I would like the expertise of the people on this board on the subject of documents that require ECO's and those that don't. We are creating new OSHA documents such as "Fire & Earthquake Action Plan" and "Injury & Illness Prevention PLan" and "Innoculation for Hepatitis B" (for those who handle returned merchandise from hospitals). These are all HR documents so do they need to be formally approved through an ECO and do they belong to the Quality System? I don't think so. I believe that referencing ISO 13485:2003 section 6.4 is only an invitation to be audited - that opens a can of worms unnecessarily. I'm in favor of keeping the docs in HR and having them accessible to all employees electronically but our Regulatory person thinks they should be "controlled documents" and part of the Q system.

Anyone? :confused:

I'm the Documentation Specialist.

I would put them in your QMS. Some auditors would consider them a type of WI that needs to be followed to stay safe. If they are not controlled with in your system how do you know if people are following the proper steps.

That is my two cents, but I am not familiar with your version of ISO.

At my previous employer we were attempting to integrate our EHS stuff, (things that you referenced above) with our TS system so that everything was under one "roof" and required a little less work to monitor and control.

The ECO process isn't a quality system function, it is a document control function. Registering to one ISO standard or 12 of them makes no difference in this subject. Document change control can, and should be managed in one central process.

That's because the various standards have the same requirements: to decide what is important to control and why; how the records will be maintained; how and when they will be disposed of; how you will ensure information is kept current, and how you will keep old information for reference.

The documents you listed sound like they may have more than one set of requirements, because some may be required by law and others provide support for workplace health and safety maintenance. The documents that describe what is required and how you do things should have change control. Documents that show what has been done--records--should not get any changes once they are completed and filed.

I don't mean to preach to the choir, only show you that there really is little difference here between quality and safety system documentation management. So don't call it Quality Document Control. Just call it Document Control.
:2cents:

I would like the expertise of the people on this board on the subject of documents that require ECO's and those that don't. We are creating new OSHA documents such as "Fire & Earthquake Action Plan" and "Injury & Illness Prevention PLan" and "Innoculation for Hepatitis B" (for those who handle returned merchandise from hospitals). These are all HR documents so do they need to be formally approved through an ECO and do they belong to the Quality System? I don't think so. I believe that referencing ISO 13485:2003 section 6.4 is only an invitation to be audited - that opens a can of worms unnecessarily. I'm in favor of keeping the docs in HR and having them accessible to all employees electronically but our Regulatory person thinks they should be "controlled documents" and part of the Q system.

Anyone? :confused:

I'm the Documentation Specialist.

Per ISO 14969, if product quality can be influenced by any of situations addressed in the OSHA documents you referenced, then they should be under the quality system umbrella.

An argument can be made on either side of this. There are those who would put everything under the QMS, but IMO I would keep it out. You may still want to control the documents, but not within the QMS.

I would like the expertise of the people on this board on the subject of documents that require ECO's and those that don't. We are creating new OSHA documents such as "Fire & Earthquake Action Plan" and "Injury & Illness Prevention PLan" and "Innoculation for Hepatitis B" (for those who handle returned merchandise from hospitals). These are all HR documents so do they need to be formally approved through an ECO and do they belong to the Quality System? I don't think so. I believe that referencing ISO 13485:2003 section 6.4 is only an invitation to be audited - that opens a can of worms unnecessarily. I'm in favor of keeping the docs in HR and having them accessible to all employees electronically but our Regulatory person thinks they should be "controlled documents" and part of the Q system.

Anyone? :confused:


I'm the Documentation Specialist.

As I have offered in other postings, I recommend all important documents should be controlled. If it is important that they be accurate and up to date, they need to be controlled.

If you buy that, then the question is not whether to control them, rather to what degree. Different kinds of documents can be controlled in different ways, depending on what is needed.

Try to keep it simple.

What's an ECO? :confused:

What's an ECO? :confused:

Paul,

I believe it's an Engineering Change Order (ECO)

Stijloor.

I would like the expertise of the people on this board on the subject of documents that require ECO's and those that don't. We are creating new OSHA documents such as "Fire & Earthquake Action Plan" and "Injury & Illness Prevention PLan" and "Innoculation for Hepatitis B" (for those who handle returned merchandise from hospitals). These are all HR documents so do they need to be formally approved through an ECO and do they belong to the Quality System? I don't think so. I believe that referencing ISO 13485:2003 section 6.4 is only an invitation to be audited - that opens a can of worms unnecessarily. I'm in favor of keeping the docs in HR and having them accessible to all employees electronically but our Regulatory person thinks they should be "controlled documents" and part of the Q system.

Anyone? :confused:

I'm the Documentation Specialist.
For sustaining and improving the process and its interactions, I would always address your type of issues within the QMS. I believe no process is so less important that you still want to adopt it but keep it out of the QMS.... Sooner or later that will turn out to be your weakest link. What you would be getting into perhaps will be a very good Integrated QMS
Wishing you good luck.....

:2cents:
…first, if your ECO’s are engineering change orders that could affect your OHSA performances, definitely you have to control them…

…and I guess, if your management agrees to let their control under QMS, I don’t see any problem on that since you are going to control them anyway… and not to mention that the generic document requirements for QMS and OHSAS are the same…

(…just a thought, if they are engineering change orders, shouldn’t be they belong to engineering? :confused:)

I would like the expertise of the people on this board on the subject of documents that require ECO's and those that don't. We are creating new OSHA documents such as "Fire & Earthquake Action Plan" and "Injury & Illness Prevention PLan" and "Innoculation for Hepatitis B" (for those who handle returned merchandise from hospitals). This has been covered elsewhere on the cove - if it is OSHA it doesn't form part of your QMS (although some disagree).
These are all HR documents so do they need to be formally approved through an ECO and do they belong to the Quality System? An Engineering Charge Order (thanks Stijloor!) to change a document - seems excessively bureaucratic.
I don't think so. I believe that referencing ISO 13485:2003 section 6.4 is only an invitation to be audited - that opens a can of worms unnecessarily.Only if it is within the scope of your certification. Which I can't see.

On the other hand you might want to distract the auditor from the real audit! :notme:

I'm in favor of keeping the docs in HR and having them accessible to all employees electronically but our Regulatory person thinks they should be "controlled documents" and part of the Q system. Why do they think they should be in - I can't see any reason. Tenuous link with infrastructure and work environment but certainly not required by ISO.

An argument can be made on either side of this. There are those who would put everything under the QMS, but IMO I would keep it out. You may still want to control the documents, but not within the QMS.

If you want to control them why not use the system that is already in place. If you have to create another system then you have just made the problem worse. :2cents: