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Risk Management Plan

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Risk Management Plan

  1. 1. Keenan & Suggs, Inc. Proposal For: Commercial Food Distributor October 26, 2016 Submitted by: Hunter Beale
  2. 2. Risk Management Plan
  3. 3. Table of Contents I. Executive Summary……………………………………………………………………….….2 II. Purpose………………………………………………………………………………….….…...2 III. Risk Identification……………………………………….….........................................3 IV. Risk Assessment………………………………………………..……………………….…….4 V. Risk Mitigation ……………………………………………………………………………….5 a. Food Safety Modernization Act…………………….……………………………...6 i. Sanitary Transport…………………………………………………….…...6 ii. Food Safety Plan ……………………………………….…………....…….7 iii. Product Recall…………………………………………………….…………8 VI. Risk Monitoring………………………………………….………………………………..…9 VII. Appendix…………………………………………………….…………………………………10 RISK MANAGEMENT PLAN - [DATE] 2
  4. 4. Executive Summary It is the the company. to operate Vending Machine Food and Related Products Distribution Centers that perpetually earn the reputation as being the best in the industry at providing available inventory, on-time delivery, competitive pricing and superior customer service. We value our customers. They are the life force of our business. We bring the values of our family and home to work in order to better serve our customers. We observe the golden rule of proprietorship, and treat each Customer, supplier and employee in the way we prefer to be treated. And because our customers are loyal, they deserve our highest standards. In alliance with our mission statement and values, it is our top priority that our customers are not only satisfied but safe. For this reason, we have set forth the following procedures to ensure the safety of our customers, employees, and reputation. We realize accidents happen however, in planning for these events we hope to minimize their impact. “You can always amend a big plan, but you can never expand a little one. I don’t believe in little plans. I believe in plans big enough to meet a situation which we can’t possibly foresee now”. — Harry S. Truman Purpose Risk Management is the process of identifying, assessing, responding to, monitoring, and reporting risks. This plan documents the processes, tools and procedures that will be used to manage and control those events that could have a negative impact on the company. It is the controlling document for managing and controlling all inventory risks. It outlines how risk management activities will be performed, recorded, and monitored throughout daily operations and provides steps and practices for recording and prioritizing risks. This plan will address: • Risk Identification • Risk Assessment • Risk Mitigation • Risk Monitoring Risk Managment Risk Analysis Risk Identification Risk Assesment Risk Control Risk Mitgation Risk Monitoring Figure 1 RISK MANAGEMENT PLAN - [DATE] 3
  5. 5. Risk Identification The objective of risk identification is the early and continuous identification of events that, if they occur, will have negative impacts on the ability to achieve performance. In order to assess risk, it must first be identified in order to determine, what threats make inventory susceptible to contamination. Identifying these risks are crucial because they allow us to minimize the chances of inventory loss. The ultimate goal of food inspections is to ensure the safety of all food products reaching consumers. To achieve this goal, a series of inspections are suggested in order to protect the quality of inventory. The guidelines set forth in the provided checklist (Appendix A) coordinate with inventory control regulations set forth in the Food and Drug Administration Title 21 Regulations. Using this checklist should assist in the everyday compliance of FDA regulations and minimize the chance of loss due to contamination. Risk Assessment Risk assessment is the act of determining the probability that a risk will occur and the impact that event would have, should it occur. This is basically a “cause and effect” analysis. The “cause” is the event that might occur, while the “effect” is the potential impact it would have to the company, should the event occur. Taking these metrics into account, we will use what is referred to as a risk matrix scale in which to measure hazards and their harms. This can be numeric (scale of 1-5), verbal (good to bad) or both. (Table 1. Risk Assessment Severity Scale) Probability of Occurrence Definition Meaning Value Frequent  Occurs frequently  Will be continuously experienced unless action is taken to change events 5 Likely • Occur less frequently if process is corrected • Issues identified with minimal audit activity 4 Occasional • Occurs sporadically • Potential issues discovered during review 3 Rare • Unlikely to occur • Minimal issue identification during focused 2 Improbable • Highly unlikely to occur 1 RISK MANAGEMENT PLAN - [DATE] 4
  6. 6. Risk Assessment The second factor is the estimate of the impact on daily operations. This can be a somewhat subjective assessment, but should be quantified whenever possible. The estimated cost, the duration of the potential delay, the changes in scope and the reduction in quality are in most cases factors that can be estimated and documented in the risk statement and then measured using the standard project management tools. Rather than detailed impact estimates the Risk Register contains five ratings for impact: Five Ratings of Impact Severity: Severe (5)  Regulatory/Compliance violations/issues  Withdrawal of product manufacturer  Tainted product  Materials breech  Production delays  Security/confidentiality breeches Significant (4)  A security finding requiring immediate corrective action prior to continued operation  Reoccurring violation of any safety regulation resulting in serious injury  Production errors containing regulatory violations that