Transcript HACCP - Soegijapranata Catholic University

HACCP
WHO & ICD
ILSI Europe
Inneke Hantoro
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
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.
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
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).
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.
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.
Food Safety Assurance
Good Manufacturing practices (GM)
and
Good Hygiene Practices (GHP)
necessary
But not always sufficient
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
Stake holders involved in HACCP
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.
HACCP Concept
• Identifying potential food safety problems
• Determining how and where these can be controlled
or prevented
• Describing what to do and training the personnel
• Implementation and recording
HACCP Program Prerequisites
• Facilities
• Supplier control
• Specifications for all
ingredients, products and
packaging materials
• Production equipment
• Cleaning and sanitation
• Personal hygiene
• Training
• Chemical control
• Receiving, storage,
shipping
•
•
•
•
•
•
Traceability and recall
Pest control
QA procedures
SOP and SSOP
Glass control
Procedures for receiving,
storage and shipping
• Labeling
• Employee food and
ingredient handling
GMP
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
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
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.
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
Areas to consider in Hazard Analysis
•
•
•
•
•
•
•
Raw materials and ingredients
Product formulation
Processing conditions
Packaging
Storage and distribution
Preparation and use
Target groups
Probability - Severity
Severity/ Keparahan/Keakutan
Probabilitas
Kritikal
Serius
Signifikan
Signifikan
Signifikan
Signifikan
Signifikan
Tidak
Signifikan
Mayor
Signifikan
Minor
Tidak
Signifikan
Tinggi
Tidak
Signifikan
Tidak
Signifikan
Medium
Tidak
Signifikan
Tidak
Signifikan
Rendah
NACMCF
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
Hazard Determination
Is the presence of agent
in raw material probable?
YES
NO
Is the presence of agent in
line or environment probable?
No Hazard
Is an unacceptable survival,
persistence or increase at
this step probable?
YES
NO
Is reduction, if any at a
further step adequate?
NO
YES
Is an unacceptable
contamination at this step
probable?
No Hazard
YES
YES
NO
NO
YES
HAZARD
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?
YES
NO
Not CCP
Q2. Will processing, including expected consumer use,
eliminate the hazard or reduce it to an acceptable level?
CCP for the raw
materials for this
hazard
NO
YES
Not CCP
• 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?
Formulation is a CCP
for this hazard
YES
NO
Not CCP
Q4. Is it likely that, at this step, a hazard will be introduced or an existing
hazard will increase to unacceptable levels?
YES
Q5. Will subsequent processing steps
including expected consumer use,
guarantee removal of the hazard or
reduction to an acceptable level?
NO
Q6. Is the process step intended to
eliminate or reduce the
hazard to an acceptable level?
NO
YES
Not CCP
CCP
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
When is deviation from normality unacceptable?
( i.e. establishment of Critical Limits )
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
Point control Hazards Control Critical
Monitoring
(raw
Measure Limits
material /
Proce- Frequency Responprocess step
dure
sibilities
Corrective
Actions
Proce- Respondure
sibility
• 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
• 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)
• 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)
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
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.
Example of
documentation
about HACCP
system deviation
report
Example of
documentation
about corrective
action report
References
• Arvanitoyannis, I.S. 2009. HACCP and ISO 22000: Application
to Foods of Animal Origin. Blackwell Publishing Ltd.
• Vasconcellos, J. A. 2004. Quality Assurance for the Food
Industry: A Practical Approach. CRC Press, Boca Raton.
• van Schothorst, M. 2004. A simple guide to understanding and
applying the hazard analysis critical control point concept 3rd
Ed. Belgium. ILSI Europe.
Group discussion
• A group is consisted of 5 students
• Read this handout and other related books thoroughly (about
HACCP theory)
• Discuss the given case study in group:
– Determine the significant hazards
– Determine the CCPs
– Create the HACCP plan (control measure, critical limits,
monitoring procedures, an corrective actions of each
hazard)
• Submit the paper on Friday, 25th Nov at 12.00 in Inne’s locker