Our subscribers to Smart Knowledge have been so helpful and positive about sharing their information to help each other. So far we’ve had 71 sites enter their Issue 8 non conformances, which we think is pretty amazing, so thank you to everyone that’s shared with us.

To those of you out there that have had your audit too, if you’d like to join in and share your Issue 8 non conformances it would help our wonderful techie community.  To view the current results and share yours with us, go to: Issue 8 non conformance trending for BRC audits

As promised, the useful data you have provided now gives us the information you can learn from – so in this article we’re going to look at the top 5 NCN’s we have so far, which are:

  1. Radiological hazard: Clause 2.7.1 

  2. Chemical control: Clause 

  3. Control of sharps: Clause 

  4. Equipment design for effective cleaning: Clause 4.6.1

  5. Culture: Clause 1.1.2

NCN 1 – Radiological

We covered this recently, so if you want to read up on this so you don’t get this Issue 8 non conformance, you can do this here: Radiological hazards

NCN 2 – Chemical control

Having contacted the sites that received these Issue 8 non conformances, it seems that they were due to unlabelled chemical containers and chemicals not stored in a locked location. Funnily enough (or not, depending on how you look at it), chemical control was number 5 in the top non-conformances for issue 7 as well.  Although clause is only a small clause, it covers a lot, so I think it would be good to cover this in more detail in its own article.

In the meantime, think about all the chemicals you use on site that your staff may want to decant. You may think it’s easier to say to staff that they must not decant chemicals at all, however; in practice this may not be possible. If staff need to decant chemicals, you need to find a simple way of allowing them to do this, without them breaking the rules. Providing staff with dedicated containers which are already labelled, to decant chemicals into is an easy fix for this.

Walk the process with those that use the chemicals to be able to understand the challenges they face, if they can’t decant chemicals and see if you can work out a solution that would work for both of you. Cleaning chemicals may be the first thing that pops to mind, but chemicals also covers things like engineering type cleaning chemicals (such as alcohol for cleaning printers), inks, lubricants and belt dressings. Don’t forget things like deionised water for batteries of forklifts etc – although this is only water, if it’s not labelled, how does your auditor know?

NCN 3 – Control of sharps

The reason the sites received Issue 8 non conformances was because:

  • Knives had not been checked as per the procedure
  • Knives that were in use, were not on the register
  • Dirty knives were stored where the clean knives should be kept
  • Tools found in a toolbox did not match the inventory
  • Tools in the toolbox were found to be in poor condition
  • Snap off blades were in use
  • Scissors were not included on the sharps register
  • A knife in the canteen, was not included in the sharps register

All of the above are more than likely silly’s that happened on the day. We all dread silly’s, but having robust systems which are easier to get right than wrong reduce the risk of it going wrong on the day. Although the canteen knife is a new one to us, it does makes sense – but we have to be honest it’s not something we’ve checked before!

Recently we saw a really good solution, where a site had put the tools (including knives) that the operator needed in a shadow box, which was locked on the wall.  Only those that were trained, were allowed a key to be able to get a knife.  The tool had to go back in the box when they’d used it and this was easy because the box was close to where the tool was needed. This way the QC’s could go round and check the tools for condition each day, as they knew where they were. You could extend this one step more and add the sign off sheet into the shadow box and have a pen on a chain in the box to sign it.  Take a tool, confirm that it’s in good condition and sign for it, there and then.

If you have any other suggestions, please do add them to the reply box below, I’m sure you can beat our suggestion!

NCN 4 – Equipment design

The Issue 8 non conformances relating to this clause were due to:

  • Plastic coating being left on a plastic guard, which meant it was becoming a foreign body hazard and trapping liquid behind it
  • Wear and flaking paint on machines, including pump trucks
  • Rust on machines, nuts and connections
  • Condensation dripping from overhead pipes
  • Leaking pumps
  • Damage and stress cracks to tote bins
  • Plastic scoops showing signs of wear and feathering
  • Discoloured ceiling light covers
  • Lack of covers on product vessels
  • A stylus pen secured with frayed nylon cord

All of the above should be picked up on your GMP inspections – but if you look at your inspections, are they detailed enough to get to this level of detail?  And, being human we tend to get used to seeing what we see every day, so it’s not until you’re stood with an auditor on the day of the audit, that sometimes we see things as they truly are.

Take a look at your GMP inspections and see if there are any trends in the issues that are picked up.  A lot of the time we use GMP inspections to provide scores for how an area is doing, but we don’t always remember to use the information on them to pick out the issues we need to resolve.

Some of these points are engineering related and also have cost implications.  So, it would be a good idea to set up a quarterly equipment audit with the senior team, including engineering, to walk the site and make a list of everything that needs doing. You could then review this in your management meetings, to ensure that the points get done and that the money to get them fixed is provided.

Some of these points also may not actually pose a direct contamination risk and so, it needs the management team to have the right mindset before they set off to look for problems.  When the contamination risk isn’t obvious it’s difficult to get people to understand what the problem is, which means they don’t have the ‘want’ to fix it.  This comes down to culture.  The team need to look at these issues with a fresh pair of eyes, which is easier said than done.  One way of doing this, is to ask the team to walk the site – as if they are showing it to their mum.  Would their mum look at it like they do?  Or, if someone was to take a picture and send it to the newspapers, what would the impact be? Even though a lot of these points, may not be a high risk problem, if we’re honest – they shouldn’t be like that and so, they need fixing.

Your site may have a near miss system for H&S issues, you could also set up something similar for staff to highlight issues with equipment and fabrication that need attention. We’d love to hear your thoughts on equipment and fabrication issues and any good ideas you have to try and stay ahead of them! Please add your comments to the reply box below.

NCN 5 – Culture

We’ve covered culture quite a bit in previous articles, if you’d like to review them and cross-check them against your system, you can do that here:


Our Best Practice Internal Auditing Course also covers management commitment and culture, so it’s a really good course to help you build your culture plan and put robust internal audit systems in place, to make sure you’re not at risk at your next BRC audit.  It will also help with your GMP inspections, which may help you to pick up equipment problems like we talked about in NCN 4!

As always, it would be great if you could get involved in the conversation and pop your comments in the reply box below.  Sharing your ideas and experience will help other techies!

Have your say…

3 thoughts on “Issue 8 non conformances – The TOP 5 so far…

  1. Hello Kassy

    Please can you advise where we can access radiological reports for other countries? Goggling brings up many many various reports but how can we be sure its from a credible source such as the government? Is there a one stop shop for this information?

    1. Hi Lauren
      That’s a great question and we’re trying to pull these together to put it onto the article, so we have the resources easy to hand.
      What countries are you looking for and I can try and pull them together?

      1. Hi Kassy

        We based our list on requests sent to us by our customers. We need to consider any raw material supplied to us that originated from a country where a radiological incident has occurred:
        Japan, UK, Ukraine, Belarus, Russia, Austria, Sweden, Finland, Norway, Slovenia, Poland, Romania, Hungary, Switzerland, Czech Republic, Italy, Bulgaria, Republic of Moldova and Greece.
        Thank you for your help.

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