Chemical Quality Assurance

Module 1. Introduction to chemical quality assurance

Lesson 2
HAZARD ANALYSIS AND CRITICAL CONTROL POINTS (HACCP)

2.1 Introduction

A system was needed that enabled the production of safe, nutritional products for use by National Aeronautics and Space Administration (NASA) starting in the late 1950’s to feed future astronauts. So, the Pillsbury company, in 1959, embarked on work with NASA to develop a process of identifying the critical points in the process at which these hazards were most likely introduced into product and therefore should be controlled. The acronym HACCP, which stands for Hazard Analysis and Critical Control Point, is one which evokes 'food safety'. Originally it was developed to ensure microbiological safety of foodstuffs, but now HACCP has been broadened to include chemical and physical hazards in foods. The recent growing worldwide concern about food safety by public health authorities, consumers and other concerned parties, and the continuous reports of foodborne outbreaks have been a major impetus in the application of the HACCP system. HACCP is a systematic preventative approach to food safety that addresses physical, chemical and biological hazards as a means of prevention rather than finished product inspection. HACCP is used in the food industry to identify potential food safety hazards, so that key actions, known as Critical Control Points (CCP's) can be taken to reduce or eliminate the risk of the hazards being realised. The system is used at all stages of food production and preparation processes.

2.2 Necessity of HACCP

Food safety has been of concern to humankind since the dawn of history, and many of the problems encountered in our food supply go back to the earliest recorded years. Many rules and recommendations advocated in religious or historical texts are evidence of the concern to protect people against foodborne diseases and food adulteration. However, in recent decades this concern has grown. There are many reasons for this as follows:

• Foodborne diseases remain one of the most widespread public health problems in the contemporary world, and an important cause of reduced economic productivity, despite progress in food science and technologies. The World Declaration on Nutrition, adopted by the FAO/WHO International Conference on Nutrition (Rome, December 1992), emphasizes that hundreds of millions of people suffer from communicable and noncommunicable diseases caused by contaminated food and water.

• The increasing incidence of many foodborne diseases, e.g. salmonellosis and campylobacteriosis, in many regions of the world.

• Increased knowledge and awareness of the serious and chronic health effects of foodborne pathogens.

• The possibility of detecting minute amounts of contaminants in food, due to advances in scientific and analytical methods.

• Emerging foodborne pathogens, e.g. Listeria monocytogenes, verocytotoxin producing E. coli, Campylobacter spp, foodborne nematodes, etc.

• An increase in the number of vulnerable people, such as the elderly, immune compromised individuals, the undernourished, and individuals with other underlying health problems.

• Increased awareness of the economic consequences of foodborne diseases.

• Industrialization and increased mass production, leading to increased risks of food contamination.

• The considerably larger numbers of people affected in foodborne disease outbreaks as a result.

• Urbanization, leading to a more complex food chain, and thus greater possibilities for food contamination.

• New food technologies and processing methods, causing concern either about the safety of the products themselves or the eventual consequences due to inappropriate handling during preparation in households or food service/catering establishments.

• Changing lifestyles, depicted by an increasing number of people eating outside the home, in food service or catering establishments, at street food stalls, or in fast-food restaurants.

• Responsibility for food preparation shared between family members who are not always aware of food safety rules.

• Increased worldwide tourism and international trade in foodstuffs, leading to a greater exposure to food borne hazards from other areas.

• Increased contamination of the environment.

• Increased consumer awareness of food safety.

• Lack of or decreasing resources for food safety.

In the light of the above reasons, there is a increasing concern about food safety, the lack of sufficient resources, and the recognition of the limitations of traditional approaches to food safety assurance which have accentuated the need for a cost-effective food safety assurance method. The HACCP system has proven to be such a system.

