Hazard Analysis Control Critical Point ( HACCP)

Do we really need it ?


Por: Oscar Acosta, Puerto Rico (ZJX Food Safety Consulting)

American Society for Quality HACCP Auditor and GMP Professional

Every year millions of people get sick, hospitalize, and even die around the world as a consequence of foodborne diseases. The Centers for Disease Control and Prevention (CDC) estimate that 48 million people get sick, 128,000 are hospitalized and 3,000 die of foodborne diseases in the United States. World Health Organization (WHO) estimates that worldwide foodborne and waterborne diarrheal diseases taken together kill about 2.2 million people annually.

Foodborne illnesses are a burden on public health and contribute significantly to the cost of health care and to the economy of each country. It poses approximately $77.7 billion economic burden in the United each year for medical costs, productivity losses, and illness-related death. This is a significant public health burden that is largely preventable. All this suffers and burden cost can be avoided.

What is HACCP?, Why is HACCP Important?, What are the benefits of implementing HACCP system?, Is HACCP New? How does HACCP work in food production?, What is the relation between HACCP system and ISO22000 standard?, and Is HACCP a cost or benefit? These are some of the questions that come to our mind when we talk about HACCP.

HACCP is a food safety management system(FSMS) that is increasingly utilized around the world in all aspects of the food industry. The system relies on process controls to minimize food safety risks in the food processing industry. HACCP is not zero risk and does not eliminate the possibility of a hazard getting into the food product. HACCP attempts to decrease that possibility to an acceptable level.

The food industry has faced new challenges such as the increasing number of emerging pathogenic bacteria (ex: E. coli 0157:H7), hygiene standards and increasing public concern on chemical contamination of food (ex: allergens) among others. Hazard Analysis and Critical Control Point (HACCP) has shown during years be the most effective system to ensure and managing food safety. Its approach focuses on preventing potential problems that are critical to food safety through monitoring and controlling each step of the process, applying science-based controls throughout the food chain from the Farm to Table.

Foodborne hazards controlled through HACCP include physical, chemical, and microbiological agents that have the potential to cause adverse health effects when food is consumed. Although consumers have historically been most concerned with chemical hazards such as pesticide residues and heavy metal contamination, microbiological contaminants and allergens have been the recent focus of public health. HACCP allows food producers to offer a safer product to the consumers, protecting their health and life.

In some country like U.S., the Food and Drug Administration (FDA) used HACCP-based principles when establishing low-acid food canning regulations in the 1970s. In 1995, the FDA issued regulations that made HACCP mandatory for fish and seafood products, and in 2001 it issued regulations for mandatory HACCP in juice processing and packaging plants. In addition, a voluntary HACCP program was implemented in 2001 for Grade A fluid milk and milk products under the cooperative federal/state National Conference on Interstate Milk Shipments program. In 1998, USDA’s Food Safety and Inspection Service mandated HACCP be used in the nation’s meat and poultry processing plants. The HACCP system has been also implemented under regulations in Europe and in other countries (e.g., Canada, Australia, and New Zealand) and is a high priority program under Codex Alimentarius which is the world food standards authority.

In Europe, EU legislation has set strict requirements on the hygiene of food entering the market. To reach the acceptable food safety level, all food processors, packagers and distributors, whose food eventually is intended for the EU market, must use appropriate hygiene practices. This practice hygiene procedure has to be based on HACCP methodology.

HACCP Brief History

HACCP was developed in the late 1950s by a team of food scientists and engineers from The Pillsbury Company, the Natick Research Laboratories, and the National Aeronautics and Space Administration. The team developed a system designed to build quality into the product to ensure food safety for the manned space program.

In 1971, Pillsbury presented this concept at the National Conference on Food Protection sponsored jointly by the Food and Drug Administration (FDA) and the American Public Health Association. Initially, HACCP consisted of three principles:
1.    Conduct a hazard analysis.
2.    Determine critical control points.
3.    Establish monitoring procedures.

