Problem: I am a manufacturing engineer working in a commercial drug substance manufacturing facility. One fine day, you are notified that one of the production bioreactors was in a state of alarm for a temperature excursion. The established acceptable range is 35.5 to 36.5 deg C (set point 36.0 deg C). The actual temperature value was at 37.2 deg C.
What are the next steps would you take to rectify this problem? Make appropriate assumptions to write your answer.
Hint: I am looking for answers that utilize various quality systems, process control and good documentation practices.