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

[Jim Wynne]

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

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).

If I were a third-party auditor I probably wouldn't write this up as a nonconformity, but I would certainly want to hear the rationale behind the decision (if there was a decision).

 

[Quality-Geek]

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

If I were a third-party auditor I probably wouldn't write this up as a nonconformity, but I would certainly want to hear the rationale behind the decision (if there was a decision).

We have several LOTO work instructions. They're included in our document control, although not necessarily as a QMS or EMS document. We are slowly but surely moving toward an "Operations Manual" which includes the QMS, EMS, and an OEE program that Honda has rolled out to suppliers. (No OHSAS yet, although that could change.) The intent is that anything that affects the business should be standardized and documents controlled. Since we're still in the early stages of this, I don't know how well it will work...but it does seem to help when we have new employees or employees move from one level or department to another.

Another reason to include it in the document control system is to protect it from unauthorized changes while allowing access.

How's that rationale???

 

[Randy]

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

We have several LOTO work instructions. They're included in our document control, although not necessarily as a QMS or EMS document. We are slowly but surely moving toward an "Operations Manual" which includes the QMS, EMS, and an OEE program that Honda has rolled out to suppliers. (No OHSAS yet, although that could change.) The intent is that anything that affects the business should be standardized and documents controlled. Since we're still in the early stages of this, I don't know how well it will work...but it does seem to help when we have new employees or employees move from one level or department to another.

Another reason to include it in the document control system is to protect it from unauthorized changes while allowing access.

How's that rationale???

Very, very smart

 

[JaneB]

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

We have several LOTO work instructions. They're included in our document control, although not necessarily as a QMS or EMS document. We are slowly but surely moving toward an "Operations Manual" which includes the QMS, EMS, and an OEE program that Honda has rolled out to suppliers. (No OHSAS yet, although that could change.) The intent is that anything that affects the business should be standardized and documents controlled. Since we're still in the early stages of this, I don't know how well it will work...but it does seem to help when we have new employees or employees move from one level or department to another.

Another reason to include it in the document control system is to protect it from unauthorized changes while allowing access.

How's that rationale???

Integrating systems is an excellent idea. As you already notice, it helps a lot for new employees, or employees moving within the company.

I sometimes think that too much separation and categorising (a la ' that's a "quality doc" but that's a safety one whereas that's EMS') isn't a good thing.

 

[Jen Kirley]

A company is required to obey lockout-tagout laws though it's not necessarily required to have a safety management system.

If I see a clear safety violation during a QMS audit, I feel obliged to call it out. This especially the case when the safety aspects are covered in a process spec of some kind, with or without a safety management system.

 

[act115]

A Quality auditor needs to stay on message, focus on things that directly effect Quality, safety does NOT. Safety is indeed very important and rules and procedures do exist and should be followed. Just because Maintenance is somewhat involved in quality does not mean every little thing they do directly impacts quality. Maintenance procedures in most cases are derived from vendor documents, industrial standards, national or international organizations like OSHA, ANSI, etc. Maintenance procedures are written to be equipment specific and should reference applicable standards or safety rules, this does NOT make them part of QSM. I have been involved in quality audits for many years (as the individual across the table sweating bullets) and I have seen ISO audits evolve from useful to useless. Originally the idea was to improve quality now it appears to only improve the sale of paper, bigger hard drives and reduce unemployment. Over reaching too far outside the immediate quality realm I believe will one day lead to the collapse of ISO 9000. Here is why, originally in order to compete a company was told it needed ISO certification to prove you made a quality product, which would increase sales and make you more money ,this is all well and good as it should be. ISO certification "requirements" via auditor "improvements" has grown to the point where an audit has went from a 6 hour meeting to a week long affair, tying up valuable personal and in some cases requiring the shut down of production.. This does not include the weeks worth of work before and after the audit. I know businesses now that look at the cost associated with this and ask is it really worth it? These added costs directly impact profits and finished product costs. At some point in time you begin to look at companies that DO NOT have ISO certification because they can offer the same product at a cheaper price, with much less hassle. That is my two cents worth, I am now prepared for the beating which is about to begin, I bruise easily.

