Quality
September 3, 2025
September 5, 2025
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What is non-compliance?

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non conformites Efalia

Treatment of non-conformities:

In an economic environment where quality makes the difference, the treatment of non-conformities is becoming a major challenge for any organization. Between strengthened regulations, growing customer requirements and international competition, controlling your quality processes is no longer optional.

How to transform your quality incidents in real levers for improvement? This guide helps you set up an efficient and structured non-compliance management system.

What is non-compliance? Definition and challenges

Definition of an NC

Non-compliance is defined as The non-satisfaction of a requirement. Concretely, it is any deviation from established standards: regulations, ISO standards, specifications, customer contracts or internal procedures.

This definition, recognized internationally in quality management systems, encompasses all types of dysfunctions affecting:

  • The manufactured products
  • The services rendered
  • Operational processes
  • Management systems

Classification of non-conformities

Organizations generally classify their non-conformances according to three levels of severity:

🔴 Critical non-conformities
Direct impact on safety, regulatory compliance, or customer satisfaction. Immediate treatment required.

🟠 Major non-conformities
Significant malfunctions that may affect the final quality or the performance of quality processes.

🟡 Minor non-conformities
Occasional differences without immediate impact but requiring follow-up to avoid worsening.

Sources of non-conformities: Identifying to better prevent

External origins

Third parties (customers, suppliers, partners)
Non-compliance with contractual commitments, inadequate technical specifications, or deliveries that do not meet expectations.

Evolving regulations
New legal requirements, regulatory updates, or changes in sector requirements.

Internal origins

Managerial failures
Non-application of guidelines, procedures not respected, or absence of good practices in the field.

Normative differences
Non-compliance with quality standards (ISO 9001, ISO 14001) for which the organization is certified.

Operational malfunctions
Problems in production processes, insufficient maintenance, or inadequate team training.

Detailed typology of non-conformities

Product non-conformities

  • Manufacturing or design defects
  • Technical specifications not respected
  • Quality issues detected prior to delivery

Service non-conformities

  • Services not in line with expectations
  • Deadlines not respected
  • Insufficient quality of service

Process non-conformities

  • Incidents during operating activities
  • Malfunctions in production chains
  • Transport or installation problems

System non-conformities

  • Procedures not applied
  • Quality system requirements not met
  • Discrepancies in the management of quality processes

How do you report non-compliance effectively?

The essential elements

A structured reporting form should include:

Identifying the declarant

  • Name, function, department
  • Date and place of detection
  • Discovery context

Detailed description of the non-compliance

  • Exact nature of the malfunction
  • Non-conforming items identified
  • Observed or potential impact

Preliminary analysis

  • Presumed origin (internal/external)
  • Apparent causes
  • Immediate consequences

Facilitate reporting

To encourage reporting, the reporting process should be:

  • Fast and easy : accessible online forms
  • Non-punitive : culture of improvement vs culture of fault
  • Traced : automatic tracking and notifications

The treatment process non-conformities

Step 1: Instruction and qualification

In-depth analysis

  • Verification of the reality of the non-compliance
  • Severity and impact assessment
  • Classification according to the established typology

Looking for root causes

  • Technical or organizational investigation
  • Use of analysis tools (5 Why, Ishikawa, FMEA)
  • Identifying root causes vs symptoms

Step 2: Action Plan

Immediate corrective actions

  • Dealing with detected non-compliance
  • Limitation of customer or regulatory impacts
  • Securing quality processes

Preventive actions

  • Modifying processes or procedures
  • Training of the teams concerned
  • Updating control systems

Assignment of responsibilities

  • Designation of a manager by action
  • Definition of deadlines for completion
  • Allocation of required resources

Step 3: Follow-up and effectiveness

Measuring effectiveness

  • Verification of the implementation of actions
  • Controlling the elimination of causes
  • Non-recurrence assessment

Capitalization

  • Updating quality processes
  • Sharing best practices
  • Enrichment of the knowledge base

Why is software for the management of non-conformities becoming essential?

The dangerous limits of manual methods

Excel and shared files: A hindrance to performance

  • Information scattered and difficult to find
  • No automated workflow: non-conformities drag on
  • Risk of loss of critical information
  • Impossible to follow trends and patterns
  • No traceability guarantee for audits

Emails and informal communications

  • History of non-centralized exchanges
  • Corrective actions not systematically followed
  • Unclear responsibilities and missed deadlines

The urgency of a structured system

As soon as your organization exceeds 10 non-conformities per month, dedicated software becomes necessary. Over 50 employees, it is essential to maintain the performance of your quality processes.

The concrete advantages of a software for dealing with non-conformities

Immediate time savings

  • Guided typing that reduces errors by 70%
  • Automatic attribution according to the types of non-conformities
  • Notifications that eliminate manual reminders
  • Instant search through the complete history

Traceability and compliance guaranteed

  • Complete and unalterable history of each non-compliance
  • Documented evidence for quality audits
  • Automatic compliance with regulatory deadlines
  • Data export for quality reporting

Management of quality processes in real time

  • Automatic and customizable dashboards
  • Detecting recurring trends and issues
  • Measuring the effectiveness of corrective actions
  • Quality KPI updated automatically

Fast and measurable ROI

  • 40% reduction in processing times on average
  • 60% reduction in recurrences thanks to the analysis of the causes
  • Savings on non-quality costs in the first year

The benefits of structured management

Operational gains

  • Reduction of processing times by 40% on average
  • Reduction in recurrences through root cause analysis
  • Improving responsiveness to malfunctions

Strengthened compliance

  • Compliance with normative and regulatory requirements
  • Full traceability for quality audits
  • Demonstration of continuous improvement

Economic performance

  • Reducing non-quality costs
  • Prevention of customer or regulatory penalties
  • Optimization of quality processes

Set up your management system

Key steps

1. Diagnosis of the existing

  • Mapping current quality processes
  • Identifying failure points
  • Assessment of non-compliance costs

2. System design

  • Defining processing workflows
  • Setting severity levels
  • Training of the teams involved

3. Progressive deployment

  • Pilot on a restricted perimeter
  • Adjustments based on field feedback
  • Generalization after validation

4. Continuous improvement

  • Monitoring of performance indicators
  • Optimization of quality processes
  • Evolution of the system according to needs

Conclusion

The treatment of non-conformities is much more than a regulatory obligation: it is a real lever for continuous improvement for your quality processes. Without dedicated software, you are navigating blindly in a sea of malfunctions.

An effective non-compliance management system turns each incident into an opportunity for measurable progress. The investment quickly translates into concrete gains: reduction of non-quality costs, improvement of customer satisfaction, and strengthening your competitive position.

The real question is no longer “do I need software?” but “how much is it costing me each day of delay in implementing it?”

Do you want to optimize the treatment of your non-conformities? Our experts support you in setting up a system adapted to your quality processes and your business challenges.

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