Streamline your deal qualification process in IS standard documents

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hello and welcome to my next executive series video our topic today is process validation with specific focus on operational qualification aaron snyder here for quality systems explained where we make quality systems simple for you make sure you subscribe to get all the good content we're putting out check out the status bar below for an outline of our agenda stick around to the end to get those bonus questions our topic operational qualification is directly linked to the process validation requirements which come from 820.75 and 1345 section 7.5.6 operational qualification in five words challenge the process at extremes at its simplest level when we do an oq we are running the process at its extremes and we need to show that it makes good product for the oq we have to understand which process parameters are critical or impact the process output and we have to establish ranges for those process parameters once those ranges are established we will identify the worst case conditions high low a combination of high and low between the various process parameters we will also challenge all software functionality if a software alarm is supposed to trigger when a certain temperature is hit we need to challenge that in the oq and show that it functions as appropriate we then set up our equipment in the worst case settings the high and the low and we run our equipment and produce some product we then take that product we inspect it and we show that it meets our predetermined acceptance criteria when we're talking about an operational qualification we're normally looking at very small runs maybe 50 to 100 parts or we could run the process for 30 minutes maybe an hour we're not talking about full production scale runs product from oq is normally scrapped in some rare instances where product is very expensive it is possible that oq product could be released to the market what's important is that that oq product is kept on quarantine until the entire validation is done and then it potentially could be dispositioned released if the validation itself is successful but in most cases the product produced during oq is scrapped and just like all of our other validations we have to have a oq protocol and a noq report so how do i know this is working first i don't start my oq until my iq report is fully signed off second i don't draft and approve my oq protocol before my process development activities are all complete signed off then third my oq protocol is fully approved and signed off before i start those oq activities fourth any product made during the oq is quarantined and scrapped when the validation is concluded fifth operators are trained to the oq protocol before they execute the oq and then finally any software that's in my equipment i have a separate oq protocol and report to challenge the functionality of that software how do i know it's not working well my oq starts before my iq is completely done before the iq report is approved second my oq starts before my process development is done i don't really have data to support my operating ranges third deviations occur and i don't document and capture them fourth operators aren't trained to the oq protocol fifth software is not fully challenged during the oq process because it's combined with the normal oq activities you need to have a separate protocol to challenge that software and then finally the product produced during oq is not controlled and it's released the distribution before the validation is complete and now for our three bonus questions first how do we document and capture our process development activities and include that data and those operating ranges into our oq protocols second do we analyze edge of failure and understand that before we conduct our oq and then finally what happens to oq product do we quarantine and scrap it or is it sometimes released to the market thank you for watching please like subscribe share and comment send any questions to me at qms.gov gmail.com this is aaron snyder from quality systems explained making quality systems simple for you