Challenge:    Batch disposition for commercial distribution by Quality unit by reviewing and approving the  COC and COA for Quality attributes is very important to comply with existing regulatory  requirements and Considering patent safety.    Because of the high volume of pharmaceutical products being manufactured and  commercialized by the firm it’s a big challenge and time-consuming. Few factors involved in the  Problem are some of the Quality attributes are either outside the allowable limit or close to the  specification limit and human need to review each and every line to identify these.       Selection:    Cross-functional team (CFT) brainstormed about the challenge and selected the mind mapping  Design tool technique, because of Human involvement and not having enough thoughts about  the problem, to explore the innovative and creative insights about the issue.    Application    Based on multiple discussions and by utilizing the tools mentioned above, the team arrived to  automate the COC/COA review process, so that the bot can review and provide output for which  the results for Quality attributes are either outside or close to the spec limit.      Insight:  Great insights were observed, and significant contributors in relates to the SLA’s for bath  release and data review factors were identified, based on the ethnography mind map analysis,  Having an IOT device with real-time review of COC/COA will be helpful    Approach:    Even though ethnography and mind map tools provide great insights and helped to identify the  Significant contributors and solutions about the challenge, review of COAs by humans provide  even more insights and confidence about the problem.


Challenge : Batch disposition for commercial distribution by Quality unit by reviewing and approving the COC and COA for Quality attributes is very important to comply with existing regulatory requirements and Considering patent safety . Because of the high volume of pharmaceutical products being manufactured and commercialized by the firm it ’s a big challenge and time - consuming . Few factors involved in the Problem are some of the Quality attributes are either outside the allowable limit or close to the specification limit and human need to review each and every line to identify these . Selection : Cross - functional team ( CFT ) brainstormed about the challenge and selected the mind mapping Design tool technique , because of Human involvement and not having enough thoughts about the problem , to explore the innovative and creative insights about the issue . Application Based on multiple discussions and by utilizing the tools mentioned above , the team arrived to automate the COC / COA review process , so that the bot can review and provide output for which the results for Quality attributes are either outside or close to the spec limit . Insight : Great insights were observed , and significant contributors in relates to the SLA ’s for bath release and data review factors were identified , based on the ethnography mind map analysis , Having an IOT device with real - time review of COC / COA will be helpful Approach : Even though ethnography and mind map tools provide great insights and helped to identify the Significant contributors and solutions about the challenge , review of COAs by humans provide even more insights and confidence about the problem .