International Regulatory Compliance

ISO 9001& ISO 9004: A Framework for Disaster Preparedness Revisited – Risk, What Risk? Catastrophe in the Gulf #5

Introduction

This is the fifth and last in this series of blogs on ISO 9001 & ISO 9004: A Framework for Disaster Preparedness Revisited. (The preceding blogs were posted on December 29, 2009, & January 4, January 14 & February 12, 2010.) For those familiar with the first two blogs, you will recall that they briefly recapped a two-part article that appeared in the February 2002 issue of Quality Progress in response to a request from the editors for an article that applied ISO 9001 & ISO 9004 to the events of September 11, 2001.

The 3^rd blog described in brief outline a comprehensive Disaster Recovery and Service Continuity Plan for a major metropolitan area in the Northeast to identify the potential risks that could affect the provision of health care facilities. It involved the identification and analysis of risks and the preparation of a plan to respond to emergencies and the preservation of health care resources. The 4^th blog focused on the Political, Ideological and Geographic Problems with Disaster Planning. Since these four blogs were published, the Deepwater Horizon Oil Spill occurred. It is not my purpose to rehash the spill, but instead concentrate on the risk management decisions/non-decisions and regulatory weakness in response to the spill. 

Regulatory Oversight

At the time of the Deepwater Horizon explosion and spill US regulatory oversight was the responsibility of Minerals Management Service an agency of the U.S. Department of the Interior. In addition to leasing federal lands to oil and natural gas, the Minerals Management Service (MMS) collected leasing revenue, one of the largest revenue sources for the federal government after the IRS. Unfortunately, rigorous regulatory oversight was not the mission given to MMS in the first decade of the 21^st Century, nor for that matter, was rigorous collection of revenues owed to the federal government.

Consequently, MMS never appeared to receive a petition to drill that it didn’t like and it certainly didn’t request anything resembling a Disaster Preparedness Plan (if it ever conceived of such an eventuality) if anything went wrong while drilling. Questions were never asked about the potential risks of deep water drilling at different depths and what contingency plans a company and its contractors might have created to contain a deep water disaster should one occur. Questions were never asked about potential environmental risks and company financial liabilities for such a disaster. Questions appeared to never have been raised about the responsibility of MMS to the federal government, the American public and more specifically to the agency’s role to safeguard the environmental integrity of the delicate ecosystem in the Gulf of Mexico for the people who lived on the Gulf.

To say that MMS planning was sloppy is much too kind, it appears that no meaningful planning existed that even contemplated a disaster, since only minor disasters had occurred in the American portion of the Gulf. An earlier disaster had occurred in the Mexican portion of the Gulf, but that was never factored into agency thinking. Also, bigger disasters had occurred in Nigeria that still soak marshes in oil today, as well as drill site oil leaks in other parts of the world. A genuine “What me worry?” still attitude prevailed.

The concept of requiring a Hazards Analysis and Risk Analysis before drilling, (requirements for manufacturing medical devices and machinery for CE Marking), appears never to have entered the consciousness of the agency. Their managerial prowess was more akin to an adult Lemonade Stand instead of an agency responsible for serious oversight of drilling for oil in the Gulf and collecting revenue for the United States (which they did badly falling billions of dollars short).

Company Oversight

Company oversight was terrible as well. Four approaches to risk management should have been taken:

Disaster Preparedness – Given the depth at which BP was drilling in the Gulf of Mexico and the potential ecological and human consequences that could occur, this should have been a first step. In particular questions should have been asked, if an accident occurred (e.g., explosion, leak, break in the pipe, etc.) what could be the potential extent of the disaster (e.g., the well, the workers, the ecosystem and the affected population)? What must we (the company) do to control and limit the damage to the affected populations? How would the damage be limited? Do we have a strategy and the technological know how to accomplish this? What will be the cost? If we don’t have the technological know how, should we wait until we are able to drill a well at this depth? None of these questions were systematically asked by MMS or BP.

