|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Visit and bookmark our web site today: http://www.WhittingtonAssociates.com 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.
If you are an auditor, chances are your auditing course was based on ISO 10011, Guidelines for Auditing Quality Systems. You were probably taught that an audit consists of five phases: Initiation, Preparation, Execution, Reporting, and Follow-Up. That terminology has changed somewhat with the replacement of ISO 10011 by ISO 19011, Guidelines for Quality and/or Environmental Management System Auditing. Audit phases are now called audit activities. Also, the "documentation review" activity has been separated from the old Initiation phase. As for Completion, it was already there in ISO 10011, but only consisted of a single sentence stating "the audit is completed upon submission of the audit report to the client." As a result, most auditing courses included it in Reporting, not as a separate phase. However, ISO 19011 lists additional completion tasks and identifies it as one of the major audit activities. Therefore, I now list the audit activities in my courses as: 1. Initiation (define audit objectives) 2. Review (examine the documents) 3. Preparation (plan for onsite activities) 4. Execution (audit the quality system) 5. Reporting (report the audit results) 6. Completion (complete the audit plan) 7. Follow-Up (conduct the follow-up audit, if needed) In addition, the key tasks for each audit activity are summarized below: Initiate the Audit
The audit is considered "complete" when:
Conduct the Follow-Up Audit
In the December, 2003 newsletter, I identified twelve ISO 9001:2000 clauses as the toughest requirements to understand and meet with conforming practices. Clauses 4.1, 5.1, and 5.4.1 were addressed in previous newsletters. This article covers clause 5.4.2, Quality Management System Planning. The next article in this newsletter deals with clause 6.2.2, Competence, Awareness, and Training. 4.1 General Requirements (and 0.2 Process Approach) - article in December, 2002. 5.1 Management Commitment - article in January, 2003 5.4.1 Quality Objectives - article in January, 2003 5.4.2 Quality Management System Planning (vs. 7.1) 6.2.2 Competence, Awareness, and Training 6.3 Infrastructure 7.3.1 Design and Development Planning 7.5.2 Validation of Processes for Production and Service Provision 8.2.1 Customer Satisfaction 8.4 Analysis of Data 8.5.1 Continual Improvement 8.5.3 Preventive Action Clause 5.4.2, Quality Management System Planning, states: Top management shall ensure that: a) the planning of the quality management system is carried out in order to meet the requirements of given in 4.1, as well as, the quality objectives, and b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. Most of the planning to meet the requirements of 4.1, General Requirements, is completed at the early stages of developing and implementing a quality management system. For example, processes must be identified for the system, along with their sequence and interaction. In addition, the criteria and methods for operating and controlling these processes must be determined. The resources and information needed to operate and monitor the processes must also be planned. Organizations must then decide how to monitor, measure, and analyze their processes, as well as, be ready to implement the actions necessary to achieve planned results and continually improve the processes. Even outsourced processes are included in the planning. The need for additional planning after the system is operational may surface during management reviews. Remember, management reviews are to ensure the continued suitability, adequacy, and effectiveness of the system. The reviews also determine if any changes are needed or opportunities for improvement exist. A key part of system planning is setting quality objectives (see the January 2003 newsletter). Since quality objectives should change over time, this type of system planning will be ongoing. As we plan for changes, 5.4.2.b requires the integrity of the system to be maintained. In other words, make sure the system continues to be effective during and after the changes. Clause 7.1, Planning of Product Realization Some organizations confuse the "system-wide" planning of 5.4.2 with the "product-specific" planning of 7.1. Planning the product realization processes means planning the processes that manufacture a specific product or deliver a unique service. If your product manufacturing or service delivery is routine and highly repetitive, the necessary planning may be carried out by merely establishing your quality manual and related documents. If not, you may need separate planning for each new order, contract, or project. The output of this planning process can be a quality plan, project plan, or a process planning checklist for new or changed products. For more information, see the article "Requirements in ISO 9001:2000 for Planning" in the January 2001 newsletter.
Clause 6.2.2, Competence, Awareness, and Training, states: The organization shall: a) determine the necessary competence for personnel performing work affecting product quality, Competence is defined in ISO 9000:2000 as the "demonstrated ability to apply knowledge and skills". Competence involves the education, training, skills, and experience necessary for people to carry out their assigned tasks. It also includes people not directly involved in making the product, or delivering the service, because their work may affect quality (e.g., planning, purchasing, and customer service). However, every person may not need all four of the competency
attributes. The requirement is that people have the appropriate combination
of competencies for their jobs. Also, don't overlook the competence required
for management, as well as, for any temporary or part-time employees.
When planning work allocations, training is one of the primary
actions that can be taken to achieve the necessary competence. The training
process begins with an analysis of the competence needs for current and
planned activities. The next step is to determine the competence levels
of the personnel assigned to, or already performing, these activities.
