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 agree with you. Procedures and Work Instructions should be available for reference, but you insult your worker and scare the bejesus out of customers if you act as if the worker cannot perform the task without following the document step-by-step.

I think where the confusion lies is that many procedures entail forms and checklists which may have to be completed each time (much like a pilot's pre-flight checklist) - obviously, an organization has to make a decision as to what is necessary in any given situation,

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.They want to see some type of procedure or instructions that can be referred to, on the shop floor. They wil compare them to the masters on file during the inspection.

You may be able use approved samples and/or photographs along with brief instructions. See the QSIT (http://www.fda.gov/cdrh/comp/qsitpage.html) page and download the QSIT Guide to inspections and the QSIT Workshop Design Controls/Process & Production Controls presentation.

We are a medical device company and I agree with the responses from Wes and Al. FDA will look for compliance much like an ISO auditor would. As with the ISO standard, people can and do interpret the requirements differently and sometimes the best thing to have is evidence that the task is being completed as planned - as Al stated usually done through forms or checklists - especially if it affects final product. Having clear evidence that what you said was to be done is done is always your best defense!

Linda

I've been a "quality person" for some 35 years and have worked under Mil Q 9858, the three generations of ISO 9001, two generations of ISO 13485 and the FDA's device and drug GMPs. I agree with Wes and Al. Any competent auditor will want to see that people know what they're doing, where to find the exact instructions if they need them, but not that they're reading the instructions every time they do anything.
By way of illustration allow me to share a "bit" I use in GMP training: I ask the attendees if they've ever been present at open heart surgery. The answer is usually negative. Then I tell them that the surgeon holds a copy of Gray's Anatomy in his left hand while cutting with the right. He looks at the book, turns to the patient, cuts, and goes back to the book before making the next cut. If they believe that then they must make sure that all their people do the same. Hopefully the audience understands that training and certification to acquire the appropriate skills and knowledge what is required.
Judah Lando