Introduction. Seafood HACCP Alliance Training Course 3-1

Transcription

1 Seafood HACCP Alliance Training Course 3-1 Introduction In Module 1 you were introduced to the HACCP concept. In Module 2 you learned about the potential food safety hazards that could be associated with seafood products. Now it's time to start learning about what you need to have in place before you develop your HACCP plan. First, you'll need to be sure that all of the necessary Prerequisite Programs are in place. You'll also need to complete several Preliminary Steps that involve gathering the information and resources that are needed to begin the process of developing your HACCP plan. There are 23 pages and 5 questions in this Module.

2 Seafood HACCP Alliance Training Course 3-2 Prerequisite Programs Let's start by learning about the Prerequisite Programs. HACCP is not a stand-alone program. It is one part of a larger system of control procedures that are necessary to ensure the safety and wholesomeness of the food you handle or process. For HACCP to function effectively, it must be built on a solid foundation. That foundation is made up of what we call Prerequisite Programs. Prerequisite programs are procedures that need to be in place to ensure that your HACCP program works. For example, compliance with Good Manufacturing Practice regulations, maintaining acceptable sanitation conditions, and having equipment maintenance programs are all necessary to ensure that you have an adequate environment for your food handling or processing operation. All of these programs and procedures provide the foundation for your HACCP system. Let's take a look at some of the specific Prerequisite Programs that you need to have in place.

3 Seafood HACCP Alliance Training Course 3-3 Good Manufacturing Practices Good Manufacturing Practices FDA's Good Manufacturing Practice regulations, commonly called the GMPs, describe the conditions and practices that must be met for food handling and processing operations or activities. These regulations are codified in federal regulations and can be found in Title 21, Part 110 of the Code of Federal Regulations. The GMPs describe measures of general hygiene as well as measures that prevent food from becoming adulterated due to unsanitary conditions. They are broadly focused and encompass many aspects of the plant's physical structure, plant operations, and personnel practices and hygiene. GMP regulations have been in effect for over 30 years, and they have been revised periodically during that time. Most state and local laws or codes are also based on these federal GMPs. To see a copy of the Good Manufacturing Practice Regulations from Part 110 of Title 21 of the Code of Federal Regulations go to page 259 of the Seafood HACCP Alliance training Manual blue book.

4 Seafood HACCP Alliance Training Course 3-4 GMP s and Your Sanitation Program Because the GMPs are so broad based and only describe the general conditions or practices for a food handling or processing facility, it may be necessary to define your sanitation program more specifically. This can be accomplished by developing your own Sanitation Standard Operating Procedures, commonly called SSOPs another Prerequisite Program. It is up to each individual firm to develop the specific procedures or SSOPs that ensure that the conditions prescribed by the GMPs are met. Typically, SSOPs describe a particular set of objectives associated with the sanitary handling of food and the cleanliness of the plant environment as well as the activities that will be conducted to meet these objectives. Take a look at the diagram to the left it provides a visual representation of the relationship between HACCP, GMPs and SSOPs. Note that the base or foundation of the pyramid includes GMPs and SSOPs both of which are Prerequisite Programs.

5 Seafood HACCP Alliance Training Course 3-5 Sanitation Standard Operating Procedures Sanitation Standard Operating Procedures Contrary to popular perception, sanitation control is not limited to cleaning equipment. Although clean equipment and a clean working area are essential for producing safe foods, so are personnel practices, plant facilities, pest control, warehouse practices, and equipment and operation design. Sanitation Standard Operating Procedures or SSOPs describe how to clean and sanitize equipment and work areas, control pests, and maintain building and grounds. In addition to describing the expected procedures, SSOPs should also describe when these procedures will be conducted, who has the responsibility to ensure that they are followed, what personnel practices are acceptable, and any other parts of the GMPs that apply to your operation. Written SSOPs describe all of the sanitation procedures needed to ensure that your plant facilities and operations comply with GMPs. They are valuable to both management and employees because they clearly describe what must be done to maintain clean and sanitary conditions and practices in your plants.

