STUDENT LEARNING OBJECTIVES FOR CHAPTER 12
Upon completing this Chapter, students should be able to:
1. Define the following terms:
- HACCP
- Prerequisite programs
- Standard operating procedures (SOP)
- HACCP plan
- HACCP team
- Process flow chart
- Hazard analysis
- Significant hazard
- Control point (CP)
- Critical control point (CCP)
- Critical limit
- Monitoring
- Corrective action
- Verification
2. List reasons why HACCP is more effective in preventing foodborne illness and injury than the traditional inspection system.
3. Explain why prerequisite programs are needed for HACCP to be effective.
4. Explain the purpose of a process flow chart.
5. Explain the 2 factors used in assessing the risk a hazard presents to the consumer.
6. List the seven steps of HACCP.
6. Give an example of a possible critical control point, a monitoring procedure, a critical limit, a corrective action, and a verification procedure

1. INTRODUCTION
We close this course with a brief discussion of a new approach to developing and implementing food safety plans called
HACCP
(pronounced “hassip”).
HACCP stands for "Hazards Analysis Critical Control Point".
This is a necessarily brief and therefore incomplete discussion. Most HACCP courses take two to three days of lectures and breakout activities just to learn the basics. In addition, there are many advanced courses that apply the basic
HACCP principles to specific commodities such as meat and poultry, seafood, fresh-cut fruits and vegetables, and juice products. The goal of this chapter is to introduce you to the philosophy of HACCP and hopefully encourage you to seek further training in this area.
For the last several decades, the task of maintaining a safe food supply has been the responsibility a government inspection system that depends heavily on spot-checks for violations of Good Manufacturing Practices and random sampling of final products. When site visits indicate substandard sanitary conditions or sampling reveals the presence of contaminants, the processor is directed to make necessary changes to the facilities, the process, or the product.
This traditional approach to food safety has many limitations.
 GMP standards are general, so they may not be applicable to all processes and may not adequately address hazards specific to certain high risk foods.
 It is expensive due to the large numbers of inspectors needed to regularly monitor the thousands of food processing establishments throughout the country.
 And an inspection-based food safety system tends to be reactive rather than proactive; that is food safety hazards are usually found or addressed after a problem has occurred.
HACCP was developed to shift the responsibility to the food processor who must systematically identify significant hazards that are unique to their particular process, product, and/or plant environment and then specify control measures that will address the identified hazards. The evolution of HACCP since the 1950's is outlined in the Learning Library link below.
Because every product, process, and processing environment is different, there is no single method for writing a HACCP plan that would apply to every type of operation.

A properly designed and implemented HACCP plan is considered the most effective way to control biological, chemical, and physical hazards that cause foodborne disease or injury. Three reasons are given for this :
1.
HACCP systematically analyzes all possible food safety risks throughout the flow of food; from receiving of raw materials and ingredients to final product shipping,
2.
It is a more efficient approach because it prioritizes hazards so that time and energy can be devoted to the most critical areas, and.
3.
Because a preventative approach prevents hazards from occurring, considerable amounts of time, money, and energy can be saved.
For these reasons, HACCP has been endorsed by U.S. and international food safety advisory groups, government agencies, and food industries throughout the world as the recommended way to control food safety hazards in food processing operations.

Procedures necessary to develop a HACCP plan can be grouped into 3 components;
1.
Prerequisite programs,
2.
Preliminary HACCP steps, and
3.
The seven HACCP steps.
The entire sequence is illustrated below.
2. PREREQUISITE PROGRAMS
Prerequisite programs
are food safety programs and policies in place that provide the basic environmental and operating conditions that are necessary for the production of safe, wholesome food. Many of the conditions and practices are specified in federal, state, and local regulations and guidelines such GMPs and the Food Code or as customer requirements.

