A move from attribute to variables acceptance sampling in an ISO-certified manufacturing plant.

摘要

The focus of this study was the implementation of a variables acceptance sampling plan in an ISO certified medical and dental device manufacturing plant, where attribute sampling had been used historically for incoming parts inspection. Justification for such a change was explored and a statistical validation study utilizing ANSI standards was conducted within the bounds of ISO, GMP, and standard quality practices. The acceptance sampling change involved the development of a new inspection procedure, and an additional quality technician training program. The outcome of this study provides for a more efficient incoming inspection program, eliminating wasted time and effort, creates potential cost savings, and increases employee development and empowerment. Additionally, through heightened employee awareness of statistical quality issues and trends, future quality improvement advantages may more easily be discovered.