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Visit and bookmark our web site today: http://www.WhittingtonAssociates.com This e-Newsletter is in HTML format and may not be
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Companies traded on the New York Stock Exchange that are ISO 9000 registered show significant improvement in their financial performance compared to firms without the registration. Analyzing the impact of ISO 9000, researchers from UCLA, the University of Maryland, and the Universidad Carlos III in Madrid, found there is a direct correlation with a firm's return on assets. "When we began this research in 1997, we were very skeptical and we were shocked by the magnitude of the effects," says David Kirsch of the University of Maryland." Not only did the 7598 studied firms with ISO 9000 registration improve their performance, but firms without ISO 9000 experienced substantial deterioration in ROA, productivity, and sales.
"Immediately after deciding to seek registration, firms experience a productivity improvement, while non-registered firms see no such improvement and eventually experience a gradual productivity decline" said the researchers. "It is clear that ISO 9000 registration did lead to relative improvements in ROA, primarily through increased productivity." In the industrial machinery and computer sector, the ROA
of certified firms after three years increased by a relative difference
of 37 percent. "Non-certified firms experienced a substantial loss of
productivity and sales compared to certified firms," according to the
researchers. Non-certified firms in the electronics and electrical equipment
sector suffered a drop in ROA that amounted to a relative difference of
55 percent by three years after registration. The ROA in non-certified
chemical companies lagged by 12%. "Given the magnitude of the performance improvements, it seems likely that other effects than ISO 9000 contributed. However, due to the use of performance matched groups and the persistent nature of the relative improvements, our findings do strongly suggest that the preparation for the ISO 9000 registration also contributed to the superior performance. The good news, clearly, is that, in all analyses we conducted, we found significant improvements in ROA. From that perspective, we can answer the question of 'Does it pay to seek ISO 9000 registration?' with a resounding 'YES!' " For more information on the yet to be published paper, contact the authors, David Kirsch, of the U. of Maryland at dkirsch@rhsmith.umd.edu, or Charles Corbett at UCLA at charles.corbett@anderson.ucla.edu. See an expanded article on the study at Manufacturing and Technology News <http://www.manufacturingnews.com>.
In an earlier newsletter, I identified twelve ISO 9001:2000 clauses as the toughest requirements to understand and meet with conforming practices. Clauses 4.1, 5.1, 5.4.1, 6.3, and 7.3.1 have been addressed in past newsletters. This article picks up with clause 7.5.2, Validation of Processes for Production and Service Provision. It states (in part): The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered. The intent of validating a process is to ensure it is capable of achieving the planned results and the organization can demonstrate this capability. So, if you cannot fully verify the resulting product or service will meet the specified requirements, the process must be validated in advance (pre-qualified). There are cases where the result of a process cannot be measured upon completion. For example, when pouring a concrete slab, the properties of the concrete are not known at the time of the pouring. For the slab to have the required strength, the amounts of cement, aggregate, and water are controlled, as well as, the mixing and delivery phases. Plus, the pouring and working of the concrete must be carried out by trained people. Concrete doesn't reach its full strength for several weeks, so samples taken at the time of pouring are not tested for a month. This is an example of a "special" process where strict controls are needed to ensure the delayed test results will be acceptable. Another situation for process validation is when the measurements cannot be made without harming the product. For example, to test a weld strength, the weld would be destroyed to obtain the necessary test pieces. Therefore, welders must be trained and qualified to perform welds according to the weld procedure to assure the weld strengths. In addition to welding, other manufacturing processes that are candidates for qualification are soldering, painting, plating, casting, forging, and heat treating. But how does process validation apply to service organizations? In some cases, the service is provided immediately to the customer, which doesn't readily allow for inspection before the service is delivered. Consider a travel agency. Failure to give the right advice will likely not be discovered by the customer until after having attempted to use the incorrect travel information. So, service organizations are not exempt from the need to validate their special processes. What about the need to validate software processes? Since many software deficiencies become apparent only after installation or use, an argument could be made that the production of any software is a special process. However, software "production" as addressed by clause 7.5.1 only covers product replication and packaging. The bulk of the work is back in software development and those activities are controlled by clause 7.3. The provisions of 7.3.4 (Review), 7.3.5 (Verification), and 7.3.6 (Validation) are the principal means for assuring software development quality. Remember, these special types of processes will be identified as part of the planning addressed by clause 7.1. The organization has to determine if any processes require validation, if the personnel must be qualified based on established