Many of the sanitary conditions and practices described in this course such as personal hygiene practices, water safety, grounds and building maintenance, sanitary design, and cleaning and sanitizing may be considered prerequisite programs.
Other examples of prerequisite programs are listed below: o o o o o o o
Supplier specifications
Receiving, storage, and shipping
Water testing
Personal hygiene
Facilities layout and maintenance
Traceback and product recall
Equipment design and maintenance o o o o o o
Waste disposal
Cleaning and sanitizing control
Toxic chemical
Pest control
Plant security
Employee training
The manner in which prerequisite programs are implemented is formally documented through written
Standard Operating Procedures
or SOPs. SOPs that document procedures related to sanitation are usually termed Sanitation
Standard Operating Procedures or SSOPs. There are many ways to write SOPs and SSOPs and for some foods, there are specific regulations on the required content and format.
Any SSOP for cleaning and sanitizing should include step-by-step details on the types of cleaners and sanitizers used, where they are used, how and when they are applied, and at what concentrations. SOPs should also indicate what actions should be taken if the procedures are not performed according to the written protocol or the procedures do not have the expected outcome. More guidelines and examples can be found in the the Learning Library.
Once the prerequisite programs are in place and working properly, work can begin on the 7 steps necessary for writing the HACCP plan.

3. THE HACCP PLAN
A
HACCP plan
is a written document that evaluates food safety risks at each step in a process and then proscribes procedures to prevent, control, or reduce the identified hazards to acceptable levels. Unlike prerequisite programs, the
HACCP plan focuses on a minimum number of
Critical Control Points
or CCPs in the flow of food where significant food safety hazards are likely to occur if they are not adequately controlled.
The task of writing a HACCP begins with a few preliminary steps. These steps are necessary in order to assign responsibilites for write the plan and to describe the food products and processes that will be addressed in the plan.
These are important steps because no two HACCP plans are identical.
Remember, what makes HACCP different than other food safety systems is the it must address food safety hazards that are unique to a particular process, product, and processing environment.
Preliminary HACCP Steps
Before starting a HACCP plan, there are some preliminary steps that need to be
taken to write and implement an effective plan. First, writing a HACCP plan should be a team effort. This way, experts with a wide variety of working knowledge of the process and product can contribute to the plan and make suggestions for workable food safety control measures. This group is known as the
HACCP team
and may include a number of individuals from several departments or areas of expertise such as:
 Quality control
 Production
 Engineering
 Maintenance
 Sanitation
 Microbiology
 Legal department

At least one person on the team should have attended a formal two or three day HACCP course.
After assembling the team, a complete written description of the food, the ingredients, processing methods, the method of distribution, and intended use should be developed. This is important since some food products present greater food safety risks than others. You may recall in Chapter 3 that we discussed higher risk foods that are at a greater risk for causing foodborne illness such as potentially hazardous foods
, ready-to-eat foods
, and foods that contain allergens
. A HACCP plan for these higher risk foods will look very different than one for a lower risk food.
Next, the HACCP team prepares a process flow diagram
. The purpose of the diagram is to illustrates each process step in the " flow of food
” from receipt of raw materials and ingredients through processing, packaging, and shipping.
Because the HACCP plan is unique to the process and the product, the accuracy of the flow chart should be verified by performing an on-site review of the process and any corrections should be made that are necessary.
To help get a better understanding of how HACCP works, an example of how
HACCP can be used in a food processing situation will be used. Processing of orange juice will be used.

3. THE HACCP PLAN (continued...)
The 7 HACCP steps
After the prerequisite programs are in place and the preliminary HACCP steps have been carried out, the next activity is to move on to the 7 HACCP steps.
These steps provide a framework for systematically focusing on the points in the process where control is necessary to prevent, eliminate, or reduce the risk of food safety hazards and where immediate corrective action should be taken if problems do occur.
Step 1 — Conduct a Hazard Analysis
The purpose of the hazard analysis
is to develop a list of potential biological, chemical, and physical hazards associated with the raw materials, ingredients, and the process methods. The HACCP team must evaluate the flow chart for all possible hazards at each process step. Then, the list of hazards is reduced to those that are “ significant
” and therefore must be addressed in the HACCP plan.
The term "significant" is used to indicate those hazards that are:
 reasonably likely to occur if it is not controlled, and
 would cause severe illness or injury to the consumer
The process of determining whether a hazard is significant or not is beyond the scope of this chapter. However, it is based on factors such as:
 the chemical and physical properties of the food and ingredients (ex. pH and water activity)
 The history of contamination and outbreaks associated with the product
 The effectiveness of prerequisite program already in place
Because this assessment is not always easy to make, many HACCP teams consult private consultants or university extension specialists to help evaluate their food safety risks.

