1. H A C C P
WHO & ICD
ILSI Europe
Inneke Hantoro

2. Introduction: Traditional QC vs Preventive System
Traditional QC programs spot-checked manufacturing conditions, and randomly sampled and tested final products to ensure safe food.
If the finished product met the specifications, it was approved; otherwise, the product was held, reprocessed, or destroyed.
Reactive & inefficient

3. Introduction: Traditional QC vs Preventive System
An HACCP program is about preventive systems — to eliminate a problem before it happens.
The actions that these systems provoke are essentially preclusive — they are designed to prevent problems rather than solve them after they have occurred.
QC checks occur during the process so that a finished product is deemed consistently safe.

4. Hazard Analysis Critical Control Point (HACCP)
The HACCP system has grown to become the universally accepted method for food safety assurance.
A major focus of the HACCP program is “from farm to table.”  HACCP is a concept as well as a method of operation, applied to all phases of food production, including agricultural production, food handling, food processing, food services, food distribution, and consumer use.
Everyone is responsible for safe food products

5. Hazard Analysis Critical Control Point (HACCP)
The Hazard Analysis and Critical Control Point (HACCP) system is a science-based system created to identify specific hazards and actions to control them in order to ensure food safety and quality.
A ‘hazard’ is ‘a biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect’ (Codex Alimentarius, 1997).

6. The need for an effective food safety assurance method
Foodborne disease are a widespread public health problem.
Emergence of foodborne disease.
Increased knowledge and awareness of the serious and chronic health effects.
New food technologies and processing methods.
Increased awareness of the economic consequences of foodborne disease.

7. The need for an effective food safety assurance method
Increase in the number of vulnerable people.
Industrialization and mass production.
Urbanization and changing lifestyle.
Increase tourism and international trade in foodstuffs.
Increase consumer awareness of food safety.

8. Food Safety Assurance Good Manufacturing practices (GM) and
Good Hygiene Practices (GHP)
necessary
But not always sufficient

10. The History of HACCP
The HACCP concept was developed in the early 1970s as a system to assure food safety
1983: WHO Europe recommends HACCP
1991: Codex HACCP draft
1998: FAO/WHO provide guidance for regulatory assessment of HACCP
2006+: Increased worldwide use of HACCP in food safety legislation

11. Stake holders involved in HACCP

12. The objectives HACCP application
Focuses on identifying and preventing hazards from contaminating food, based on sound science.
Permits more efficient and effective government oversight, primarily because record keeping allows investigators to see how well a firm is complying with food safety laws over a period, rather than how well it is doing on any given day.
Places responsibility for ensuring food safety on the food manufacturer or distributor.
Helps food companies to compete more effectively in the world market.
Reduces barriers to international trade.

13. HACCP Concept Identifying potential food safety problems
Determining how and where these hazards can be controlled or prevented
Describing what to do and training the personnel
Implementation and recording

14. HACCP Program Prerequisites
Traceability and recall
Pest control
QA procedures
SOP and SSOP
Glass control
Procedures for receiving, storage and shipping
Labeling
Employee food and ingredient handling
Facilities
Supplier control
Specifications for all ingredients, products and packaging materials
Production equipment
Cleaning and sanitation
Personal hygiene
Training
Chemical control
Receiving, storage, shipping
GMP

15. Preliminary Tasks of HACCP Program
Choosing the HACCP team
Description of the food product and its distribution
Description of the intended use and consumer of the product
Development of a flow diagram describing a food product manufacturing process
Verification of the flow diagram

16. The principles of HACCP
1. Conduct a hazard analysis
2. Determine the CCPs
3. Establish critical limit(s)
4. Establish a monitoring system
5. Establish corrective actions
6. Establish verification procedures
7. Establish documentation
Source: CODEX

17. 1. 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 should be addressed in the HACCP plan.

