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The QA Pharm

Quality Insider

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

There is nothing here about perfection

Published: Monday, June 6, 2011 - 05:30

Once upon a time I asked, “What does it mean to operate in a state of control?” at an off-site “strategy” meeting of a senior management group. You know the kind of meeting that I'm talking about—one in which 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 current good manufacturing practice (CGMP) compliance ball.

After a bit of awkward silence, someone offered a stab at the answer with, “Zero defects.” Another rebuked his colleague, “That’s so passé. It should be ‘right first time.’” The next 10 minutes was the 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 punish less than 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 affect the trend, or that prevent recurrence of the problem.

To make this more relevant, I drew an analogy with their sales and marketing department.

Their markets are broken down into regions and further into territories. Each territory manager has sales targets that they track and report 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 are made, and actions are taken. An eye is kept on the metrics to see if their decisions and actions were effective.

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 patient and investor.

What they expected to hear were “Strategies for Avoiding a 483,” but what I gave them was a refresher in “Management 101.”


About The Author

The QA Pharm’s picture

The QA Pharm

The QA Pharm is a service of John Snyder & Co. Inc., provider of consulting services to FDA-regulated companies to build quality management systems and develop corrective actions that address regulatory compliance observations and communication strategies to protect against enforcement action. John E. Snyder worked at the lab bench, on the management board, and as an observer of the pharmaceutical industry for more than 30 years. His posts on The QA Pharm blog are straight talk about the challenges faced by company management and internal quality professionals. Synder is the author of Murder for Diversion (Jacob Blake Pharma Mystery Series Book 1).