pose direct consequence to the quality of inventory Moderate (3)  Security finding requiring a corrective action plan  Production element errors that may pose indirect consequences to the operation Minor (2)  Minor errors in company policy & procedures  Production errors containing quality system and / or opportunities for improvement  Regulatory/compliance violation  Security/confidentiality element affected Negligible (1)  Improperly executed communications Statistically, the level of risk can be calculated as the product of the probability that harm occurs multiplied by the severity of that harm. In accordance with the Risk Matrix (Appendix B) The company will be able to quantify different levels of risk, helping to better prioritize loss exposure. It is suggested that any risk with a quantitative risk over “5” be immediately documented and addressed by the crisis management team to be corrected. RISK MANAGEMENT PLAN - [DATE] 5
  7. 7. Risk Mitigation The communication of pertinent information in a timely matter is essential to effective crisis management. For this reason, knowing one’s role within the crisis management procedure is crucial to save time and ultimately minimize loss. By establishing a clear concise job description or list of responsibilities, employees should aware of their responsibilities. The division between staff, management, and upper management should have varying roles within the response plan. Table 2 provides a generic outline of the difference in duties and responsibilities each could accomplish. (Table 2 Position Responsibilities) Position Task Upper Management • Establish a crisis management team • Implement a crisis management plan • Communicate information down the vertical structure to next level management of policies and expectations • Handle communication between regulatory agencies and public statements Management • Ensure, that workers and other persons are not put at risk from work carried out by the company. • Ensure the workplace, including entry and exit and anything arising from the fixtures, fittings or plant are without risks to health and safety of the plant. • Establish and implement risk management systems for all functions and activities of the company. • Communicate to upper management any risk greater than a “5” on the risk matrix. Staff • Compliance with Risk Management Policy. • Contribute to the establishment and implementation of the risk management system. Staff members should know their role within the risk management procedure and who to report any inventory quality issues to. RISK MANAGEMENT PLAN - [DATE] 6
  8. 8. FDA Food Safety Modernization Act The Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011. The legislation affects every aspect of the U.S. food system, from farmers to manufacturers and wholesalers. The FSMA has given the Food and Drug Administration (FDA) new authorities to regulate the way foods are grown, harvested, processed and sold. The law grants FDA a number of new powers, including mandatory recall authority. It aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. How does this affect Distributors and Wholesalers? Sanitary Transportation Transportation operations that must be conducted in order to prevent food from becoming unsafe during transport, including: • Ensuring adequate temperature controls • Preventing contamination of food by contact with raw food or nonfood items • Protection from cross-contact, i.e., food allergens • Protection of food transported in bulk If a shipper, loader, receiver or carrier becomes aware of an indication of a possible material failure of temperature control or other conditions that may render the food unsafe during transportation, the food shall not be sold or otherwise distributed. The shipper or loader is responsible for sanitary conditions (e.g., inspecting truck) unless reassigned in written agreement. Responsibilities: • Condition and cleanliness/sanitation of the vehicle/rail car • Specifying sanitation and temperature requirements • Inspection prior to loading • Temperature control- equipment and monitoring • Sanitation- procedures, documentation, sharing information • Hand washing facilities if food is not fully packaged RISK MANAGEMENT PLAN - [DATE] 7
  9. 9. A Food Safety Plan The FDA has established the proper steps to assess risk associated food inventory through the Food Safety Plan (FSP). The FSP consists of the primary elements in a preventive controls food safety system that provides a systematic approach to the identification of food safety hazards that must be controlled to prevent or minimize the likelihood of foodborne illness or injury. It contains a collection of elements that describe activities to ensure the safety of food during manufacturing, processing, packing, and holding. The FSP consist of the following elements: • A written food safety plan (FSP) A “preventive controls qualified individual” (PCQI) (Appendix C) must develop (or oversee the development of) the FSP. A PCQI is a person with the education, training, or experience to develop and apply a food safety system. A PCQI can be qualified through job experience or by completing training equivalent to the standardized curriculum recognized as adequate by FDA. • Hazard analysis Hazard analysis is to identify whether there are hazards requiring a preventive control. This hazard analysis must be written, regardless of whether any hazards requiring a preventive control are identified. • Preventive controls When the hazard analysis identifies hazards requiring a preventive control, preventive action must be taken. For wholesalers this means maintaining proper temperature control for inventory and ensuring it is being monitored. • Monitoring You must establish and implement written procedures, including the frequency they are to be performed, for monitoring preventive to fully describe your monitoring program, the procedures should answer four questions: (1) What will be monitored? (2) How will monitoring be done? (3) How often will monitoring be done? and (4) Who will do the monitoring? • Corrective actions You must establish and implement corrective action procedures that would apply if preventive controls are not properly implemented, as appropriate to the nature of the hazard and the nature of the preventive control. These include corrective action procedures that must be taken if you detect the presence of a pathogen or appropriate indicator organism in a ready-to-eat product as a result of product testing or if you detect the presence of an environmental pathogen or appropriate indicator organism through your environmental monitoring activities. • Verification When calibration or an accuracy check of a preventive control monitoring instrument shows that the instrument is not accurate, you should evaluate the monitoring records since the last instrument calibration to determine whether the inaccuracy would have contributed to a deviation. For this reason, food safety plans with infrequent calibration or accuracy checks can place more products at risk than those with more frequent checks if a problem with instrument accuracy occurs. RISK MANAGEMENT PLAN - [DATE] 8
  10. 10. Product Recall The company should ensure that it can demonstrate it has taken all reasonable and appropriate steps to protect consumers and has fulfilled its legal obligations. In the event that a food safety issue occurs rapid identification and removal of unsafe food from the distribution chain should immediately take place while informing clients and government agencies of the presence in the market of a potentially hazardous food. While the Consumer Product Safety Commission encourages immediate notification, it is the legal responsibility of any company to report any hazard within 24 hours of obtaining reportable information. In the event a company does not voluntarily recall a product, the FDA now has authority to force a mandatory recall under FSMA Determining the Need for a Recall Food that has become contaminated, or mislabeled, is subject to recall. When food is adulterated, it may be impure, unsafe, or unwholesome; contain a pathogen (for example, Salmonella), a foreign material (for example, plastic), or an undeclared allergen; or there may have been a packaging failure. How are unsafe products discovered? • Manufacturer or distributor tests or observations • Test results from product sampling by the regulatory agency • Field inspections, or investigations, by regulatory agencies • Epidemiologic data (data on the occurrence of disease in a population) collected by local or state public health departments or federal agencies. If a regulatory agency finds that food has microbiological or chemical adulteration, or has statutory violations, such as mislabeling, it presents the evidence to the manufacturer and asks the manufacturer to recall the product. Once a food recall is announced by the manufacturer, responding to a Food Recall typically through a press release, the manufacturer is required to notify all of its affected consignees. FSIS and FDA alert consumers about food recalls through press releases, notices posted on their respective websites, and notices posted on www.foodsafety.gov/recalls. For assistance in determining the correct path of action, consult the product recall flowchart (Appendix E). Product Recall Classifications Class I •Dangerous or defective products that predictably could cause serious health problems or death. • Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve Class II •Products that might cause a temporary health problem, or pose only a slight threat of a serious nature •Example: a drug that is under-strength but that is not used to treat life- threatening situations. Class III •Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. •Examples include: a minor container defect and lack of English labeling in a retail food. RISK MANAGEMENT PLAN - [DATE] 9
  11. 11. g Crisis Procedure Risk Monitoring Continuous monitoring by the project risk manager and the crisis management team ensures that new and changing risks are detected and managed and that risk response actions are implemented and effective. Risk monitoring and control keeps track of the identified risks, residual risks, and new risks. It also monitors the execution of planned strategies for the identified risks and evaluates their effectiveness. Risk meetings should be held regularly to update the status of risks in the risk register, and add new risks. This is not necessary for minor level risk, and may only be needed for the certain level risk the risk management chair or upper management determines. Risk monitoring is a valuable step that can help determine how effective the implemented crisis procedure is and what can be improved upon. Regular meeting and monitoring will help loss prevention by determining the changing aspects of risk and how to manage them. Before • Upper mangement has assenbeled a crisis mangement team with a risk mangement chair to head and respond in the event of inventory containimation. •A crisis proceedure has been implemented and food safety plan established by upper mangement. •Risk are identified by mangement and staff in accordance with FDA regulations using the checklist provided (see appendix A). •Assess what aspects of daily operation are considering at risk using the risk matrix provided (see appendix B). Anything over a "5" should be reported to management. •Manufacturers and client contacts are organized and up to date and posted for quick reference •Everyone knows their roles within the criris management proceedure. During •Immediately suspend the sale of item in question and quarantine until contamination can be determined •Gather information and details of the contamination using the report form in order to convey details to clients, manufacture, and regulatory agency (see appendix D). •Use the product recall flowchart to help determine if a recall to clients is necessary or which stage the contaminated inventory has reached in the supply chain. •Properly dispose of contaminated inventory and implement corrective action. After •Have upper management issue statement to the affected party to ensure good will and future relations. •Assess how contamination happened and monitor for future incidents. •Continue to identify and assess risk. RISK MANAGEMENT PLAN - [DATE] 10
