Change Control Decision Tree - When medical devices that are approved with a PMA

[totally]

When medical devices that are approved with a PMA are affected by changes in an organization it would be nice to have a decision tree to help determine who needs to review the change. Can anyone point me to change control decision tree examples for PMA products?
Thanks!

 

[Stijloor]

When medical devices that are approved with a PMA are affected by changes in an organization it would be nice to have a decision tree to help determine who needs to review the change. Can anyone point me to change control decision tree examples for PMA products?
Thanks!

Any medical device expert who can help here?

Thank you.

Stijloor.

 

[jkuil]

I do not fully understand the aim of your question.
If you need to decide when to submit a 510(k) for a change to an existing Device read the FDA guidance by following link
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080235.htm

 

[JohnDavis]

I’m looking for a template that provides thought provoking questions in a decision tree for yes/no to lead to whether a change order is required or a change order is not required.

 

[JohnDavis]

This would be for change control to help guide employees on proper decision making where a change order may not be needed and only document change request is all what’s required.

 

[Tagin]

I'm not a medical device guy, but this seems like it would be a helpful list of criteria to guide you in your decision process:
Changes that Require a PMA Supplement: PMA Supplements and Amendments

 

[indubioush]

This would be for change control to help guide employees on proper decision making where a change order may not be needed and only document change request is all what’s required.

Since you have a process for changing documents and another process for "change orders," then the easiest way is to have a set list of document types that need a change order prior to going through the document change process. For example, if you are changing a history record, even if the change is minor, you will still have to document decisions regarding the effect on verification/validation, risk management, and regulatory filings. You will also have to document the disposition of your current inventory, which will be "use current stock" or something like that if the change doesn't actually affect the product. Much better to have a clear line like this versus leaving this decision to a change originator who may or may not have a proper understanding change control. In my opinion, every change to a document referenced on the DMR would require a change order.

 

[JohnDavis]

We actually have 1 process and everything goes through change orders. My boss was asking if document changes have to go through the change order process every time to LEAN out the process and I’m not sure if it’s possible since we are a regulated company.

My boss is Interested in putting together a decision tree with a yes or no so somebody can figure out what direction they need to go in. Implementation plans seem to fail because something gets overlooked which is the biggest problem. So I’m being asked to make a decision tree with a yes/no format based on facts to guide an employee down the right path without them trying to guess. If there is a good decision tree out there on change control it would be much appreciated!! Thanks

 

[indubioush]

I am a little confused because you mentioned change orders and document change requests, but then you said you only have one process. Do you mean that every document change goes through the change order process and also the document change request process?

I urge you to not have a decision tree. What will happen is that people will not look at it, and your document control person will become the bad guy telling people they are doing things wrong. It is better to build the decisions into the form. Here is my suggestion, which worked well at a previous company:

There was a change request form and a document change order. Not every change required a change request. On the document change form, this question was listed: "Is this a change to design, equipment, labeling, manufacturing process, material, software, specification, supplier? __ No __Yes, CR#__________.
If the answer was yes, the originator of the document change needed to list the change request number. The change request form had questions like, what is the verification/validation plan?, what is the affected product?, what is the proposed disposition?, which risk management documents were reviewed?, what is the proposed change to severity rating and occurrence rating?, etc. It also had an indication of whether all required actions had been completed.

If the answer on the document change order was no, the originator just continued working on the document change order.

Hope that helps.

 

[JohnDavis]

It helps but my boss wants a decision tree with yes/no. I had a decision tree more in a flow chart and it drilled down into the details a bit to much apparently. I need to make it very high level so a second grade student can follow it.