BRC Packaging risk assessments galore!

The effective date (when you’ll be audited from) for BRC Packaging Issue 6 is fast approaching.  If you have your audit from Feb 2020, you’ll need to be ready.

There is one massive change to the standard for packaging manufacturers, who were previously classed as basic hygiene – as the standard is now combined into one.  There is no longer a set of requirements for high hygiene sites and another for basic hygiene sites.

What does that mean for basic hygiene sites?

Well, before you panic, most of the requirements in the basic hygiene Standard and the high hygiene Standard were the same, so it’s not as scary as it may first sound. However, and this is a big HOWEVER, it will mean some extra work for you, if you’re a basic hygiene site.

Now, it means that all of the requirements apply to you, unless you can prove that they don’t.  And, the only way you can prove that they don’t apply to you, is to provide a risk assessment which justifies clearly – why they don’t.

There are parts of the Standard, that are confusing.  For example, the statement of intent for medical screening, refers only to food contact or hygiene sensitive packaging (i.e. the high-hygiene sites), however, further down in the clauses it says you need a risk assessment to confirm what you must put in place.  So, don’t fall into the trap of thinking you don’t need a risk assessment, even where it states that it doesn’t apply to basic hygiene packaging.

Risk assessment

So, both high hygiene sites and basic hygiene sites now need to get really good at risk assessments, because you need them for most sections of the Standard. How you construct the risk assessment will depend on the subject, but we’ll be working through examples of these in the forthcoming articles for you.

To start with we thought it would be a good idea to provide you with a list of all the risk assessments you’ll need, so that you can appreciate the size of the task that you have in front of you. Please bear in mind when looking at this list, that some of these risk assessments can be carried out within your hazard and risk analysis for section 2 and also 5.4 process control.  However, you’ll need to make it really clear, if you incorporate them into one (or two), how they link back to the relevant sections.

What risk assessments do you need?

Ok, here you go – here’s the list of all the 46 risk assessments that we’ve found in the Standard:

  • 2.1 Hazard and risk analysis – product safety
  • 3.3.4 product lifetime for record retention
  • 3.4.3 statement of compliance review frequency
  • 3.4.5 specification review frequency
  • 3.5.1 internal audit frequency
  • 3.5.5 GMP inspection frequency
  • 3.7 supplier approval and monitoring
  • 3.8 vulnerability assessment
  • 3.9.2 outsourced/subcontracted processes
  • 3.10 approval and monitoring of service suppliers
  • 3.13.1 traceability (where traceability can’t be focused down to a small batch)
  • 3.13.4 what constitutes an incident
  • 4.1.1 local activities and site location
  • 4.1.3 building fabrication to prioritise actions
  • 4.2.4 glass windows to determine if is protection needed
  • 4.2.5 glass items to determine protection requirements
  • 4.2.6 elevated walkways
  • 4.2.8 ventilation
  • 4.3.1 water
  • 4.3.2 product contact steam, ice, air and gas
  • 4.4 threat assessment
  • 4.5.2 product process flow
  • 4.6.2 new equipment maintenance
  • 4.7.4 maintenance activity
  • 4.8 hygiene and housekeeping tasks, methods and frequency
  • 4.8.5 environmental monitoring
  • 4.9.1 glass, brittle plastics, ceramics and similar materials
  • biological control
  • 4.10 waste movement and flow
  • 4.10.2 process waste
  • 4.11.2 pest management scope and frequency
  • 4.11.6 infestations
  • 4.11.7 following an infestation
  • 5.1.2 product trials
  • 5.3.1 printed packaging
  • 5.4 quality and integrity hazard analysis
  • 5.5.2 measuring devices accuracy, calibration and corrective action
  • 5.6 product inspection
  • 5.8 incoming goods inspection
  • 5.9 storage
  • 5.10.2 transportation of materials
  • 6.1 agency training verification
  • 6.2 personal hygiene
  • 6.3 staff facilities
  • 6.4 medical screening
  • 6.5 protective clothing

Please note, where you are including traded products in the scope of your audit, you will need to include traded products in the above risk assessments.

That’s a long list!  Over the coming articles we’ll go through risk assesment methodology, the important factors for what you need to include in them and what you need to get out of them.

If you have any specific questions, please just pop them in the reply box below!

Have your say…

6 thoughts on “BRC Packaging risk assessments galore – 46 to be exact!

  1. This is very informative. I really appreciate the good work done by the team. Eagerly waiting for the risk assessment methodology employed and the outcome of the same


  2. Hello,

    Does it mean we have to have a separate risk assessments for all of those above?
    We produce secondary packaging and our risk assessment is built in HARA. Would I need to add all of those above for HARA?

    1. Hi Justyna

      You can have it within your HARA or separate. But if you have it within, then you need to make sure the scope of each risk assessment is covered – so it’s really clear.


      1. Do you mean that when I risk assess I have to make sure I am clear in what exactly I am assessing? I need to do risk assessment on the frequency of various audits done on site including GMP frequency. I just do not see how I can built it into HARA when HARA lists all hazards and audit is not a hazard. Thank you for your replay. It is so nice to know you can get an advice for experts 🙂

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