Doc.Ref.

No: PRO_HACCP_04
Procedure for HACCP Plan Rev.No/ Issue Date 0 / 01-05-2023

1.0 Purpose
To establish and maintain a uniform approach to establish HACCP Plan
2.0 Scope
This procedure applies to all activities related to raw materials, storage, processing, packing and
dispatch of product manufactured by us from all the plants.
3.0 Responsibility
Responsibility for follow-up of this procedure lies with the Product Safety System Team.
4.0 Description of Activity
4.1 Preparation of Product Safety System Team Details:
a) Each step identified in the Process Flow Charts is transferred to the Hazard Identification and
Control Chart.
b) For each step the following are identified:
 Significant Hazards
 Control Measures
 CCPs (if any)
 Critical Limits (in case of CCP)
 Monitoring Methods / Procedures (in case of CCP)
 Corrective Actions (in case of CCP)
 Records (in case of CCP)
 Verifications (in case of CCP)
 Point of Attention or Pre-requisite Program (POA / PRP)
4.1.1 Significant Hazard
Hazard identified in the hazard identification process is analyzed for its severity and occurrence
and to determine its impact on Product safety.
To identify the significant Product Safety Hazards, Risk – Severity analysis is conducted.
OCCURENCE:
Every hazard identified in the process is evaluated for the probability of its occurrence. Occurrence is
given a value from 1 to 5 depending on the probability of occurrence in the following manner:
Probability of Occurrence Occurrence Factor
Very High 5
High 4
Moderate 3
Low 2
Negligible 1

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Procedure for HACCP Plan Rev.No/ Issue Date 0 / 01-05-2023
SEVERITY
Each identified hazard is also evaluated for its potential to cause Product safety problems and
its impact on the human health.
Each hazard is given a Severity Factor from 1 to 5 depending on the severity it can cause to the
health of a person consuming the product in prescribed manner. The S everity Factor is
determined in the following manner:
Impact On Health Severity Factor
Very Severe (Causing death) 5
Severe (Long-term Illness) 4
Moderate (Short-term Illness) 3
Low impact (Momentary sickness feeling) 2
Negligible 1

The Risk Factor is then calculated as follows:

RISK FACTOR (RF) = OCCURENCE (O) X SEVERITY (S)
All the hazards having Risk Factor equal to or greater than 10 are considered to be significant
hazards, which are then put to the decision tree to determine CCPs.
4.1.2 Control Measures
a) For each identified hazard at least one control measure is identified.
4.1.3 Determining Critical Control Points
a) A CCP is defined as any point, step or procedure at which control can be applied and a Product
safety hazard can be prevented, eliminated or reduced to an acceptable level.
b) The determination of critical control points (CCPs) is based upon the assessment of severity, likely
occurrence of hazards and what can be done to eliminate, prevent or reduce the hazards at a
process step.
c) The selection of CCPs are made on the basis of:
 Identified hazards and likely occurrence in relation to what constitutes unacceptable
contamination;
 Operations to which the product is subjected to during processing and preparation, and;
 Intended use of the product.
d) Control measures for significant hazards are identified on the HACCP Plan as a CCP/CQP.
e) The CCP Decision Tree as given in Annexure-1 is used for CCP determination.
4.1.4 Critical Limits (Principle – 3)
A) For each Critical Control Point critical limits are established. For each CCP, establish Critical
Limits, i.e. a criterion that must be met for each preventive measure associated with a CCP. For
establishing CLs, refer to the regulatory standards guidelines, literature, surveys, and
experimental studies or experts’ views, as necessary.
B) Critical limits are defined as values that separate acceptability from unacceptability. These

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 Doc.Ref.No: PRO_HACCP_04
Procedure for HACCP Plan Rev.No/ Issue Date 0 / 01-05-2023
parameters, if maintained within permissible limits, confirm the safety of the product.
C) As far as possible, provide appropriate tolerance levels to the CLs. While establishing CLs,
ensure that the Critical Limits can be measured relatively easily and quickly. As far as possible,
avoid limits, e.g. time consuming, non-conforming / linear tests.
C One or more critical limits may be set to control an identified hazard. Critical limits may be set for
factors such as:
 Temperature - cold store/heating/sterilization
 Time (minimum time exposure), etc.
4.1.5 Monitoring CCP (Principle– 4)
A) Monitoring of critical limits by observation and/or test determines if the process step is in
control.
B) For each critical limit the following are defined:
 What – defines the target of the control measure
 How – defines the methodology used to monitor the critical limit
 Where – defines the location for undertaking the activity
 When – defines the timing or frequency of the activity
 Who – defines the responsibility for undertaking the monitoring
4.1.6 Corrective Action (Principle – 5)
a) Where the monitoring function detects a nonconformance where critical limits have been exceeded,
corrective action is taken.
b) Corrective actions need to address:
Reworking of the products:
 Disposition of affected product
 Correction of the process
c) The required corrective action is noted on the HACCP Plan.
d) Details of non-conformances and the action taken are recorded on Nonconformance Reports.
e) If the prescribed verified corrective action does not take care of the deviation, relevant people at plant
analyze the problem and take corrective action. This is documented on corrective action report.
f) Product Recall:
1) If any product after being dispatched is found to be unsafe for human consumption the batch is
identified and recalled from the distributors and dealers.
2) To recall the identified batch, dealers and distributors are informed about the batch number and
asked to send the material back to the plant.
3) Production in-charge, quality control in-charge, store in-charge, packing in-charge with relevant
personnel analyze the problem and find out the cause of nonconformity. After analysis, they
identify the Product safety hazard and decide whether the product could be re-processed or not.

