Non-Conformance Management

Non-conformance management tracks, investigates, and resolves quality issues through a structured process of documentation, root cause analysis, and corrective action. This guide covers the NCR process.

Overview

Non-conformance management enables you to:

• Document quality issues
• Track non-conformance reports
• Conduct root cause analysis
• Implement corrective actions
• Prevent recurrence
• Monitor resolution

Accessing Non-Conformance

Navigate to Quality → Non-Conformance to manage NCRs.

Understanding Non-Conformance

Non-Conformance Types

Type	Description	Example
Material	Raw material defect	Wrong specification
Process	Production error	Incorrect assembly
Product	Finished goods issue	Failed testing
Documentation	Paperwork error	Missing certificate
Supplier	Vendor quality issue	Defective delivery
Customer	Field complaint	Return/complaint

NCR Status

Status	Description
Draft	Being documented
Open	Investigation pending
In Progress	Being investigated
Awaiting Action	Corrective action needed
In Action	CAPA in progress
Pending Closure	Verification needed
Closed	Resolved

Severity Levels

Level	Description	Response
Critical	Safety/regulatory	Immediate action
Major	Function affected	Urgent action
Minor	Performance impact	Normal priority
Cosmetic	Appearance only	Low priority

NCR Process Flow

Standard Workflow

Issue Identified → NCR Created → Investigation →
Root Cause Identified → CAPA Defined →
Action Implemented → Effectiveness Verified → Closed

Detailed Steps

1. Detection - Quality issue found
2. Containment - Isolate affected items
3. Documentation - Create NCR
4. Investigation - Analyze cause
5. Disposition - Decide on affected items
6. Corrective Action - Fix root cause
7. Verification - Confirm effectiveness
8. Closure - Complete NCR

How-To Guides

How to Create Non-Conformance Reports

Creating an NCR

1. Go to Quality → Non-Conformance
2. Click New NCR
3. Enter details:

Field	Description
Title	Brief description
Type	NC category
Severity	Impact level
Source	Where detected
Product	Affected item
Quantity	Amount affected

4. Describe the issue
5. Attach evidence
6. Submit NCR

Documentation Requirements

Include:

• Clear problem statement
• Affected quantities
• Location/lot information
• Detection circumstances
• Supporting photos/documents
• Immediate actions taken

How to Investigate Non-Conformances

Investigation Process

1. Review Documentation

   • Original NCR details
   • Product specifications
   • Process documentation
   • Historical data

2. Gather Information

   • Interview involved parties
   • Review work instructions
   • Check equipment records
   • Examine physical evidence

3. Analyze Data

   • Timeline construction
   • Process review
   • Data analysis
   • Pattern identification

4. Determine Root Cause

   • Use analysis tools
   • Verify cause
   • Document findings

How to Conduct Root Cause Analysis

Analysis Methods

Method	Description	Best For
5 Whys	Ask "why" repeatedly	Simple issues
Fishbone	Cause-effect diagram	Multiple factors
8D	Structured process	Complex problems
FMEA	Failure mode analysis	Prevention

5 Whys Example

Problem: Product failed inspection

Why 1: Dimension out of spec
Why 2: Tool worn beyond limit
Why 3: Tool change not performed
Why 4: No tool monitoring system
Why 5: Process not defined
→ Root Cause: Missing process control

Fishbone Analysis

        Personnel    Methods
              \      /
               \    /
                \  /
         Problem → Defective Product
                /  \
               /    \
              /      \
        Materials   Equipment

Categories to consider:

• Man - Training, skills, supervision
• Machine - Equipment, maintenance
• Material - Raw materials, supplies
• Method - Procedures, processes
• Measurement - Calibration, accuracy
• Environment - Conditions, cleanliness

How to Determine Disposition

Disposition Options

Option	When to Use	Action
Use As Is	No functional impact	Accept with approval
Rework	Can be corrected	Fix and re-inspect
Return	Supplier issue	Send back
Scrap	Cannot be used	Dispose properly
Sort	Some good items	Separate and use good

