Our Corporate Culture
OUR CORPORATE CULTURE
We have a dedicated quality assurance team at each production facility who examine the finished products before shipment. Our quality assurance team comprises 91 employees, most of whom have experience in the industry in which we operate. Our quality assurance procedures are carried out at various stages of the production process, including incoming, in-process and outgoing stages. We establish quality assurance standards for individual customers and evaluate such standards on a continuous basis with our customers. To closely monitor our production processes, each of our product groups has a quality control team consisting of experienced technicians and supervisors.
Our incoming quality control team and sourcing team work together to inspect incoming raw materials used in our prosthesis production processes. We require our raw materials suppliers to establish and maintain stringent quality assurance systems throughout their production processes and be able to provide timely support in the event that incoming raw materials do not meet our quality standards. Our raw materials suppliers observe FDA, CE, Chinese SFDA or other relevant certification requirements depending on the intended market destination.
In our centralized production facilities in Shenzhen, our in-process quality control team is responsible for quality assurance inspection at various stages of the prosthesis production process. We perform quality checks at the end of every stage of production process to ensure that the semifinished prosthesis meets all the relevant quality standards before we begin the next stage of process. We also implement comprehensive in-process quality control checklists throughout the entire production process and record traceable information to identify and address issues.
Finished prosthesis products undergo further quality assurance examination before they are shipped to our customers. Products that do not meet our quality standards are returned to production facilities or digital production center for repairs or recycled based on the level of defects. In addition, our quality assurance team located in our service centers samples the incoming products to ensure that our quality meets or exceeds customer expectations.
Both of our centralized production facilities in Shenzhen have received ISO 9001:2008 certification for quality management system and ISO 13485:2003 for medical device manufacturing. The ISO 13485:2003 certification is an international standard in quality management for medical device manufacturing, and it specifies requirements for a quality management system where we need to demonstrate our ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements. The ISO 9001:2008 standard provides a tried and tested framework for taking a systemic approach to managing our processes so that we consistently turn out products that satisfy customers’ expectations.
Customer Feedback / Warranties
We hold periodic quality reviews with our customers, with a view to improving the entire quality assurance procedures. All cases are tracked digitally, with a unique case number that identifies the technicians involved in fabrication, time of day completed, and the lot numbers of the materials used. This data helps us to determine the cause of any non-conformance of our product if we receive complaints from our customers.
Our production processes generate solid waste and liquid waste at various stages of the manufacturing process. The waste we generate includes waste ceramic blocks and plaster residues. Since these types of waste are relatively simple to collect, we have installed various equipment in our facilities to collect such waste. We believe that such arrangement is adequate to reduce the impact from our production on the environment, and accordingly there is currently no plan to adopt new technology or engage in extensive research and development efforts to further reduce pollution.
Health and safety matters
With a view to ensuring compliance with relevant laws and regulations on health and safety, our subsidiaries have adopted certain administrative guidelines on occupational health and safety in the workplace. Operational manuals and safety guidelines on production procedures are also implemented regarding the safe operation of production equipment and machinery, devices, chemicals and wax and casting lines during the production process. We have also adopted emergency response procedures such as (i) procedures for explosions of boilers and pressure vessels and (ii) procedures for electric shocks. We require new employees to participate in safety training to familiarize themselves with the relevant safety rules and procedures. We appoint qualified consulting firms to conduct on-site safety assessment and hazard identification.