Is Identification and Traceability a procedure or more of a guideline?

Hi again guys,

just want to have your opinion, is Identification and Traceability a procedure or more of a guideline?

tnx again....

Re: Identification and Traceability

Hi kidpaddy,

I would say that it is a procedure and not a guideline, and needs to be built very much in the system.

Re: Identification and Traceability

'Identification and Traceability' is a requirement of the standard, and necessarily needs to be addressed in your system (unless you have opted for exemption of the clause, which, I doubt, is possible).

How your organisation addresses the requirement is entirely upto the organisation. You have to establish what works best for the organisation. Wether you need a seperate procedure or you weave it in your other operational procedures.

Re: Identification and Traceability

If you are ISO9001 then it is a "Where Appropriate" "Shall", so you determine when Identification and Traceability is required, so a Procedure would be required to make that distinction and apply the identification and traceability requirements. A procedure would also give you detail. You can't simply state identify and trace this product. You must state how you do that.

If you ISO TS, then you shall identify and trace your product, without the "Where Appropriate".

Also remember not to isolate your processes. The identification and traceability of products is not a separate procedure, but should be built into your Product Realisation process. Always maintain those links. A product Identification and traceability procedure is useless if you don't know where it fits into your system.

KidPaddy said:

Hi again guys,

just want to have your opinion, is Identification and Traceability a procedure or more of a guideline?

tnx again....

Click to expand...

Good advice so far.

It would help to know what kinds of product(s) you are involved with. The idea of identification and traceability is very dependant on what you're dealing with and who the customer is. If you are processing one product, then i.d might not be a big deal, and yet, the customer or a regulation might make traceability very important. Or vise versa........

Keep the information coming.........

Identification and traceability may be able to be split i.e. most organisations need to know what things are (identify them) but not all have to provide traceability. ISO 9001 states 'where traceability is a requirement.....'

The requirement may come from various sources such as regulatory, customer, industry specific, etc. I advise organisations to find out what these are before jumping in and trying to provide batch traceability where it may not be required as it can be an unnecessary expense.

Many people discuss that there is not "shall" and hence traceability not required. But remember, in this age, when ever a recall is required, traceability comes handy.

So though not a recommendation, I strongly advise to have Identification and Traceability as an important procedure in the Quality Management System.

Re: Identification and Traceability

Manix said:

Also remember not to isolate your processes. The identification and traceability of products is not a separate procedure, but should be built into your Product Realisation process. Always maintain those links. A product Identification and traceability procedure is useless if you don't know where it fits into your system.

Click to expand...

I agree. I chose to create a procedure for Preservation of Product - identification and traceability is part of it. I also address identification and traceability requirements being identified during contract review (as AndyN pointed out above) and incorporated into process control documents in other procedures like Contract Review, APQP and Control of Production and Service Operations. You will also find identification and traceability requirements in specific work instructions such as the attached Raw Material Receiving Work Instruction.

KidPaddy said:

Hi again guys,

just want to have your opinion, is Identification and Traceability a procedure or more of a guideline?

tnx again....

Click to expand...

Hi, KidPaddy. IMHO we need to just be clear about terminology here. Clause 7.5.3 places a requirement (where appropriate) for the organization to identify product.

So, if it is appropriate, you should identify product in production. Now if you decide you need a procedure then it gets written into one (or more) procedures.

If you don't want a procedure but want to document a set of requirements then it can be called a "rulebook" or anything you want.

I personally wouldn't call it guidelines because that implies you can ignore them.

Same applies for traceability - both in house and out in the market place. You decide if it is needed and if it is needed then you write it into procedure(s) or rule sets.

Hello KidPaddy,

Let's not forget about the requirement to "identify product status with respect to monitoring and measurement requirements"

Whatever inspections, tests or other verification activities you perform on your product, you need to be able to distinguish among product that has passed, product that has failed and product that has yet to be inspected and/or tested.