Identification and Traceability 7.5.3 by Location

[Titus]

Good Morning!

Although I have over 30 years in manufacturing, this is a first for me to get involved in a forum.

We are in the process of Implementing ISO 9001:2008 and unfortunately upgrading to a different Manufacturing software at the same time. I have a couple of questions in regards to 7.5.3 Identification and Traceability. We have product identification handled throughout our process flow except for the warehouse. Smaller parts in tubs are identified with a bar coded tag. We process large parts as well and they can take up a large amount of space. Some of which is stored outside.

Is one tag sufficient enough to identify one lot of parts?

or

According to Craig's ISO 9001 in Plain English we can identify by location. Has anyone used the identification by location?

[Stijloor]

Originally Posted by Titus

Good Morning!

Although I have over 30 years in manufacturing, this is a first for me to get involved in a forum.

We are in the process of Implementing ISO 9001:2008 and unfortunately upgrading to a different Manufacturing software at the same time. I have a couple of questions in regards to 7.5.3 Identification and Traceability. We have product identification handled throughout our process flow except for the warehouse. Smaller parts in tubs are identified with a bar coded tag. We process large parts as well and they can take up a large amount of space. Some of which is stored outside.

Is one tag sufficient enough to identify one lot of parts?

or

According to Craig's ISO 9001 in Plain English we can identify by location. Has anyone used the identification by location?

Welcome to The Cove Forums!

Yes that's possible, as long as everyone in the organization understands and complies with it and product mix is prevented.

Stijloor.

[qusys]

Originally Posted by Titus

Good Morning!

Although I have over 30 years in manufacturing, this is a first for me to get involved in a forum.

We are in the process of Implementing ISO 9001:2008 and unfortunately upgrading to a different Manufacturing software at the same time. I have a couple of questions in regards to 7.5.3 Identification and Traceability. We have product identification handled throughout our process flow except for the warehouse. Smaller parts in tubs are identified with a bar coded tag. We process large parts as well and they can take up a large amount of space. Some of which is stored outside.

Is one tag sufficient enough to identify one lot of parts?

or

According to Craig's ISO 9001 in Plain English we can identify by location. Has anyone used the identification by location?

Hi, agree with Stijlor.
According to the identification by location, currently many organizations also use also RFID on lots. So also in the warehouse you could have a better control from traceability and identification standpoint to responde to the clause.
Hope this helps

[Ted Schmitt]

Originally Posted by Titus

Is one tag sufficient enough to identify one lot of parts?

Yup

Originally Posted by Titus

Has anyone used the identification by location?

We use location on a particular shelf as identification of approved status. As long as material is in the warehouse and stored in its appropriate bin/shelf/box etc, it is considered as approved.

[Titus]

Thanks for the response!

I am going to get with the shipping manager to review the information with him and put a plan together.

[Cornwap]

Hi Titus,

ISO/TS16949 (for automotive) added a note under clause 7.5.3:

NOTE - Inspection and test status is not indicated by the location of product in the production flow unless inherently obvious such as material in an automated production transfer process. Alternatives are permitted, if the status is clearly identified, documented, and achieves the designated purpose.
Although you are not going for TS it might be worth bearing this in mind if you supply any automotive companies that are used to this standard.

Best regards
Phil

[jkuil]

The amount of effort and detail of identifying and tracing items should match the risks associated with commingling: what is the likelihood that the items get mixed and how serious the consequences. E.g. if the items can easily be distinguished from each other e.g. by colour codes, the need for identification labeling is low. Likewise, if the manufacturing process prevents the use of the incorrect part because it can not be assebled/fitted. If commingling can result in lifethreatening malfunction of e.g. a plane, a car or a medical device, you better assure your identification and traceability method prevents any commingling.
You can use your ERP system for traceability, the status being identified electronically rather than by labeling the item or the lot.

[Titus]

Thanks,

We do not supply any automotive compainies at this time. We did have a Company try to implement the TS requirement on its suppiers but failed. We are getting into Wind Energy, where traceability is required. Identification is maintained throughout the production and storage process.

Our system has the cabability to apply a lot ID # to the material when it is picked to the job.

We only have a few large products that would be stored by location and the customer that these belong to do not require traceability at this time, however the more I think about it the more I am inclined to require a tag on the product. We spend enough time as it is searching for information.

Thanks!

Titus