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A good device project manager should be conversant with the use of network (PERT-type) and bar (Gantt-type) schedules. The PERT-type is invaluable for understanding the complex interrelationships between the many functions and disciplines involved in developing the device. The Gantt-type is clearer for timescale, overlap and slack within the project and represents the better format for management reporting. |
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Where several organizations are involved in a development, it is essential that they all work to the same schedule. This can be achieved only if they all have access to the same software planning tool and regularly share their thinking on scheduling. The plans of each contributing party, particularly where they interact, should be consistent. All too often, we see quite well-structured plans for individual functions which demand the impossible or fail to deliver the essential information to the rest of the team. This should be avoided by proper integration in the top-level plan. |
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A common pitfall is to consider the planning job done once the schedules are written. Plans are the most effective way to ensure timely delivery, by tracking at least weekly, often daily, and sometimes hourly. If the project manager looks after the hours and days, the years will take care of themselves. |
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B.
Failure Modes and Effects Analysis |
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Failure Modes and Effects Analysis (FMEA) is a technique which originated in the aerospace and nuclear industries where successful performance first time is important. The method is to use prior experience, to brainstorm, or otherwise to predict in any way possible how the device and its interaction with the drug, its assembly, and filling can go wrong. The likelihood and effect of such a failure, then, is predicted. Failure modes, particularly where they are deemed to be likely and where the effect is severe, are then avoided by redesign or by some other means. By following this process, a more robust device results. A certain level of FMEA, properly documented, is required within Europe to acquire the CE mark. |
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Good practice calls for regular, independent design reviews during the project. All sorts of embarrassing problems to do with fit and function can be avoided by recognizing them early enough. Employing a fresh pair (or several fresh pairs) of eyes to look critically at the project helps to flush out problems that the team cannot or will not see. The scope of independent reviews can be to cover the entire project in all its aspects including both |
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