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Welcome to the Whittington &
Associates e-Newsletter!
This e-Newsletter is in HTML format and may not be
displayed properly by some email programs. Please click on our web site
address above to see the e-Newsletter with its proper formatting.
According to a study released by the National Association of Manufacturers, "intense global competition and the rising cost of doing business in the U.S. threaten manufacturing's capability to maintain the nation's economic strength and standard of living." The report cites the causes of the decline of U.S. manufacturing as:
In an earlier newsletter, I identified twelve ISO 9001:2000 clauses as the toughest requirements to interpret and implement. Clauses 4.1, 5.1, 5.4.1, 5.4.2, 6.2.2, 6.3, 7.3.1, 7.5.2, 8.2.1, and 8.4 have been addressed in past newsletters. This article picks up with clause 8.5.1, Continual Improvement. ISO 9001:2000, clause 8.5.1, states The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive action, and management review. Continual improvement is defined in ISO 9000:2000 as the "recurring activity to increase the ability to fulfill requirements". In other words, the process of establishing objectives and finding opportunities for improvement is a continual process. Clause 8.5 is titled "Improvement" and consists of: 8.5.1 Continual ImprovementContinual improvement is a distinct activity from corrective and preventive action. If not, why have a separate clause for it? Corrective action eliminates a detected problem and prevents it from repeating (avoids recurrence). Preventive action anticipates possible problems and prevents them from happening (avoids occurrence). However, continual improvement may involve just getting better and faster, without being triggered by a specific problem or potential problem. If your quality policy and related quality objectives are not being achieved, then opportunities for improvement exist. These opportunities should surface at management review meetings when quality measurements are compared to quality targets. Audit results may also identify improvement areas. An actual nonconformity found during an audit will result in corrective action. A trend analysis of past problems may indicate a need for preventive action. However, audits using the process approach should also be searching for areas that could become more efficient or effective. The steps involved in continual improvement are: 1. Identify possible improvement areas 2. Analyze and justify the needed action 3. Determine the availability of resources 4. Decide to implement the improvement 5. Implement the agreed to improvement 6. Measure its impact on the organization 7. Consider results at management review 8. Continually look for new improvements Management should continually seek to improve process efficiency and effectiveness rather than wait for problems to reveal opportunities for improvement. When a problem does occur, the cause must be determined and a corrective action taken to prevent its recurrence. ISO 9001:2000 emphasizes "planning" for the system, its resources, its processes, and the measurements necessary to evaluate performance. Part of this planning is to anticipate what might go wrong and try to prevent the occurrence of these potential problems. Even when processes are producing conforming products, the
processes could possibly be more efficient and effective. The aim of a
continual improvement program is to increase the odds of meeting requirements
and satisfying customers. The quality policy must include a commitment to continual improvement. To ensure this focus, the management representative must report to top management on the need for improvements. In fact, "recommendations for improvement" is a required topic at management reviews. Any actions or decisions about improvements at these meetings must be recorded. If customer satisfaction is the most important ISO 9001:2000 requirement, then continual improvement may be a close second. Without ongoing improvement, your organization will be unable to meet future requirements and keep customers satisfied.Clause 8.1 says the organization must implement monitoring, measurement, analysis, and improvement processes to continually improve the effectiveness of the quality management system. Continual improvement must be a permanent objective. Systems do not remain static. They either improve over time, or end up regressing compared to customer expectations. Don't use corrective and preventive actions as examples of continual improvement. Look for processes that need to be revamped for improved efficiency and effectiveness. Focus on improving your quality management system and watch your business grow.
ISO 15288:2002 may be the next standards phenomenon. It's timeliness and applicability to organizations in all sectors could give it a considerable impact on the world of business, similar to ISO 9000. Just as the ISO 9000 family of standards has distilled the essential characteristics of quality management into a set of generic requirements, ISO 15288 (Systems Engineering - System Life Cycle Processes) offers a portfolio of generic processes for the optimal management of all stages in the life of any product or service. Many products and services are actually multi-part systems with hardware, software, and human interfaces. These systems are planned from a cradle-to-grave perspective and produced through processes that may cut across the internal and external boundaries of organizations. "ISO 15288 enables organizations to handle the complexity of present day products and services," says Stuart Arnold, who edited the standard. "It fits well with basic business practices and with quality management practices already in place. It offers a route to business improvements that will become necessary as technology offers fresh opportunities, and as customers demand products with better performance and services that better meet their needs." The standard provides processes for all stages in a product life cycle, from conception and development to production, utilization, support, and retirement. ISO 15288 supplies a "red thread" to guide the development of these processes by defining for each one the purpose it fulfills, the outcomes to be achieved, and the activities that need to be performed. The detailed content of the processes will be filled in by the user according to the specific product and to the organizational context and requirements. According to Stuart Arnold: "The principles and practices found in ISO 15288 can be applied to all industrial sectors. They are well known in the aerospace and defense communities, they are being applied in industries associated with transportation and energy, and they are beginning to influence technical aspects of services such as health care and law enforcement. In the foreseeable future, the approaches described in this International Standard will become an aspect of standard business practice across industry." ISO 15288:2002 is available from the ANSI Electronic Standards Store for $118.Perform a standards search at: <http://webstore.ansi.org/ansidocstore>.
ISO 15189:2003 has been published for medical laboratories to implement quality management systems based on ISO 9001:2000. "The new standard will help medical laboratories to organize their operation efficiently", said John Zlockie, Secretary of the technical committee which developed the new standard. "It will help them to comply with regulatory requirements, to meet the expectations of their clients and, most importantly, to improve or maintain their service to patients." ISO 15189:2003 (Medical Laboratories - Particular Requirements for Quality and Competence) provides a framework for the design and improvement of process-based quality management systems by medical laboratories. It is based on ISO 17025:1999, General Requirements for the Competence of Testing and Calibration Laboratories, but provides specific requirements for its implementation in medical laboratories. The new standard is intended to
promote a common approach to the quality management of medical laboratories
and to all aspects of their operation, from patient preparation and identification,
to the collection and examination of clinical samples. According to John Zlockie, ISO
15189 will also prove useful to accreditation bodies engaged in the recognition
of the competence of medical laboratories as a basis for their activities.
"ISO 15189 will be an important template for assessing and recognizing
the competence of medical laboratories in their technical capacity and
the effective quality management of a professional service and its staff
- with or without the aim of accreditation." Perform a standards search at: <http://webstore.ansi.org/ansidocstore>.
To enroll in these public classes, go to Class Schedule at our web site, or call us at 800-404-7585. The classes taught by Larry Whittington are shown in gold. ISO 9001:2000 Lead Auditor (ANSI/RAB-NAP
Accredited) - BSI Management Systems
ISO 9001:2000 Internal Auditor (ANSI/RAB-NAP Accredited) - BSI Management Systems
ISO 9001:2000 Auditor Transition (RAB-Approved)
- Course developed by Larry Whittington
Implementing ISO 9001:2000 (for New Systems)
- Course
developed by Larry Whittington
Understanding ISO 9001:2000
Understanding ISO 9001:2000 Requirements
(Atlanta Only - $295) - Course
developed by Larry Whittington
ISO 9001:2000 Conversion
(for Existing Systems) - Course developed by Larry Whittington
Quality
System Documentation (Revised for ISO 9001:2000)
- Course developed by Larry Whittington
The above public courses can be offered on-site at your
facility. In addition, we offer these on-site courses:
To arrange an economical on-site class, please call us at 800-404-7585.
© 2000-2003 Whittington & Associates, LLC. All rights reserved. You may copy this e-Newsletter provided you copy it completely, do not change it, and include this copyright notice. |
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