Activity

  • Dkonara921 replied to the topic how far is "As Far As Possible" in the forum Risk Analysis for Medical Devices 6 years, 10 months ago

    The way that I interpret this regulation is that companies have to prove that their manufacturing processes are performing at the most optimal level possible. It’s impossible to have a 100% efficient system, many of the things that happen in nature (e.g. chemical reactions, space phenomenon) generate waste and increase the entropy of the universe. Companies have to prove that they are at the point in which they cannot afford to expend more resources to reducing defects or that such an attempt can disrupt and ruin whatever progress that they have made already. “As far as possible” has to take into account that it may be possible to improve quality of your products but the company may be not have the resources to carry out the necessary projects that would results in higher product quality. you would have to rely on statistical analysis and results from the customers themselves(e.g. compliants) that quality has improved. Another way to think about AFAP is that companies have to show that they are improving overall in quality; they cannot and should not trying to do something risky or expensive to get great results fast. If quality is improving slowly, I think that this would still count as abiding by AFAP because it shows that businesses are making an effort to improving their products and reduce risks. AFAP means essentially doing the best you can with what you have.