Engineering Change Request/Order (ECR/ECO) or Document Change Request/Order (DCR/DCO)

MBeth

Starting to get Involved
#11
Re: Engineering Change Request/Order (ECR/ECO) or Document Change Request/Order (DCR/

I work for a medical device contract manufacturer and am struggling with this exact same issue... they want to use one form to capture all documentation changes. One thing I have not seen on any of the forms that I have been looking at on this site is one that would be specific to a meddev company--i.e. would capture review of risk analysis, validation, inventory, training requirements, customer notification.... can anyone out there help with examples? I'll share an example of what I have as soon as I finish it, but any help now would be greatly appreciated.

You all are the best!
 
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Laura

#12
Re: Engineering Change Request/Order (ECR/ECO) or Document Change Request/Order (DCR/

Hi MBeth

I just noted your question from October of last year. I am currently in a similar situation with a start-up med diag company. I am looking for a template of an ECO Procedure and an ECO form that encompasses the necessary requirements. Did you come up with anything that you could share with me.

Many thanks

Laura
 

MBeth

Starting to get Involved
#13
Re: Engineering Change Request/Order (ECR/ECO) or Document Change Request/Order (DCR/

believe it or not, we're still working on it, but I will post what I have so far (with the confidential info omitted, of course). I'll get to it later today
 
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Laura

#14
Re: Engineering Change Request/Order (ECR/ECO) or Document Change Request/Order (DCR/

:) These things always take more time that one thinks. Thanks.

Laura
 
K

kalliz50

#15
Re: Engineering Change Request/Order (ECR/ECO) or Document Change Request/Order (DCR/

I initiated a single form to try to capture any type of change I'll try to attach it here feel free ... i am finding now after using it for 2-3 years that i really need to split out the EC's and document changes just to get it moving through the sign off process simple little form changes should not have to go through the rigorousness of this process ... but defining what's what will be tricky - i'm also trying to find something simple to use for document changes versus EC changes ...
 

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morock13

#16
Re: Engineering Change Request/Order (ECR/ECO) or Document Change Request/Order (DCR/

Just to put my 2 cents in... don't really have time to put all down of what I think... But here it is... Remember that this is a Quality System... it is always sugested that you only use a single system for any given operation. thus for any change, no matter what it is for, should follow a single system, within this system you can then seperate the Engineering changes with Document changes with a class rateing. Remember that engineering also creates documents such as assemby docs for mfg and other procedures. these are Engineerng controled documents, but if you put them under a DCR/DCO is means seperation of systems.
Mike
 
A

Always Compliance

#17
Re: Engineering Change Request/Order (ECR/ECO) or Document Change Request/Order (DCR/

I agree with morock13, For my view you need to keep it simple. The process within the quality system should be the same and the category should differentiate the level of 'control' required for that category. Clearly defined process/procedure and training all personnel involved should be satisfactory.
 
Q

QA_RA_Lady

#18
Re: Engineering Change Request/Order (ECR/ECO) or Document Change Request/Order (DCR/

HI there... I'm getting dizzy reading all of the responses to your post... :)

I had a similar issue with my design control process... 1 group wanted a ECO, the othere a DCO.

Here's what I did:
I reviewed both proceudres side by side.
I identified all the differences (there were very few)
And I combined them. We are now using a CHange Order for all design changes company wide.

The differences that I identified were mainly in the reivew and approval of the dif kinds of changes... other differences included consideration of distributed copies, etc. now for each change order we consider EVERYTHING and handle appropriately.

This has been the best process improvement I've ever made...
All employees are now capable of creating, routing, approving a change order (regardless of their department) everyone knows how to handle a change order when they see it come accross their desk...
 
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oskameyer

#19
Re: Engineering Change Request/Order (ECR/ECO) or Document Change Request/Order (DCR/

Hi QA_RA_Lady,

Would you mind posting the Change Order form that you use so I can see what you meant by "we consider EVERYTHING and handle appropriately?"

Thanks.
 
J

Jodster24

#20
Re: Engineering Change Request/Order (ECR/ECO) or Document Change Request/Order (DCR/

Thanks Kalliz50. I was trying to make a one page change form for product and document changes and your change notice was exactly what I was envisioning. It gives me a great starting point!!
 
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