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Many auditors audit by going into areas, finding things that they don’t like and then announcing their non-conformities at a closing meeting at the end of the audit.  This is somewhat of an old-fashioned way of auditing and whilst it may be the way audits have traditionally been done it is certainly not the best way of auditing by modern standards.

During our auditor training courses we cover, amongst other things, the importance of doing the above correctly.

Raising non-conformities

These must be highlighted at the time and not saved up for the closing meeting.  The importance of raising non-conformities at the time that they are discovered cannot be emphasised enough.  The reasons for this include:

  • You are at the actual place where the issue occurred.
  • Usually all of the right people, equipment, procedures and records are there as well.
  • It helps ensures that you are actually correct and have fully understood the situation.
  • It gives the people being audited (auditees) an appreciation of how the audit is going.

Saving non-conformities up until the end of the audit and then announcing them for the first time at the closing meeting often results in difficult and confrontational meetings.  Better to have a closing meeting when you are confirming any non-conformities that were agreed during the audit itself.

Raising non-conformities against the standard

Non-conformities must be raised against the specific clause of the standard that you are auditing against.  For many people reading this article the standard will be GMP.  A related blog article  lists commonly found non-conformities linked to clauses of EU GMP.

Categorising non-conformities

It is very common to categorise non-conformities based on their severity.  There is no official standard that states what a Major Non-Conformity is.  In the first instance auditors should consult their own internal company procedures and policies to see if they already have something internally covering non-conformity classifications.

The following are general examples of what I have seen when working with a number of pharmaceutical companies:

CRITICAL – a significant risk that the end-user of the product will be harmed or killed OR a large number of related MAJORS.

MAJOR – absence of a specific requirement of the standard (such as no training, no calibration, no protection of product) OR a potential to harm or kill the end-user OR not following the requirement of the manufacturing/ marketing authorisation OR a large number of related MINORS.

MINOR – isolated lapses in following own company’s or GMP’s requirements.  No significant risk evident.

OBSERVATION – a concern that is not supported by firm evidence that something is wrong.

OPPORTUNITY FOR IMPROVEMENT – a way of spreading best practice (as auditors seek to add-value rather than just find faults).

Critical, major and minor non-conformities must be linked to clauses of the standard and must be dealt with after the audit via corrective action.

Give praise and complement where appropriate

Finally, don’t forget that the role of the auditor is not to find as many faults as you can.  Non-conformities will inevitably be raised during audits, but don’t forget to give praise and positive feedback when you see it.  Don’t worry if you don’t find any non-conformities – it is possible that a site or department is very good and are exceeding expectations.

I hope you find this post useful, as usual feel free to comment below.  If you would like any help and support with auditor training and development please get in touch.


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