)Performance insufficiencyCamera classifier misses pedestrians in dark clothing at night beyond 25 mCamera, perception modelHB-02
FI-03 (Example)Specification insufficiencyThreat assessment ignores objects partly hidden at a curve exit until fully visibleFusion, threat assessmentHB-03
FI-04 (Example)Specification insufficiencyConstant acceleration prediction misjudges a vehicle braking hard aheadThreat assessmentHB-03

3.2 Triggering conditions

IDTriggering conditionInsufficiency triggeredPlausibility in the use domainEvidence
TC-01 (Example)Low metal gantry on a downhill motorway sectionFI-01Frequent on certain road networksRadar test drive log [LOG-NNN]
TC-02 (Example)Pedestrian in dark clothing on an unlit road with oncoming headlampsFI-02Common in winter monthsNight test campaign [NT-NNN]
TC-03 (Example)Parked vehicle directly after a sharp curveFI-03Occasional on rural roadsAccident database query [ACC-NNN]
TC-04 (Example)Lead vehicle brakes at above 8 m/s^2FI-04RareNaturalistic driving study [NDS-NNN]

3.3 Reasonably foreseeable misuse

IDMisuseCauseEffectMeasure
MU-01 (Example)Driver follows closely, expecting the function to brakeOver-trust after weeks without interventionLate driver reaction in HB-03Owner manual wording, follow-distance warning (FM-03)
MU-02 (Example)Driver covers the camera area with a phone holderLack of awarenessDegraded detectionBlockage detection and driver message (FM-04)

3.4 Evaluation of the system response

For each pair of triggering condition and insufficiency, decide whether the response of the function is acceptable against the criteria in section 2.2. If it is not, a functional modification is needed (section 4); if it is, the pair moves into the verification and validation strategy as a known scenario.

PairResponse acceptable?ReasoningNext step
TC-01 / FI-01 (Example)NoBraking events seen in test drivesFM-01
TC-02 / FI-02 (Example)NoDetection below AC-02 targetFM-02
TC-03 / FI-03 (Example)Yes, to be confirmedSimulation shows speed reduction before impactKnown scenario SC-30
TC-04 / FI-04 (Example)Yes, to be confirmedWarning still precedes impactKnown scenario SC-31

4. Functional modifications (cl. 8)

IDModificationTypeAddressesSide effects checkedStatus
FM-01 (Example)Require camera confirmation before full braking on radar-only stationary objects at above 60 km/hPerformance improvementTC-01 / FI-01Reduced reaction for real stationary vehicles in fog, added to section 3.2 as a new triggering condition for analysisImplemented in [release]
FM-02 (Example)Retrained perception model with night pedestrian data set, low-light camera modePerformance improvementTC-02 / FI-02Model change also assessed under ISO/PAS 8800 processImplemented
FM-03 (Example)Follow-distance indicator and owner manual explanation of limitsHuman-machine interfaceMU-01Distraction reviewImplemented
FM-04 (Example)Camera blockage detection that degrades to warning only and informs the driverRestriction plus driver informationMU-02False blockage messages counted in field KPI-04Implemented

5. Verification and validation strategy (cl. 9)

5.1 Methods

IDMethodPurposeScenariosCoverage argument
VV-01 (Example)Sensor-level bench and track testsVerify sensor performance at known limitsSC-01 to SC-09One test per specified limit in section 1.3
VV-02 (Example)Scenario-based simulation with sensor modelsVerify the decision logic over parameter rangesSC-10 to SC-31Parameter sweeps on speed, offset, light and target type
VV-03 (Example)Proving ground tests with soft targetsVerify the integrated systemSelected known scenariosHighest-risk combinations from VV-02
VV-04 (Example)Open-road test fleetSearch for unknown scenarios and estimate unintended braking rateAllRoute mix matched to target market traffic statistics
VV-05 (Example)Shadow mode in a customer fleet, function computes but does not brakeEstimate unintended braking rate at scaleAllRepresentative only if the fleet covers the operational design domain

5.2 Validation target derivation

For acceptance criterion AC-01, the example uses a zero-failure test argument based on a Poisson model: with a target rate lambda of 1 per 100,000 hours and a confidence of 95%, the hours needed with no event observed are -ln(0.05) / lambda, about 3.0 / lambda.

QuantityValue (Example)
Target rate (lambda)1 x 10^-5 per hour
Confidence95%
Events allowed0
Required hours299,573 h
Average speed assumed45 km/h
Equivalent distanceabout 13.5 million km
Required hours if 1 event is allowed474,386 h

Planned exposure: 95,000 h of open-road test fleet (VV-04) plus 210,000 h of shadow mode data (VV-05), a total of 305,000 h, which exceeds the zero-event target. Record why the shadow mode data is representative (regions, seasons, road types) and how events are labelled.

