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ISO9001 And The Preservation Clause

Preservation may sound like an unusual thing to talk about when it comes to ISO9001:2015 but that's exactly what clause 8.5.4 is all about and as is the tendency for this standard it's a small clause, only 20 words in fact, and a short note to give some hints, surely that can't be a big deal then?... well it is and here's why.

Clause 8.5.4 is 100% about how you ensure the output of your production or service, i.e. your end product is maintained in a way that ensures that it meets all the requirements of the product or service that you have previously identified, essentially what are you going to do to ensure that the product reaches the end customer undamaged and fully functional.

It's not enough to think about this preservation requirement at the end of the process you need to build it into your entire system in several areas for example: 

Identification 

Identifying the product or service clearly throughout the process is important, you must know what you are making and that this stays the correct item through out the entire process. Think of it as making a car, you start off with a requirement to make a blue car part number 1234 but part way through it gets accidently painted red because the part number isn't' attached to it and they had red paint in the spray guns. So creating a way of clearly identifying the products being produced start to finish is key, especially if subassemblies are involved the product evolves over the course of the process.

Handling 

How you handle and move product around the operation needs to be thought of to ensure that there is no risk of damaging the product. In electronics we used conveyors and trolley racks with 3mm edge slots that could hold the boards without touching components and accidentally knocking them off for example. Gloves were worn to not get finger grease onto the boards which can cause problems, electrostatic flooring meant we created an environment that was shock free again to protect the products being handled. In certain parts of the plant it was positively pressurised which ensured that that area was kept dust free to avoid contamination of the product, this is particularly important in food or medical processes for example. All of this was backed up by training of the staff, so they knew why these things were important.

Packaging 

Correctly packaging your product is critical to ensure it reaches the end customer in working order. The type of packaging, the quantity, shape, does it have to be airtight or water tight need to be taken into account. When handling packaging in previous companies we even carried out drop tests on the packaging as it had to meet specific packaging standards to mitigate damage in transit. As part of the packaging you may also need to thing about how you add security to the packaging, does it need to be tamper proof, do the tapes or labels on it need to be tamper evident and so forth.  

Storage 

How you store your product is really important and how you do it may depend on a number of things, for example if you are making a food type product you may need to keep it refrigerated, electronics need to be obviously kept dry and in a controlled temperature, so those things are pretty obvious.

It may be that you require different set ups for storage both short term and long term and within warehousing where say a forklift was required to be used

Contamination Control 

I hinted at this previously but it's so important but it's worth stressing that ensuring you control contaminates to the right level is key, you may not need to worry about dust or moisture or any form of contaminant or you may need to implement an ISO class 4 clean room (that's' pretty clean).

Summary 

ISO9001:2015 clause 8.5.4 is a total of 20 words outlining the need for the organisation to ensure preservation of the product but don't be fooled by the brevity of the clause there is a lot to think about here to meet this requirement. Identification, handling, contamination, storage and packaging are just some examples that the standard provides but there may well be more requirements within your organisation. The responsibility to take the time and identify these things is down to your team and then ensure that it's captured in your processes.


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Monday, 19 August 2019

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