One of the Most Important Quality Measures is Compliance

According to “The 2013 Global State of Quality Research” conducted by ASQ®, APQC® (American Productivity & Quality Center), and the ASQ Advisory Panel, percent compliance is one of the most important quality measures used today at a rate of 96% in manufacturing and 83% in services.

Can SPC Software Enhance Your Regulatory and Customer Compliance?

Automotive Industry Action Group (AIAG) Reporting
Picture of the Automatic Certificate of Analysis Report. Grakon LLC’s customers require that all of their business be at least less than 50 Defective Parts per Million (DPPM), some less than 15. This is close to the Six Sigma range. Grakon also follows Automotive Industry Action Group (AIAG) for capability requirements. “Typically, the standard is Cpk of 1.67; however, our internal goal is to be greater than 2. Synergy SPC Software has really helped us with quality system compliance, and continuous improvement,” said Don Barlett of Grakon LLC.

Audits
“We are able to show our customers in real-time that their product is “in control”. We bring every customer to an SPC station where they can view the data live. Without Synergy, we wouldn’t be able to do that. I use Synergy to demonstrate that our processes are in control,” remarked Mike Woznicki of SPIROL International.

Certifications
“In addition to being International Organization for Standardization (ISO) 9001:2008 certified, we are also preparing for AS9100, the quality system standard for aerospace, and working on ISO 13485 for medical. Synergy is making it much easier to track the information required for these certifications. All the information is in the database,” said Wayne Maurer of MET Plastics.

Customer Reporting
“I use Synergy mostly for the bag weight program for our materials. We pre-weigh powdered chemicals as to their weight specification. We send along a histogram with every Certificate of Analysis for every bag in each production run. With Synergy, it is easy to find out-of-specification bags. I can look on the chart and it shows exactly which bag is out-of-specification,” remarked Glen Peters of Polymerics.

U.S. Food and Drug Administration (FDA) Reporting
“One of the things we really like about the Synergy 3000 and its enhanced reporting capabilities is that now we are able create the required FDA reports to see how we are operating in real-time,” commented Tim Stutzman of Oregon Freeze Dry.

Are you striving to increase your regulatory and customer compliance? Let Zontec’s Synergy software reporting capabilities help you ensure the quality of your product compliance and documentation for customers.