Enterprise Risk Management – Given the Global risks undertaken by BP, it should have employed the strategy taken by several other European Corporations and hired an outside firm to help conduct an assessment of corporate risks (e.g., physical, financial, geographic, political, ecological) faced by the corporation in its various global operations. Eventually, the risks would be refined and passed on to BP management, the CEO and members of the Board to consider. Such a list should be bold in concept to assure that risks aren’t ignored because they might disturb the sensibilities of key managers and Board members. Eventually, the list is prioritized and becomes the basis for future planning. Unfortunately, the only risks that seemed to occupy the company at the time were financial risks, i.e., how to reduce the cost of drilling and cut corners, which some commentators suggested helped precipitate the disaster. The objective is protect the future of the company

Hazards Analysis/Risk Analysis – This should have been a first step with any project that presented a degree of risk and it should have been revisited at key stages to make certain that all hazards and risks were visited and revisited to assess all of the possible risks presented by deep water drilling. It is an essential FDA & EU requirement for manufacturing any medical device and an essential requirement for manufacturing any product that is going to be CE Marked. It also is an essential requirement for equipment for NASA, but does not appear to been given a concern by BP. A program entitled Drill was aired by Frontline on PBS on October 26, 2010 reviewing the history of BP in the Texas City Refinery explosion, the largest pipeline spill on the North Slope of Alaska, the sinking of BP’s Thunder Horse oil platform in the Gulf of Mexico and finally the Deep Water Horizon explosion and leak in the Gulf of Mexico. Instead of assessing risk and taking steps to reduce the risks, the program, commentators safety specialists, investigators and other oil company CEO’s testifying before congress suggested that BP took unnecessary risks.

 Crisis Management – Crisis management appears to be the one area that received attention. It is the plan of action to limit the damage from adverse publicity when an event happens that could adversely affect the company. For example, in the case of Pepsi-Cola several years ago when syringes were reported to be in cans of Pepsi, it was necessary to dispel the rumors and control the damage. In the case of BP in the Deep Water Horizon the desire to deal with adverse publicity or “control the spin” was true.

Risk Management and Disaster Preparedness

The zeal to pursue offshore drilling of oil and natural gas on federal land in the Gulf of Mexico or anywhere else whatever the risks (“drill baby drill”) and the contempt of politicians for federal regulation in the first decade of the 21^st Century foredoomed the creation of a federal agency with any meaningful responsibility or clout. Following the Deep Water Horizon Disaster, MMS has been reformed into two major programs, Offshore Energy and Minerals Management and Minerals Revenue Management. Both are under the US Department of Interior. Deep water drilling and revenue are now tightly regulated. It remains to be seen how effective the new regulatory powers are exercised.

It will take years to learn the extent of damage to the Gulf’s sensitive ecosystem. It is not as horrible as Chernobyl, but it isn’t slight. Hopefully, future drilling will be more responsible. Only time will tell.

The cove pictured above in the photograph is virtually identical to the same cove captured by Salvador Dali in two of early his paintings in 1920 and 1921. The cove is on Cap de Creus near the resort town of Cadequés on Spain’s Costa Brava. Dali’s home and studio are located nearby and can be visited today. Fortunately, no mineral deposits or oil are found nearby to lure companies and destroy the beauty of the area.

If you would like to talk about comprehensive strategies concerning Disaster Preparedness, Enterprise Risk Management, Hazards Analysis/Risk Analysis or Crisis Management for a free preliminary consultation at my new e-mail address jameskolka@gmail.com.  

FDA’s QSR & EU’s CE Marking Requirements – A Medical Device Regulatory Design Failure

Introduction  

On the front page of the August 20, 2010 issue of the New York Times an article caught my attention, U.S. Inaction Lets Look-Alike Tubes Kill Patients. The article describes a pregnant mother who was losing weight and was hospitalized so that she could be fed through a tube until the birth of her daughter.  

But in a mistake that stemmed from years of lax federal oversight of medical devices, the hospital mixed up the tubes. Instead of snaking a tube through Ms. Rogers nose and into her stomach, the nurse instead coupled the liquid-food bag to a tube that entered a vein. Putting such food directly into the bloodstream is like poring concrete down a drain. Ms. Rogers was soon in agony.  

The baby died and soon after Ms. Rogers died. As noted in the article, Hospitalized patients often have an array of clear plastic tubing sticking out of their bodies to deliver or extract medicine, nutrition, fluids, gases or blood to veins, arteries, stomachs, skin, lungs or bladders. Much of the tubing is interchangeable, and with nurses connecting and disconnecting dozens each day, mix-ups happen – sometimes with deadly consequences.  

Possible Resolution

Presently, an International Standards Body is seeking consensus on specific designs for tubes for different bodily functions, but the work is not complete and apparently its formal recommendations will take years more. Efforts have been made by medical device manufacturers of dialysis machines to establish more effective controls, but a uniform system has not been adopted by FDA.  

