As an auditor with over 15 years of experience, I’ve seen how crucial it is for auditors, especially those who are new to the field, to correctly identify non-conformities without falling into the trap of guessing or inferring from the data observed. The ability to discern when a non-conformity exists is central to the integrity of the audit process and the value it brings to the organization being audited. This article outlines the process for identifying non-conformities, shares best practices, discusses common pitfalls, and underscores the importance of a methodical approach.

What constitutes a non-conformity?

A non-conformity occurs when there is a deviation from the requirements specified in the relevant standard/requirement, company policies, or other applicable criteria being audited to. This could manifest as a process not being followed as documented, records not maintained as required, or an output that doesn’t meet the defined quality standards.

The Process of Identifying Non-Conformities

1. Preparation and Familiarization: Before starting the audit, thoroughly review the ISO standard applicable to the organization, along with any relevant company documentation such as procedures, work instructions, and previous audit reports. This foundational knowledge is crucial for identifying gaps during the audit.
2. Gathering Evidence: During the audit, collect objective evidence through interviews, observations, and review of documents and records. The evidence should be factual, verifiable, and relevant to the requirements of the standard. Be wary of how your biases and prejudices can influence how you interpret and perceive the data/situation.
3. Evaluating Evidence: Compare the gathered evidence against the criteria set forth in the standard/requirement being audited to. This step requires critical thinking and attention to detail. Ask yourself, “Does this evidence demonstrate alignment with the standard’s requirements (intent)?” If the answer is no this may constitute a non-conformity. In some cases, further evidence may be needed before concluding. Do not rush to a conclusion.
4. Recording Findings: When a potential non-conformity is identified, it’s important to document it clearly and accurately. Include specific details such as the clause/cite of the standard/requirement that was not met, the evidence supporting the finding, and the impact of the non-conformity on the organization’s operations or quality management system i.e. how did the system fail. Focus the non-conformity away from blame on the individual. At times you may find yourself deciding which clause from the standard may best address the problem. In these cases, identify what causal analysis each clause would drive and chose the clause that may inherently address the other clause as well.
5. Verification and Validation: Before finalizing a non-conformity, cross-check the evidence and consult with relevant personnel to ensure that the finding is valid and not a result of misunderstanding or insufficient information.

Best Practices for Identifying Non-Conformities

Remain Objective: Auditors must maintain objectivity throughout the audit. Avoid making assumptions or letting personal biases influence your judgment. Focus solely on the evidence and the criteria.

Ask Open-Ended Questions: During interviews, ask open-ended questions that encourage detailed responses. This can reveal more information than closed questions and help in identifying underlying issues. Other questioning techniques include silent questions, closed questions and hypothetical questions. An auditor must use their judgement in determining which question type to use.

Use Checklists Wisely: While checklists are useful tools, they should not be the sole focus of the audit. Use them as a guide, but remain open to exploring areas not explicitly covered by the checklist if evidence points to potential non-conformities.

Seek Clarification: If there is uncertainty about whether a situation constitutes a non-conformity, seek clarification from the auditee or your audit team. This can prevent misunderstandings and ensure accurate findings. You may even consult a peer/colleague so long as the confidentiality of the audit is maintained.

Common Pitfalls and How to Avoid Them

Guessing at Non-Conformities: One of the most significant pitfalls for new auditors is guessing when they are unsure. This may also manifest in inference of evidence i.e. assuming information to be accurate based on the known without consideration of the unknown. This often leads to inaccurate findings, which can undermine the audit’s credibility. To avoid this, always rely on concrete evidence and seek clarification when in doubt.

Overlooking Minor Issues: Small issues can escalate if not addressed. New auditors might hesitate to report minor non-conformities, but it’s important to document them as they may indicate larger systemic problems.

Failure to Connect Evidence to Requirements: Sometimes, auditors identify issues but fail to connect them directly to the relevant standard clause. This can weaken the finding and make it harder for the organization to address the issue. Always link your findings directly to the standard.

The Importance of Accuracy in Identifying Non-Conformities

Accurately identifying non-conformities is essential for several reasons. First, it helps the organization understand where their systems are failing to meet standards and where improvements are needed. Second, it ensures the integrity of the audit process. When auditors guess or inaccurately identify non-conformities, they risk damaging their reputation and the trust placed in them by the organization. Finally, precise identification of non-conformities helps in continual improvement, which is a core principle of process based system standards.

Conclusion

For new auditors, developing the skill to accurately identify non-conformities without inferring is a critical aspect of their role. By following a structured process, adhering to best practices, and being mindful of common pitfalls, auditors can ensure that their findings are accurate, valuable, and contribute to the continual improvement of the organizations they audit.

This approach, outlined above, will help new auditors build confidence in their ability to identify non-conformities accurately, ensuring the value and credibility of the audit process.