Actualité

25 April 2025

How to Manage
Non-Conformance with Optimized Digital Management?

In regulated sectors such as pharmaceuticals, medical devices, or food & beverage, each non-compliance can jeopardize product quality, safety, or regulatory compliance.

GxpQMS, non-comformance, non-compliance, quality, traceability

If you are an executive, a quality manager, or a QHSE manager, managing non-compliances is an integral part of your responsibilities. You are therefore looking for the best method to streamline their processing and resolution.

Non-compliance is a sign of failure in a process or product, indicating that the expected results do not meet the initial requirements.

In regulated industries, implementing a non-compliance management system is a top priority to ensure continuous improvement.

What is a Non-Compliance?

Non-compliance refers to any situation where a process, product, or service deviates from specified requirements, whether internal (SOPs, quality specifications) or external (ISO standards, regulations such as CFR 21 Part 11 or ICH Q10). This could involve a non-compliant batch, an improperly followed procedure, miscalibrated equipment, or a discrepancy identified during an audit.

Effectively managing non-compliances is therefore a strategic imperative, both for maintaining quality control and ensuring regulatory compliance.

Quality Management: How to Handle Non-Compliances

Le cycle de vie d’une non-conformité est composé de plusieurs étapes afin d’avoir une gestion et une résolution optimale.

1. Detection of Non-Compliance

Any stakeholder within the company can identify a non-compliance. Stakeholders include customers, suppliers, internal and external auditors, employees, and public authorities, among others.

Non-compliance can be detected during internal or external audits, quality controls, customer complaints, or issue investigations.

At the time of detection, it’s important to clearly describe the non-compliance and provide all necessary information for its reporting—such as documents showing what should have been done but wasn’t, evidence demonstrating the non-compliance, the date, and the person who identified it.

2. Declaration of Non-Compliance

The reporting phase involves entering detailed information about the non-compliance, often using structured methods such as the 5W1H (Who, What, Where, When, Why, How) or the 5M (Man, Machine, Method, Material, Measurement) approach.

During reporting, it’s crucial to identify whether an immediate action (correction) can be taken to address the non-compliance as quickly as possible.

In fact, when a non-compliance is reported, a two-step approach is essential:

Control the issue to minimize risks — for example, by notifying the customer, isolating the affected product, or immediately adjusting the impacted process.
Take immediate corrective action — which involves implementing the necessary process to bring the product or process back into compliance.

3. Handling of the Non-Compliance by Quality Assurance (QA)

It is important to include the date on which Quality Assurance (QA) takes charge of the non-compliance in the management process. QA is responsible for initiating any necessary immediate actions and describing them, indicating whether an action has already been taken or not.

QA will validate the reported information and initiate the review and analysis of the non-compliance.

4. Review and Analysis of the Non-Compliance

This step is crucial to prevent the recurrence of the non-compliance in the future. It involves identifying the root cause, along with several key elements to define:

Impact on product quality (product or process affected)
Recurrence
Root cause
CAPA (Corrective and Preventive Action), if necessary

5. Creation of CAPAs (Corrective and Preventive Actions)

The planning of corrective and/or preventive actions is determined based on the analysis of the non-compliance. It is essential to identify the persons responsible for carrying out the actions and to establish a timeline for their implementation.

6. Final Evaluation and Closure of the Non-Compliance

In the Quality Management System, this is a key phase. It determines whether the corrective and preventive actions implemented were effective or not. Closing a CAPA involves notifying the person who reported or identified the non-compliance, along with providing the CAPA report and a conclusion.

In cases where no CAPA is required, the non-compliance is closed during the review and analysis phase, and relevant stakeholders are notified accordingly.

Quality Management: Digitalizing Non-Compliance Management

Too many companies still manage their non-compliances using Excel files, emails, or paper documents, leading to increased risks of information loss, lack of traceability, and delays in corrective actions.

With GxpManager, you can structure the entire non-compliance lifecycle—from detection to closure, including root cause analysis and the implementation of CAPAs (Corrective and Preventive Actions). Every step is tracked, monitored, and validated.

Non-Compliances: Better to Prevent than to Suffer the Consequences

GxpManager helps you implement a proactive approach: trend monitoring, alerts on recurring deviations, and integration with risk management processes.

You reduce the cost of poor quality, minimize non-compliant products, and increase customer satisfaction.

An eQMS: How Your Company Can Benefit

Reduction in the number of recurring non-compliances.

Improvement in regulatory compliance (ISO, GMP, FDA, etc.).

Better responsiveness and collaboration between teams.

Full audit trail for inspections or quality audits.

Dashboard with real-time data to monitor your quality KPIs.

Book a demo of GxpQMS and discover how our platform can transform your non-compliance management, strengthen your regulatory compliance, and boost your quality performance.

How to Manage Non-Conformance with Optimized Digital Management?

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