6 |Quality Assurance
Under PHC standards, quality actions required in new product development must clear three hurdles: AQ-0 approval for design completion, AQ-1 decision for shifting to mass production and AQ-2 decision for shipping mass-produced units.
In order to clear the a hurdle and move on to the next, all product quality issues must bead dressed, otherwise the process will not continue.
Delaying solutions
until the later stages is strictly prohibited.
The pre-production model manufactured using actual production facilities is subject to various verification and review processes. It is conducted mainly by the Quality Assurance department and performed with a customer’s point of view. The verification process is conducted in the dedicated laboratory laboratories of the Quality Assurance department. The process to verify product readiness is wide-ranging, including temperature control status, safety, reliability, basic operation and product usability. Next, the PP model must also undergo a drop test in our test room to verify reliability. For example, the recently launched MDF-DU702VH (VIP ECO) that has undergone drop testing for extended periods and is still being verified; no abnormalities have been found. If one should appear, the cause of the failures will be integrated into improvements in the manufacturing process. Finally, checking and evaluating a product means exanimating its basic operations and functions from a customer’s perspective. For example, a pre-production model’s performance is verified referring to the instruction manual utilizing non-technical staff from various departments without a direct connection to the product.
This process helps ensure our manuals are easy to understand and potential misuse of the product is minimized.
Bringing a new product to
market is not the only goal of the Quality Assurance department.
If a product already installed in a customer's laboratory is performing optimally, determining the cause and rectifying it is a very important task for us. If, after delivery to a customer, the performance is not optimal, we register the information on our BMQS system (Biomedical Product Quality System). The system allows global teams in sales, quality assurance, customer service, technology, production, marketing and other areas access and share information. Causes for each issue are discussed and analyzed so that necessary countermeasures can be quickly implemented. In rare instances where products become repeatedly problematic, the product in question is returned to the factory for disassembly and analysis to discover the root cause of the issue. The root cause is corrected with the goal of ensuring that the same problem does not reoccur and is added to our extensive catalogue of lessons learned. Furthermore, changes are made to production to enhance overall product quality and that so any solution is implemented to other products where possible.
Based on information gathered from our markets, we incorporate all of the lessons learned from the beginning of our product development and cross-organizational activities to avoid reintroduction of any quality issue we have encountered
over our 50+ year history.
One example of our extreme total quality focus was initiated several years ago, to deal with an industry wide challenge; the long-standing “refrigerant gas leakage" issue. This issue was particularly problematic as it would often appear until when refrigeration products were several years old and starting to slowly warm-up. The “Gas Leakage Restraint Project“, implemented by cross-organizational personnel, aimed at resolving this long standing issue and involved members from the quality assurance, manufacturing, and technology departments. The project examined and clarified gas leakage causes as well as enhance welding condition methods, work standardization, and testing precision. Their efforts resulted in the industry’s most advanced method of preventing causes of refrigerant leaks. This ground breaking project resulted in reducing the potential for refrigerant leakage even in products where symptoms would not occur until well into the future and increased overall product quality significantly.