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QFD — quality function deployment, also known as the house of quality approach. Kaizen — 改善, Japanese for change for the better; the common English term is continuous improvement. Zero Defect Program — created by NEC Corporation of Japan, based upon statistical process control and one of the inputs for the inventors of Six Sigma.
According to current Good Manufacturing Practice (GMP), medical device manufacturers have the responsibility to use good judgment when developing their quality system and apply those sections of the FDA Quality System (QS) Regulation that are applicable to their specific products and operations, in Part 820 of the QS regulation. [5]
Vagueness stems from the term "best" which is subjective. While some research and evidence must go into determining a practice the "best" it is more helpful to simply determine if a practice has worked exceptionally well and why. Instead of it being "the best", a practice might simply be a smart practice, a good practice, or a promising practice.
The ISO 9000 family is a set of international standards for quality management systems.It was developed in March 1987 by International Organization for Standardization.The goal of these standards is to help organizations ensure that they meet customer and other stakeholder needs within the statutory and regulatory requirements related to a product or service.
The first definition of quality history remembers is from Shewhart in the beginning of 20th century: "There are two common aspects of quality: one of them has to do with the consideration of the quality of a thing as an objective reality independent of the existence of man. The other has to do with what we think, feel or sense as a result of ...
In such ways, the subjectivity of quality is rendered objective via operational definitions and measured with metrics such as proxy measures. In a general manner, quality in business consists of "producing a good or service that conforms [to the specification of the client] the first time, in the right quantity, and at the right time". [3]
Life Extension shares 21 science-backed tips to help you establish a wellness-focused lifestyle and keep you in top-notch health as the years bring experience, wisdom, and other distinguishing traits.
Performance = total count / target counter, by definition this is the percentage of total parts produced on the machine to the production rate of machine. Quality = good count / total count, by definition, this is the percentage of good parts out of the total parts produced on the machine. Cycle time ratio (CTR) = standard cycle time / real ...