Process Changes, but Work Instructions/Process Maps are not updated

[John Broomfield]

Andy,

Yes, I should not have put the clause reference in the parentheses and not expressed my opinion.

But all we have is hearsay regarding any failure of management which is why I posed the possible nonconformity statement as a question.

I'm hoping to elicit more information.

Perhaps the nature of the nonconformity is "failure to monitor the process and to correct its documented procedure", who knows?

But the undocumented procedure seems to be working just fine.

John

 

[azuker]

Thanks again to you all for your input.

I see Andy's point in digging deeper to address why the process owner did not update the documents to reflect their communicated change in procedure. On that level, there is a "disconnect" between the process owner and their understanding of documentation use and the importance of keeping it updated because those documents do not exist simply for the purpose of auditing or "meeting ISO requirements." They exist as practical support tools for reference and training just to name a couple of reasons. In my opinion, that lack of understanding needs to be addressed.

Our document control procedure does state that it is the process owner's responsibility to keep documented procedures up to date and current to prevent the use of obsolete documents.

My opinion is that common sense dictates that if you document a process, you would want to update that documentation when a process changes.

 

[drgnrider]

If during an employee interview, an internal auditor finds that a process has changed, but work instructions and process maps have not been updated to reflect that change, how should that finding be reported/classified?

How long between the process change and the interview: Days, weeks, months? What is your organizations typical time for the document revise/reissue process?

Due to LEAN Manufacturing, over the course of months, we have had a few processes experimented with before the revised process accepted. Then it took a few weeks to get the ISO documents through the rewrite process. So basically from the first "change" to the process it was months when the procedure was incorrect. Granted, we suspended the ISO document and noted the process trials on the ISO document to show it was being reviewed/revised.

I agree, interviewing the process owner and others will see how the process changes were communicated to everyone involved, (IMO very important without an official process document), as it evolved as well as what progress was being done on the document rewrite.

I don't like issuing a document and have it changed multiple times while the kinks are worked out of the new/revised process; submit the document when the process is running smooth... at most, it should be within a few weeks.

 

[Illek]

As a document controller I can say there can be several reasons changes are not posted right away. Often what seems like a simple change to a department head could end up being complicated for document control. We had a form someone wanted to be made obsolete but it was a form other departments and other locations used that they didn't know about. It also was in several work instructions. I also had to ensure it didn't impact the Canadian Aviation and foreign Regulations and we are required to comply with. We also had to look at customer requirements. One simple request took quite a while to process and months to close. The change request (or whatever your doc controller uses) could be open and processing the document but the change just may not have been implemented yet.



illek

 

[normzone]

Yeah, always dig deeper in cases like this. Is it only this one document that's behind the times? Are they all behind the times? Are active changes in play on all of them?

There may a breakdown of the whole system, or the organization may be in the midst of an improvement cycle.

 

[Helmut Jilling]

Thank you for that confirmation. In this instance, a workflow was changed to make an improvement. The change was communicated to staff via email and implemented, but the work instruction and process map that support the procedure had not been updated at the time of audit.

Reasonable time must be allowed to consider a change, test it, review results, and review results with customers....and finally implement it as a permanent change. "Reasonable" time can vary depending on the change. In the interim, the process and the changes need to be "controlled" as a change to ensure the expected changes are being carried out, and the process and customers' product results are still being achieved.

If the process is being managed appropriately, and according to your change control procedure, there may not be a finding. If not, it is probably a finding.

 

[kzachawk]

I guess the answer to your question would be how minor was the change and what does you document control procedure state concerning changes? I would not encourage writing any internal non-conformance against a requirement of the ISO MSS, I would state your N/C via the requirements of your organizations defined MSS (its own procedures).

Some mature systems allow for minor changes to occur which might not require documents and process maps to change and some require a complete change in everything no matter how minor the change. I guess the real question becomes is it really necessary to alter system documents based on the change which occurred?

An example might be that a process on a manufacturing assembly line was moved from one work station to the next to balance work, although in its entirety the work remains the same. The other end of the spectrum would be where process work is actually performed very differently than prior to the change.

My guess is you don't have a solid handle on change management.