Step 2 — Identify Critical Control Points
The next step is identify
Critical Control Points
(CCPs)
A critical control point (CCP) is a process step where an identified significant hazard can be prevented, eliminated, or reduced to an acceptable level. Each significant hazard identified in the hazard analysis must be controlled at a critical control point. Some examples of critical control points used in the food industry are:
 Inspection of raw materials and ingredients upon receipt
 Formulation procedures
(ex. addition of acids, salts, antimicrobials)
 Cooking
 Pasteurization
 Acidification
 Chilling
 Drying
 Disinfection procedures
 Metal detection
 Labeling
To make the HACCP plan more manageable, the number of CCPs should be kept to a minimum by placing them at the last possible point in the process.
For example, there are multiple points in a food process where food contamination with metal fragments might occur. But the CCP should be at a process step which is the last chance to ensure the safety of the product. Thus, a metal detection step after the product has been packaged, and after which there is little chance for contamination to occur, would be the best step to assign as a CCP.
Step 3 — Set Critical Limits
A critical limit
(CL) is a maximum and/or minimum value to which a biological, chemical, or physical parameter must be controlled at a CCP to prevent, eliminate, or reduce the occurrence of a significant food safety hazard to an acceptable level. While a critical control point identifies the step where a hazard is controlled, the critical limit provides the parameters necessary to carry out the control measure.
Examples of critical limits include:
 Temperature
 Water activity
 Moisture level
 Viscosity
 Time
 Rate


 pH
Concentration
 Physical dimensions
 Weight
The critical limit value for the pasteurization process would be a thermal process temperature of at least 160°F for 15 seconds??.
Step 4 — Establish Monitoring Procedures
Monitoring is the act of conducting a planned sequence of observations or measurements to assess whether the criteria for the CL are met and the CCP is in control. Monitoring is also a way to track trends that can be used to predict and prevent future problems from occurring.
Procedures for monitoring should be clearly defined and specific. Components of the monitoring procedure are shown is this chart along with examples from the OJ example:
 Who monitors?
 What do they monitor?
 How do they monitor?
 When do they monitor?
 What records are necessary to document the process?
 What equipment, materials, or tools are needed?
It is imperative to clearly identify the individual responsible for monitoring and to train employees thoroughly so that they understand the importance and purpose of monitoring procedures.

3. THE HACCP PLAN (continued...)
The 7 HACCP steps...
Step 5 — Determine Corrective Actions
When monitoring indicates that there is a deviation from the Critical Limit, corrective actions
must be taken to immediately correct the problem.are predetermined steps to be taken to bring the CCP back into control.
Corrective actions should be clearly defined and specific. Examples of corrective actions are:
 Re-pasteurization
 Additional cooking time
 Adding acid or salt
 Re-formulation
 Removing foreign material and passing through detector again
Sometimes, errors cannot be corrected economically or without substantially lowering the quality of the product. In these cases, corrective actions might be:
 Rejecting a shipment
 Discarding a product
 Diverting the product to some other use (such as animal feed)
Effective correction procedures require giving employees considerable authority to stop the process, retain product that is not in compliance, and adjust the process while holding the product. If corrective actions become necessary or are not practical, the HACCP Plan may need to be revised to more effectively prevent recurrence of the hazard.
Step 6 — Establish Verification Procedures
Verification
is defined as activities, other than monitoring, that determine if the
HACCP plan is working as planned and if it is effectively reducing food safety risks. Verification activities are usually performed by someone other than those performing monitoring procedures. Verification activities may be confirmed by:
 Reviewing monitoring records to ensure proper completion
 Reviewing corrective actions to ensure timely performance
 Calibrating monitoring devices (ex. thermometers, pH meters, flow rates)

