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Raising non-conformities

March 30, 2012

Dominic Parry

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 or visit our web-site.

9 Comments

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  1. MOHANKUMAR #
    March 30, 2012

    NICE ONE AS USUAL

  2. March 30, 2012

    COMMENTS ALSO RECEIVED FROM LinkedIn:

    Hi Dominic,
    I enjoyed your article, but not sure that I agree fully with your assertion that non-conformances must be linked to clauses in a standard. I think this is true when auditing supplier or contractor facilities, but not sure that it is the best approach for internal audits where one is concerned with ensuring that the operation is complying with the c of cGMP.There are often items that cannot be categorically traced to a clause, but could attract a regulatory citation.For example, recent FDA 483s have cited companies for recording ‘PASS’ as a result instead of the specific results in ID tests. Would it not be difficult to cite this specifically against a clause? It is not really a non-conformance, more of a current interpretation or expectation. Yet should it not be pointed out at audit as a concern? Thoughts welcome.

    REPLY:

    Thank you. It is good audit practice in all industries to list non-conformities against a standard, and I don’t see what we (pharma) should be any different. The problem with USA GMP (as written in 21 CFR 211) is that it is not updated, so unlike EU GMP you may have a problem, but no clause to pin it on. This does make auditing against USA GMP difficult.

  3. ideweerd #
    March 31, 2012

    I also appreciate it when auditors bring up findings at the time of discovery. It gives us a chance to explain the situation and give more detail. Maybe the finding is just a misunderstanding, or the audits needs some more information. Even worse than having non-conformance spring on you during the close out meeting are when they just show up randomly in the audit report. That really drives me crazy!

    We are also in agreement over citing audit findings against specific standards or regulations. It is not an auditors place to impose their opinions on the auditee. Recommendations are fine, but they should not require corrective action. Even in a situation like the US GMP which is broadly written and has many “guidances” and “industry standards,” non-conformances should still target a specific requirement in 21 CFR 211.

    Another intelligent and informative post!

    • April 1, 2012

      Thanks for your comments – much appreciated.
      I think it is a disgrace when auditors add non-conformities to audit reports that they forgot to mention during the audit.

  4. April 1, 2012

    COMMENT FROM LinkedIn:
    Very good article, I liked ” raising of Non conformity at audit site rather than to have at closing meeting. As per me it will improve the impact, acceptance and subsequent action and improvement.
    Posted by Ashish patel

  5. April 2, 2012

    COMMENT FROM LinkedIn:
    Hi Dominic. Another reason for pointing out non-conformances immediately is to give the auditee an opportunity to correct the infraction immediately. Even the FDA will not cite a corrected infracton on a FD-483
    Posted by Margaret MacMurray

  6. April 2, 2012

    COMMENT FROM LinkedIn:
    As with any interactions with auditors, it is always a good idea to be proactive in addressing concerns. From personal experience, and If asked, the majority of auditors usually agree to providing companies a daily wrap up of any concerns and/or open items.
    Posted by mark edmonds

  7. T.B.Kumar #
    June 12, 2012

    I have faced many audits. As pointed out by Dominic, some auditors especially USFDA auditors points out then and there, though they note it. We immediately take a corrective action, make approprriate documents and present them. The auditors also mark that the action is taken and NC is closed. This approach was very useful to me when I was facing HPFBI, Canada. We cleared with very few minor observations. Thanks Dominic.

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