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Overview

The Risk Control Plan Risksheet provides a structured approach to risk mitigation by organizing analysis into hierarchical levels, supporting progressive workflow views that guide users through risk identification, control definition, verification planning, and acceptance decisions. The configuration implements dual probability calculations for medical device contexts and unified characteristic classification for manufacturing contexts.
Risk Control Plan Hierarchy Patterns

MEDICAL DEVICE (ISO 14971):
  Use Step (L1)
    ├─ Hazard (L2)
    │   ├─ Hazardous Situation (L3)
    │   │   └─ Harm (L4) → Risk Value → Risk Controls → Requirements → Verification

MANUFACTURING (AIAG):
  Process Step (L1)
    ├─ Characteristic (L2)
    │   └─ Control Method (L3) → Equipment → Sample Frequency → Reaction Plan
This risksheet template supports two independent configurations in your project. Choose one based on your industry context: ISO 14971 for medical devices, AIAG for automotive manufacturing. Each maintains separate column groups and workflow views.

Configuration Schema

Metadata Properties

NameTypeDefaultDescription
idstringcontrol-plan-risk or control-plan-manufacturingUnique configuration identifier
namestringRisk Control Plan (Medical) / Risk Control Plan (Manufacturing)Display name in Risksheet picker
descriptionstringISO 14971 risk control workflow / AIAG production control workflowConfiguration purpose
versionstring1.0Configuration version for tracking updates
module_typestringrisksheetAlways risksheet for this configuration type

Hierarchy Definition (Medical Device - ISO 14971)

NameTypeDefaultDescription
hierarchyDefinition.levelsarray4 levelsDefines the four-level ISO 14971 hierarchy
levels[0].namestringuseStepLevel 1: Use Step work item type
levels[0].displayNamestringUse StepHuman-readable name for row headers
levels[1].namestringhazardLevel 2: Hazard work item type
levels[1].displayNamestringHazardHazard title display
levels[2].namestringhazardousSituationLevel 3: Hazardous Situation description
levels[2].displayNamestringHazardous SituationSpecific scenario where hazard manifests
levels[3].namestringharmLevel 4: Potential harm/injury
levels[3].displayNamestringHarmConsequence of hazardous situation

Hierarchy Definition (Manufacturing - AIAG)

NameTypeDefaultDescription
hierarchyDefinition.levelsarray3 levelsDefines three-level AIAG manufacturing hierarchy
levels[0].namestringprocessStepLevel 1: Process Step work item type
levels[0].displayNamestringProcess StepManufacturing operation/stage
levels[1].namestringcharacteristicLevel 2: Product or Process Characteristic
levels[1].displayNamestringCharacteristicQuality attribute to control
levels[2].namestringcontrolMethodLevel 3: Inspection/control method
levels[2].displayNamestringControl MethodDetection or prevention technique

Column Groups and Organization

Medical Device Risk Control Plan (ISO 14971)

Identification Section (Blue)

Column IDNameTypeDefaultFormula/Logic
useStepIdUse Step IDwork_itemLinks to useStep work item
useStepTitleUse Stepwork_item_attributeDisplays useStep.title
hazardIdHazard IDwork_itemLinks to hazard work item
hazardTitleHazardwork_item_attributeDisplays hazard.title
situationDescriptionHazardous SituationtextFree-form description of scenario
harmDescriptionHarmtextInjury or damage consequence

Risk Assessment Section (Pre-Control)

Column IDNameTypeDefaultFormula/Logic
severityBeforeSeverityenumValues: S0 (Negligible), S1, S2, S3 (Critical)
p1BeforeP1: Situation OccurrenceenumProbability hazardous situation occurs: 1-5
p2BeforeP2: Harm OccurrenceenumProbability harm given situation: 1-5
riskProbabilityBeforeRisk Probability (Pre)formulariskProbabilityBefore(p1Before, p2Before) computes P1 × P2
riskValuePreInitial RiskformulariskValueBefore(severityBefore, riskProbabilityBefore) uses risk matrix
riskClassPreInitial Risk ClassdecoratorColor-coded: Green (1=acceptable), Yellow (2=ALARP), Orange (3=reduce), Red (4=unacceptable)

