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Internal audits are often scheduled, and therefore
conducted, according to the ISO 9001:2000 clause structure. These audits
are more focused on judging conformity than evaluating effectiveness. Looking
clause by clause, the quality management system may appear conforming, yet
be fragmented and ineffective. Auditors should adopt the process approach
and assess the quality management system through its natural workflow. Of
course, this requires understanding the business and its process linkages.
Audit planning and interviews should identify for each process:
Process audits can be conducted horizontally or vertically. A horizontal audit follows a process trail across multiple functional areas. It is good choice for assessing the process interfaces between departments. A vertical audit covers all the key processes within a functional area. This approach is good at examining the interfaces within a department, but may miss the interactions with other departments. ISO 9001:2000 uses the Plan-Do-Check-Act methodology.
As a result, one logical requirement may be addressed in multiple clauses.
Auditing by clause defines an artificial audit scope. A process may span
different departments and a department may have multiple processes. So, audits
should be scheduled for vertical (process) or horizontal (department) coverage.
If scheduled by department, ensure interfaces with internal suppliers (upstream)
and internal customers (downstream) are included. Whether
auditing horizontally or vertically, remember audits must still address all
the applicable clauses (requirements) over the annual audit schedule.
Auditors should view the quality management system as a set
of integrated processes (by understanding the interfaces and interactions).
Adopt the process approach for your audits. Add value by looking at more
than just conformity. Evaluate the linked processes for their “effectiveness”.
Verify their controls and identify any process risks. Also, determine opportunities
for improvement. Auditors can promote the process approach through their own audit methods. If you are interested in more on this subject, see the Auditor Update course description. Our next class is in Atlanta on July 23, 2004. ISO 9001:2000 requires the collection and analysis of a lot of data. Organizations rely on this information to make important decisions. However, a new survey by Forrester Research shows most enterprises have a big problem with information quality (IQ). Forrester principal analyst Lou Agosta finds that while many firms have improved their IQ, problems persist. They are "addicted to data", he writes, "but in quality denial". Indeed, company-wide approaches to IQ seem to be the exception rather than the rule. Fully one-fifth of the firms responding to the survey had no consistent IQ strategy, and those that did, tended to have scattered approaches. Almost a third of the respondents dealt with IQ inconsistently, on a localized basis. Consequently, even though companies are gathering huge quantities of data from business processes and transactions, much of it is obsolete, duplicated, or just plain wrong, subverting its usefulness as actionable information. Moreover, inconsistent and inaccurate information creates business uncertainty, leaving a company swimming in a tide of data, but unable to confidently act. According to Agosta, it is not enough for companies to sift through data, looking for defects on a case-by-case basis; that's "firefighting, not information quality improvement". What firms need to do is to get serious with IQ improvement, and approach it strategically, as an information product quality control issue, in terms of a service-level agreement, or as a commitment to a system design for information quality. Most importantly, companies have to be willing to take a close look at themselves and establish IQ processes before deploying technology to solve the problem. Enterprises have to create an information quality "safe harbor" that will allow employees to expose IQ problems without retribution, and then take steps to correct them. Agosta observes that a major reason why IQ issues remain unresolved is that employees fear that management will "shoot the messenger". Companies need to implement a clear and consistent IQ policy and quantifiable processes across the enterprise and identify and empower an IQ evangelist to lead and coordinate the effort at the highest level. Agosta concludes that the problem, though substantial, can be solved through the application of IQ best practices. The above portion of this article was based on an article by Matthew Friedman in Enterprise Applications Pipeline http://www.enterpriseappspipeline.com>. The Guidance document on Terminology used in ISO 9001:2000 and ISO 9004:2000 defines "data" as facts, especially numerical facts, collected together for reference or information. In our July 2001 newsletter, we further defined data, information, knowledge, and wisdom. Data:
Factual material such as measurements and statistics, frequently quantifiable. Accessible: Data is available and retrievable. Complete: Data is not missing and of sufficient depth and breadth for our work. Concise: Data is compactly represented. Consistent: Data is presented in a consistent format. Friendly: Data is easy to manipulate and apply to different tasks. Correct: Data is accurate and reliable. Defined: Data definitions are clear. Interpretable: Data is in appropriate languages, symbols, and units. Objective: Data is unbiased and impartial. Relevant: Data is applicable and helpful Secure: Data is protected and access is restricted. Timely: Data is sufficiently up-to-date for our work. Understandable: Data is easily comprehended. Value-Added: Data is beneficial and provides advantages from its use. Information quality is a hot topic. Perform an Internet search on "information quality" and find conferences, courses, papers, and practices on the subject.
