Risk Management in a very small low tech, Class 1 Medical Device Manufacturer

T

theGrod

#1
I am looking for some help with Risk Management because it is a very huge requirement for ISO-13485. Is there anyone out there that has a easy to understand training, ppt presentation, manual or something that can explain how to do risk management in a very small low tech, class 1 medical device manufacturer? I have some things but they are very complicated and way more than we need. They are also not very user friendly. I would accept recommendations as well. Thanks.
 
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#2
Re: Risk Management

I am looking for some help with Risk Management because it is a very huge requirement for ISO-13485. Is there anyone out there that has a easy to understand training, ppt presentation, manual or something that can explain how to do risk management in a very small low tech, class 1 medical device manufacturer? I have some things but they are very complicated and way more than we need. They are also not very user friendly. I would accept recommendations as well. Thanks.
Not to put too fine a point on it, but where did you get "some things" about risk management? Some folks make the error of copying processes and procedures (P&P) from organizations that are completely unlike their own because those P&P "work" for those organizations. A similar situation is encountered when trying to adapt generic documents sold or available free on the internet because too much effort is made trying to reconfigure the organization to fit the P&P, rather than reconfiguring the P&P to fit the organization [beyond word processing the name of the new organization into the document.]

Simply stated, just sit down and list the potential risks YOUR organization could possibly face, arrange them in two orders - first, the order in which they could possibly occur from most often to least. Then order them according to the worst possible outcome to your organization if they should occur. Assigning relative values to those risks will enable you to have a range of events. Then determine WHAT you would do to ameliorate those risks and what action you would take if they do occur. In short, that's the basics of ANY risk assessment. Smart folk regularly review their lists to determine if they need to be reordered or if some risks need to be removed or added.

Rarely will any two organizations have the same risks with the same probability of occurring and the same degree of damage to the organization if they do occur. Certainly, preventive measures and corrective actions will also be different.
 
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