18. Information needed for hazard analysis:
the agents that could be present in the food under study
the severity of the effects and the likelihood of their occurrence
the levels that could cause adverse health effects
the conditions that could lead to unacceptable levels

19. Areas to consider in Hazard Analysis
Raw materials and ingredients
Product formulation
Processing conditions
Packaging
Storage and distribution
Preparation and use
Target groups

20. Probability - Severity
Probabilitas
Severity/ Keparahan/Keakutan
Kritikal
Serius
Mayor
Minor
Signifikan
Tidak
Tinggi
Medium
Rendah
NACMCF

21. Probability - Severity
Probabilitas:
Tinggi – mungkin terjadi
Medium – dapat tejadi
Rendah tidak mungkin terjadi
Keparahan/Keakutan:
Kritikal – akan otomatis mengakibatkan makanan tidak aman
Serius – kemungkinan mengakibatkan makanan tidak aman
Mayor – dapat mengakibatkan makanan tidak aman
Minor – kemungkinan tidak mengakibatkan makanan tidak aman

22. Hazard Determination HAZARD YES No Hazard NO
Is the presence of agent in raw material probable?
Is the presence of agent in line or environment probable?
Is an unacceptable survival, persistence or increase at this step probable?
Is an unacceptable contamination at this step probable?
Is reduction, if any at a further step adequate?
HAZARD

23. 2. Determination of CCPs Critical control point decision tree
Questions to be asked for each raw material used
Q1. Is it likely that the raw material contains the hazard under
study at unacceptable levels?
Q2. Will processing, including expected consumer use,
eliminate the hazard or reduce it to an acceptable level?
YES NO
Not CCP
CCP for the raw materials for this hazard

24. Questions to be asked for each process step
Q3. Is the formulation/composition or structure of the intermediate
product/final product essential for preventing the hazard under study
from increasing to unacceptable levels?
Not CCP
Formulation is a CCP for this hazard
YES NO

25. Q4. Is it likely that, at this step, a hazard will be introduced or an existing
hazard will increase to unacceptable levels?
Q5. Will subsequent processing steps
including expected consumer use,
guarantee removal of the hazard or
reduction to an acceptable level?
Q6. Is the process step intended to
eliminate or reduce the
hazard to an acceptable level?
YES NO
Not CCP
CCP

26. 3. The establishment of critical limits
A criterion which separates acceptability from unacceptability
Critical limits can be:
Values of pH, aw, temperature, time
Absorbed radiation dose
Levels of disinfectant or antimicrobial agents
Level of cleanliness
Limits of residues
Limits of contaminants
Limits of microbiological criteria

27. When is deviation from normality unacceptable?
( i.e. establishment of Critical Limits )

28. 4 & 5. Monitoring and Corrective Action
The key document
Holding all the essential details about the steps or stages
in the process where there are CCP’s
The HACCP Control Chart

29. Control measure
Any factor or activity which can be used to prevent, eliminate, or reduce food safety hazards to an acceptable level
Critical limit
The safety boundaries (criteria that separate safe from unsafe)
Sources of information: literature, regulation, experiment, etc
Contain safety buffer zone

30. Monitoring
Observation or measurement to ensure that the process is operating within the critical limit
Based on some form of inspection and testing
The frequency depends on the nature of the CCP and the type of monitoring procedure
Clarify to all personnel involve (what to do and how to do it)

31. Corrective action
The action should be taken when the result shows a deviation from the critical limit
Adjust the process to bring it back under control
Deal with the material produced under the deviation period
Hold on the product
Rework
Release product after sampling and testing
Direct into less sensitive products, e.g. animal feed
Clarify to all personnel involve (what to do and how to do it)

32. 6. Verification
The application of methods, procedures, tests, and other evaluations, in addition to monitoring, to determine conformity with the HACCP plan.
This is primarily the responsibility of the industry, however some verification activities can be undertaken during regulatory assessments
Conformity:
Activities are carried out according to the established procedures
e.g. the HACCP plan and prerequisites

33. 7. Establishment of the record - keeping procedures
An HACCP program should be thoroughly documented and implemented establishing procedures for the identification, storage, retrieval maintenance, protection, and disposition of documents.
The documentation generated must be formal written records providing factual evidence that an activity has been performed in a timely manner in accordance with established procedures.
Information contained in corrective action records provides a description of the deviation and an evaluation of the corrective action taken, as well as a notation as to final disposition of the affected product.
The name of the individual responsible for taking the corrective action should be included.

34. Example of documentation about HACCP system deviation report

35. Example of documentation about corrective action report

36. References
Arvanitoyannis, I.S HACCP and ISO 22000: Application to Foods of Animal Origin. Blackwell Publishing Ltd.
Vasconcellos, J. A Quality Assurance for the Food Industry: A Practical Approach. CRC Press, Boca Raton.
van Schothorst, M A simple guide to understanding and applying the hazard analysis critical control point concept 3rd Ed. Belgium. ILSI Europe.