One of my biotechnology clients hired me to conduct a quality system gap assessment. During my first day of work, I participated in a conference call with the top management of the company. The conference call allowed the top management to identify for me which departments were the sources of their business issues, and where I should focus my efforts. They identified the Validation program, the Environmental Monitoring program, and the Laboratory Operations as the root of the problem. They tasked me with providing them a separate report about each department, to allow each supervisor to be responsible for addressing the findings of my report. After meeting with many departments, I toured the facility and spent several hours with the Laboratory personnel. One of the most telling remarks that the laboratory staff mentioned to me was that the turnover rate was above 80% in the company. This high percentage shocked me, and I was driven to know why, especially since no one was able to provide me with a plausible answer.
Upon reviewing their SOPs and other documentation, I noticed that the number of CAPAs, NCRs, LIRs, and Deviations were quite high.
By looking at how the production processes were designed, I realized that their core process was basically a manual process that was copied from the R&D bench without any scale up. It was also quite clear that the process had very tight time limits to complete each step along the process. As a scientist and quality professional, I could see that the product itself was an outcome of a genius idea and there were so many patients who were in need of it. Unfortunately, because it was a manual process, there was also room for egregious errors.
Because I am black belt six sigma certified, I decided to use my mathematical skills to explain what was wrong with the process.
After some number crunching, I was able to show my client the following results:
– As the production process was manual, there existed a high opportunity for error, regardless of how often you provide training to them.
– Since it was a manual process, and due to the high number of CAPA, NCRs,LIRs, OOSs, and deviations, the process that was running your operation was only at a 3 sigma level.
– Because the inevitable gap existed between what was expected, and what you received in reality, and because it was a manual process (designed by a development scientist while working at his/her bench), the process was also inherently vulnerable to human errors.
– Also, since several other similar products were still in the development pipeline, there was an urgent need to optimize the production process.
– If you optimize your process, the sigma level will increase while employee frustration diminishes, and you will enjoy retaining your employees for much longer employment timeframes. After completing my assessment work, I had to prepare my reports and present my findings, so the client could be ready for the next step in process improvement before the upcoming FDA inspection. Here were a couple of my findings:
– Reorganizing the production process will significantly improve the error handling reports, and help alleviate the pressure that your employees face every day.
– Instead of performing process re-qualification every six months, which wastes about 4200 hours every six months of requalification work on ISO 5 clean rooms, we could reduce their frequency to be on an annual basis. However, this will require prior communication with the FDA to explain the rationale and the risk level involved, and then getting approval from the FDA, before starting the actual work.
What do you thing the top management decided to do?