ASQ Presentation Assistance
- Thread starter Ed Panek
- Start date
Do you mean like risks to be assessed under a 14971-based process when using calibrated equipment? In use (of the product), in V&V, in production? In whatever scenario, the equipment could be reporting incorrect data on which decisions are made. Maybe you have a laser system and part of the procedure is to confirm the laser output is in a particular range (using a calibrated meter). Incorrect data reported could lead to treatment with actual power output too low (ineffective treatment) or actual power output too high (burns / other harms). Is that where you're going?
I am focusing on using risk to determine calibration frequencies, maintenance, Back up equipment, Model selection (Premium or low cost)
Agenda is 3 items
•A review of specific text of ISO 13485, ISO 14971 and FDA regarding metrology and calibration and how risk can be in used in the planning of these processes.
•A review of FDA Findings regarding calibration
•Ideas to consider for risk-based metrology planning
Agenda is 3 items
•A review of specific text of ISO 13485, ISO 14971 and FDA regarding metrology and calibration and how risk can be in used in the planning of these processes.
•A review of FDA Findings regarding calibration
•Ideas to consider for risk-based metrology planning
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I've found that small and mid sized companies tend to rely on excel and for calibration notifications which always seems like a recipe for disaster. Other types of software options or suggestions on how to better handle reminders of infrequent calibration would be informational to me at least.
Other avenue is the use of Calibration Standards when used seldomly. Some manufacturers will say they don't need recalibration, but from personal experience, I got a finding for using the MFGs suggestion despite pushing back on it.
Other avenue is the use of Calibration Standards when used seldomly. Some manufacturers will say they don't need recalibration, but from personal experience, I got a finding for using the MFGs suggestion despite pushing back on it.
Let's see... because of the tie to 14971, it seems to me that you want to present a strawman 'rating scale' and demonstrate how (or if) a change in the calibration frequency could be reflected in a change in ratings.
Similarly: I can imagine that you can come up with some extreme ends of the spectrum where at one end calibration (effectively) "does nothing" to affect a risk rating and at another end the calibration might actually be the only thing driving the rating.... blah blah RCOA blah fishcakes.
Similarly: I can imagine that you can come up with some extreme ends of the spectrum where at one end calibration (effectively) "does nothing" to affect a risk rating and at another end the calibration might actually be the only thing driving the rating.... blah blah RCOA blah fishcakes.
Now there's good content for a slide!
I may or may not be quoting a representative of a NB.Now there's good content for a slide!
