We’ve arrived at the top of the NCN list!
This week we bring you the TOP BRC non-conformance in audits since the launch of version 7.
Supplier approval and monitoring is now the No. 1 non-conformance received by sites, since the launch of version 7. Traceability is now No.2 non-conformance, however one of the clauses in the traceability section, is actually linked to supplier questionnaires, so sits within the supplier approval process too. In this week I’ll cover both, so you can check your system and make sure you’re not at risk of getting these non-conformances on your audit.
I’ve provided you with a check sheet in this post to help you carry out traceability exercises with your suppliers, to meet the standard for low risk suppliers. The non-conformances we will cover in this section are relating to the below clauses:
3.9.3 (new clause)
AREA OF COVERAGE
Raw material risk assessment
Supplier risk assessment
Traceability approval of low risk suppliers
NCN SITE %
Clause 220.127.116.11 – Raw material risk assessment
We’ve covered this a number of times before, so I’m not going to go into detail on this clause. This section now expects the raw material risk assessment to cover 2 new elements, which are:
Packaging must be included in the raw material risk assessment. To find out more about raw material risk assessments you can read a previous post:
Food fraud also needs to be included, however I would recommend that you cover food fraud as part of section 5.4 Product Authenticity, Claims & Chain of Custody. To learn more about how to comply with the food fraud assessment (otherwise known as vulnerability assessment), you can read our previous posts:
If you would like some help putting your vulnerability assessment together, we have published methodology, eLearning and documentation available instantly. You can check them out and see how much they can help you here:
Clause 18.104.22.168 – Supplier risk assessment
There are a couple of elements which are new to this section, which are tripping sites up, these are detailed below.
Supplier Risk Assessment – The main non-conformances in this area are due to the fact that the risk assessment carried out is not comprehensive enough. I’ll explain how you can make sure your risk assessment is detailed enough to comply…
Each supplier must be risk assessed, against certain elements. Remember a raw material risk assessment and a supplier risk assessment are different, so ensure that you have both!
A raw material risk assessment looks at the risks involved with the raw material itself (the risk of Salmonella in egg for example), whereas a supplier risk assessment looks at the risks due to a particular supplier supplying you with the raw material(s).
The risk assessment for your suppliers needs to assess the ability of the supplier to provide and deliver the raw materials to the specification agreed, therefore you could assess them on things like:
- Delivery performance
- Non-conformances – either from delivery issues or complaints due to the raw material
- Volume of raw material used
- The inherent risk of the raw material supplied
The volume of raw material is a key element. Flour may be a low risk ingredient – from a microbiological point of view, however if you are a bakery it is a key ingredient. Lack of supply of flour, or a contamination issue in the flour would have a huge impact on the business, therefore you would expect flour to be assessed by a bakery and it not to come out as low risk.
We have documentation packs which meet 3.5 Raw Material & Supplier Approval & Monitoring and provide you with both a raw material risk assessment and supplier risk assessment systems, plus supplier questionnaires that you can just pick up and use. Our Bells & Whistles pack even provides you with loads of examples for your raw material risk assessment and goods in systems that you can use.
Scope of the Supplier Audit or Questionnaire
You need to ensure that where you have determined through risk assessment (as above) that an audit or a supplier questionnaire is required to approve or monitor your supplier, you must ensure that the scope of your audit or questionnaire covers:
- Product safety
- HACCP review
- Good manufacturing practices
The above are new requirements to the standard, so take a look at your audit scope or your questionnaire and make sure that they cover all of the elements above. It would be a good idea to ensure that they are formatted so that the above titles are used – your auditor will like to see the exact wording from the standard.
I have a couple of other posts that will help you in this area as well, that you can read:
You also need to make sure that if you do supplier audits, that you use a competent auditor. The BRC does not say that your auditor needs to have formal qualifications (such as lead assessor) however, you need to be able to prove that they are competent. This is clearly very difficult without any evidence. One way of doing it, is to have a formally qualified individual shadow your auditor on an audit to assess them and provide them with a certificate if they prove to be competent.
Clause 3.9.3 – Traceability approval of low risk suppliers
BRC have now stated that a supplier questionnaire is only acceptable for approval and monitoring of low risk suppliers. In addition to this; they have added a new requirement to version 7, where you have to conduct a traceability exercise with all of your low risk suppliers as part of the approval and monitoring. Unfortunately, rather than putting this in with the supplier approval and monitoring requirements, they have decided to put it in the traceability section – I think this may be why it’s getting missed.
Go through all of your suppliers which have been approved using a supplier questionnaire and make sure you’ve carried out a traceability exercise with them. This can be a desktop exercise, but you do need to review the information and ‘approve’ the test. To help you with this I’ve provided you with a traceability check sheet, that you can provide to your suppliers, so that they present the traceability test to you in a way in which you can easily check it and review it.
Finally just behind the top NCN is…
Clause 3.9.1 – Traceability
The second most common NCN since V7’s release is clause 3.9.1. This isn’t a new clause, but sites are still getting non-conformances because they are forgetting to include traceability of work in progress materials, re-work and packaging.
One way of making sure that this doesn’t get missed, is firstly to carry out a full review, to make sure all elements are covered and then, you could include a question on your routine GMP audits – to check the product being produced at the time – are processing ingredients, rework, WIP and packaging being traced. Also don’t forget to trace WIP packaging, such as baking paper or plastic sheets on trays.