6 Seafood HACCP Alliance Training Course 3-6 Sanitation Monitoring An important component in a sanitation program is monitoring. Methods for monitoring sanitation practices will vary according to the type and size of your processing operation. Typically a checklist can be used to record conditions and verify that sanitation procedures are conducted properly. The frequency of sanitation monitoring will also vary depending on your operation. For example, if you process a cooked, ready-to-eat product, employee practices will need to be monitored more often throughout the day than in plants that produce raw products which will be cooked by the consumer. Another example is monitoring for pests. The grounds around your plant may require monthly monitoring to assure that vegetation is not overgrown and attracting pests. However, the areas inside your plant may need to be inspected daily to ensure that there are no pests in food handling or storage areas.

7 Seafood HACCP Alliance Training Course 3-7 Sanitation Requirements of the FDA Seafood HACCP Regulation For seafood processors, sanitation monitoring and record keeping is mandatory for eight key areas of sanitation identified in the FDA's Seafood HACCP regulation. FDA now requires that you monitor and keep records of your monitoring observations for these eight key sanitation conditions and practices. The 8 key sanitation conditions and practices are: 1. The safety of water used with food, food contact surfaces, or for making ice 2. Condition and cleanliness of food contact surfaces 3. Prevention of cross contamination 4. Maintenance of hand-washing, hand-sanitizing, and toilet facilities 5. Protection from adulterants 6. Labeling, storage, and use of toxic compounds 7. Employee health conditions 8. Exclusion of pests

8 Seafood HACCP Alliance Training Course 3-8 In addition to monitoring records, if a deficiency in any of the sanitation areas is observed and recorded, a correction will be necessary to maintain control of that area or condition. The correction that is taken then needs to be documented on your sanitation record to demonstrate that control of that area or condition has been re-established. Monitoring, record keeping and correction can also help you identify trends and problem areas. Space for noting corrections should be included on monitoring forms. An example of an SSOP checklist that includes the eight key areas of sanitation is provided in the next module (4). The Seafood HACCP Alliance has developed a oneday Sanitation Control Procedures (SCP) training program that focuses on control procedures, monitoring, and record keeping for each of these 8 areas of sanitation. To see a list of Alliance SCP courses scheduled in the U.S., visit this web site: Additional information on these sanitation requirements is available in other Seafood HACCP Alliance training courses. Monitoring frequencies for each of these 8 areas of sanitation are recommended in the Seafood HACCP Alliance "Encore" course. For a more in depth view of sanitation monitoring, frequencies of monitoring and record keeping from the Seafood HACCP Alliance "Encore" course, visit this website: seafood/module3/ucdavissanit.html

9 Seafood HACCP Alliance Training Course 3-9 Sanitation Controls and Food Safety Hazards When SSOPs are in place, HACCP can be more effective because it can concentrate on the hazards associated with your food or processing operations and not on the processing plant environment. Well-designed SSOPs that are fully and effectively implemented can be valuable in helping to control hazards like bacterial pathogens. Identification of critical control points may be influenced by the effectiveness a company's sanitation program. For example, SSOPs can help control bacterial hazards by specifying procedures to: 1. avoid product cross-contamination by proper product flow and limiting employee tasks and movement; 2. locate handwashing and sanitizing stations near the processing area to facilitate proper handwashing; 3. ensure appropriate equipment maintenance and cleaning and sanitizing procedures. SSOPs can likewise be used to help control chemical contamination from sanitizers and other chemicals found in food processing operations.