Dr. Robert Smith, an FDA device reviewer who left the agency on July 31 and was among nine agency employees who in 2009 decried the agency’s device approval process as illegal and dangerous, said that the tubing problem, which had gone on for decades, was another example of how the agency failed to protect the public. “FDA could fix this tubing problem tomorrow, but because the agency is so worried about making industry happy, people continue to die”. Dr. Smith said.  

Regulatory Requirements

FDA QSR Design Requirements  

FDA design requirements place responsibility on medical device manufacturers:  

§820.30 Design controls

(a) General  

(1) Each manufacturer of any class III or class II device and the class I devices listed in paragraph (a)(2) of this section shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.  

(b) Design and development planning. Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process. The plans shall be reviewed, updated, and approved as design and development evolves.  

(c) Design input. Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to the device are appropriate and address the intended use of the device including the needs of the user and patient. The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s). The approval, including the date and signature of the individual(s) approving the requirements, shall be documented.

To the QSR language could be added the FDA Guidance Document, Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management, July 18, 2000.  

1.0 Introduction  

Addressing use-related hazards should be undertaken within the context of a thorough understanding of how a device will be used. Essential components of this understanding include:   ·      Device users, (e.g., patient, family member, physician, nurse, professional caregiver) ·      Typical and atypical use, ·      Device characteristics, ·      Characteristics of the environments in which the device will be used, and ·      The interaction between users, devices, and use environments.  

This, of course, is eminently sane advice. Unfortunately, it can’t be followed by the medical device industry until FDA, the EU and their international counterparts agree on a standard for tubing. Meanwhile, patients will suffer and many will die until the impasse is resolved.  

EU’s CE Marking Medical Device Design Requirements  

The EU medical device design requirements are a bit different. While ISO 13485: 2003 Medical devices – Quality management systems – Requirements for Regulatory purposes is similar to FDA’s Quality System Regulation, the EU also contains medical device requirements in the body of the revised Medical Devices Directive 2007/47/EC and Annex I Essential Requirements that would apply to the issue of medical device tubing. The question of tubing would be raised, but again could not be addressed because of the impasse in the International Regulatory Body.  

Risk Management  

Finally, questions would be raised about the tubing by ISO 14971: 2007 Medical devices – Application of risk management to medical devices. In Annex C, Questions that can be used to identify medical device characteristics that could impact on safety several questions are raised that would impact medical device tubing. The following questions are illustrative:  

C.2.26 Does installation or use of the medical device require special training or special skills?

Factors that should be considered include the novelty of the medical device and the likely skill and training of the person installing the device.  

C.2.29 Is successful application of the medical device critically dependent on human factors such as user interface?  

C.2.29.1 Can the user interface design features contribute to use error?  

Factors that should be considered are user interface design features that can contribute to use error. Examples of interface design features include: control and indicators, symbols used, ergonomic features, physical design and layout, hierarchy of operation, menus for software driven devices, visibility of warnings, audibility of alarms, standardization of color coding.  

Summary  

The answers to these questions are easy and low tech. The tubes all look alike, but carry different media, e.g., nutrition, blood, oxygen, dialysis fluid, air to inflate blood-pressure cuffs, anesthesia, intravenous medicines, etc. The New York Times article cited an example where a nurse mistakenly put a spinal anesthetic into a vein, killing a 16-yeqr old mother giving birth. The nurse had worked two eight-hour shifts the day before.   Clearly, skill and training are necessary, but skill and training can be compromised by fatigue, the complex array of tubes attached to each patient and the ability of the nurse or nurse practitioner to differentiate between the tubes when dealing with several different patients. I can only imagine what happens in a developing country or disaster relief field hospital with less trained personnel and a chaotic environment. It can only exacerbate the maze of look-alike tubing.

It is grimly ironic to read the statistic of 100,000 deaths per year due to medical errors and realize that several error deaths are due to a regulatory inability to agree on an International Standard for medical device tubing. If you have any questions about, FDA’s QSR, the EU CE Marking Medical Devices Directives, ISO 14971: Risk Management or Human Factors Analysis concerning medical devices, you can contact me for a free preliminary consultation at theguide1@comcast.net.      