Through experience with its new management system, Pillsbury quickly adopted two additional principles.
4.    Establish corrective actions to take when deviations occur at a CCP.
5.    Establish critical limits to be enforced at CCPs.
In 1989, The National Advisory Committee on Microbiological Criteria for Foods (NACMCF) published the first HACCP document. This standard codified the practice of HACCP to date, including seven principles.

In 1993, the Codex Alimentarius Commission issued its first HACCP standard, which provided the first international definition for HACCP. In the same year, NACMCF revised its guidance standard, thus codifying the currently used five preliminary steps and seven principles of HACCP.

The five preliminary steps were a critical addition to HACCP. The first step required that HACCP be developed by a cross-functional team. Preliminary steps two through five enabled the team to develop a detailed understanding of the customer, product, and process used to manufacture the product. In 1997, both Codex and NACMCF revised their standards. As part of the revision process, NACMCF harmonized the U.S. definition of HACCP with the Codex definition. Pre-
Requisite Program (PRP) was identified as necessary for the successful implementation and maintenance of the HACCP process.

The acceptance of HACCP changed third party audit systems internationally. In the United States, the “sanitation audit” was expanded to include Pre-
Requisite Program (PRP) and HACCP. In Europe, private food safety audit schemes were developed. These schemes included the preliminary steps and principles of HACCP, along with PRP and elements from the 1994 version of ISO (International Organization for Standardization) 9001, a standard that described the requirements of a Food Safety Management System (FSMS). ISO 22000 is a standard developed by the International Organization for Standardization which deals with food safety, it is a general derivative of ISO 9000. The ISO 22000 family of International Standards addresses food safety management involving the following elements; interactive communication, system management, prerequisite programs and HACCP principles.

In 2007, an ISO joint working group made up of ISO Technical Committee 34 (food products) and the ISO’s Committee on Conformity Assessment developed ISO/TS 22003. This technical specification lays out the rules for auditing and certifying organizations to ISO 22000. As part of these requirements, auditors must be knowledgeable in both the food-processing sector they are auditing and in managing system audits. ISO 22003:2007 also contains requirements for both the certification and accreditation bodies. These requirements are designed to give customers information and confidence about the way suppliers earn certification.

One major contribution of these newer standards is the separation of validation and verification. Traditionally, HACCP classified validation under verification. Validation is now seen as a separate function. The following definitions can be used to clarify the differences among validation, verification, and monitoring.

Validation: Obtaining evidence that the control measures managed by the HACCP plan and the operational PRPs are effective. This is an assessment conducted prior to starting operations.

Verification: Confirming through the provision of objective evidence that the specified requirements have been fulfilled. This is an assessment carried out during and after operations.
Monitoring: Conducting a planned sequence of observations or measurements to assess whether control measures are operating as intended. This is an activity undertaken during operations.

Is HACCP a Cost or Benefits?

What is the cost of human health or life? If the answer is priceless then it is a benefit. HACCP provides businesses with a cost effective system for control of food safety, from raw materials through to production, storage and distribution to sale and service of the final consumer. The preventive approach of HACCP not only improves food safety management but also complements other quality management systems. The following among others are the main benefits of HACCP.

1.Reduced risk of foodborne disease

2.Increased awareness of basic hygiene

3.Increased confidence in the food supply.

4.Improved quality of life (health and socio-economic).

5.Increased consumer and/or government confidence.

6.Reduced legal and insurance costs.

7.Increased market access.

8.Reduction in production costs (reduced recall \ wastage of food).

9.Improved product consistency.

10.Improved staff-management commitment to food safety.

11.Decreased business risk.

12.Reduced public health costs

13.Trade facilitation

14.Increased confidence of the community in the food supply

15.Improved food safety

16.Consistency in inspection criteria

17.Compliance with food law

18.Reduction in complaints

What are the costs of implementing and maintaining a HACCP system?

As a general guideline taken from the literature, the following are estimates cost of implementing and maintaining a HACCP system.

