Address:
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Mail Code: S102-1331
, P O Box 516 St. Louis, MO, 63166-0516, United States
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Abstract:
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While preparing for the CCT examination, I was reminded of why I left the commercial calibration field, after a career of many years in that industry sector. As the Quality Manager of an accredited laboratory, it was my responsibility to interface with a customer base whose purchases orders reflected the desire for their calibration vendor to adhere to various quality standards including ISO 17025, ANSI/NCSL Z540, ISO 10012, QS9000, ISO/TS 16949, and AS9100, as well as FDA/GMP criteria, Nuclear regulations, and a plethora of other assorted quality documents. The references provided by ASQ to study for the CCT examination emphasize many of these varying standards, and highlight the need of American Industry to be unique, with the test itself occasionally serving as a treasure hunt to identify differences between ISO 17025 and ANSI/NCSL Z540. In a similar fashion, those calibration laboratories that provide services to other organizations spend so much time differentiating between levels of service and pounding square pegs into round holes that their quality departments are taxed to the breaking point. The net result is that numerous critical elements including proficiency testing, intermediate checks of calibration standards, internal system audits, the development of valid uncertainty budgets, and the refinement of calibration procedures do not receive the attention they deserve. This has a direct impact on product quality and customer service. This paper presents a strategy that embraces the international reliance on ISO 17025 as a competence standard for calibration and testing laboratories, while utilizing ISO 10012 as a conformance standard to evaluate calibration programs. All other metrology related quality standards could be eliminated. The author provides objective evidence of several areas in which the existing ANSI/NCSL Z540 standard is lacking and actually serves to deprecate the quality of work performed. Also addressed is the commitment level required from the metrology community, and the objectives, which will have to be achieved in order to make this evolution a reality. The failure to embrace the concept of streamlined quality standards in this community will serve as yet another nail in the coffin of our nation's manufacturers.
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