6.2 labelling & Pack Control
The management controls of product labelling activities shall ensure that products will be correctly labelled and coded.
This section of the standard has been updated with 2 new clauses and is more detailed, bringing into the standard more of the clauses which are defined in the retailer COPs. This is because one of the top reasons for recalls and withdrawals is due to product in the wrong packaging – which means that a customer could be consuming a product that contains different allergens than those listed on the pack.
This clause is all about ensuring that the correct printed packaging is used for the right product. Many pieces of retailer packaging are similar in design and so this makes it even harder to ensure that the correct packaging is used.
It’s a good idea to try to manage the packaging in a way in which it makes it easy to get it right. This starts right at the beginning at goods in and then following the process all the way through to when the packaging is used. I will provide you with some details below of how you can do this – but please be aware I’m providing you with this information to help you make it easier to get right – it’s not part of the requirements of section 6.2:
Part of the acceptance procedures should be that the packaging in the boxes is checked against the label on the outside of the box. (It has been known for packaging suppliers to put the wrong packaging in the box). To do this a piece of packaging has to be removed from the box and checked. Once checked and confirmed it is correct, it is then a good idea to attach this packaging to the outside of one of the boxes but not covering the original label. This makes it easier later in the process when operatives are looking for the packaging to see it, as they can go by the label on the box and/or the piece of packaging attached to the outside.
When packaging is delivered depending on the volume delivered, it may be on mixed pallets. The boxes should be separated onto different pallets to go into the stores. Leaving them on a mixed pallet increases the risk of an operative coming to collect the correct packaging, finding it on the pallet and not realising the pallet contained other types of packaging and so, taking 2 boxes – one right and one wrong.
In Use Storage
Once packaging is removed from the main stores it’s advisable to have set places for the packaging to be stored, so people get used to where the packaging is stored that they’re looking for. The shelves should also be labelled with the individual names of the pieces of packaging so it’s easy to find what you’re looking for. You can make this even easier to navigate by having a colour coded system for different customers, recipes etc.
Changes to Packaging
When ever the artwork changes for a piece of packaging it is really important that this is communicated to those who handle packaging, at goods in, in the stores and on the line. This way they know that they are looking for something that looks different from what they are used to and the new design looks like.
(NEW) 6.2.1 There shall be a formal process for the allocation of packaging materials to packing lines and control in the packing area which ensures that only the packaging for immediate use is available to the packaging machines. Where off-line coding or printing of packaging materials occurs, checks shall be in place that only correctly printed material is available at the packaging machines.
To comply with clause you need to ensure that there is a documented procedure, which all relevant personnel are trained on. The procedure needs to include how the printed packaging should be issued to the line. Ideally retailers want this to include a ‘mass balance’ of the packaging – meaning that a quantity of packaging is issued to the line (for example 1,000 printed pots) and that the quantity used to complete the order is accounted for (say 850 printed pots) and so the remainder (150 printed pots) were returned to the store. However, practically this is really difficult to achieve especially when you are using something like printed labels, as counting or working out how many labels have been used or are left on the reel is really hard. In reality having a procedure that states that the printed packaging will be taken from the stores and issued to the line only once all the previous packaging has been removed from the line and put back in the stores is adequate. There must be checks and confirmation that this has happened prior to packing commencing, which is part of clause 6.2.2 which we’ll talk about on the next update. This clause however does cover checks of printing of packaging which happens off line – such as labels that are printed away from the packing line. To ensure that the off line printing is accurate, there must be a documented procedure. This procedure must detail where the information is taken from for printing and how it is controlled. For example the date and trace code that is used in the printing needs to come from a controlled document or system. Prior to commencing printing a piece of the packaging should be checked against a standard and also the controlled document (for information that changes such as trace or dates), this check should be documented and confirmed as correct prior to printing. Once the printed packaging is issued to the line, again it must be checked to ensure that the correct printed packaging has been received.
For the section 6.2 Labelling & Pack Control – when packaging of a product has been completed, all printed packaging must be removed away from the line BEFORE the next set of packaging is brought to the line.
Be careful! The standard now says that when printed packaging is removed from the line it must be stored in a ‘designated, secure location with authorised access’. There are not many sites that I’ve seen that have the facilities to do this. This would mean either containing all printed packaging in a locked room where only certain trained personnel have access, or securing areas within the store using something like a cage. Where the ‘secure area’ is not provided I would suggest you write into your procedure what controls you have in place instead, for example this may be that all personnel who have access to the area know that they must not take packaging under any circumstances – that only trained personnel are allowed to do this. This must be trained out and documented. It is recommended that if you do this, this requirement is added to your GMP audits – personnel could be questioned as to whether they think they are allowed to take packaging, where the wrong answer is provided, then re-training must be completed.
Remember that you need the procedure needs to cover all printed packaging, so if your product includes more that one piece of printed packaging you need control them all. This also means that when you get to applying checks (covered in 6.2.3) you need to confirm that each piece of the packaging is correct.
That’s it for this week. It’s up to you now, your challenge for the next two weeks (if you choose to accept it) is to look at the way you handle your packaging and your packing procedures to see if they comply with clause 6.2.1 and see if you can implement any of my suggestions to make it easier for your team to get it right. Next time we’ll cover 6.2.2 and 6.2.3.
If you need any help with implementing these changes we can always help you, we’re happy to provide free advice either through the comments section below or if you prefer over the phone on 07955 211023 or via email at firstname.lastname@example.org