Bev -
I usually completely agree with your posts, but when you say:
"If you have very few escapes then there is nothing wrong with a small sample audit. A catastrophic event will be caught. There is no supreme law that you must use a statisticaly based plan for all inspections."
than I have to reply that in the world I live in (FDA regulated), there is a law (really a law with penalties up to and including incarceration):mg:
I do agree in less regulated industries a more ad hoc approach would be OK.
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR820.250]
[Page 150]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 820_QUALITY SYSTEM REGULATION--Table of Contents
Subpart O_Statistical Techniques
Sec. 820.250 Statistical techniques.
(a) Where appropriate, each manufacturer shall establish and
maintain procedures for identifying valid statistical techniques
required for establishing, controlling, and verifying the acceptability
of process capability and product characteristics.
(b) Sampling plans, when used, shall be written and based on a valid
statistical rationale. Each manufacturer shall establish and maintain
procedures to ensure that sampling methods are adequate for their
intended use and to ensure that when changes occur the sampling plans
are reviewed. These activities shall be documented.