When CE Marking Machines, “The Whole Machine Must Be Greater Than The Sum Of Its Parts!” #1

Or put another way, a manufacturer cannot assemble a series of CE Marked machines and declare “Voila” this assembly is synergistically CE Marked. The assembly itself must itself be CE Marked, have a Technical File (Parts A & B), an Annex I Health and Safety Requirements Checklist, identify the EN Harmonized Standards that allow for a demonstration of conformity with the Essential Requirements, include a Risk assessment/hazards analysis and a Compliance Protocol including a copy of the EC Declaration of Conformity.  

The Machinery Directive and Amendments in 1996 (Machinery Directive 89/392/EEC as Amended by 91/368/EEC and 93/68/EEC)  

My first complex machine assembly was described in my April 6, 2009 Blog. The company had a contract to create an automated assembly line to manufacture fuel injection systems for a new GM automobile plant that was being built in Portugal. I worked with company employees to CE Mark two stand-alone machines to create components of the fuel injection system.   

Next they had to purchase four additional CE Marked machines from other companies to manufacture components of the fuel injection system, which was achieved. Finally, they had to CE Mark the whole assembly line, comprised of the six CE Marked machines and the conveyor system that carried the fuel injection system through each stage of its manufacture to the finished fuel injection system.  

The assembly system had to be subjected to the rigors of a every CE Marked Machine, e.g. Annex I Essential Health and Safety Requirements Checklist, identification of those EN Harmonized Standards to satisfy the identified essential requirements and allow for a presumption of conformity to the essential requirements, conduct a risk assessment/hazards analysis (at that time using EN 1050) to determine if the system satisfied the essential health and safety requirements of the Machinery Directive, complied with the Low Voltage and EMC Directives, create a Technical File (Part A& B) and draft an EC Declaration of Conformity.  

Since that time I have worked with other companies CE Marking complex machines. Most have followed the path described above, but one asked for initial help on the first three machines on an assembly line, purchased additional CE Marked machines and decided that they could finish the remainder of the work by themselves, including CE Marking the whole assembly line and complying with the new EMC Directive by conducting “in situ” testing on the site of the installation.  

Reading between the lines it was clear that the division CEO wanted to declare that the several CE Marked Machines constituted a completed “CE Marked machine” and did not want to subject the whole assembly to the rigors of the CE Marking process. Since this occurred after I finished my work with the company, I don’t know what finally transpired, however, the complexity and size of the final assembly presented some significant risks that could not have been resolved by declaring that the, “whole was equal to the sum of its parts.” It might even mask some serious safety risks created by the interaction of the several CE marked machines.  

The Machinery Directive in 2010 (Directive 2006/42/EC Of The European Parliament And Of The Council of 17 May 2006 on Machinery, and amending Directive 95/16/EC (recast)  

While the behaviors described above still exist, the revised Machinery Directive is more precise in what is meant by a machine. Nonetheless, I still see efforts to collect CE Marked components and machines and declare that the combination is therefore CE Marked. The Definition of a Machine in the revised Directive is stated in Article 2.  

Article 2  

Definitions  

The following definitions shall apply: 

(a)‘machinery’ means:  

--an assembly, fitted with or intended to be fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application,  

-an assembly referred to in the first indent, missing only the components to connect it on site or for a specific application,  

--an assembly referred to in the first and second indents, ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or structure,  

--assemblies of machinery referred to in the first, second and third indents or partly completed machinery referred to in point (g) which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole,  

--an assembly of linked parts or components, at least one of which moves and which are joined together, intended for lifting loads and whose only power source is directly applied human effort,  

(b)’interchangeable equipment’ means a device which, after the putting into service of machinery or of a tractor, is assembled with that machinery or tractor by the operator himself in order to change its function or attribute a new function, in so far as this equipment is not a tool;  

(c)’safety component’ means a component:  

--which serves to fulfill a safety function,  

--which is independently placed on the market,  

--the failure and/or malfunctions of which endangers the safety of persons, and  

--which is not necessary in order for the machinery to function, or for which normal components may be substituted in order for the machinery to function.  

(g)’partly completed machinery’ means an assembly which is almost machinery but which cannot in itself perform a specific application. A drive system is partly completed machinery. Partly completed machinery is only intended to be incorporated into or assembled with other machinery or other partly completed machinery or equipment, thereby forming machinery to which this Directive applies.  

