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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.
ISO 10006:2003, Quality Management Systems - Guidelines for Quality Management in Projects, offers a structured approach for the optimal management of all processes involved in the development of any project (that may cut across both the internal and external boundaries of organizations involved in its development). It can be used by organizations to ensure that they are applying the process-based approach of ISO 9001:2000 to projects, although the use of ISO 10006 in third-party certification is not a requirement. It can, however, be used as a basis for agreement between the organizations involved in the project. "The creation and maintenance of process and product quality in a project requires a systematic approach," said Reg Sutcliffe, a member of the working group that developed the standard. "ISO 10006 provides an approach aimed at ensuring that the customer's stated and implied needs are understood and met, that other interested parties' needs are evaluated, and that the organization's quality policies are taken into account in the management of the project." The new standard outlines principles and practices applicable to projects of varying complexity, size, and duration. It allows organizations to monitor and realize objectives, not only of the project processes, but also of the project product itself, therefore, achieving quality in both. Regardless of the size of the enterprise, the type of organization, or the kind of product or process involved, users will benefit from reviewing their project management activities against the standard's best practice. ISO 10006:2003 replaces 10006:1997.
By improving the alignment with ISO 9001:2000, and supplementing guidance
in ISO 9004 for continual improvement of project processes, ISO 10006
will serve as a strategic tool for any manager or professional tackling
projects in today's competitive business world.
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, 8.4,
and 8.5.1 have been addressed in past newsletters. This article completes
the list with clause 8.5.3, Preventive Action.. The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems. A documented procedure shall be established to define requirements for a) determining potential nonconformities and their causes, b) evaluating the need for action to prevent occurrence of nonconformities, c) determining and implementing action needed, d) records of the results of action taken (see 4.2.4), and e) reviewing preventive action taken. Preventive action is defined by ISO 9000:2000, Fundamentals and Vocabulary, as the action taken to eliminate the cause of a potential nonconformity or other undesirable potential situation. As a result, the preventive action process is an important improvement activity. By taking preventive actions, you avoid potential problems and their adverse effect on your processes, products, and customer satisfaction. A documented procedure shall be established ... In ISO 9001:1994, clause 4.14 stated the need for a documented procedure for corrective and preventive action. As a result, many organizations had a single procedure addressing both types of action. Unfortunately, preventive action was not always clearly understood and often had inadequate or incorrect coverage. Some organizations confused correction with corrective action, as well as, corrective action with preventive action. Forms would include fields for corrective action, followed by root cause and then preventive action. Of course, you can't take corrective action until you know the cause. The listed corrective action was really the immediate fix or correction. When asked for examples of preventive action, organizations would point to the "preventive action" taken to keep the nonconformity from happening again, but that was really the "corrective action". Remember that 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). As an example, a nonconformity found during an audit will result in corrective action. However, a trend analysis of past audit problems may indicate the need for preventive action. ISO 9001:2000 has placed corrective and preventive action in unique clauses (8.5.2 and 8.5.3) and separately identifies the need for documented procedures. This doesn't mean corrective and preventive actions can't be covered in the same procedure, but it does emphasize the need to focus on their unique differences. a) determining potential nonconformities and their causes Preventive actions can be identified by monitoring performance trends. Clause 8.4.c states that the analysis of data must provide information on the characteristics and trends of processes and products, including opportunities for preventive action. Your organization should analyze data, such as:
b) evaluating the need for action to prevent occurrence of nonconformities Clause 8.5.3 states that preventive actions must be appropriate to the effects of the potential problems. In other words, your organization isn't forced into taking actions that don't make good business sense. Resources are limited. Although a trend may indicate potential problems, there may be higher priorities. The consequences of not taking action should be considered. The suspect trend could be monitored to ensure it doesn't become more severe and warrant action. c) determining and implementing action needed The analysis of potential root causes may determine multiple possible actions. These potential approaches are evaluated and the best solution selected based on implementation risks and expected benefits. d) records of the results of action taken When deciding on the preventive action in the prior step, remember to consider that the results must be reviewed. Ensure that records are kept for analysis purposes and as evidence of conformity with the requirements of clause 8.5.3. e) reviewing preventive action taken The key to understanding this sub-clause is examine the word "review". According to ISO 9000:2000, review is defined as the activity undertaken to determine the suitability, adequacy, and effectiveness of the subject matter to achieve the established objectives. So, reviewing doesn't just verify that the action was taken, it judges the effectiveness of the action in preventing the potential problem. 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. Preventive action requires a proactive approach. Also, the status of preventive actions must be covered at management reviews (according to clause 5.6.d).
ISO 10007:2003 provides organizations
with guidelines for "configuration management" to help them improve customer
satisfaction and product quality by managing the activities related to
product design and maintenance. Use of ISO 10007 should provide a better
understanding of, and control over, the physical and functional changes
to products, as well as, the subsequent effects on documents, processes,
and resources throughout their life cycle. For example, the components of
a vehicle are heavily interrelated and any change made to one part of
the vehicle may have profound impacts on other parts. The changes may
affect documentation, cost, schedule, and even the vehicle as a whole.
Configuration management attempts to identify all affected processes and
documentation of the physical and functional changes over a product's
life cycle in order to mitigate or eliminate any adverse effects. "Configuration management is a
management technique that is used to improve an organization's ability
to manage a product efficiently and ISO 10007 provides a structure for
the management of this technique," said Lorri Hunt, Convenor of the working
group that updated the standard. The standard provides a "road
map" for applying configuration management to all stages in the life of
any product, in any sector, regardless of the size, complexity, and nature
of the product, and its environment. It can be used by organizations to
meet the requirements for product identification and traceability requirements
in ISO 9001:2000 - although its use is not a requirement.
The Southeastern Quality Conference will be held at the Cobb Galleria Centre in Atlanta, Georgia on October 27-28, 2003. The conference is sponsored by the Atlanta ASQ Section, Institute of Industrial Engineers, and Georgia Tech Economic Development Institute.Thirty speakers in up to four conference tracks will present quality subjects across a variety of industry sectors. The price is only $275 with early registration (before September 15, 2003) and includes lunch both days. A partial list of speakers includes:
Please contact Larry Aft at 404-786-1541 or laft@bellsouth.net to register for the conference.
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 (RAB Accredited)
- BSI Management Systems
ISO 9001:2000 Internal Auditor (RAB 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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