A System of Leadership for the 21st Century: Lessons from Theodore Roosevelt David Markovitz - President, GMP Training Systems One hundred years ago, the first federal vitro Diagnostics industries, FDA has regulations affecting the Life Sciences identified seven systems of control. industry were enacted. This was an era They are: Management controls, that saw the United States government Corrective and Preventive action, Design take an active role in protecting the controls, Materials controls, Records, consumer. Both the pharmaceutical Documents, and Change controls, industry and the processed food industry Equipment and Facilities controls, and were new and growing rapidly at the Production and Process controls. birth of the 20th century. In August 2002, the FDA announced The past one hundred years has seen GMP’s for the New Millennium, a tremendous strides in health care and life science and risk-based approach to sciences. Today, innovations and new product quality regulations incorporating ideas are bursting forth faster than ever an integrated quality systems approach. before. Product life cycles are They’ve identified and integrated the shortening. Competition from around following principles into this new the globe is more intense than ever. The initiative: baby boomer generation is aging, and Risk-based orientation. putting relentless pressure on the life Science-based policies and sciences industry for solutions, standards. preventions, and cures for all sorts of Integrated quality systems maladies. orientation. International cooperation. Strong Public Health protection. The Pressures to Change This and other new initiatives no doubt The Food and Drug Administration is will put even more pressure on the Life now examining our systems of control Sciences industries to perform at and our systems of management. In increasingly higher standards. It is February of 2002, FDA implemented a becoming more difficult to successfully systems approach to inspections for the lead and manage an enterprise in the life pharmaceutical industry. They have sciences arena. identified six overall systems to be managed effectively. These are: Quality system, Facilities and Looking to the Past Equipment system, Materials system, Production system, Packaging and The answers to sustaining a healthy and labeling system, and the Laboratory thriving enterprise may just lie in our Control system. The FDA makes it clear past. One hundred years ago a that management is responsible for the remarkable man, Theodore Roosevelt, development and upkeep of these held the Presidency. He was President systems. In the Medical Device and In- of the United States from 1901 to 1909. Copyright 2005 ALL RIGHTS RESERVED 1 GMP Training Systems www.GMPTrainingSystems.com Theodore Roosevelt, enshrined on Mt. ration consists of only four or five items, Rushmore, is considered by historians to which taken together just meet the be among the top five Presidents in requirements of a strong and healthy terms of effectiveness and leadership. man, the loss of one item is a serious This article examines Roosevelt’s thing. If we had been given canned leadership philosophy and how we can corn-beef we would have been all right, apply his lessons in today’s competitive but instead of this the soldiers were world. issued horrible stuff called ‘canned fresh beef.’ There was no salt in it. At the Roosevelt’s influence was felt long best it was stringy and tasteless; at the before he became President. He was a worst it was nauseating. Not one-fourth New York State Assemblyman while in of it was ever eaten at all, even when the his early 20’s, served as Civil Service men became very hungry.” Commissioner for two Presidents, was President of the New York City Board of Eight years later Roosevelt occupied the Police Commissioners, Assistant White House when Upton Sinclair wrote Secretary of the Navy, a Colonel in the his landmark book, The Jungle. United States Army, and Governor of Sinclair’s exposé on the filth and New York. It was in 1898 during the contamination in the meat processing Spanish American War that Roosevelt industry rocked the nation. Roosevelt, got his first inkling that there were being a voracious reader, obtained an problems in the processed food industry. advance copy of Sinclair’s book. One In the spring of 1898, the battleship USS can picture Roosevelt slamming down Maine blew up in Havana harbor. The the book, and shouting, “AHA! Now I United States declared war on Spain. know why that ‘canned fresh beef’ was Roosevelt resigned as Assistant so horrible.” After corresponding with Secretary of the Navy and, along with Sinclair, Roosevelt ordered Secretary of Colonel Leonard Wood, formed the 1st Agriculture James Wilson to get to the US Volunteer Cavalry. The press bottom of this matter. An investigation dubbed