Introduction to the Manual - sokrasmart.files.wordpress.com€¦ · Introduction HACCP is the...

1

HACCP TRAINER’S MANUAL

Introduction to the Manual

The course materials comprise of this Trainer’s Manual and the Trainees Handouts.

This Trainer’s Manual consists of the following items: Presentation slides, trainer’s review notes and suggested readings as

needed. Worksheets and workshop discussion Suggested Quiz per session Training Evaluation Form

The objective of the trainer’s manual is to guide the trainers in the preparation, discussion and delivery of each session.

In most sessions, there are trainer’s tips and suggested readings to prepare the trainer on the subject matter.

For the workshops, the specific worksheets consist of instructions and templates, as applicable. Discussion of the workshop outputs are done after every workshop and relate learnings with the objective(s) of the workshop.

To test the understanding on the completed sessions, quiz may be given by the trainer.

Suggested quiz questionnaires and answer keys are provided per session.

Review through recitation is done as a recap of the previous day’s sessions. This is

done during the first 30 minutes of the next day’s session. It can be done through

recitation or sharing from the participants on what previous day’s topics they most

remember. Another way of recap is through a group quiz to be given by the trainer

wherein at least 3 enumeration questions are asked to the teams to help them review.

The suggested quiz questions can also be used by the trainer for review of the previous

day’s session.

Depending on the availability of a HACCP-certified company in the area, it is recommended to include a trip to a HACCP-certified company for the participants to gain fist-hand information from the company on their HACCP implementation.

2

Introduction

HACCP is the acronym for Hazard Analysis Critical Control Point. It is a system which

identifies, evaluates and controls hazards which are significant for food safety.

In the 1960's, the Pillsbury Corporation developed the HACCP control system with

National Aeronautic Space Administration (NASA), to ensure food safety for the first

manned space missions. The HACCP system and guidelines for its application were

defined by the Codex Alimentarius Commission in the Codex Alimentarius Code of

Practice. This Commission implements the Joint Food and Agriculture Organization

(FAO) of the United Nations and World Health Organization (W.H.O.) Food Standards

Program.

In the early 1960s, a collaborated effort between the Pillsbury Company, NASA, and the

U.S. Army Laboratories began with the objective to provide safe food for space

expeditions. In order to ensure that the food that would be sent to space was safe, they

imposed strict microbial requirements, including pathogen limits (including E.

coli, Salmonella, and Clostridium botulinum). Using the traditional end product testing

method, it was soon realized that almost all of the food manufactured was being used

on testing and very little was left for actual use. It was realized that a new approach was

needed.

NASA's own requirements for Critical Control Points (CCP) in engineering

management would be used as a guide for food safety. CCP derived from Failure mode

and effects analysis (FMEA) from NASA via the munitions industry to test weapon and

engineering system reliability. Using that information, NASA and Pillsbury required

contractors to identify "critical failure areas" and eliminate them from the system, a first

in the food industry then. Baumann, a microbiologist by training, was so pleased with

Pillsbury's experience in the space program that he advocated for his company to adopt

what would become HACCP at Pillsbury.

Soon thereafter, Pillsbury was confronted with a food safety issue of its own

when glass contamination was found in farina, a cereal commonly used in infant food.

HACCP was promoted in Pillsbury for producing commercial foods, and applied to its

own food production. This led to a panel discussion at the 1971 National Conference on

Food Protection that included examining CCPs and Good Manufacturing Practices in

producing safe foods. Several botulism cases were attributed to under-processed low-

acid canned foods in 1970-71. The United States Food and Drug Administration (FDA)

asked Pillsbury to organize and conduct a training program on the inspection of canned

foods for FDA inspectors. This 21 day program was first held in September 1972 with

11 days of classroom lecture and 10 days of canning plant evaluations. Canned food

regulations (21 CFR 108, 21 CFR 110, 21 CFR 113, and 21 CFR 114) were first

http://en.wikipedia.org/wiki/Title_21_of_the_Code_of_Federal_Regulations

3

published in 1969. Pillsbury's training program to the FDA in 1969, titled "Food Safety

through the Hazard Analysis and Critical Control Point System", was the first time that

HACCP was used.

HACCP was initially set on three principles, now shown as principles one, two, and four.

Pillsbury quickly adopted two more principles, numbers three and five, to its own

company in 1975. It was further supported by the National Academy of Sciences (NAS)

that governmental inspections by the FDA go from reviewing plant records to

compliance with its HACCP system. A second proposal by the NAS led to the

development of the National Advisory Committee on Microbiological Criteria for

Foods (NACMCF) in 1987. NACMCF was initially responsible for defining HACCP's

systems and guidelines for its application and were coordinated with the Codex

Committee for Food Hygiene, that led to reports starting in 1992 and further

harmonization in 1997. By 1997, the seven HACCP principles became the standard.

HACCP expanded in all realms of the food industry, going into meat, poultry, seafood, dairy, and has spread now from the farm to the fork which means that HACCP system can be applied throughout the food chain from the primary producer to the final consumer. Besides enhancing food safety, other benefits in applying HACCP include more effective use of resources and more timely response to food safety problems. In addition, the application of the HACCP system can aid inspection by food control regulatory authorities and promote international trade by increasing buyer confidence in food safety. In U.S and in Europe, a HACCP Plan is a legal requirement for specific food products. Often times, it serves as a passport for doing business to these countries.

HACCP consists of 7 principles:

Principle 1 Conduct a Hazard Analysis

Principle 2 Determine CCP

Principle 3 Establish Critical Limit

Principle 4 Establish Monitoring of CCP

Principle 5 Corrective Action Procedures

Principle 6 Verification Procedures

Principle 7 Documentation and Records

4

There are twelve steps required to develop a HACCP plan and these are designed to ensure that the seven principles are applied correctly. These twelve steps represent the five preliminary steps and 7 HACCP principles developed by Codex Alimentarius.

