M
MyronW
Our internal audit schedule had become an unwieldy nightmare for me. I am the only auditor, and the schedule was not process based, it was not logic based, it was not anything based. It was just a mess that I inherited, so I took it upon myself to make some sense of it.
Fortunately, I had just completed an audit cycle, and our system is in pretty good shape, so I didn't have any huge messes to clean up. I started looking at different ways to schedule the audits according to the standard: status, importance, results of previous audits, etc., and found that none of these criteria are useful for setting up a baseline schedule. That's why new folks stand around with that deer-in-the headlights look when they try to set up their first schedule. It doesn't make sense to set up a results-based schedule when you don't have any results to work with!
After much thought and work, I developed an annual internal audit schedule that is based on the FDA's QSIT Manual. I was careful to keep it as process-based as I could, although there is room for improvement. All of the ISO 13485:2003 elements are covered, but they are not sequential, nor are they intended to be.
Have a look, and let me know what you think. So far it's worked out quite well!
Myron
Fortunately, I had just completed an audit cycle, and our system is in pretty good shape, so I didn't have any huge messes to clean up. I started looking at different ways to schedule the audits according to the standard: status, importance, results of previous audits, etc., and found that none of these criteria are useful for setting up a baseline schedule. That's why new folks stand around with that deer-in-the headlights look when they try to set up their first schedule. It doesn't make sense to set up a results-based schedule when you don't have any results to work with!
After much thought and work, I developed an annual internal audit schedule that is based on the FDA's QSIT Manual. I was careful to keep it as process-based as I could, although there is room for improvement. All of the ISO 13485:2003 elements are covered, but they are not sequential, nor are they intended to be.
Have a look, and let me know what you think. So far it's worked out quite well!
Myron