 Reviewing calibration records
 Sampling and testing raw materials, ingredients, and finished products for compliance with safety criteria
An important part of the verification step is validation
of the HACCP plan.
Validation focuses on collecting and evaluating scientific and technical information to determine whether the HACCP plan, when properly implemented, will effectively control the identified food hazards.
 Researching new processing techniques or regulatory requirements
 Reviewing the scientific validity of the HACCP plan by consulting the scientific literature
Generally, verification and validation procedures are reviewed on a yearly basis or anytime there are major changes to the product or process.
The frequency of verification activities varies according to the risks inherent to the process and product. Reviewing records might be done on a weekly or monthly basis while laboratory testing might occur less frequently. Generally, the entire HACCP plan is reviewed on a yearly basis or anytime there are major changes to the product or process.
Step 7 — Establish Recordkeeping and Documentation Procedures
Recordkeeping is perhaps the most difficult part of HACCP. But recordkeeping and documentation procedures are increasingly relied upon by customers and sanitarians as proof that all foodborne hazards have been considered and that each is being adequately controlled. Records also can be used to observe trends, such as an ineffective chilling system, thereby allowing corrective actions to repair the problem before it becomes serious. A “paper trail” of the flow of food is also necessary should there be a recall or a claim that a product was the cause of a foodborne illness.

The types of records that are kept within the HACCP plan include:
 Information gathered during the preliminary steps (i.e. list of HACCP team members, description of the food, its distribution, intended use and consumers, and process flow chart)
 A summary of the hazard analysis, including the rationale for determining significant hazards
 A HACCP plan summary table that includes CCPs, critical limits, monitoring procedures, corrective actions, and verification procedures
 Daily monitoring and corrective action logs
 Verification records
 Equipment calibration records
 Supplier certification records
 Laboratory testing data
 Scientific studies that demonstrate adequacy of the control procedures
 Employee training records
Although technically not part of the HACCP plan, records that document the compliance and adequacy of prerequisite programs may also be included.

4. HACCP IN THE REAL WORLD
The basic concept behind HACCP, as discussed above, is that experience and scientific data must be used to determine process-specific food safety hazards and appropriate control measures. However, as HACCP has become an integral part of the food safety control system, the original concept has been modified over the years. Three forms of HACCP have emerged:
1.
Scientific HACCP
2.
Government HACCP
3.
Customer HACCP
Scientific HACCP
This is the original form of HACCP. In scientific HACCP, the planning process is based on a logical assessment of the risks at hand and the control measures needed to keep food safe. The scientific approach should always be used when first developing the HACCP plan. However, government regulations and customer purchasing specifications may dictate changes to the plan.
Government HACCP
Governments are increasingly incorporating HACCP into their regulatory food safety systems. In the United States, the U.S. Department of Agriculture requires meat and poultry processors to develop HACCP plans while the Food and Drug Administration requires seafood and juice products to do the same.
There are specific requirements for the content and format of HACCP controls and prerequisite programs within the regulations and guidance documents. The processor must conclude certain hazards are significant and control them with
CCPs to remain within the law, even if the processor’s hazard analysis indicates otherwise.
Customer HACCP
Often a buyer insists that a supplier have a HACCP plan in place that includes certain CCPs and prerequisite programs. For example, a customer may have particular concerns about metal contamination and require installation of a metal detector and monitoring as a CCP. Even if the hazard analysis has determined that the risk for metal detection is not significant, most manufacturers will comply in order to maintain that relationship

5. SUMMARY
Beyond the assurances that HACCP offers for producing safe and wholesome products, the process control techniques learned are also likely to lead to quality improvements and increased efficiency.
A HACCP plan is a dynamic system that requires regular refinement and updating as new regulations and technologies emerge. More thorough training is necessary to gain a more complete understanding of HACCP. There are many 2 or 3 day interactive workshops offered by university food science departments, commodity groups, or commercial training companies that provide additional training.