12 steps of HACCP:

1. Assemble HACCP Team

2. Describe Product

3. Identify the intended use

4. Construct flow diagram

5. On-site confirmation of flow diagram

6. Conduct a hazard analysis 7. Determine Critical Control Points (CCPs). 8. Establish Critical Limits 9. Monitor CCPs 10. Establish preplanned corrective actions to be taken

11. Establish verification procedures to monitor results.

12. Ensure proper documentation and records of HACCP process are maintained

Acronyms

CFR Code of Federal Regulations

HACCP Hazard Analysis Critical Control Point

CCP Critical Control Point

NAS National Academy of Sciences

NACMACF National Advisory Committee on Microbiological Criteria for Foods

FAO Food and Agriculture Organization

FMEA Failure mode and effects analysis

NASA National Aeronautic Space Administration

RTE Ready-to-Eat

WHO World Health Organization

5

Definition of Terms Control (verb): to take all necessary actions to ensure and maintain compliance with

criteria established in the HACCP plan.

Control (noun): the state wherein correct procedures are being followed and criteria

are being met.

Control measure: any action and activity that can be used to prevent or eliminate a

food safety hazard or reduce it to an acceptable level.

Corrective action: ant action to be taken when the results of monitoring at the CCP

indicate a loss of control.

Critical Control Point (CCP): a step at which control can be applied and is essential to

prevent or eliminate a food safety hazard or reduce it to an acceptable level.

Critical limit: a criterion which separates acceptability from unacceptability

Decision tree: A series of questions linked diagrammatically to be answered with Yes

or No. The answers determine which path is followed and which decision this leads to. This is a tool that can be used for CCP determination.

Deviation: failure to meet a critical limit

Flow diagram: a systematic representation of the sequence of steps or operations

used in the production or manufacture of a particular food item.

HACCP: a system which identifies, evaluates, and controls hazards which are

significant for food safety.

HACCP plan: a document prepared in accordance with the principles of HACCP to

ensure control of hazards which are significant for food safety in the segment of the

food chain under consideration.

Hazard: a biological, chemical or physical agent in, or condition of, food with the

potential to cause an adverse health effect.

Hazard analysis: the process of collecting and evaluating information on hazards and

conditions leading to their presence to decide which are significant for food safety and

therefore should be addressed in the HACCP plan.

Monitor: the act of conducting a planned sequence of observations or measurements of

control parameters to assess whether a CCP is under control.

Step: a point, procedure, operation or stage in the food chain including raw materials,

from primary production to final consumption.

Validation: obtaining evidence that the elements of the HACCP plan are effective.

Verification: The application of methods, procedures, tests and other evaluations, in

addition to monitoring to determine compliance with the HACCP plan.

6

Objectives of the Course

By the end of the sessions participants should be able to:

1. To give working knowledge on how to identify the food safety hazards per

process steps

2. To understand the principles of HACCP

3. To understand how to document a HACCP system appropriate for food

operations

4. To be able to train the trainers on handling and delivery of HACCP training

course

Target Audience

Food sector • Food handlers • Owners • Managers • Supervisors • Trainers • Students

Training Course Outline

Session Title Timing and Activities

Session 1 HACCP: A Must to Food Industry Time: 15 min

Discussion: 20 min

Quiz: 10 min

Session 2 Food Hazards

Time: 15 min

Discussion: 20 min

Quiz: 10 min

Session 3 Prerequisite Programs

Time: 10 min

Discussion: 20 min

Quiz: 10 min

Session 4; 12 Steps to HACCP Application Time: 15 min

7

Step 1 Step 1: Assemble the HACCP

Team

Workshop 1: HACCP Team

Time: 30 min

Presentation and Discussion: 1 hr

Quiz: 10 min

Session 4;

Step 2

12 Steps to HACCP Application

Step 2: Describe the product and

method of distribution

Time: 15 min

Discussion: 15 min

Quiz: 10 min

Session 4;

Step 3


Step 3: Identify intended use

Time: 15 min

Workshop 2: Product Description and

Intended Use

Time: 30 min


Quiz: 10 min

Session 4;

Step 4


Step 4: Construct process flow

diagram and plant schematic

Time: 30 min

Workshop 3. Process Flow Diagram and Plant Schematic

Time: 1 hr


Quiz: 10 min

Session 4;

Step 5


Step 5: On-site verification of

process flow diagram and plant

schematic

Time: 15 min

Discussion: 15 min

Quiz: 10 min

Session 4;

Step 6


Step 6: Conduct hazard

analysis

Time: 1 hr.

Workshop 4: Hazard Analysis

Time: 2 hrs

Presentation and Discussion: 2 hrs

Quiz: 10 min

Session 4;

Step 7


Step 7: Determine Critical

Control Point (CCP)

Time: 30 min

Workshop 5: CCP Determination

8

Session 4;

Step 8


Step 8: Establish Critical limit

for each CCP

Time: 30 min

Workshop 6: Validate Critical Limit

Time: 30 min

Presentation and Discussion: 30 min

Session 4;

Step 9


Step 9: Establish a Monitoring System for each CCP

Time: 30 min

Workshop 7: Monitoring Procedure

Time: 30 min

Presentation and Discussion: 1.5 hrs

Session 4;

Step 10


Step 10: Establish Corrective

Actions

Time: 30 min

Workshop 8: Corrective Actions

Time: 1 hr


Session 4;

Step 11


Step 11: Establish Verification

Procedures

Time: 30 min

Discussion: 30 min

Quiz: 10 min

Session 4;

Step 12


Step 12: Establish

Documentation and Record

Keeping

Time: 30 min

Workshop 9: Verification and Record Keeping

Workshop 10: HACCP Plan and Final Flow Diagram

Time: 30 min

Presentationa nd Discussion: 1 hr

Session 5 HACCP Pointers

Time: 30 min

Discussion: 30 min

Examination: 20 min

Session 6 Observation Tour to a HACCP-certified Company

Time: ½ day

Sharing and Discussion: 2 hr

Course Evaluation: 15 min

9

Session 1: HACCP: A Must to Food Industry

Time: 15 min

Learning objectives:

By the end of the session participants should be able to:

know the history of HACCP

know the benefits of HACCP implementation

Refer to Slides # 7 to 17

Discussion points:

1. What is the main strength of HACCP?

2. Why is HACCP a preventive system?

Emphasize that the main strength of HACCP is the focus on food safety. HACCP is a

preventive system because it identifies and evaluates the hazards and establish control

measures to address the significant hazards. It establishes a HACCP Plan for every

Critical Control Point (CCP), monitors the CCP and develops corrective actions in case

of deviations. Essentially, it focuses on CCPs where the significant hazards have been

pointed out by the HACCP team.