10 Seafood HACCP Alliance Training Course 3-10 Sanitation Controls and HACCP Controls Hazards which are inherent to the product or are associated with a discrete processing step must be controlled with HACCP. Hazards associated with the processing environment or personnel are usually better controlled with sanitation procedures. The distinction between CCP's and sanitation controls is not always clear. For this reason sanitary controls can be included in the HACCP plan. However, in most situations processors should not complicate their HACCP plan with sanitation monitoring requirements. In some situations, effective SSOPs may reduce the number of critical control points in HACCP plans. Relegating control of a hazard to SSOPs rather than the HACCP plan does not minimize its importance or indicate lower priority. In fact, some hazards are typically controlled by a combination of SSOPs and HACCP critical control points. For instance, plant sanitation, employee hygiene and strict handling procedures are often as important for controlling the bacterial pathogen Listeria monocytogenes in cooked food operations as the actual cooking and refrigeration steps that are likely to be identified as critical control points in a HACCP plan. If sanitation controls are included as part of a HACCP plan, they must lend themselves to all aspects of a critical control point (CCP) such as establishing critical limits, monitoring, corrective actions, verification and record-keeping procedures. A Clean-in-Place (CIP) system for equipment is a good example of sanitation controls that could be handled as a CCP within a HACCP plan. A CIP system's effectiveness can be monitored, critical control points can be established, monitoring records can be maintained, and appropriate corrective actions can be established when the critical limits are not met. On the other hand, a processor's pest-control program should be included in its SSOP rather than its HACCP plan.

11 Seafood HACCP Alliance Training Course 3-11 Other Prerequisite Programs We've discussed two important Prerequisite Programs that must be in place: a sanitation program or SSOPs and GMPs. Now let's look at some other Prerequisite Programs that may be needed for certain types of operations. Facilities - There may be specific state or local code requirements for food handling or processing establishments in your area that specify where your operation should be located, and how it is constructed and maintained. You may also need to obtain specific permits or licenses from state or local authorities. Production Equipment - All equipment should be constructed and installed according to established sanitary design principles, manufacturer recommendations, and any state or local codes. Preventive maintenance and calibration schedules should be established and documented using manufacturer and other information as appropriate. Standard Operating Procedures - Procedures that describe how routine operations such as receiving, storage, labeling, shipping etc. are to be conducted may need to be established to ensure that products and packaging materials are handled and processed appropriately to ensure their safety and wholesomeness.

12 Seafood HACCP Alliance Training Course 3-12 Other Prerequisite Programs (continued) Supplier Controls - You may need to establish controls to ensure that your suppliers have effective GMP, HACCP, or other food-safety programs in place. Product Specifications - You may need to develop written specifications for all ingredients, products and packaging materials and send them to your suppliers. These specifications may include quality requirements, acceptable portion sizes, or other requirements not related to safety. Personnel Policies - Policies and procedures for employees and other persons who enter the manufacturing plant should be established. These policies may cover a variety of things related to employee behavior and performance and could include training requirements for GMPs, sanitation procedures, personal safety, HACCP etc. Traceability and Recalls - Procedures that ensure that raw materials and finished products are coded and labeled properly and meet the requirements of all appropriate federal, state, and local food labeling and/or weights and measures regulations. A recall system should also be in place so that rapid and complete traces and recalls can be done when product retrieval is necessary. Other examples of prerequisite programs might include quality-assurance procedures, standard processing procedures, and product formulations and recipes.

13 Seafood HACCP Alliance Training Course 3-13 Preliminary Steps for Developing a HACCP Plan Whew! Now that we've described the programs that provide the foundation for your HACCP plan, let's get started developing your plan. Before you start to apply the 7 principles of HACCP, you need to complete some Preliminary Steps. Failure to properly address these Preliminary Steps may lead to ineffective design, implementation and management of the HACCP plan. There are five Preliminary Steps: 1. Assemble the HACCP team, 2. Describe your food product(s) and how they are distributed 3. Identify the intended use and the consumers of your food product(s) 4. Develop and verify your process Flow Diagram 5. Obtain training and a management commitment Lets take a look at each one individually.

