The "Recall Epidemic"
Risk management is a numbers game, but it's a people problem:
► many do FMEA, but how many use Detection in their Risk Priority Number (RPN) calculation. ► many do FMEA, but how may also use Fault Tree Analysis (FTA).
► many purposely design meetings, but how many create knowledge synergy. For example, inviting team members with product knowledge and risk management specialists with expertise.
► how many actually design all hands meetings to create sharing synergy in wide ranging reviews of components and sub-components, interfaces and interactions.
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Maybe you have no record of FDA medical device recalls. But, does that mean you have no related effort, worry and costs?
Risk management could be natural. And, recalls could be like black swans. | ||||||||
What's in Your History Files? ™
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Richard L. Bollinger
618 Fifth Street Ann Arbor, MI 48103 |
TOKENS LEFT
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