Documentation for Health & Safety (OSHA) require ECO's?

M

Marquee05

#1
#1
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.
 
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F

funkj - 2008

#2
#2
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.
 
Jen Kirley

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#3
#3
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:
 
D

Doug Tropf

Quite Involved in Discussions
#4
#4
Marquee05 said:
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.
Click to expand...
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.
 
A

Al Rosen

Staff member
Super Moderator
#5
#5
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.
 
H

Helmut Jilling

Auditor / Consultant
#6
#6
Marquee05 said:
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.
Click to expand...
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.
 
somashekar

somashekar

Staff member
Super Moderator
#9
#9
Marquee05 said:
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.
Click to expand...
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.....
 
J

joshua_sx1

#10
#10
: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:)
 
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