them the Rough Riders. After was conducted and a report filed with training near San Antonio, Texas, the the President. Roosevelt used that report Rough Riders took trains to Tampa, to move through Congress the long- Florida, where they embarked on ships stalled Pure Food and Drug Act and the taking them to Cuba. Once there, Meat Inspection Act. He signed both Roosevelt led the Rough Riders up Acts into law on June 30, 1906. Kettle Hill, then San Juan Hill, thus ending Spanish Rule in North America. Dr. Harvey Wiley was the Chief In 1899, Roosevelt documented his Chemist in the US Department of experiences in a book entitled The Agriculture when the Pure Food and Rough Riders. Drug Act went into effect on January 1, 1907. He thus became the first Describing the voyage from Tampa to Commissioner of what today is called Cuba, Roosevelt said, “The travel rations the Food and Drug Administration. which had been issued to the men for the voyage were not sufficient, because the meat was very bad indeed; and when a Copyright 2005 ALL RIGHTS RESERVED 2 GMP Training Systems www.GMPTrainingSystems.com Roosevelt takes Charge knew he could bring the United States onto the world stage. And he also knew As Vice-President in 1901, Roosevelt that doing so would require the support was thrust into the Presidency upon the of the American people. He was likely assassination of President William the first President who used the Press to McKinley. With the country reeling his advantage to get that support. from an anarchist’s action in gunning down the President, Roosevelt was quick Roosevelt felt that a canal through the to visibly assume the mantle of power. isthmus of Panama was critically He was a man of action, and he didn’t important in achieving the aim of world take long to strengthen the power of the power and respect from the world’s Presidency. It was Roosevelt who leading nations. First, it would reduce coined the phrase, “Bully pulpit,” which the cost of shipping goods from coast to is still in use today. He believed coast, and second, and most important to strongly in leading by example. He Roosevelt, was that it would enable the knew that, especially as President, US Navy to move between the two great people would watch him to see if his oceans with greater dispatch. In his actions were consistent with his words. quest to get the canal built, he This authenticity helped him achieve encountered many critics and adversaries everything he was able to accomplish as within Congress. After leaving office, the 26th President of the United States. he said in 1911, “I am interested in the Panama Canal because I started it. If I Leadership, as embodied by Theodore had followed conventional, conservative Roosevelt, is a system. There are methods, I should have submitted a several parts to how he led and dignified paper to the Congress, and the managed; yet they are closely woven debate would have been going on yet, together as a system. It is difficult to but I took the canal zone and let examine any single element of his Congress debate, and while the debate leadership method without seeing how it goes on the Canal does too.” needs the other elements present to make it succeed. Yet, to learn from this great When Roosevelt took office in 1901, the leader, we’ll examine separately those United States Navy was the fifth largest elements that comprise the Roosevelt in the world. For Roosevelt, this System of Leadership wouldn’t do. A leading power must have a large Navy, and he pressed Congress to fund a Navy that was Creating and Communicating a second only to Great Britain by the time Vision his term as President ended in 1909. He sent the entire fleet, sixteen battleships dubbed the Great White Fleet, around Roosevelt had a vision that the United the world to call in every major port of States become a leading world power. the world. This voyage sent a The country in 1901 was still recovering resounding message to the entire world from the Civil War. The United States that the United States was now a force to was not recognized as a leading world be reckoned with. power by the leading powers of the day, mainly European nations. Roosevelt Copyright 2005 ALL RIGHTS RESERVED 3 GMP Training Systems www.GMPTrainingSystems.com Lesson Number One – Create and that he alone didn’t have the military Communicate a Vision experience to accomplish this. He arranged for Col. Leonard Wood, an Develop a vision for your company, accomplished military man, to take your division, or your department. charge, and Roosevelt assisted him as Lt. Those people working in your enterprise Colonel. He knew that he did not have should know exactly what it is they’re the military competence at that point, being asked to achieve. An effective having only served in the New York leader will not only develop a clear state militia.