General Notes
This Clause requires that you must consider if statistical techniques are applicable to your operations.
Please Note : This term (although frequently believed to cover the process of determining standard deviations, norms, limits of deviation, etc) actually covers any form of "number-crunching".
Clause 4.20.1 Identification Of Need
BE CAREFUL :
Before you decide that these techniques do not apply, I must warn you that they probably do! In section 4.14 - Corrective & Preventive Actions, I mentioned the need to analyse causes of problems. You will almost certainly be performing some form of analysis here, even if it is only to say that out of 17 problems, 10 were caused by the Quality Auditor (or whatever).
In practice, some Quality Registrars are somewhat slap-dash about this interpretation. Nevertheless, you should describe how such analyses are conducted, and how they are presented. this information is often extremely useful to person who has to perform the analysis, which may only conducted once every six months, long after the process has been forgotten.
If you do perform statistical analyses, you must identify where they apply and define the methods used.
Clause 4.20.2 Procedures
As well as having procedures to cover the analysis (and also the collection of the data, etc), you must review the suitability of the methods used.
This may be best reviewed during Management Review Meetings - Clause 4.1 in the case of smaller organisations, or QA team meetings, etc.
