introduction - cornell universityseafoodhaccp.cornell.edu/blackboard/module3/pdfmod3/mod3.pdf ·...

Seafood HACCP Alliance Training Course 3-1

IntroductionIn Module 1 you were introduced to the HACCPconcept. In Module 2 you learned about thepotential food safety hazards that could beassociated with seafood products. Now it's time tostart learning about what you need to have in placebefore you develop your HACCP plan.

First, you'll need to be sure that all of thenecessary Prerequisite Programs are in place.You'll also need to complete several PreliminarySteps that involve gathering the information andresources that are needed to begin the process ofdeveloping your HACCP plan. There are 23 pagesand 5 questions in this Module.


Prerequisite ProgramsLet's start by learning about the Prerequisite Programs.

HACCP is not a stand-alone program. It is one part of a larger system ofcontrol procedures that are necessary to ensure the safety and wholesomeness ofthe food you handle or process. For HACCP to function effectively, it must be builton a solid foundation. That foundation is made up of what we call PrerequisitePrograms.

Prerequisite programs are procedures that need to be in place to ensure that yourHACCP program works. For example, compliance with Good ManufacturingPractice regulations, maintaining acceptable sanitation conditions, and havingequipment maintenance programs are all necessary to ensure that you have anadequate environment for your food handling or processing operation. All of theseprograms and procedures provide the foundation for your HACCP system.

Let's take a look at some of the specific Prerequisite Programs that you need tohave in place.


Good Manufacturing PracticesGood

Manufacturing

Practices

FDA's Good Manufacturing Practice regulations, commonly called the GMPs,describe the conditions and practices that must be met for food handling andprocessing operations or activities. These regulations are codified in federalregulations and can be found in Title 21, Part 110 of the Code of FederalRegulations. The GMPs describe measures of general hygiene as well as measuresthat prevent food from becoming adulterated due to unsanitary conditions. Theyare broadly focused and encompass many aspects of the plant's physicalstructure, plant operations, and personnel practices and hygiene.

GMP regulations have been in effect for over 30 years, and they have beenrevised periodically during that time. Most state and local laws or codes are alsobased on these federal GMPs.

To see a copy of the Good Manufacturing Practice Regulations from Part 110 ofTitle 21 of the Code of Federal Regulations go to page 259 of the Seafood HACCPAlliance training Manual “blue book”.


GMP’s and Your Sanitation ProgramBecause the GMPs are so broad based and only

describe the general conditions or practices fora food handling or processing facility, it may benecessary to define your sanitation programmore specifically. This can be accomplished by

developing your own Sanitation StandardOperating Procedures, commonly calledSSOPs—another Prerequisite Program. It is upto each individual firm to develop the specificprocedures or SSOPs that ensure that theconditions prescribed by the GMPs are met.Typically, SSOPs describe a particular set ofobjectives associated with the sanitary handling offood and the cleanliness of the plant environmentas well as the activities that will be conducted tomeet these objectives.

Take a look at the diagram to the left—it provides avisual representation of the relationship betweenHACCP, GMPs and SSOPs. Note that the base orfoundation of the pyramid includes GMPs andSSOPs—both of which are PrerequisitePrograms.


Sanitation Standard Operating Procedures

Sanitation

Standard

Operating

Procedures

Contrary to popular perception, sanitation control is not limited to cleaningequipment. Although clean equipment and a clean working area are essential forproducing 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 andsanitize equipment and work areas, control pests, and maintain building andgrounds. In addition to describing the expected procedures, SSOPs should alsodescribe when these procedures will be conducted, who has the responsibility toensure that they are followed, what personnel practices are acceptable, and anyother parts of the GMPs that apply to your operation.

Written SSOPs describe all of the sanitation procedures needed to ensure thatyour plant facilities and operations comply with GMPs. They are valuable to bothmanagement and employees because they clearly describe what must be done tomaintain clean and sanitary conditions and practices in your plants.


Sanitation MonitoringAn important component in a sanitation program ismonitoring. Methods for monitoring sanitationpractices will vary according to the type and size ofyour processing operation. Typically a checklist canbe used to record conditions and verify thatsanitation procedures are conducted properly.

The frequency of sanitation monitoring will alsovary depending on your operation. For example, ifyou process a cooked, ready-to-eat product,employee practices will need to be monitored moreoften throughout the day than in plants thatproduce raw products which will be cooked by theconsumer. Another example is monitoring forpests. The grounds around your plant may requiremonthly monitoring to assure that vegetation isnot overgrown and attracting pests. However, theareas inside your plant may need to be inspecteddaily to ensure that there are no pests in foodhandling or storage areas.


