Hi All. My organization is composed of a number of different divisions, of which some use common procedures and others are fully exempt from the procedures. To address this, I have developed wording in the Scope of our procedures, BUT, the problem now is that in some cases one division may follow only a portion of the procedure and remain exempt from other portions. What is the recommended approach to capturing the exemptions? Should a form be developed and attached as an associated document to the procedure in which it relates? Any advice is much appreciated.

Lynn

Hi All. My organization is composed of a number of different divisions, of which some use common procedures and others are fully exempt from the procedures. To address this, I have developed wording in the Scope of our procedures, BUT, the problem now is that in some cases one division may follow only a portion of the procedure and remain exempt from other portions. What is the recommended approach to capturing the exemptions? Should a form be developed and attached as an associated document to the procedure in which it relates? Any advice is much appreciated.

Lynn

You need to tell us what standard you're talking about, and give a little more detail--an example--of following part of a procedure and being "exempt" from the rest of it.

Hello, Lynn!

Under which particular aspect are you concerned with? Do you have regulatory issues, or just an external auditor? What is the scope of the QMS?

The term "exempt" has always been interesting to me. Why do they feel they want to follow part of it, and not others? Is there some compelling reason why you would have a procedure to essentially do one thing, but have different parts of the organization doing that one thing differently? Setting aside many different things, to me the essential value of a good quality system is getting everyone on the same page of music.

To answer your question, I am unfamiliar with how to make "exemptions". In the past, I would write different procedures to reflect what each group is actually doing.

Thank you both for your response. I work for a CRO that is governed by global regulatory agencies and we also adhere to ISO 9001:2000 and obviously, we get audited from our Sponsors ALOT! Some of our work is full-service, while other times, the projects won't require us to adhere to every portion of each procedure. Most of the time, we write Project Specific Procedures to address the exceptions. My original thought was also to write separate procedures for each area where there were exceptions, but, this could get quite tedious, given we have so many different instances of this occuring.

I think the biggest cause of this conflict right now is that we have "Core Process" procedures that are perfect for a FULL SERVICE project, but they don't address what happens if the project is not full service.

I really appreciate both of your input. I will discuss this further with my supervisor to get her take on your thoughts.

Tigger14,

I’m a bit confused. Could it be that you are confusing projects with programs and procedures? Could be I’m confusing myself.

For instance, an organization will create procedures around a design control process to provide guidance to engineers on how to develop and document a design. The complexity of the design model will vary between organizations and between industries. The idea here is that by executing against the design model, the engineer and project team will develop the very best product and support documentation.

As to be expected, there is a broad range of variation in the complexity of product and the projects they are developed under. A new design might require close adherence to all procedures within the design program. A different configuration of the product probably would not. Here, only some of the procedures of the design program might be necessary. As a fundamental step within design control, a plan needs to be established that will communicate amongst other things, the inputs and outputs of the design effort. The project plan is a useful tool as it can communicate to an outsider what the organizations intentions are and the reasoning behind it. Of course, the program needs to establish that this is the common practice.

In the example above, a new configuration of a matured product probably would not require that every aspect of the design program be followed. Perhaps the change to the widget does not raise new questions regarding its performance, so design verification is not necessary. In the project plan, you can provide rationale why you will not be executing against design verification procedures. Or perhaps the change affects the design cosmetically and not mechanically, so the desire here is to execute against a portion of the procedure. The bottom line here is that a plan, with the appropriate rationale, provides the flexibility one might need.

I’m not sure if you can draw a correlation between your issue and the example I gave (full service vs partial service), but I hope I haven’t confused you further.

Good luck.

Kevin

Thank you both for your response. I work for a CRO <snip>

CRO Combat Replenishment Operations
CRO Combat Rescue Officer
CRO Commonwealth Relations Office
CRO Community Redevelopment Office
CRO Community Relations Office
CRO Community Reuse Program
CRO Complete with Related Order
CRO COMSEC Responsible Officer
CRO Congressional Relations Officer
CRO Continuity Recheck Outgoing (ITU-T)
CRO Continuous Reliable Operation
CRO Contract Research Organization
CRO Contractor Repair Only
CRO Control Room Operator
CRO Creative Roleplaying Organization (live action roleplaying games)
CRO Creole/Creole (language)
CRO Criminal Records Office
CRO Crisis Response Operations
CRO Criterion Reference Objective
CRO Croatia
CRO Customer Relationship Officer

:D

Contract_research_organization CRO

Stijloor.

Contract Research Organization (CRO (http://en.wikipedia.org/wiki/Contract_research_organization))

Stijloor.

I'm betting on one that's not on the list: Clinical Research Organization.

I'm betting on one that's not on the list: Clinical Research Organization.

I would also take that bet. Almost a sure thing.

I'm betting on one that's not on the list: Clinical Research Organization.

I am not a betting man, but you may be right...we'll find out. :)

We may both be right....(CRO (http://en.wikipedia.org/wiki/Clinical_research_organization))

Stijloor.

