Project

Cleanroom Training to Decrease Deviations Related to Process Error and Operator Error

Executive Summary Cleanroom Training to Decrease Deviations Related to Process Error and Operator Error Ajinomoto Althea Inc. Jaycee Nguyen 04 May 2017 Professional Master's Degree Program California State University, San Marcos During Spring 2017 Semester-In-Residence, Ajinomoto Althea, Inc., a contract manufacturing company located in San Diego, was the company sponsor. Ajinomoto Althea, Inc. has rapidly increased in size and clients over the past three years, which caused the current training method to become obsolete. The current method consisted mainly with familiarizing oneself with the Standard Operating Procedures (SOPs) and on the job training by senior operators during GMP operations. As the company increased in size and workforce, this method was no longer efficient as novice operators began to outnumber senior operators. Another obstacle in this method of training involved the company’s fast-paced environment—making it more difficult for senior operators to take time to train new operators, and thereby decreasing production. With the implementation of a formal training program that also incorporates visual training videos, Ajinomoto Althea, Inc. can have an organized system of documented training that occurs in a non-GMP process development lab. This will minimize production delay or product impact, while also providing more clarification than the SOPs alone. Multi-session trainings were held in both a non-GMP process development lab and GMP suites that were cleared for a specific timeframe when certain equipment was needed. These sessions focused on highly unique processes that were determined to be the root causes of previous deviations. Training videos were used to demonstrate highly technical automated fillers and vial washer set-up were also created to minimize unnecessary improper use of critical equipment in the cleanroom core. Upon completion of the training program, operator error and process error based on deviations were collected and compared. Based on the data collected, operator based error deviations decreased whereas process based errors increased slightly. This showed that the training program was more helpful to decrease operator error deviations than process error deviations. When evaluating where during the process the increase in deviations occurred, it was determined the slight increase in process error may have originated in during the aseptic filling process. Many times issues that occur during the filling process require equipment troubleshooting from the operators, which can not be planned or trained for.

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