Our company manufactures medical devices and began manufacturing in China in 1995. The Chinese factory took our regulatory programs and FDA documentation and used them to distribute goods that we had rejected for import to the United States and other foreign markets to sell in the Chinese markets. They used our trademarks without telling us and kept the profits. We discovered that they used our registrations to import to their own trading company in the United States. Those shipments failed.
Our quality levels are designed to ensure consistent compliance with ISO, WHO, FDA, and ASTM requirements. The inability to know that only the goods that we approved to our quality requirements were in distribution was an unacceptable business risk. There were detailed contractual requirements for established quality parameters. Because payment is generally made at export, the ability to receive credit for defective goods was poor and rejection, once the goods had arrived, proved ineffective. Communication in China flows down but does not flow up because of the cultural desire to protect superiors. This has quality ramifications relative to corrective and preventive action, and the ISO requirement for continual improvement. It is cheaper to manufacture in China, however, one must also be prepared to qualify raw materials there. This can add cost or compromise quality. The Chinese quality levels for raw materials are not as good as in the West, so the logistics of planning for specialty goods must be considered. Once all of the parameters are set, it does not mean that the factory will not change them. We had several instances where we caught changes that were made without change control or documentation.
We decided to control our own processes and labels and returned manufacturing to the United States in 2000. Not because it was cheaper, but because it could be more efficiently controlled and quality levels could be maintained.
It would be nice to think you can shut the lid on Pandora’s box as you suggested. Pandora couldn’t and neither can those who manufacture in China. So much happens without direct oversight. Once it is not caught, it will continue until it is. Even then, compliance is achieved only until it’s thought there is no chance of being caught again.
Lillie C. Thomas, M.S.
Vice President of Quality Assurance and Regulatory Compliance
Custom Services International Inc.