Sanitation Requirements of theFDA Seafood HACCP RegulationFor seafood processors, sanitation monitoring and record keeping is mandatoryfor eight key areas of sanitation identified in the FDA's Seafood HACCP regulation.FDA now requires that you monitor and keep records of your monitoringobservations 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 makingice

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


In addition to monitoring records, if a deficiency inany of the sanitation areas is observed andrecorded, a correction will be necessary tomaintain control of that area or condition. Thecorrection that is taken then needs to bedocumented on your sanitation record todemonstrate that control of that area or conditionhas been re-established. Monitoring, recordkeeping and correction can also help you identifytrends and problem areas. Space for notingcorrections should be included on monitoringforms. An example of an SSOP checklist thatincludes the eight key areas of sanitation isprovided in the next module (4).

The Seafood HACCP Alliance has developed a one-day Sanitation Control Procedures (SCP) trainingprogram that focuses on control procedures,monitoring, and record keeping for each of these 8areas of sanitation. To see a list of Alliance SCPcourses scheduled in the U.S., visit this web site:http://seafood.ucdavis.edu/Events/sanitation.htm

Additional information on these sanitationrequirements is available in other Seafood HACCPAlliance training courses. Monitoring frequenciesfor each of these 8 areas of sanitation arerecommended in the Seafood HACCP Alliance"Encore" course.

For a more in depth view of sanitation monitoring,frequencies of monitoring and record keeping fromthe Seafood HACCP Alliance "Encore" course, visitthis website:http://distance-ed.arme.cornell.edu/seafood/Module3/UCDavisSanit.html


Sanitation Controls andFood Safety HazardsWhen SSOPs are in place, HACCP can be moreeffective because it can concentrate on the hazardsassociated with your food or processing operationsand not on the processing plant environment.

Well-designed SSOPs that are fully and effectivelyimplemented can be valuable in helping to controlhazards like bacterial pathogens. Identification ofcritical control points may be influenced by theeffectiveness a company's sanitation program. Forexample, SSOPs can help control bacterial hazardsby specifying procedures to:

1.avoid product cross-contamination by properproduct flow and limiting employee tasks andmovement;

2. locate handwashing and sanitizing stationsnear the processing area to facilitate properhandwashing;

3.ensure appropriate equipment maintenanceand cleaning and sanitizing procedures.

SSOPs can likewise be used to help controlchemical contamination from sanitizers and otherchemicals found in food processing operations.


Sanitation Controls and HACCPControlsHazards which are inherent to the product orare associated with a discrete processing stepmust be controlled with HACCP. Hazardsassociated with the processing environment orpersonnel are usually better controlled withsanitation procedures.

The distinction between CCP's and sanitationcontrols is not always clear. For this reasonsanitary controls can be included in the HACCPplan. However, in most situations processorsshould not complicate their HACCP plan withsanitation monitoring requirements.

In some situations, effective SSOPs may reduce the number of critical controlpoints in HACCP plans. Relegating control of a hazard to SSOPs rather than theHACCP plan does not minimize its importance or indicate lower priority. In fact,some hazards are typically controlled by a combination of SSOPs and HACCPcritical control points. For instance, plant sanitation, employee hygiene and stricthandling procedures are often as important for controlling the bacterial pathogenListeria monocytogenes in cooked food operations as the actual cooking andrefrigeration steps that are likely to be identified as critical control points in aHACCP plan.

If sanitation controls are included as part of a HACCP plan, they must lendthemselves to all aspects of a critical control point (CCP) such as establishingcritical limits, monitoring, corrective actions, verification and record-keepingprocedures. A Clean-in-Place (CIP) system for equipment is a good example ofsanitation controls that could be handled as a CCP within a HACCP plan. A CIPsystem's effectiveness can be monitored, critical control points can beestablished, monitoring records can be maintained, and appropriate correctiveactions can be established when the critical limits are not met. On the otherhand, a processor's pest-control program should be included in its SSOP ratherthan its HACCP plan.


Other Prerequisite ProgramsWe've discussed two important PrerequisitePrograms that must be in place: a sanitationprogram or SSOPs and GMPs. Now let's look atsome other Prerequisite Programs that may beneeded for certain types of operations.

• Facilities - There may be specific state orlocal code requirements for food handling orprocessing establishments in your area thatspecify where your operation should belocated, and how it is constructed andmaintained. You may also need to obtainspecific permits or licenses from state or localauthorities.

• Production Equipment - All equipmentshould be constructed and installed accordingto established sanitary design principles,manufacturer recommendations, and any stateor local codes. Preventive maintenance andcalibration schedules should be establishedand documented using manufacturer and otherinformation as appropriate.

