Understanding the Critical Elements of Nonconformity Reporting in Audits

In the world of quality management, the accurate reporting of nonconformities is paramount. A well-structured nonconformity report not only identifies issues but also provides a clear path for corrective actions. However, the effectiveness of these reports hinges on the precise documentation of requirements, evidence, and rationale. This article outlines the essential elements of nonconformity reporting and illustrates how to properly structure these reports to ensure they are both defensible and actionable.

1. Requirement:

The requirement section is crucial in nonconformity reporting. It is essential to copy and paste the exact text from the standard and/or your procedure. This ensures accuracy and prevents misinterpretation. Do not paraphrase!!! Paraphrasing can lead to the loss of critical information and may result in the misunderstanding of the requirement.

Example:

• Requirement: ISO 9001 clause 8.5.2 Identification and Traceability requires, “The organization shall use suitable means to identify outputs when it is necessary to ensure the conformity of products and services.”

This example demonstrates how the exact text from the standard is directly quoted to avoid any misinterpretation.

2. Evidence:

Objective evidence is the backbone of a nonconformity report. Objective evidence only! It is vital to ensure that the evidence provided is factual and verifiable. The evidence should be information which can be proven true, based on facts obtained through observation, measurement, test, or other means as stated in the ISO 8402:1994 standard. Objective evidence must have a component that enables it to be verified by someone not present at the audit. This ensures that the evidence stands up to scrutiny even when reviewed independently.

Example:

• Evidence: An unidentified box of metal parts found under the desk in front of Machine 2B in the Bending Department.

This evidence is specific, observable, and can be verified by another auditor or individual who wasn't present during the initial audit.

3. Rationale (Disconnect):

The rationale connects the requirement to the evidence by explaining the disconnect or nonconformity. This step clarifies why the evidence does not meet the requirement and provides the basis for the nonconformity finding.

Example:

• Rationale (Disconnect): Parts were not identified as required by ISO 9001.

This rationale clearly explains the gap between the requirement and the evidence, making the nonconformity easy to understand.

4. Actual Example of Nonconformity Report:

Here’s how these points come together in a real-world scenario:

• Requirement: ISO 9001 clause 7.1.5.2 requires, “When measurement traceability is a requirement or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be calibrated or verified, or both, at specified intervals.”
• Evidence: Interviews with the management of the company, review of calibration log.
• Rationale for Finding: No calibration frequency set for step blocks yet, and some were calibrated 10 years ago; not clear if this is acceptable or not. Therefore, the interval for calibration of the step blocks has not been “specified” as required by ISO 9001.

This example demonstrates how to document a nonconformity effectively by following the Requirements, Evidence, and Rationale structure. It ties everything together clearly and concisely, allowing for a robust, defensible nonconformity report.

5. The Importance of Adhering to These Points:

Without the three critical points:

• Your findings can be challenged.
• Your findings can be thrown out.
• Your findings will be misunderstood/not understood at all.
• No one can take containment.
• The problem cannot be corrected.

It is evident that following these steps meticulously ensures that nonconformity findings are valid, understood, and actionable.

Credit goes to respected Christopher Paris I have just reproduced what he discussed in one of his videos https://youtu.be/WRbcbm-5nwA?si=9AawCSuKRz5Koxv6

Thank you Christopher Paris for this valuable content.