WHITE PAPER. Food Safety, From Farm to Fork. A Best-Practice Approach to Implementing a Food Safety Management System

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1 WHITE PAPER Food Safety, From Farm to Fork A Best-Practice Approach to Implementing a Food Safety Management System

2 Executive Summary Now, more than ever, all food chain stakeholders are required to demonstrate their commitment to food safety and quality. Recent food-related events have led regulatory bodies like the FDA to examine not only their internal processes but to also set forth standards and initiatives to increase regulation and oversight of the food production supply chain. Major food retailers are now requiring that their suppliers adhere to the Safe Quality Food (SQF) initiative, as well as other food safety regulations such as Hazard Analysis and Critical Control Points (HACCP), and ISO This is due to the increase in safety regulations in the food and beverage industry which has resulted in a higher demand for suppliers to demonstrate that they have incorporated safety and quality initiatives into their food production processes. An increasing number of major food retailers will only accept products from suppliers who can demonstrate these food safety and quality principles. The leading methods for demonstrating safety and quality in the food chain are to implement HACCP, ISO and SQF food safety processes into a Food Safety Management System (FSMS). HACCP involves identifying hazards within the FSMS and controlling them through prerequisite programs (PRPs) and/or Critical Control Points (CCPs) in the food production and preparation process. ISO guides the HACCP process and incorporates it into its standard, and SQF incorporates both HACCP and ISO processes into its certification standard. Typically, companies use a combination of manual processes and limited consolidation of compliance data within their food safety programs. This is often time consuming and provides little traceability and transparency of data, running a higher risk of error and noncompliance than if using an automated system. This paper will describe how automating an FSMS will streamline processes and procedures related to HACCP, ISO 22000, and SQF ensuring compliance to regulations in the food and beverage industry. We will also look at how FSMS technology solutions are able to adopt a best-practices approach in implementing these food safety initiatives, giving companies the traceability and transparency needed to demonstrate they are providing a safe, quality product. A Recipe for Food Safety: ISO 22000, HACCP, and SQF ISO incorporates HACCP into its standard and helps guide the HACCP process. A good FSMS will automate the necessary methods required by the ISO standard, while an automated FSMS with a robust set of modules will streamline business processes, reducing compliance costs and risk, while dramatically enhancing ISO compliance. This results in the effective mitigation of the cost and compliance risk associated with manual systems. For example, the ISO standard requires a stakeholder: Demonstrate a commitment to food safety and document food safety procedures: An FSMS with a Document Control system will automate procedures by managing the creation, approval, distribution, revision, and archiving of all controlled documents. Provide competent food safety personnel: An Employee Training system manages identification, authorities, responsibilities, training, and certification requirements for all employees through an easy-to-use environment. Specify acceptable food hazard levels: Risk Assessment and Decision Tree Analysis tools provide quantitative methods for identifying potential hazards in order to determine the best method for control. Monitoring and Inspection tools allow for the coordination and implementation of test plans to test and record the results of the control process and notify appropriate resources of deviations and nonconformances.