• Standard Operating Procedures -Procedures that describe how routineoperations such as receiving, storage, labeling,shipping etc. are to be conducted may need tobe established to ensure that products andpackaging materials are handled andprocessed appropriately to ensure their safetyand wholesomeness.


Other Prerequisite Programs(continued)

• Supplier Controls - You may need to establishcontrols to ensure that your suppliers haveeffective GMP, HACCP, or other food-safetyprograms in place.

• Product Specifications - You may need todevelop written specifications for all ingredients,products and packaging materials and send themto your suppliers. These specifications mayinclude quality requirements, acceptable portionsizes, or other requirements not related to safety.

• Personnel Policies - Policies and procedures foremployees and other persons who enter themanufacturing plant should be established. Thesepolicies may cover a variety of things related toemployee behavior and performance and couldinclude training requirements for GMPs, sanitationprocedures, personal safety, HACCP etc.

• Traceability and Recalls - Procedures thatensure that raw materials and finished productsare coded and labeled properly and meet therequirements of all appropriate federal, state, andlocal food labeling and/or weights and measuresregulations. A recall system should also be inplace so that rapid and complete traces andrecalls can be done when product retrieval isnecessary.

Other examples of prerequisite programs mightinclude quality-assurance procedures, standardprocessing procedures, and product formulations andrecipes.


Preliminary Steps for Developing a HACCP PlanWhew! Now that we've described the programs that provide the foundation foryour HACCP plan, let's get started developing your plan. Before you start to applythe 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.


Develop Your HACCP TeamThe 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 plansuccessfully, many industries find it helpful to build a HACCP team. When only oneperson develops the HACCP plan, some key points can be missed ormisunderstood in the process. For small companies, the responsibility for writingthe HACCP plan may fall to one person. This is acceptable, but opportunities toinvolve employees and to seek outside assistance from universities, Sea Grant orCooperative Extension programs, consultants, or other resources should be usedas needed.

The team approach minimizes the risk that key points will be missed or thatimportant parts of the operation will be misunderstood. It also encouragesownership of the plan, builds company involvement, and brings in different areasof expertise. The team should consist of a variety of individuals with differentspecialties, and individuals who are directly involved in the plant's dailyoperations. The team may include personnel from maintenance, production,sanitation, quality control and laboratory.

The team develops the HACCP plan, writes SSOPs, and verifies and implementsthe HACCP system. The team should be knowledgeable about food-safety hazardsand HACCP principles. When issues arise that cannot be resolved internally, it mayalso be necessary to enlist outside expertise.

Go ahead now and make a list of who you think should be on your HACCP team.


Describe Your Product(s) andHow They are DistributedThe 2nd Preliminary Step asks you toidentify what products you handle orprocess and how they are distributed. Toadequately describe your products youneed to think about and make a list of thespecies of fish and shellfish that you handleor process as well as the various productforms for each of these species. You willuse this list to properly identify all of thepotential species-related food safetyhazards that could be associated with yourproducts when we show you how to conductyour Hazard Analysis (HACCP Principle #1in Module 5). For specialty firms such asmolluscan shellfish processors ordistributors their species list may onlyinclude 2 or 3 different species. Other firmssuch as full service wholesalers may handle50 to 100 different species of fish andshellfish over the course of a year.


Species

WherePurchased

HowStored

WhereReceived

HowShipped

HowPackaged

HowConsumed

Fish

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Gro

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Pro

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Iced

Fro

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Ref

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Ref

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Air

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You also need to consider how your products are received, handled or processed,and distributed. An important factor to include in your product description iswhether or not each species is refrigerated, iced or frozen in your operation andduring distribution. This information will be important to consider whendetermining if certain types of hazards are reasonably likely to occur for youroperation. You also need to consider how your products are packaged. Specificfood safety hazards such as the bacteria that can cause botulism are associatedwith products that are vacuum packed or packed in containers with reducedamounts of oxygen.

The FDA and the Seafood HACCP Alliance developed a worksheet for their EncoreHACCP training course that can help you develop your species list. This worksheetincludes 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 yourHazard Analysis. A copy of this Species List Worksheet is shown below. You canprint as many copies of this form as you need from your computer.

Now that you've printed the form, go ahead and fill it out, listing all of the fish orshellfish species and products that you handle or process. Then mark each box toindicate how they are purchased, received, stored, shipped and packaged.

Voila! Your second Preliminary Step is now completed.


Identify the Intended Use of YourProductsThe 3rd Preliminary Step asks you to identify howeach of your products are intended to be used andwho are the intended consumers of your products.Let's look at intended use first.