 

[Jen Kirley]

A Quality auditor needs to stay on message, focus on things that directly effect Quality, safety does NOT. Safety is indeed very important and rules and procedures do exist and should be followed. Just because Maintenance is somewhat involved in quality does not mean every little thing they do directly impacts quality. Maintenance procedures in most cases are derived from vendor documents, industrial standards, national or international organizations like OSHA, ANSI, etc. Maintenance procedures are written to be equipment specific and should reference applicable standards or safety rules, this does NOT make them part of QSM. I have been involved in quality audits for many years (as the individual across the table sweating bullets) and I have seen ISO audits evolve from useful to useless. Originally the idea was to improve quality now it appears to only improve the sale of paper, bigger hard drives and reduce unemployment. Over reaching too far outside the immediate quality realm I believe will one day lead to the collapse of ISO 9000. Here is why, originally in order to compete a company was told it needed ISO certification to prove you made a quality product, which would increase sales and make you more money ,this is all well and good as it should be. ISO certification "requirements" via auditor "improvements" has grown to the point where an audit has went from a 6 hour meeting to a week long affair, tying up valuable personal and in some cases requiring the shut down of production.. This does not include the weeks worth of work before and after the audit. I know businesses now that look at the cost associated with this and ask is it really worth it? These added costs directly impact profits and finished product costs. At some point in time you begin to look at companies that DO NOT have ISO certification because they can offer the same product at a cheaper price, with much less hassle. That is my two cents worth, I am now prepared for the beating which is about to begin, I bruise easily.

Welcome to the Cove!

We are not a group of ISO bobblehead dolls here. I do not think you are going to get "beat up" for not approving with ISO's evolution and its cost. Not everyone here is completely sold on its value.

As for maintenance documents, I also think it's important to stick to the subject of process design and controls when auditing. No way am I going to comb through the line-by-line details of these processes when auditing to ISO, or even TS 16949, and I don't expect every piece of instruction to be controlled by the document control system. 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. So I would not expect an instruction for lockout-tagout to be part of the QMS. I'd probably be satisfied to see lockout-tagout being used during maintenance - no clear violations of the law evident during my audit.

 

[Jim Wynne]

Welcome to the Cove!

We are not a group of ISO bobblehead dolls here. I do not think you are going to get "beat up" for not approving with ISO's evolution and its cost. Not everyone here is completely sold on its value.

As for maintenance documents, I also think it's important to stick to the subject of process design and controls when auditing. No way am I going to comb through the line-by-line details of these processes when auditing to ISO, or even TS 16949, and I don't expect every piece of instruction to be controlled by the document control system. 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. So I would not expect an instruction for lockout-tagout to be part of the QMS. I'd probably be satisfied to see lockout-tagout being used during maintenance - no clear violations of the law evident during my audit.

I think we're asking the wrong question, and that has to do with the idea that we really don't think in terms of a "quality management" system, but in terms of an ISO system. The question that should be asked is not "Should lockout/tag-out be covered by the ISO system?" but "Is this a process that needs to be controlled?". The answer to the first question might be debatable, but the answer to the second question isn't. 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.

 

[bobdoering]

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 - why have "two sets of books"? If you have a need to know where a procedure is - either legally, by ISO, or just plain curiosity - control them in the same place.

How much extra overhead do you generate trying to maintain more than one list of controlled documents, or rooting around desk drawers and piles of papers looking for something not controlled? Why do people look at this as some medieval torture? Think of it like this...what if the library did not have the books cataloged? Would the "cost savings" of either stuffing books on any shelf or piling them up on desks be a net benefit? Sad thing is, it is not so much of a stretch for many organizations.

 

[act115]

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.