14 Seafood HACCP Alliance Training Course 3-14 Develop Your HACCP Team The first preliminary step is to decide who will develop your HACCP plan. Although one person may be able to analyze hazards and develop a HACCP plan successfully, many industries find it helpful to build a HACCP team. When only one person develops the HACCP plan, some key points can be missed or misunderstood in the process. For small companies, the responsibility for writing the HACCP plan may fall to one person. This is acceptable, but opportunities to involve employees and to seek outside assistance from universities, Sea Grant or Cooperative Extension programs, consultants, or other resources should be used as needed. The team approach minimizes the risk that key points will be missed or that important parts of the operation will be misunderstood. It also encourages ownership of the plan, builds company involvement, and brings in different areas of expertise. The team should consist of a variety of individuals with different specialties, and individuals who are directly involved in the plant's daily operations. The team may include personnel from maintenance, production, sanitation, quality control and laboratory. The team develops the HACCP plan, writes SSOPs, and verifies and implements the HACCP system. The team should be knowledgeable about food-safety hazards and HACCP principles. When issues arise that cannot be resolved internally, it may also be necessary to enlist outside expertise. Go ahead now and make a list of who you think should be on your HACCP team.

15 Seafood HACCP Alliance Training Course 3-15 Describe Your Product(s) and How They are Distributed The 2nd Preliminary Step asks you to identify what products you handle or process and how they are distributed. To adequately describe your products you need to think about and make a list of the species of fish and shellfish that you handle or process as well as the various product forms for each of these species. You will use this list to properly identify all of the potential species-related food safety hazards that could be associated with your products when we show you how to conduct your Hazard Analysis (HACCP Principle #1 in Module 5). For specialty firms such as molluscan shellfish processors or distributors their species list may only include 2 or 3 different species. Other firms such as full service wholesalers may handle 50 to 100 different species of fish and shellfish over the course of a year.

16 Seafood HACCP Alliance Training Course 3-16 You also need to consider how your products are received, handled or processed, and distributed. An important factor to include in your product description is whether or not each species is refrigerated, iced or frozen in your operation and during distribution. This information will be important to consider when determining if certain types of hazards are reasonably likely to occur for your operation. You also need to consider how your products are packaged. Specific food safety hazards such as the bacteria that can cause botulism are associated with products that are vacuum packed or packed in containers with reduced amounts of oxygen. The FDA and the Seafood HACCP Alliance developed a worksheet for their Encore HACCP training course that can help you develop your species list. This worksheet includes a list of items for all of the factors related to product form (refrigerated, iced or frozen), packaging, and source that you will need to consider in your Hazard Analysis. A copy of this Species List Worksheet is shown below. You can print as many copies of this form as you need from your computer. Where Purchased Where Received How Stored How Shipped How Packaged How Consumed Species Fisherman Grower Processor Refrigerated Iced Frozen Refrigerated Iced Frozen Refrigerated Iced Frozen Air Pack Reduced Oxygen Raw Cooked Now that you've printed the form, go ahead and fill it out, listing all of the fish or shellfish species and products that you handle or process. Then mark each box to indicate how they are purchased, received, stored, shipped and packaged. Voila! Your second Preliminary Step is now completed.

17 Seafood HACCP Alliance Training Course 3-17 Identify the Intended Use of Your Products The 3rd Preliminary Step asks you to identify how each of your products are intended to be used and who are the intended consumers of your products. Let's look at intended use first. For most raw seafood products it is generally assumed that consumers will cook the product before it is eaten. There are, however, some important exceptions. Bivalve molluscan shellfish like clams and oysters are likely to be eaten raw. Some species of fish or shellfish are also eaten raw in sushi or sashimi dishes. Other types of fish and shellfish are processed to produce products that may not be cooked by the consumer before they are eaten. Some examples are cooked shrimp, smoked fish, pickled or marinated dishes such as ceviche, surimi, fish salads, crabmeat or heat-andserve seafood entrees. For these products bacterial or viral pathogens are likely to be a health risk because they will not be thoroughly cooked by the consumer before they are eaten. In contrast, these pathogens are not likely to be a health risk in raw shrimp or raw fish if they will be thoroughly cooked by the consumer before they are eaten. Identifying the intended use of your products in this Preliminary Step will help you to conduct your Hazard Analysis in Module 5. The Species List Worksheet provides space in the last column to indicate whether each of your products will be eaten raw or cooked.

