3. Continuous improvement
Completing a GMP inspection
This article looks at good manufacturing practices (GMP) and how they should be inspected.
This article is written to meet the following sections of the Standards:
| BRCGS Food Safety Issue 9 | 3.4.4 Documented inspections |
| BRCGS Packaging Issue 6 | 3.5.5 Hygiene and fabrication-based inspections |
| BRCGS Agents & Brokers Issue 3 | n/a |
| BRCGS Storage & Distribution Issue 4 | 3.2.5 Documented inspections |
| FSSC 22000 Version 5.1 | 2.5.12 Site inspections |
| IFS Food Version 7 | 5.2.1 Site and factory inspections |
| SQF Edition 9 | 2.5.4.3 GMP inspections |
Contents
GMP inspections
If you’re a food site, a food-contact packaging site or a storage and distribution site, you need to do GMP inspections.
Agents and brokers don’t need to complete GMP inspections as they don’t have a physical facility to check. Non food-contact packaging sites can complete GMP inspections if they wish to (it would definitely be good practice) but the BRCGS standard doesn’t state that they must either.
A GMP inspection, is not a systems audit, so you don’t have to record evidence of conformance. It’s a more practical assessment, which is why we call it an inspection (not an audit). A format which allows conformance or non-conformance to be ticked, is acceptable. Where there’s a non-conformance, then what was wrong and what to be done to correct it must be documented.
As a minimum GMP inspections must look at hygiene, clean as you go, equipment, fabrication and personal hygiene.
For more information on the scope of GMP inspections refer to Managing the internal audit programme.
The requirements
There are a lot of requirements in the standards about how system audits must be carried out, but no requirements about how GMP inspections must be carried out. They state what the inspections must look at and that inspectors must be impartial – but that’s about it. So here is a guide about what must be checked and key points about completion of GMP inspections.
Frequency
How often GMP inspections must be completed must be based on risk, but this doesn’t mean you need to have a huge risk assessment. Think of it as a level of risk – from high-risk areas being the riskiest, to external areas being the least risky. Therefore, high-risk areas must be done frequently and external areas infrequently – with other areas fitting in order of risk in-between.
The standards and retailers also have specific requirements around the frequency of the GMP inspections. For example, an additional fabrication inspection and a hygiene inspection must be carried out once every 3 months.
BRCGS Food Safety Issue 9
The changes relating to Issue 9 for GMP inspections are:
- That changes in the factory must trigger a review of the frequency of inspections.
- The results of GMP inspections must be reviewed by management at performance reviews.
- That any non-conformances that are identified during GMP inspections must follow the typical non-conformance management procedure.
GMP
The following provides an outline of the type of good manufacturing practices and practical controls that must be assessed during the GMP inspections.
Records
Records must be completed following the procedure and all data entered onto records must be legible. Data recorded must be accurate.
People management
Staff, visitors, and contractors must adhere to personal hygiene and protective clothing rules.
Fabrication, equipment, and tools
The fabrication in the area, equipment and tools, must be clean and not pose a foreign body risk.
Wooden pallets must not be present in open product areas.
Engineering equipment must be correctly stored away when not in use.
Allergen equipment must be used and stored correctly.
Knives must be labelled and in good condition. Snap off blades must not be present.
Cleaning
Spills must be addressed at the earliest opportunity.
Pooling water must be cleared away regularly.
Hosepipes must stored off the floor. Drains must be clear and not smell.
Cleaning equipment and chemicals must be correctly stored away when not in use.
Waste must be segregated and emptied regularly.
Pest management
Pest monitors must be in good working order, secure and clearly labelled.
Product defence
Where access controls are required, these must be in place.
Digital systems must not be left unsecure.
Non-conforming materials
Any materials that are non-conforming must be clearly labelled, so that they don’t get used by mistake.
Completing the GMP inspections
The GMP inspector must be trained so that they know how to follow the internal audit programme procedure and complete the related GMP inspection records.
It’s also a good idea to train inspectors on how to:
- Organise the inspection with the person that’s responsible for the area.
- What to look for, including good manufacturing practices (GMP) as detailed above, and practical controls (CCPs, process controls and records etc.)
- How to identify and record non-conformances.
- Communicate the results.
- How to close out any non-conformances that are completed during the inspection.
- How to submit the inspection.
Role-based internal audit training
You can choose from a range of courses, each one designed for a particular role in your team. Find out why this type of training is better and quicker, than the internal audit training that you’ve used before.
Hello Kassy,
Our sites operate under BRC certification and I’m assisting our team to establish a GMP checklist to inspect the canteen and locker/changing area. Do you happen to have or know of such checklist? If so, please kindly share if you don’t mind. Thank you much in advance for your assistance.
