Lock-out / Tag-Out Procedures as Quality Controlled Documents?

[Jim Wynne]

If I only had one organization doing all my auditing and did not have to deal with the federal government, I could only have one set of "Books". In a library you have different sections fiction, non fiction, etc. Any organization of any size has safety rules which are primarily "controlled" by the government with input from the company to make the rules/laws more specific to the business. These rules cannot be changed by some whim of an auditor who does not like the format they are presented in. I have had to change calibration procedures many times just for this reason. Is an ISO auditor willing to take responsibility for any change that may be made to a safety rule due to their input? What if the change even though it seemed small resulted in an injury, this can easily be the case in LOTO, a very specific order of events MUST happen.
Over the years I have had to endure many audits on safety, quality, maintenance, engineering, etc.(I bet you guessed that already). We have an auditor for our auditors. Do you believe the Safety Auditor should dictate how the ISO documentation is written and controlled?
All this having been said, YES all documentation needs to be organized and controlled BUT the controlling "Group" should be the subject matter experts that have the primary ownership for the documentation. And they should ONLY have input into the documentation that falls under their subject matter expertize.

I think you might be confusing the document writing/approving process with control of documents. Approval is part of control, but there's more to control than just approval. There's no reason I know of that all of a company's non-confidential documentation can't be managed under one control system. Documents can be written and approved by the proper authorities and still be controlled in the same system.

 

[JaneB]

A Quality auditor needs to stay on message

If by that you mean that an auditor should stay with the scope of their audit, yes indeed. But hence the question that started the thread.

It works better in the Cove overall if we (generally) in one thread stay with the scope of a topic And this isn't a general one about whether broadly speaking quality audits have any business with safety issues, but a very specific case.

Now, I can see from your response you have strong feelings about various issues, but they're somewhat offtopic and hence largely irrelevant to the current topic under discussion.

I don't see the problem (in fact far from it) in controlling docs to make sure they're current, accurate and fit for purpose, and superseded versions aren't hanging around.


If you have a system/processes that are cumbersome and bureaucratic and aren't producing value, my solution would be simply to change them so they aren't.

 

[JaneB]

Given that an ISO 9001-certified company has, by definition, a document control system, does it make any sense to create a different system of control because we can't agree whether or not the process is quality-related? I think not. Documents and processes can be controlled without including them in the scope of the certified QMS, and they can be controlled using the same methods and resources.

I agree with you Jim, but for the following.

I think we must acknowledge that some certified companies (or would-be) unfortunately set up some very bureaucratic and cumbersome systems of document control, believing (wrongly) that this is how it 'has' to be to be 'properly controlled'. There are heaps of examples in the Cove alone, alas, and barely a week/month goes by without someone either proposing or insisting on one of that ilk.

And with that being the case, I can see why some would prefer not to use such systems if they could find any way whatsover of avoiding them.

 

[John Martinez]

Good comments. Thanks JaneB for keeping them on topic.

Lets throw this into the mix...If the maintenance was not performed, then they would produce non-conforming product. Example (example changed to protect the guilty). A sewing machine breaks a needle, continuing to sew would produce a non-conforming product. Again, the organization chose to include maintenance within their QMS.

The lock-out; tag-out is not only safety; however, a needed step to continue to produce a conforming product. This step is NOT covered in their QMS. It is covered by a separate safety department document which does not meet the controls of the QMS, nor has ANY controls what so ever (i.e. no date, who authorized, revision level, etc.)

In other words...no lock-out, no needle change, no needle change, either work stops and you are late on delivery to the client (affects customer satisfaction), or produce non-conforming product which is unacceptable to ship (again affects customer satisfaction, and customer satisfaction IS part of a QMS).

I'm auditing QMS only. The organization only has a QMS. No Safety management system.

Originally Posted by Jennifer Kirley

In general, the documents should be controlled when their lack of control (as in availability, most recent change or approval of change) could negatively impact an outcome of the process or produced good/services.

That's the case here. No lock out/tag out, the process can not continue without producing non-conforming product.

 

[adickerson]

No lock out/tag out, the process can not continue without producing non-conforming product.

That seems fair, for me I guess it would depend on the frequency of downtime and repair. In this case maintenance is part of the QMS but sometimes things can get over controlled and documented. If the lock-out-tag-out was performed by a specialized safety/maintenance crew on rare occasion I don't seem much reason to make it a nonconformity. However if line operators are required to do LOTO on a weekly basis I don't see how this could happen without the QMS being involved.

As a manager of the organization being audited I would like my LOTO system to be controlled someway. Even if it is a bit of a stretch to make it fit into the QMS system. So, I would bring it up to management regardless of it fit or not.

I just want to say one thing about the scope of ISO audits - safety is everyone's responsibility at all times. If I ever knew an auditor (internal or 3rd party) saw a serious safety issue and never reported it becuse it was "out of the scope of the audit" we would have some serious words .

 

[ScottK]

Good comments. Thanks JaneB for keeping them on topic.

Lets throw this into the mix...If the maintenance was not performed, then they would produce non-conforming product. Example (example changed to protect the guilty). A sewing machine breaks a needle, continuing to sew would produce a non-conforming product. Again, the organization chose to include maintenance within their QMS.

The lock-out; tag-out is not only safety; however, a needed step to continue to produce a conforming product. This step is NOT covered in their QMS. It is covered by a separate safety department document which does not meet the controls of the QMS, nor has ANY controls what so ever (i.e. no date, who authorized, revision level, etc.)

In other words...no lock-out, no needle change, no needle change, either work stops and you are late on delivery to the client (affects customer satisfaction), or produce non-conforming product which is unacceptable to ship (again affects customer satisfaction, and customer satisfaction IS part of a QMS).

I'm auditing QMS only. The organization only has a QMS. No Safety management system.


That's the case here. No lock out/tag out, the process can not continue without producing non-conforming product.

In my experience in doing both QMS implementation and being the EHS guy for years, I think this is a real reach, John.

The customer (internal and external) defines nonconforming product and I know of no customer that will reject a part because the lockout/tagout program is not part of the QMS.

Again - yes it's a more efficient practice to have all procedures in one system and that's clearly the way to go, but the effect of an OSHA required procedure on product quality is minimal to the point of being negligible, and the ISO standard only cares about product quality and customer satisfaction.

I would train any of my auditor to point it out as an OFI and leave it at that.