posted 01 November 2000 02:32 PM               

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.

posted 01 November 2000 06:13 PM               

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...