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Risk Management Portal - Beyond ISO 14971 - Incorporate $$ into the Risk Assessment
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Risk Management Portal - Beyond ISO 14971 - Incorporate $$ into the Risk Assessment
Risk Management Portal - Beyond ISO 14971 - Incorporate $$ into the Risk Assessment
Risk Management Portal - Beyond ISO 14971 - Incorporate $$ into the Risk Assessment
Risk Management Portal - Beyond ISO 14971 - Incorporate $$ into the Risk Assessment
Risk Management Portal - Beyond ISO 14971 - Incorporate $$ into the Risk Assessment
Risk Management Portal - Beyond ISO 14971 - Incorporate $$ into the Risk Assessment
Risk Management Portal - Beyond ISO 14971 - Incorporate $$ into the Risk Assessment
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Risk Management Portal - Beyond ISO 14971 - Incorporate $$ into the Risk Assessment


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Some Related Topic Tags
cost of poor quality (copq), cost of quality (coq), cost reduction, iso 13485 - medical device qms, iso 14971 - medical device risk management, medical device company or industry, forms and templates (general), risk management and analysis
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  Post Number #1  
Old 27th March 2007, 05:09 PM
k3nny

 
 
Total Posts: 44
I Say... Risk Management Portal - Beyond ISO 14971 - Incorporate $$ into the Risk Assessment

All,

We are a medical device facility under the guidelines of ISO 13485:2003 as well as FDA scrutiny (ISO 14971). With that said, I am also interested in preventing the risk management system from just being used for Quality and Regulatory purposes. Does anyone use / have forms that not only address a risk through QA/RA, but have found a way to incorporate $$ into the risk assessment.

Our systems are segmented here - I am not here to blame but our software package is very restrictive. Recently, I have taken this over. However, realized that once this is complete and the design is released it is not used for a comparative analysis against the development costs, ongoing QA, future development projects other than to create another risk assessment for a new project.

I am referring to the entire Risk Management including questionnaires, FMEA's, etc..

Any thoughts?

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  Post Number #2  
Old 2nd April 2007, 01:15 AM
Gert Sorensen's Avatar
Gert Sorensen

 
 
Total Posts: 1,278
Re: Risk Management Portal - Beyond ISO 14971 - Incorporate $$ into the risk assessme

Any takers on this one??
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  Post Number #3  
Old 24th May 2011, 08:16 AM
df_df

 
 
Total Posts: 4
Re: Risk Management Portal - Beyond ISO 14971 - Incorporate $$ into the risk assessme

We have taken $$ into account in our process FMEAs. We use an RPN system with a 1-10 scale and have assigned all "injury" a severity 9 (minor injury) or 10 (major injury/death). Lower severities generally involve money - either scrap, rework, lost productivity, etc. For these we generally assign higher severities to harms that will cost the firm more $$ and lower severities that will cost the firm less to fix/remedy. We also have a 2-tiered mitigation requirement. For severities of 9 or 10 we mandate risk mitigation for RPNs above a certain threshold. For lower severities (i.e. lost $$) it is up to the team to decide whether to implement mitigations and what is ALARP.

In contrast, our Design FMEA and System Hazard Analysis only have severities based on harms to the patient/user/environment and do not have severities based on any monetary losses to the company.
Thank You to df_df for your informative Post and/or Attachment!
  Post Number #4  
Old 8th July 2011, 03:07 PM
cjssag

 
 
Total Posts: 22
Re: Risk Management Portal - Beyond ISO 14971 - Incorporate $$ into the risk assessme

Great question and very helpful answer! Since money is the language of management, I try to get my clients to practice Cost of Quality, especially Cost of Poor Quality with near fanatical fervor. Nothing gets Management "help" better than a big, bad number with a $ prefix.
  Post Number #5  
Old 11th July 2011, 02:11 AM
SilkTie

 
 
Total Posts: 22
Re: Risk Management Portal - Beyond ISO 14971 - Incorporate $$ into the risk assessme

That's the healthiest approach with the QMS. Not only look at the regulations, points and commas, but also at the people and the balance book. This way it is an active part of the whole organisation, which adds to the well-being of all, including the CEO and CFO. And this way it becomes clear that the complete QMS is relevant to all.
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