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Part 2: GMP Audits – NCN’s #8-5

Continuing on from our last post, where we go through the most common NCN’s sites are receiving since BRC V7 was launched.  If you missed the last post, you can check that out here. 

NCN #8 Ceiling & Overheads (clause 4.4.5)

This clause is all about making sure that anything over the product does not pose a risk of contamination. It is not just restricted to fabrication such as the roof, ceiling and walls, but it also includes any equipment as well that is above product or raw materials. Below is a list of all the possible issues that may cause a non-conformance to this clause. Have a look through and think about whether your plant may be at risk of any of them…

  • sealant that has come loose and is hanging from ceiling edging
  • mound growth of the ceiling or walls in warm damp areas such as wash rooms
  • steps that go over conveyoring need to have solid treads (steps) and also kick plates on the edges so that debris from shoes cannot get kicked over the edge
  • peeling paint from walls, ceilings or even overhead painted equipment
  • debris build up on overhead fan/extraction units
  • worn insulation around pipework, which is coming loose
  • dripping condensation on overhead pipework that is not lagged or insulated
  • product debris from overhead product conveyors dropping onto open product below

Make sure you assess open product or material areas (don’t forget areas above food contact packaging), to see if there is any risk of contamination falling from above.  Make sure that high level conveyors have catch trays underneath and that open product conveyors have covers where there is a risk of contamination falling from above.

NCN #7 Door Control (clause 4.4.9)

There are two main issues with regard to door control, that most sites suffer from…

  • external doors being left open when not in use
  • external doors not being sufficiently proofed to prevent pest ingress

Make sure that checks for door control and proofing are included in your monthly GMP audits, so that any slips in compliance are picked up and tackled straight away.

NCN #6 Equipment & Maintainance (clause 4.6.1)

This clause is all about ensuring that any new or existing equipment does not pose a risk to the product…

In order to comply you need to ensure that existing equipment is risk assessed and where there are significant risks, these are removed where possible or controlled.

Prior to installation of new equipment, the equipment needs to be assessed to ensure that it can be effectively cleaned and that the equipment does not pose any significant chemical or physical risks.  You need to be able to provide evidence to show that the equipment has been commissioned.  To help with this I’ve provided you with a commissioning sign off form for you to use. 

It’s a good idea to have a walk around your plant and just make sure that equipment has enough access underneath it, behind or to the sides of it (if located by a wall) to clean. Where there is very minimal space to clean (say only a 5cm gap) then this gap should be sealed up, so debris cannot get into it. Make sure the gap is cleaned though before you do this, so it doesn’t create a pest issue when its blocked up.

NCN #5 Chemicals (clause 4.9.1.1)

This clause covers quite a lot of requirements, so I’ve created a list below of all the things you need to make sure you’ve got covered…

  • Chemicals that are used on site must be approved and must be shown to the auditor in the form of an approved chemicals list – make sure you include cleaning chemicals, engineering chemicals, inks and lubricants
  • There should be a documented approval process which explains what steps must be taken to approve a new chemical
  • That there is a material safety data sheet and specification for each chemical on the approved list
  • That all chemicals on the approved list are food grade
  • That the chemicals are not strongly scented, as this may cause taints
  • Make sure that operators who use chemicals have chemical training
  • Make sure that operators using chemicals have the right equipment to transport and use the chemicals, so they don’t have to put chemicals in containers which are not labelled
  • That containers that hold chemicals are always clearly labelled
  • That chemicals are stored in locked area when not in use
  • That chemicals that are in use are not accessible to those that are not trained to use them
  • Chemicals are stored so that they do not pose a risk of product contamination (in case of leaks etc)
  • That acid and alkaline chemicals are not stored together, but are sufficiently segregated
  • That procedures for use of the chemicals follow the manufacturers guidelines, e.g. ensuring that cleaning chemicals are rinsed after use
  • That chemicals used do not contain prohibited substances, the best way to ensure this to purchase them from reputable suppliers

I would suspect that the majority of the non-conformances in this area come from the day to day adherence to the clause – ensuring the locked areas are kept locked and making sure that chemicals are handled correctly – not keeping them in unlabelled containers.  So make sure that these type of things are checked on your GMP audits.

3 Comments

  • Olu says:

    Please can you explain further about the Document Approval Process for Chemical Suppliers and Equipment commissioned process.

    • Kassy Marsh says:

      Hi,

      Sure, no problem! It’s not a document approval process as such, but you do have to document the approval – if that makes sense?

      You must approve any new chemicals before they are used (just like you would with ingredients). It’s up to you to define what the approval process looks like for chemicals, but I would recommend that you look at things like:
      – is the chemical coming from an approved supplier?
      – is the chemical approved for use in food facilities (does it have a food grade certificate)?
      – what is the application of the chemical going to be (e.g. cleaning detergent) and does the manufacturer recommend it for this use?
      – what are the instructions for use recommended by the manufacturer and do they work for your application?
      – does it pass for H&S (COSHH)?
      On the ok, for all of the above, you would need to trial the chemical and make sure it passes. For cleaning chemicals you may need to validate the cleans, using swabs etc.

      For approval of new equipment, the process is similar – you need to put together a process of all the things you’ll check prior to installation of the kit. I created a check sheet for this, on this post, that should help you do this.

      I hope this helps, but if you have any more questions – just reply through the comments.

      Thanks
      Kassy

  • Olu says:

    yes this has been very helpful.

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