Add Safety Policies/LOTO/etc. to Controlled Documents?

J

jbdominguez

#1
I am responsible for both our QMS and HR/Safety (among other things), and I would like to know if it is appropriate to include our Safety policies, LOTO procedures, Hazard Communication, etc. as part of our controlled documents. We are ISO 13485:2003 Certified, with discussions on becoming ISO 9001:2008 Certified.
 
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RoxaneB

Super Moderator
Super Moderator
#2
I am responsible for both our QMS and HR/Safety (among other things), and I would like to know if it is appropriate to include our Safety policies, LOTO procedures, Hazard Communication, etc. as part of our controlled documents. We are ISO 13485:2003 Certified, with discussions on becoming ISO 9001:2008 Certified.
Let me ask this...why wouldn't you?

I suggest that for the purposes of a business culture, drop terms like "quality management system" and "safety management sytem". Instead, adopt "business management system" or "<company name>'s management system".

Where is the value in having some procedures follow your document control process while others are outside of the system?

Does your company believe in keeping employees safe and having them return home at the end of the day?

Does your company understand the value of the document control process?

If your answers to above three questions are "there is no value", "yes" and "yes", then perhaps you've answered the question in your original post. :)
 
J

jbdominguez

#3
Makes sense. When I came into the organization, the safety policies were separate. I just wanted to make sure that I was on the right track by wanting to control them as we do our manufacturing procedures. Thanks!
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
Let me ask this...why wouldn't you?
In my experience, the reason most organizations avoid adding non-quality related requirements (e.g. occupational safety or waste management) to documents such as procedures, has to do with the "unfounded fear" that, if they add such requirements to a quality related procedure, an external auditor could audit against those requirements as well, when conducting an audit against ISO 9001 or ISO 13485, for example.

We have had this discussion many times in the past and auditors must stick to the scope of an audit, irrespective of the fact that an enlightened organization might have added non-quality related issues to a document. In other words, if I am conducting a QMS audit, I must NOT delve into non-quality related issues. Section 0.4 of ISO 9001 makes that very clear.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#5
While I agree with Roxane (as I usually do) I have to point out that there is no requirement to do so.

I've had this conversation in just about every company I've worked for and it always just makes more sense to have a single document control system for all your documentation.
Having OSHA or DEP required documents in the control system does not mean that they will be audited by registrars or internal auditors... that is usually the fear. But ISO 13485 and ISO9001 auditors audit to a standard that doesn't include EHS stuff.


Having multiple doc control systems is like spending extra to have a PC for gaming and a Mac for multimedia... wait... I do that...:frust:
 

RoxaneB

Super Moderator
Super Moderator
#6
ScottK said:
While I agree with Roxane (as I usually do)
Smart man! :D

ScottK said:
I have to point out that there is no requirement to do so.
True, there is no requirement. There is also no requirement for me to brush my teeth and hair in the morning before coming into work...but I do both. Why? (see next quote)

ScottK said:
...just makes more sense
However, as you and Sidney reminded the Original Poster...Scope! Not the mouth-wash, but the parameters/boundaries of the audit that should keep auditors in line.
 

qusys

Trusted Information Resource
#7
I am responsible for both our QMS and HR/Safety (among other things), and I would like to know if it is appropriate to include our Safety policies, LOTO procedures, Hazard Communication, etc. as part of our controlled documents. We are ISO 13485:2003 Certified, with discussions on becoming ISO 9001:2008 Certified.
It is your choice and you could evaluate the risk of not doing so, as well as pro's and con's.
If you want to pursue also OHSAS certification and ISO 9001, this could be an advantage. ISO9001 foresees document control procedure and even if there is no requirment for controlling safety procedures, policies and so on, you could think to create an integrated system that encopass all documentation that you esteem necessary for the functioning ofyour mgmt systems ( ISO 9001, ISO 14001,OHSAS 18001, ISO 13845...).:bigwave:
 

kgott

Quite Involved in Discussions
#8
Does your company understand the value of the document control process?. :)
I find that an interesting question RCBeyette. Just checking for something I may not know here but apart from:

- preventing waste caused by using out of date documents eg specs
- an orderly and structured way of creating, issuing, changing, re-issuing and storing documents
- reducing time to access required documents used day-to-day
- as an aid in reducing various risks
- as an aid in learning from previous mistakes

is there any other advantages in controlling documents I can relate to other staff and management?

thanks
 

RoxaneB

Super Moderator
Super Moderator
#9
I find that an interesting question RCBeyette. Just checking for something I may not know here but apart from:

- preventing waste caused by using out of date documents eg specs
- an orderly and structured way of creating, issuing, changing, re-issuing and storing documents
- reducing time to access required documents used day-to-day
- as an aid in reducing various risks
- as an aid in learning from previous mistakes

is there any other advantages in controlling documents I can relate to other staff and management?

thanks
Your list is a nice starting point, kgott, but focuses heavily on the benefits to the documents themselves. Let's expand upon "an aid in reducing various risks"...how would explain that to people in your organization?

Consider the following:

  • A tool to promote standardized application of tools/methods within activities (i.e., everyone should be doing it the same way with the same stuff)
  • Facilitates a common language within the organization. Everyone uses the same tools, methods, documents so that in multi-department meetings we're all speaking the same language of the organization.
  • Standardized training material - everyone is trained on the same material and the appropriate/applicable personnel are trained when there is a revision.
  • Having a robust document control system supports the documentation of best practices which, in turn, should guide people on how to achieve the goals of their performance metrics. (i.e., If you have documented practices but no metrics, how do you know if your practices are correct? If you have metrics but no documented practices, how to ensure people can achieve their goals?)

This does go slightly off topic from the original poster's request, but it is important for an organization to understand the importance of document control and how it fits into the concept of routine management (i.e., standardization (tools, methods, documents), training, application, results, failure analysis and assessing).
 

kgott

Quite Involved in Discussions
#10
Consider the following:

  • A tool to promote standardized application of tools/methods within activities (i.e., everyone should be doing it the same way with the same stuff)
  • Facilitates a common language within the organization. Everyone uses the same tools, methods, documents so that in multi-department meetings we're all speaking the same language of the organization.
  • Standardized training material - everyone is trained on the same material and the appropriate/applicable personnel are trained when there is a revision.
  • Having a robust document control system supports the documentation of best practices which, in turn, should guide people on how to achieve the goals of their performance metrics. (i.e., If you have documented practices but no metrics, how do you know if your practices are correct? If you have metrics but no documented practices, how to ensure people can achieve their goals?).
Thank you for adding to my knowledge store RCBeyette, much appreciated.
 
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