We’re now over 12 months on from when BRC Food Safety Issue 8 went live and the NCNs you have provided, is producing some good trending information.

The following provides guidance on what to do to make sure your site doesn’t get these NCNs.

Although the trending has come from food sites, the guidance applies to packaging and storage & distribution sites too.

We’ve already covered the top 5 NCNs so far (https://techni-k.co.uk/issue-8-non-conformances/) and so, in this article we’re going to cover the 6th and 7th NCNs, which are:

  • Clause 3.3.1 – record keeping
  • Clause 4.11.1 – that the premises must be clean and hygienic

NCN 6 – Record keeping

We covered this in a previous article: Document control for Issue 8 – Digital Storage (https://techni-k.co.uk/document-control/), so just review your current system and make sure it’s compliant.


NCN 7 – Clean and hygienic

The fact that these non-conformances are being assigned to 4.11.1 tells us that it’s the general standard of cleaning that isn’t acceptable.

If you look at the trending information for section 4.11 housekeeping and hygiene though, you can see that there are also quite a few non-conformances for 4.11.2 (cleaning procedures) and 4.11.6 (cleaning equipment).

This indicates that perhaps sites which get a non-conformance for the general standard of cleaning, may also get another non-conformance for cleaning procedures or equipment as well.

What does this tell us?

If the general standard of cleaning isn’t right, then this means the systems itself isn’t working as it should. You can have the best cleaning procedures and equipment in the world, but if the time, manpower and training isn’t allocated to cleaning, then the result will be poor.

And also, you can have all the time in the world to clean and all the manpower you need, but if you don’t give them right tools to do the job, including instructions and training on how to do it right – then again, the results will be poor.

In order to have the right standards of hygiene, all the pieces of the puzzle need to be in place. So, let’s go back to basics.

What do we need to clean?

As a minimum, the hygiene schedule needs to cover all areas of the site where raw materials, product, packaging, waste and processing equipment are handled, processed or stored.  The environment, surfaces and the equipment in these areas must be on the hygiene schedule.

The first thing that needs to be done to create a robust hygiene system, is to define which areas of the site need to be covered by the hygiene schedule.  It’s a good idea to actually mark these down on a site plan.

Here’s a top tip! 

One thing that frequently is a factor when it comes to poor hygiene standards at sites, is that there are no defined responsibilities for areas from a GMP or ‘clean as you go’ point of view.

Can you currently walk into any area of your factory and be able to pinpoint who is accountable for keeping that area clean and tidy?  I’m sure you’ll be able to say yes to that question; for the easy areas, like stores, the weighing up area, or the production area.  But what about the grey areas that always get forgotten?  Who is accountable for the tub wash or the wash room?  Do you have areas of the site where two areas meet, that are a bit of a no-mans land?  Like bulk infeed areas or water treatment areas?

These areas tend to be the ones which get missed.  When you’re marking out the areas of accountability on your site plan, think carefully about where areas join and make sure all of the areas are covered – so it’s clear who is accountable for which areas for GMP and clean as you go.

 

How often should we clean?

Once you’ve worked out all the areas and equipment that needs cleaning, you then need to work out how often they should be cleaned.

This should be done using risk assessment.  The typical severity and likelihood method works well for this.

Work out for each clean if the clean is carried out to:

  • Prevent pathogenic contamination which would be high risk,
  • prevent general hygiene micro contamination which would be medium risk, or to,
  • prevent physical contamination which would be low risk (depending on the type of physical contamination of course).

Then work out the likelihood of that clean causing product contamination, as a general rule the following works well:

  • High risk would be for product contact surfaces and equipment,
  • medium risk would be for non product contact surfaces in areas where the product is open
  • low risk would be for areas and equipment where the product is enclosed.

 

Using the above you can then work out what overall risk rating each area and piece of equipment should be.  Then set a frequency for each risk and apply that.

 

Procedures

Cleaning procedures are typically called CIC’s (cleaning instruction cards) and these are what you use to train your staff.

They need to include at least the following:

  1. What is to be cleaned – so the name of the equipment or area. And, where it is part of a piece of equipment, a description of which bit.
  2. Who is responsible for actually doing the clean
  3. How often the clean must be done (based on your risk assessment)
  4. What equipment is needed to do the clean
  5. What chemicals are needed and at what strength they need to be used at
  6. A step-by-step method of how the clean should be done

 

It is also good practice to include the following as well:

  • The reference of the cleaning record that should be completed when the clean is done, so that they link together
  • How long the clean should take – this helps the person carrying out the clean to understand how big or small the job is and can also be used by the person managing the cleaning schedule, to calculate how much time is needed for all the cleans that are planned
  • Photographs which help to explain how equipment should be dismantled and put back together
  • Who is responsible for checking the clean after it’s done and how often this should be done (every clean, once per week etc.)
  • Photographs of key inspection points that the person checking the clean should use, to make sure that the clean has been done effectively.

It’s also a good idea to go back to your list of items and areas that need cleaning and include the reference for the CIC (procedure) and the reference for the cleaning record for sign off, next to each one.  That way you can cross check that you’ve got them all covered.

Chemicals

Making sure you use the chemicals at the right strength is obviously really important and making sure that you follow the method provided by the supplier, to ensure that the clean is effective and there is no risk of chemical residues.  We’ve covered chemicals in a previous article: https://techni-k.co.uk/chemical-control/

Cleaning the cleaning equipment

Another point that commonly gets forgotten is cleaning of the cleaning equipment.  If you’re using dirty equipment to do the clean, you’re not going to get the right results.

Put your cleaning equipment on your list, risk assess it for frequency and create cleaning instruction cards (CICs) for them.  They should be managed just like everything else, so you’ll need cleaning records for them too.

Training

Once you’ve got all your cleaning instruction cards (CICs) are done and your cleaning records ready, you need to train them out to everyone who will be doing the cleans and also anyone who will be verifying the cleans.

There will most likely be a lot of CICs to train out, to a large number of people.  So, including the list of CICs on your training matrix to help you make sure you cover everyone that’s needed. And don’t forget to set a retraining frequency.

Review

When your system is up and running, it’s not finished – it should constantly be in a state of review.

Use the verification of your cleans to see if they are working. If cleans are failing when they are checked and having to be recleaned, this is an indication that the system isn’t working.  Your task is then to find out why it isn’t working.  Has the training not been adequate?  Perhaps there isn’t enough time being allocated? Maybe the cleaning method isn’t sufficient?

You also should use your GMP inspections and internal and external audits to highlight if your cleaning frequencies are adequate.  If you are getting non conformances for cleaning, either the system isn’t effective or your not cleaning it often enough.

And, on the flip side – get those that are cleaning to report back to you, if they go to do a clean and it doesn’t need doing.  You can use this information to reduce the frequency of such cleans.


 

I hope that’s been helpful and you can now go and really scrutinise your system to ensure that it’s effective – so you don’t fall foul of this common non-conformance.

As always, if you have any knowledge or experience that you can share on this topic, please do so and add it into the comments section below. Or if you have any questions, please do the same and I’ll do my very best to help.

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