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What are the three main elements of a nonconformity?

Published in Nonconformity Elements 4 mins read

A well-documented nonconformity is fundamentally composed of three critical elements that provide a clear, actionable, and verifiable report of a deviation from established requirements. These elements ensure that the nonconformity is properly understood, addressed, and contributes to effective corrective actions.

The Core Components of a Nonconformity

For any nonconformity to be effectively identified and resolved, it must clearly articulate what went wrong, against what standard it went wrong, and the evidence supporting this claim.

1. Audit Evidence

This element refers to the objective, factual information collected during an audit that supports the auditor's findings. It's the "what was observed" or "what was found" during the assessment.

  • Description: Factual information, records, statements of fact, or other verifiable information that demonstrates the existence of a nonconformity.
  • Importance: Provides the objective proof necessary to validate the nonconformity. Without robust evidence, a nonconformity report lacks credibility and can be challenged.
  • Examples of Evidence:
    • Specific document names and revision numbers, along with the sections found to be non-compliant.
    • Dates, times, and locations of observations (e.g., "On [date] at [time] in [area], two out of five reviewed records lacked the required signature from [role].").
    • Interview summaries, clearly stating who was interviewed and relevant quotes or paraphrased statements.
    • Photographs or videos (when permitted) showing the condition.
    • Measurement data or test results.

2. The Requirement

This element specifies the particular standard, policy, procedure, regulation, or expectation that has been violated. It's the "what should have been" or the baseline against which the nonconformity is measured.

  • Description: The specific clause from a standard (e.g., ISO 9001:2015 Clause 8.5.1), an internal procedure (e.g., QP-001, Section 4.2), a regulatory guideline, or a customer specification that was not met.
  • Importance: Establishes the context and legitimacy of the nonconformity. It defines what the organization was supposed to do, making the deviation clear. It guides the organization in understanding the rule that was broken.
  • Examples of Requirements:
    • "ISO 9001:2015, Clause 8.5.1, Control of Production and Service Provision, requires that 'the organization shall implement production and service provision under controlled conditions.'"
    • "Company Procedure PRO-005, Document Control, Section 3.1, states that 'all controlled documents must be reviewed and approved by the Department Head prior to issue.'"
    • "Customer Specification CS-012, Packaging Requirements, mandates 'all finished products must be packaged in tamper-evident sealing.'"

3. The Statement of Nonconformity

This is the clear, concise description of the deviation itself, directly linking the audit evidence to the violated requirement. It articulates what went wrong, bringing the first two elements together.

  • Description: A precise sentence or paragraph that details the discrepancy between the observed evidence and the stated requirement. It explains how the requirement was not met.
  • Importance: Provides a definitive declaration of the issue, enabling clear communication and effective root cause analysis. It focuses on the facts and avoids subjective language.
  • Formulation Best Practices:
    • Direct: Clearly state what was found and what the requirement was.
    • Specific: Avoid vague terms; use exact details from the evidence and requirement.
    • Concise: Get straight to the point without unnecessary elaboration.
    • Example Structure: "It was found that [audit evidence] which is contrary to [the requirement]."
      • Example: "During the review of calibration records for measurement equipment, calibration certificate #1234 for pressure gauge PG-001 was found to be expired since [date], which contradicts documented procedure OP-CAL-001, Section 4.5, stating that 'all measuring equipment must be calibrated prior to use and remain within their valid calibration period.'"

Summary of Nonconformity Elements

Element Description Key Purpose
Audit Evidence Factual findings, observations, or verifiable data collected during the audit. Provides objective proof that a deviation exists.
The Requirement The specific standard, policy, procedure, or rule that was violated. Establishes the baseline against which the deviation is measured.
Statement of Nonconformity A clear, concise declaration linking the evidence to the violated requirement. Articulates the exact nature of the nonconformity.

Practical Insights for Documenting Nonconformities

Effective nonconformity documentation is crucial for organizational improvement. When preparing nonconformity reports:

  • Be Objective: Focus solely on facts and observable data, avoiding personal opinions or assumptions.
  • Be Specific: Provide enough detail so that anyone reading the report understands the exact issue without needing further clarification.
  • Refer to Requirements Explicitly: Always cite the exact clause, section, or document number of the requirement that was not met.
  • Focus on the 'What': Describe what occurred, not necessarily why it occurred (that's for root cause analysis).
  • Maintain Clarity: Use plain language that is easy to understand across all levels of the organization.