FDA’s Voluntary Audit Program and the Hangman's Paradox

Dan O’Leary President at Ombu Enterprises, LLC recently shared with me the hangman paradox as it relates to FDA audits. For those of you who haven’t taken a course in epistemology lately, here is the paradigm:

Heather Thompson

June 19, 2012

5 Min Read
FDA’s Voluntary Audit Program and the Hangman's Paradox

Dan O’Leary President at Ombu Enterprises, LLC recently shared with me the hangman paradox as it relates to FDA audits. For those of you who haven’t taken a course in epistemology lately, here is the paradigm:

A judge tells a condemned prisoner that he will be hanged at noon one day in the following week but that the execution will be a surprise to the prisoner. He won’t know until the executioner knocks on his cell door that day. The prisoner draws the conclusion that he will escape from the hanging. His reasoning is in several parts. He begins by concluding that the ‘surprise hanging’ can’t be on Friday, as if he hasn’t been hanged by Thursday, there is only one day left—and it won’t be a surprise. He then reasons that the hanging cannot be on Thursday either, because Friday has already been eliminated and if he hasn’t been hanged by Wednesday night, the hanging must occur on Thursday, making a Thursday not a surprise either. He similarly concludes that the hanging cannot occur on Wednesday, Tuesday or Monday. Joyfully he retires to his cell confident that the hanging will not occur at all. The next week, the executioner knocks on the prisoner’s door at noon on Friday—which, of course, was an utter surprise.

“Applying the paradox to FDA inspections, a firm can reason it will never have a surprise inspection in the two-year period—until it has one,” says O’Leary,

O’Leary told me this story because I asked him whether any companies were planning to take part in FDA’s pilot program for voluntary auditing. FDA’s plan is to allow companies to voluntarily submit ISO 13485 audits conducted by Notified Bodies acting under the Global Harmonization Task Force (GHTF) founding regulatory members in lieu of FDA QSR audits. The ISO audits are conducted on a yearly basis, while QSR inspections are conducted every 2 years. Of course, QSR inspections are based on FDA availability. In some regions where FDA might not have enough inspectors, these audits might happen every 5-6 years. QSR audits are a purposeful surprise—companies are given about five days to prepare.

O’Leary sees taking part in the pilot program “an opportunity to avoid an FDA inspection.” He explains that manufacturers will be required to submit 2 years of audit reports (e.g., the first report would be 2011 and 2012; the second report would be 2012 and 2013). In exchange, assuming the audits are successful, the company is taken off FDA’s work plan for one year. But, “you never know if you were on the work plan; this is not public information,” O’Leary explains.

According to Bart Lago, founder of Experienced Metrology, Health Physics, the biggest benefit in participating is convenience. “A company would not have its operations disrupted for a week by an audit,” Lago says. “Audits always seem to occur when new projects are starting up or major equipment overhauls are being performed.” The voluntary audits can  be scheduled in advance.

Another convenience: most medical device companies are already conducting the necessary audit requirements. “Most manufacturers already have a contract with a notified body for an annual audit because it is required for the CE Mark in Europe and the CAMDCS system for Canada,” O’Leary says. In addition, Nancy Duarte-Lonnroth director of quality, regulatory affairs, healthcare for Celestica says that it enables more controls in the supplier system. “OEMs now have a better opportunity to encourage suppliers to go in this direction, providing OEMs greater control over, and confidence in, their supply chain players,” she says.

If convenience, predictability, added control, and saved effort are appealing to medical device firms, it is reasonable to assume that most companies would be eager to take part. But I’m not so sure the program will be that popular.

There is pervading skepticism about FDA among device makers, exemplified by Robert Rosenloft, a compliance manager at Abbott Nutrition. “How many companies are really willing to share external audit info with the FDA?” he asks. “You would be providing your dirty laundry to the agency on a yearly basis, regardless of if they were going to audit or not. You are giving them the ammunition they need to come to your business for cause.”

Indeed, experts advise extreme caution in participating in the voluntary program. “It is imperative that manufacturers should review in detail the audit reports and communications before deciding whether to submit,” advised Brent Noblitt, cofounder and senior partner of Noblitt and Rueland in a recent editorial on Consultant’s Corner.

If a company does decide to participate, it should be aware of a few limitations. O’Leary says submissions might need a few years to get two reports in the required format, due to the following restrictions:

  • Audits must be conducted under the regulatory scheme of one of the founding GHTF partners.

  • The ISO 13485 audit and the resulting report must satisfy the GHTF Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers.

  • The most recent eligible ISO 13485 audit report submitted will also need to be consistent with Health Canada’s GD211 Guidance on the content of quality management system audit reports.

  • The audit report is submitted to the FDA within 90 days from the last day of the most recent ISO 13485 audit.

Despite his reasons to take part, even O’Leary guesses “there will not be many submissions.” It seems that companies will continue to opt for a hangman’s game. If they do, its a missed opportunity and a real shame.

—Heather Thompson

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