10

Quiz 1.

1. HACCP means:

a. Hazard Analysis Conditional Control Point

b. Hazard Analysis Critical Control Point

c. Hazard Assay Critical Control Point

d. Hazardous Analysis Critical Control Point

e. none of the above

2. HACCP is

a. Reactive system

b. Zero-defect system

c. Preventive food safety system

d. Quality system

e. None of the above

3. HACCP is applicable to :

a. Primary producers

b. Food and feed manufacturers

c. Food packaging manufacturing

d. Retailers

e. All of the above

4. HACCP requires

a. Management commitment

b. Employee participation

c. HACCP team

d. All of the above


5. HACCP application:

a. From farm to plate approach

b. From supplier to customer

c. Defines preventive measures for hazard control

d. Product specific, line and site specific

e. All of the above

11

Session 2: Food Hazards

Time: 15 min



to know the different food safety hazards that may affect food products

to know the control measures for food safety hazards


Review Notes

A food safety hazard is a biological, chemical, physical agent in or condition of food that could cause the consumer an adverse health effect.

Biological hazards can be bacteria, fungi, viruses, parasites and algae. Biological hazards account for 93% of foodborne disease outbreaks.

Chemical hazards are residues or contaminants found in food can cause an adverse effect on the consumers. These can come in the form of pesticide residues, veterinary residues, cleaning chemicals, chemical additives, phyllotoxins, and allergens among others.

Physical hazards are objects that are not normally found in food which may cause illness or injury to the consumer, e.g. glass, metal, stones, wood, pests, jewelry.

12

Quiz 2.

1. Examples of physical hazards:

a. Bolts and nuts

b. Plastic packaging

c. Dead insects

d. All of the above


2. Examples of control measures:

a. Certificate of Analysis

b. Visual inspection

c. Metal detector

d. Use of X-ray machine

e. All of the above

3. Examples of chemical hazards

a. Pesticide residue

b. allergens

c. Aflatoxin content

d. All of the above

e. a and b only

4. Examples of biological hazards

a. Salmonella

b. Metals

c. Jewelry

d. Mold, yeasts and viruses

e. A & d

5. Sources of biological hazards

a. People

b. Machine and equipment

c. Environment

d. Water

e. All of the above

13

Session 3: Prerequisite Programs

Time: 10 min



to know the PRPs for HACCP

to state the functions of PRP


Review Notes

Prerequisite programs are HACCP support programs including GMP and SSOP which

are required to provide a solid foundation on which to build a HACCP system. HACCP

PRPs include such areas such as: Personal hygiene, Water supply, Pest control,

Training, Approved suppliers, Product identification and traceability, Cleaning program,

Preventive maintenance and Calibration program.

In an agricultural production context, HACCP PRP could include Good Agricultural

practices (GAP).

14

Quiz 3.

1. Prerequisite programs for HACCP may include:

a. GMP

b. GAP

c. SSOP

d. All of the above


2. An organization can implement HACCP without putting in place required PRPs

such as GHP and SSOP.

a. True

b. False

3. Requirements for effective PRP and HACCP implementation:

a. Management commitment

b. Employee participation

c. a & b

d. none of the above

e. only a is correct

4. SSOP focus areas include:

a. Checklist

b. Measurement

c. Validation

d. Audit

e. Prevention of cross contamination

5. Prerequisite programs:

a. Aims to produce safe food

b. Depends on the segment of food chain

c. Necessary to maintain a hygienic environment

d. All of the above


15

Session 4: 12 Steps to HACCP Application

Step 1: Assemble the HACCP Team

Time: 45 min



know the requirements for HACCP team membership

To know the responsibilities of HACCP team


Review Notes

To fully understand the product and be able to identify all likely hazards and CCPs, it is

important that the HACCP team is made up of people from different functions of the

food operations (multidisciplinary). The team should have knowledge of the entire life

cycle of the product, from raw materials, production processes, and storage of the

finished goods to delivery to customers. The team should be sufficient to support all the

technical and operational requirements of the product process flow.

16

Workshop 1: HACCP Team

Objective of the workshop: to understand the importance of the HACCP team in terms of knowledge, experience and leadership.

Emphasize on the important requirements for HACCP team membership such as multi-disciplinary, knowledgeable about the products, its materialism, packaging materials and process.

Workshop procedure:

• Group the participants with 5 members per team

• Each group forms a HACCP team

• List the people who should form the HACCP Team and the reasons (knowledge/skills) why they are selected.

• Use Worksheet No. 1

• Time Limit : 15 minutes

• Sample presentation by groups

Worksheet 1: HACCP Team Qualification Matrix

Function in the Team

Name Position in the Company

Knowledge/Skills/Training

17

Quiz 4.

1. HACCP team

a. Should be composed of QA staff only

b. Should consist of multi-disciplinary team members

c. Trained on GMP and HACCP

d. Should be made up of Production personnel only

e. b & c

2. HACCP Team Leader

a. Only GM should be the Team leader

b. Operator is the best Team leader

c. Should be a leader, knowledgeable on GMP and HACCP and operations

d. All of the above


3. Consultant should be the HACCP team Leader because he/she is knowledgeable on GMP and HACCP.

a. True

b. False

4. The number of HACCP team members:

a. At least 10

b. Depends on the size of the organization

c. Only one is enough

d. None of the above

5. HACCP team Leader should be involved in HACCP-related activities only so that the HACCP program can be finished on time.

a. True

b. False

18


Step 2: Describe the product and method of distribution

Time: 15 min



Know the information about the raw materials and packaging materials specifically their biological, chemical and physical specifications

Know the specifications of finished goods specifically their biological, chemical and physical specifications


Review Notes

To start a hazard analysis, a full description of the product, including customer

specifications, should be prepared. This should include information relevant to safety,

e.g. chemical residue regulation/target level, composition, physical/chemical properties

of the raw materials and the final product, the amount of water available for microbial

growth (aw), the amount of acid or alkali in the product (pH). Also information regarding

how the product is to be packaged, stored and transported should also be considered

together with facts regarding its shelf life and recommended storage temperatures.

