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.
User questions & answers