Risk Control Mitigation Section (Orange)

Column IDNameTypeDefaultFormula/Logic
controlIdRC IDwork_itemLinks to riskControl (task) work item
controlTitleRisk Controlwork_item_attributeDisplays control task title
controlTypeTypeenumValues: inherent-safety-design, protective-measure, informative-measure, external-control
controlDescriptionControl DescriptiontextHow control mitigates the risk
verificationMethodVerification MethodenumHow effectiveness is verified: test, analysis, inspection, demonstration

Residual Risk Assessment (Post-Control)

Column IDNameTypeDefaultFormula/Logic
severityAfterSeverityenumTypically unchanged unless control is architectural
p1AfterP1: Residual OccurrenceenumProbability after control implementation
p2AfterP2: Residual Harm OccurrenceenumProbability harm given residual situation
riskProbabilityAfterRisk Probability (Post)formulariskProbabilityAfter(p1After, p2After) computes P1 × P2
riskValuePostResidual RiskformulariskValueAfter(severityAfter, riskProbabilityAfter)
riskClassPostResidual Risk ClassdecoratorColor-coded risk classification after control

Acceptance Section (Purple)

Column IDNameTypeDefaultFormula/Logic
acceptanceDecisionRisk Accepted?enumValues: yes, no, conditional
additionalControlsPossibleAdditional Controls?enumValues: yes, no (informs acceptance logic)
benefitRiskJustificationBenefit-Risk JustificationtextISO 14971 required: explains why residual risk acceptable
finalRiskFinal Risk LevelformulariskValueFinal(riskValuePost, acceptanceDecision)

Traceability Section (Green)

Column IDNameTypeDefaultFormula/Logic
linkedRequirementsRequirementsmulti_item_linkBack-linked sysReq/desReq from riskControl tasks; renders with Velocity template filtering
linkedTestsVerification Testsmulti_item_linkNested: from Requirements → testCase items; three-hop traceability
fmeaReferenceRelated FMEAmulti_item_linkBack-linked failureMode items via analyzedIn role for methodology integration

Manufacturing Control Plan (AIAG)

Process Definition Section (Blue)

Column IDNameTypeDefaultFormula/Logic
processStepIdProcess Step IDwork_itemLinks to processStep work item
processStepTitleProcess Stepwork_item_attributeManufacturing operation (e.g., “Sensor Housing Assembly”)
equipmentIdEquipmentwork_itemLinks to systemElement filtered by equipment type via queryFactory
equipmentNameEquipment Namework_item_attributeDisplays equipment title and capacity
Equipment picker uses queryFactory to filter systemElement items by equipment category. Requires pre-established equipmentType or equipment links in Polarion. If list appears empty, verify systemElement items have correct type classification.

Characteristics Section (Purple)

Column IDNameTypeDefaultFormula/Logic
characteristicIdCharacteristic IDwork_itemLinks to characteristic work item (product or process)
characteristicTypeTypeenumValues: product-characteristic, process-characteristic
characteristicNameCharacteristicwork_item_attributeDisplays characteristic title and dimension
classificationClassificationformulaMerges classifications: product SC/CC takes precedence if both exist
classDecoratorClass BadgedecoratorSC (orange #ff8c00), CC (red #c62828) or blank
classBackgroundRow HighlightdecoratorLight orange for SC rows, light red for CC rows
targetValueTarget ValueformulaMerged from product/process characteristic; uses specFormula precedence
toleranceToleranceformulaMerged from product/process characteristic; shows ±range or min/max

Control Methods Section (Green)

