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Are we doing enough to meet Identification and Traceability 7.5.3 Requirements?

D

dalzell40

#1
Here is the long and short of the question:

The company that I work for wants to go to a min max inventory pull on items such as screws, adhesives, rags, tape, etc.

The manner in which I have suggested doing this is when taking something out of inventory such as screws to document the lot number and the work order that the product will be used for. Now, those screws may be used for other products and will be used on multiple work orders. With that being the case, when screws are pulled again from inventory, the person pulling the screws would document the next work order next to the same lot. With this process we would have a tighter control of pin pointing lots if a recall occurs.

What is being suggested by the warehouse is that we know through our mrp system what lots come in and used without implementing additional work in documenting the work order that matches the lot. I understand that what is being suggested here will allow a larger window on suspect lots in a recall condition.

Question: Is what is being suggested by the warehouse enough traceability and requirements or should we implement something more?
 
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Jim Wynne

Staff member
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#2
Re: Identification and Traceability 7.5.3 Are we doing enough to be compliant??

Here is the long and short of the question:

The company that I work for wants to go to a min max inventory pull on items such as screws, adhesives, rags, tape, etc.

The manner in which I have suggested doing this is when taking something out of inventory such as screws to document the lot number and the work order that the product will be used for. Now, those screws may be used for other products and will be used on multiple work orders. With that being the case, when screws are pulled again from inventory, the person pulling the screws would document the next work order next to the same lot. With this process we would have a tighter control of pin pointing lots if a recall occurs.

What is being suggested by the warehouse is that we know through our mrp system what lots come in and used without implementing additional work in documenting the work order that matches the lot. I understand that what is being suggested here will allow a larger window on suspect lots in a recall condition.

Question: Is what is being suggested by the warehouse enough traceability and requirements or should we implement something more?
What types of products? Are they regulated somehow such that wide-scale recall might be necessary, or are referring to containment of suspect material? If the former is true, you'll likely need some sort of serial identification of individual assemblies/finished products, which would be tied to information regarding the provenance of the components.

On the other hand, if you're trying to facilitate containment of nonconforming products, the MRP trail could be enough. It depends on how fine the traceability needs to be for practical purposes. If you can maintain a reasonable level of traceability and provide the rationale for the strategy, you shouldn't have any issues with the standard.
 
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