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

Ok, let me get this out front. On a pure ISO 9001 audit, I do not cover safety issues in my report or findings. Ok? Yes, if I see a safety issue, I point it out to my guide for their use, but not in the report.

Another auditor brought something up for discussion. At first, I was against it; however, after I heard his argument, I thought it was a stimulating discussion and I’d put it out here for comment.

The organization includes their maintenance department. Their safety department put out lock-out; tag-out procedures on the equipment for the maintenance department when maintenance is performed. The documents have no controls on them.

According to my auditor friend, since the organization chose to include maintenance, and since maintenance performs work partially according to those documents, then they must be controlled within the QMS.

Not convinced yet? Since these are infrastructure items that affect product quality (6.3 b), then maintenance work, and subsequent work instructions should be QMS controlled.

No, they do not have a Safety Management System.

Before I ask my question, I have one request. Lets please leave whether or not safety items should be included in a QMS report for another thread. Thanks in advance.

What do you think about this auditor’s argument. QMS controlled or not and why?

Re: Lock-out; tag-out procedures as quality controlled documents?

Just off the top of my head, I'm thinking about 4.2 and (paraphrasing) documents necessary to ensure the effective operation and control of processes, and then further on in 4.2, the requirement for those documents to be controlled.

Given (a) maintenance is included in the QMS, and (b) presumably the processes included in maintenance must be controlled, and (c) lockout/tag-out is a maintenance process (being safety-related is, I think, irrelevant) then I would say the document(s) should be controlled.

Re: Lock-out; tag-out procedures as quality controlled documents?

John Martinez said:

Ok, let me get this out front. On a pure ISO 9001 audit, I do not cover safety issues in my report or findings. Ok? Yes, if I see a safety issue, I point it out to my guide for their use, but not in the report. <snip>

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I agree in principal with your colleague, but I think his reasoning is off.
My reasoning would be more along the lines of OSHA requires a lockout/tagout program, why not just put it in your document control system? And I would make that a recommendation, not a finding.

Lockout/Tagout is very peripheral to the quality of the product and satisfaction of the customer, which is all 9001 really cares about (section 1.1). So I think tying it to product quality weak.
And all QMS's must include maintance to some extent, if there is a maintenance department and the do PMs and keep machines running, which do affect quality and satisfaction much more directly.

Re: Lock-out; tag-out procedures as quality controlled documents?

ScottK said:

I agree in principal with your colleague, but I think his reasoning is off.
My reasoning would be more along the lines of OSHA requires a lockout/tagout program, why not just put it in your document control system? And I would make that a recommendation, not a finding.

Lockout/Tagout is very peripheral to the quality of the product and satisfaction of the customer, which is all 9001 really cares about (section 1.1). So I think tying it to product quality weak.
And all QMS's must include maintance to some extent, if there is a maintenance department and the do PMs and keep machines running, which do affect quality and satisfaction much more directly.

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This is an interesting question, and I think your ideas are reasonable. I'm not sure about how peripheral lockout/tag-out is though, when a serious accident happens and a person and a machine are put out of commission indefinitely, both of which could cause a significant blow to productivity and perhaps in an extreme case the ruination of the company. Aside from the human aspect, the ability to deliver product is part of quality.

Re: Lock-out; tag-out procedures as quality controlled documents?

Jim Wynne said:

Just off the top of my head, I'm thinking about 4.2 and (paraphrasing) documents necessary to ensure the effective operation and control of processes, and then further on in 4.2, the requirement for those documents to be controlled.

Given (a) maintenance is included in the QMS, and (b) presumably the processes included in maintenance must be controlled, and (c) lockout/tag-out is a maintenance process (being safety-related is, I think, irrelevant) then I would say the document(s) should be controlled.

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The Jim way is logically down to putting in place a procedure for an activity. Note here that all what Jim has said is about ISO 9001 requirements of how a company is involved in the maintenance activity procedure and no word about safety management or OHSAS is made.
It is because we are exposed to these several management systems, that we tend to seperate issues as safety concerned or environmental concerned and block them out. If a QMS is mapped with safety department having lock-out and tag-out procedure and the safety department interacts with the maintenance department in this process, it is a clear QMS process and must be in the control loop.
No half games with some included and some kept away in the pretext of not being a QMS concern.

Re: Lock-out; tag-out procedures as quality controlled documents?

They were placed into the management system and are in scope, but only those that are specifically and directly tied to the QMS, not all of the safety stuff. This however could be even more difficult for all involved if they foolishly include all safety as a quality process which I have seen happen.

Really, really thin ice for the auditor because he/she has to stay fixed to looking at the quality side of the procedures and not the safety side.

This is of course a 6.3/6.4 and possibly 7.5.1 issue and as noted 4.2.1d

Re: Lock-out; tag-out procedures as quality controlled documents?

Jim Wynne said:

Given (a) maintenance is included in the QMS, and (b) presumably the processes included in maintenance must be controlled, and (c) lockout/tag-out is a maintenance process (being safety-related is, I think, irrelevant) then I would say the document(s) should be controlled.

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I concur.

Re: Lock-out; tag-out procedures as quality controlled documents?

I am responsible for my org's Quality Management System - the Document Controller reports to me

our document control system is an integrated system to cover a whole suite of management systems including OHS & Environment

in the OHS area of our document control system we have isolation, tagging, locking & barricading standard procedures

it's all very simple really


cheers @KerrieAnne on Twitter aka machrk

Re: Lock-out; tag-out procedures as quality controlled documents?

In a paper mill, when we shut down a machine for maintenance, the mechanics put over 90 locks on one machine!

The amount of work as well as the diligence this commands easily qualifies for LOTO to be included in a quality system.

I have no problem with this although I think that's where I would draw the line.

Tamale

Re: Lock-out; tag-out procedures as quality controlled documents?

Jim Wynne said:

This is an interesting question, and I think your ideas are reasonable. I'm not sure about how peripheral lockout/tag-out is though, when a serious accident happens and a person and a machine are put out of commission indefinitely, both of which could cause a significant blow to productivity and perhaps in an extreme case the ruination of the company. Aside from the human aspect, the ability to deliver product is part of quality.

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The question isn't whethere that have a program or not...they do. And it's been demonstrated.
The question is whether it should be in the document control system of the QMS... We all agree it should, but I don't think it must...

what you are saying is more of concern for a OSHA inspector or even a customer to bring up in an audit... L'Oreal, for example, does safety and environmental audits of key suppliers to judge risk (at least they did about 8 years ago).