Basic Concepts in the Implementation of the

Food Safety Management System:

ISO 22000: 2005

Dr. Nada EL DARRA, Assistant Professor of Food safety & Technology

Spring 2019-2020
Week number 9 & 10
7.6 Establishing the HACCP plan
7.6.2. Identification of CCPs

• Critical control point: a step in a process where control is essential to prevent

or eliminate a food safety hazard, or reduce it to an acceptable level.
 Decision Tree
Q1 Do preventative control measures exist?
Modify step,
Yes No process or product
Is control at this step Yes
necessary for safety?

No Not a CCP Stop*

Is this step specifically designed to eliminate or reduce

Q2 Yes
the likely occurrence of a hazard to an acceptable level?**

No

Could contamination with identified hazard(s) occur in excess of

Q3
acceptable level(s) or could these increase to unacceptable level?**

Yes No Not a CCP Stop*

Will a subsequent step eliminate identified hazard(s)

Q4 or reduce likely occurrence to acceptable level(s)?** CCP
Yes No
* Proceed to the next identified hazard in the described process
** Acceptable and unacceptable levels need to be determined within the
Not a CCP Stop* overall objectives in identifying the CCPs of the HACCP Plan
 Food safety Hazards

Associated with the Production Associated with the Production

Environment or personnel. Processes_ Production usally
Can be undertaken without occuring this time
production activity
Risk assessment
(level of concern)

No/low perceived risk. CCP decision

May be controlled as tree
an ORP
Not a CCP

Prerequisite program Operational Prerequisite

program Critical control Points
Modified version
of the decision
tree
 Check HACCP generic models

https://www.inspection.gc.ca/food-safety-for-industry/archived-food-guidance/safe-food-
production-systems/haccp-generic-models-and-guidance-documents/generic-model-
spices/eng/1364478208697/1364478402035?chap=0#s8c4

http://haccpalliance.org/alliance/haccpmodels.html

Check the Tahini line implementation

 HACCP Generic Model_ Spices – Ready-to-Eat Fresh-Cut Vegetables – Forms - HACCP Generic
Model for Ready-To-Eat Fresh-Cut Vegetables - Food - Canadian Food Inspection
Agency.pdf 427.04KB

file:///C:/Users/User/Downloads/HACCP%20Generic%20Model_%20Spices%20%E2%80%93%20Ready-to-Eat%20Fresh-
Cut%20Vegetables%20%E2%80%93%20Forms%20-%20HACCP%20Generic%20Model%20for%20Ready-To-Eat%20Fresh-
Cut%20Vegetables%20-%20Food%20-%20Canadian%20Food%20Inspection%20Agency%20(1).pdf
Identify CCPs in your project
7.6 Establishing the HACCP plan
7.6.3. Determination of critical limits for CCPs

• Critical limits
-Values of monitored actions which separate the acceptable from the unacceptable.
-Are established to determine whether a CCP is under control. If a critical limit is exceeded or
violated, the products affected are deemed to be potentially unsafe.
-Shall be measurable and meet requirements of government regulations and/or company
standards and/or be supported by other scientific data.
-May be set for factors such as temperature, time, water activity, moisture level etc. These
parameters, if maintained within boundaries, will confirm the safety of the product.

• Critical limits based on subjective data (visual inspection) shall be supported by instructions
and/or education and training
Critical Limits (Principle 3)

A Critical Limit is a criterion that separates

acceptability from unacceptability.

Critical Limits shall be established

to ensure that the identified
acceptable level of the food safety
hazard in the end product is not
exceeded
Critical Limits
Measurable

Set Carefully
Applied to all
CCPs

Correctable Justifiable

Validated
Critical Limits
Criteria most frequently used for Critical
Limits:
• Time
• Temperature
• Aw
• pH
• Preservatives
• Salt concentration
• Viscosity
7.6 Establishing the HACCP plan
7.6.3. Determination of critical limits for CCPs

• Sources of information on critical limits include:

- Scientific publications/ research data
- Regulatory requirements and guidelines
- Experts (e.g. thermal process authorities, consultants, food scientists, microbiologist,
equipment manufacturers, sanitarians, academics)
- Experimental studies (in-house experiments, contract laboratory studies)

• The rational for the chosen critical limits shall be documented.

