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One of the questions I get asked a lot (and it really is a lot!) is "How does ISO define traceability?" that's always accompanied with: what do they want, what things do I need put in place, will it be expensive and but my customer doesn't care about it!
The answer, initially at least is, "It depends!" Obviously, this is not overly helpful, so we never leave it there we need to understand what it depends upon and who you are trying to satisfy.
The 1st part of the it depends discussion is which standard are we talking about since ISO have a great many standards and many have requirements for traceability but lets focus on the most popular which gets the most amount of interest ISO9001:2015. ISO13485:2016 for Medical Devices has additional requirements for traceability on top of 9001 as does ISO22000 for Food safety but those are for other posts.
The ISO 9001:2015 clause for traceability also includes identification. That makes sense really since it will be pretty hard to trace something if you can't first identify it. There are three parts of the requirement, here's what it says:
The organisation shall use suitable means to identify outputs when it is necessary to ensure the conformity of the products and services.The organisation shall identify the status of the outputs with respect to monitoring and measurement requirements throughout production and service provisionThe organisation shall control the unique identification of the outputs when traceability is a requirement and shall retain documented information necessary to ensure traceability. 8.5.2 Identification & Traceability
The organisation shall use suitable means to identify outputs when it is necessary to ensure the conformity of the products and services.
The organisation shall identify the status of the outputs with respect to monitoring and measurement requirements throughout production and service provision
The organisation shall control the unique identification of the outputs when traceability is a requirement and shall retain documented information necessary to ensure traceability.
As we all know when ISO says Shall it means you must, so obviously you must do these things, erm… no because they have that extra little bit when it is necessary or when it is a requirement. So who decides if it's necessary or a requirement, typically your end customer or the industry you are in is the answer, hence the original 'it depends' statement because your customers and your industry may not require them or may only require some level of traceability.
From an ISO point of view however, according to the ISO9000:2015 Fundamentals and Vocabulary document Traceability is purely the ability to trace the history, application or location of your product and it can relate to a number of things such as:
Great, now we have the ISO definition what exactly does that mean in terms of traceability for products (we will talk about measurement another time), what is the plain English translation?
It is not as complicated to get your head around as some people think. Take one of your products and imagine that you need to recall them because your supplier has found a manufacturing fault at their plant that impacts some of your products but not all of them, what would you need to put in place to do that? Imagine you had to draw a straight line of sight from your suppliers parts to your customers, what would you need to put in place to be able to get the right ones?
Working backwards you need to know:
Some other things to think about, if you subcontract some of your process say you send your product out to someone who splits it into smaller sizes, a roll of material for example, you need to be able to keep track of those bits of material and show which larger roll they came from and that means ensuring your subcontractor has adequate traceability as well.
The easiest way to figure this out is to work through the process that we've talked about here, from either end, i.e. a supplier tells you have a fault or a customer tells you have a fault.
When it comes from the customer you need to work back to the batch of product that the faulty product came from to identify the faulty part, then work forward again to identify all the other products made with that faulty part.
Traceability is not hard when you design your system correctly and you make sensible decisions and not over complicate things.
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You can also call John on 0211649739 to set up a meeting
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