ISO 9000:2000: Question about Statistical Techniques



I am a Quality Mgmt Representative at an ISO 9002:1994 registered Company, we are creating our action plan for transition to 2000. I am not clear on the application of statistical techniques, from which we are presently excluded under the 1994 version. I am told it is not as easily excluded under 2000. Exactly what kinds of analytical tools are we considering for stat techniques ?? Can someone clarify ?

Jim Biz

Well just some thoughts:

We run annual statistcal (SPC) product process checks on critical machines in house, to verify machine/process capabilities.

We run individual short run 30-50 part CP/CPK studies on new part critical dimensions.

We use Pareto and Trend/over-time charting statistics for reporting nonconformance trends - customer complaints - internal scrap - on time delivery- corrective actions etc....

Our registration auditor gladly pointed out that current 9002 guidelines do not "state what type" of statistical technique is required... Only that the need for statistical techniques (gathering numerical values)be recognized/identified, THEN after they are identified there is a documented procedure method to put them to use - perform an analysis - report results - make decisions according to the results.

Also as I overview the new 2000 standard "analysis for effectiveness" appears to be the re-occuring trend. I would expect that a numerical value (statistical)analysis will be the most clear way to comply.


[This message has been edited by Jim Biz (edited 08 March 2001).]


Thanks Jim,

We have discussed being careful not to make this requirement too cumbersome. I take your point that real meaning can be derived from analyses of customer complaints for example, also trend analysis of various product characteristics during production. Currently we mainly view these from a "is it within the specification" standpoint, so tend analysis (and related actions of course) can have meaningful value.

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