2.3 HACCP Terminology

a) Hazard

A biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.

b) Contamination

Exposure of food products to hazards, which can cause illness, disease, or even death.

c) Control (verb)

To take all necessary actions to ensure and maintain compliance with criteria established in the HACCP plan.

d) Control (noun)

The state wherein correct procedures are being followed and criteria are being met.

e) 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.

f) Corrective action

Any action to be taken when the results of monitoring at the CCP indicate a loss of control.

g) Control Point

Any step at which biological, chemical, or physical factors can be controlled.

h) Critical Control Point (CCP)

An Essential Point at which Control can be applied so that a Food Safety Hazard can be PREVENTED, ELIMINATED, or REDUCED to an Acceptable Level. It is the last step in the flow of food where a hazard can be controlled.

i) Critical Limit

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 to an acceptable level the occurrence of a food safety hazard.

j) Deviation

Failure to meet a critical limit.

k) Flow diagram

A systematic representation of the sequence of steps or operations used in the production or manufacture of a particular food item.

l) HACCP (Hazard Analysis Critical Control Point)

A system designed to identify, evaluate, and control of the potential food safety hazards.

m) HACCP Plan

The written document to describe the procedures based on the principles of HACCP and specific conditions.

n) Risk

Probability that conditions will lead to a hazard.

o) Prerequisite Programs

Procedures, including Good Manufacturing Practices that address operational conditions providing the foundation for the HACCP system.

p) Monitor

To conduct a planned sequence of observations or measurements to assess whether a CCP is under control and to produce an accurate record for future use in
verification.

q) Corrective Action

Procedures followed when a deviation occurs.

r) Step

A point, procedure, operation or stage in the food chain including raw materials, from primary production to final consumption.

s) Validation

Obtaining evidence that the elements of the HACCP plan are effective.

t) Verification

Those activities, other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to the plan.

2.4 What is Hazard?

It is the potential to cause harm to the consumer (the safety aspect) or the product (spoilage aspect).The hazard associated with food safety can be of physical (extraneous matter), chemical (pesticides, insecticides, radionucleides, carcinogenic components, allergens) and biological nature (pathogens, microbial toxins).

2.4.1 Classification of hazards

Based on process and basic ingredients hazards can be classified as follows:

• A food product containing sensitive ingredient

• Manufacturing process does not contain controlled processing step

• There is substantial potential for abuse in distribution or in consumer handling

On the basis indicated above with different combinations of hazard class, as positive (+) or no hazard as (0) is designated and then it is categorized as

Category 1

Special category for products meant for sensitive consumers like baby foods.

Category 2

Which contain either of two hazards as given above

Category 3

When one hazard is present

Category 4

When no hazard is present

The probability that a hazard will be realized is called risk and is assessed as low, medium, high, it is identified by three modes.

2.4.2 Failure modes effect analysis

It is applied to the process and includes systematic listing of each step of the process and then listing every mode of failure of these steps that can affect the quality of the end product.

2.4.3 Fault trees

Fault which may occur in the final product is stated and each process step involved in manufacturing that product is identified with reference to its relevance in causing the stated fault.

2.4.4 Delphi technique

Where a group of experts from different disciplines arrive at a consensus regarding the risk attached to a process or a product. This may be done through a questionnaire circulated to process workers followed by discussion on the answers by the group of experts and possibly more questions and discussion until an informed decision is reached on the risks involved.

2.5 Types of Hazard

2.5.1 Physical hazard

• Hairs

• Stones

• Stems and seeds

• Bones fragments and feathers

• Matchsticks

• Jewelery

• Nails nuts and bolts

• Buttons

• Bidis and cigarettes

2.5.2 Chemical hazards

• Cleaning agents

• Adulterants

• Excess of permissible additive

• Non permissible additive

• Veterinary residue

• Pesticides residue

2.5.3 Biological hazards

2.5.3.1 Invisible

• Bacteria

• Yeast

• Protozoa

• Molds

• Viruses

2.5.3.2 Visible

• Fly

• Worms

• Cockroaches

• Caterpillars

• Weevils

2.6 Principles of HACCP

HACCP is based around seven established principles.

2.6.1 Principle 1

Conduct a hazard analysis: Plants determine the food safety hazards and identify the preventive measures the plant can apply to control these hazards. A food safety hazard is any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.

2.6.2 Principle 2

Identify critical control point: A critical control point (CCP) is a point, step, or procedure in a food process at which control can be applied and, as a result, a food safety hazard can be prevented, eliminated, or reduced to an acceptable level.

