Abstract: A predictive indicator tool for predicting the risk of a manufacturing process producing products having defects. Manufacturing sub-processes are identified for the process and s a series of 12 questions is applied to each sub-process. The questions are generated using Six Sigma statistical techniques. The questions are scored and an associated algorithm is applied to produce a quantitative score is indicative of risk. The quantitative risk score is compared to an alert level.

Abstract: A predictive indicator tool for predicting the risk of a manufacturing process producing products having defects. Manufacturing sub-processes are identified for the process and s a series of 12 questions is applied to each sub-process. The questions are generated using Six Sigma statistical techniques. The questions are scored and an associated algorithm is applied to produce a quantitative score is indicative of risk. The quantitative risk score is compared to an alert level.

Abstract: A suspension of microorganisms includes a detectable indicator material, such as a food coloring, for ensuring that a biological indicator receives a preselected population of the microorganisms. A microorganism delivery system delivers the suspension with the indicator material from a tank (10) to a plurality of needles (18) where it is delivered to a carrier material (22), such as filter, chromatography, or blotter paper, or glass fiber passing beneath the needles or micropipetted onto non-absorptive or non-penetrable carriers, such as plastic polymers or stainless steel coupons. In the event of a malfunction in the system, such as a blockage in one of the needles or intermittent delivery of the microorganism suspension, the absence of color on the impregnated carrier material indicates the absence of microorganisms.