3 Food Industry in the News President Obama has called for a full review of the FDA s food safety operations. 1 Over the past few years the Food and Beverage industry has seen its largest number of product recalls, leading to stricter food safety and quality regulations. In addition to ISO and HACCP, the SQF certification standard adds an extra layer of compliance for the food and beverage industry. SQF is recognized by the Global Food Safety Initiative (GFSI) and is the most prominent food safety standard that incorporates both safety and quality. SQF offers one solution for the entire supply chain 2 by offering two certification codes the SQF 1000 Code for primary producers and the SQF 2000 Code for manufacturers. Both codes demonstrate that a producer or manufacturer has maintained food quality and safety plans that are critical to their processes. Many of the major food retailers are requiring that their suppliers be SQF certified to demonstrate that they have the highest level of safety and quality standards in place. SQF s ability to incorporate quality into its standard provides assurance to retailers that the food their supplier produced, handled, prepared, processed, and distributed has been through the strictest food safety standards available and is of the highest degree of quality. 3 A Best-Practices Approach to FSMS: Automating the HACCP Plan HACCP is a critical part of food safety and can be implemented on its own or as part of an ISO program. Here we will look at a best-practices approach to HACCP, and explain what technology solutions fit in with many of the principles to help automate and streamline the process. Conduct a Hazard Analysis Through the use of a hazard analysis, stakeholders identify points in the production process where a risk could occur, determine the severity of the risk, and identify control measures for any significant risk. Hazards are broken down into three categories biological, chemical, and physical. During the hazard analysis, a risk assessment will need to be conducted to determine severity of risk. Technology Solution For Hazard Analysis Risk Assessment/ Decision Tree Analysis Using an FSMS that will outline the process steps for each product and incorporate risk-based technology, such as Quantitative Risk Assessment or Decision Tree Analysis, enables stakeholders to identify potential hazards for each process step. The ability to track the type of hazard, identify the roles involved, and determine the type of control needed to mitigate any hazard is key to providing safe, quality food. An automated FSMS should be able to track this information, provide revision control, as well as generate reports on materials/process steps and the potential hazards they present. Furthermore, an automated FSMS will be able to use Decision Tree technology to automatically determine if the control is in a PRP or required as a CCP. Prerequisites Lay the Foundation for a Good HACCP Plan A critical part of a FSMS is the ability to maintain procedures. A strong HACCP program is built on PRPs and is guided by the ISO standard. Did you Know... Currently, Federal law does not require organizations to share test results of food contaminants, potentially allowing contaminated products to be distributed at a company s discretion. 4 PRPs incorporate the generic procedures FDA only requires HACCP processes in such as Sanitization seafood and fruit and vegetable juices. Standard Operating USDA only requires HACCP processes in Procedures (SSOPs) and red meat and poultry. Good Manufacturing Practices (GMPs) that Companies that can analyze quality data hourly through the use of their quality must be taken into management platforms are able to account to ensure a safe reduce the amount of products recalled and hygienic workplace. by 10%. 5 These describe the proper hygienic practices needed to create a safe environment. PRPs set the foundation for a strong HACCP plan and range from facility management to pest control, to environmental considerations and beyond. PRPs also define control measures to ensure a safe environment in the food chain. Technology Solution For Prerequisites Revision Controlled PRP linked to Document Control and Audits An automated FSMS should be able to document prerequisite plans describing the control, the roles involved, how the control is being executed, and the frequency at which it s being monitored. Any records, such as procedures, work instructions, or specification(s) related to the PRP should be automatically linked to the plan. These records should reside in a revision controlled Document Control system. The benefit here is that anytime a PRP is reviewed or revised, any affected documentation can also be reviewed for change control. The ability to link PRPs to an Audits application enables users to regularly audit PRPs and make necessary changes to ensure

4 processes within the FSMS are up to date and adequately controlled. An Audit application provides the ability to generate comprehensive reports that are key in demonstrating that PRPs are working as intended. Identify CCPs When a hazard analysis determines that there is a significant risk in the process that requires control by either a prerequisite or a certificate of analysis from a vendor, a CCP may be needed. If so, a series of specific questions to investigate if that process warrants a CCP is prudent. Technology Solution For CCPs Risk-based Decision Tree Analysis and Document Control Using intelligent automated Decision Tree technology, an FSMS can guide users through the process of determining if a hazard requires a CCP and provide a revision controlled environment that will establish the conditions for CCPs. An automated FSMS should be able to document CCPs by describing the process steps, the critical limits, the monitoring procedures involved, the frequency at which it is being monitored, and any related corrective actions. Any records such as procedures, work instructions, or specification(s) related to CCPs should be automatically linked to the plan. These records should reside in a revision controlled Document Control system. Anytime a CCP is reviewed or revised, any affected documentation can also be reviewed for change control. Establish Monitoring Procedures Monitoring procedures are used to allow visibility into whether all CCPs are under control and will provide stakeholders with a verification record for future use. Technology Solution For Monitoring Procedures Monitoring and Inspection An FSMS should have a Monitoring and Inspection system in Technology Enablers for Automating HACCP When implementing an automated HACCP, SQF, or ISO Food Safety Management System, there are several technology enablers that help to streamline and make food safety more efficient. Below are just a few of such available technologies: Document Control Automates procedures by managing the approval, creation, archiving, and distribution of all controlled documents and is readyto-use for such document types as manuals, work instructions, procedures, product specifications, forms, job descriptions, test methods, and inspection specifications. Corrective and Preventive Action (CAPA) Generates a CAPA request which routes through root cause, review, corrective action taken, and verification stages. Multiple reports are automatically generated, providing an effective method for tracking the cause and costs of incidents. Employee Training Manages identification, authorities, responsibilities, training, and certification requirements for all employees through an easy-to-use environment. This database simplifies the process of scheduling and recording training. Meetings Used to plan and schedule meetings, distribute the agenda, record minutes, as well as assign action items and corrective action requests. Risk Assessment Calculates risk through various quantitative methods, updates risk at multiple points in the process, and displays risk mitigation history by event. Risk charts are available to identify key risk indicators, and the risk form can be integrated with other modules to assess risk in the FSMS business process where it was detected and then recorded. Nonconforming Materials Manages all steps in the nonconformance process and generates CAPAs that link directly to the original nonconformance. Monitoring and Inspection Arranges test plans to test and record the results of the monitoring process and provides notification of adverse events from exceeding limits. Tests and records measurements to ensure compliance with regulations. Results are collected and documented in test plans, and can be viewed to assess performance. Audits and Surveys Automates the process of audits and surveys, including internal/ external audits and customer satisfaction surveys. Scheduled and random audits can be generated by the system and assigned to personnel based on availability. Change Management Used to initiate and manage changes made to processes or product lines within the system. Includes the ability to collect related postproduction data, define and design the change process, approve and source all elements of the change, and provide verification on the status of changes in real-time. Project Control Organizes and automates the process of managing tasks, activities, and deliverables within quality and compliance projects. Users have the ability to create, track, and control projects by identifying the stages of the project, allocating tasks to individuals, and tracking the progress of each task.