Where appropriate, labelling information should be included. This information will help

the HACCP team to identify significant hazards associated with the process. If the

HACCP study involves multiple products, a separate product description must be written

for each product.

19

Quiz 5

1. Product description should include:

a. Quality aspects only

b. should include information relevant to safety

c. should be as short as possible

d. a & b

e. none of the above

2. Product description

a. Information will help the HACCP team to identify significant hazards associated with the process.

b. labelling information should be included

c. include HACCP team members

d. a & b

e. all of the above

3. Select the correct statement. a. A separate product description must be written for every food product unless

they are groups of products with similar hazards b. Customer preparation and special labelling issues are not needed in a

product description c. It is best to write the product description after the completion of the hazard

analysis by which time you will be more familiar with the hazards involved in producing the product.

d. In the product description, the term “end product characteristics” refers to all the characteristics of the food that the customer regards as important.

e. None is correct

4. HACCP Step 2

a. Assemble the HACCP Team

b. Identify intended use

c. Appoint the HACCP Team Leader

d. Describe the product


5. Product description should be as short as possible.

a. True

b. False

20


Step 3: Identify intended use

Time: 15 min



Know the requirements of the intended users of the product

Know the sensitive population that must be considered as users of the products


Review Notes

How the product is intended to be used is an important consideration. Information on

whether the product will be consumed directly, or be cooked, or be further processed,

will all have a bearing on the hazard analysis. The nature of the target group for the

product may also be relevant, particularly if it includes any member of the sensitive

population such as infants, the elderly, pregnant and lactating women, the sick and the

immunocompromised. If the product is not intended for these groups, this must be

explicitly stated on the product labels.

21

Workshop 2: Describe the product and Intended Use

Objectives of the workshop: For the participants to describe their products

comprehensively and to identify the intended users of the product.

• Emphasize that communication with suppliers, regulatory agencies and

customers re specifications of raw materials, packaging materials and finished

goods. These information are vital during hazard analysis.

Workshop procedure:

• Group the participants into 5 per team

• Let the group decide on a product to work on

• Using Worksheet No. 2, describe the selected product. Refer to sample worksheet. This will be the template that will be used.

• Time limit: 15 minutes

• Sample presentation by teams : 10 minutes per presentation

22

Worksheet 2. Describe the Product and Intended Use

Characteristics of End-Products

Name (product, group, line)

Type ( e.g. raw, cooked, RTE)

Key physical and chemical characteristics (

water activity, pH)

Key processing steps

Incoming Materials

List all raw materials with RM numbers

High-risk ingredient ( allergen, microbial risk,

foreign body source)

Packaging Materials in contact with food

Rework

Others (processing aids, preservatives)

Claims and Label Information

Instructions for use by Consumers (including

use or storage after opening)

Statements for safe use (e.g. allergen

information, special instruction for safe use )

Distribution and Storage

Distribution instructions (e.g. ambient,

chilled, frozen)

Storage Instructions (e.g. ambient, chilled,

frozen)

Shelf Life Conditions

Use by Consumers

Intended Use

Target group of users and special consumer

considerations (infants, elderly)

Reasonable expected mishandling and misuse

23

Quiz 6.

1. HACCP Step 3

a. Assemble the HACCP Team

b. Identify intended use

c. Appoint the HACCP Team Leader

d. Describe the product


2. The sensitive groups ( At risk groups) in the populations are:

a. Elderly, sick, pregnant, immuno-compromised, and infants

b. People who work hard in the food industry because they are exposed to

hazards.

c. Elderly, sick, pregnant and infants

d. Depressed, weak and mentally disturbed

e. AIDS patients

3. If the product is not intended for a specific group, this must be explicitly stated

on the product labels.

a. True

b. False

4. If the product contains a small amount of allergen, it may not be declared on

the label.

a. True

b. False

5. People with allergy is among the sensitive population.

a. True

b. False

24


Step 4: Construct process flow diagram and plant schematic

Time: 30 min



Know how to draw a detailed process flow of a product and plant

schematic

Know how to prevent cross-contamination by proper plant layout


Review Notes

The first function of the team is to draw up a detailed process flow diagram of the product. The expertise of the team is important at this stage. The process flow diagram provides picture that encompasses all the steps in the product life cycle including:

Details of all process activities including inspections, transportation, storage, and delays in the process

Inputs into the process such as raw materials, water, air, chemicals, processing, storage, packaging, etc. and

Outputs – product, waste, rework, by-products

The systematic layout of process flow diagram makes it easier to identify sources of potential contamination, suggests controls and provides a focal point of discussion and evaluation by the HACCP team.

25

Workshop 3. Process Flow Diagram and Plant Schematic

Objective of the workshop: To draw a complete process flow of a specified product and

the plant schematic based on the inputs of the HACCP team.

Emphasize the importance that the participants know the processes involved in the manufacture of their products.

In plant schematic, emphasize that prevention of cross-contamination is very important.

• Using the same grouping and the described product, draw a detailed Process

Flow Diagram.

• The process flow diagram will identify the important process steps (from

receiving to final shipping) used in the production of the specified product.

• Each process step should be considered in detail and the information expanded

to include all relevant process data:

– all ingredients and packaging used

– sequence of all process operations (including raw material addition)

– Time/temperature history of all raw materials and intermediate and final

products, including the potential delay.

– Flow conditions for liquids and solids

• Note: This process flow diagram will be used for the remainder of your course

exercises.

• Draw a plant schematic showing traffic flow of employees and materials

• Time limit: 30 minutes

• Group presentation : 10 minutes per team

26

Quiz 7.

1. Each process step should be considered in detail and the information expanded.

a. True

b. False

2. The process flow diagram will identify the important process steps (from

receiving to final shipping) used in the production of the specified product.

a. True

b. False

3. Process flow diagram

a. To include all ingredients and packaging used

b. Rework

c. By-products are indicated

d. All of the above


4. Plant schematic is not required to show areas of cross contamination.

a. True

b. False

5. Plant schematic shows traffic flow of employees and materials.

a. True

b. False

27


Step 5: On-site verification of process flow diagram and plant schematic

Time: 30 min

Learning objective:


To verify the completeness and veracity of the drawn process flow diagram

on the shop floor


Review Notes

Upon completion of the documentation of the process flow diagram, it should be

subjected to confirmation by the HACCP team to verify that it reflects the actual

process. This a step by step practice to check that all information regarding materials,

practices, controls etc., have been taken into consideration by the team during the

preparation of the process flow diagram. The best way of achieving this is a hands-on

walk through of the whole process in action. This should be performed by all members

of the HACCP team during all stages of operation over different periods and shifts.

