$3,500 A Page: And You Wonder Why Pharmaceuticals Are So Expensive?

February 2, 2006 Blog No Comments

Technical reviews are an essential part of the documentation process, but unwieldy, inexpedient, and iterative reviews can serve as red flags for systemic problems in an organization. These problems have nothing to do with the quality or importance of a document, but as the author, you can use them to identify and head off damage to your document and the company, and to respond strategically.

I was assigned to write an overview of a computer system comprised of in-house computer applications. This overview was a regulatory requirement, and my department had been “dinged” in an internal audit for not having one. If an oversight agency came calling, the company would be subject to fines without this document. I put together an aggressive timeline with ten days for the two managers and two SMEs to provide input and sign off, and I delved into the fray.

From the outset, the project was beset by problems. I discovered an exponentially growing list of “helper apps” and “tools” (think kudzu vine that needed to be included. The lead developer was out on vacation. Meetings interfered with the experts’ schedules. You know the drill. I pulled together what we had and got the (much larger than anticipated) document out for initial review.

Enter the legendary blue-penciler (or red-pen, if you please). I put together a brief memo explaining that grammar, spelling, and formatting would be addressed in the final review, and would she please focus on the technical accuracy in her edits. The document came back to me with notes like “needs wider margins” and “this isn’t the right template.” The technical content didn’t receive any feedback, but – you guessed it – she edited my editing memo. She also gave the document to two other people “to look over” (Red Flag #1). Each of them gave me input (some it mutually contradictory – Red Flag #2), and we were off.

My manager and I went through the contradictory comments one by one. She told me which to incorporate and which to discard. I updated the document and made a spreadsheet listing each suggested change, who had proposed it, and what the response had been. If the comment had not been incorporated, I explained why. I sent this spreadsheet, along with the document, back to Blue Pencil, reiterating my request for technical feedback. She sent the document – without the spreadsheet—to her other two reviewers, who of course wanted to know why all of their changes hadn’t been made. One of them came to my desk and dictated them to me in a copy of the document. Since my manager wasn’t around, I kept a copy of the “before” document, and when she returned presented her with both, explaining that I needed her to address the person who had come to my desk and explain why all the changes had not been originally made. Rather than confront the person, she told me to send out the “new” document to our other reviewers (#3), and not to use the spreadsheet to track changes anymore. The document went out to the next round of reviewers, who objected to some of the new material.

I was in hell.

It was at this point that I started keeping track of the reviews and the reviewers, as it was clear that I was going to miss my deadline.

Weeks went by. Each reviewer passed the document to a couple of other people in a process I came to think of as “Six Degrees of Documentation” (because eventually, everyone in the whole world was sucked into the reviews). The deadline came and went as I tried to manage the suggestions that flooded in. Old tensions between the business side and IT manifested themselves, with business trying to produce a full and detailed picture and IT trying to minimize their exposure (Red flag 4…and 5, and 6). As a consultant, I was relatively powerless to call a stop, so I made edits, undid them, made new ones…each time saving a version of the document. Six months after the original deadline, we were up to version 65 and the document was a department-wide joke. I received an award at a staff meeting for my work on it. And still it wasn’t signed.

It wasn’t until eight months after the original deadline that the document was finally approved and archived– because the manager was transferring to a new department and needed it “done.” No one was pleased with the final result.

I ran a few numbers, and taking a very conservative hourly cost of $20 for each reviewer, plus my time, I calculated that the 68 revisions of the document (no exaggeration) had cost the company at the very least $53, 000. All this for a document that no one was happy with, and which had swelled from 19 pages to 46 and back down to 15…. but still didn’t meet the regulation.

What’s the upshot? Problems during review cycles may be indicative of a systemic cultural pathology in a department or company. And if you don’t or can’t address that pathology, then big bucks can go to waste. It’s important that companies recognize that fear, ambivalence, and internal conflict are all roadblocks to completing documentation—and that they cost companies a lot of money. Here’s my advice: before a project can get out of control, keep a few metrics on how long a document takes to review, how many people review it and how long it takes you to make changes. If things do go wrong, run some numbers assuming a conservative hourly estimate for all these things and run it past your boss or the reviewers themselves. Sometimes, money talks when reason fails.

Some companies will never realize how much the document-review hamster wheel costs them, or will never get off the wheel if they do. But there are a few other things you can do to protect yourself when red flags appear (you may have to experiment with some or all of these, depending on the degree of dysfunction you face):

If you face Red Flag # 1, and your reviewers are passing documents along to other unplanned-for reviewers, this may indicate that your designated reviewer feels unsure of her technical expertise, or is reluctant to take final responsibility. Try speaking to your “official” reviewer face-to-face. Make it clear that she was chosen for her technical expertise and explain what you need from her and who else is included in scheduled reviews. Ask her directly whether she thinks there are other people who need to see the document, and if there are, what she thinks they can add. In some cases this will prevent unsolicited reviews. If you find that she still cannot resist the urge to pass along the document, do two things: first, ask her to let you know before she does this so that you can add time to your schedule. And second, ask her to serve as a conduit to pass along and interpret the comments from “her” reviewers. Appeal to her expertise, and indicate that you need her help to sort out the good stuff. Once she realizes this means more work, she may back off…and if she doesn’t at least you will have her assistance when you have to balance conflicting feedback.

Mutually contradictory feedback, Red Flag #2, may be a symptom of underlying animosities or turf wars. You need to get everyone in the same room. Call a face-to-face meeting with all the reviewers, official and unofficial. Show up with copies of the document for everyone, and if possible a laptop and overhead projector. Your goal with this meeting is to address each comment one by one and ask for consensus from your reviewers. Make changes only when the attendees can agree, or ask your “lead” to adjudicate. It will be harder for a supervisor to dodge decision-making responsibility.

Red Flag #3, a person who won’t take a stand or won’t make a decision, may be the toughest challenge, especially if you are a consultant and Ms. Wishy-Washy is an employee. An indecisive or inconsistent supervisor may feel she lacks the backing of her management, may have been burned in the past for being direct, or may be in a role that exceeds her competence. Her vacillation can eventually make you question your own sanity, and your first priority must be to protect yourself. Take advantage of all tools at your disposal to retain versions and backups, and to record decisions. While my irresolute boss nixed my comment tracking spreadsheet, in general this approach is a good idea both for the writer and for the reviewers. Get in the habit of recording substantial comments in a spreadsheet, along with who provided them, the date, and the final disposition of the comments.

If you sense there is a longstanding rivalry or territorial dispute at work, Red Flag #4, take a “divide and conquer” approach: try to identify “specialists” in each area, and ask them, in person, to review documents for certain content only. Tell the reviewer that she or he is considered an expert in certain information, and that to avoid taking too much of her time, you are only asking for feedback in X, Y, and Z—and if possible, only give her the parts of the document that match her expertise. In this way, it is sometimes possible to “partition” your documents, reducing tensions between reviewers and minimizing competing opinions.

In brief, recognizing that document review drama may be a symptom of a deeper problem, and by responding to that problem with some psychological insight, you can save yourself and your company time and money. The next time the seemingly inexplicable happens during a document review cycle, try to analyze the personalities and respond accordingly. You’re bound to come out ahead—after all, $3500 would buy a lot of psychotherapy.

Lisa Woods is a consultant to the pharmaceutical and insurance industries who specializes in computer system validation, regulatory compliance, and making unwieldy documentation manageable, useful, and compliant. Contact Lisa.