All Participation, All Effort, All Sharing – On the Construction of EMM’s Quality Management System

Quality management system (hereinafter referred to as “QMS”) is the management system that commands and controls EMM in terms of quality. It combines resources, processes, and manages them systematically by using process management methods. It generally includes management activities, resource provision, product realization, measurement, analysis and improvement and other related processes. The construction of QMS is particularly important for the long-term development of enterprises. It helps enterprises have the ability to continuously and stably provide products and services that meet customer requirements and comply with legal and regulatory requirements. It helps enterprises enhance customer satisfaction. It enables enterprises to deal with organizational operational risks.

During establishment, EMM upheld the concept of total quality management and initially established a QMS in line with medical device laws, regulations, and standards. Total quality management refers to a management approach that an organization takes quality as the center and all staff participation as the basis, with the aim of achieving long-term success by making customers satisfied and the organization’s owners, employees and other stakeholder’s benefit. However, in the early stage of quality management, EMM mainly relies on quality inspection and quality control to achieve quality management. At this time, under the leadership of managers, participants passively and mechanically follow quality requirements, and the organization achieves the purpose of quality management by assessment.

In the process of gradually deepening and improving the QMS, the depth and breadth of all participation have been greatly improved. In 2017, EMM’s new factory location started, and the quality work focused on the quality education and training of all staff, aiming to establish and strengthen the value of “quality first, everyone is responsible”. Simultaneously, the responsibilities and authorities of each department and post are detailed with specific, clear, and practical instructions. No matter what the position is, in addition to the skills and ability, the requirements for quality awareness and defect awareness are also emphasized. All staff begin to perceive the importance of their role in the quality management system and realize that not complying with the procedure will bring negative or even disastrous effects. At this stage, the whole quality management process is promoted under the constraints of GMP and regulatory compliance. Employees are transformed from passive to active participants. EMM has entered the stage of “all effort” thereafter, in which all employees, from the general manager to each grass-root employee, actively participate in the construction of the quality system and make their best efforts. The enterprise established and improved the entire quality management system by making each employee understand how his/her position function in the operation of the system and what responsibilities his/her department undertake under the system. “All effort” encouraged each member to earnestly fulfill his/her active role and integrate into the overall operation process.

Through the continuous improvement of the QMS, EMM has always adapted to the changing laws, regulations, and standards, and fully decomposed the quality responsibilities to various functional departments and posts. EMM takes measures by providing training of skills, quality standards, defect awareness and publicizing quality policy and quality objectives to all staff, establishing complete quality performance appraisal system to strengthen the understanding and execution of QMS. All departments fully perform their responsibilities and authorities, and the quality team monitors these activities properly, to ultimately deepen the understanding of the quality management system.  

When encountering problems, staff take the initiative to communicate within and between departments. Gradually, an efficient, coordinated, and precise QMS has been formed, and a quality work atmosphere of all participation and all effort has been formed. All departments and employees are responsible for their own output. Operators know well the operation skills and quality points of each step; they check the products they make to prevent unqualified products from flowing into the next process. Inspectors are responsible for the products they inspect, acting as the eyes of customers to prevent unqualified products from flowing into the customer’s hands. And once quality issues occur, they are key positions to report and help to control and solve.

Recent years, EMM’s products have passed MDR CE, FDA, NMPA and other certifications. Our quality management system can smoothly pass external audits of notified bodies and customers alike. Our products are widely praised by customers and have gained a good reputation in the market. EMM can cooperate with more customers, provide employees with stable job opportunities and salaries, and more employees have got the chance to acquire higher knowledge and skills. We spare no effort to continue EMM’s commitment to our staff to become a better version of themselves. More employees have the opportunity to get promoted, and we have seen a better and brighter future. All these cannot be achieved without the strong and firm support of the EMM’s top management, our general manager and management representative, and to the reliable guarantee of the quality management system of “All participation” and “All effort”. All employees can enjoy the rich harvest. So far, we have officially stepped into the stage of “all sharing” of the QMS.

Through implementing the quality management concept of “all participation, all effort, and all sharing”, EMM has established an effective QMS, which has improved the quality management level and enhanced the foundation of a quality first approach. We are making unremitting efforts to achieve the grand goal of embracing and growing to exceed industry standards.

Biography of Lily Li

My name is Lily, Chinese name Li Li. I joined EMM company after graduating with a bachelor’s degree in language in 2012. I have worked in the quality department for 12 years. After joining EMM, I began to focus on learning the product, material knowledge, together with the medical device regulations and standards. Through years of efforts, I have accumulated rich experience in medical device laws, regulations and product related requirements. Currently, I serve as a QA manager, responsible for the daily management of the quality team, and work with management representative to maintain our QMS, actively participating in internal audit, external audit, handling customer complaints etc.

I like to try new things and face new challenges. In my spare time, I like to engage in making handicrafts and food creation.