My company is developing a medical device. BOM is maintained. As part of the development, devices are manufactured and used for compassionate treatments as well as in clinical trials. There are instances in manufacturing work instructions in which several revisions of the same part are defined for the same assembly step, or more than one part for the same step. In all of these cases, the there is no change of Form Fit Function and it are real interchangeable parts. These instances are consistent with BOM and related ECO-decisions (e.g. disposition of changed component).
From a (QA) documentation control perspective I cannot have multiple revisions alive at the same time. Hence I have difficulties how to manage the configuration management of the device. Please note that this is a small company in which we cannot allow, from resources perspective, a very complicated solution. I'd love to get advice.
From a (QA) documentation control perspective I cannot have multiple revisions alive at the same time. Hence I have difficulties how to manage the configuration management of the device. Please note that this is a small company in which we cannot allow, from resources perspective, a very complicated solution. I'd love to get advice.