Risk based Impact Level related to Customer Complaints

tebusse

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#1
Greetings everyone,

I recently started working for a medical device company that produces software after having worked in biopharma for the past four years in operations.

One of the projects I was assigned is to develop a risk based impact level related to customer complaints with definitions and criteria. I've reviewed our complaints handling system and it appears that while each complaint is categorized (e.g. functional defect, basic operations, user error, etc.) and investigated, risk analysis is not part of the procedure.

Is anyone able to provide guidance on where to begin? I'm having difficulty in going from concept to actual application.

Regards, Tonia
 
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red66climb

#2
Re: risk based impact level of complaints

That's a great question and many companies are converting their complaint process over to a risk-based process to comply with the requirement for implementing risk management throughout product realization (clause 7.1). EtQ is software that has a systematic way to do this, but I like to keep it simple. Best practices in risk management for medical devices is ISO 14971. Annex G indicates, in a single sentence, that detection is only appropriate if it is "proactive". The example I like to give is that you don't want to have a user detect that the cord on their device is getting warm--just before it catches on fire. For complaints, you have a device malfunction of some kind. Therefore, look up the failure mode in your design risk assessment. The analysis should indicate the severity of the failure mode and the probability of occurrence of harm. As part of the risk review for complaints, you should verify that the severity and probability of occurrence of harm match your analysis. If they don't, you have to re-evaluate your risk analysis. If they do, then the complaint should not be unexpected. As a company you can prioritize your complaints based on the product of these two numbers (i.e. = severity x occurrence). The higher the score, the higher the priority. These scores would be documented on the complaint record and in the complaint log for tracking purposes.
 
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