Reliability-based Reduced Sampling Approach  

Oleh:

Kai, Ng Chee ; Khim, Chua Chui

Jenis: Article from Proceeding
Dalam koleksi: 12th ANQ Congress in Singapore, 5-8 Agustus 2014, page 1-7.
Topik: Design Verification (DV); Drop Impact; Distribution Fit; Accelerated Life Testing (ALT); Stress Level
Fulltext: RL1-1.4-P0405.pdf (630.35KB)

Isi artikel

In today’s medical device industry practice, a large sample size is usually required for high risk/major defect classification quality characteristic in the product design verification (DV) testing. The situation becomes more severe when the testing involves attribute data testing, where 2,301 samples are required if an organization targets to obtain a 90% certain that at least 99.9% of the product will be within the specification limits. In some cases, the large sample size is not feasible due to expensive sample preparation cost, pressing needs for shorter product development time-to-market, etc. Understanding the confidence/probability of passing the product acceptance criteria prior to the DV can be especially important when it involves reducing the test samples. Therefore, this paper suggests a “Reliabilitybased Reduced Sampling Approach” where the approach adopts Accelerated Life Testing (ALT): Product Stress and User-rate Acceleration Testing. The idea of this paper is to provide a systematic analysis approach to the product development project team in defining the confidence of passing the acceptance criteria prior to the proposal to reduce the test samples. The “confidence analysis” is to provide better justification to support the idea of reducing the test samples, instead of by hunch. The analysis approach helped the team to conclude that the design of needle collector to withstand the drop test was adequate. Therefore, the team decided to reduce the number of samples for design verification testing. The decision has not only improved the DV testing time significantly but also reduced the testing cost

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