Sunday, May 29, 2011

What Does it Mean to Operate in a State of Control?

Once upon a time, I asked this question of a senior management group at an off-site “strategy” meeting. You know—one of those meetings where a working breakfast was followed by a day of golf, and I was the one doing the working.

The question was particularly germane to the purpose of my invitation, because these executives did not want to follow the path of other major industry giants into ruin by taking their eye off the proverbial CGMP compliance ball.

After a bit of awkward silence, someone offered a stab at the answer: Zero Defects. Another rebuked his colleague: That’s so passé. It should be Right First Time. The next ten minutes was Battle of the Buzzwords and I was the game show host. Conversation erupted in a murmur across the room.

I responded by saying that perfection was a worthy goal, but statistically impossible. I am highly suspicious of perfection, and firms that reward the strict definition of perfection drive bad behavior. In fact, when things are too perfect—I suspect fraud.

That quieted the room.

To operate in a state of control does not mean perfection. It does mean; however, the capability of a firm to detect and self-correct trends before it becomes a problem. And whenever a problem does emerge, the firm is capable of taking action to understand the reasons behind the problem, and make decisions that favorably effect the trend, or that prevent recurrence of the problem.

To make this more relevant, I drew an analogy with their Sales and Marking Department.

Their markets are broken down into regions and further into territories. Each territory manager has sales targets that they track and report up to the regional director. The regions report to countries. Eventually, all the performance metrics reach the company boardroom. Unfavorable trends and problems are investigated, decisions made and actions are taken. An eye is kept on the metrics to see if their decisions and actions were effective in increasing sales.

There is nothing here about perfection.

In this analogy, the market represents the Quality Management System and the regions and territories are its various parts organized by discipline. The territory managers, regional directors and the boardroom are the system owners and responsible management that exercise governance. Sales performance metrics are quality system performance metrics.

It was one of those beautiful “ah ha” moments.
I was intentionally being provocative with my question because I wanted this group that was responsible for a multi-billion dollar business to seriously consider how they were exercising stewardship of their pharmaceutical portfolio—for patients and investors.

What they expected to hear were Strategies for Avoiding a 483, but what I gave them was a refresher in Management 101 followed by one heck of a round of golf.

The QA Pharm

Saturday, May 14, 2011

FDA: For Corrective Action Plans, Where are the Resources?

Can you imagine the stream of firms that venture in to their respective FDA district offices to give presentations on their Warning Letter response and to offer their assurance that they truly “get it”?

You can be sure that theses firms had several dry runs and dress rehearsals to hone their material before stepping into what they perceive to be hostile territory. Their presentations were carefully crafted by the VP, SVP, EVP and vetted by the lawyers. Consultants who claimed to have "been there and done that" were invited guests to the prep meetings to give their insight into what “sells” at the FDA. 

When the meetings at the FDA are over, the firm’s representatives heave a sigh of relief and offer each other congratulations that it went well, because it “felt good.” It “felt good” because no one on the FDA side of the table objected or got upset. So they go back to their colleagues and claim victory. The story gets exaggerated and turns into something like, “They really liked our presentation.”

In my experience, the only thing that “sells” at the Agency is results. The FDA “response” is a practiced, neutral expression that never is meant to signal agreement or acceptance. It’s all part of their “We’ll see it for ourselves when we come back to re-inspect,” modus operandi

However, we are starting to see a very interesting twist at FDA that suggests they have finally figured out that there is more they can do to ensure effective action than sit through fancy presentations acting nonplussed while having smoke blown up their proverbial tailpipe.

The new twist is embedded in the Teva Warning Letter dated January 31, 2011, but only recently posted on the FDA website. (The delay of which I always find curious.)

The theme of Teva’s Warning Letter is a problem of cross-contamination. Teva dutifully responded with their corrective action plan, which baited the usual response from the FDA--with a bit of a twist.

We recognize that your October 7, 2010 response states that you are in the process of developing a risk management program for control of cross-contamination of the products produced at the Jerusalem Oral Solid Dosage (OSD) plant. However, you did not submit that plan, or data to support the effectiveness of the plan, with your response. We also recognize your commitment to finish the risk assessment within four months. Please provide us with any update on your timeline, and the identification of resources allocated to address this issue. 

It is not uncommon for the FDA to expect a plan and timeline in a response. In fact, it is a frequent failing of companies to not provide a plan or timeline for completing corrective actions. However, in the case of Teva, FDA also requested the allocated resources to be identified.

That's the twist, and that's huge.

Frankly, this makes a lot of sense. The most successful corrective action plans have been those where the direct responsible individuals are named and appear in detailed project plans. There is a clear picture of what success looks like and how to get there. But most of all, the resources are identified to execute the work.

The regulation has always required sufficient numbers of qualified individuals to perform operations; so specifically asking about resource allocation to do the work is fair game. 
Unusual—but fair.

In the past, the sincere delivery of a good presentation might have passed with the usual skepticism. Now be prepared to tell about the resources to pull it off.

Without the resources, it's just another pretty presentation.

 The QA Pharm