Solution Summary

Attribute Data Collection and Analysis

Non-conformance / Complains


Regardless of the industry, quality is a simple equation, the inverse of yield. The fewer defects our processes can produce, the better quality our products are. Assuming we do not increase our quality numbers by lowering our expectations, everything we do is oriented to reducing the incidence of defects.

Variables SPC has become prevalent in many industries, particularly durable goods such as Automotive, and is just coming into its own in others such as Food and Pharmaceuticals. Variables are easy to understand and such quantitative measures are easy to chart. The number is either within specification / control or it isn’t and we can react to specific measurements. In many ways, industry has taken the position of measuring anything that can be measured.

Attributes are qualitative measurements. Is it good/bad, go/no-go, pass/fail. Analysis of defects is the foundation of quality assurance. First identify the most prevalent or most costly defects, then determine what is likely causing the defects, then determine what we can measure to avoid the occurrence of the defect. While most packages offer the standard functions, we have found that there are only a few that offer the superior functionality that provides the capability to provide solutions to achieve net contents control for regulated industries.

Firstly, the vendor and solution meets all of our criteria for selecting systems.

Secondly, we have found that industry leading SPC solutions provide an excellent balance between very sophisticated statistical analysis capabilities, and extremely easy to use data collection capability. The mathematics are validated by qualified statisticians. Although there are about 150 SPC software packages available, there are only 4 or 5 that are enterprise oriented, 21CFR part 11 compliant, ODBC compliant, configurable, and easy to integrate with other MES and ERP systems.

Thirdly, the solutions we recommend are competitively priced for both small clients as well as multi-plant, multinational implementations.

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This page last updated: 08/31/2011