  12. 12. Appendix Appendix A Title 21 Code of Federal Regulations, Sec 110.36 Yes Needs Improvement 1. Are products stored on a first-in, first-out basis to reduce the possibility of contamination through spoilage? 2. Are old products kept in front of the new to help with inventory cycles of first in first out? 3.Are all incoming products dated to ensure a proper rotation of stocks and for internal tracking purposes? 4. Are items overstocked? This increases the chances of spoilage and contamination. 5. Are incoming vehicles inspected? 6. Are dusty, faded or discolored containers checked regularly? 7. Are all products spoiled by damage, insects, rodents or other causes stored in a designated “Quarantine Area” to prevent their contact with safe products? 8. Are such quarantined items disposed of quickly to prevent the development of pest breeding places? 9. Are incoming materials inspected for damage or contamination so that they can be rejected? 10. Are unused materials properly resealed to prevent contamination? 11. Are materials stored in a safe manner? Food related items should not be stored with non-food related items. Materials should be stacked so that vents and blowers are not blocked. Stacks of materials should be orderly for safety purposes. 12. Do you have an effective recall procedure set up? RISK MANAGEMENT PLAN - [DATE] 11
  13. 13. Appendix B. Risk Matrix Negligible 1 Minor 2 Moderate 3 Significant 4 Severe 5 Very Likely 5 5 10 15 20 25 Likely 4 4 8 12 16 20 Moderate 3 3 6 9 12 15 Unlikely 2 2 4 6 8 10 Rare 1 1 2 3 4 5 RISK MANAGEMENT PLAN - [DATE] 12
  14. 14. Appendix C Who needs PCQI Training? The Food Safety Modernization Act (FSMA) was signed into law in 2011. The goal is to make the food supply in the USA is safe by shifting the focus of federal regulators from responding to contamination to prevention. By September 16, 2016 the majority of companies need to have a Food Safety Plan that has been prepared by a "Preventive Controls Qualified Individual (PCQI)". This means that companies need to have a PCQI in place quickly so they can prepare and implement the Food Safety Plan before the September 2016 compliance date. While the list of FSMA’s new requirements is dense and varies greatly for some types of facility, one key change that applies to nearly all food companies is the introduction of a preventive controls qualified individual (PCQI). Not only does FSMA require facilities to have a food safety plan implemented by the deadline date, but the plan must be prepared and applied by a properly trained PCQI. 1. How does a person become a PCQI? 2. I am HACCP trained, is that enough? First, the general route to becoming qualified as a PCQI is to take the standardized training course taught by a "Preventive Controls Lead Instructor". This is an instructor that has applied to the Food Safety Preventive Controls Alliance (FSPCA) been accepted and completed the Lead Instructor training course. They are able to register the class with Association of Food and Drug Officials and students will receive an AFDO certificate if they successfully complete the class. This approach clearly meets the requirements defined in 117.180 (c)(1) of the preventive controls rule. What about other options? Because the rule is new, it has not been demonstrated what experience the FDA would consider as at least equivalent to that provided through the standardized curriculum. However, there are some clues given in the responses to public comments. The responses state: " There are some differences in the requirements of the human preventive controls rule compared to the requirements of Hazard Analysis and Critical Control Points regulations for seafood, juice and meat and poultry such that training provided by the International HACCP Alliance may not be equivalent. Such an individual may need to obtain supplemental training specific to the rule. Alternatively, a person who has received the international HACCP Alliance training and has implemented a HACCP plan may be qualified through job experience." If you are experienced with HACCP, the standard course will cover information that you already know about food safety. However, it will also help you become knowledgeable about the rule, be able to evaluate your current system and be talking the same language when the inspectors arrive. It will also give you assurance that you can demonstrate your qualification as a PCQI, and turn that “may be qualified” into a Qualified. RISK MANAGEMENT PLAN - [DATE] 13
  15. 15. Appendix D Information Reporting Form Name Position in Business Phone Number Date & Time Location Brand of Suspected Contamination Name of Suspected Food Package Size Quantity Affected Reason for Suspicion Details Other Comments RISK MANAGEMENT PLAN - [DATE] 14
  16. 16. Appendix E Product Recall Flowchart The table below illustrates a flowchart of logical questions one could ask to assist in their decision during a potential contamination. The colors indicate which stage of the risk management procedure the company is currently facing. Source: Australian Food and Grocery Council RISK MANAGEMENT PLAN - [DATE] 15
  17. 17. Appendix F Useful Contacts Food and Drug Administration Greenville 300 Executive Center Dr., Greenville, SC 29615 Website: fda.gov Phone: (864) 234-9966 Food and Drug Administration Charleston 4600 Goer Dr. North Charleston, SC 29406 Website: fda.gov Phone: (843) 746-2990 RISK MANAGEMENT PLAN - [DATE] 16