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How to Successfully Manage Non-Conformities and Corrective Actions in ISO-Certified Systems

How to Successfully Manage Non-Conformities and Corrective Actions in ISO-Certified Systems 1200 800 Lorena Terente

Managing non-conformities and corrective actions is essential for maintaining the integrity and continuous improvement of any organization, especially within ISO-certified management systems. This guide will help you understand what non-conformities are, their origins, and how to manage them effectively through corrective actions.

What are Non-Conformities?

In the context of ISO-certified systems, a non-conformity is a failure to meet a specific requirement, which could be:

  • External (e.g., non-compliance with legislation, ISO standards, or supplier requirements).
  • Internal (e.g., non-compliance with internal procedures or management system requirements).

These unmet requirements can involve:

  • Customers (e.g., order specifications, ISO certifications).
  • Public Administration (e.g., legal regulations).
  • Other stakeholders (e.g., workers, shareholders, suppliers).
  • The organization itself (e.g., internal policies, procedures).

Turning Non-Conformities into Opportunities for Improvement

While non-conformities are often viewed negatively as failures or errors, they should be seen as opportunities for improvement within a continuous improvement framework. By addressing non-conformities proactively, organizations can enhance processes, prevent future issues, and improve overall performance.

Common Sources of Non-Conformities

Non-conformities can arise from various sources within an organization, including:

  • Internal process management by responsible personnel.
  • Internal audits or control inspections.
  • Risk and opportunity management.
  • Compliance audits with legal and regulatory requirements.
  • Customer complaints and claims.
  • External audits (often a primary source of non-conformity detection).
  • Management reviews.
  • Product quality controls.
  • Employee alerts.

Types of Non-Conformities

Non-conformities are often classified by severity:

  • Major Non-Conformity: A significant breach that jeopardizes the management system’s integrity, such as serious non-compliance with laws or prolonged minor non-conformities.
  • Minor Non-Conformity: A minor deviation that does not severely affect the system’s efficiency or integrity, such as a missing signature on a non-critical document.
  • Observation: Not a non-conformity, but an area identified for potential improvement, like simplifying documentation processes.

Actual vs. Potential Non-Conformities

  • Actual Non-Conformities: Non-compliance that is currently occurring and supported by objective evidence (e.g., unlabelled waste containers as per an environmental management system procedure).
  • Potential Non-Conformities: Situations that could lead to non-compliance if not addressed (e.g., actions observed during processes that could eventually result in a non-conformity).

Corrective Actions: Definition and Importance

A corrective action is an action taken to eliminate the root cause of a detected non-conformity, ensuring it does not recur. This goes beyond merely correcting the issue and focuses on preventing future occurrences by addressing underlying causes.

Steps to Manage Non-Conformities and Implement Corrective Actions

  1. Detection: Identify and document the non-conformity, including evidence, the violated requirement, and related details.
  2. Effect Analysis: Assess the impact of the non-conformity and take immediate actions to mitigate any adverse effects.
  3. Root Cause Analysis: Investigate and identify the root causes using methodologies such as Ishikawa diagrams, Pareto analysis, or the 5 Whys technique.
  4. Corrective Action: Define and implement corrective actions to address the root causes, with clear responsibilities and deadlines.
  5. Preventive Actions: Establish measures to prevent potential non-conformities from arising.
  6. Follow-up: Monitor the implementation and effectiveness of corrective actions.
  7. Verification and Closure: Verify the effectiveness of the actions and formally close the non-conformity once it has been resolved.

Effective Documentation of Non-Conformities

Proper documentation is critical, especially in ISO-certified systems. Non-conformities should be clearly described, supported by solid evidence, and linked to specific criteria or requirements that have been violated.

Assessing the Magnitude of Non-Conformities

Assess the magnitude of non-conformities by considering:

  • Probability of Occurrence: How often the non-conformity might occur (e.g., annually, monthly).
  • Consequence: The impact if the non-conformity occurs (e.g., negligible, minor, moderate, major, catastrophic).

Examples of ISO Standard Non-Conformities

ISO 14001 Non-Conformities (Environmental Management):

  • Unlabelled waste containers.
  • Incomplete environmental aspect assessments.
  • Failure to measure emissions or discharges.

ISO 9001 Non-Conformities (Quality Management):

  • Product defects or non-compliance with customer specifications.
  • Process deviations affecting quality or delivery timelines.

ISO 45001 Non-Conformities (Occupational Health and Safety):

  • Missing risk assessments or safety equipment controls.
  • Lack of evidence for safety training or protective equipment issuance.

Digital Solutions for Managing Non-Conformities and Corrective Actions in ISO Systems

Consider using digital tools like Eurofins EcoGestor to streamline the management of non-conformities. These platforms can automate tasks such as documentation, assigning responsibilities, and tracking corrective actions, reducing reliance on paperwork and improving overall efficiency.

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