Criteria and Rationale for Selection of Risk Management Tool

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#1
1) ""what factors""/""How to"" determine the suitability/fitness of a tool(cause-effect - DRBFM - FMEA - FMECA...) to your product/process/industry etc.,
1.1 Does the simplicity of the tool figure in the above factors. (simplicity - easy to implement/understand etc.,)
1.2 I have not much heard about DRBFM (Design Review Based on Failure Mode) in the regulatory circles, will it be accepted by FDA.
1.3 is it true that regulatory only accepts the tools which are somewhere used/cited in the rules/guidances!!!

2) Do you use mutilpe tools based on the stage of product development; If yes, how do you maintain the continuity of risk assessment between multiple tools.
 
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Stijloor

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#2
1) ""what factors""/""How to"" determine the suitability/fitness of a tool(cause-effect - DRBFM - FMEA - FMECA...) to your product/process/industry etc.,
1.1 Does the simplicity of the tool figure in the above factors. (simplicity - easy to implement/understand etc.,)
1.2 I have not much heard about DRBFM (Design Review Based on Failure Mode) in the regulatory circles, will it be accepted by FDA.
1.3 is it true that regulatory only accepts the tools which are somewhere used/cited in the rules/guidances!!!

2) Do you use mutilpe tools based on the stage of product development; If yes, how do you maintain the continuity of risk assessment between multiple tools.
Can someone help with this?

Thank you very much!!

Stijloor.
 

Wes Bucey

Quite Involved in Discussions
#3
1) ""what factors""/""How to"" determine the suitability/fitness of a tool(cause-effect - DRBFM - FMEA - FMECA...) to your product/process/industry etc.,
1.1 Does the simplicity of the tool figure in the above factors. (simplicity - easy to implement/understand etc.,)
1.2 I have not much heard about DRBFM (Design Review Based on Failure Mode) in the regulatory circles, will it be accepted by FDA.
1.3 is it true that regulatory only accepts the tools which are somewhere used/cited in the rules/guidances!!!

2) Do you use mutilpe tools based on the stage of product development; If yes, how do you maintain the continuity of risk assessment between multiple tools.
The tools you cite are really only variations of FMEA, which is part of "Risk Assessment."

For example, if a Failure Mode & Effects Analysis by an organization's "team" determines that the design of a product may be somehow triggering predicted failures, the design may be sent back for Review/Rework. I recall a number of occasions when we (our Contract Machining business) would make recommendations to a customer about changing a design AFTER we went through our internal FMEA about what obstacles might arise when making parts to the customer's original design. We didn't use the terms FMEA or DRBFM with the customer - we called it "value engineering."

Similarly, anywhere between initial design and after delivery of a product into the end user's hands, someone may come up with the idea that the product as originally designed may have flaws which make it easy for a user to have a "failure."

Two such instances come to mind on medical devices:
In the first, dials on an automatic IV machine were confusing and one or two nurses [each week] around the world made errors in setting the rate of infusion of a drug, resulting in patients getting either too little or too much of the doctor-recommended dosage, resulting in death or injury to the patient. There was a widely-publicized case which triggered a recall and subsequent redesign of the device to add "mistake proofing" changes to the controls to eliminate errors involving the settings of the machine. (Sadly, it did not eliminate dyslexics who either miswrote the dosage order (doctor) or who misread the dosage order (nurses.))

The other instance was a personal one. A customer came to us with a design for a component on a medical device. Our engineers immediately noticed an edge and acute angle corner which "might" injure an end user. We called it to the customer's attention and it was redesigned to eliminate the hazard BEFORE we began production.

To the best of my knowledge, FDA does not mandate the tool beyond the concept of "Risk Assessment." Certainly, the companion to FDA regulations (ISO13485) used to harmonize regulations among a number of foreign jurisdictions does not cite ANY tool like FMEA to be used in Risk Assessment.

Added in edit: Do not get hung up on the name of a tool used in Risk Assessment - the tools are all just aspects of the PROCESS of Risk Assessment and should never be considered in isolation from any other aspect of Risk Assessment.
 
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