Merging West and East into a Successful Quality System

By Elaine Lu

Exact Medical Manufacturing is a company forged in the West and operating in the East. It is not only the merging of western and eastern ideas, but also western and eastern culture.

In the western mindset, good quality is free. What costs money are the bad quality things. All the actions that involve not doing jobs right the first time is where the money is spent. Why spend all this time finding and fixing and fighting when you could prevent the incident in the first place?

In the eastern mindset, there is no way to attain true quality through prevention. Quality is inspected to be successful. It was clear that some beliefs are so basically ingrained that they cannot be changed overnight.

So EMM top management embarked on a deliberate strategy of establishing a culture revolution that would last forever. The “audit program” and “bonus incentive program” were initiated at EMM in 2012Y. The “audit program” aims to determine conformance to procedures in process, critically analyze the product that is the result of the process, help employees understand the concept of quality and thereby form a habit of doing things right the first time. To carry out “audit program”, we took below three actions.

First, an audit team with quality education was set up. The auditors in the team were trained well on the concepts and procedures of quality and problems that have adverse effect on the product as well as the expectation of the customer.

Second, a massive training program was initiated to explain what quality is all about and how important to implement the “audit program” so that anyone could understand it and enthusiastically support it.

Third, the “scoring and bonus incentive program “was launched. Everyone would be scored and rewarded for their consistent conformance to procedures and following the program.  The incentive program was critical. Rewarding the behavior the company desired was the lynch pin that achieved the success of the program.

As with most cultures, change is hard to accept, but through time and dedication the EMM culture began to embrace our quality first approach to manufacturing.

As time went by, everyone involved has evolved into embracing and enjoying fruits of “audit program”. Firefighting was replaced with defect prevention; quality was recognized as a genuine “first among equals”; the habit of doing things right the first time became a routine. EMM is now at a place where no one even remembers the old way. The routine is well established and reliable.

Quality is an achievable, measurable, profitable entity that can be installed once you have commitment and understanding, and are prepared for hard work.

Biography of Elaine Lu

Elaine Lu joined Exact Medical Manufacturing in 2009. Ms. Elaine has witnessed company growth over last eight years, which made her life and career change as well.

During last eight years, Ms. Elaine has established, maintained and implemented the Quality Management System within four EMM facilities adequately and effectively. In the process, she has developed a strong, stable and competent team to work with her. In the past years, she has led the team to successfully pass numerous customer audits, US FDA audits, CFDA audits etc.

As a team leader of EMM CN, Ms. Elaine has opportunity to get involved in every detail of each process of the company, which lays foundation for successful and robust Quality System.

Ms. Elaine is an influential employee. She is able to inject energy and spirit into individuals around her.

In her free time, Ms. Elaine likes playing Yoga, Guzheng (string instrument) and Jogging.