Joined 10/13/2018
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2 Posts
Greetings ASQ Members,
Would anyone have suggestions on tools/tips for developing a risk based approach to medical device and drug product internal quality system audits? I'm looking to develop a risk based approach for determining the scope (i.e. products, processes, systems etc. reviewed) as well as the frequency. Not sure if there are generic tools for risk ranking -as an example - that are being used.
Thanks - Wayner
Would anyone have suggestions on tools/tips for developing a risk based approach to medical device and drug product internal quality system audits? I'm looking to develop a risk based approach for determining the scope (i.e. products, processes, systems etc. reviewed) as well as the frequency. Not sure if there are generic tools for risk ranking -as an example - that are being used.
Thanks - Wayner
4 Replies
Joined 12/17/2018
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5 Posts
Hi Wayner,
The Aspect Failure Mode Effect Analysis, a FMEA based tool can be used for risk based implementation.
Best, Girish
The Aspect Failure Mode Effect Analysis, a FMEA based tool can be used for risk based implementation.
Best, Girish
Joined 01/28/2019
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6 Posts
FMEA .. its simple to follow and there is provision for constant review and re evaluation of risks
Joined 05/07/2019
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1 Posts
Good afternoon;
A great resource you may want to consider is Barry Craner. I had the honor of participating in the Risk Management: Tools & Audits for all Trades; one of the Pre-Conference workshops at the Annual ASQ Audit Division Conference in Orlando, FL on Tuesday - Wednesday of this week. He has a depth of knowledge of this subject for the Medical Devices industry.
Sincerely,
Lisa
A great resource you may want to consider is Barry Craner. I had the honor of participating in the Risk Management: Tools & Audits for all Trades; one of the Pre-Conference workshops at the Annual ASQ Audit Division Conference in Orlando, FL on Tuesday - Wednesday of this week. He has a depth of knowledge of this subject for the Medical Devices industry.
Sincerely,
Lisa
Joined 06/30/2018
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15 Posts
I am offering a webinar on this in May. Attached is a secure pdf file with more information. Webinar Aplomet RBQA 20200409.pdf