If there are differences between the constructed flow diagram and the actual operation,

the HACCP team needs to assess and decide which process flow diagram will be

followed. The team can amend the flow diagram where appropriate. This task is very

important because if there are missed steps, a hazard or hazards may also be missed.

28

Quiz 8.

1. Who should conduct the on-site confirmation of the process flow diagram?

a. GM

b. Manager

c. HACCP team Leader

d. HACCP Team


2. On-site confirmation of the process flow diagram should be done:

a. On day shift only

b. All shifts

c. One batch only


3. HACCP Golden Rule

a. Miss a step, Miss a hazard

b. Miss the confirmation, miss the step

c. Miss the shift, miss the hazard


4. On-site confirmation should be done after hazard analysis.

a. True

b. False

5. If there are differences between the constructed flow diagram and the actual

operation, the HACCP team needs to assess and decide which process flow

diagram will be followed.

a. True

b. False

29


Step 6: Conduct hazard analysis

Time: 1 hr.



To identify potential food safety hazards that can most likely occur in the food under consideration

To evaluate the potential food safety hazards as to its likelihood of occurrence and severity to cause injury or illness.

To decide what hazards are significant and must be addressed in the HACCP plan


Review Notes

Effective hazard identification and hazard analysis are the keys to a successful HACCP

Plan. All significant or potential hazards that may occur in each ingredient and at each

stage of the process flow should be considered. Food safety hazards for HACCP

programs have been classified into three types of hazards:

Biological: typically foodborne bacterial pathogens such

as Salmonella, Listeria and E. coli, also viruses, algae, parasites and fungi.

Chemical: There are three types of chemical toxins found in foods: naturally

occurring chemicals, e.g. cyanides in some root crops, and allergenic

compounds in peanuts; toxins produced by micro-organisms, e.g. mycotoxins,

and algal toxins; and chemicals added to the commodity by man to control an

identified problem, e.g. fungicides or insecticides.

Physical: contaminants such as broken glass, metal fragments, insects or stones.

The HACCP team should list all of the hazards that may be reasonably expected to

occur at each step according to the scope of the HACCP study as indicated in the

verified process flow diagram.

30

The HACCP team should next conduct a hazard analysis to identify for the HACCP

plan, which hazards are of such a nature that their elimination or reduction to

acceptable levels is essential to the production of a safe food.

In conducting the hazard analysis, wherever possible, the following should be included:

the likely occurrence of hazards and severity of their adverse health effects (risk

analysis);

the qualitative and/or quantitative evaluation of the presence of hazards;

survival or multiplication of microorganisms of concern;

production or persistence in foods of toxins, chemicals or physical agents; and

condition leading to above

It is a way of organizing and analyzing the available scientific information on the nature

and size of the health risk associated with the hazard. Only those hazards considered

by the HACCP team to present an unacceptable risk of being present are taken forward

to Step 7, Principle 2.

Once a significant food safety hazard has been identified, then appropriate control

measures should be considered. These are any action or activity that can be used to

control the identified hazard, such that it is prevented, eliminated, or reduced to an

acceptable level. The control measure may also include training of personnel for a

particular operation, covered by GAP, GMP, and GHP.

Consideration should be given to what control measures, if any exist, can be applied to

each hazard. More than one control measure may be required to control a specific

hazard(s) and more than one hazard may be controlled by a specified control measure.

A tool that is available to the food safety team in hazard significance analysis and

assessment is the Hazard Significance Matrix.

Hazard Significance Matrix

31

Workshop 4: Hazard Analysis

Objective of the workshop: To let the participants experience how to conduct complete

hazard analysis of an identified product.

Emphasize that the HACCP Team needs to be knowledgeable on the product, its raw

materials, its packaging materials and the process involved in the manufacture of the

product.

Workshop procedure:

• Using the flow diagram of the product selected, list the potential food safety

hazards in the production of your chosen product.

• Using the Hazard Analysis Table provided, complete the columns under Principle

1.

• Time Limit: 1 hour

• Group Presentation: 20 min/group

Worksheet 4. Hazard Analysis

Principle1 Principle 2

Step/Input Hazard Cause Lik Sev S.F. Control

Measures

Q1 Q2 Q3 Q4 CP/CCP Reason

for

Decision

32

Quiz 9

1. HACCP Team needs to be knowledgeable on the product, its raw materials, its

packaging materials and the process involved in the manufacture of the product.

a. True

b. False

2. More than one control measure may be required to control a specific hazard(s) and more

than one hazard may be controlled by a specified control measure.

a. True

b. False

3. In conducting the hazard analysis, wherever possible, the following should be included:

a. the likely occurrence of hazards and severity of their adverse health effects

(risk analysis);

b. the qualitative and/or quantitative evaluation of the presence of hazards;

c. survival or multiplication of microorganisms of concern;

d. production or persistence in foods of toxins, chemicals or physical agents;

and condition leading to above

e. all of the above

4. Once a significant food safety hazard has been identified, then:

a. appropriate control measures should be considered

b. No action should be taken

c. Make it as CCP

d. All of the above


5. The HACCP team should list all of the hazards that may be reasonably expected to

occur at each step according to the scope of the HACCP study as indicated in the

verified process flow diagram.

a. True

b. False

33


Step 7: Determine Critical Control Point (CCP)

Time: 30 min



To identify the point or points in the process where the food safety hazards can best be controlled.

To identify criticality of control points through the use of a CCP decision tree


Review Notes

Each step in the process flow diagram, within the scope of the HACCP study, should be

scrutinized and the relevance of each identified hazard should be considered. It is also

important to remember the stated scope of the HACCP analysis at this stage. The team

must determine whether the hazard can occur at this step, and if so whether control

measures exist. If the hazard can be controlled adequately, and is not best controlled at

another step, and is essential for food safety, then this step is a CCP for the specified

hazard. A decision tree can be used to determine CCPs, and an example of the Codex

decision tree is shown below. However, the Decision tree is only a guide; the HACCP

team's judgment, expertise and knowledge of the process are the major factors in

establishing CCPs.