7.6 Establishing the HACCP plan
7.6.3. Determination of critical limits for CCPs

• An acidified beverage may have acid addition as the CCP

-If insufficient acid is added, the product would be under-processed with potential for the
growth of pathogens. The critical limits in this case would apply to pH.

- Beef patties are cooked in a continuous oven:

- The critical limits could be:
- Minimum internal temperature of the patty; oven temperature; time in the oven
determined by the belt speed in rpm, patty thickness
Examples of critical limits:
7.6 Establishing the HACCP plan
7.6.3. Determination of critical limits for CCPs

• If monitoring shows a trend toward lack of control at a CCP, operators can take action
to prevent loss of control of the CCP before the critical limit is exceeded.
-The point at which operators take such action is called “operating limit”.
- Operating limits should not be confused with critical limits

Critical limits_are the safety limits that must be met for each control
measure at a CCP.
One single value which separates safe from unsafe

Operational limits_provide a buffer or action zone for process

management.
Allows a certain amount of variation in normal process operation while
ensuring that food safety is not compromised
Examples of critical limit:
Determine the critical limits in your project
7.6 Establishing the HACCP plan
7.6.4. System for the monitoring of CCPs

• Monitoring: is “the act of conducting a planned sequence of observations

Or measurements of control parameters to assess whether a CCP is under control”.

• Monitoring: is the scheduled measurement or observation of a CCP

relative to its critical limits.

• Monitoring: must be able to detect loss of control at the CCP.

Monitoring System for each CCP

(Principle 4)
On/Off
line

Tools &
WHERE methods
Related to
the CCP
WHAT HOW
Monitoring
System

Frequency
Responsibilities WHO WHEN
Monitoring System for each CCP
Monitoring procedures:
- Must have a written procedures-real time and accurate
- List frequency-continuous or intermittent
- Done by trained employee – maintain training records
- Monitoring techniques (online/offline)
- Audited and verified

- Monitoring methods must provide rapid results. Most methods are physical
Or chemical measurements:
Example: time, temperature, pH, water activity
7.6 Establishing the HACCP plan
7.6.4. System for the monitoring of CCPs

• The purpose of monitoring include:

- To measure the performance level of the system’s operation at the CCP

- To determine when there is deviation from a critical limit.

- To establish records that reflect the performance level of the system’s operation
at the CCP to comply with the HACP plan.
 7.6 Establishing the HACCP plan
7.6.4. System for the monitoring of CCPs
• Monitoring is the process that the producer relies upon to show that the
HACCP plan is being followed.
- It provides the producer with accurate records enabling him to show that
the conditions of production are in compliance with the HACCP plan.

• Ideally, monitoring should provide information in time to allow any

adjustments to the process, thus preventing loss of control of the process and
critical limits being exceeded.
• Operating limits are often used to provide a safety margin which allows extra
time to adjust the process before the critical limit is exceeded.
 7.6 Establishing the HACCP plan
7.6.4. System for the monitoring of CCPs
• There are many ways to monitor the critical limits of a CCP.-
-Monitoring can be done on a continuous (100%) (more reliable).

- Where monitoring is not continuous, the amount and frequency of monitoring

should be sufficient to provide an acceptable level of assurance that the CCP is
under control.
The higher the frequency of monitoring, the less product will be affected when
there is a loss of control at the CCP.
Monitoring equipment
- Must be maintained and calibrated
- Should have a warning and automatic divert system.

- Examples: thermometers, clocks, metal detectors, pH meters, scales

• Continuous:
- Time and temperature charts.
- Metals or X-ray detectors
- Bar code scanners for allergen labeling.

• Non-Continuous:
- Product temperature checks.
- pH checks
- Allergen label check
How to monitor?
Observation
Measurement

Why to monitor?
Detect loss of control
Corrective Actions
Quarantine/recall products
Microbiological tests Too slow
Expert interpretation
Further tests

Not efficient
 7.6 Establishing the HACCP plan
7.6.4. System for the monitoring of CCPs
• Most monitoring procedure will need to be rapid.
-For this reason, physical and chemical measurements or visual observations,
which may be done rapidly, are often preferred to microbiological testing.
-Examples of some physical and chemical measurements are temperature, time,
pH, moisture level and water activity.

