Non-Conformance

Ensure that every product meets the established quality criteria.

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What Is Non-Conformance?

In the industry, non-conformance indicates situations where a product, service, or procedure does not align with established standards, criteria, or anticipated outcomes. Such inconsistencies may arise at different phases, such as manufacturing, quality assurance, or service execution. Tackling non-conformances is essential for upholding quality, ensuring safety, and adhering to regulatory requirements.

Identification

During inspections, audits, tests, or through customer input, non-conformances are detected.

These may include flaws, departures from expected standards, or failures to meet regulatory requirements.

Documentation

Every non-conformance is recorded, frequently in a Non-Conformance Report (NCR), which provides information on the problem’s characteristics, consequences, and possible causes.

To trace and fix the problem, proper documentation is necessary.

Root Cause Analysis

Finding the root cause of the non-conformance is essential to stopping it from happening again.

For this, methods like fishbone diagrams and the “5 Whys” are frequently employed.

Corrective and Preventive Actions (CAPA)

Corrective measures are implemented to address the problem after the fundamental cause has been found.

To make sure that such non-conformances don’t happen again, preventive measures are also put in place.

Review and Closure

After the problem has been fixed, the non-conformance is closed and the efficacy of the remedial measures is evaluated.

The resolution and any modifications to processes or procedures are reflected in the revised documentation.

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