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krp67 replied to the topic how far is "As Far As Possible" in the forum Risk Analysis for Medical Devices 6 years, 4 months ago
My interpretation of AFAP is twofold: Businesses are doing just enough to be competitive or Businesses are going above and beyond to be the best. In the medical device realm to be the best is to have the require ISO, CDR , FDA etc regulations that allow them to be certified to sale and produce medical devices. Practical it is impossible to be perfect in every area of the business. When working at my internship I realized that it is a challenge to have good quality. Their was load of ammunition that passed quality and went on to be painted only to realize after the parts were rusted. Therefore, my company had to tell their customer what happened and the possible fix. The quality is also, affected by external factors such as heat in the summer causes the parts to have a less coated surface due to humidity. These factors are impossible to regulate since we cannot control the Sun. There are measure that can be taken like having an air condition plant but, that might cost way to much to run and it better off not doing it. Therefore to reach the possible it will be a challenge given the environment the business is in.