When a Boston surgeon, author, and public health expert came out in late 2009 with the seminal book, “The Checklist Manifesto: How to Get Things Right,” the timing could not have been better for the food industry. The book became popular, especially among industry executives, during 2010, the year when Congress adopted the Food Safety Modernization Act (FSMA). With FSMA’s goal of preventing foodborne illnesses, every food industry executive was already thinking about the added complexity and cost. http://www.dreamstime.com/stock-photography-close-up-manager-wearing-yellow-vest-using-handheld-large-warehouse-image49290932But here was Dr. Atul Gawande, who practices surgery at Boston’s prestigious Brigham and Women’s Hospital and is also a professor at Harvard University’s School of Public Health, saying something as simple as a checklist could be the key to preventing even experienced surgeons from sewing up patients with medical instruments left inside. Gawande’s clarion call for checklists was heard by government and industry. The U.S. Food and Drug Administration (FDA) now seems to be popping them out with regularity as FSMA implementation rolls along.  FSMA’s Food Defense, HACCP Validation, Product Tracing and Electric Document Conformance are among the recent FDA checklists for helping companies met FDA compliance.. In many ways, checklists are turning out to be the “head of the spear” for the software and technology necessary in the war against food poisoning. If you’ve strolled through the produce section of a major grocery story lately, computerized voices are even telling people there when to do certain tasks. On the record, everybody is positive about change. Throughout the rule-making and industry comments on FSMA, complaints were numerous and public about the complexity. Something called the “water metrics” was an ongoing subject of complaint for the complexity it brought to water use for produce, and that was but one example. There have been many others. Off the record, it’s easy to get into a discussion about whether checklists, maintained by hand or computerized, are driving complexity or solving it. History does provide an answer to that question. PAR_sidebarChecklists were invented out of necessity by a committee because the government was about to make a disastrous decision to shun technology due to an unwillingness to take responsibility for making a correct, but easily misunderstood, decision. We need to “turn back time” to 1934 when Boeing, Douglas, and Martin were competing at Wright Field in Dayton, OH, for a contract with the U.S. Army Air Corps (USAAC) to provide the government with a new long-range medium bomber. Boeing’s entry to the contest was its Model 299, which “flew circles” around Martin’s Model 146 and the Douglas DB-1. The Boeing bomber model scored highest in all the evaluation categories. Then came the actual flight trials. Model 299 taxied out and took off for a smooth climb, but then stalled, turned on one wing, and fell to the ground in a ball of flames. Army Major Ployer P. Hill, who was at the controls, and Boeing’s chief test pilot Leslie Tower were both killed. The media then, like the media now, made “an instant decision” that Model 299 was “too much plane for one man to fly,” and that the contracts from the U.S. and Canadian governments should go to Douglas, the runner-up with more bomber and passenger airliner history at the time than Boeing. Several of the flying USAAC officers, however, worked behind the scenes to carve out a 12-plane order for Boeing’s model “for further testing.” But to rescue it was one thing. To save it was another. The inquiry into the accident that killed Hill and Tower, both among the world’s flying elite at the time, was “pilot error.” The elevator lock was not released prior to takeoff and, although Tower realized it soon after that, his realization came too late. Working on the problem, the air officers of the 2nd Bombardment Group at Langley, VA, figured out there was just a lot to remember when flying the complex bomber. In other words, it was not a piloting problem; it was a memory problem. Tasks had to be completed in the proper order and at the right times or accidents could happen and people could be killed. The solution the committee of pilots arrived at was the checklist. The 2nd Bomb Group then logged 1.8 million miles in the new Boeing bomber without an accident. That’s why pilots use checklists today. The Army Air Corps ended up buying 13,000 of the new bombers from Boeing. It was the most storied aircraft of World War II — the B-17 Flying Fortress. In his book, Gawande makes a comment that certainly could apply to food safety in the 21st century: “We have accumulated stupendous know-how,” he says. “Nonetheless, that know-how is often unmanageable.” Only mistakes explain why allergens have come to dominate the number of food recalls the industry has experienced over the past few years, says a food business insider. Allergen-related recalls usually follow the placement of a label which does not list an allergen known to the company and for which proper labeling usually exists. Product goes out with the wrong label just because a mistake was made. If food safety is really going to improve, government and industry agree it requires making far fewer mistakes, and that means using paper or electronic checklists, probably lots of them.

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  • Paul_LK

    Great introduction to the history of checklists!
    Before switching
    to military public health (Medical Service Corps), I was in Naval Aviation as
    an aircrew member (over 1,600 flight hours). Later, as an Environmental Health
    Officer, I conducted too many inspections to remember, usually in accordance
    with some prescribed checklist accompanied with a standard form. Checklists
    certainly have a place in system safety (i.e., the human factor component), but
    they must be used with caution. Checklists are merely reminders that help with
    complex systems, and the inspector (or pilot) must understand the purpose of
    checklist items – and the consequences or risks of failing to accomplish each
    checklist item. Unfortunately, inspectors sometimes do not fully understand the
    purpose of each checklist item, or know how to prioritize them based on risks.
    And too often, the organization responsible for food safety views the checklist
    as a compliance “hoop to jump through” rather than a safety tool. Properly
    using a checklist requires the right mix and level of education, training,
    and experience.

  • Gary

    Checklists can be a very effective tool depending on how they are drafted and implemented. If they add to the complexity of the system or process then they need to be revised or removed altogether. Not everything needs a checklist.

    In our company our process is very simple and straight-forward. No checklist is necessary because there are only a few steps (literally). In each customer audit/inspection I have to explain why we don’t regularly use checklists; for some of our larger customers it is completely foreign to them. This tells me the people don’t really understand the true purpose of a checklist which is unfortunate.