In last month's newsletter, we covered
Syntax and Vocabulary from our list of writing concepts. This
month we pick up with Complexity and Numbers.
Documents should not contain too little or too much information. They must be written at the appropriate level of detail. The right level of detail depends on the type of document, process frequency, work force stability, and the knowledge, skills, and experience of the reader. Documents with inadequate detail may lead to process errors. However, too much information can bore the reader and result in mistakes from inattention. All documents assume a certain level of user knowledge. Check on the user qualifications for performing the described process. Write for a typical reader, not a specific reader. Find out what your audience needs to know and how the information should be presented for their understanding and use. Write to help the reader, not just to describe the subject. Don’t write in isolation. Get to know your “customer”.
The prior article in this newsletter dealt with documenting complex topics at the right level of detail. This article is about documenting numerical information. Numbers may be needed in a document to represent
instrument readings, calculated values, or control settings. Quantities are
most often accompanied by a unit of measure and should be expressed as numerals.
In general, use numbers (0, 1, 2) instead of spelling them as words (zero,
one, two). However, spell out the number if it has no unit of measure, e.g., “use one of the following”. Or, if it may cause confusion, e.g., “use one
9 volt battery” rather than “use 1 9 volt battery”.
If applicable, specify the unit
of measure with the numbers. Use the same units of measure as indicated on
the equipment, for example, degrees Fahrenheit. Specify numbers only to the
precision (exactness) available on the equipment or data source. Use ranges
to specify acceptable limits of operation. For example, 10 - 20 is a range.
Do not express it as an error band (15±5). Avoid asking users to make a calculation. If it is necessary, provide them with a calculation aid in the document to simplify the formula and reduce errors.
Science.gov has served as a gateway to reliable information
about science and technology from across Federal government organizations
since its launch in December 2002. Now, the interagency alliance has launched
Science.gov 2.0, hailing it the “next major step in government science information
retrieval.” Use of the site remains FREE with no registration required. The “FirstGov for Science,” as it is called, serves the educational and library communities, as well as, business people, entrepreneurs, agency scientists, and anyone with an interest in science. The advantage of Science.gov is that it lets users search for information by subject, rather than by the agency sponsoring it. Secretary of Energy, Spencer Abraham said: “From the most current information on new technologies, to historical research results, to the most promising medical advancements, Science.gov connects citizens to the world of science.” Hosted by the DOE’s Office of Scientific and Technical Information, Science.gov is made possible through a collaboration of the Departments of Agriculture, Commerce, Defense, Education, Energy, Health and Human Services, and Interior, as well as, the Environmental Protection Agency, the Government Printing Office, the National Aeronautics and Space Administration, and the National Science Foundation, with support from the National Archives and Records Administration.This article is an edited version of an article by Paula J. Hane in Information Today <http://www.infotoday.com>.
To enroll in these public classes, go to Class Schedule at our web site, or call us at 800-404-7585. Classes taught by Larry Whittington are shown in yellow. ISO 9001:2000 Lead Auditor
(RAB Accredited) - BSI Management Systems
ISO 9001:2000 Internal Auditor (RAB Accredited) - BSI Management Systems
ISO 9001:2000 Auditor
Update - The Process Approach
Implementing ISO 9001:2000
Understanding ISO 9001:2000
Understanding ISO 9001:2000
Requirements (Atlanta Only - $295)
Quality System Documentation
(ISO 9001:2000)
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.
© 2000-2004 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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