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Punchlist for a “483” – Worm Sorting

It was a week after the Design Review that I realized that I had a can of worms in the Reporting Requirements. I had the client on the phone. I asked for report samples to start the report building process. There was a brief silence on the other end of the phone.

The report samples weren’t ready. How about the reports from the old system? They were rethinking the reporting. “DingDingDingDing” – off went the worm detector, too late.

As the story emerged, the situation was this: A number of different groups would be using the reporting from this system, where they had done their own reports in the past (worm one). They were currently engaged in finger pointing, because the thrust of the FDA citation (the “483”) that started this development initiative in the first place was around incident reporting, follow-up and corrective action on a system-wide basis, not just incident by incident (worm two). The different opinions about the nature and use of Incident Reporting were moving apart, not together (worm three). The visibility of the issue at the Senior Management level was crystallizing the different opinions among the groups, making it harder to develop a consensus set of reports (worm four). In an effort to show innovative new approaches to Incident Management and Control, some far-fetched and complex ideas were emerging about the reports that were needed (worm five). You get the Idea.

So there I was: I had a contractual requirement to deliver a substantial set of increasingly complex reports. The reports were undefined. The reports would use complex, emerging selection and analysis criteria, still under discussion. The deadline was fast approaching. Yes, I could insist on the reporting requirements settling down before proceeding, but I knew I wouldn’t get the delivery payments until everything was done. I saw the reporting part of the project stretching out into the distance, lines converging to a project vanishing point on the horizon. And I would catch much of the blame if the system was late.

In retrospect, I shouldn’t have missed this Can of Worms – It followed logically from the events that initiated the project in the first place. The lesson: Keep asking “Why are we doing this system?”, even if you think you know. Five whys should be enough!

Posted on Saturday, January 7, 2006 at 10:46PM by Registered CommenterLarry Cone in , | CommentsPost a Comment

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