Improving Quality with Integrated Statistical Tools


Kim, John; Larsen, Michael   (1998, ASQ)   Medtronic, Inc., Minneapolis, MN

Annual Quality Congress, Philadelphia, PA    Vol. 52    No. 0
QICID: 10686    May 1998    pp. 218-225
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Article Abstract

ISO 9000 section 4.20 covers the integration of statistical tools into quality improvement systems. Steps in this integration include identifying the needed tools and deciding how to document them. Identification can start with a compilation of candidates, arranged by product life cycle. Then the list can be refined as the tools take their places in the quality manual. Documentation of the tools consists of procedures that may be separate documents or elements of larger processes. Each procedure should cover the what, where, when, who, and how of tool application. Who has responsibility for each tool is especially important. To assess statistical practices, auditors should consider the following points. Make the statistical assessment part of quality system audits. Focus on key areas like process control and testing. Have a clear assessment procedure that employs a metric. Give assistance and advice to the tool owners. Document the results, and share best statistical practices with the entire organization.


Audits,Assessment,ISO 9000,Statistics,Quality tools

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