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Validating Preventive Food Safety and Quality Controls: An Organizational Approach to System Design and Implementation

Validating Preventive Food Safety and Quality Controls: An Organizational Approach to System Design and Implementation

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Validating Preventive Food Safety and Quality Controls: An Organizational Approach to System Design and Implementation

5/5 (1 évaluation)
647 pages
83 heures
Dec 27, 2016


Validating Preventive Food Safety and Quality Controls: An Organizational Approach to System Design and Implementation is a how-to-guide for food industry personnel providing essential preventative control system guidance to help design and implement scientifically verifiable food safety controls in food processes. This reference includes proven tools and techniques to move positively towards the validating preventive control challenges that the food industry is facing, and helps implement compliance strategies to adhere to the food safety and modernization act requirements.

  • Covers a systematic strategy for validating preventive controls
  • Presents ways to learn how to improve control over suppliers and includes strategies to evaluate food risk and supplier performance
  • Prepares your business to comply with changing food safety and quality planning, standards, and audits
  • Includes Chipotle case study which challenges students to plan a valid preventive system
Dec 27, 2016

À propos de l'auteur

Dr. John Ryan was the Administrator for the Hawaii State Department of Agriculture's Quality Assurance Division. He was responsible for developing food safety and traceability systems within the state of Hawaii. Dr. Ryan piloted the USA's first farm-to-fork award winning internet-enabled RFID food traceability system and one of America's early high-technology sensor based temperature control supply chain food safety system. He has recently worked with a number of international companies to establish real-time international food traceability that reports trans-Pacific transportation temperatures and tests for bacteria, explosives and container tampering. He spent two years as co-team leader for President Obama's FDA/CDC Information Technology team and also served on the FDA Performance Management and Standards Developments team. He is the president of Ryan Systems, located in Canyon Lake, CA.

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Aperçu du livre

Validating Preventive Food Safety and Quality Controls - John M. Ryan


Chapter 1


Understanding common and assignable causes, laws, and costs


Understanding the difference between system and assignable causes of food safety, and quality problems is critical to understanding and addressing preventive food safety and quality controls. Failure to distinguish and assign responsibility for each type of cause or failure to distinguish between quick fixes and those requiring causal analysis present companies with an inability to overcome obstacles. Cost concepts focusing on the idea that prevention saves a lot more money than response are presented for reader consideration.

The chapter reviews laws that may or may not have preventive control concepts that have been passed by the European Union, the United States, Canada, and Mexico. Commonality in the general approach taken by different countries will, in the future, most likely be resolved through harmonization of business and government and intercountry agreements. Regardless of country perspectives or laws, the need for preventive food safety and quality controls goes significantly beyond what any single country has defined creating a need for international harmonized rules such as ISO 22000 or ISO 22005.

U.S. FDA expanded enforcement capabilities are also discussed.


Food safety; food quality; preventive controls; common causes; assignable causes; preventive controls; prevention costs; external failure costs; internal failure costs; appraisal costs; supply chain; primary production farm; secondary activities farm; risks; ISO; corrective action; prevention; causal analysis; functional improvement teams; corrective action teams

Preventive Thinking

The idea of preventive controls is not new. Seatbelts and airbags are considered preventive controls as they help to prevent injury or death in the event of automobile collisions. Prevention is a word often used in many applications as the forefront of reducing costs, damaged equipment, lost lives, injury, and the like.

Within the scope of food safety and quality, preventive controls as an operational concept is still evolving because of the evolution of many food supply chain adjustments from old world approaches to more modern systems capable of tracking and documenting the impact that applying preventive controls may have on human health. For the most part, food producers, processors, packers, transporters, retailers, restaurants, and others involved in growing and delivering food to the world’s millions are, too many degrees, confused about just what preventive controls are, or how they work or whether or not they are effective.

Although many food supply players have worked diligently to define and implement controls that prevent food from losing shelf life or from causing people to get sick and die, many others are left in a state of confusion regarding what, when, or how to do many of the things needed to establish effective preventive controls.

The idea that the food supply chain should implement a system of preventive controls means that a systematic approach to controlling and eliminating those systemic and assignable causes that can define, measure, and control or eliminate pathogenic, chemical, or physical contaminants in food must be taken. As health threatening bacterial, chemical, and physical objects can be introduced into the food supply from any of hundreds of sources and as how to control of many of these hazards is not yet known by the scientific (let along farming) world, confusion reigns.

Regardless, in many industries over the past 20 or so years, highly effective preventive control systems have been developed beginning from similar levels of ignorance, resistance and confusion. Trial-and-error approaches have basically led the charge.

The challenges facing the food industry are not new. The only really new issue is that as the food industry is only the latest industry to have to step up to the plate. Initial resistance may be seen from those who simply don’t believe food safety is an issue. Other companies haven’t waited for the crowd and have simply moved on implementing those pieces of a food safety and quality system that they know is needed. These companies have also led their suppliers and customers into new ideas and solutions for the problems made public in the daily news.

Wikipedia defines hazard prevention as the process of risk study, elimination and mitigation in emergency management [1].

That definitions sort of parallels what is becoming the groundwork for basic requirements in the food industry. Identify what risks are associated with different food types and the processes the food is going through then work to eliminate those risks through better control systems. Of course, truly preventive systems are not based solely on emergency management but are based on determining, controlling, and eliminating causes for the emergencies.

Preventive Actions Versus Corrective Actions: Requirements for New Thinking

Much of the documentation you will read about the Food Safety Modernization Act (FSMA) uses the words corrective action while promoting prevention. Unfortunately, corrective actions are often conducted in a way that encourages quick fixes to get some operation back up and running after something has gone wrong. Such necessary operational adjustments are not preventive.

Take recalls, for instance. When a food company has produced a product that might be harmful to humans or animals, the company is encouraged or forced to implement a recall. It is unfortunate to hear even Food and Drug Administration (FDA) officials calling recalls preventive. That type of thinking exhibits a belief that the recall will prevent more people from getting sick or dying. However, recalls, if one is to follow preventive thinking, are in no way preventive. They are a reaction to a problem that is simply a quick fix or attempt to backtrack from what can be called an external escape.

A recall is exactly like trying to get the horse back into the barn after it has escaped. Prevention of the horse escape would imply that the owner had put in place gates or barriers that actually kept the horse in the barn in the first place. Prevention of the horse escape would go much further that having gates in the barn, prevention, in this case, might mean that the horse was tethered to the stall in which the horse resided.

Prevention and the establishment of a preventive control plan (PCP) means to go as far back into the process as possible to understand the causes of a problem. Understanding causes is not the same as looking at a symptom of a problem and circumventing the symptom with some temporary adjustment. Prevention means to establish a formal approach to looking at the symptom or problem and performing a standardized and systematic approach to determining the cause of the symptom. Such a process may be called causal analysis.

Simply, the product that escaped, either to other food chain members or to the public, is the result of the company’s system to establish and manage a preventive control system. Recalls are a symptom of the lack of a valid PCP and an indication of a lack of ability or understanding regarding causal analysis.

Most people in the food supply chain, from the farm through to the retail or restaurant operation, are capable of understanding what the FSMA calls bacterial, chemical, or physical adulterants or hazards to food safety. Many bacteriological adulterants come from the farm. Things like salmonella, listeria and Escherichia coli are found on farms. They get onto the product and are moved like a contaminated river into and down the food chain. One must assume, therefore, prevention of these hazards must begin on the farm. And while these bacteriological adulterants exist in nature and are virtually everywhere, humans have to date failed to develop an ability to find and eliminate these causes at the

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