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ISO 9001 Cl. 8.5.2 and 8.5.4 - Identification in Products

Q

QAMTY

#1
Hi everybody

Regarding to identification of products (see below)
Should this identification be done by using supplier code (label of the product) or must be a label of mine, designed and controlled into my Quality system?

Please feed me back
Thanks


8.5.2 Identification and traceability
The organization shall use suitable means to identify outputs when it is necessary to ensure the
conformity of products and services.
The organization shall identify the status of outputs with respect to monitoring and measurement
requirements throughout production and service provision.
The organization shall control the unique identification of the outputs when traceability is a
requirement, and shall retain the documented information necessary to enable traceability.

8.5.4 Preservation
The organization shall preserve the outputs during production and service provision, to the extent
necessary to ensure conformity to requirements.
NOTE Preservation can include identification, handling, contamination control, packaging, storage,
transmission or transportation, and protection.
 
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howste

Thaumaturge
Super Moderator
#2
No. Or yes. Or maybe. The standard is vague because each organization needs to determine identification needs for their own situation. What do YOU need to ensure product is suitably identified is the question. And the word "label" is not used in the standard anywhere.
 
B

BoardGuy

#4
[FONT=&quot]If your system was based on ISO 9001:2008 there is no real change to requirements of these two sections and your current method should work just fine.[/FONT]
 
Q

QAMTY

#5
Thanks Howste, Gulfman and Boardguy
I think the only think I have to consider, is to write down somewhere
that I comply these clauses by using the tags/labels which come in the packages of the raw material.
wouldn´t be of confusion for employees to have different kind of identifications?
some of them having numbers, letters, barcodes? comparing it with the mine which could be the same label/tag for all the products?

Thanks
 

Eredhel

Quality Manager
#6
We, like most probably, use the Job # from our ERP software for traceability. It can be put on a tag, bag, label, traveler, written on a part, et cetera. It's one traceability number with multiples ways to attach it, if that's what you mean. Not sure how you are doing your traceability though.
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#7
Hi everybody

Regarding to identification of products (see below)
Should this identification be done by using supplier code (label of the product) or must be a label of mine, designed and controlled into my Quality system?

Please feed me back
Thanks


8.5.2 Identification and traceability
The organization shall use suitable means to identify outputs when it is necessary to ensure the
conformity of products and services.
The organization shall identify the status of outputs with respect to monitoring and measurement
requirements throughout production and service provision.
The organization shall control the unique identification of the outputs when traceability is a
requirement, and shall retain the documented information necessary to enable traceability.

8.5.4 Preservation
The organization shall preserve the outputs during production and service provision, to the extent
necessary to ensure conformity to requirements.
NOTE Preservation can include identification, handling, contamination control, packaging, storage,
transmission or transportation, and protection.
Let's take this sentence by sentence:

"The organization shall use suitable means to identify outputs when it is necessary to ensure the conformity of products and services."

This would fall under the Organizational Control. The documents/labels that are furnished by the Supplier are the beginning of the traceability. During the organization's process, using a traveler/work order that has a unique identification, would meet the intent. Using stamps (acceptance/rejection)would cover the conformity issue when applied to the specific operation completed.

"The organization shall identify the status of outputs with respect to monitoring and measurement"

This addresses the inspection or operational outputs. The Traveler/Work Order mentioned above would also meet the intent. Reflecting acceptance or rejection.

"The organization shall control the unique identification of the outputs when traceability is a requirement, and shall retain the documented information necessary to enable traceability."

This could the number assigned by your ERP System as long as the number is not used again. This would also involve Serialization, if required, by Contract/Purchase Order.

"The organization shall preserve the outputs during production and service provision, to the extent necessary to ensure conformity to requirements.
NOTE Preservation can include identification, handling, contamination control, packaging, storage, transmission or transportation, and protection
."

This is addressing the requirements to protect the product throughout the operational processes.

This is just my interpretation, and others may have another interpretation.
 
B

BoardGuy

#8
Thanks Howste, Gulfman and Boardguy
I think the only think I have to consider, is to write down somewhere
that I comply these clauses by using the tags/labels which come in the packages of the raw material.

Thanks
[FONT=&quot]If your current method is working for your organization I would not add additional layers that would add confusion. Within your quality manual or as a stand-a-lone document describe your method for identifying the product and how you maintain its traceability through your production process.[/FONT]
 

Mike S.

Happy to be Alive
Trusted Information Resource
#10
I would think it would depend on the chemical and circumstances of its storage. Do you have a good justification for your "no expiration date" designation? Would the manufacturer of the chemical agree? Has the container been opened? What were the storage conditions (exposure to temperature, light, etc.)?
 
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