Dealing with non-conformities

When non-conformities are raised during audits a sequence of events needs to follow afterwards in order to deal with the non-conformity correctly. This post highlights the main process that good auditors should use, as well as highlighting any potential problem areas.

The key stages of the whole process for dealing with non-conformities are listed below. These are covered in more detail in our Pharmaceutical Lead Auditor training course.

Non-conformity found

The non-conformity must be correct and raised against a clause of the standard that you are auditing against.

Non-conformity agreed

The non-conformity should be agreed at the time – not saved until the closing meeting. They will be raised at the closing meeting, but this should be to confirm what was agreed during the audit.

Corrective action proposed

The auditee can tell you what they intend to do to fix the problem. The auditor can respond with their thoughts.

Corrective action taken

Action has been taken that is thought will correct the non-conformity.

Corrective action effectiveness checked

It is essential that evidence is found to show that the corrective action has been effective. This could include analysis of data, a reduction in problems, an updated document, more training, an internal audit and/or a visit or review of the whole area or process. There are lots of ways in which you can check for effectiveness.

Inform auditor

The auditor needs to be informed that the non-conformity has been dealt with for good.

Auditor reviews information

The auditor reviews the evidence provided to check that they are satisifed that the non-conformity has been dealt with.

If satisfied – non-conformity closed

The auditor should inform the auditee that the actions are suitable.

If not satisfied – non-conformity remains open

The auditor should inform the auditee that the actions are not suitable and further actions are required.

Audit report updated

The audit report is updated to record the closure of any non-conformities.

Relevant personnel informed

Key personnel involved in the audit are informed once all non-conformities have been closed.

Review at next audit

Some non-conformities are worth following up at any subsequent audit, just to check that all actions were taken and were effective.

One of the main problems with audits is people not taking effective corrective action. This is often why problems are not dealt with correctly and re-occur. An auditor should be tenacious, and if they are not satisfied with corrective actions taken then they should say so!

Good luck with your auditing.

Dominic

Annex 1 has finally arrived, 25th Aug 2022 saw the publication of Annex 1. Normally, updates to GMP chapters and Annexes have a 6-month lead time for implementation. In the case of the new Annex 1, the lead time is 12 months, except for clause 8.123 relating to lyophilization which has 24 months lead time.

Annex 1 was first issued in 1971 as the only annex in the first ever UK guide to Good Manufacturing Practice. Since then, there have been several updates but not full revisions. In 2012 there was a proposal to revise Annex 1 with a re-proposal in 2014 by the UK’s MHRA. At the time, a full rewrite was considered unlikely and instead the intention was to provide a document that would confirm regulatory expectation and as such, not place any new requirements or costs on the pharmaceutical industry.

While this principle, is still upheld, it was clear from the first draft for public comment of December 2017, that a rewrite was being undertaken. The first draft created around 6200 comments coming from regulatory organizations, such as the pharmaceutical cooperation scheme, regulatory bodies outside of the EU, support organizations such as the Parenteral Drug Association, the Parenteral and Healthcare Sciences Society, the Pharmaceutical Microbiology Interest group as well as representatives from the manufacturers within the pharmaceutical industry to name just a few. Rarely do updates require a second public consultation but in the case of the annex 1 update a second draft was issued in March 2020 although this was a more targeted review in terms of the sections and clauses that comment was being sought for.

About the author

Andy Martin

Andy started working in the Pharmaceutical industry in 1985 as a lab technician for Smith & Nephew. Following this he had a number of roles culminating when he took over as QA Microbiology Manager. In 2003 he moved into Pharmaceutical Training and then in 2007 he moved back into Microbiology when he took up the position of Microbiology Manager for Catalent Pharma Solutions. Since 2012 he has operated as a consultant specialising in Microbiology and Quality Systems.

Training courses on Annex 1

There are a number of half-day workshops organised to take you through the changes in more detail and to look at how they relate to your organisation.

More details