What is Non-Conformance?

Nonconformance (NC) occurs when a product, service, or process deviates from industry-defined standards or regulations.  As a result of nonconformance, companies get affected in terms of reputation, costs, effectiveness, and efficiency.

In terms of audit, a nonconformity is identifying the evidence of the process has not been performed properly according to the requirements of the standard. The main purpose of performing an audit is to find the deviations in the actual vs planned processes and to verify that the practice of being conformed to what is planned.

Types of Non Conformances:

Usually, internal auditors categorize nonconformances as major or minor.  The main difference between these two types of nonconformance is how many corrective actions are measured or taken to overcome the process deviations.

Irrespective of the type of non-conformance two points need to be considered.

1. Nonconformance should be addressed immediately.
2. Minor nonconformance should be addressed instantly without delay as it can become major non-conformance.

The best way to identify whether its major or minor nonconformance is by considering its frequency, detection, and impact.

Minor Nonconformance:

Minor nonconformance is a small weakness in business processes or procedures that could lead to major conformance if it is not solved instantly.

Some of the minor conformances are

• Single missing/Unsigned document
• Unauthorized change in documentation
• Missegregation of non-conforming products
• Improper machine calibration

This nonconformance will not cause any breakdown in your business operations. But if they occur in huge numbers and are not solved instantly, definitely it will become a major nonconformance and disintegration in business procedures. If any minor nonconformance is identified in your internal audit it should be considered as a potential improvement.

Major Nonconformance:

A major nonconformance is something that can cause significant failure in an organization’s processes or procedures. It is a deviation in the practice of following the intended business operations or objectives.

Major nonconformance occurs when the key requirement of your standard is attained, the absence of it altogether, or failure to maintain conformance. As a result, it will lead to crop-up failure in the process or task and multiple significant errors.

Some of the major conformances are

• Multiple missing/Unsigned documents
• Frequent unauthorized changes in documentation
• Multiple violations of standard requirements
• Shipping out of untested products.

Major nonconformance is considered to be a big issue as it can impact directly your business. For instance, you can see a drop in customer satisfaction or company reputation.

Identifying Nonconformance:

Information and insights are valuable sources that help to identify the non-conformance of any business and respond with corrective actions. Following are the few ways organization can identify non-conformance.

1. Monitoring and Review:

A mechanism is to be defined to monitor and review the design, manufacturing, delivery, and other operation phases. The monitoring and review process can easily identify areas of any improvement and make necessary changes to prevent nonconformance.

2. Conduct internal review:

Every organization needs self-evaluation, assessing their business process, and examining important feedback completely. This kind of self-evaluating approach is useful to reinvent the business process or find any hole in the process to prevent from nonconformance happening.

3. Internal & External Audit:

The organization can build an internal expert team to audit the entire business process for ensuring quality assurance.  They can also allow external inspectors and auditor to examine their QMS framework and its implementation to build confidence in their own ecosystem and avoid nonconformance.

4. Key performance indicators(KPI):

Businesses should define and maintain performance indicators as checklists and measure their entire business workflow. While measuring the performance it should meet the planned procedures without any deviation. It helps to identify non-conformance.

Nonconformance is unavoidable in any organization but it can be easily identified and resolved if the organization has the right quality nonconformance management software. With AURA QMS software, you can maintain the complete quality management needs including nonconformance management. To get a free demo on AURA nonconformity quality management software contact us info@auraqualitymanagement.com.