Why Most Document Reviews Are Not Really Reviews Ver Final Draft

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Address the root cause of poor review performance and not just the symptoms.

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Why Most Document Reviews Are Not Really Reviews Ver Final Draft

  1. 1. Why Most Document Reviews are not Really Reviews: the good, the bad, and the ugly of review practices in the clinical sciencesThe importance of understanding the root causes of poor review outcomes<br />
  2. 2. To Bring Change<br />For effective CAPA you must identify and manage root cause not just the symptoms<br />This dictum applies absolutely to review practices<br />
  3. 3. Starting Point: Know Where You Want to Look<br />Recognize the differences between: <br />Practices and processes<br />Cooperation and collaboration<br />Inspection and review<br />
  4. 4. Bottom-line<br />If you want to improve collaborative work practices, but your systems are built around cooperative processes, then you will never get the there.<br />Fix the process and then work on the practices<br />
  5. 5. Root Cause of Poor Review Outcomes<br />No formal training in review<br />Reviewer discipline<br />
  6. 6. No Formal Training Results In<br />Failure to recognize differences between review and inspection<br />Lack of meaningful markers and metrics to establish quality<br />Lack of appreciation for how rhetorical strategy varies by document genre<br />Lack of understanding of situational reading behavior<br />
  7. 7. Failure to recognize differences between review and inspection<br />Symptoms:<br />“word smithing” even when requested to avoid doing so<br />5 people with 5 suggestions how to rewrite one sentence<br />Starting on page one, line one, word one and reading document in serial progression<br />
  8. 8. Lack of meaningful markers and metrics to establish quality<br />Symptoms:<br />Competing opinions about “what to do” or “how to state” in a document<br />Continually revisit a narrative in successive drafts<br />Work on a narrative until “take it away from me”<br />Use previous work (narratives or full documents) as benchmark to judge current work<br />
  9. 9. Lack of appreciation for how rhetorical strategy varies by document genre, document section, audience situation<br />Symptoms:<br />All feet will fit one shoe:<br />Repurposing without account for audience, genre, or section intention<br />“the template is king…long live the king!!”<br />“well when I was writing manuscripts we…..”<br />Well this does not work for me<br />
  10. 10. Lack of understanding of situational reading behavior<br />Symptoms:<br />If we write it…..they will read it<br />I am an SME and that means all SMEs like me read “just like I do”<br />I want documents written just like how I think/conduct science<br />Starting to review from page 1, line 1, and reading straight through to page n<br />
  11. 11. Reviewer discipline<br />Right people wrong time<br />
  12. 12. Reviewer discipline<br />Right people wrong time<br />It’s gotta be done my way<br />
  13. 13. Reviewer discipline<br />Right people wrong time<br />It’s gotta be done my way<br />Misapply review focus<br />
  14. 14.
  15. 15. In Summary<br />Recognizing non-productive review practices should be an object of focus for more organizations <br />Know where you want to look<br />Address root cause not just symptoms<br />For CAPA: take small bites of the apple<br />Start measuring and reporting<br />Changing non-productive practices not an easy matter because of deeply in-grained learned behavior<br />

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