• It is essential that all monitoring equipment be properly calibrated for

accuracy.
 7.6 Establishing the HACCP plan
7.6.4. System for the monitoring of CCPs
• The worst scenario is that in which monitoring procedure indicate that
Any one of the critical limits is exceeded, which indicates loss of control of a
CCP.
- This lack of control is considered to be a deviation resulting in the production of
a hazardous or unsafe product.
- The situation required immediate identification and control of the affected
product and corrective action.
 7.6 Establishing the HACCP plan
7.6.4. System for the monitoring of CCPs
• The control measures are intended to control a hazard at each CCP:
- The monitoring procedures will determine if the control measures are being
implemented and ensure that critical limits are not exceeded.
- The monitoring specifications for each CCP should be written to given
information on:
❖ What will be monitored,
❖ How critical limits and preventive measure will be monitored.
❖ Frequency of monitoring
❖ Who will monitor.
7.6 Establishing the HACCP plan
7.6.4. System for the monitoring of CCPs
• Staff training for monitoring critical control points:
- The individual responsible for monitoring a CCP must:
❖ Be adequately trained in the CCP monitoring techniques
❖ Fully understand the importance of CCP monitoring
❖ Have ready access to the monitoring activity
❖ Accurately report each monitoring activity
❖ Have the authority to take appropriate action
❖ Immediately report critical limit deviation
Examples of monitoring:
For the identified CCPs in your project
establish the methods for monitoring
7.6 Establishing the HACCP plan
7.6.5. Action when monitoring results exceed critical limits

HACCP Principle 5: Establish corrective action procedures

Corrective action_action to be taken when the results of monitoring at the CCP indicate a
trend toward or actual loss of control (Codex) .

Planned corrective actions to be taken when critical limits are exceeded shall be specified in
the HACCP plan.

The actions shall ensure that the cause of nonconformity is identified, that the parameter (s)
Controlled at the CCP is (are) brought back under control, and the recurrence is prevented.

Documented procedures shall be established and maintained.

7.6 Establishing the HACCP plan
7.6.5. Action when monitoring results exceed critical limits
The producer should control deviations:
- Identification of deviation
- Isolation of affected product.
- Evaluation of affected product.

Example of Corrective action:

- Isolation and holding product
❖ Reprocessing
❖ Diverting to safe use
❖ Rejecting e.g. raw material supplier
❖ Destroying the product
→ Sometimes called witnessed destruction
Note: can sometimes divert food to animal feel
Not always possible- depends on the hazard.
 7.6 Establishing the HACCP plan
7.6.5. Action when monitoring results exceed critical limits
The following information should be recorded in the deviation and corrective
action records.
- Deviation
- Product/code
- Date produced/ held/ release
- Reason for the hold
- Amount of product held
- Results of evaluation: amount analyzed, analysis report, number and nature of defects
- Signature of personnel responsible for hold and evaluation
- Disposition of held product
- Signed authorization for disposition.
 7.6 Establishing the HACCP plan
7.6.5. Action when monitoring results exceed critical limits
Corrective action
- Cause of deviation identified
- Corrective action taken to correct deficiency
- Follow-up/assessment of effectiveness of corrective action
- Date
- Signature of person responsible
 7.6 Establishing the HACCP plan
7.6.5. Action when monitoring results exceed critical limits
Corrective action that is Preventive
- Pro-active requirements:
- Prevent deviation (only possible if operating limits are established)
- Identify, correct and eliminate the root cause of the deviation and restore process control
- Identify the product that was produced during the deviation and determine disposition
- Document all actions taken (i.i. Product Safety Incident Report)
- Be specific and thoughtful (Do not simply say: notify the quality manager)
Examples of corrective action:
HACCP Generic Model: Moulded Dark Chocolate with Almonds – Forms

https://www.inspection.gc.ca/food-safety-for-industry/archived-food-guidance/safe-food-production-systems/haccp-
generic-models-and-guidance-documents/generic-model-dark-chocolate-with-
almonds/eng/1364492141579/1364492481518?chap=2#s15c2