criteria, and its equipment must be qualified prior to use. Validation shall demonstrate the ability of these processes to achieve planned results. The organization shall establish arrangements for these processes including, as applicable a) defined criteria, b) approval of equipment and qualification of personnel, c) use of specific methods and procedures, d) requirements for records (see 4.2.4), and e) revalidation. The requirement is to validate any special processes to show in advance that they can provide the planned results. But what does "validation" really mean? Validation is defined by ISO 9000:2000, 3.8.5, as the "confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled." The subclauses of 7.5.2 (a-e) identify the necessary steps to validate a process. First, decide on the criteria for validating the process. Next, define the requirements for qualifying the people and approving any process equipment. Then, identify the specific methods and procedures to be used. Also, determine the records that must be kept to demonstrate all the required validation steps have been successfully completed. And, at planned intervals, or when process parameters change, the process must be re-validated. A procedure for process qualification may include:
ISO 9004:2000 Guidance Some of you may have tried to find guidance for 7.5.2 in ISO 9004:2000, but found none. With no guidance included at that section of the document, the number 7.5.2 was assigned for guidance on 7.5.3, Identification and Traceabilty (which throws off the clause numbering for the rest of clause 7.5). However, there is ISO 9004 guidance for 7.5.2, just not where you expected it. See 7.1.3.3, Product and Process Validation and Changes. It states that particular attention should be paid to validation of processes:
If your organization had no "special" processes, your quality manual would have explained that a policy wasn't included since the requirements weren't applicable. Some of you may plan on using that precedent to exclude clause 7.5.2 in your new quality manual. However, don't make that assumption too quickly. With the separate clause number and expanded coverage, coupled with re-trained 3rd party auditors, it might be determined that you actually have some processes that match the description of clause 7.5.2. If a process is determined to be a special process at another company, it doesn't automatically mean it will be a special process for your organization. The specified requirements for the two process outputs may be different. In addition, the organizations have different resources and equipment, which may allow one to determine conformity to requirements, while the other would have to handle the same process as a "special" process. Any process, special or not, must be well defined and performed by competent people. If an organization properly plans and develops its production and service processes, there may not be a big difference between a process that can be verified and a special process that must be validated prior to its use.
The following list shows the most actively benchmarked business processes by members of The Benchmarking Exchange. The data is collected from thousands of TBE members and ranked by the most benchmarked process for the past twelve months. 1. Employee Development Training
To write an effective document, you should follow some basic rules for sentence construction. Use of the proper syntax will result in more clear communications. Grammar Usage If you do not use accepted grammar, readers may misunderstand the message of your document. Even if the errors do not confuse the reader, they may reduce your credibility as an author. Subjects and verbs must agree in number. For example, “the audits are complete” and “the audit is complete”. Writing “ensure one of the machines are in service”, instead of the correct “ensure one of the machines is in service”, may result in the wrong operator action. Another error is the intentional omission of articles (a, an, the). A noun can be meant in a general or specific sense. Leaving out an article may change the meaning of the sentence. For example, “the meeting is attended by the supervisors of the process area” indicates all the supervisors attend the meeting. However, “the meeting is attended by supervisors of the process area” may indicate some supervisors attend the meeting. Concise Writing Decide what you want to say, and say it in as few words as possible. Remove every word, phrase, or sentence that can be discarded without sacrificing clarity or violating any grammar rules. Active Sentences Imperative (active) sentences use an action verb. For example, "open the valve” is an active statement. A passive sentence would be “the valve is opened”. Positive Statements Write instructions as positive statements. For example, “ensure the switch is closed”. Avoid negative statements, such as, “ensure the switch is not open”. Short Sentences Break long sentences into several short sentences that contain fewer actions. Punctuation Usage Use punctuation to aid in understanding, such as, commas to separate items in a list. Use a colon to indicate a list is to follow. Use semicolons to separate items in a list that contains internal commas. Use apostrophes to indicate possession, not to make a word plural.
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)
Implementing ISO 9001:2000 (for New Systems)
Understanding ISO 9001:2000
Understanding ISO 9001:2000 Requirements
(Atlanta Only - $295)
ISO 9001:2000 Conversion (for Existing Systems)
Quality System Documentation (Revised for
ISO 9001:2000)
The above public courses can be offered on-site at your
facility. In addition, we offer the following unique on-site courses:
To arrange an economical on-site class, please call us at 800-404-7585.
© 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. |
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