| By Industry Journalist Thomas R. Cutler |
| Monday, 11 May 2009 |
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Statistical Process Control: A Mandate for the Pharmaceutical Industry is the title of a feature article authored by manufacturing journalist Thomas R. Cutler in the current issue of Manufacturing Alumni. The value of statistical process control (SPC) technology is undeniable; the solutions providers of SPC within the pharmaceutical industry have often neglected the unique sector
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challenges and their approach has often identified the weaknesses. Pharmaceutical industry projects are not reusable for similar parts or processes, but must be recreated for each part within a part family. Some of the technologies communicate these projects are text files (not a database, so if they are deleted accidentally they are lost); similarly limited formula functions are available (some math, logic functions). These may seem like rudimentary issues; however they defy the efficacy of SPC.
Other discrepancies or inefficiencies are found among many SPC solutions providers who require the Design of Attribute sample size function force the user to manually enter a defect entry for every piece in a sample, including zero values for pieces that have no defects.
Major pharmaceutical operations managers complain that, "We could not get gage entry to work, and could not get technical support to solve the problem."
Complaints about some systems included the fact that the user must set up their own database, getting IT
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involved and that security features were stored in an .ini file (test file that is exposed to any user with knowledge how to find and manipulate it.)
Evan Miller, President of Hertzler Systems, and leading SPC solution GainSeeker noted that, "Encoding this information in a database is absolutely essential.
Too often Variable Statistical Analysis is weak in other SPC solutions because it's easy to blend data from two features on one characteristic on one histogram giving a chart that does not represent the process.
We addressed this issue and made sure that the X-axis labels are in appropriate increments and can be automation scaled to receive real-time meaningful information. Similarly actual values are displayed on charts and non-normal analysis need not be forced."
Hertzler Systems' GainSeeker Suite, an automated SPC software system (http://www.hertzler.com/php/solutions/spc.software.php), has been a leader in Statistical Process Control and Six Sigma for over twenty years, and includes a diverse customer base in service, transactional and manufacturing environments; clients include:
BAE Systems, Crown Audio, IDEX Corporation, McCormick & Company, Inc., Hormel Foods Corporation, Titleist & Footjoy, and TaylorMade-Adidas Golf Worldwide.
The company's software and services enable clients to collect and analyze data; building a robust data building |
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a robust data infrastructure for making data-driven decisions. These capabilities help clients to reduce costs, cycle time and errors, and increase profitability.
Hertzler Systems (www.hertzler.com) provides seamless, accurate data acquisition solutions that drive business transformation. The company provides the leading real-time data acquisition and analytics software, the GainSeeker Suite.
This powerful and flexible system is best used by lean and progressive companies. Gainseeker Suite allows companies to connect with devices and other information systems, collecting data and alarming key personnel when problems arise; this technology allows organizations to analyze data for root cause problems, converting data into knowledge.
Hertzler Systems Inc. www.hertzler.com Adrienne DePew Communications Manager info@hertzler.com 800.958.2709
About the Author
Professional Marketing Firm for the Manufacturing Community and Manufacturing Journalist to most manufacturing magazines
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