27 February 2012

Inefficient Meeting Practices Cost Money

As I read the meeting manifesto by Al Pittampalli, Read This Before Our Next Meeting (now available to read for free from Amazon), I noticed many similarities between what Pittampalli writes and what Greg has been advising clients for years. Mainly, that there is a high cost to inefficient and ineffective work practices.

Anyone working in corporate America will be able to relate to the book, and, hopefully, learn from it. For us at McCulley/Cuppan, the focus is, as always, on how those in biomedical R&D can improve work practices.

Below are a few highlights from the book that relate to what we consider best practices (bolded text is quoted from the book).


The Modern Meeting moves fast and ends on schedule.
"Traditional meetings seem to go on forever, with no end in sight." How often have you felt this way? And how often do these meetings accomplish the intended purpose of the meeting, if there was a clearly stated purpose?

What we've seen over the years is that review meetings, those scheduled to discuss a document in person, last for hours, going from page 1 to page n through a document, with hours wasted on word choice and often leaving the author feeling overwhelmed. When the time limit is up on this type of meeting, more meetings are scheduled that will follow the same pattern.

The Modern Meeting limits the number of attendees.
More often than not, executives are involved in these document review meetings, even on meetings focused on editing and not strategic review, along with anyone who ever had anything to do with the project. How many man-hours are wasted sitting in a meeting instead of working on discovery or development? As Greg mentioned in his post "Editing When You Should be Reviewing Costs Serious Money", "when all the hidden costs associated with review are added in, the cost-per-page to produce a final version document becomes significant."

Meetings should be scheduled for a set amount of time, a time limit that is short enough to prevent repetitive attacks on one word or phrase (nitpicking), but long enough to actually allow for the goal of the meeting to be accomplished. Only the people who are directly responsible for a decision or must act on that decision should be in the meeting. Just because a person provided a line of text to the document does not mean that they should attend the meeting. If a person feels they must be included, provide them with a meeting outline and/or a meeting recap.

The Modern Meeting rejects the unprepared. 
Often meetings are scheduled to review a draft of a document, but the meeting ends with only a few pages of that 100 page document having been marked up. Then more meetings are scheduled and the cycle continues.

Meetings should have a clearly defined purposed. If a meeting has a clearly declared purpose, the leader of the meeting should be able to provide a list of items to accomplish for the meeting and the time allotted for each action item. This helps the scheduler of the meeting weed out people whose presence is unnecessary. This also ensures everyone is prepared for the meeting. According to Pittampalli, if you aren't prepared, you shouldn't attend.

The Modern Meeting produces committed action plans.
At the end of a well-organized meeting, there should be a committed action plan, not just a deadline. Too often with our clients we've seen meetings that produce reams of notes for the authors of the document with a deadline that keeps moving as more notes are piled into the author's inbox.

If meetings, and work practices in general, are efficient and focused only on the contributions of those directly involved, there is less opportunity for circular arguments and nitpicking and less contradictory comments for the author to wade through. Plus there is more time to actually work.


For more tips on improving meetings, follow Al Pittampalli on Twitter at @Pittampalli or view his blog.

07 February 2012

More on What is a Document?

So what is a document?

In response to my last blog post, I have been asked by several individuals—"so then what is a document?"

My short answer—"I do not know for sure."

Now for the long answer.

The widely accepted definition for a document is as a textual record. This definition served us well in the past. But now with digital records, semiotics, and information retrieval tools; I am not sure the definition meets the needs of how we communicate in 2012.

As early as the 1930s Paul Otlet, an Information Scientist of considerable renown, suggested that the definition of documents also include digital images and even three dimensional objects. I am not prepared to toss all the elements Otlet describes into the mix. But I am prepared to suggest that documents are organized physical evidence and as such the organization transcends the classic definition for a document as this vehicle is a less relevant communication medium in 2012 than it was is 1982. I do not have a preferred term, I wish I did, but I do suggest we attempt to move away from the term document as it suggests a domain for organized physical evidence that does not match the reality of the digital age.

Suzanne Briet suggested a definition some time ago that a document is evidence in support of a fact. I rather like this notion. She makes the point that documents should not be viewed as being concerned with texts, but with access to the evidence. I suggest this is the essence of all regulatory writing that I talk about often in this Blog. If one considers the models in place for electronic drug submissions, thinking in the classic terms of 8.5 x 11 and A4 is really not very useful.

Rather it is better to be thinking in terms of taxonomies of information or perhaps even semiotics. Semiotics is the study of signs, indication, designation, signification, and communication. Semiotics is closely related to the field of linguistics. I look at semiotics as a valid attribute for this discussion because the life sciences are driven by numbers and what are numbers, but signs and the significance of those signs.

Then there is Michael Buckland who talks about how a key characteristic of “information-as-knowledge” is that it is intangible: one cannot touch it or measure it in any direct way. Knowledge, belief, and opinion are personal, subjective, and conceptual. Therefore, to communicate them, they have to be expressed, described, or represented in some physical way, as a signal or communication.

What we are really talking about happening in regulatory submission packages is the conveyance of knowledge.  This conveyance often transcends the boundaries of a traditional text, that is, a document as it is generally defined. The Briet notion of "evidence in support of a fact" works well as a definition of a document especially if we change the quote to read "evidence is support of a claim."


03 February 2012

Need a New Mental Model for Regulatory Documents

Wow……I have been away from this blog a whole lot longer than intended. Those competing interests….like you all understand….are the bane of my existence.

For the past couple months I have been looking closely at how people think about the “vehicles” used to communicate with regulatory health agencies. I am using the word vehicle here because I am trying to divorce myself from the notion of document, in particular, the notion of “a document.” In the modern times of on-screen reading and linked files, what is a document anyhow? To me it is the entire corpus somebody may be able to access, not just one slice of that body.

In my consulting/training interactions at McCulley/Cuppan, I find that the majority of people I interface with in the client setting operate within the mind set of individual documents (some have even smaller boundaries and operate by document sections) that are stand alone with well defined boundaries (pages and page counts.)

I want to argue that the vehicle of communication for regulatory submissions is not a document. It is the full and complete dossier submitted by the sponsor. Documents are just placeholders where I go to get a piece or pieces of information that help answer my questions. I want to argue that the regulatory reader does not see a dossier as a set of documents. Rather they see a dossier as a corpus of information that they will use to answer question and make decisions. The contents are just vehicles they peruse to get what they want.

Applying my working model means you stop seeing documents as “stand alone” and stop saying “this document has to tell a story.” I’d also like you to stop using the word document. That word has baggage I am trying to jettison. Instead I want people to view their work at least as “modules” and preferably as vehicles that help a user to answer very specific questions. Bottom line, a research report is just a part of the constellation that tells the stories. Note the plural form as we have many stories to tell in a dossier, not just one.

Applying my working model means you stop seeing your work as being like a novella—something to be read from page 1 to page n. Applying my working model means you see your body of work as something that is read in a coordinate manner that is defined by very narrowly defined aspect rules of inclusion/exclusion. Applying my model means you stop seeing pages and sections and you start seeing concepts and topics.

My argument is that the selective professional reader at regulatory health agencies cares little about documents, sections, pages, and data tables. I am suggesting such readers care solely about making informed decisions and where in the submission dossier they find vehicles that can get answers to their concept and topic questions.