How to meet ISO9001 traceability requirements

This Week's Question 

This week's question comes from one of our clients that we are helping with their ISO9001 implementation, they asked " what do I need to do to meet the traceability requirements of the ISO 9000 standard"

The Feedback

If we start at the customer side of things, they'll want to know what batches of product they need to pull out so you need to know the batch numbers that are going to be affected from your process. That means you need to know what parts are going into each batch and where that batch is going, what customer has batch 1, batch 2, batch 4 or batch 40 and which of those batches are effect affected.

On the raw material side of things, we want to know where that raw material is getting used which products is getting used in and which batches of those products it's actually getting used in that way you have batch traceability again.

If those individual products are used in a secondary system you want to know which secondary systems within your business, it's going into so again you have that flow through of the batch disability and at the end of the day where those batches get sent to more customers and if they're in warehousing which we're housing they get put into.

It's not just about that however, it's also about what people potentially are building the product so if Bob is having an off day and he's got some of the product wrong you want to know which batches Bob worked on similarly from a machine point of view you might have a machine that has got a malfunction in it and you might want to have to recall the products that that machine made. So you need to know which machine. So the end result should be that you should be able to run a report or collect the information that says all the products with part number abc as a raw material need to be recalled. Or all the products made by Bob or all the products went through machine one need to be recalled, those product batches were sold to the following customers that would give you full traceability.

I hope that's been helpful hope, that's explained a little bit about traceability. It's a fairly large topic and will vary, as we said, from product to product, customer to customer and industry to industry.

Thanks very much for tuning in again we hope you got something out of that as always send us your questions uh either in the links below or through our website, we'd love to hear from you and as always let's keep improving, thanks a lot.

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