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Process Compliance Excellence

Six Sigma is a disciplined, data-driven approach and methodology for eliminating defects (driving towards six standard deviations between the mean and the nearest specification limit) in any process -- from manufacturing to transactional and from product to service. The fundamental objective of the Six Sigma methodology is the implementation of a measurement-based strategy that focuses on process improvement and variation reduction through the application of Six Sigma improvement projects. Improving process and product quality from three or four sigma to Six Sigma results in significant reductions in the cost of poor quality, which can run as high as 20 to 30 percent of total sales revenue for a three to four sigma company. General Electric, one of the most successful companies implementing Six Sigma, has estimated benefits on the order of $10 billion during the first five years of implementation.

Why Is Six Sigma Important In Achieving Compliance?
History of Six Sigma

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Compliance and quality go hand in hand. A recent survey sited testimonials from sites with greater than 500 employees reporting a 75% reduction in customer complaints
with 5% increase in productivity. The same survey sited 75% reduction in manufacturing cycle time with $2 billion in overall savings. The results are clear. However, with compliance initiatives, one of the greatest challenges of Six Sigma is
the management of information associated with Six Sigma projects. Regulated organizations should consider implementation of Six Sigma programs to improve product quality and safety while lowering costs. The following list of best practices will help establish better control over information associated with Six Sigma initiatives and help keep compliance initiatives on track.

Six Sigma Information Management Best Practices

  1. Corrective action process.  A comprehensive, top-down corrective action process is central to the six sigma process.

     
  2. Project Management .  Managing project information throughout Six Sigma implementation is a daunting task. With multiple project focus normally associated with simultaneous Six Sigma compliance initiatives, managing and controlling project information is critical.

  3. Establish Well-Integrated Training Program.  Training is at the heart of Six Sigma and regulatory compliance. The entire U.S. Code of Federal Regulations is permeated with training requirements for the various processes within regulated organizations. Current best practice for training around Six Sigma projects is to establish an integrated training environment using advanced Learning Management technology to facilitate online training and tracking.

  4. Compliance Balanced Scorecard Management.  The Balanced Scorecard methodology (Kaplan & Norton) is widely recognized as a performance management tool that tracks progress against stated goals and objectives in a "balanced" manner. Performance measures are balanced across four key categories, linked by vision and strategy. The four key categories are:

    • Financial

    • Internal business process

    • Customers

    • Employee learning and growth


    Current best practice for Six Sigma initiatives is to establish performance measurement criteria for compliance initiatives looking at both direct and indirect benefits of the project. These metrics should be tracked throughout the life of the project.

  5. Centralized Repository For Document Control .  Most Six Sigma initiatives involve the collection and management of project documentation from multiple Six Sigma programs. Access and collaboration around this information is central to the effectiveness of any Six Sigma initiative. Current best practice is to establish an online training and tracking programs to reduce the cost of training and improve the timeliness of training related to Six Sigma.

  6. Enterprise Collaboration .  Internal collaboration has been proven to deliver quantifiable business benefits that directly support the achievement of compliance objectives across the enterprise. These benefits may be directly translated into bottom-line savings. Often, organizational, process, and technology barriers impede collaboration resulting in built-in inefficiencies, higher costs, and greater regulatory risks. Current best practice for enterprise collaboration from a technical view point is to establish regulatory systems such that they facilitate a "community" of professionals working with the same information on demand.

  7. Establish Buy-in From The Highest Level.   Six Sigma and compliance initiatives alike must have the highest level of support within the organization. At the C-suite level, resources and performance goals must be established to ensure alignment and consistency throughout the business. The current best practice is to establish a team for Six Sigma/compliance initiatives with an executive champion or project sponsor.

  8. Compliance Process Control & Six Sigma .  Amadeus' Compliance Process Control suite can easily be applied to Six Sigma initiatives. Contact Amadeus for details at info@amadeussolutions.com.



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