You are consulting with a healthcare organization that has heavy document contro

Question

You are consulting with a healthcare organization that has heavy document control needs because all of their documents become legal descriptions of their products, which means that the FDA (Food and Drug Administration) includes them in reviews of your products and services. There is long history of managing documents with extensive revisioning controls, checking them in and out, and tracking every change in from the most minor spelling correction to production of new content. This is necessary for FDA compliance. Now, the Chief Executive Officer wants to move to online documentation co-developed with clients via wiki’s with “in draft” and “final” clearly indicated. This is a big leap in performance changes for the document developers. In order for this to be successful, describe the various perspectives that will need to considered and explain the key requirements of each.

Explanation / Answer

In order to successfully change the system for managing documents within the healthcare organization to wikis with clients' input one would need to compare the system behaviors between the current system and the proposed system. Included in the comparison would be determining how the new input from the online documentation co-developed with clients affects the documentation, its' accuracy, and ultimately the output to the FDA.

The various perspectives that would need to be considered will be how the new process and its' results impact the partnership with the clients, the document developers, and the FDA as well as the Chief Knowledge Officer's goal. At the very basic level the individual or team currently working with the documents will be affected. It would be important not to make the work more cumbersome or less accurate than it currently is. Key requirements for this group would include maintaining the benefits inherent in the current process while adding the benefit of their clients' expertise. The worker must have the skill or knowledge with which to take part in the wikis as well as the motivation based on improved results. The Chief Knowledge Officer's perspective would need to be considered since he is the one interested in making the change. His key requirements appear to be adding co-developed documentation. The operation of the organization would be the next perspective that would need to be considered. Overall the new process must improve upon current results. Change for the sake of change is never appreciated. Nor is adding more layers of work with little payoff. The benefits must be sufficient to outweigh the costs of making a change. Clients would require the ability to take part in the wiki easily and make meaningful contributions. There must be valuable feedback attained from having clients' co-development in order to successfully strengthen bonds between the company and the clients. Finally the FDA 's perspective will also need to be considered: the results must continue to be law abiding, clear, and thorough.

I used pg 39-53 from your book as a source.

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