Customer Audit - Root Cause Help - ISO 9001:2008 Cl. 7.5.3

[dr1vn]

We recently had a customer audit and the auditor discovered several instances of parts on shelves that were not clearly identified.

There were parts that did not have a label, but these were things like old printers and R&D parts that were just placed onto a quarantine shelf. As well, we had parts in our shipping area shelf that had bar codes that could not scan so the part could not be shipped. The part was on a shelf, but the shelf was not labeled.

The auditor took all these findings and bucketed them into one minor NC.

Our interpretation of the standard was that the part is identified as we could use the part and serial number and look it up in our system to determine the status of the part. The auditor felt everything should have a label AND should be on a properly labeled shelf/location.

I'm struggling to do a root cause given the multiple different errors. I'm gathering the people involved and will do a 5-whys, but just wondering if anyone has some other considerations I should think about pre-meeting?

Training issue?
No process to properly identify locations?

 

[Randy]

Re: Root Cause Help - 7.5.3

It doesn't matter what the auditor feels

Does your procedure match the requirements of 7.5.3, yes or no?

Are you following your procedure, yes or no?


If you get lost in the loop, make something up, fix it and see if it works. If your fix doesn't work, think of something else and fix it again. Above all else use your system to work for you and not you for it.

Ask the auditor for a specific requirement and if he can't give you anything othjer than "I feel or I think" ask him to move on or move out!

 

[howste]

Re: Root Cause Help - 7.5.3

Our interpretation of the standard was that the part is identified as we could use the part and serial number and look it up in our system to determine the status of the part. The auditor felt everything should have a label AND should be on a properly labeled shelf/location.

Can you post the text of the nonconformity? We can't see what the auditor saw, but as you describe the situation it's possible that the auditor wrote the NC against his opinion instead of against the requirements. If this is true you should appeal it.

 

[Sidney Vianna]

Re: Customer Audit - Root Cause Help - ISO 9001:2015 Cl. 7.5.3

Training issue?
No process to properly identify locations?

Check this post.

 

[dr1vn]

Re: Customer Audit - Root Cause Help - ISO 9001:2015 Cl. 7.5.3

We have yet to receive the final report from the customer so I can't give you the text yet...

We had an argument with the auditor over the interpretation of the standard, but in the end we gave in as it is a process improvement. As well, we do have people in the org putting items onto shelfs that are clearly labelled for something else. It may not directly violate the standard, but it is a practice that should be stopped.

After our own internal meeting, we decided that we where we identify a shelf as "Incoming" or "On hold", putting items that are not "Incoming" or "On hold" at these locations is not a good practice. To this end, we are going to make marked bins and temporary shelf labels so that when we have these orphan items they can be properly identified and can still be placed onto a shelf.

 

[Sidney Vianna]

Re: Customer Audit - Root Cause Help - ISO 9001:2015 Cl. 7.5.3

There were parts that did not have a label, but these were things like old printers and R&D parts that were just placed onto a quarantine shelf. As well, we had parts in our shipping area shelf that had bar codes that could not scan so the part could not be shipped. The part was on a shelf, but the shelf was not labeled.

Classic example of a 2nd party auditor lacking competence in performing effective audits and decides to micromanage a supplier.

Using the risk based thinking principle embedded in ISO 9001:2015: what are the risks of the (so called) non-labeled parts being misused and/or shipped to a customer by mistake? If your system can be demonstrated as robust enough to prevent this unintended outcome, the customer auditor's concern should have been put to rest, had s/he been willing to think logically.

Now, you have to artificially come up with a fictitious root cause and pretend to perform corrective action. Sad.

 

[howste]

Re: Customer Audit - Root Cause Help - ISO 9001:2015 Cl. 7.5.3

Oops, I missed the 2nd party bit. I was thinking 3rd party.

 

[BoardGuy]

Re: Customer Audit - Root Cause Help - ISO 9001:2015 Cl. 7.5.3

I would definitely appeal this finding if it was truly raised against ISO 9001:2015, Clause 7.5.3 which is document control and not tractability, Clause 8.5.2.

 

[howste]

Re: Customer Audit - Root Cause Help - ISO 9001:2015 Cl. 7.5.3

I would definitely appeal this finding if it was truly raised against ISO 9001:2015, Clause 7.5.3 which is document control and not tractability, Clause 8.5.2.

It looks like someone erroneously added ISO 9001:2015 to the title after it was posted. I've edited it back to 2008.

 

[dr1vn]

Re: Customer Audit - Root Cause Help - ISO 9001:2015 Cl. 7.5.3

Thanks. Yes it was ISO 9001:2008... After our internal meeting the consensus was that this should have been an opportunity for improvement and not an actionable finding.

That's an interesting point about the 2015 version and applying Risk to the finding. In that case, I think there is a clear argument to be made why this is not a finding.

However, there is an opportunity here for us as an organization to do better in keeping things organized and controlled. When we did a further analysis after the audit we found labelled parts on an unlabelled shelf that were still waiting on disposition. Had they been in a location that was identified as "waiting disposition" they would have acted on... Again, not really a finding, but a way for us to improve.