Engineering Change Order Industry Standards

#1
Hi friends. I'm new to the forum, and to the med device industry.

I was hoping I could gather...opinions? insight? experiences? into the engineering change order process. Do you begin with an engineering change order request? Who initiates/approves request? What is the anticipated workflow? I feel as though I need more information about the general process than I am receiving in my day to day environment.

I know this information may vary, but I am looking to see what the industry expectations are for this process. I welcome any and all responses. Thank you so much in advance!
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Good day Revision36, welcome to The Cove!

I could give you chapter and verse, but I am wondering what, if anything you expect to see that differs from other fields and other standards? Do you have a copy of ISO 13485:2016?
 
#3
Hi Jen! I'm happy to be here. There is much to learn!

I do have a copy of that standard. I suppose I don't know very much about the process, in general. I haven't found as many answers to the "whys" behind why certain things are done, when they are done, etc., so I am basically looking for ECOs for Dummies. Do you have any resources beyond ISO 13485:2016 that might be helpful? Even classes, etc. I know this is probably vague. A testament to how much I don't know, that I don't even know how to facilitate asking the right questions.
 

William55401

Involved In Discussions
#4
Welcome to the Cove. To keep it simple, ensure through your change process that the Design History File, especially Risk Management File (RMF) , is maintained as changes occur. I am assuming you are post design release and in production and talking just about changes in a post production environment.

Terminology? Sure, call it a Change Request (CR) while it is assembled and in review. Maybe it becomes a Change Order (CO) after approval and is in implementation phase. Don't get hung up on names. Keep it simple and easy to navigate for users. Some mature (and large) orgs have multiple CR merge into a single CO

Initiator. It depends. Typically, product changes are initiated by the responsible Design Engineer but this may be a different person after production release. Component / material changes may have different specification owners. No matter who initiates, the process must ensure an overall product impact (including Regulatory Filing Decision-- owned by the Reg department) and DHF (including RMF) impact. Assurance personnel will own their documents that may also be subject to CR /CO process.

While not an explicit regulatory requirement, including a decision on "Is this a Design Change?", is often helpful. Your Org creates it's own Design Change definition. That Design Change decision (if Yes), would trigger a more rigorous change process vs. non Design Changes that would be more of an express lane. Test your Design Change definition with scenarios before approving and implementing. Some orgs have a Design Change plan that explicitly assess if Inputs, Outputs, V&V, and Transfer are impacted. That plan would define actions that must be closed during the CO phase (Implementation) after the CO is approved.

Approvers? Assuming a design change, Design, Mfg, Quality, Regulatory are typical. If claims / customer requirements are impacted, then Mktg is in the loop.

Work Flow. I am assuming you are working a paper based system and not connected to an eQMS with built in workflow. Typical change phases are: Initiation (desk work for the owner and functional experts like Reg Affairs on Filing Impact, a design change decision is made an all impacted documents are identified), Review, Approval, Implementation Phase where Actions (docs updated, supplier process validation, training on a revised Mfg procedure - just a a couple of task examples) and ultimately the CO is closed after all tasks complete.

Good Change work comes from connecting with your peers outside of filling out forms / entering data into the system Vet the change with your peers BEFORE putting pen to paper / fingers to keyboard.

HTH. Have fun.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#5
Many thanks to William55401! That was very well said. :agree1::thanks:

In case you want to avoid keeping filing cabinets full of paper, I want to add the electronic Change Order option for MS Outlook users. Outlook has a Vote feature that allows an organization to send a document for review as an email attachment, and collect approvals/rejections and comments from personnel inside or outside of the office. It is hard to beat the time and date stamp that this feature provides, plus the assurance that the approvals are really from the authorized people when they must log into their computers with a password.

It is very important to keep records of the changes and approvals. You can save the email containing the attachment and approvals as a file in your network, and keep backups of your data in a safe place.

I hope this helps!
 
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