2.6.3 Principle 3

Establish critical limits for each critical control point: A critical limit is the maximum or minimum value to which a physical, biological, or chemical hazard must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level.

2.6.4 Principle 4

Establish critical control point monitoring requirements: Monitoring activities are necessary to ensure that the process is under control at each critical control point. In the United States, the Food Safety and Inspection Service (FSIS) is requiring that each monitoring procedure and its frequency be listed in the HACCP plan.

2.6.5 Principle 5

Establish corrective actions: These are actions to be taken when monitoring indicates a deviation from an established critical limit. The final rule requires a plant's HACCP plan to identify the corrective actions to be taken if a critical limit is not met. Corrective actions are intended to ensure that no product injurious to health or otherwise adulterated as a result of the deviation enters commerce.

2.6.6 Principle 6

Establish record keeping procedures: The HACCP regulation requires that all plants maintain certain documents, including its hazard analysis and written HACCP plan, and records documenting the monitoring of critical control points, critical limits, verification activities, and the handling of processing deviations.

2.6.7 Principle 7

Establish record keeping procedures the HACCP system is working as intended: Validation ensures that the plans do what they were designed to do; that is, they are successful in ensuring the production of safe product. Plants will be required to validate their own HACCP plans.

Verification ensures the HACCP plan is adequate, that is, working as intended. Verification procedures may include such activities as review of HACCP plans, CCP records, critical limits and microbial sampling and analysis. FSIS is requiring that the HACCP plan include verification tasks to be performed by plant personnel. Verification tasks would also be performed by FSIS inspectors. Both FSIS and industry will undertake microbial testing as one of several verification activities.

2.7 Implementation of HACCP

HACCP is a system that assists organizations to identify potential food safety hazards in the entire food supply chain and to take preventive measures for their control. HACCP focuses on the prevention of hazards rather than relying on end product testing. The following sequence of 12 steps, included in the guidelines developed by the Codex Committee on Food Hygiene, is the recommended approach to develop a HACCP programme.

2.7.1 Step 1 Assemble HACCP team

Set up a multi-disciplinary team that includes representatives from production, sanitation, quality control, food microbiology, etc. This team should be assigned specific segments of the food chain to be covered in the HACCP system, and be entrusted with developing a HACCP system as described from Step 2 onwards. Top management must give its full support to the team. If the required expertise is not available within the company, bring in help from a consultant.

2.7.2 Step 2 Describe product

Draw up a full description of the product for which the HACCP plan is to be prepared, including product composition, structure, processing conditions, packaging, storage and distribution conditions, required shelf life, instructions for use, etc.

2.7.3 Step 3 Identify intended use

Identify the intended use of the product by the end-user or consumer. You need to determine where the product will be sold as well as the target group (e.g. institutional catering, homes for senior citizens, hospitals, etc.)

2.7.4 Step 4 Construct flow diagram

You need to carefully examine the product/process and produce a flow diagram around which to base the HACCP study. Whatever the format you choose, study all the steps involved in the process – including delays during or between the steps from receiving the raw material to placing the end-product on the market – in sequence, and present them in a detailed flow diagram with sufficient technical data. In the diagram, you might also want to include the movements of raw materials, products, wastes, a plan of working premises, equipment layout, product storage and distribution, and of employee moves or changes.

2.7.5 Step 5 On-site confirmation of flow diagram

The HACCP team should confirm the processing operation against the flow diagram during all stages and hours of operation and amend the flow diagram if necessary.

2.7.6 Step 6 List all potential hazards associated with each step, conduct a hazard analysis, and consider any measures to control hazards

Using the flow diagram, the team should list all the hazards – biological, chemical or physical – that may reasonably be expected to occur at each process step, and describe the preventive measures that can be used to control such hazards (for example, the use of air curtains, hand and feet washing at entrance to processing areas, wearing of head gear, use of good manufacturing practices [GMP]/standard operating procedures [SOP]/ sanitation standard operating procedures [SSOP], etc.)

