What are non conformorties-Major

The writing and categorizing of non-conformance reports is one of the essentials skills that an auditor must develop.  The method and presentation of the findings of an audit will vary from company to company but no matter what format is used, effective reporting will lead to effective corrective actions being taken.

 

It is the Lead Auditor’s responsibility to ensure that all reports raised during the course of an audit comply with the guidelines issued by his/her own organization.

 

Non-Conformance Categories

 

It is unusual for a company to categories its non-conformances for Internal audits and they may or may not do so with Second Party audits of their suppliers.  This does not mean however that the organization in question should not priorities the corrective action according to the magnitude of the problem and commensurate with the risks encountered.

 

However a Third Party audit non-conformance demands categorization and they fall into two types – MAJOR and MINOR.

 

A major non-conformance is one which raises significant doubts as to whether the product or service supplied will meet agreed requirements.

 

A MAJOR non-conformance may therefore be defined as:

 

The absence of a procedure as required by the standard, or the total breakdown in the implementation of a procedure.

     

      Legal or regulatory requirements are not complied with.

 

NOTE: A number of Minor non-conformances listed against the same requirement can represent a total breakdown of a system and thus be considered as a Major non-conformance.

 

Examples of MAJOR non-conformances are:

 

·      Inappropriate, inadequate or total absence of procedures required by the Standard.  In the case of a Third Party audit these should have been identified in the initial stages when the documentation is reviewed.

 

·      Combined effect to failure to follow laid down procedures across a broad spectrum of the company’s operations.

 

·      Consistent failure to carry out corrective actions within the agreed time-scale form previously identified non-conformances.

 

·      Several examples of informal and unauthorized drawing/planning changes.

 

·      Considerable number of items of measuring and standards equipment uncalibrated or outside the calibration date.

 

Note: A SINGLE MAJOR NON-CONFORMANCE WILL MEAN THAT APPROVAL OF A COMPANY’S SYSTEM CANNOT BE RECOMMENDED UNTIL CORRECTIVE ACTIONS DEMONSTRATE EFFECTIVENESS.

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