5 HACCP Prerequisite Programs Incorporate the generic procedures-ssops, GMPs-that must be taken to ensure a safe and hygienic workplace. PRPs set the foundation for a strong HACCP plan Record-keeping Records that ensure you that the HACCP system is followed and is adequate Verification Procedures conducted to ensure compliance with the HACCP Plan Hazard Analysis Identify points in the production process where a risk is likely to occur Critical Control Point Hazards not controlled by a PRP or CofA Data from HACCP plan critical event feed into the QMS Results from QMS activities feed back into the HACCP plan QMS NCMR Launched if a defect is found Deviation Look for planned deviations Ask, is the event critical? RISK ASSESSMENT Corrective Action Take action on critical events Change Mgmt Resulting changes to the system Document Ctrl Update affected records Training Train employees place that ensures compliance with a HACCP plan. Through the use of this system, stakeholders will be able to set up test plans, record the results of the monitoring process and notify all users of events that require investigation. Should a CCP result in a failure, an automated FSMS should have the ability to automatically generate a nonconformance, look for any deviations, and recommend action based on the data. This could be scrap, reuse, use as-is, and, in some instances, the generation of a corrective action to investigate the event. Establish Corrective Actions A critical part of a FSMS is the ability to initiate a corrective action for a process or product deviation (e.g., if a nonconformance is generated as a result of exceeding CCP critical limits). The goal of corrective action is to bring the process back to a controlled state and investigate the root cause with the ultimate goal of taking action to eliminate the cause. Corrective actions are also key in implementing a continuous improvement program. Technology Solution For Corrective Action Corrective and Preventive Action (CAPA) The FSMS can streamline and simplify the process through the use of a Corrective and Preventive Action (CAPA) module. This system will route all events through review, root cause, corrective action taken, and verification stages, and will generate reports automatically, which will provide an effective method for tracking the source and cost of all adverse events. Implementing Risk Assessment tools with the CAPA system will allow stakeholders to effectively determine the risk level of the event and set the priority based on the risk, allowing stakeholders to handle the most critical CAPA s first. Establish Record Keeping and Documentation Procedures Record-keeping procedures are required to ensure that the HACCP system is following the HACCP plan and that the plan is adequate. All of the support documents from development of the HACCP plan should be stored. Technology Solution For Record Keeping and Documentation Procedures Document Control, Deviation and Change Management An FSMS should have a Document Control system in place, which manages the creation, approval, distribution, revision, and archiving of all documentation within the FSMS. Look for a Document Control system that links to the PRPs and has the ability to execute change requests across multiple documents. The benefit is that when a prerequisite is audited and needs to be changed, all affected documents can also be a part of that change. Truly automated systems provide a significant level of traceability within the processes that they automate, whether by a well defined audit trail, revision control, or corrective action