2.7.7 Step 7 Determine critical control points (CCPs)

You may wish to use a decision tree with “yes” or “no” answers to facilitate the determination of CCPs (See Annex A). When applying the decision tree, you need to remain flexible and use common sense to avoid, wherever possible, unnecessary control points throughout the whole manufacturing process. If you identify hazards at a step where control is necessary for safety and no preventive measures exist at that step, you need to modify the process at that step, or at an earlier or a later stage, to include a preventive measure. For example, in a slaughterhouse, covering carcasses with a sanitized cloth to prevent infection by flies is a preventive measure at the carcass stage, which substitutes for a preventive measure such as washing the prepared meat at the next stage, as it will not be possible to disinfect the meat at this stage, i.e., during cutting or mincing operations.
ii) In dairy industry take the case of Paneer which contains as high as 70% moisture which is conducive for microbial growth. Studies carried out on microbial quality of paneer have indicated that it is often contaminated with Staphylococcus aureus and Coliforms. The HACCP has been applied to identify the Critical Control Point for Coliforms and Staphylococcus contamination.The analysis of various samples from raw material to the final product had indicated that the contamination is due to food handlers using bare hands to remove the excess water in paneer (NIN, Hyderabad; Unpublished observations). The food handlers were informed about the importance of personal hygiene and they were asked to wash their hands with soap before touching the paneer, and the quality of paneer was tested after the intervention. Results indicated that cleaning of hands with soap before starting the operation drastically reduced Coliform contamination in the final product.

2.7.8 Step 8 Establish critical limits for each CCP

You need to establish critical limits for each CCP. They are normally derived from specifications included in the food legislation of a country or in national or international standards (e.g. moisture levels in milk powder, or pH level and chlorine limit in potable water, etc.). When limits are not taken from regulatory standards (e.g. frozen storage temperature) or from existing and validated guides of good manufacturing practices, the HACCP team should ascertain the validity of such limits relative to the control of identified hazards and critical points.

2.7.9 Step 9 Establish a system of monitoring each CCP

Monitoring is the scheduled measurement or observation of a CCP to determine conformance to its critical limits. The monitoring procedures must be able to determine loss of control, if any, at the CCP (e.g. improper control of the temperature that may lead to faults in the functioning of a pasteurization unit in a dairy plant). Monitoring for CCPs needs to be done rapidly, as they later relate to on-line processes, and there is usually no time for lengthy analytical testing. Physical and chemical measurements are often preferred as these can be done rapidly and can frequently indicate microbiological control of the product. The programme of observations or measurements should properly identify for each critical point

• Who is to perform monitoring and checking
• When monitoring and checking are performed; and
• How monitoring and checking are performed.

All records and documents associated with monitoring CCPs must be signed by the person(s) doing the monitoring.

2.7.10 Step 10 Establish corrective actions

The HACCP team should develop specific corrective actions and document them in the HACCP plan for each CCP in the HACCP system so that they can deal with deviations when they occur. Such corrective action should include:

• Proper identification of the person(s) responsible for implementation of a corrective action;
• Actions required to correct the observed deviation;
• Action to be taken with regard to products manufactured during the period when the process was out of control and written records of measures taken.

The actions must ensure, for example, that the CCP has been brought under control, that procedures or conditions that created the out-of-control situation have been corrected, and the food affected, disposed off safely, etc.

2.7.11 Step 11 Establish verification procedure

Develop a verification procedure to ensure that the HACCP system is working correctly. The procedure should include the frequency of verification, which should be conducted by a responsible and independent person. Examples of verification include auditing methods, random sampling and analysis, etc.

2.7.12 Step 12 Establish documentation and record keeping

The HACCP system requires efficient documentation and accurate record keeping. For example, hazard analysis, identified CCPs and their limits (including revisions, if any) should be documented. Examples of records are CCP monitoring records, records of deviation found and corrective action taken on them, etc.

Annexure- A

Fig. 2.1 Example of decision tree to identify CCPS

2.8 Example of HACCP Worksheet

Fig. 2.2 Example of HACCP Worksheet

Process steps will help in identifying the CCPs