If a step is identified where a food safety hazard exists, but no adequate control

measures can be put in place either at this step or subsequently, then the product or

process should be modified at that step, or at any earlier or later stage, to include the

control measure.

34

Workshop 5: CCP Determination

Objective of the workshop: to let the participants experience how to determine CCP by

using the CCP Decision Tree.

Emphasize that Decision Tree is a tool which can assist in determining CCP. Practice

on the use of the tool needs to be done.

Workshop procedure:

• Using the Hazard Analysis Table, work on the columns under Principle 2.

• Use the Decision Tree as guide in deciding whether a step/input is a CCP or CP.

• Time Limit: 45 minutes

Worksheet 5: CCP Determination

Principle1 Principle 2

Step/Input Hazard Cause Lik Sev S.F. Control

Measures

Q1 Q2 Q3 Q4 CP/CCP Reason

for

Decision

35

Do preventive control measures exist?

Is the step specifically designed to eliminate or reduce the likely occurrence of a hazard to an acceptable

level? **

Could contamination with identified hazard(s) occur in excess of acceptable level(s) or could these

increase to unacceptable levels?**

Will a subsequent step eliminate identified hazard(s) or reduce likely occurrence to acceptable levels?**

NO YES

Is control at this step necessary for safety?

NO Not a CCP STOP*

YES

Modify steps in the process or product

YES

NO

NO YES

NO YES

Not a CCP STOP* CRITICAL CONTROL POINT (CCP)

* Proceed to the next identified hazard in the described process

** Acceptable and unacceptable levels need to be determined within the overall objectives in identifying the CCPs of the HACCP plans

Not a CCP STOP*

Q2

Q3

Q4

Q1

Decision Tree to Identify CCP

36

Quiz 10.

1. A “CCP” is defined by Codex as

a. The act of conducting a planned sequence of observations or measurements

of control parameters to assess whether a CCP is under control

b. Any action and activity that can be used to prevent or eliminate a food safety

hazard or reduce it to an acceptable level

c. A step at which control can be applied and is essential to prevent or eliminate

a food safety hazard

d. Hazard analysis control points

e. A monitoring step

2. The decision tree

a. Should always be followed

b. Should be used as a guide only

c. Cannot be used to determine CCP

d. Consists of a logical series of questions that are asked for each hazard

identified

e. b & d

3. If a step is identified where a food safety hazard exists, but no adequate control

measures can be put in place either at this step or subsequently, then

a. The product or process should be modified at that step, or at any earlier or

later stage, to include the control measure.

b. Nothing should be done

c. Stop the analysis

d. All of the above


4. There may be a process which has no identified CCP.

a. True

b. False

5. The HACCP team's judgment, expertise and knowledge of the process are the

major factors in establishing CCPs.

a. True

b. False

37


Step 8: Establish Critical limit for each CCP

Time: 30 min

Learning objective:


To apply quantifiable values in controlling identified critical control point or CCP.


Critical limit is a prescribed tolerance (a specification) for a control measure that must

not be exceeded if the hazard is to be controlled at that particular step in the process.

Criteria often used include measurements of temperature, time, moisture level, pH,

water activity, and sensory parameters such as visual appearance. In the case of

mycotoxins for example, they may include the moisture content or the temperature of

the product. All critical limits, and the associated permissible tolerances, must be

documented in the HACCP Plan Worksheet and included as specifications in operating

procedures and work instructions.

If the critical limit for a control measure is exceeded, hazard may exist. Hence it is vital

that they are accurate. Stating the reason why a critical limit is selected is called

justification. Justification could relate to customer requirements, regulatory

requirements. Codes of practice, or food standards. Validating a critical limit is proving

that the critical limit established, in fact, control the hazard.

Where HACCP guidance developed by experts has been used to establish critical limits,

care should be taken to ensure that these limits fully apply to the specific operation,

product or groups of products under consideration. These critical limits should be

measurable.

38

Workshop 6: Validate Critical Limit

Objective of the workshop: To prove that the critical limits that have been choses really control the hazard.

Emphasize that validation of critical limits may involve experimental studies.

Workshop procedure:

• Using the Critical Limit Validation Record, describe the procedures that you will undertake to validate the critical limit that you have established per CCP.

Worksheet 6: Critical Limit Validation Worksheet

Step/Input Critical Limit Justification Details

39

Quiz 11.

1. Select the correct statement

a. Critical limits establish the difference between safe and unsafe

b. If a critical limit is exceeded, a hazard may exist.

c. Critical limits must be justified and validated.

d. All of the above statements are correct.

e. None of the above statement is correct.

2. If the critical limit for a control measure is exceeded, hazard may exist.

a. Hence it is vital that they are accurate.

b. Hence , it is vital that they are validated

c. Hence it is vital that they are measurable

d. All of the above are correct

e. None of the above statement is correct

3. Which statement is not correct?

a. Stating the reason why a critical limit is selected is called justification.

b. Justification could relate to customer requirements, regulatory

requirements. Codes of practice, or food standards.

c. Validating a critical limit is proving that the critical limit established, in fact,

control the hazard.

d. Critical limit need not be validated

e. All of the above

4. Who should validate the critical limit?

a. Competent and trained individual

b. Untrained operator

c. COO

d. The whole HACCP Team

e. All of the above

5. All critical limits, and the associated permissible tolerances, must be

documented in the HACCP Plan Worksheet and included as specifications in

operating procedures and work instructions.

a. True

b. False

40


Step 9: Establish a Monitoring System for each CCP

Time: 30 min



To control the identified critical control point through conduct of planned sequence of observations.

To document the procedures on how to conduct the plan in the control of operation.

To record monitoring results


Review Notes

Monitoring is the mechanism for confirming that critical limits at each CCP are being

met. The method chosen for monitoring must be sensitive and produce a rapid result so

that trained operators are able to detect any loss of control of the step. This is

imperative so that corrective action can be taken as quickly as possible so that loss of

product will be avoided or minimized.

