Peter Chan, PhD

To minimize the gap of discrepancies must start from senior management. If senior management lack QC knowledge or experiences, they do not see an issue. This is very common in QC labs. Technically if everyone uses the same song book to sing the same song, we expect a more consistent outcome. Unfortunately, not everyone interprets the same song book the same across the board. In QC lab, the discrepancies of different shifts usually are due to different background QC analysts. Well experienced senior QC analysts will do a better job than a less experienced junior QC analyst. Supervisor level up management should pay attention to all QC folks day to day performance. More On-the-job cross training to staff is a good starting point.

This is an interesting question. Quality standard always is # 1 priority for all companies. If any unexpected project change impacts quality standard must go through risk assessment by quality compliance department. Quality compliance department will decide and make a final decision for any unexpected project change....Go or Don't Go.

One of the role of QC is to release finished products for commercial use. All QC tasks must be prioritized according to both manufacturing and packaging schedules to meet customer demand/order. Customer order fill is one of the KPI of operation. QC tasks also include, but not limited to, releasing raw materials, packaging printed and non-printed materials for operation use. QC must be flexible enough to allocate resources to meet customer demand/order. By the way, no customer...no money to support QC functions!

During interview, I will share the QC projects that had done before. Through those QC projects, I simply share what I had learned from these QC project and how I contributed to make those QC project successfully implemented.

Only well trained QC analysts can resolve the discrepancies. In really, many QC analysts are so called "Cook Book" chemists because most of them are either lack of critical thinking skills or cannot perform QC testing until minimum supervision to resolve daily QC issues. In reality, if supervisors level and up management are lack of QC testing knowledge, it will even wider the gap of discrepancies.

According to GMP, plant operation is typically broken down into five main components: People, Products, Procedures and Processes. Technically, senior management MUST set the tone for maintaining high standard and ensuring quality control throughout the plant. In practice, only well-trained operators make things work. Good training program for plant operators is a key to maintain high standard and ensure quality control in plant operation.