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

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

2. To Bring Change For effective CAPA you must identify and manage root cause not just the symptoms This dictum applies absolutely to review practices

3. Starting Point: Know Where You Want to Look Recognize the differences between: Practices and processes Cooperation and collaboration Inspection and review

4. Bottom-line If you want to improve collaborative work practices, but your systems are built around cooperative processes, then you will never get the there. Fix the process and then work on the practices

5. Root Cause of Poor Review Outcomes No formal training in review Reviewer discipline

6. No Formal Training Results In Failure to recognize differences between review and inspection Lack of meaningful markers and metrics to establish quality Lack of appreciation for how rhetorical strategy varies by document genre Lack of understanding of situational reading behavior

7. Failure to recognize differences between review and inspection Symptoms: “word smithing” even when requested to avoid doing so 5 people with 5 suggestions how to rewrite one sentence Starting on page one, line one, word one and reading document in serial progression

8. Lack of meaningful markers and metrics to establish quality Symptoms: Competing opinions about “what to do” or “how to state” in a document Continually revisit a narrative in successive drafts Work on a narrative until “take it away from me” Use previous work (narratives or full documents) as benchmark to judge current work

9. Lack of appreciation for how rhetorical strategy varies by document genre, document section, audience situation Symptoms: All feet will fit one shoe: Repurposing without account for audience, genre, or section intention “the template is king…long live the king!!” “well when I was writing manuscripts we…..” Well this does not work for me

10. Lack of understanding of situational reading behavior Symptoms: If we write it…..they will read it I am an SME and that means all SMEs like me read “just like I do” I want documents written just like how I think/conduct science Starting to review from page 1, line 1, and reading straight through to page n

11. Reviewer discipline Right people wrong time

12. Reviewer discipline Right people wrong time It’s gotta be done my way

13. Reviewer discipline Right people wrong time It’s gotta be done my way Misapply review focus

15. In Summary Recognizing non-productive review practices should be an object of focus for more organizations Know where you want to look Address root cause not just symptoms For CAPA: take small bites of the apple Start measuring and reporting Changing non-productive practices not an easy matter because of deeply in-grained learned behavior