I included paragraph (g) to underscore an earlier point. Recently, I was contacted by a company that makes a wide variety of machines that “cannot perform a specific application” or task unless connected to a power source, i.e. “a drive system.” The person who contacted me said that their partly completed machines were CE Marked and they wanted to purchase a power source that also was CE Marked.  He assumed that the combination would therefore be CE Marked.  

Needless to say, he was wrong on several counts. He could not CE Mark his partly completed machines, however, he could do all of the work required for CE Marking and issue a Declaration of Incorporation. Next, he could purchase an appropriate drive system, attach it to his partly completed machine and then CE Mark the whole combination as a machine, but he could not put he two together and declare that they were “Voila,” CE Marked.  

The Machinery Combination Confusion Continues In 2010  

It is frustrating to say the least. The lack of understanding about the safety dimensions of the Machinery Directive continue today. Too many companies want to adopt a quick and mindless route to CE Mark their machines. Combining a powerful drive system with a powerful drilling or excavation machine without a full CE Marking protocol for the combination, including an ISO 14121-1:2007 Risk Assessment & Hazards Analysis is as foolish as the BP Deep Water Horizon venture that didn’t attempt to calculate the risks of Deep Water Drilling in the Gulf of Mexico. The potential liabilities could erase any benefits and destroy the company. Clearly, Disaster Preparedness and Enterprise Risk Management weren't even being contemplated by such companies.  

Blog #2 will focus on additional aspects of the Machinery Directive discussed in the Guide to application of the Machinery Directive 2006/42/EC, 2^nd Edition, June 2010, General Editor, Ian Fraser. I will also discuss the potential US product liability exposure of non-compliant machines sold in the EU, in the event of an accident. If you have product liability concerns regarding the Machinery Directive & related Directives, you can contact me for a free preliminary consultation at theguide1@comcast.net 

Brussels You Have a Problem! – Out Of Date CE Marked Components & EC Declarations Of Conformity – Machinery #2

Introduction  

The first blog of this title identified the problem of out of date CE Marked Components and EC Declarations of Conformity, EC Declarations of Incorporation and EN Standards. Presumably, 1 January 2010 marked the date when CE Marked products must contain the latest revised EU Directives and latest EN harmonized standards. It is now six months later. As noted in my first blog on this topic, I discovered that component suppliers to my customers have been lax on this account. Not only have they not updated their EC Declarations of Conformity, EC Declarations of Incorporation and EN harmonized standards, in far too many cases they are out of synch by several years. This is a technical problem and potentially serious legal problem for component suppliers and their customers in both the EU and US. It also is extremely lazy and sloppy.  

Machinery Directive Market Surveillance  

I concluded the first blog in this set with a brief reference to provisions that were inserted into the Machinery Directive to improve market surveillance when the Directive was adopted in 2006. Below you will find those three provisions from the prior blog followed by several other provisions set forth in the revised Machinery Directive which are now supposed to be in force:  

·      Monitor conformity of machines with the relevant Directives  

·      Empower authorities to take action with necessary speed to remove machines from the EU market  

·      Fix rules concerning legal sanctions for non-compliance  

·      Organize surveillance activities to cover all stages of a machine lifecycle (placing on the market, use, withdrawal including recovery, recycling and destruction)  

·      Record and ensure the follow-up of complaints or reports concerning non-compliant machines  

·      Monitor accidents and damage to health concerning machines on the market  

·      Implement market surveillance programs for categories of machines and categories of risk  

·      Carry out checks of conformity of machines on the market  

·      Require the necessary documents and information for machines on the market

·      Where relevant, sample machines and subject them to the necessary inspections and tests  

·      Initiate the relevant infringement procedures for non-compliant machines  

·      Ensure that machines comply with the essential requirements of the relevant Directives  

·      Exchange market surveillance information with member states  

·      Develop joint member state projects for market surveillance  

·      Survey machines on the market to assure that CE marking and documentation requirements have been met and that machines have been designed and manufactured in accordance with the essential requirements of the relevant directives and don’t present any danger to personnel  

·      Create rapid and confidential exchange of information where machines could present a serious and immediate risk to the public interest  

·      Increase involvement of the machine manufacturer in the procedure  

·      Check for documents (essential requirements checklists, technical data, EN harmonized standards, risk analyses, notes, certificates of conformity, etc.)  

