Drowning in ECR/ECO/ECN Document Changes

[Heather312]

Hello Covers!
I am working on implementing a quality system in a small, custom manufacturing medical device company and I am falling down a rabbit hole when it comes to change requests. Since every device is custom (we have nothing off the shelf) the current ECR in place is being used for document change requests rather than engineering. This is leading me to think maybe I should create a separate DCR/DCO/DCN document line but because we are a small company (less than 10 employees) I do not want to be buried in paperwork for a simple document change. Having DCR and ECR also leads to some grey area over which request to use when. A request to change our work instructions is a document but may also be considered engineering so which document do you then use??? Also, we do not currently have separate ECO/ECN documents. Our ECR is being used to cover everything on the order and notification side since again our change requests are document based. So basically my questions are:

-Should I develop and incorporate a DCR specific for document changes? How do I distinguish between when to use a DCR vs an ECR? Could I have a standard Change Request form to cover all changes for both documents and engineering?
-Is it necessary to have a ECO/ECN doucments as well as an ECR? Could it all be on one document?

My main goal is streamline the change request procedure and KIS within our small group. Obviously, if we grow/change/expand I will further develop our procedures. Any input would be greatly appreciated!

 

[Vitalix]

Hi Heather312, I don't have much experience in MD QMS (have just started couple of months ago), but I think one general CR is sufficient for everything you do. Just develop a form in a way that you can "n/a" irrelevant sections.
Also we don't have eco and ecn, and it all works just fine.
The goal is to produce a good product and to have certain control over changes but to not bury yourself in the superfluous paperwork.
Hope that helps!
Vit


Envoyé de mon iPhone en utilisant Tapatalk Pro

 

[Jason3312003]

I'm currently working in a 65 person medical device company. We use a single CN form for every change. It avoids confusion as to which form to use. I've also worked in systems with multiple forms, and it does get confusing especially when you make changes from cross functional teams.

In our system we establish questions for every change and those are separated by discipline. We then differentiate who needs to sign off which document types (drawings, inspection sheets, risk documents, etc). This helps control the change through appropriate departments (Engineering, quality, operations, etc). It's fairly streamlined and I believe the delegation of roles in getting the CN routed is the key. If someone is making a change they are responsible in getting it approved by various departments. Then it funnels to doc control

 

[BradM]

Hello Heather! Welcome to the Cove!

My first thought is.... to keep it simple. If you can have one form serve as your change tool, then just have one change document.

Second... do you have a procedure/ process that defines when Change Control is needed? For example, if someone discovers a typo in a procedure, will that require Change Control? Also, who (and what levels) need to sign?

What I would do is have one Change Document to cover changes in your organization. I would keep the changes specific in the change control, but that one change could encompass document and engineering changes. However, don't get too specific/ detailed that you have thousands of these things that you cannot manage.

 

[54DLL]

Can on ECO suffice for administrative document changes?

I am new to this Forum and I have been tasked with updating all of our QDP, SCP and SOPs to add a process owner and to make a company name change. This is a 20 people medical device company.

Since these changes does not affect the products we manufacture and/or sell, is the a way I can incorporate a change my Doc Control procedure that would allow administrative changes without REV each document?

Thank you

 

[AndyN]

Re: Can on ECO suffice for administrative document changes?

I am new to this Forum and I have been tasked with updating all of our QDP, SCP and SOPs to add a process owner and to make a company name change. This is a 20 people medical device company.

Since these changes does not affect the products we manufacture and/or sell, is the a way I can incorporate a change my Doc Control procedure that would allow administrative changes without REV each document?

Thank you

Yeah, just make the change. If you were printing your documents on paper which had a new letter head/logo already printed you would simply use that. The content hasn't changed, just the paper it's printed on. Go ahead, make the change. For "CYA" purposes, issue ONE change notice and say you're changing the name for all documents (you could attach a list of affected documents)

 

[54DLL]

Re: Can on ECO suffice for administrative document changes?

Thank you for that info. I can also do one change document notating that I had updated some of the process owners and typo's in some of the documents too?

 

[AndyN]

Sure! Why not?

 

[cosmeticqg]

Hi All! I found this thread interesting and had question regarding the use of ECNs between customer and suppliers. I work for a company that uses a turn-key model, where our suppliers provide us with product meeting specific criteria. It's not contract manufacturing, as we only provide a few details of what the product should do. Our supplier make the products in accordance to our requests. While it's a bit more complicated, we use ECNs for everything, including regulatory changes. In my opinion, regulatory requirements do not warrant issuance of ECNs from the customer to suppliers-- as the supplier should technically ensure all product are compliant to the applicable rules and regulations. If anything, we should just communicate the requirements so that they can incorporate. Thoughts from this team? Am I completely off?

 

[John Broomfield]

Hi All! I found this thread interesting and had question regarding the use of ECNs between customer and suppliers. I work for a company that uses a turn-key model, where our suppliers provide us with product meeting specific criteria. It's not contract manufacturing, as we only provide a few details of what the product should do. Our supplier make the products in accordance to our requests. While it's a bit more complicated, we use ECNs for everything, including regulatory changes. In my opinion, regulatory requirements do not warrant issuance of ECNs from the customer to suppliers-- as the supplier should technically ensure all product are compliant to the applicable rules and regulations. If anything, we should just communicate the requirements so that they can incorporate. Thoughts from this team? Am I completely off?

From what you say you are subcontracting design as well as manufacturing.

Being as you’ve carefully selected suppliers for their design capability you should already be confident in their monitoring of regulatory changes and responding to them for timely ongoing compliance of their products (complete with approved ECNs) for your customers.

Is this sufficient for your customer’s configuration management? Your system may need some service design. That would be my concern.