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Procedure for HACCP Plan Rev.No/ Issue Date 0 / 01-05-2023
4) If the product could be re-processed and Product safety hazard can be eliminated/reduced to
acceptable levels, the product is re-processed considering the financial implications of it.
5) If it is not possible to eliminate/reduce the Product safety hazard to an acceptable level, the
product is destroyed in a safe manner after securing the Director’s permission.
4.1.7 Establish Record Keeping (Principle – 6)
For each CCP identify the records to be maintained, considering the monitoring mechanism,
detailing components to be observed and recorded, the responsibility for monitoring and record
keeping. Update CCP worksheet accordingly. Train / inform concerned personnel for monitoring
and record keeping to ensure effectiveness of the Product Safety System.
4.1.8 Verification (Principle – 7)
The purpose of verification is to ensure that Product Safety System is operating and effective
control for Product safety is established. This is done at least once in a year. The verification is
done by Product Safety System Team members and identified internal auditors. The Product
Safety System is verified during internal audits or special verification checks by:
a) Reviewing the Product Safety System and its records.
b) Reviewing the deviations and product dispositions. Ensure that the verification methods are different
from monitoring procedure and evidence of verification is available through appropriate records.
c) Confirmation that CCPs are kept under control.
d) Analysis of recalls (if any) and product dispositions.
e) Assessment of all specific control measures, deviations and corrective actions taken to seek
confirmation of implementation and effective control of CCPs.
f) Assessment of all general control measures to seek confirmation of implementation and to
demonstrate effective control of associated hazards.
g) Compliance of the actual flow diagrams and layout with the documented situation. The same is
reviewed once in a year.
h) Compliance of the PRP documents with the operational situation.
i) Evaluation of conformity with applicable legislation and regulations (as well as conformity to
foreseeable changes in legislation and regulations) and identification of changes in legislation
and regulations concerning Product safety.
j) Review of gaps between current and desired level of knowledge, awareness and training of staff
with respect to hygiene and Product safety, resulting in effective (on-the-job) training sessions.
k) Consistency of the current documentation.
l) Product test records and analytical verification for sampling methods followed.
m) Analysis of customer and consumer complaints related to hygiene and Product safety
Records of verification are maintained with Product Safety System Team Coordinator.
4.1.9 Validation
a) Reviewing of the Product Safety System and its records.
b) Reviewing of deviations and product dispositions.
c) Conformation that CCPs are kept under control.
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Procedure for HACCP Plan Rev.No/ Issue Date 0 / 01-05-2023
d) Scientific data or other information demonstrating the particular control measures that address
specific hazard
4.1.10 Documentation & Records: Records in prescribed formats are kept for each CCP for
verification and to take corrective action in case of deviation.

5.0 References
5.1 PRO/SYS/04 Procedures for Control of Quality Records.
5.2 Factory Floor Plan.
5.3 BRC Global Standard For Packaging Materials, Issue 6, August 2019

6.0 Enclosures
Nil

7.0 Formats / Exhibits

7.1 E/HACCP/01 Product Safety Team
7.2 E/HACCP/02/XX Product Description
7.3 E/HACCP/03/XX Process Flowchart
7.4 E/HACCP/04/XX Hazard Analysis Report
7.5 E/HACCP/05 HACCP Plan
7.6 E/HACCP/06 Corrective Action Plan for CCP
7.7 E/HACCP/07 Verification and Validation Plan
7.8 E/HACCP/08 OPRP

Annexure-1: CCP Determination Tree

Do
Docontrol
controlmeasure(s)
measure(s)exist
existfor
forthe
the
Q1 identified hazards?
identified hazards?

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 Doc.Ref.No: PRO_HACCP_04
Procedure for HACCP Plan Rev.No/ Issue Date 0 / 01-05-2023

Modify step, process

Yes No or product

Is control at this step

necessary for safety? Yes

No Not a CCP Stop (*)

IsIsthe
thestep
stepspecifically
specificallydesigned
designedto toeliminate
eliminateor
or
Q2 reduce
reduce the likely occurrence of a hazardto
the likely occurrence
acceptable
of
acceptablelevel?
level?
a hazard toan
an Yes

No

Could
Couldcontamination
contaminationwith
withidentified
identifiedhazard(s)
hazard(s)occur
occur
Q3 ininexcess
excess of acceptable level(s) orcould
of
increase
acceptable level(s) or couldthis
this
increasetotounacceptable
unacceptablelevels?
levels?

No Not a CCP Stop (*)

Yes

Will
Willaasubsequent
subsequentstep
stepeliminate
eliminateidentified
identifiedhazard(s)
hazard(s)
Q4 or
orreduce
reducelikely
likelyoccurrence
occurrencetotoan
anacceptable
acceptablelevel?
level?

CRITICAL CONTROL POINT

No
Yes

Not a CCP Stop (*)

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