Implementation Costs

In terms of costs to implement, if you choose a full do-it-yourself approach, the only real costs will be the time for resources dedicated to the implementation process and in time spent writing documents and training your staff. If you have little experience with HACCP, or have limited internal resources, you might choose to get some outside professional help through a management system consultant.  If you choose to use external help, costs will vary depending on your country and the typical day rate. In the United Kingdom as an example it vary between £400 – £1000 depending on the consultant.  There are advantages by recruiting a consultant as you are able to guarantee your registration within a given period; however it is essential you research their credentials prior to engaging them.

Certification Costs

Costs of registration are dependent on the size of your organization. Most registrars charge a certain rate per day to be on-site at your facility. This day rate will vary depending on your country and the typical day rate. In the United Kingdom for example it will vary between £300 – £800.00 auditor days depending on the registrar. Small companies with less than 20 staff could expect one auditor on site for 1-3 days; large companies can expect several auditors on site for up to up to 10-15 days.

Other fees include application fees, certificate fees or annual license fees.

To maintain your certification, the registrar must return annually to audit a portion of your system. These costs will be less than the original visit, since the time spent will be shorter. Once every three years, the registrar returns to audit your entire system.

Implementation of HACCP

The implementation of HACCP consists of 12 steps. The first five are preliminary steps and the others seven are the principles.

1.Assemble a HACCP team, with a team leader to lead in designing and implementing HACCP. The team must have a good knowledge of the business. Initially, the team will be required to spend a reasonable amount of time and effort to develop and implement the HACCP system.

2.Describe the product(s)

3.Define the intended end user

4.Draw up a flow diagram to show each step of your operation.

5.Validate the flow diagram by walking through the operation to confirm that the flow diagram is correct and check that it covers all the products produced in the particular process being studied.

Once these steps have been completed enough information will have been gathered to apply the 7 principles:

6.Identify the potential hazards associated with food production at all

stages, from growth, processing, manufacture and distribution to the

point of consumption (Principle 1).

7.Determine the points, procedures and operational steps that can be

controlled to eliminate the hazards or minimize their likelihood of

occurrence; these are the critical control points (CCPs) (Principle 2).

8.Establish critical limits which must be met to ensure that the CCPs are

under control (Principle 3).

9.Establish a system to monitor control of CCPs by scheduled testing or

observations (Principle 4).

10.Establish the corrective action to be taken when monitoring indicates

that a particular CCP is not under control (Principle 5).

11.Establish procedures for verification which include supplementary tests

and procedures to confirm that the HACCP system is working effectively

(Principle 6).

12.Establish documentation concerning all procedures and records

appropriate to these principles and their application (Principle 7).

HACCP Pre-requisites

HACCP is not a standalone system. Before implementing HACCP, food businesses must already be operating to standards of good hygiene practice and in compliance with the good manufacturing practices. Prerequisite programs are critical to the successful implementation of HACCP.

1. General Pre-requisites

Good Manufacturing Practices (GMPs)

Good Hygiene Practices (GHPs)

Standard Operating Procedures (SOPs)

Sanitation Standard Operating Procedures (SSOPs).

2. Specific Pre-requisites

Construction, layout and facilities of premises
Supplies of water, power and other utilities
Waste control
Equipment suitability – cleaning and maintenance
Measures for the prevention of cross contamination
Supplier control and management of purchased materials
Cleaning and sanitizing
Pest control
Personal hygiene
Traceability systems
Recall procedures

All prerequisite programs should be documented, regularly audited, reviewed periodically and modified when necessary. As a general rule, prerequisite programs are managed separately from HACCP plans, however, sometimes there may be certain parts of prerequisite programs that are integrated into a HACCP plan.

Answer to the original article question (Do we really need it?). The answer is yes, we do. HACCP is consider the best approach know up to date to identify and control any hazards in a proactive way that could pose a danger to the preparation of food and to the human health. Although, there is no internationally recognized auditing standard for HACCP, the seven HACCP principles are included in the ISO 22000 standard. HACCP is a food safety management system that can be implemented as a separate risk management system, or as part of a certification to ISO 9000.

What we expect to see in the future?

We expect to see HACCP systems been introduced as mandatory measures in all sectors of food industry , in addition to further improvement that will allow countries food processing industry to deliver safe food products to their consumers anywhere in the global marketplace.