You then identify any gaps that exist between the required competence
and available resources. This information is used to define possible training
solutions. See ISO 10015:2001, Guidelines for Training, to: The April 2002 newsletter provides more information about this training guidance document. b) provide training or take other actions to satisfy these needs, Although training may end up being the best solution, don’t overlook other actions, such as, changing processes, improving procedures, rotating jobs, outsourcing, or recruiting fully training people. If your organization wants to acquire the training from an outside source, read "Ten Tips for Choosing a Training Provider" in the November 2002 newsletter. Training must be carried out by people with the appropriate skills, qualifications, and experience. Therefore, records should be maintained as evidence of the special competence of employees used as trainers. c) evaluate the effectiveness of the actions taken, It is not enough to just take actions (including training) and keep records, you must also evaluate the effectiveness of those actions. In the case of training, your organization may want to consider these 6-R's:
Reaction: What was the reaction of the participants? This measure is an assessment of the student satisfaction as expressed on an evaluation form at the end of the training session.
Retention: What learning has taken place? This measure can be determined through a pre-test and post-test to indicate how much information has been retained by the students. It can show what skills, knowledge, or attitudes have changed, and by how much.
Relevance: Have the participants applied what they learned? Students assess the relevance of the training through a follow-up evaluation a few months after they return to their jobs. Rating: Has their job performance improved? This rating summary of the participants is extracted from their performance appraisals while maintaining strict confidentiality of personal information. Results: Did the application of the learning
produce the desired results? This measure focuses on the business results
achieved after the training has completed. Business results can be judged
by comparing performance data to measurable targets, as well as, witnessing
process results during internal audits. If "on-the-job" training is required, then its effectiveness must also be evaluated. d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and,
Employees should be told their jobs are important and given timely feedback on their performance against departmental objectives. The place to start is during orientation sessions for new employees. This awareness training could cover the:
A good way to explain the relevance and importance of a job is to relate it to the quality policy, meeting requirements, and satisfying the customer. Ensure the transmitted information is clear and understandable, as well as, adapted for the intended audience. e) maintain appropriate records of education, training, skills, and experience (see 4.2.4). Records must be kept of the competencies for all employees whose work may affect product quality. If a job requires a specific education level, there must be proof the people performing that job have the necessary degree, e.g., an official school transcript. If job training is required, records must be available as evidence that employees have successfully completed the training, e.g., class rosters, course certificates, and test results. If special skills are needed, records must show that the employees have demonstrated those skills, e.g., equipment sign-off forms. The records should clearly indicate that employees are deemed competent to perform their assigned tasks.
The convergence of environment-friendly products with company profits is furthered by a new ISO technical report. ISO/TR 14062, Environmental Management – Integrating Environmental Aspects Into Product Design And Development, will enable organizations to identify the likely effects on the environment of their future products and make effective decisions during the design and development stages to improve their environmental performance. "More organizations are coming to realize that there are substantial benefits in integrating environmental aspects into product design and development," said Dr. Kun-Mo Lee, convenor of the ISO working group that developed the report. "Some of these benefits may include: lower costs, stimulation of innovation, new business opportunities, and improved product quality." ISO/TR 14062 describes concepts and current practices relating to the integration of environmental aspects throughout the six typical stages of the design and development process: planning, conceptual design, detailed design, testing/prototype, market launch, and product review. All goods and services have an environmental impact in all phases of their life cycle, from the extraction of raw materials, via production packaging and use, to disposal and recycling. ISO/TR 14062 provides a systematic framework for anticipating and solving problems, while allowing the flexibility to make changes and improvements along the entire design and development process. It also aims to promote creativity and maximize innovation and opportunities for the environmental improvement of goods and services. For example, water or energy consumption during the "use stage" of a home appliance may generate the greatest environmental impact of any stage of the product's life. Improving the efficiency of water or energy use as part of product design and development can reduce the environmental impact of these products. One of the most prominent features of ISO/TR 14062 is the emphasis of management on the success of the integration activities. The technical report recognizes that management decisions will determine the framework and targets of the program, the level of support the work will receive, and the degree of optimization the program will achieve. The report is aimed at all those involved in the design and development of all types of products – product developers and designers, experts from marketing, production, environment, procurement, service personnel, and customer representatives – in all types of organizations, regardless of size, location and complexity. It is written for those directly involved in the process of product design and development and for those responsible for the policy and decision-making process.
"Why Standards Matter," a free online course that introduces the basics of the voluntary standardization process, is available from the American National Standards Institute, a nonprofit organization that administers and coordinates the U.S. voluntary standardization system. Go to <http://www.standardslearn.org>.
To enroll in any of these public classes, go to the 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)
Implementing ISO 9001:2000 (for New Systems)
Understanding ISO 9001:2000
Understanding ISO 9001:2000 Requirements (Atlanta Only - $295) ISO 9001:2000 C
onversion (for Existing Systems)
Quality System Documentation (Revised for ISO 9001:2000)
To arrange an economical on-site class, please call
us at 800-404-7585.
ASQ Quality Audit Division Conference
ASQ's Business Excellence and Customer Satisfaction Conference
Association for Quality and Participation - 25th Annual
Conference 11th Annual Conference on Quality in the Space and Defense
Industries March 10-11, 2003 in Dallas, TX ASQ Quality Management Division Conference WESTEC 2003 - Advanced Productivity Exposition 25th International Conference on Software Engineering
57th Annual ASQ Quality Congress
© 2000-2002 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. |
|
|
|
|
|
|