For most raw seafood products it is generallyassumed that consumers will cook the productbefore it is eaten. There are, however, someimportant exceptions. Bivalve molluscan shellfishlike clams and oysters are likely to be eaten raw.Some species of fish or shellfish are also eaten rawin sushi or sashimi dishes. Other types of fish andshellfish are processed to produce products thatmay not be cooked by the consumer before theyare eaten. Some examples are cooked shrimp,smoked fish, pickled or marinated dishes such asceviche, surimi, fish salads, crabmeat or heat-and-serve seafood entrees. For these products bacterialor viral pathogens are likely to be a health riskbecause they will not be thoroughly cooked by theconsumer before they are eaten. In contrast, thesepathogens are not likely to be a health risk in rawshrimp or raw fish if they will be thoroughlycooked by the consumer before they are eaten.

Identifying the intended use of your products inthis Preliminary Step will help you to conductyour Hazard Analysis in Module 5. The Species ListWorksheet provides space in the last column toindicate whether each of your products will beeaten raw or cooked.


Identify the Intended Consumersof Your ProductThe next part of this Preliminary Step also asksyou to identify who are the consumers of yourproducts. The purpose of this step is to identifywhich products might be sold to consumers athigher risk from food borne illness.

Most firms who sell their products to retailstores or restaurants would identify theintended consumers of their products as thegeneral public. For most healthy people in the

general population, the risks associated withmost foodborne illness are not likely to be lifethreatening. However, some groups of people

are much more likely to experience complicationsfrom a food borne illness that could be lifethreatening.

Processors who sell seafood products to firmsthat serve special higher risk populations mayneed to add additional controls for some foodsafety hazards. Examples of firms ororganizations that serve higher risk groups includehospitals, clinics, nursing homes, elderly feedingcenters, day-care centers, schools, etc. that servethe elderly, young children, or people with acute orchronic illnesses that make them more susceptibleto complications of food borne illness.

Congratulations! You've now completed the thirdPreliminary Step.


Develop and Verify Your ProcessFlow DiagramThe 4th Preliminary Step asks you to develop andverify your Process Flow Diagram. A process flowdiagram can be developed in simple block orsymbol form that shows all of the steps required toprocess and distribute your food product. ThisPreliminary Step provides an important visual toolthat the HACCP team will use to develop yourHACCP plan. It is important to include all the stepswithin the facility's control, including receiving andstorage steps for all raw materials. Another stepthat is often overlooked, is the rework step. Theflow diagram should be clear and complete enoughso that people unfamiliar with the process canquickly comprehend how your products movethrough your operation. An example of a simpleprocess flow diagram for a fish filleting operation isshown to the left.


Verify the Process Flow DiagramThe 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 teamshould walk through the facility and follow products through the operation to besure that the process flow diagram lists each processing step. Any requiredchanges in the flow diagram should be made at this point. The walk-throughallows 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 diagramduring the walk-through.

So go ahead and make a flow diagram of one or more of your processes. Ofcourse you'll have to wait until you're off-line to verify it.

You've now completed the fourth Preliminary Step.


Management CommitmentThe 5th and last Preliminary Step is designed to ensure that the individual orteam developing the HACCP plan understands the HACCP concept and how theyshould develop their plan. At this point the team should also obtain anycommitments necessary from management or owners to ensure that the plan willbe fully implemented.

For a HACCP plan to work, it is extremely important to have the support of topcompany officials such as the owner, director and chief executive officer. Withoutit, 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'twork. This is one reason why FDA's Seafood HACCP regulation requires that ahigh level company official sign the HACCP plan and that it has been accepted forimplementation.


HACCP TrainingEducation and training are important elements in developing and implementing anadequate HACCP program. Employees who will be responsible for the HACCPprogram must be adequately trained in its principles. A requirement of FDA'sSeafood HACCP regulation is that a trained individual performs specific HACCPfunctions including: developing the HACCP plan, reassessing and modifying theHACCP plan in accordance with corrective action and verification requirements,and performing record reviews specified in the regulation. This "trained" individualis someone who has attended a course like this one, or who has acquired on thejob experience that is equivalent to the information in a standardized trainingcurriculum such as this.

Individuals who complete this Internet training course and a one day SegmentTwo practical training session or who attend a live three-day Seafood Alliance orequivalent training course meet the training requirement of the FDA regulation.


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 YourKnowledge page (page 3-23). Submit your answers beforemoving on to Module 4.

Good Luck!

introduction - cornell universityseafoodhaccp.cornell.edu/blackboard/module3/pdfmod3/mod3.pdf ·...

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