1) Not all organization changes are clearly explained and/or communicated. What have you done when you found out about an unexpected change or were confused by a change? 2) 2) A manufacturing operator informs you that they noticed a foreign particle in a reagent bulk solution after dispensing into its final container. There is no specification for the reagent bulk regarding foreign particle contamination. The Manufacturing Area Manager tells you that the reagent bulk solution is a “Research Use Only” material, and that we have committed to shipping this solution to the customer in 24 hours. Given this information, would you release the material to the customer? Why or why not? What actions would you take to execute on that decision? 3) 3) You are part of a team implementing a process change to replace a product container (the product is a liquid) from one that is of a translucent material to one that is an opaque material. Is this a minor or major change? What are the necessary deliverables and the sequence of execution in order to implement this change? 4) What is calibration and its importance?