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Statistical Process Control

Regardless of the industry, processes have built in variation.

Regardless of the level of automation, processes have built in variation.

Like a 12 step programme, the first step is to recognize this, and the second is to get an idea of how much variation there is in your processes. Without data, it is just an opinion you need to collect data in order to understand the variation and decide if it is acceptable. If you are like everyone else, it is not acceptable, and there are numerous ways you can reduce the variation (which usually means achieving cost reductions and quality improvement). One client told us that his automatic filling machines controlled his 20 ounce packages to within +/- 1/100th of an ounce! When we went out to the line and pulled 10 random packages, we found a spread of over 3 ounces that equates to 15% variation that he did not know existed.

QIC has worked with a number of SPC solutions at its clients running on many platforms (AS40), UNIX, PC) and with a wide range of capabilities. 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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