How to Write a Non-Conformity?

In quality management, effectively identifying and documenting nonconformities is pivotal for fostering continuous improvement and upholding the standards of a management system. This blog post aims to guide you through the nuances of writing clear, actionable nonconformities.

What is a Nonconformity?

A nonconformity occurs when a product, process, or service falls short of meeting predefined standards, specifications, or requirements. It highlights discrepancies that need corrective measures.

ISO 9000 Definition

As per ISO 9000, a nonconformity is defined as the "non-fulfillment of a requirement," emphasizing the necessity to comprehend what constitutes a requirement and the implications of its non-fulfillment.

Components of a Nonconformity

Effective nonconformity writing includes:

1. Requirement: Specify the exact standard, procedure, or requirement that was breached.
2. What is Wrong: Describe the deviation or gap between the expected and actual scenarios.
3. Evidence: Furnish objective evidence that corroborates the existence of the nonconformity.

Crafting an Effective Nonconformity

To write succinct and impactful nonconformities, consider the following tips:

• Be Precise: Detail the specific requirement from the standard, procedure, or specification that has not been met. Clearly describe the observed deviation, ensuring that the description of what is wrong is directly linked to the requirement. This precision aids in understanding the exact nature of the nonconformity and the steps needed for resolution.
• Use Clear Language: Avoid technical jargon or vague terms that could lead to ambiguity. Your goal is to make the nonconformity understandable to all stakeholders, regardless of their technical background. Clear language ensures that the nonconformity is easily interpretable and actionable.
• Rely on Objective Evidence: Objective evidence forms the backbone of a credible nonconformity report. This evidence can include records, statements of fact, observations, or measurements that support the nonconformity claim. Ensure that the evidence is indisputable and directly related to the nonconformity.
• Avoid Naming Individuals: Focus on the process or system rather than attributing fault to individuals. Use positions or roles (e.g., "The Quality Manager" instead of personal names) when referencing responsibilities. This approach emphasizes system-level improvements over personal blame.
• Fact-Based Reporting: Ensure that the nonconformity is based on facts rather than opinions. This objectivity helps in focusing on the issue at hand and prevents the defensive responses that can arise from perceived personal criticism.
• Include Specific Locations and Dates: When relevant, pinpoint the exact location and date of the observed nonconformity. This specificity helps in tracing the issue back to its source and understanding the context of the nonconformity.
• Keep It Concise: While detail is important, unnecessary length can dilute the impact of your message. Strive for a balance between providing enough detail for clarity and being as concise as possible.
  

Examples of Good and Bad Nonconformities

Good Nonconformity:

ISO 9001:2015 clause 7.1.5.2 requires that monitoring and measuring equipment be calibrated or verified at specified intervals.  (Requirement). During the audit, it was discovered that calibration records for thermometers T-021 and T-034 used in the quality control lab were last calibrated on 01/20/2023, exceeding their annual calibration cycle. (What is Wrong and objective evidence:)

Bad Nonconformity:

The lab thermometers aren't being checked regularly. It seems like some are really old and might not be accurate anymore.

In the good example, the nonconformity is presented with clarity, directly linking it to the specific requirement, detailing the discrepancy, and grounding the assertion in solid evidence. Conversely, the bad example lacks specificity, clear reference to standards, and objective evidence, making it less actionable.

Conclusion

Writing nonconformities is an essential skill within quality management that aids in pinpointing and rectifying gaps in the management system. By accurately defining the requirement, stating the deviation, and underpinning the nonconformity with evidence, you pave the way for meaningful improvement and adherence to established norms and procedures.