Monitoring can be carried out by observation or by measurement, on samples taken in

accordance with a statistically based sampling plan. Monitoring by visual observation is

basic but gives rapid results, and can therefore be acted upon quickly. The most

common measurements taken are time, temperature and moisture content.

41

Workshop 7: Monitoring Procedure

Objective of the workshop: To establish timely and appropriate monitoring procedure

per CCP.

Emphasize that monitoring should be done by trained personnel and that monitoring is

done to know when a CCP is out of control and that corrective action can be taken.

Also, it helps identify problems before they occur, pinpoint the cause of the problem,

help verify the HACCP plan and help prove due diligence.

Workshop procedure:

Using the Hazard Analysis Table, work on the columns under Principle 3 &4.

Using the established Critical Limit, develop a monitoring procedure per

CCP


Worksheet 7. Monitoring Procedure

P1 P2 P3 P4 P5 P6 P7

Step/Input Hazard Control

Measure

CCP

Type

Critical

Limit

Monitoring Corrective

Action What & Who

Verification

What & Who

Records

What Where How When Who Immediate

Preventative

42

Quiz 12

1. Monitoring involves:

a. Planning when to collect information

b. Using unbiased collectors

c. Proving due diligence

d. Defining where to collect data

e. All of the above

f. a, b & d

2. In HACCP, the only appropriate type of monitoring is:

a. Objective- through measurement

b. Subjective through observation using our senses

c. Discontinuous – at time intervals

d. Continuous

e. All of the above

3. Who should monitor?

a. Individual who is trained to do monitoring

b. CEO

c. HACCP Team leader

d. All of the above


4. In monitoring, recording of results should be:

a. On time

b. tampered

c. Done after the shift

d. Done before audits

e. All of the above

5. In monitoring, testing and measuring equipmnet must be:

a. Available

b. Calibrated

c. Missing

d. In good working condition

e. a, b &d

43


Step 10: Establish Corrective Actions

Time: 30 min



• Determine appropriate corrective actions to revert the process back to its normal operation

• Determine proper product disposition of non-conforming products

• Control non-conforming products


Review Notes

If monitoring indicates that critical limits are not being met, thus demonstrating that the

process is out of control, corrective action must be taken immediately. The corrective

action should take into account the worst case scenario, but must also be based on the

assessment of hazards, risk and severity, and on the final use of the product.

Operators responsible for monitoring CCPs should be familiar with and have received

comprehensive training in how to effect a corrective action.

Specific corrective actions must be developed for each CCP in the HACCP system in

order to deal with deviation when they occur.

Corrective actions must ensure that the CCP has been brought back under control.

They must also include appropriate disposition of any affected product. Whenever

possible an alarm system should be introduced which will activate when monitoring

indicates that the critical limit is being approached. This is usually included in the

features of some equipment such as metal detector and X-ray machine. Corrective

action can then be applied to pre-empt a deviation and prevent the need for any product

wastage through disposal.

44

Workshop 8: Corrective Actions

Workshop objective: For the participants to act as HACCP team and formulate

corrective actions in case there are deviations in critical limit.

Emphasize that the HACCP team needs to ensure that CCP operator is effectively

trained on the corrective action procedures.

Workshop procedure:

• Using the HACCP Table, establish Corrective actions if there are deviations in the CCPs

• Write the Corrections or Immediate Actions on process and affected products

• Write the Corrective Actions based on root cause analysis – These are long term actions

Time Limit: 30 minutes

Worksheet 8: Corrective Action Procedure

P1 P2 P3 P4 P5 P6 P7

Step/Input Hazard Control Measure

CCP Type

Critical Limit

Monitoring Corrective Action What &

Who

Verification What & Who

Records


Preventative

Assignment:

1. Each participant need to submit the Hazard analysis of the product assigned to

them. Translate the Hazard Analysis Worksheet in Word or Excel File.

2. Each participant need to submit the HACCP Plan for the product assigned to them.

3. This will form 20% of the rating per participant. Due date of submission is on the

3rd day before the exam.

45

Quiz 13.

1. If monitoring indicates that critical limits are not being met, thus demonstrating

that the process is out of control, corrective action must be taken:

a. Later

b. Tomorrow

c. After the production shift

d. Immediately


2. Specific corrective actions must be developed for each CCP in the HACCP

system in order to deal with deviation when they occur.

a. True

b. False

3. If there are deviations, there should be:

a. Corrections

b. Corrective Actions

c. Verification

d. a & b

e. a, b & c

4. Which of the following statement is not correct?

a. Corrective actions must ensure that the CCP has been brought back under control.

b. They must also include appropriate disposition of any affected product.

c. Whenever possible an alarm system should be introduced which will activate

when monitoring indicates that the critical limit is being approached. This is

usually included in the features of some equipment such as metal detector

and X-ray machine.

d. Corrective action can then be applied to pre-empt a deviation and prevent the

need for any product wastage through disposal.

e. All of the above statement are incorrect

5. Who formulates the corrective action?

a. Operator

b. HACCP Team Leader

c. HACCP team

d. COO

e. All of the above

46


Step 11: Establish Verification Procedures

Time: 30 min



• To make practical plans to check how well the HACCP Plan is working in practice.

• To validate the established HACCP Plans control parameters

• To challenge the effectiveness of the established HACCP system.

• To do continual improvement of the HACCP system


Review Notes

Once the HACCP plan has been drawn up, and all of the CCPs have been validated,

then the complete plan must be verified and reviewed at regular intervals. This should

be the responsibility of the HACCP team. The appropriateness of CCPs and control

measures can thus be determined, and the extent and effectiveness of monitoring can

be verified. Microbiological and/or alternative chemical tests can be used to confirm that

the plan is in control and the product is meeting customer specifications. A formal

internal auditing plan of the system will also demonstrate an ongoing commitment to

keep the HACCP plan up to date, as well as representing an essential verification

activity.

Ways in which the system can be verified include:

validating HACCP e.g. validating HACCP plan, prerequisite programs,

methodology and 12 steps of Codex has been implemented effectively

reviewing of monitoring records

collecting samples for analysis by a method different from the monitoring

procedure

interviewing staff, especially CCP operators

observing operations at CCPs

checking CCP monitoring records

internal audit by the HACCP team

formal audit by independent person

47

Quiz 14.

