NCR Management

Non-Conformity Report (NCR) management is the process of documenting, investigating, and resolving quality issues when products fail to meet established standards.

What is an NCR?

An NCR (Non-Conformity Report) is a formal document that records:

What: Product details and batch information
Where: Location/branch where non-conformity was detected
When: Date and time of detection
Why: Failed parameters and measurements
How: Root cause analysis and corrective actions

NCRs are critical quality records required for ISO compliance and regulatory audits. All No Conforme products must be documented.

When to Create an NCR

An NCR must be created when:

1. No Conforme Classification

Any product receiving 'no-conforme' status from the conformity analysis:

if (overallStatus === 'no-conforme') {
  // NCR required
  // Product cannot be released without resolution
}

Triggers:

Sólidos measurements outside yellow tolerance limits
pH outside specified min-max range
Appearance does not match standard

2. Critical Quality Parameters

Even if overall status is Semi-Conforme, NCRs may be required for:

Repeated Semi-Conforme results (trend analysis)
Critical safety parameters (pH for personal care products)
Customer complaints
Process deviations

3. Other Quality Events

Contamination incidents
Equipment malfunction affecting product quality
Raw material deviations
Packaging defects

Failing to document No Conforme products with an NCR is a serious quality system violation and can result in regulatory non-compliance.

NCR Information Requirements

Based on the enriched record structure from analysis-utils.ts, NCRs should capture:

Product Identification

{
  lote_producto: string,           // Batch/lot number
  codigo_producto: string,          // Product code (e.g., "LIMLIM")
  familia_producto: string,         // Product family/category
  fecha_fabricacion: string,        // Manufacturing date
  tamano_lote: number,              // Batch size
  sucursal: string                  // Branch location
}

Quality Measurements

{
  ph: number | null,                // pH measurement
  solidos_medicion_1: number | null, // First solids measurement
  solidos_medicion_2: number | null, // Second solids measurement
  solidos_promedio: number | null,   // Average solids
  apariencia: string                 // Recorded appearance
}

Analysis Results

{
  analysis: {
    overallStatus: 'no-conforme',
    failedParams: ['solidos', 'ph'], // Which parameters failed
    phStatus: 'no-conforme',
    solidsStatus: 'no-conforme',
    appearanceStatus: 'conforme',
    isConform: false
  }
}

Additional Required Fields

Inspector name: nombre_preparador (from record)
Detection date: Timestamp of analysis
Deviation description: Specific details of non-conformity
Root cause: Identified cause of the issue
Corrective action: Immediate action taken
Preventive action: Long-term solution to prevent recurrence
Disposition: What happened to the non-conforming product

Disposition Options

1. Rework

When: Product can be brought into specification through reprocessing Example: Sólidos content too low → add concentrated ingredients → re-test

// After rework, product must be re-analyzed
const reworkedRecord = analyzeRecord(reworkedProduct)
if (reworkedRecord.analysis.overallStatus === 'conforme') {
  // Close NCR, release product
}

2. Downgrade

When: Product doesn’t meet premium specs but is safe and functional Example: Premium detergent with appearance defect → downgrade to economy line

3. Use As-Is (with Approval)

When: Product technically non-conforming but acceptable for specific use case Requirements:

Quality manager approval
Customer acceptance (if applicable)
Risk assessment documentation

Use as-is is only permitted for non-critical parameters. Personal care products and safety-critical items cannot be released as-is.

4. Scrap/Disposal

When: Product cannot be salvaged and must be disposed of Example: Severe contamination, critical parameter failures, expired materials

5. Return to Supplier

When: Non-conformity is due to raw material issues Action: Document issue, return material, file supplier NCR

NCR Workflow

1. Detection

const enrichedRecord = analyzeRecord(productionRecord)
if (enrichedRecord.analysis.overallStatus === 'no-conforme') {
  // Trigger NCR workflow
  initiateNCR(enrichedRecord)
}

2. Containment

Quarantine affected batch
Mark inventory as “HOLD”
Prevent shipment/use

3. Investigation

Review production records
Interview preparadores (operators)
Inspect equipment
Test raw materials
Identify root cause

4. Corrective Action

Implement immediate fix
Determine disposition
Process product accordingly

5. Preventive Action

Update procedures if needed
Retrain operators
Adjust process parameters
Calibrate equipment

6. Verification

Verify corrective action effectiveness
Monitor subsequent batches
Confirm issue resolved

7. Closure

Document all actions taken
Obtain quality manager approval
Update metrics and trend analysis
Archive NCR records

Failed Parameters Reference

The failedParams array identifies specific quality issues:

type FailedParam = 'ph' | 'solidos' | 'apariencia' | 'color' | 'aroma'

Sólidos Failures

Indication: failedParams.includes('solidos') Possible Causes:

Incorrect formulation
Raw material concentration variance
Measurement error
Incomplete mixing

Investigation:

Verify refractometer calibration
Check raw material certificates
Review mixing time and temperature
Inspect batch records

pH Failures

Indication: failedParams.includes('ph') Possible Causes:

Acid/base imbalance
Raw material pH variance
pH meter calibration drift
Contamination

Investigation:

