Thanks to Annie Duke for pointing me in your direction, David! Just finished Range. 💯 (Let’s talk about the mathematical concept of generality? Analogy.)
I too read Subtract, which led me to correspond with Leidy Klotz about the subtraction technique I produced while working for an international medical devices company 🩹.
Thanks to Annie Duke for pointing me in your direction, David! Just finished Range. 💯 (Let’s talk about the mathematical concept of generality? Analogy.)
I too read Subtract, which led me to correspond with Leidy Klotz about the subtraction technique I produced while working for an international medical devices company 🩹.
Like all companies in our industry, we had reams and reams of processes, procedures, forms, checklists,... to ensure our products’ safety and efficacy. With all that compliance overhead, for a period, we were still delivering products with an unacceptable level of defects. (Think recalls and the like.) My manager put a halt on product updates until we could develop an oversight process (sounds like addition) to ensure lower/no defects. In short, I conceived of a process where every change and any subsequent defect discovered would undergo and “impact assessment” whereby the potential impact to safety, efficacy, user experience, reliability, and a couple other quality principles could be qualitatively assessed/(in)validated. (This is similar to the qualitative assessment adopted by NASA post shuttle accidents highlighted in Range.) The upshot: the reams of processes/procedures were still there to satisfy regulatory compliance, but the impact assessments, done by a more engaged/psychologically safe team, eliminated/significantly reduced product defects. It was almost as if all the previous processes/procedures could have been subtracted and replaced by a much simpler (in)validation process. In the end, we verified (much) less and validated more.
Btw, in an over 30-years career, I was outsider of sorts to product quality. But, I did publish a 2019 paper on medical device software impact assessments in American Society for Quality’s (ASQ) Software Quality Journal. Look me up on LinkedIn for an e-copy there.
Thanks to Annie Duke for pointing me in your direction, David! Just finished Range. 💯 (Let’s talk about the mathematical concept of generality? Analogy.)
I too read Subtract, which led me to correspond with Leidy Klotz about the subtraction technique I produced while working for an international medical devices company 🩹.
Like all companies in our industry, we had reams and reams of processes, procedures, forms, checklists,... to ensure our products’ safety and efficacy. With all that compliance overhead, for a period, we were still delivering products with an unacceptable level of defects. (Think recalls and the like.) My manager put a halt on product updates until we could develop an oversight process (sounds like addition) to ensure lower/no defects. In short, I conceived of a process where every change and any subsequent defect discovered would undergo and “impact assessment” whereby the potential impact to safety, efficacy, user experience, reliability, and a couple other quality principles could be qualitatively assessed/(in)validated. (This is similar to the qualitative assessment adopted by NASA post shuttle accidents highlighted in Range.) The upshot: the reams of processes/procedures were still there to satisfy regulatory compliance, but the impact assessments, done by a more engaged/psychologically safe team, eliminated/significantly reduced product defects. It was almost as if all the previous processes/procedures could have been subtracted and replaced by a much simpler (in)validation process. In the end, we verified (much) less and validated more.
Btw, in an over 30-years career, I was outsider of sorts to product quality. But, I did publish a 2019 paper on medical device software impact assessments in American Society for Quality’s (ASQ) Software Quality Journal. Look me up on LinkedIn for an e-copy there.