Risk Management throughout Product Realization

C

chaberg

#1
Our company is a component manufacturer, supplying components to the Medical industry. We recently went through our ISO13485 and ISO9001 certification audits and one of the minor findings noted was that our Risk Management Process was not comprehensive enough (did not cover all processes within 7.0)

In the developement of our Quality Systems, we chose to establish seperate processes for our Inquiry, Quote and Order Management Processes.

While establishing potential risks in other process seems pretty straight forward, we are struggling with what Risks might come out of the Inquiry and or Quote processes. We have had a number of meetings, but always end up back where we started as there does not seem to be any risks that link back to the definition of "harm" as defined by the standard.

Any insight or examples out there that might help guide us thru this process?
 
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D

Duke Okes

#2
Re: Risk Management - throughout product realization

Feasibility (e.g., technical capability, capacity, servicing) should be assessed as part of quoting, taking orders, etc.
 

somashekar

Staff member
Super Moderator
#3
Our company is a component manufacturer, supplying components to the Medical industry. We recently went through our ISO13485 and ISO9001 certification audits and one of the minor findings noted was that our Risk Management Process was not comprehensive enough (did not cover all processes within 7.0)

In the developement of our Quality Systems, we chose to establish seperate processes for our Inquiry, Quote and Order Management Processes.

While establishing potential risks in other process seems pretty straight forward, we are struggling with what Risks might come out of the Inquiry and or Quote processes. We have had a number of meetings, but always end up back where we started as there does not seem to be any risks that link back to the definition of "harm" as defined by the standard.

Any insight or examples out there that might help guide us thru this process?
Being the manufacturer to the medical industry and meeting the requirements of ISO 13485, you have to move a little forward and enquire with your customer about the Risks your component can pose to the device they assemble. You have to get a broad understanding from this how and what are the safety critical aspects that you can control and bring them into your risk management documentation. These will comprise off all the activities you perform as manufacturer (the clause 7) to deliver the components to your customer.
 
S

SteveK

#4
If you have conducted a risk assessment to ISO 14971 (e.g. a foreseeable probability and severity rating), a quote or inquiry might lead you to supplying:

• Wrong component
• Incorrect material specification
• Contaminated item
• Damaged item
Etc

This would then constitute possible ‘harm’ if was then incorporated into a medical device. Also to aid matters have you a 'Risk Management Policy'? If you have one, this 'blanket cover' may assist in removing the NC :2cents:

Steve
 
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