6 histories. Companies are able to draw on this historical data to improve for the future and maintain well-documented processes. Many food chain organizations will have a deviation program in place to manage deviations that occur within their processes. Through use of an automated Deviation module, organizations can identify deviations, develop a deviation plan with target completion dates, approve proposed deviations, and verify the completion of deviations that are in process. Continuous improvement is a critical part of the success of any organization, and having procedures in place for change management is a key feature in a FSMS. Having an automated Change Management system and change log will provide a repository that shows what steps to follow when making changes to both processes and products, and provides a clear definition of how to execute such changes. Establish Verification Procedures Verification procedures are procedures, methods, tests, and audits that are conducted to ensure compliance with the HACCP plan and to determine whether any modification or review is needed. This can include equipment calibration and process audits to ensure manufacturing processes are under control. The FSMS should be able to assist stakeholders in each of these areas. Technology Solution For Establishing Verification Procedures Audits, Monitoring and Inspection and Change Management An Audits system will automate the process of auditing the HACCP plan. Look for an FSMS that allows stakeholders to schedule audits of the FSMS on a regular basis. The Auditing system should be flexible enough to cover everything from PRPs to CCPs, and even affected documentation. Furthermore, look for a system that can automatically generate comprehensive audit reports that provide evidence of how the HACCP plan is being controlled. Another step in an automated FSMS is the process of establishing verification tasks to be performed by plant personnel. Using an automated Monitoring and Inspection system, organizations are able to take the requirements for the HACCP plan and regularly perform inspections, record the results, and determine actions to be taken as a result of each inspection. As part of the continual verification process to ensure the HACCP plan is up to date, it is important to provide evidence of changes or revisions to the plan over time. Having an automated Change Management system and change log will provide a repository that shows what changes were made to the prerequisites or HACCP plan, why the change(s) was made, and what resulted from each change. Food Safety Down the Supply Chain: Incorporating Suppliers More and more food chain stakeholders are relying on multiple suppliers to provide the components necessary to produce food and beverage products. The effects of globalization and market demand have made the supply chain increasingly complex. The ability to create visibility down the supply chain and provide traceability into supplier quality and supplier safety is key to maintaining compliance to food safety standards such as HACCP, ISO 22000, and SQF. Through the use of an automated FSMS, food chain stakeholders are now able to incorporate their suppliers directly into their business processes, enabling suppliers to be involved in related quality and safety events. Furthermore, organizations are able to rate their suppliers based on quality and safety criteria and, based on their overall rating, select the safest and highest quality suppliers for their brand. For example, if a nonconformance is found and a corrective action is generated, specific elements of that corrective action can be electronically sent to the affected supplier in real-time. The supplier completes their portion of the corrective action and the supplier s input is immediately reflected. Automated supplier rating systems enable the review and selection of the best suppliers and provide visibility on areas where suppliers need to improve. A good FSMS should provide a Supplier Portal whereby suppliers can review their rating and take action to improve compliance and become a preferred vendor for the food chain stakeholder s organization. This concept of automated supplier collaboration through the FSMS provides a high level of visibility into supply chain quality, faster collaboration on quality and safety events with suppliers, and continuous improvement through use of Supplier Rating systems. Reaping the Benefits of a Food Safety Management System Through the implementation of best practices, PRPs, preliminary steps and principles throughout a HACCP plan, adherence to the ISO food safety management standard and SQF certification, food chain stakeholders can demonstrate their system is functioning at the highest ability to produce a safe and high quality product for the customer while reducing risk.

