S
stomson58
In reference to FDA-QSR 820.20(b)(2), does anyone have a baseline reference on the estimated number of quality engineers / document control personnel required for a corporation of approximately 250 personnel?
Q
Quality-Geek
Apparently my employer feels that 1 is too many...I am responsible for doc control, daily QA activities (I supervise the department, we have no QA manager), customer and supplier communication, corrective actions, daily ISO "stuff" and internal audits, reports (monthly, although there is always someone with a special request), and I forget what else.
Recently I explained to the big boss (again) that this is way too much for one person. I am now the ISO geek - MR, doc control, and related activities. The QE we hired last spring is now taking over my other responsibilities. Life is much better!
Recently I explained to the big boss (again) that this is way too much for one person. I am now the ISO geek - MR, doc control, and related activities. The QE we hired last spring is now taking over my other responsibilities. Life is much better!
QMMike
Involved In Discussions
I'm with ya!
I am the QA Manager - I'm responsible for doc. control, calibration, direct supervision of my TWO inspectors (2 buildings 3 shifts each), customer supplier communications, CAPA, Management Review, our ENTIRE TS program, data analysis, APQP/PPAP, new product sampling, receiving "inspection", ect. ect. ect... Oh yeah... also IT support
