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Discrepancies - Determine the Magnitude and Assessing the Risk


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  Post Number #1  
Old 1st November 2000, 03:32 PM
Jim Biz's Avatar
Jim Biz

 
 
Total Posts: 486
Read This!

Just some "thoughts" - there are many ways to approach this:

Counting to determine the magnitude - and assessing the risk in realistic terms.

Example 2 parts of 5,000 may or may not be large enough to justify "documented correction" UNLESS the 2 defectives have an underlying life-safety criticality attached to it. - which increases the liability risk to the producer.

A level can be set at 0.5% per lot (or whichever size & % your management is comfortable with) as a "threshold" level indicating a documented action should take place.

If the root cause of a problem "occurs 4 times weekly" obviously there is a high level of risk of re-occurance, until documented correction can settle the matter.


(For example) If we produce 10,000 parts and 2 are found 0.05mm short of specified legnth
the magnitude and risk of re-occurance is viewed here as not being justified for documented actions.

Probably did not answer your question entirely - but possibly others have a better viewpoint - or other approaches to a complex wide open for interpretation standards statement.

Regards
Jim

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  Post Number #2  
Old 1st November 2000, 07:13 PM
Al Dyer

 
 
Total Posts: n/a
Christine,

Think about a complete FMEA review of the process in question.

Using the FMEA as a living tool is good business practice and a good way to document that the magnitude of a problem is researched.

Depending on your customers, a FMEA review is sometimes required for all corrective actions. This thought process works just as well for documenting preventive actions.

ASD...


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Al Dyer
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  Post Number #3  
Old 2nd November 2000, 01:28 AM
Christine

 
 
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Discrepancies

How do you define the magnitude of the problem and risks encountered when corrective and preventive action is taken
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