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Quality Control Woes: What’s a CEO to Do?

Medical products companies are struggling to assure FDA and the American people that their products are “safe as manufactured and distributed.” We don’t know whether quality control has become lax, FDA is discovering more problems or industry has just had a run of bad luck.

We do know that quality control relies on a lot of people maintaining tough standards…and that manufacturing is rarely a priority of a drug and device company CEO. Earlier this year, in the wake of Toyota’s problems, FDA Matters asked: “what’s a CEO to do?”

Here is an edited version of the answer I provided.

First and foremost, believe (really believe) that bad things can happen to you and your company. Being FDA-regulated means “always worrying that you will have to say you’re sorry.” Foods, drugs and devices are central to our everyday life. By their nature, problems are to be expected. Deadly consequences are never more than one mistake or misjudgment away.

Don’t assume that you can limit the damage. Problems escalated quickly for Toyota, revealing flaws in the company’s process and attitude, not just its products. And concerns kept multiplying, while confidence dwindled in the company’s ability to fix the problems.

Recognize that “the buck stops here.” Typically, Congress and the media are fascinated by what the CEO knew and when he knew it. But it is quite beside the point. The CEO is responsible and will be held accountable for the actions and failures of all the company’s employees and contractors.

Trust, but verify. In a large, multi-national company, there are an endless number of decisions. Hiring good people and delegating is necessary, but not sufficient. Even the best employees find it difficult to tell their boss about a serious issue that might require costly pre-emptive action. It’s too easy to think: last year’s worst fears never materialized, so maybe today’s concerns won’t turn out to be bad either.

Don’t drink the Kool-Aid. Everyone wants to be part of the team–-to believe in the products they are creating. It becomes hard to be objective about the good and bad points of what one’s company and team are doing. The CEO needs to believe the worst is possible, ask the tough questions and be skeptical when everyone responds “we’re okay.”

Your crisis management plan is not enough. Crisis planning is a step-child of corporate communications. Not enough companies have such plans and few take them seriously enough to practice and update them. I doubt many companies have plans that prepare them to deal with simultaneous multi-system failure.

In a hurricane of adversity, it is unavoidable that companies will be “shaken to the core.” As with real storms, the survivors will be those who built sounder structures, monitored performance closely, and put plans in place for the “once in a hundred years” event that devastates everything.

Such preparation does not happen naturally and cannot be delayed until the storm clouds appear.

However, CEO’s can commit to running reviews that anticipate and prevent problems, as well as prepare for dealing with the worst. FDA Matters sees at least three keys to success in this type of “360 degree” inquiry:

  • no person, project, product, or process can be protected from review,
  • employees need to know that they can speak confidentially and without fear of reprisal, and
  • outside experts are needed to perform reviews and audits, because no one can be sufficiently objective about their own work or team.

Please help me get this message into the hands of CEO’s. The company and job you save may be your own.


Some related columns:

“Safe”: Many Meanings Complicate FDA Policymaking
May 23rd, 2010 Being in favor of safe foods and safe medical products is not enough if you are FDA, the media, Congressional authorizers and appropriators, OMB, and industry. It sounds good, but what does it really mean? In the FDA context, “safe” means many things, some of which are barely related to each other. Read the rest of this entry »

Black, White, Shades of Gray
November 13th, 2009 Civil and criminal investigations are becoming a more prominent feature in the world of FDA-regulated industries. People who never gave any thought to this….suddenly find themselves needing to understand how investigations work. Read the rest of this entry »

The Beatings Will Continue…
November 1st, 2009 It has been an expensive year for pharmaceutical companies. Billions of dollars have been paid to federal and state governments and whistleblowers in settlement of allegations and lawsuits. The complaints include off-label marketing and overcharging Medicaid, but there are many others. Read the rest of this entry »

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