6. Evaluation of known scenarios (cl. 10)

ScenarioDescriptionMethodCriterionResultVerdict
SC-25 (Example)Overhead gantry, downhill, 120 km/hVV-02, VV-04No braking above 5 m/s^20 events in 1,200 passesPass
SC-12 (Example)Pedestrian in dark clothing, unlit road, oncoming headlamps, 40 km/hVV-02, VV-03Detection rate at least 95%1,022 of 1,060 runs (1,000 simulated, 60 track), 96.4%Pass
SC-30 (Example)Parked vehicle after a sharp curve, 80 km/hVV-02Impact speed reduced by at least 20 km/hMean reduction 27 km/hPass
SC-31 (Example)Lead vehicle brakes at 9 m/s^2 from 100 km/hVV-03Warning before impact, braking initiatedWarning at 1.4 s, braking at 1.1 sPass with note: below 1.6 s design value, analysed in FI-04

7. Evaluation of unknown scenarios (cl. 11)

ActivityExposure or volume (Example)New scenarios foundAction
Open-road test fleet VV-0495,000 h across 4 climate zones2 (tunnel exit glare, reflective road works barrier)Added to the catalogue as SC-40 and SC-41 for evaluation in section 6 (rows not shown)
Shadow mode VV-05210,000 h0 unintended braking events above 5 m/s^2None
Randomised simulation with mutated scenarios2 million generated scenarios1 (cyclist emerging behind a bus)Added as SC-42
Expert review of field events from the previous generation340 events reviewed0 newNone

Total exposure for AC-01: 305,000 h with zero qualifying events, above the 299,573 h target. Residual uncertainty: [state the regions, seasons or road types that are under-represented].

8. Evaluation of the achievement of the SOTIF and release (cl. 12)

CheckResultEvidence
All SOTIF-relevant hazardous behaviours have acceptance criteria[Yes / No]Section 2.2
All triggering conditions evaluated or modified[Yes / No]Sections 3 and 4
Known scenarios pass their criteria[Yes / No, with notes]Section 6
Unknown scenario exposure meets its target[Yes / No]Sections 5.2 and 7
Residual limits disclosed to the driver[Yes / No]Owner manual [OM-ref], HMI specification
Field monitoring in place[Yes / No]Section 9

Release recommendation: [Release / Release with conditions / Do not release], with reasoning. Conditions: [list]. Signed: [@sotif-lead], YYYY-MM-DD; reviewed by [@assessor].

9. Operation phase activities (cl. 13)

IDIndicatorSourceThreshold for actionOwnerReview frequency
KPI-01 (Example)Unintended braking events above 5 m/s^2 per 100,000 hFleet event data where the customer has agreed to data sharingAny confirmed event triggers root cause analysis[@name]Monthly
KPI-02 (Example)Customer complaints about phantom brakingDealer and hotline reports3 complaints with the same road location[@name]Monthly
KPI-03 (Example)Front collisions at curve exitsAccident and warranty dataIncrease compared with baseline[@name]Quarterly
KPI-04 (Example)Camera blockage messages per 1,000 hFleet dataAbove design expectation[@name]Quarterly

Privacy note: collect only the vehicle data needed for the indicators, with the legal basis and retention set by the data protection team.

10. Traceability matrix

Hazardous behaviourCriterionInsufficiencyTriggering conditionModificationScenariosVerdict
HB-01 (Example)AC-01FI-01TC-01FM-01SC-25, VV-04, VV-05Pass
HB-02 (Example)AC-02FI-02TC-02FM-02SC-12Pass
HB-03 (Example)AC-03FI-03, FI-04TC-03, TC-04FM-03SC-30, SC-31Pass with note

11. Glossary and references

TermWorking meaning in this file
Functional insufficiencyA weakness of the specification or of the performance of the function that can lead to hazardous behaviour without any fault
Triggering conditionA circumstance of the scenario that activates a functional insufficiency
Known and unknown scenariosScenarios already identified and analysed, versus scenarios not yet identified; each can be hazardous or not
Validation targetThe amount of evidence (hours, distance, test cases) planned to show that an acceptance criterion is met
Shadow modeRunning the function in the background without actuation, to compare its decisions with real traffic
ReferenceEdition or dateUse
ISO 21448, Road vehicles, Safety of the intended functionality2022 (first edition, June 2022; replaced ISO/PAS 21448:2019)Activity structure and clause numbers
ISO 26262 series, Road vehicles, Functional safety2018 (second edition)Faults, HARA link
ISO/PAS 8800, Road vehicles, Safety and artificial intelligence2024 (December 2024)Machine-learning elements
ISO/SAE 21434, Road vehicles, Cybersecurity engineering2021Threats out of SOTIF scope
SAE J3016, levels of driving automation[Edition applied]Automation level vocabulary
EU example: Commission Implementing Regulation (EU) 2022/1426 (automated driving systems of fully automated vehicles)Adopted 5 August 2022, check the consolidated textType-approval context for automated driving systems: https://eur-lex.europa.eu/eli/reg_impl/2022/1426/oj/eng
UK and US[Applicable rules and guidance at the time of release]UK: Automated Vehicles Act 2024 and its secondary legislation; US: NHTSA rules and guidance. Check the current official texts

Standard and licence note

Structure aligned with ISO 21448:2022 (Road vehicles, Safety of the intended functionality, first edition, published June 2022, current as checked in October 2026; the ISO catalogue lists it as under revision, with a working draft in preparation, so check for a new edition). Clause numbers 4 to 13 are given for orientation only. All wording, tables, IDs and the worked example are original; no text, figure, table or definition is reproduced from the standard. The acceptance criteria, rates and test results are fictional examples, not recommended values. Check the current edition, any amendment and the type-approval rules of your target markets before use. This template is not regulatory, type-approval or legal advice: check the current official texts and involve a qualified safety assessor.

Official text: ISO, purchase or licensed access: https://www.iso.org/standard/77490.html (also available from national standards bodies).

Template licence: MIT.

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