Hi Hien, Hope you’re well, it’s been a while! 🙂 We do have these, but they’re all now on our fancy new software – audIT.app. The software automates the process. You can watch a demo of it here: https://techni-k.co.uk/knowledge-base/audit-app-full-demo/
Kassy
Thank you very much, Kassy and yes, it’s been a while since we last communicated. Hope all is well.
I will share the link you sent with our sites and revert back if there’s anything else that we need.
Thanks again and Happy Holidays.
Regards,
Hien T.
Sorry, if you can see the time the note was written I wouldn’t have been coherent but we were testing our first mince pies!
I think GMP “checks” need to be audits, you are checking that the pre-requisites have been implemented. This, as an audit (3.4.1), needs to show compliance as well as non-compliance. Each BRC/BRCGS audit that I’ve had has taken this view and has even questioned whether “complies” was sufficient a statement.
The Hygiene inspection and the Fabrication inspections you are right, these form separate inspections and do not need to show compliance.
Regarding to the issues from the GMP inspections being raised as part of the non-conformance management – where exactly BRC mentions this in Issue 9 as I must have missed this? This is addition to the clause 3.4.3 however, are the GMP inspections part of the internal auditing programme or part of fabrication and hygiene inspections? I have always accounted GMP inspections under clause 3.4.4 therefore, actions from those reports wouldn’t need to go through non-conformance management. Could you clarify this please?
Hi Justyna,
Sorry for the delay, just getting back to grips with things now that Issue 9 is nearly done.
It’s clause 3.4.4 that says that actions from GMP inspections must be handled like those from system audits. GMP inspections are part of the internal audit programme. They can also be referred to as fabrication and hygiene inspections.
I’m not sure what you’re saying here “I have always accounted GMP inspections under clause 3.4.4 therefore, actions from those reports wouldn’t need to go through non-conformance management.” I agree GMP inspections come under 3.4.4 – but why would this mean that non-conformances from them, wouldn’t get managed as non-conformances?
Kassy
Hi Kassy,
Thank you for your replay.
We have always managed actions from the GMP inspections through the reports and corrective actions recorded there. We would only raise non-conformance from the GMP for occurring and major issues. Is this not correct thinking? Does it mean for Issue 9 we need to raise non-conformance for every individual action from the GMP inspection?
Many thanks, Justyna
Hi Justyna
I think this is getting lost in the definition. A non-conformance is a deviation from the standard. So anything you find on a GMP inspection that doens’t meet the standard, is by definition, a non-conformance. A corrective action is something you apply to correct a non-conformance. So the ‘actions’ that you are identifying and then applying corrective action to, on your GMP inspections, are non-conformances. This means you must handle the corrective actions from them, as you would any corrective action identified as a non-conformance.
Does that make sense?
Kassy
Hi there. I’m a little worried about this advice, unless you can persuade me otherwise. I think that the GMP comes under audits from issue 9.
“3.4.1 The scope of the internal audit programme shall include, although this is not an exhaustive list:
•HACCP or food safety plan, including the activities to implement it (e.g. supplier approval, corrective actions and verification)
•prerequisite programmes (e.g. hygiene, pest management)
•food defence and food fraud prevention plans
•procedures implemented to achieve the Standard.
GMP is the “audit” of the pre-requisite programme and so does need to show compliance and non-compliance.
3.4.4 Inspections of maintenance and hygiene do not need to show compliance.
Please look and see that I’m wrong or not.
Morning Julie,
I think you’re saying that a GMP inspection doens’t need to record compliance, and non-compliance. Which is correct.
Where does the advice imply otherwise? Sorry, I’m a little confused. 🙂
Kassy
Kassy,
Is there any frequency recommendations and ‘repeats’ for GMP inspections please?
Hi Chris,
Open product areas must be at least monthly. However, the frequency for everything else must be based on risk. So, the minimum for low risk would be monthly, high-care and high-risk would be more than that. Non product areas, can be less.
Kassy
Hi, a very helpful article as always. I work in Argentina in a fish factory and we conduct daily checks, the first preoperative and the second and even a third operative. The inspection covers all the above mentioned and even labels that can be obsolete. My risk analysis gives me monthly inspections in some cases but we do it daily anyway.
Regards
Hi
We currently roll out GMP training and have an internal audit system which audits all of the above topics on an annual basis. Therefore would there be a need to complete a seperate GMP inspection as well? Would we be given a non-conformance under BRC issue 9 by not doing a GMP inspection?
Kind Regards
Hi Tracy
Depends – if you’re a food contact packaging site, then yes. If you’re not producing food contact packaging then you don’t have to have GMP inspections as well as sytem audits.
Thanks
Kassy