Change Management Process

#1
Hello All.

First time Cove post, thank you in advance for the responses. I work as a quality engineer for a contract medical device manufacturing company (ISO 13485) and I am in the process of working on our change management process. I am having a hard time generating a risk assessment template for possible changes.

ISO 14971, Medical Devices - Application of Risk Management to Medical Devices, Table E.2 provided some examples of initiating events and circumstances.

Deciding When to Submit a 510(k) for a Change to an Existing Device Guidance for Industry and Food and Drug Administration Staff
Though this won't be sent from us and rather our contracted customer, I thought this document was helpful for reference. The Figures are super helpful in this document, but I am still needing help with creating a risk-based assessment.

I was wanting to know opinions.

I am thinking personnel will complete an Engineering Change Form and then follow the Figures from the 510(k) document to help with the the flow of the change management process. Once they get to the risk-based assessment they will answer the following questions from ISO 14971 and determine the risk level. Thoughts? If anyone has a template, I would appreciate it.

Thank you.
 

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yodon

Staff member
Super Moderator
#2
You're a CM and you're making changes to the device itself? That puts you into design controls!

If just to the manufacturing processes, do you have any kind of Process FMEA? Those normally identify ways manufacturing can fail and what the potential risks are. That NEEDS to be done in conjunction with your customer since they can only say (and have to defend) what the severity would be. If you have that, you can refer too it as to how risk is assessed.
 

BradM

Staff member
Admin
#3
Welcome!

Will your change management form cover everything, or one for process type changes and one geared for engineering type changes?

Do you already utilize some type of risk language to determine critical non-critical systems like… safety, efficacy, data for submissions, etc.?
 
#4
You're a CM and you're making changes to the device itself? That puts you into design controls!

If just to the manufacturing processes, do you have any kind of Process FMEA? Those normally identify ways manufacturing can fail and what the potential risks are. That NEEDS to be done in conjunction with your customer since they can only say (and have to defend) what the severity would be. If you have that, you can refer too it as to how risk is assessed.
Not making changes to the device itself, just possible manufacturing process changes. I hadn't considered a FMEA as the risk assessment itself, I appreciate your input.
 
#5
Welcome!

Will your change management form cover everything, or one for process type changes and one geared for engineering type changes?

Do you already utilize some type of risk language to determine critical non-critical systems like… safety, efficacy, data for submissions, etc.?
We currently have one change management form to cover everything.
I haven't found anything as such so far.
 

Tagin

Trusted Information Resource
#6
First time Cove post, thank you in advance for the responses. I work as a quality engineer for a contract medical device manufacturing company (ISO 13485) and I am in the process of working on our change management process. I am having a hard time generating a risk assessment template for possible changes.

ISO 14971, Medical Devices - Application of Risk Management to Medical Devices, Table E.2 provided some examples of initiating events and circumstances.

Deciding When to Submit a 510(k) for a Change to an Existing Device Guidance for Industry and Food and Drug Administration Staff
Though this won't be sent from us and rather our contracted customer, I thought this document was helpful for reference. The Figures are super helpful in this document, but I am still needing help with creating a risk-based assessment.

I was wanting to know opinions.
First, you probably are aware - but just in case - it sounds like you are referencing the older 14971:2007 and not the current 14971:2019, as there is no Annex E in the current version. The corresponding table in 14971:2019 is C.1.

Second, I think some of your difficulty in creating this risk template is due to an unclear definition your company's scope of risk responsibility, which may stem an from unclear scope of your company's responsibilities relative to your customer. Both former and latter should be clarified in partnership with your customer. You do not want to take on risk responsibility that is not within your scope. This does not mean blithely ignoring risks outside of your scope, but rather that the prudent action is to inform the customer in such cases, and let them make the assessment. Presumably your customer requires their approval prior to any changes you make anyway, so in large part your role as a CM is providing them good-quality information that will feed into their risk assessment.
 
#7
First, you probably are aware - but just in case - it sounds like you are referencing the older 14971:2007 and not the current 14971:2019, as there is no Annex E in the current version. The corresponding table in 14971:2019 is C.1.

Second, I think some of your difficulty in creating this risk template is due to an unclear definition your company's scope of risk responsibility, which may stem an from unclear scope of your company's responsibilities relative to your customer. Both former and latter should be clarified in partnership with your customer. You do not want to take on risk responsibility that is not within your scope. This does not mean blithely ignoring risks outside of your scope, but rather that the prudent action is to inform the customer in such cases, and let them make the assessment. Presumably your customer requires their approval prior to any changes you make anyway, so in large part your role as a CM is providing them good-quality information that will feed into their risk assessment.
Thanks for the response Tagin. You are absolutely right, I was referencing the older version. I am going to have to find 14971:2019.
You make very great points regarding the risk responsibilities. We of course do have to get prior approval to any changes and of course aren't making modifications to the device, but rather possible changes in the manufacturing process.
I am struggling where to go after personnel fills out a change management form. Should we perform a FMEA to calculate the risks and then proceed accordingly based on FMEA results? My only worry is this would take a great deal of time as there may be many change management forms requested. Would it be best to perform something similar to 14971:2019 C.1 after receiving the form request? Any suggestions?
 
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Tagin

Trusted Information Resource
#8
Thanks for the response Tagin. You are absolutely right, I was referencing the older version. I am going to have to find 14971:2019.
You make very great points regarding the risk responsibilities. We of course do have to get prior approval to any changes and of course aren't making modifications to the device, but rather possible changes in the manufacturing process.
I am struggling where to go after personnel fills out a change management form. Should we perform a FMEA to calculate the risks and then proceed accordingly based on FMEA results? My only worry is this would take a great deal of time as there may be many change management forms requested. Would it be best to perform something similar to 14971:2019 C.1 after receiving the form request? Any suggestions?
If your customer is not giving you any other specific requirements for your change assessment, then using a FMEA seems to make sense. Presuming that you have a pFMEA for the existing process, then the change being proposed to the process should typically affect only one or a few entries in that pFMEA, and it is those few changes that you are assessing:
- what risks changes occur on these steps?
- what mitigation changes are occurring?
- what are the final risk values on these steps?

We are a CM for some medical customers, and to me, the customer is responsible for assessing these changes on a design level and hazard level. You are the experts in the manufacturing process; the customer is the expert in the design, safety assessments, legal/marketing claims, certifications, etc. of their device. When you propose a change to the customer, they want your expertise on what risks may occur on the manufacturing process, not the other areas where they have expertise and responsibility.

Finally, "My only worry is this would take a great deal of time as there may be many change management forms requested." Why are their so many process changes being requested? Is this ongoing improvements, or fixing flawed processes, customer-driven changes, etc? It raises my concern when process changes keep being requested.
 

yodon

Staff member
Super Moderator
#9
We are a CM for some medical customers, and to me, the customer is responsible for assessing these changes on a design level and hazard level. You are the experts in the manufacturing process; the customer is the expert in the design, safety assessments, legal/marketing claims, certifications, etc. of their device. When you propose a change to the customer, they want your expertise on what risks may occur on the manufacturing process, not the other areas where they have expertise and responsibility.
Very well said! This should be required reading by every CM.
 
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