·      Physically examine machines, check on the presence of CE marking, other markings and possible regulatory labels  

·      Physically check on the name and address of the manufacturer and/or the person responsible for placing the machine on the market (authorized representative)  

·      Physically check for undue or incorrect CE marking or other regulatory marking

·      Where necessary, conduct laboratory tests to determine the conformity of the machine with the essential requirements of the relevant Directives  

·      Use robust practices to detect serious cases of non-conformity and the probability of risk  

·      Ensure effective communication and coordination between market surveillance activities and other organizations that intervene in the field of safety of machines (health and safety at work authorities and customs authorities)  

·      Provide for the rapid exchange of consumer machine information   ·      Implement EU Regulation 339/93 on the conformity of machines imported from third countries (now replaced by Regulation 765/2008)  

·      Take account of data concerning industrial accidents involving machines  

·      Link with the EU General Product Safety Directive  

·      Develop member state legal sanctions for non-compliant machines  

·      Improve administrative cooperation between EU member states for non-compliant machines  

·      Strengthen rules for worker safety and worker reporting on machines improperly CE marked  

Summary  

These are excellent steps and can’t be put in place soon enough. For those of us who take machinery safety seriously, enforcement of the rules would help us convince our clients in the US and other third countries that the EU is serious about machinery safety. Given the number of fly-by-night & bait-and-switch consultants filling the web pages with easy CE assurances and simple templates telling manufacturers that it won’t cost anything to CE Mark their products, serious enforcement can’t come fast enough.

The EU is unique in their systematic approach to product safety, and machinery safety in particular. Except for those products and machines covered by FDA, we have no comparable regulatory approach in the US. I would like to believe that US manufacturers share the EU belief in machinery safety (and some do share that belief), but I know better from personal experience.

Many clients have complained that safety increases the price of machines and makes them less competitive in the US market. I remind them of the 2002 Minnesota lawsuit where a US machinery manufacturer made a safe machine for the EU to satisfy CE Marking standards and a less safe machine for the US and paid the price in a $35 million punitive damages award to the plaintiff in a product liability lawsuit. Unfortunately, this fact doesn’t impress companies willing to take a risk, even if it harms people. Their question is, can I come up with an alternative?

I would love to work with the EU in improving their market surveillance and the hope for residual carryover to the US. As the world no doubt knows by now, antipathy to regulation runs high in the US (witness the US Materials Management Service paper mâché regulation of offshore drilling). Apparently, only catastrophe changes minds. If you have any questions concerning compliance and product liability vis-à-vis the revised Machinery Directive, you can contact me for a free preliminary consultation at theguide1@comcast.net.

ISO 9001& ISO 9004: A Framework for Disaster Preparedness Revisited #4

Before Disaster Planning – Vesuvius, Pompeii & Herculaneum 79 AD  

On August 24, 79 AD, the Roman Historian, Pliny the Younger was awakened by his mother to look at a huge cloud in the sky. “A cloud was forming over Vesuvius which looked very-much like a pine-tree. In fact it stretched upward like the trunk of a tall tree and then branched out wide.”(The picture above is such a pine-tree on the Amalfi Coast overlooking the Mediterranean, 40 miles South of Vesuvius.)   

Political and Cultural Problems with Disaster Planning  

I was raised in Eau Claire, Wisconsin where the Eau Claire River flows into the Chippewa, River. It is a former lumber town founded in 1856. By1885 the town contained 32 lumber mills and sawed 800 million board feet of lumber, the largest lumber town in the world at that time. The mills were fed by logs brought by train from as far away as Lake Superior, 250 miles distant. By 1917 the last log was sawed and the last lumber mill was shut down. The lumber industry moved West.

A by product of the two rivers merging and low lying areas of the town around the original mill sites was frequent flooding that occurred in the Spring when the snow melt swelled the rivers beyond their banks.   My father, Henry W. Kolka, who was a Professor of Geography and Chair of the Geography Department at the State University in Eau Claire, recommended that the city consider relocating houses from low lying areas to higher ground and clearing the flood prone areas to create City Parkland which would be relatively unaffected by periodic flooding. The city fathers were appalled at such a suggestion. In their minds it bordered on socialism. My father countered that spending money to constantly clean up flooded homes was a wasteful use of public funds. Many years later, however, the recommendation was adopted.  

Several years later, when I was a new faculty member at the University of Wisconsin-Green Bay and a member of an interdisciplinary research team studying a lake watershed in Northeastern Wisconsin, we made a similar recommendation about the County swapping high land for marshland and met with a similar response. (This example will be addressed at length in future environmental blogs.)