Approval Requirements

Disposition	Approver
Use As Is	Quality Manager + Customer (if applicable)
Rework	Quality Lead
Return	Quality Lead + Purchasing
Scrap	Quality Manager

How to Define Corrective Actions

CAPA Process

Corrective and Preventive Actions:

1. Define Action

   • What needs to be done
   • Who is responsible
   • When to complete
   • Resources needed

2. Implement Action

   • Execute plan
   • Document activities
   • Track progress
   • Report status

3. Verify Effectiveness

   • Check implementation
   • Measure results
   • Confirm improvement
   • Monitor sustained

Action Types

Type	Purpose
Containment	Stop immediate problem
Corrective	Fix root cause
Preventive	Prevent recurrence
Improvement	Enhance process

CAPA Example

NCR: Incorrect component installed

Containment Action:
- Quarantine all affected units
- 100% inspection of WIP
- Due: Immediate

Corrective Action:
- Add visual aid at workstation
- Update work instruction
- Due: 5 days

Preventive Action:
- Implement poka-yoke fixture
- Add verification step
- Due: 30 days

How to Track and Monitor NCRs

NCR Dashboard

View at a glance:

• Open NCRs by status
• Aging analysis
• By type/source
• Trend over time

Tracking Metrics

Metric	Description	Target
Open NCRs	Currently unresolved	Lower
Average Age	Days to closure	<30 days
On-Time Closure	Closed by due date	>90%
Recurrence Rate	Same issue repeats	<5%

Status Updates

Regular updates required:

• Investigation progress
• Actions taken
• Target date changes
• Completion status

How to Close NCRs

Closure Requirements

Before closing:

• [ ] Root cause identified
• [ ] Disposition completed
• [ ] Corrective actions implemented
• [ ] Effectiveness verified
• [ ] Documentation complete
• [ ] Approvals obtained

Closure Process

1. Review all documentation
2. Verify actions complete
3. Confirm effectiveness
4. Manager approval
5. Close NCR
6. Archive records

Effectiveness Verification

Methods to verify:

• No recurrence over time
• Process monitoring
• Follow-up inspection
• Statistical analysis

Advanced Features

Supplier NCR Management

Track vendor quality issues:

• Supplier notification
• Response tracking
• Credit/debit handling
• Performance impact

Customer Complaint Integration

Link to customer issues:

• Complaint to NCR
• RMA processing
• Resolution tracking
• Customer communication

Cost of Quality Tracking

Track NCR costs:

• Scrap costs
• Rework costs
• Return costs
• Investigation costs

Automated Escalation

System escalation:

• Aging alerts
• Severity-based escalation
• Management notification
• Performance reports

Best Practices

📋 Documentation

• Clear descriptions
• Complete information
• Supporting evidence
• Timely recording

🔍 Investigation

• Thorough analysis
• Root cause focus
• Team involvement
• Data-driven

⚡ Action

• Timely response
• Effective solutions
• Proper verification
• Sustainable fixes

📊 Learning

• Trend analysis
• Pattern recognition
• Knowledge sharing
• Prevention focus

Configuration

NCR Settings

Navigate to Settings → Quality → NCR:

• Types - NCR categories
• Severity Levels - Definitions
• Workflow - Approval process
• Aging Thresholds - Alert timing

CAPA Settings

• Action Types - Categories
• Due Date Rules - Defaults
• Verification Requirements - Criteria
• Escalation Rules - Triggers

Notification Settings

• Creation Alert - Who notified
• Assignment Alert - Responsibility
• Overdue Alert - Late actions
• Closure Alert - Completion

Troubleshooting

Common Issues

Cannot create NCR

• Check permissions
• Verify required fields
• Review workflow rules
• Contact administrator

NCR stuck in status

• Check pending actions
• Verify approvals complete
• Review blocking conditions
• Escalate if needed

Actions not completing

• Review action requirements
• Check resource availability
• Verify due dates realistic
• Adjust and update

Cannot close NCR

• Verify all actions complete
• Check effectiveness verified
• Review approval requirements
• Complete pending items

Next Steps

Learn about Quality Analytics to analyze quality trends and performance metrics.