HACCP Generic Model: Spices – Forms

https://www.inspection.gc.ca/food-safety-for-industry/archived-food-guidance/safe-food-production-systems/haccp-
generic-models-and-guidance-documents/generic-model-spices/eng/1364478208697/1364478402035?chap=4#s10c4

HACCP Generic Model: Spices – Ready-to-Eat Fresh-Cut Vegetables – Forms

https://www.inspection.gc.ca/food-safety-for-industry/archived-food-guidance/safe-food-production-
systems/haccp-generic-models-and-guidance-documents/generic-model-fresh-cut-
vegetables/eng/1371034721098/1371034722410?chap=4#s10c4
Establish corrective actions for your
project
 7.7 Updating of preliminary information and documents specifying the
PRPs and the HACCP plan
Following the establishment of OPRP (s) and/or the HACCP plan, the
Organization shall update:

- Product characteristics
- Intended used
- Flow diagrams
- Process steps
- Control measures
7.8 Verification planning

Verification is “the application of methods, procedures, tests and other

evaluations, in addition to monitoring to determine compliance with the
HACCP plan”.

- Careful preparation of the HACCP plan with clear definition of all the
necessary items does not guarantee the plan’s effectiveness

- Verification and auditing methods, random sampling and analysis, can

be used to determine if the HACCP system is working correctly
 Validation, Verification and Improvement of
Food Safety Management System

Validation of
Monitoring Verification Improvement
Control
control Of system Of system
measures

Internal Audit
Control Hazard
Valid method and Evaluate Continual
Produce conform
results individual Update
end product
verification result
 7.8 Verification planning

Each HACCP plan should include verification procedures for individual CCPs
and for the overall plan.
- HACCP plans are expected to evolve and to improve with experience and
new information.
- Periodic verifications helps improve the plan by exposing and strengthening
weaknesses in the system and eliminating unnecessary or ineffective control
measures.

- Verification activities include:

- HACCP plan validation
- HACCP system audits
- Equipment calibration
- Targeted sample collection and testing
7.8 Verification planning

Validation is the act of assessing whether the HACCP adequately identifies and
Controls all significant food safety hazards or reduces them to an acceptable level.

HACCP plan validation should include:

• Review of hazard analysis
• CCP determination
• Justification for critical limits based on current foo sciences and regulatory
requirements.
• Determination of whether monitoring activities, corrective actions, record keepin
Procedures and verification activities are appropriate and adequate.
HACCP Principle 6: Establish verification procedures
 Validation VS. Verification
What is validation?
❖ Based on science/ technical data and in-plant studies
❖ Usually a “one time activity”

What is verification?
❖ Based on observations and record review
❖ Usually activities that are repeated routinely
 Validation activity examples
Confirming critical limits control the identified significant hazards.

❖ Process capability study (i.e. salt percentage in product)

❖ Determining if a certain cleaning procedure removes allergenic proteins.

 Verification activity examples
Record reviews:
❖ CCPs monitored as required by the Plan
❖ Processes operating within operational limits
❖ Corrective action taken & document as needed
❖ Completeness of HACCP plan

Accuracy of product description and flow chart.

Calibration of monitoring equipment
Routine testing
Behavioral observation
Third part and internal audits
Examples of verification action:
Examples of verification action:
HACCP Principle 7: Establish documentation & records

• Records are essential to provide evidence of safe food production.

• Record accuracy is vital
• CCP monitoring records must be:
❖ Reviewed by authorized personnel
❖ Signed off by both CCP monitor and reviewer
❖ Reviewed prior to release of the product

Full records of corrective action must be maintained

HACCP Principle 7: Establish documentation & records
• Records keeping

HACCP records_consider how and where to store

HACCP plan

CCP monitoring records

HACCP corrective action records

Verification records

Also needs evidence of HACCP team training

HACCP Principle 7: Record and document requirements
• Records requirements:
❖ Recorded at the time of observation
❖ Use blue or black ink for hand-written record
❖ Do not fill out time before observation is carried out

• Document requirements:
❖ Name of record
❖ CCP correlated with it
❖ Document control info (revision date, version, approval)
❖ Space for monitor’s initials/ signature, date ad time of checks
Documentation and record
keeping
➢ Data used to control deviation, shelf-life, hazards,
• Support document for critical limits, product description, intended use, flow
HACCP development diagram, hazard analysis, CCPs, critical limits for each
CCP, verification activities, etc.