Both of these incidents are minor disasters and both underscore a critical problem in disaster planning – political structures and cultural perceptions. The political entity (City, County, State, Federal Government) has to be large enough to effectively address a problem and cultural perceptions have to be able to grasp potential solutions to a problem. The shopworn phrase, “Think Outside the Box.” runs up against another shopworn phrase, “If it ain’t broke, don’t fix it.” Neither phrase is useful when confronting a potential disaster.

Political, Ideological and Geographic Problems with Disaster Planning

While political boundaries are artificial human constructs, they are real boundaries when it comes to disaster planning. In addition to political systems planning for a potential disaster, these artificial human constructs are not well prepared to handle diverse geographic issues such as a River like the Mississippi which flows through several Cities and States to the Gulf of Mexico. As a navigable river it also is subject to the jurisdiction of the federal government. The Mississippi River has flooded several times throughout its history of human habitation.  

Therefore, a disaster preparedness solution must include these different political entities in the planning process. Add to the mix, the Army Corps of Engineers that regulates the flow of the river for barge navigation via a complex system of locks and you have a diverse political stew attempting to solve a common problem from very different political and geographic perspectives. 

The most recent Great Flood on the Mississippi occurred in 1993 causing $15+ billion dollars of damage in 10 States. Prior great Floods occurred in 1844, 1927, 1951 and 1973. As in the example of Eau Claire, cities along the Mississippi were settled when transportation was by water. Consequently, low-lying cities on the waters edge have flooded numerous times. Finally, after the 1993 flood several cities opted to move to higher ground in Illinois and avoid another flood in the future.

Hurricane Katrina  

The most striking example of a failure in disaster planning and disaster preparedness in the United States was Hurricane Katrina in August 2005. No political entity – the City of New Orleans, the States of Louisiana, Mississippi, Alabama, Florida and the Cities, Parishes and Counties along the Gulf Coast were prepared for the catastrophe, least of all the US Government which kept calling it a State or City problem.

It was a pathetic breakdown in any kind of planning and an absence of a useful emergency response plan. FEMA (Federal Emergency Management Authority) proved to be inept and slow, preferring to blame the States and City of New Orleans. Once the President focused he did not intervene to address the situation in a timely fashion. There were 1,836 persons confirmed dead and 705 missing. The damage has been calculated at $90.9 billion (2009) dollars, the worst natural catastrophe in US history.  

On November 18, 2009, US District Court Judge Stanwood Duval ruled that the Army Corps of Engineers failure to properly maintain the Mississippi River Canal Outlet (MRGO), linking New Orleans, Louisiana to the Gulf of Mexico led to catastrophic flooding during Hurricane Katrina.

“   It is the court’s opinion that the negligence of the Corps, in this instance by failing to maintain the MRGO property, was not policy, but insouciance, myopia and short-sightedness.” “For over 40 years the Corps was aware that the Reach II levee protecting Chalmette and the Lower Ninth Ward was going to be comprised by the continued deterioration of the MRGO…The Corps had an opportunity to take a myriad of actions to alleviate this deterioration or rehabilitate the deterioration and failed to do so. Clearly, the expression ‘talk is cheap’ applies here.”   

Who Is Responsible For Disaster Preparedness?  

Unfortunately, this is the key question, amplified by the inept political response to Hurricane Katrina – no one appeared to be in charge and fingers pointed in all directions while a city and its people were in desperate condition. The world looked on and couldn’t believe that such a calamity could happen in America. It looked more like a developing country that lacked the political structure and resources to address such a crisis. There were even debates about the proper role of government.  

Since the Federal Government is the only political entity that governs the entire region and is responsible (via the Army Corps of Engineers) for maintaining the Mississippi River Canal Outlet, it should take the lead in working with the states and cities in addressing the crisis so that it isn’t repeated in the future, but isn’t clear if disaster preparedness planning is happening now in any coherent way. I am quite certain that the EU would be far more aggressive in disaster preparedness planning if faced with a similar crisis. Infrastructure development is far more advanced in he EU and its member states than in the US.  

Blog number #5 will address other types of disasters and what is being done to address disaster preparedness in those areas. It also will draw upon ISO 9001 & ISO 9004 to provide an enhanced framework for disaster preparedness. If you have disaster preparedness concerns, you can contact me for a free preliminary discussion at theguide1@comcast.net.