CRO - Contract Research Organization. Sorry guys. You are all much too advanced for me. I thouht my query was an easy one, but I suppose I am simply causing more confusion than anything. :tg:

CRO - Contract Research Organization. Sorry guys. You are all much too advanced for me. I thouht my query was an easy one, but I suppose I am simply causing more confusion than anything. :tg:

Most of us are very inquisitive and analytical. Now I can start the weekend with great peace of mind...:D

Stijloor.

Have a great weekend.

CRO - Contract Research Organization. Sorry guys. You are all much too advanced for me. I thouht my query was an easy one, but I suppose I am simply causing more confusion than anything. :tg:

It wasn't confusing. Usually when someone posts an Acronym they usually will spell it out and then put the Acronym in parenthesis or visa versa. There are so many Acronyms used now that some can be misinterpreted or misunderstood.

For your questions: It is Friday and most people are on their way home from work. There will most likely be responses on Monday to your question. Be patient.


:topic: Stijloor, you would have won the bet.:applause:

Thanks and I will remember not to use acronyms without spelling them out in the future. Enjoy your weekend.

It wasn't confusing. Usually when someone posts an Acronym they usually will spell it out and then put the Acronym in parenthesis or visa versa. There are so many Acronyms used now that some can be misinterpreted or misunderstood.

For your questions: It is Friday and most people are on their way home from work. There will most likely be responses on Monday to your question. Be patient.


:topic: Stijloor, you would have won the bet.:applause:

:topic: I would have shared the proceeds with you and Jim...:D

CRO - Contract Research Organization. Sorry guys. You are all much too advanced for me. I thouht my query was an easy one, but I suppose I am simply causing more confusion than anything. :tg:

You're fine, tigger, and thanks for being a good sport letting us joke around a bit.

Ok, back to work...

In reading Kevin's post, I personally think he is on the target quite well for your situation.

Within the project framework, what about having a Project guideline checklist? This would mark the processes that are applicable to your specific job, and consequently addressing which sections of the procedures are necessary. Like Kevin mentioned, maybe one of your projects does not require all 30 sections of the design control procedure. If the responsible person signed a checklist stating as such, that would show for that project what processes were being performed, and thus what level of procedures would need to be followed.

I still begin to itch all over :tg: when any organization has a system where you pick and choose portions of procedures to comply with. So, just make sure it is identified what processes are to be initiated, and I might have the customer sign it where they acknowledge the scope of the project.

I think you and Kevin are both right on! What I might suggest is creation of a master list of procedures that are being used per project and if sections are exempt, then that should be listed as well.

Thanks to all for your input! I hope you are all having a good weekend!!!

tigger14,

The weekend is going well here in CT. The weather today was terrific! I'm glad that we could help you out. Don't forget to come back to this thread with a follow-up letting us know how you made out. It's always nice to complete a thread with an update for future readers who may have a similar situation.

Should you have more questions, ask away. Folks here are always happy to help solve problems.

Regards,

Kevin

Thank you both for your response. I work for a CRO that is governed by global regulatory agencies and we also adhere to ISO 9001:2000 and obviously, we get audited from our Sponsors ALOT! Some of our work is full-service, while other times, the projects won't require us to adhere to every portion of each procedure. Most of the time, we write Project Specific Procedures to address the exceptions. My original thought was also to write separate procedures for each area where there were exceptions, but, this could get quite tedious, given we have so many different instances of this occuring.

I think the biggest cause of this conflict right now is that we have "Core Process" procedures that are perfect for a FULL SERVICE project, but they don't address what happens if the project is not full service.

I really appreciate both of your input. I will discuss this further with my supervisor to get her take on your thoughts.

Because you're dealing with a service as opposed to a manufactured product, the approach must be different. For either purpose, it's all about process control, so what you need to do is develop your system with control of processes as the goal. Each project you do might be different in terms of the nature of the delivered service, but they will most likely all be the same in terms of the goal. Each project should have its own design documentation, but that documentation should be developed in a framework of meeting some basic requirements. The framework is your written system documentation--the requirements for designing and executing projects. You shouldn't have to worry about "exemptions"; all of your projects should be expected to meet the same basic requirements of fulfillment.

Thanks All, I will keep you posted. I am on vaca this week :tg:. I will let you know when I get back the end result of this thread.

Hi There. Bet you thought I forgot to come back and provide the resolution that was decided by my company. No, it just takes quite a while before they can make a final decision. Okay, here it is....We have updated the scope of our SOPs to be very generic. We defined every possible project type we have in the organization (i.e., full service, multi, stand-alone, consulting, etc.) and we created a waiver form that is to be completed and attached as a related document to the procedure that will not be followed, in addition to other pertinent information. The waiver will be approved by the original signers of the SOP and QA. The form will provide details to provide a justification on why the procedure is not being followed. Thank you all again for your wisdom (and sarcasm in some cases...:sarcasm:).

tigger14,

Thanks for the update. Hopefully the plan you developed will give you the flexibility you need.

Regards,

Kevin