S
S Roche Hendrix
I need help with a sanity check. Please bear with me as I try to explain.
I am being told by a couple of people, that based on their experience with FDA inspections, advice from consultants, and their training to 21 CFR Part 820 Quality System Regulation, the FDA would expect to see documented procedures out (basically in hand) when associates are performing a task.
I am new to the Medical Device world and my experience is with the ISO 9001 standard. I agree that the relevant version must be available at point of use and that steps being followed must match what the procedure states, but having a procedure out and following it step by step is not necessary in most cases. If this is required for all tasks, I think it is impractical, unnecessary and in some cases unsafe. It is also very situational. I consider documented procedures as training tools, references and a means to create and maintain consistency. Check Sheets, Poke Yoke and other job aids are often more practical ways to ensure the procedure is being followed than actually having a procedure in front of you.
Much of what we do is based on education/training and experience that could not possibly be done by following a step by step procedure. I have a problem with setting requirements that are "because FDA requires it". If the requirement does not make sense to the person doing it, the chances they won't follow it are high.
If any of you can share your experiences relative to this with the FDA I would appreciate it. I would also appreciate all other's thoughts.
I am being told by a couple of people, that based on their experience with FDA inspections, advice from consultants, and their training to 21 CFR Part 820 Quality System Regulation, the FDA would expect to see documented procedures out (basically in hand) when associates are performing a task.
I am new to the Medical Device world and my experience is with the ISO 9001 standard. I agree that the relevant version must be available at point of use and that steps being followed must match what the procedure states, but having a procedure out and following it step by step is not necessary in most cases. If this is required for all tasks, I think it is impractical, unnecessary and in some cases unsafe. It is also very situational. I consider documented procedures as training tools, references and a means to create and maintain consistency. Check Sheets, Poke Yoke and other job aids are often more practical ways to ensure the procedure is being followed than actually having a procedure in front of you.
Much of what we do is based on education/training and experience that could not possibly be done by following a step by step procedure. I have a problem with setting requirements that are "because FDA requires it". If the requirement does not make sense to the person doing it, the chances they won't follow it are high.
If any of you can share your experiences relative to this with the FDA I would appreciate it. I would also appreciate all other's thoughts.