Calibrate pH meter with fresh buffers
Re-test product sample
Check neutralizing agent addition
Review water quality

Apariencia (Appearance) Failures

Indication: failedParams.includes('apariencia') Possible Causes:

Phase separation
Contamination
Incomplete dissolution
Raw material quality

Investigation:

Visual inspection for particulates
Check mixing process
Verify raw material lot numbers
Test solubilizer/emulsifier function

Conformity Status and NCR Severity

Status	NCR Required	Severity	Response Time
Conforme	No	N/A	N/A
Semi-Conforme	Optional*	Low	48 hours
No Conforme	Yes	Medium-High	Immediate

*Semi-Conforme may require NCR if:

Multiple consecutive batches Semi-Conforme
Trending toward No Conforme
Critical parameter (pH for personal care)

Metrics and Trend Analysis

Track NCR metrics to identify systemic issues:

Key Metrics

NCR Rate: Number of NCRs per total batches produced
Cost of Quality: Financial impact of non-conformances
Resolution Time: Average time from detection to closure
Recurrence Rate: Percentage of repeated NCRs for same issue
Parameter Distribution: Which parameters fail most often

Trend Analysis

// Identify most common failure modes
const failureStats = ncrs.reduce((acc, ncr) => {
  ncr.analysis.failedParams.forEach(param => {
    acc[param] = (acc[param] || 0) + 1
  })
  return acc
}, {})

// Identify problematic products
const productFailures = ncrs.reduce((acc, ncr) => {
  acc[ncr.codigo_producto] = (acc[ncr.codigo_producto] || 0) + 1
  return acc
}, {})

Best Practices

1. Immediate Documentation

Document NCRs as soon as non-conformity is detected. Don’t wait until end of shift.

2. Thorough Investigation

Don’t assume cause without investigation. Equipment calibration issues often masquerade as product issues.

3. Root Cause Analysis

Use 5 Whys or Fishbone diagrams to identify true root cause, not just symptoms.

4. Objective Evidence

Include photos, measurements, and test results. Subjective descriptions are insufficient.

5. Training

Ensure all preparadores understand:

How to identify non-conforming products
When to escalate issues
Proper documentation procedures

6. Follow-up

Verify corrective actions are effective through subsequent batch monitoring.

Integration with Analysis System

The analyzeRecord function automatically identifies NCR candidates:

export const analyzeRecord = (record: any): EnrichedRecord => {
  // ... analysis logic ...
  
  return {
    ...record,
    analysis: {
      isConform,
      failedParams,
      phStatus,
      solidsStatus,
      appearanceStatus,
      overallStatus
    }
  }
}

// Use in NCR workflow
const analyzed = analyzeRecord(productionRecord)
if (analyzed.analysis.overallStatus === 'no-conforme') {
  createNCR({
    ...analyzed,
    ncrNumber: generateNCRNumber(),
    reportedBy: currentUser,
    reportedAt: new Date(),
    status: 'OPEN'
  })
}

Location: lib/analysis-utils.ts:34-133

Conformity Classification - Understanding No Conforme status
Control Charts - Prevention through statistical process control
Standards & Specifications - Quality standards reference

Get Started

Core Modules

Quality Management

User Management

Configuration

​NCR Management

​What is an NCR?

​When to Create an NCR

​1. No Conforme Classification

​2. Critical Quality Parameters

​3. Other Quality Events

​NCR Information Requirements

​Product Identification

​Quality Measurements

​Analysis Results

​Additional Required Fields

​Disposition Options

​1. Rework

​2. Downgrade

​3. Use As-Is (with Approval)

​4. Scrap/Disposal

​5. Return to Supplier

​NCR Workflow

​1. Detection

​2. Containment

​3. Investigation

​4. Corrective Action

​5. Preventive Action

​6. Verification

​7. Closure

​Failed Parameters Reference

​Sólidos Failures

​pH Failures

​Apariencia (Appearance) Failures

​Conformity Status and NCR Severity

​Metrics and Trend Analysis

​Key Metrics

​Trend Analysis

​Best Practices

​1. Immediate Documentation

​2. Thorough Investigation

​3. Root Cause Analysis

​4. Objective Evidence

​5. Training

​6. Follow-up

​Integration with Analysis System

​Related Topics

Build docs developers (and LLMs) love

NCR Management

What is an NCR?

When to Create an NCR

1. No Conforme Classification

2. Critical Quality Parameters

3. Other Quality Events

NCR Information Requirements

Product Identification

Quality Measurements

Analysis Results

Additional Required Fields

Disposition Options

1. Rework

2. Downgrade

3. Use As-Is (with Approval)

4. Scrap/Disposal

5. Return to Supplier

NCR Workflow

1. Detection

2. Containment

3. Investigation

4. Corrective Action

5. Preventive Action

6. Verification

7. Closure

Failed Parameters Reference

Sólidos Failures

pH Failures

Apariencia (Appearance) Failures

Conformity Status and NCR Severity

Metrics and Trend Analysis

Key Metrics

Trend Analysis

Best Practices

1. Immediate Documentation

2. Thorough Investigation

3. Root Cause Analysis

4. Objective Evidence

5. Training

6. Follow-up

Integration with Analysis System

Related Topics