1. Verification is:

a. Auditing the HACCP Plan

b. Testing the finished product to see if it meets the customer’s requirements

and/or food safety parameters.

c. Examining the HACCP plan to ensure that it is capable, as written, of

producing food that is safe to eat/good quality, and that it is being followed.

d. All of the above


2. Validation is part of/or an element of verification.

a. True

b. False

3. Who is/are the most responsible person/s for verification of the HACCP system?

a. Manager

b. COO

c. Operator

d. Certifying Body

e. HACCP Team

4. Verification is a means of HACCP improvement.

a. True

b. False

5. Verification of the HACCP system is:

a. Optional

b. Should be done at least once a year

c. Should be done if asked by the COO only

d. Should be done externally


48


Step 12: Establish Documentation and Record Keeping

Time: 30 min



• To provide evidence of conformance to requirements

• To provide evidence of the effective operation of the HACCP system

• To formalize a plan on how to control HACCP related documents and other food safety related records


Record keeping is an essential part of the HACCP process. It demonstrates that the

correct procedures have been followed from the start to the end of the process, offering

product traceability. It provides a record of compliance with the critical limits set, and

can be used to identify problem areas. Furthermore, the documentation can be used by

a company as evidence of due diligence.

Records that should be kept include: all processes and procedures linked to GMP,

GHP, and CCP monitoring, deviations, and corrective actions.

Documents should also include those that recorded the original HACCP study, e.g.

hazard identification and selection of critical limits, but the bulk of the documentation will

be records concerned with the monitoring of CCPs and corrective actions taken. Record

keeping can be carried out in a number of ways, ranging from simple check-lists, to

records and control charts. Manual and computer records are equally acceptable, but a

documentation method should be designed that is appropriate for the size and nature of

the enterprise.

49

Workshop 9: Verification and Record Keeping

Workshop objectives:

To review the monitoring of the CCP and assess if HACCP is implemented

according to plan and is effective

To identify the needed HACCP records to support the HACCP system

specifically the monitoring records

Emphasize that monitoring is very important and that monitoring records are objective

evidences of the HACCP implementation and are always the subject of audit.

Workshop procedure:

• Using the HACCP Table, complete Principles 6 & 7 sections.

• Establish the verification procedures

• Name the specific records used in the monitoring and verification procedures

• Time: 30 min

Worksheet 9. Verification and Record Keeping

P1 P2 P3 P4 P5 P6 P7


CCP Type

Critical Limit


Who


Records


Preventative

50

Workshop 10: HACCP Plan and Final Flow Diagram

Workshop objective: To let the participants consolidate the results of the previous

workshops into a HACCP Plan and indicate the identified CCP on the process flow

chart.

Emphasize that the HACCP Team should be trained on the terminologies of HACCP

and the important contents of the HACCP Plan.

Workshop procedure:

• Using the completed HACCP Table, prepare a HACCP Plan for the identified

CCP in your process flow diagram.

• For each CCP, establish Critical Limit, Monitoring procedure , Corrective Action,

Verification procedure and required HACCP records.

• Draw a Flow Diagram indicating the CCP


• Group Presentation: From Flow Diagram to HACCP Plan (20 minutes per team)

Worksheet 10. HACCP Plan

P1 P2 P3 P4 P5 P6 P7


CCP Type

Critical Limit


Who


Records


Preventative

51

Quiz 15.

1. Hazard analysis worksheets are not important and can be thrown away after encoding.

a. True

b. False

2. Documents that are required in HACCP system:

a. HACCP Plan

b. GMP or PRP documents

c. Policies, Guidelines and Procedures

d. Specifications

e. All of the above

3. Records that are important in HACCP system

a. Training records of the HACCP team and CCP operators

b. Hazard analysis records

c. Test results for raw materials, packaging materials, finished goods

d. CCP monitoring records

e. All of the above

4. Documents and records pertaining to operations and HACCP:

a. Should be controlled

b. Not filed

c. Not kept

d. Written in pencil


5. Records and documents are important because:

a. It demonstrates that the correct procedures have been followed from the start

to the end of the process, offering product traceability.

b. It provides a record of compliance with the critical limits set, and can be used

to identify problem areas.

c. Documentation can be used by a company as evidence of due diligence.

d. All of the above


52

Session 5: HACCP Pointers

Time: 30 min



Learn the steps to HACCP program implementation

Appreciate the challenges and formulate solutions on HACCP program implementation


53

Workshop 11: HACCP Program: Challenges and Solutions

Workshop objective: To anticipate potential problems and formulate preventive measures

Emphasize that realistic identification and assessment of the problem is very important to be ready with the preventive measures to prevent occurrence or mitigate the situation.

Workshop Procedure:

• Group the participants

• What are the challenges and possible solutions to the problems and challenges

• Identify the resource needed to address the challenges

• Identify responsibilities

Worksheet 11. HACCP Challenges and Solutions

Challenges Solutions Resource Needs Responsibility

Submission of Assignment: Hazard analysis Worksheet and HACCP Plan per participant (20% of the rating)

Exam (80% of the rating)

Examination

Time: 20 minutes

54

Session 6: Observation Tour to a HACCP-certified Company

Time: ½ day


Objective of the Activity:

a. To gain first–hand information from a HACCP implementing companies through interview with Top Management and HACCP Team

b. To view live HACCP documents

Procedure:

The trainer needs to arrange a half day tour to a HACCP-certified company before the start of the training so that appropriate schedule can be allotted for the activity.

Course Evaluation

Time: 10 min

References

1. Codex Alimentarius Food Hygiene Basic Texts. 1997. Food and Agricultural Organization of the United Nations. World Health Organization, Rome.

2. FAO/IAEA Training and Reference Centre for FAO/IAEA training and Reference Center for Food and Pesticide Control. 2001. Food Manual on the application of the HACCP system in mycotoxin prevention and control. Food and Agriculture Organization of the United Nations, Rome.

3. Loken, J.K. 1995. The HACCP Food safety Manual. John Wiley & Sons. New York. pp318

Date post:	14-Aug-2020
Category:	Documents
Upload:	others
View:	2 times
Download:	0 times