Preparing for an audit—whether it's a customer audit, external certification audit, or an internal audit—is a crucial step in ensuring process conformance and operational efficiency. While companies often focus on avoiding nonconformities, the true goal should be to achieve conformance by proactively addressing risks.
Through our experience working with organizations across various industries, we've identified three of the most common nonconformities that arise during audits. Addressing these issues ahead of time not only helps organizations succeed in audits but also ensures ongoing conformance and process improvement.
1. Document Control – A Common but Fixable Issue
One of the most frequently cited nonconformities in audits relates to document control, or more formally, the control of documented information. The reason this issue arises so often is simple—documentation provides tangible, verifiable evidence of conformance.
A common example occurs when a previous revision of a control plan remains on the production line instead of the latest approved version. Imagine an auditor requesting the control plan for a specific production line and finding both:
Rev. Level C (2025) – Current Version
Rev. Level B (2023) – Outdated Version
This immediately signals a failure in document control and can lead to nonconformities. Often, outdated documents remain in use due to informal process changes, where employees update work instructions without properly routing them through the document control system.
How to Ensure Conformance:
Implement strict document version control to prevent outdated versions from remaining in production areas.
Regularly audit documentation on the floor to ensure only the latest versions are accessible.
Use a centralized document control system that requires formal approval before changes are implemented
2. Control of Nonconforming Material – Preventing Uncertainty in Production
Another frequent issue relates to the identification and segregation of nonconforming material. Organizations are required to clearly mark and separate materials that are:
Suspect or awaiting evaluation
Confirmed as defective
Being reworked or scrapped
However, in many cases, nonconforming parts end up mixed with production parts because:
One department suspects an issue but has not escalated it for formal evaluation.
The quality team has not yet reviewed the parts for disposition.
Rework and scrap parts are not physically segregated, causing confusion.
This lack of control can lead to defective products unintentionally making it into production, which poses significant quality and safety risks.
How to Ensure Conformance:
Use clearly marked "hold" or "quarantine" areas (e.g., a red cage, designated bins, or a separate room) for suspect materials.
Define roles and responsibilities so that only authorized personnel can make final decisions on nonconforming materials.
Implement a robust tracking system to ensure rejected or reworked parts are properly documented and managed.
3. Managing Critical & Special Characteristics Across Documentation
A third high-risk area for nonconformities involves special, critical, or significant characteristics—whether defined by the customer, supplier, or design owner. These characteristics must be consistently documented and linked throughout:
Customer requirements & drawings
Control plans
Failure Mode and Effects Analysis (FMEA/PFMEA)
Work instructions
Failure to properly document and communicate these critical characteristics across departments can lead to misalignment and process risks. If employees on the production floor are not aware of critical tolerances or control requirements, product integrity may be compromised.
How to Ensure Conformance:
Verify that all special characteristics are clearly mapped from customer requirements to shop floor instructions.
Conduct internal reviews to ensure that process and design changes do not impact critical characteristics without proper controls.
Train employees on the significance of these characteristics and their role in maintaining conformance.
Ensuring Long-Term Conformance Beyond the Audit
While preparing for an audit is important, organizations should aim for continuous conformance, ensuring that adherence to standards is a standard operating practice, not just an audit requirement.
By proactively addressing these three common areas of nonconformity—document control, nonconforming material management, and critical characteristic documentation—organizations can strengthen their quality management systems, improve process reliability, and build long-term trust with customers.
Would you like to learn more about improving audit readiness and best practices for conformance? Explore our training programs designed to help professionals navigate industry requirements with confidence.
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