INSIGHT
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mdi Consultants
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That is all quite interesting, you may say, but "Do I have this problem, and if so, where is it?"
Much to our chagrin, it appears that the problem is in everybodys system. It is in your mainframes, desktop computers, and the embedded chips in your office equipment, your manufacturing equipment, your quality control equipment, and your calibration equipment. Furthermore, your dependable suppliers, distributors, and regulators have exactly the same problem and if they do not fully appreciate the problem they are not going to properly correct it; this will adversely impact your business! Finally, and only poorly understood by most, the Y2K problem even exists in devices that do not externally appear to be date sensitive or date dependent. Virtually all silicon chips are made primarily from an assemblage of pre-designed library modules if the chip has a non-compliant library module, it may have a failure problem. Most of us can relate to "hardware" problems. They are tangible, understandable, and part of our everyday experience. Very few of us (including many good programmers) can properly relate to "software" problems. Understanding the difference between hardware and software is crucial not just from a safety and reliability perspective, but also from a testing perspective; if you use hardware style tests for software, you will get back irrelevant results. Understanding the difference between hardware and software is crucial Let us briefly review some of the big differences between hardware and software, so as to gain an appreciation of the conceptual differences:
Management Solution ApproachNow that you appreciate certain aspects of the Y2K problem and understand that it can impact your business, affecting your revenues, your product quality, your customers loyalty, and your regulatory position, what can you do about it? As usual, the answer is good management. And, since every business problem can be turned to a business opportunity, you need to think about how the time, effort, and other resources you use can improved your current enterprise. In general, the evaluation of your organizations susceptibility to Y2K problems either internally or externally (from your suppliers, distributors, and regulators) is a business process engineering endeavor. There are two diametrically opposite approaches: the Hammer & Champy innovation style re-engineering approach versus the Imai kaizen style continuous process improvement approach (see Hammer & Champy, "Reengineering the Corporation", 1993, ISBN 0-88730-640-3 and Imai, "Gemba Kaizen", 1997, ISBN 0-07-031446-2). You would be best served by employing a combination of the two called the Ergonomic Quality approach, which institutes an ergonomic focus on all aspects of the enterprise (see Gross, "The Right Fit", 1996, ISBN 1-56327-111-7). With this approach, you re-examine and re-assess all your business processes not only for Y2K concerns, but also to improve the efficiency and effectiveness of the entire enterprise from a user perspective.
Implementing the "fixes" is only a small part of the management solution Risk assessment and risk management start with a hazard analysis; its not just for medical devices or pharmaceutical products, it works for the whole organization. An incomplete hazard analysis (or a wrong criticality assessment or a wrong test strategy), inadequate resources (insufficient time for testing, lack of management commitment or administrative support, or insufficient personnel and test equipment), or improper post-test revalidation (test-related failures) are all issues that need careful management attention. But doing the assessment, developing the remediation plan, and implementing the "fixes" is only a small part of the management solution. The truly important and difficult part of the management solution is the continuation-planning component. It consists of the triad of contingency planning, event management, and target date processes. This is the core of the risk management process, since - not matter how hard you try - you and your staff cannot fix all the problems or prevent all the adverse events. It is here that you systematically think through how your organization will respond to a particular crisis (internal or external), who will be responsible for managing a particular crisis, and what parameters cannot be exceeded without damaging other aspects of the enterprise. It is this process of thinking through the events that may confront you that will give you the tools and confidence to handle the crisis.
For further information, click on the hyperlinks below. Our staff can assist you in all aspects of your managerial efforts from strategic planning to project management to test protocol development and analysis of results. We can help your staff analyze your enterprise and implement a structured, systematic program of risk management and process improvement so that your efforts in the Y2K arena will not only protect you, but improve your ability to compete in the market place.
Further On-line Information
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on these INSIGHTS we hope that you let us hear them. If you have any of your own INSIGHTS
that you feel would be of value to other companies, we would be pleased to hear from you
and to discuss them with you and if you allow, we would even put them up on this site for
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