Legal NC vs Operational NC: Classify Correctly to Close Correctly

In an industrial environment, the correct identification and classification of non-conformities (NC) are essential to ensure compliance with standards and regulations, as well as to ensure operational efficiency. The difference between a legal non-conformity and an operational non-conformity may seem subtle, but it has significant implications for problem handling and resolution.

Understanding Legal Non-Conformity

A legal non-conformity is related to the non-compliance with requirements established by laws, standards, or regulations applicable to the sector. In Brazil, examples include failing to meet the requirements of CONAMA Resolution 430/2011, which deals with the conditions and standards for effluent discharge, or failing to comply with the guidelines of NR-12, which addresses workplace safety in machinery and equipment.

The recently published Federal Senate Resolution No. 1 of 02/29/2024 also establishes guidelines that, if not met, would result in a legal non-conformity. Failure to meet these requirements can result in fines, sanctions, or even the interruption of operations.

Practical Example

Imagine a chemical products factory in São Paulo that, during an internal audit, discovers that its pollutant emission levels are above the limits allowed by CONAMA Resolution 491/2018, which regulates air quality standards. This situation constitutes a legal non-conformity, requiring immediate corrective actions to avoid penalties from CETESB.

Understanding Operational Non-Conformity

On the other hand, an operational non-conformity refers to deviations from the procedures or internal parameters established by the organization itself to ensure process efficiency and quality. These deviations may not directly violate a law or regulation but impact the effectiveness of operations and the quality of products or services.

For example, an automobile factory in Paraná may have an internal procedure that requires parts to be checked at three quality control points along the production line. If this procedure is not followed, it constitutes an operational non-conformity, which can lead to defects in the final products and consequently to financial and reputational losses.

Classification Criteria

To correctly classify non-conformities, some steps should be followed:

1. Source Identification: Determine whether the problem's origin is an external requirement (legal) or an internal procedure (operational).
2. Impact Verification: Assess the potential impacts of the deviation, both legally and operationally.
3. Specialized Consulting: In cases of doubt, consult legal or compliance specialists to confirm the nature of the non-conformity.

Action Plan: Closing the Non-Conformity

Once the non-conformity is classified, it is crucial to develop a robust action plan to ensure its effective resolution. This involves:

• Defining Responsibilities: Assign clear responsibilities for implementing corrective actions.
• Setting Deadlines: Establish realistic deadlines for correcting non-conformities, considering complexity and available resources.
• Monitoring and Review: Implement a continuous monitoring system to track the progress of actions and review the effectiveness of the corrections made.

For illustration, consider a food factory in Minas Gerais that identified an operational non-conformity in storage temperature control. The action plan could include updating temperature sensors, training operators on the importance of temperature control, and periodically reviewing temperature records to ensure continuous compliance.

Common Errors in Classification and Resolution

Companies often make mistakes when classifying or resolving non-conformities. A common error is underestimating a legal non-conformity as operational, which can result in severe legal consequences. Another error is the lack of communication between departments, which can delay the identification and resolution of non-conformities.

Additionally, some organizations fail to adequately document non-conformities and the actions taken, making future audits and proof of compliance difficult. Using an integrated management system (IMS) can facilitate traceability and effective management of this information.

When to Seek Specialists

In many cases, the complexity of non-conformities may require consulting specialists. This is especially true when dealing with complex legal requirements or when the non-conformity may have significant business impacts. Specialists can assist in interpreting standards, defining appropriate corrective actions, and implementing more effective control systems.

Companies seeking excellence in non-conformity management often rely on the support of specialized consultancies, such as Legnova, which offers customized solutions to meet the specific needs of each organization, ensuring legal compliance and operational efficiency.