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.
Happy Holidays and Thanks for your Support!
We are pleased to inform you that our 2007 1st Qtr courses are now posted on our website.
To see the course description, schedule, and on-line registration click on the course title below.
All courses can be delivered at your company. Don’t see a course or location that fits your needs?
November Quality Digest Survey:
If your company is registered to ISO 9001 or a similar quality management system standard, does top management set an expectation of adherence to the standard for the purposes of improving quality, or just enough adherence to get a good audit report from your registrar?
Forty Eight Percent adherence to get a good audit report! We agree that many organizations today are still focused on the CB report for validation of an effective management system. We find organizations that use their documented operational and quality system in order to improve quality(survey says 46%) take the time to streamline, improve, and inquire internally as to “Does this work and can we make it better?”
How do you audit the conformity of an organization to the continual improvement requirements of ISO 9001:2000? First, lets review the definition of continual improvement, “The recurring activity to increase the ability to fulfill requirements.”
Clause 8.5.3 requires continual improvement of a quality management system through the use of:
In addition, clause 5.3 requires the Quality Policy to include a commitment to the continual improvement of the effectiveness of the quality management system. Both these clauses refer to continually improving the “effectivessness” of the system. To fully understand continual improvement, we need to know that the term effectiveness means, “the extent to which planned activities are realized and planned results are achieved.”
Continual improvement is more than just corrective action (based on a detected nonconformity) or preventive action (based on a potential nonconformity). An organization may identify a unique improvement activity based on their desire to become better and faster at what they do, instead of just reacting to actual or future nonconformities. See if they are identifying specific improvement activities, especially at Management Review. And, how were the target rates of improvement determined? Are the plans being approved, resources being allocated, and progress being tracked?
Are the improvement projects keyed to increasing the level of conformity to requirements and better satisfying customers? See if performance trends indicate a continual improvement in results. Remember, if they aren’t meeting an improvement target, that doesn’t make it a nonconformity … they may have set an aggressive objective. However, if not met, they should be understanding why not and revising their plan.
One of the difficulties in auditing a preventive action program is that some organizations don’t understand well the differences between corrective actions and preventive actions.
A Corrective Action is taken on a detected nonconformity to prevent it from happening again. An organization will first correct or contain the problem, and then determine its root cause so they can take corrective action to prevent its recurrence.
When we act to “prevent” a repeat of a detected nonconformity, that is full and complete corrective action, not preventive action.
Preventive Action is when we anticipate a potential problem and take action to eliminate the possible causes and prevent the occurrence of the nonconformity.
Auditing a preventive action program begins with a review of the preventive action procedure required by ISO 9001:2000. Of course, an organization may choose to have corrective actions and preventive actions covered in the same documented procedure. This is acceptable as long as the requirements in both clause 8.5.2 and 8.5.3 are adequately addressed.
The best time to take preventive actions is early in the product cycle, e.g., performing Failure Mode Effects Analysis and conducting Design Reviews. However, these actions are integral to the process and won’t necessarily be captured on preventive action forms.
When auditing a preventive action program, find out how potential nonconformities are identified. If they aren’t analyzing trends and looking for warning signs, they may be ignoring possible problems that could be avoided if only they were considered.
Examine the preventive action records to see if the organization is following their procedure. Find out how they identify causes and determine the appropriate actions. Review the results to see if their actions were effective in preventing the problems.
The new Automotive Industry Action Group (AIAG) voluntary standard for healthcare delivery is now in its second review, with an anticipated launch no later than 2008.
Medical errors in the United States are well documented. There is growing evidence of the applicability of automotive process methodlogy to healthcare. The Institute of Medicine (IOM) has indicated that the first critical step to effect change in healthcare delivery is the application of engineering principles used in other industries.
The IOM reports that between 15 and 25 common chronic conditions account for the majority of the health servcies delivered. These would lend themselves to standardization of common sets of services, which is another of the engineering principles mentioned in the report.
According to a study by the Center for Studying Health System Change The large number of hospital quality reporting programs and the lack of coordination among them means hospitals are scrambling to fulfill their many various requirements.
According to the study, hospitals have devoted additional resources and staff to quality measurement and improvement, but inadequate IT systems have made the reporting a burden to staff.