Archive for October, 2008

Driven By Metrics

Wednesday, October 1st, 2008
Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet. Sustaining Edge Solutions, Inc. Newsletter Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet. )
Performance Improvement Solutions for Your Business Needs October 2008
Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet. In this issue

Greetings!

Welcome to Sustaining Edge Solutions E- Newsletter

Our newsletters provide guidance on operational and quality systems ISO 9001, AS9100, ISO/TS 16949, TL 9000, ISO 13485, ISO 14001, and others. This includes process improvement methods Six Sigma, Lean Enterprise, and other topics of interest to our readers.

If you have any questions about the articles appearing in this issue, or you want to suggest topics for future issues, please let us know.

Newsletter Sign-up


Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet. Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet. Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet.

Driven By Metrics
Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet.
new_year

Performance metrics are a vital part of managing an organization. Many organizations have a tendency to select metrics by copying what competitors measure, what is read in the business press and what benchmarked firms are using.

The best organziational metrics keep the focus on its strategic direction, not the direction in which others are going.

Organizations should:

  • Define a competitive vision and a strategy to achieve it.
  • Set objectives aligned to the vision and strategy.
  • Create processes to deliver on that vision and
  • Set metrics that will monitor how well they are doing on the objectives. That will allow those managing the processes to keep them going in the right direction.
  • Revise them over time to account for changes that impact their potential value.

A simple but important step in metrics selection is applying the Pareto principle to ensure the critical measures are available while not swamping the organization with a lot of noise.

The types of metrics and the right mix of metrics drives effective outcomes. For example, some metrics should focus on customer needs (externally focused, effectiveness metrics) and some on organizational needs (internally focused, efficiency metrics) so the organization can effectively balance the management of resources used to achieve the market results. An organization with high customer satisfaction and costs that create negative profitability is not going to be a sustainable venture.

Some metrics should be able to evaluate results (outcome or lagging metrics), while others should allow proactive management of the vital factors (process or leading metrics) that create those outcomes. For example, on-time delivery (an outcome) might be significantly impacted by equipment reliability (a leading indicator for delivery performance). However, equipment reliability is an outcome measure for the maintenance management process. As much as possible, metrics should be biased toward business drivers, such as process or leading indicators, instead of outcomes.

Once the desired metrics have been identified, the real work begins. Decisions must be made regarding:

  • Who owns the metric.
  • Where will the data be acquired and how often.
  • How might the raw data be manipulated (normalized) to allow more equivalent comparisons over time.
  • How often should the metrics be reported and analyzed for decision making.

Although it might sound simple, creating operational definitions is an important component of metric details. In other words, what is meant by the terms as expressed in mathematical terms (for example, numerator, denominator and time boundaries)? A company might ask, “What is meant by on-time delivery? When it is picked up by the carrier or when it arrives at the target location.

For more information see the Quality Progress article written by Duke Oates.

Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet.

Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet. Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet. Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet.

Malcolm Baldrige Case Study
Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet.

A case study packet that includes documents used for training Baldrige examiners is available through The Baldrige National Quality Program. The packet also provides documents used in the award evaluation process by illustrating the format for an application, how an applicant might respond to the criteria requirements, and how examiner teams evaluate and score applications.

Also available is the The Baldrige Criteria for Performance Excellence which provides a systems perspective for understanding performance management. They reflect validated, leading-edge management practices against which an organization can measure itself. With their acceptance nationally and internationally as the model for performance excellence, the Criteria represent a common language for communication among organizations for sharing best practices. The Criteria are also the basis for the Malcolm Baldrige National Quality Award process.

This free information is available in PDF format at the National Institiute of Standards and Technology website.

Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet.

Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet. Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet. Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet.

Management System for Medical Devices
Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet.
new_year

ISO 13485–“Medical devices–Quality management systems–Requirements for regulatory purposes” is the standard for organizations engaged in the manufacture of medical devices. According to the most recent survey by the International Organization for Standardization there were a total of 8,175 current ISO 13485 registrations across 82 countries.

Although being registered does not fulfill the requirements of the various industry regulators, such as the U.S. Food and Drug Administration (FDA), ISO 13485 is now commonly used as the basis of regulatory requirements. The standard is an essential consideration not only for exporters but for the local market, global suppliers, and subcontractors to prove that their products are of the highest quality.

ISO 13485 is based on the ISO 9001 format with additional requirements relating to design, special processes, environmental control, traceability, documentation records, and regulatory actions. This is an outcome of the primary objective for the creation of ISO 13485, which was to facilitate standardized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices but excludes some of the requirements of ISO 9001 that are not appropriate in a regulated environment.

The primary difference between ISO 13485 and ISO 9001 is that ISO 9001 requires the organization to demonstrate continuous improvement, whereas ISO 13485 requires only that the organization demonstrate that the quality system is implemented and maintained. Thus many organizations maintain dual registration against both standards.

Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet.

Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet. Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet. Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet.

Employees are Biggest Security Threat
Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet.

According to research by Secure Computing, 80% of IT directors said in a recent survey that insider threats were their biggest security danger. Security problems created by employees are far more serious than the threats posed by external hackers and criminals, the new research reports.

Less than one in five respondents said external threats from hackers are more dangerous. This could be due in part to 37% of respondents saying they have experienced a leak of sensitive information in the past year.

Email was identified by 34 % of respondents as the biggest current security risk to organizations, followed by VoIP (25 %), and browser-related threats (21 %). Despite this apparent confidence, however, four in five respondents feel they could be better prepared for web-borne threats.

Viruses topped the list of external threats for 31 % of respondents, followed by spam (18 %), and data leaks (14 %). When asked to rank their biggest external security concerns, hackers are surprisingly the area of least concern. Less than a quarter of respondents feel that hacking is the biggest threat. Malware appears to be the major headache, with 56 % identifying it as their biggest worry.

Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet.

Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet.

Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet. Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet. Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet.

Training Courses
Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet.

Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet. training

To see the course description, schedule, and on-line registration click on the course title below. Courses are awarded Continuing Education Units.



Understanding & Implementing ISO9001:2000

ISO 9001:2000 Process Based Internal Auditor
Documenting Your Quality Management System

Understanding & Implementing AS9100B:2004
AS9100B: 2004 Process Based Internal Auditor
Documenting Your Quality Management System

Understanding and Implementing ISO/TS16949:2002
ISO/TS16949:2002 Process Based Internal Auditor
Documenting Your Quality Management System

Understanding and Implementing ISO14001:2004
ISO14001:2004 Process Based Internal Auditor

The Five Pillars of a Lean Workplace Organization
Continuous Process Improvement
Lean Six Sigma

All courses can be delivered at your company. Don’t see a course, location, or date that fits your needs?

Contact Us

Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet.

Quick Links
Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet.


Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet. Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet.