A departure of a quality characteristic from its intended level or state that occurs with severity sufficient to cause an associated product or service not to meet a specification requirement, compromising a customer’s expectation for a product or service.

Overview: What is non-conformity?

Non-conformity means something went wrong in a product, service or process. Detection of non-conformities comes from audits, inspections, document adequacy reviews, checks or tests, customer or stakeholder complaints or feedback, general observations or experience or other process-related quality activities.
There are two types of non-conformance:

  1. Minor non-conformance, and
  2. Major non-conformance

Minor non-conformities seldom occur and detection is not difficult. For example, a missing signature on a document or unauthorized changes to a document is minor non-conformities.

Major non-conformities become more challenging to detect and have a more significant negative impact on customers. Multiple missing signatures on documents or many unauthorized changes to documents are significant non-conformities.

Three Benefits of Detecting Non-conformance

A Non-conformance is a mura, the Japanese term for inconsistency. There are definite benefits to detecting muras — non-conformities. Three benefits include:

1. More efficient use of resources

Efficient use of resources benefits the business and its customers by bringing down the cost of production.

2. Reducing customer complaints

Customers are the lifeblood of a company. Reducing complaints is one indication that the company is performing efficiently.

3. Improved quality management

A working nonconformance management system is a series of building blocks providing a clear grasp of the process and its objectives.

Why Is Non-conformance Important to Understand?

Organizations with a management system in place are better prepared to identify non-conformities. This ability serves several purposes:

It ensures conformance to the procedure.

Having the team look for and identify non-conformities keeps everyone aware of company procedures and processes.

It ensures the effectiveness of the system.

Observing the procedures and processes exposes areas requiring attention for improved compliance.

It drives improvement

Addressing non-conformance focuses on improving areas that need attention or change.

An Industry Example of Non-conformance

In manufacturing, non-conformance can be an unexpected event that happens in the manufacturing process. It is a deviation from a set standard or requirement.

Non-conformance management solutions allow for the identification and documentation of these quality events, apply standard risk criteria to classify, route incidents appropriately, then enforce a structured failure analysis, identifying root causes, isolating and final implementation of a solution.

Five Best Practices When Thinking About Non-conformance

Configured non-conformance management solutions include:

1. Identification

Proper identification of non-conformity areas lets organizations streamline the recording and management of production.

2. Documentation

The use of web forms allows the documentation of non-conformance events from many sites.

3. Evaluation

Complete prioritization to accomplish conformity for any affected sites.

4. Containment

Perform the necessary steps to ensure the non-conformance is controlled and prevented from being misused.

5. Disposition

Approved final activities ensure effective and efficient results.

Frequently Asked Questions (FAQ) about non-conformance

What is a Non-Conformance Report?

A non-conformance report documents non-conformances in an organization.

What Is the Purpose of a Non-Conformance Report (NCR)?

To help the organization rectify the problem and implement appropriate changes clearly, concisely, and logically defining the problem.

What Is the Non-Conformance Process?

The non-conformance process has five vital parts:

1. Contain the problem

2. Immediate remedial action

3. Analysis of root cause

4. Lasting corrective actions

5. Confirmation that the process was effective

Final Thoughts

When a process, service, or product does not match the first specifications, non-compliance results. Non-compliances disrupt the smooth flow of operations. A failure to detect and rectify non-conformity problems leads to corrective costs, money damages, and loss of reputation. Such non-conformance needs to be noticed, analyzed, and corrected at the earliest identification.

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