Column IDNameTypeDefaultFormula/Logic
controlMethodIdControl MethodtextControl technique description (e.g., “SPC via X-bar/R chart”)
measurementMethodMeasurement MethodenumValues: visual-inspection, gage, automated-test, destructive-test
sampleSizeSample SizeintegerNumber of parts per production run (e.g., 5)
sampleFrequencyFrequencyenumValues: per-part, per-shift, daily, weekly, per-lot
upperSpecLimitUSLdecimalUpper specification limit for characteristic
lowerSpecLimitLSLdecimalLower specification limit for characteristic

Reaction Plan Section (Orange)

Column IDNameTypeDefaultFormula/Logic
outOfControlActionOut-of-Control ActiontextWhat to do if measurement exceeds limits (e.g., “Stop line, sort parts, notify supervisor”)
reactionResponsibleResponsibleenumRole or team (e.g., “Quality Engineer”, “Line Supervisor”)
docReferenceDocumentationtextReference to SOP or work instruction

Progressive Workflow Views

Medical Device Risk Control Plan Views

View 1: Identify Risks

Columns shown: UseStepId, Hazard, HazardousSituation, Harm, Severity
Purpose: Initial hazard identification phase (3 columns)
User activity: Capture all potential hazards and consequences

View 2: Initial Risk Assessment

Columns shown: UseStepId, Hazard, SeverityBefore, P1Before, P2Before, RiskProbabilityBefore, RiskValuePre
Purpose: Compute pre-control risk levels (8 columns)
User activity: Assign severity and probability ratings; view calculated initial risk matrix value

View 3: Risk Controls Definition

Columns shown: ControlId, ControlTitle, ControlType, ControlDescription, VerificationMethod
Purpose: Define mitigation strategies and acceptance criteria (5 columns)
User activity: Create risk control tasks with verification approach

View 4: Residual Risk Evaluation

Columns shown: SeverityAfter, P1After, P2After, RiskProbabilityAfter, RiskValuePost, AcceptanceDecision, BenefitRiskJustification
Purpose: Evaluate effectiveness and acceptability (10 columns)
User activity: Apply residual ratings; document acceptance rationale

View 5: Full Analysis (All Columns)

Purpose: Complete workflow view for review and sign-off
User activity: Comprehensive audit across all phases

Manufacturing Control Plan Views

View 1: Process Definition

Columns shown: ProcessStepId, EquipmentId, CharacteristicName, Classification
Purpose: Link process steps to characteristics (4 columns)

View 2: Control Setup

Columns shown: CharacteristicName, TargetValue, Tolerance, MeasurementMethod, SampleSize, SampleFrequency
Purpose: Define control parameters (6 columns)

View 3: Complete Plan

Columns shown: All columns
Purpose: Full manufacturing control plan for PPAP submission

Formulas and Calculations

Medical Device Risk Probability Formulas

// Pre-control probability (initial assessment)
function riskProbabilityBefore(p1, p2) {
  // P1: probability hazardous situation occurs (1-5)
  // P2: probability harm occurs given situation (1-5)
  // Result: combined probability scale 1-25
  return parseInt(p1) * parseInt(p2);
}

// Post-control probability (residual assessment)
function riskProbabilityAfter(p1After, p2After) {
  return parseInt(p1After) * parseInt(p2After);
}

Risk Value Matrix Formulas

// Pre-control risk value using ISO 14971 risk matrix
function riskValueBefore(severity, probability) {
  // Severity: S0 (1) → S3 (4)
  // Probability: 1-25 (from P1×P2 product)
  // Returns risk level: 1=acceptable, 2=ALARP, 3=reduce, 4=unacceptable
  const sev = getSeverityScore(severity);
  const probScore = Math.min(5, Math.ceil(probability / 5));
  return getRiskMatrixValue(sev, probScore);
}

// Accepts residual probability and severity
function riskValueAfter(severity, probability) {
  return riskValueBefore(severity, probability);
}

// Final risk decision incorporating acceptance logic
function riskValueFinal(residualRisk, acceptanceDecision) {
  if (acceptanceDecision === 'yes') return 1; // accepted
  if (acceptanceDecision === 'conditional') return 2; // conditional acceptance (ALARP)
  return residualRisk; // return residual risk if not accepted
}