18 Seafood HACCP Alliance Training Course 3-18 Identify the Intended Consumers of Your Product The next part of this Preliminary Step also asks you to identify who are the consumers of your products. The purpose of this step is to identify which products might be sold to consumers at higher risk from food borne illness. Most firms who sell their products to retail stores or restaurants would identify the intended consumers of their products as the general public. For most healthy people in the general population, the risks associated with most foodborne illness are not likely to be life threatening. However, some groups of people are much more likely to experience complications from a food borne illness that could be life threatening. Processors who sell seafood products to firms that serve special higher risk populations may need to add additional controls for some food safety hazards. Examples of firms or organizations that serve higher risk groups include hospitals, clinics, nursing homes, elderly feeding centers, day-care centers, schools, etc. that serve the elderly, young children, or people with acute or chronic illnesses that make them more susceptible to complications of food borne illness. Congratulations! You've now completed the third Preliminary Step.

19 Seafood HACCP Alliance Training Course 3-19 Develop and Verify Your Process Flow Diagram The 4th Preliminary Step asks you to develop and verify your Process Flow Diagram. A process flow diagram can be developed in simple block or symbol form that shows all of the steps required to process and distribute your food product. This Preliminary Step provides an important visual tool that the HACCP team will use to develop your HACCP plan. It is important to include all the steps within the facility's control, including receiving and storage steps for all raw materials. Another step that is often overlooked, is the rework step. The flow diagram should be clear and complete enough so that people unfamiliar with the process can quickly comprehend how your products move through your operation. An example of a simple process flow diagram for a fish filleting operation is shown to the left.

20 Seafood HACCP Alliance Training Course 3-20 Verify the Process Flow Diagram The accuracy of the flow diagram is critical to conduct your hazard analysis. Because of this, your process flow diagram needs to be verified. The HACCP team should walk through the facility and follow products through the operation to be sure that the process flow diagram lists each processing step. Any required changes in the flow diagram should be made at this point. The walk-through allows each team member to gain an overall picture of how the product is made. It may be helpful to invite additional plant personnel to review the diagram during the walk-through. So go ahead and make a flow diagram of one or more of your processes. Of course you'll have to wait until you're off-line to verify it. You've now completed the fourth Preliminary Step.

21 Seafood HACCP Alliance Training Course 3-21 Management Commitment The 5th and last Preliminary Step is designed to ensure that the individual or team developing the HACCP plan understands the HACCP concept and how they should develop their plan. At this point the team should also obtain any commitments necessary from management or owners to ensure that the plan will be fully implemented. For a HACCP plan to work, it is extremely important to have the support of top company officials such as the owner, director and chief executive officer. Without it, HACCP will not become a company priority or be effectively implemented. Experience has shown that unless there is a "buy in" from everyone, it just won't work. This is one reason why FDA's Seafood HACCP regulation requires that a high level company official sign the HACCP plan and that it has been accepted for implementation.

22 Seafood HACCP Alliance Training Course 3-22 HACCP Training Education and training are important elements in developing and implementing an adequate HACCP program. Employees who will be responsible for the HACCP program must be adequately trained in its principles. A requirement of FDA's Seafood HACCP regulation is that a trained individual performs specific HACCP functions including: developing the HACCP plan, reassessing and modifying the HACCP plan in accordance with corrective action and verification requirements, and performing record reviews specified in the regulation. This "trained" individual is someone who has attended a course like this one, or who has acquired on the job experience that is equivalent to the information in a standardized training curriculum such as this. Individuals who complete this Internet training course and a one day Segment Two practical training session or who attend a live three-day Seafood Alliance or equivalent training course meet the training requirement of the FDA regulation.

23 Seafood HACCP Alliance Training Course 3-23 Check Your Knowledge Now you need to return to Module 3 via the Internet. Click through the text pages until you get to the Check Your Knowledge page (page 3-23). Submit your answers before moving on to Module 4. Good Luck!