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






