Gotta Go Gambling

Shades of Gray When repeat determinations are carried out on a sample and one or more of the individual results are outside the specs, the following criteria could apply  

44) by willfully changing the number of decimal places to suit the circumstances. It is understood that the right procedure is to round to a pre-determined number of digits after all of the calculations are performed with a sufficiently large number of significant digits. (See Section 1.1.5.) 

The simple situation The analytical method uses an instrument that provides an immediate readout of the definitive result, for example 

The simple situation is what the lawyers had in mind when drafting the rule, science Hollywood style The other situation is illustrated with files OOS RISK X.xls. (See Example 56.) 

The Strictest Interpretation In the following, the language of the Barr decision (see notes at end of this section) is interpreted in the most restrictive sense, namely that each and every measurement has to comply with the rule no values outside the limits.  

The complex situation The analysis involves some instruments (e.g., dissolution apparatus, HPLC, balance), dozens of samples, and several analysts, and could take days to perform. If nobody notices anything particular about the individual snippets of work or any of the results, no observations of probable operator error are documented. When the supervisor then inserts number after unspectacular number into the formula, all results turn out to be within specification limits, with the exception of one or two that are barely outside. But, no documentation, no operator error, just inexplicable OOS, full investigation  

---