7 According to a survey conducted by the Aberdeen Group, product recall is the top risk impacting the food and beverage industry, followed closely by product noncompliance 6. By incorporating HACCP, ISO and SQF processes into the FSMS, quality throughout the process is increased, decreasing the chances of a recall. In fact, 77 percent of food manufacturers are planning on increasing safety throughout their supply chain this year by improving the frequency of quality analysis and data collection. Companies that can analyze quality data hourly through the use of their quality management platforms are able to reduce the amount of products recalled by 10 percent. 5 By automating each step in the process through the use of an FSMS, food chain stakeholders can remain confident that their processes are compliant and that each step in the process is closely monitored to ensure that operational risks are kept under control. An FSMS will also give food chain stakeholders the ability to streamline processes, reduce inefficiencies due to paper-based forms, as well as provide greater visibility into their system all with the goal of demonstrating their commitment to food safety and quality. Most notably, using quantitative Risk Assessment tools, stakeholders can identify hazards more effectively, make the process more efficient, and mitigate any unforeseen risks down the food chain. Conclusion In this paper, we have discussed how implementing an automated food safety management system that follows the principles of HACCP, ISO 22000, and SQF can assist all food chain Steps to SQF Certification: Safe, Quality Food Determine which level of certification is needed: SQF 1000 Code: Primary Producers SQF 2000 Code: Manufacturers Determine Appropriate Certification Level: Level 1: Food safety fundamentals For those with proven prerequisite programs and food safety controls 3 Level 2: Certified HACCP safety plans All requirements stated in Level 1 are in place as well as CCPs determined from HACCP plan and a food safety risk assessment of both product and process 3 Level 3: Comprehensive Quality Management System (QMS) development this level incorporates Level 1 and Level 2 requirements as well as quality aspects and the associated controls required for a QMS and for comprehensive food safety 3 What to Provide: Guidance documents for specific food industry sectors such as grain production, aquaculture, the growing and production of produce, and intensive animal production systems 3 A third-party audit to verify that the producer is adhering to requirements stated in the SQF 1000 Code 3 Innovative optional modules for responsible social and environmental practices 3 stakeholders in demonstrating their commitment to food safety and quality and assure retailers and consumers that their product has been prepared with the safest food safety and quality processes. We also went over ISO and how it incorporates HACCP processes into its standard as well as the SQF initiative that incorporates both HACCP and ISO processes into its certification requirements. We described some of the best practices needed to successfully implement and automate the FSMS, including using Document Control to automate procedures by managing the approval, creation, archiving, and distribution of all controlled documents and using Risk Assessment to calculate risk through various methods at various points in the processes. We also looked at how an FSMS can help automate each process in the HACCP plan, such as using a Monitoring and Inspection module to ensure that critical limits are not exceeded, using a CAPA module to establish corrective action procedures to bring a CCP back to a controlled state, and using Audits, Calibration /Maintenance and Change Management applications to assist in the verification procedures. We discussed how an automated FSMS can help stakeholders comply with the various food quality and food safety initiatives by performing a food safety hazard analysis, specify acceptable food hazard levels, and control monitoring and measuring methods. We also discussed how food chain stakeholders are using Supplier Rating systems to incorporate suppliers into the business processes and therefore increase visibility into supplier performance. Finally, we went over how incorporating automated HACCP processes into the production process can help organizations demonstrate their commitment to safe quality food. We also looked into other ways in which an organization can benefit from automation, such as improving efficiencies and streamlining processes as well as fostering continuous improvement within the organization and down the supply chain. By implementing these best practices and procedures into a business system, food chain stakeholders ensure a system that will function at its highest ability to streamline business processes, automate procedures, and incorporate food safety initiatives from the beginning of the production process and throughout the food chain ultimately demonstrating compliance to food quality and food safety initiatives.

8 About EtQ Celebrating 20 Years of Excellence Founded on March 4, 1992 by former lead auditors of Underwriters Laboratories, EtQ has always had a unique knowledge of compliance processes related to Food Safety, Quality, and Environmental Health and Safety (EHS) Management. This year, EtQ celebrates 20 years of excellence and continues to be the leading Food Safety, EHS, Quality and Compliance solution provider for identifying, mitigating and preventing high-risk events through integration, automation and collaboration. EtQ encompasses a wide variety of industries, providing solutions for Food Safety, EHS, Aviation Safety, Quality, and FDA Compliance Management. EtQ uses best in class integrated modules and enterprise application integration to manage and measure these compliance processes and execute organizational change. EtQ s solution, Reliance, is an enterprise suite of modules designed to foster operational excellence in businesses with modules and utilities such as HACCP, Supplier Rating, Risk Management, CAPA, Document Control, Employee Training, Customer Complaints, Audits, and many more. EtQ has been providing software solutions to a variety of markets for 20 years. For more information, please visit References: 1. Lyndsey Leyton. Obama Faults FDA on Food Safety. February 3rd, article/2009/02/02/ar html. February 9th, SQF Institute. Frequently Asked Questions. com/frequently_asked_questions.pdf. February 6th, SQF Institute. The SQF Program: A Basic Guide. sqfi.com/sqf_brief_guide.pdf. February 9th, Ricardo Alonso-Zaldivar, Brett J. Blackledge. Loopholes Allow Contaminated Food to go Unchecked. com/hostednews/ap/article/aleqm5jelgwcg-feeyh8kz7tt45zodsikgd965ie780. February 9th, Cecere, L; Jacobson, S; Draper, L. (2008, September). How Safe is your Food Supply Chain? AMR Research. 6. Shah, M; Littlefield, M. (August 2008). Risk Mitigation in Manufacturing Operations: Enterprise Risk Management. Aberdeen Group.

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