Risk Management Process, How far do I need to go?

Melissa

Starting to get Involved
#1
First Time Poster :)
I work at a manufacturing facility that makes medical devices - we are a contact facility, meaning we do not design the product. As far as risk management goes, i cant really say much about anything else other then our production processes/human errors -- would it be necessary for me to go beyond -- such as an effect to end user?
 
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Cthames

Involved In Discussions
#4
Your risk management should ensure your production process is able to output product which meets the designer's specifications. I wouldn't worry about users. That should've been accounted for in the design specifications provided by the designer.
 

William55401

Quite Involved in Discussions
#5
The legal manufacturer (your customer) owns the end to end 14971 risk mgmt process. Production and process controls, at your facility, are relevant to the overall RMF (risk management file). Typically, your firm will have create and maintain process FMEA that complement your customer's overall risk mgmt approach. Hope this helps.
 

Melissa

Starting to get Involved
#7
The legal manufacturer (your customer) owns the end to end 14971 risk mgmt process. Production and process controls, at your facility, are relevant to the overall RMF (risk management file). Typically, your firm will have create and maintain process FMEA that complement your customer's overall risk mgmt approach. Hope this helps.
Assuming that I should get the customers Risk Management file to have mine compliment theirs?
 

Cthames

Involved In Discussions
#8
Assuming that I should get the customers Risk Management file to have mine compliment theirs?
If anything, the customer should be asking for yours. For a simple FMEA, I'd analyze any potential hazards from production. For instance, how are you mitigating the risk of untrained personnel assembling materials? You train personnel and don't let unauthorized personnel into production areas. How are you ensuring no bad product escapes your facility? You are performing inspections.

These are pretty general, but you can follow the same manner of thinking for product-specific risks. PM me if you'd like to share more information about the products and I can maybe offer some slightly more specific guidance.
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#9
Since you will be responsible for creating the Batch Records that the manufacturer will sign off on, they should also have the Risk Process on hand. This will help define your QC checks in the process.
 

Tidge

Trusted Information Resource
#10
First Time Poster :)
I work at a manufacturing facility that makes medical devices - we are a contact facility, meaning we do not design the product. As far as risk management goes, i cant really say much about anything else other then our production processes/human errors -- would it be necessary for me to go beyond -- such as an effect to end user?
There has been some good advice. Here is how I see things, for a contract manufacturer (CM):

The CM ought to have Process FMEA that focus on implementing risk controls to minimize the production of non-conforming product. I'm somewhat of a stickler about asking for the specific evidence showing that the implement controls really are reducing this risk, but this can be a touchy subject. If a CM has a known scrap rate, the CM should (minimally) be able to explain the rate (pre- and post-controls) and use it to justify whatever sort of sampling plan is implemented.

The customer ought to be telling the CM what (if any) processes/controls they require the CM to implement, and then the customer should assess the risk controls (for such processes). This assessment will be drive by their Risk Management file, which is where the consideration for the patient/customer comes into play. For example, is is common that plastic parts from an injected molding process will have some amount of "mold release" on them... the customer may want the CM to remove manufacturing fluids (because of risk to patients), or they may decide to do it themselves. In this example: if the customer decides to take on the parts cleaning by themselves, there isn't much point for a CM to consider patient risk... the CM will still be focused on making parts "to spec".

If the customer is pushing risk controls for patient/user/stakeholder safety to a CM; the customer is still responsible for assessing the appropriateness and effectiveness of those risk controls.
 
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