➢ Record kept to demonstrate the adherence of HACCP

• Record generated by plan and implementation, and to be aware of the
HACCP plan process details

• Methods and procedures ➢ Description of monitoring system, plans for corrective

actions, record keeping procedures, verification
procedures

• Records of employee ➢ Records should be kept for employee, particularly at

training programmes deviation, corrective actions and verification.
7.9 Traceability system

• The organization shall establish and apply a traceability system that

enables the identification of product lots and their relation to batches of
raw materials, processing and delivery records.

• The traceability system shall be able to identify incoming material from

the immediate suppliers and the distribution route of the end product.

• Traceability records shall be maintained for a defined period.

7.9 Purpose of Traceability

• Protect customers
• Document the product history
• Ease the withdrawal and/or recall of products
• Reduce consequences of non-conformities
• Communicate information to stakeholders
• Increase transparency and confidence
7.9 Purpose of Traceability

• Identification of the incoming material from the immediate suppliers

• Identification of the initial distribution route of the end product

• Identification of product lots and their relation to batches of raw

materials, processing and delivery records.
7.9 Duration of the record keeping

• Fixed time frame is not set in, but the following recommendation is
given:
- Generally for all products: 5 years from date of manufacturing or delivery
- For products with a shelf life above 5 years: the period of the shelf life +
6 month
- For highly perishable products with “a use by” date less than 3 months
or without a specified date: 6 months after the date of manufacturing or
delivery.
7.10 . Controlling of non-conformity
7.10.1. Corrections
• Corrective actions shall be initiated when critical limits are exceeded or
when there is a lack of conformity with OPRP (s).

• A documented procedure shall be established and maintained defining:

- The identification and assessment of affected end products to determine
their proper handling
- A review of the corrections carried out.
7.10 . Controlling of non-conformity
7.10.1. Corrections
• The organization shall take actions to:
- Identify and eliminate the cause of detected nonconformities
- Prevent the recurrence
- Bring the process or system back into control after nonconforming is
encountered.
7.10 . Controlling of non-conformity
7.10.1. Corrections
• Corrections are done to deal immediately with unsafe products, while
corrective actions are designed to prevent recurrence by addressing
causes.

• Corrective actions take a longer term perspective and a more systemic

approach.

• Data derived from the monitoring of OPRPs and CCPs shall be evaluated
by competent person to initiate corrective actions.
7.10 . Controlling of non-conformity
7.10.2. Corrective actions
• Reviewing nonconformities (including customer complaints)
• Reviewing trends in monitoring results that may indicate development
towards loss of control
• Determining the cause (s) of nonconformities
• Evaluating the need for action to ensure that nonconformities do not
recur
• Determining and implementing the actions needed
• Recording the results of corrective actions taken
• Reviewing corrective actions taken to ensure that they are effective
7.10 . Controlling of non-conformity
7.10.3. Handling of potentially unsafe products
• The organization shall handle nonconforming products by taking action
to prevent the nonconforming product from entering the food chain
unless it is possible to ensure that:
- The food safety hazard(s) of concern has(ve) veen reduced to the defined
acceptable levels.
- The food safety hazards (s) of concern will be reduced to identified
acceptable levels prior to entering into the food chain
- The product still meets the defined acceptable level(s) of the food safety
hazard (s) of concern despite the non conformity
7.10 . Controlling of non-conformity
7.10.3. Handling of potentially unsafe products
Each lot of product affected by the nonconformity shall only be released
as safe when:
- Evidence that the control measures have been effective.
- The results of verification activities demonstrate that the affected lot of
product complies with the identified acceptable levels for the food safety
hazard(S) concerned.
7.10 . Controlling of non-conformity
7.10.3. Handling of potentially unsafe products
Following evaluation, if the lot of product is not acceptable for release, it
shall be:
-reprocessed or further processed to ensure that the food safety hazard is
eliminated or reduced to acceptable levels.
- Destroyed and/or disposed as waste
7.10 . Controlling of non-conformity
7.10.4. Withdrawals
• Withdrawn products shall be secured
• Results of withdrawals should be an input to management review
• Withdrawal program shall be verified (mock or practice withdrawals)