Manufacturing Classification Formula

// Merge product and process characteristic classifications
function getMergedClassification(productClass, processClass) {
  // Product characteristic SC/CC takes precedence if both exist
  // Returns SC or CC or empty string
  if (productClass && (productClass === 'SC' || productClass === 'CC')) {
    return productClass;
  }
  return processClass || '';
}

// Target value precedence (product first, process second)
function getMergedTargetValue(productTarget, processTarget) {
  return productTarget !== undefined ? productTarget : processTarget;
}

// Tolerance value merge
function getMergedTolerance(productTol, processTol) {
  return productTol !== undefined ? productTol : processTol;
}

Cell Decorators and Visual Styling

Risk Class Color Coding (Medical Device)

Risk ClassColorHexInterpretation
1 (Green)Green#4caf50Risk acceptable; no action required
2 (Yellow)Yellow#ffc107ALARP (As Low As Reasonably Practicable); monitor; may need controls
3 (Orange)Orange#ff9800Unacceptable; risk reduction required
4 (Red)Red#f44336Unacceptable; design must be changed
function riskStyle(riskValue) {
  const classes = {
    '1': 'rpn1', // green background
    '2': 'rpn2', // yellow background
    '3': 'rpn3', // orange background
    '4': 'rpn4'  // red background
  };
  return classes[riskValue] || 'rpn1';
}

SC/CC Characteristic Badges (Manufacturing)

// Special Characteristic badge rendering
function renderSCBadge(classification) {
  if (classification === 'SC') {
    return '<span style="background:#ff8c00; color:white; padding:4px 8px; border-radius:3px;">SC</span>';
  }
  if (classification === 'CC') {
    return '<span style="background:#c62828; color:white; padding:4px 8px; border-radius:3px;">CC</span>';
  }
  return '';
}

// Row background highlighting
function getRowClass(classification) {
  if (classification === 'SC') return 'row-sc'; // light orange #ffe0b2
  if (classification === 'CC') return 'row-cc'; // light red #ffcdd2
  return '';
}

Row Header Color by Residual Risk

function rowHeaderAPNew(residualRisk) {
  // Apply residual risk color to entire row header
  // Enables global risk visibility without scrolling
  return riskStyle(residualRisk); // reuses risk matrix coloring
}

Dynamic Filtering (QueryFactory)

Equipment Assignment Filtering

Equipment picker auto-filters systemElement items based on type classification:
{
  "queryFactory": {
    "query": {
      "type": "systemElement",
      "filters": [
        {
          "field": "elementType",
          "operator": "equals",
          "value": "equipment"
        }
      ]
    }
  }
}
Requirement: systemElement work items must have elementType custom field set to “equipment” or linked via equipment link role for picker to populate.

Characteristic Assignment Filtering

Characteristics are filtered by equipment selection via context:
{
  "contextAware": true,
  "filterBy": {
    "field": "linkedEquipment",
    "sourceColumn": "equipmentId"
  }
}
Requirement: characteristic work items must have established links to equipment systemElement items.
TypeRole in ConfigurationLink Role
useStepISO 14971 Level 1parent
hazardISO 14971 Level 2parent_of
riskControl (task)Mitigation elementmitigates
sysReq / desReqRequirements linked from risk controlrefined_by
testCaseVerification linked from requirementsverified_by
processStepAIAG Level 1parent
characteristicAIAG Level 2characteristic_of
systemElementEquipment referenceequipment
failureModeCross-methodology FMEA referenceanalyzedIn

Cross-References

Configuration Files

Location: .polarion/nextedy/sheet-configurations/ File naming:
  • Medical device: risk-control-plan-iso14971.yaml
  • Manufacturing: risk-control-plan-manufacturing.yaml
Both configurations share the same risksheet.json template but with different hierarchyDefinition and column group configurations.