8.5.2 "...identify the status..."

[qusys]

Good day Cove family.
Curious as to your thoughts regarding this statement. Particularly in context of the following example...

a) Organization has a bin/container of in-process widgets.
b) The "router" (identifies part number, lot number, and its progress (level of completion) through the various processes that it goes through as it moves through the facility) is not with the product.
NOTE: When asked, the operators were able to locate the router after some searching.
c) The location of the bin is not in a marked location nor otherwise intuitive to an observer in regard to its status (it is not currently being processed, it is not in a designated staging location, etc..etc...

In other words, someone unfamiliar with this product would not be able to identify where it is supposed to go next, what the part number is, what the lot number is , etc..etc...

Does the the described condition violate the requirements stated in 8.5.2?

What say all of you?

Thanks in advance for your input.

Hi John,
a question: is traceability a requirement here? If yes, the organization has to retain documented information in this sense.
If so, is this requirement met?
However , generally speaking a risk analysis of the process flow could have raised up attention for this operation and if the risk is low, the organization could accept.
Did you have scrap or misoperation for this?

 

[Bev D]

It really is going to be dependent on the specific situation, product and regulatory control. (Since this is in the generic ISO900 forum I would assume that you are not USDA or FDA controlled. Aerospace and OSHA controls will also have specific strict controls.

IF there is only one unidentified lot and the traveler can be found and subsequent testing can correctly identify the product and detect any non-conformance’s then you are probably fine for that lot.

Although the lack of control is concerning: is this truly a one time occurrence or is it routine? Better fix it regardless of the QMS requirements since it is a colossal waste of time at best and train wreck waiting to happen at worst.

 

[Big Jim]

I would think that one could argue that it violated 8.5.1, production under controlled conditions. Something was certainly out of control while the product and / or its production documentation were lost. I would be inclined to investigate this as a possibility. At this point I'm inclined to think I would not write it up as a nonconformance, at least not without further investigation.