DABUR NEPAL PVT. LTD.RAMPUR, TOKANI, BARA (NEPAL)
FOOD SAFETY MANUAL Revision Number: FSSC
Sectio
n
No
Title ISO 22000
Clause
Reference
No. of
Pages
1 Contents
2 Master control document
3 Company profile
4 Amendments Record Sheet
5 Foreword
6 Manual Administration
7 Distribution List
8 Scope
9 General
10 Application
11 References
12 Terms, Definition, Abbreviations, List of
Procedures, Manuals,
Regulatory Requirements
13 Food Safety Management System 3.0
14 General requirements
Documentation requirements
Management responsibilities Management
commitment
Food safety policy
Food safety management system planning
Responsibility and authority
Food safety team leader
Communication
4.1
4.2
5.0
5.1
5.2
5.3
5.4
5.5
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DABUR NEPAL PVT. LTD.RAMPUR, TOKANI, BARA (NEPAL)
FOOD SAFETY MANUAL Revision Number: FSSC
Emergency preparedness and response
: Management review
Resource management
Provision of resources
Human resources
Infrastructure
Work environment
Planning and realization of safe products
General
Prerequisite programmes (PRPs)
Preliminary steps to enable hazard
analysis
Hazard analysis
Establishing the operational prerequisite
programmes (PRPs)
Establishing the HACCP plan
Updating of preliminary information and
documents specifying the PRPs and the
HACCP plan
Verification planning
Traceability system
Control of nonconformity
Validation, verification and improvement of
the food safety management
General
Validation of control measure
combinations
Control of monitoring and measuring
Food safety management system
5.6
5.7
5.8
6.0
6.1
6.2
6.3
6.4
7.0
7.1
7.2
7.3
7.4
7.5
7.6
7.7
7.5
7.9
7.10
8.0
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DABUR NEPAL PVT. LTD.RAMPUR, TOKANI, BARA (NEPAL)
FOOD SAFETY MANUAL Revision Number: FSSC
verification
Improvement
8.1
8.2
8.3
8.4
8.5
15 List of Manual
16 Regulatory document
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DABUR NEPAL PVT. LTD.RAMPUR, TOKANI, BARA (NEPAL)
FOOD SAFETY MANUAL Revision Number: FSSC
Cross references between the HACCP principal and application steps and clauses of ISO 22000:2005 & PAS-220:2008HACCP Principle HACCP application Steps ISO 22000 : 2005 & PAS-
220:2008Assemble HACCP team Step 1 7.3.2 Food safety teamDescribe product Step 2 7.3.3
7.3.5.2
Product characteristicsDescription of process steps and control measures
Identify intended use Step 3 7.3.4 Intended useConstruct flow diagram Step 4 7.3.5.1 Flow diagrams On – site conformation of flow diagram Step 5
Flow diagram
Principle 1Conduct a hazard analysis
List all potential hazards
Conduct a hazard analysis
Consider control measures
Step 6 7.4
7.4.2
7.4.3
7.4.4
Hazard analysis
Hazard identification and determination of acceptable levels
Hazard assessment
Selection and assessment of control measures
Principle 2Determine the critical control points (CCPs)
Determine CCPs Step 7 7.6.2 Identification of critical control points (CCPs)
Principle 3Establish critical limit(s)
Establish critical limits for each CCP
Step 8 7.6.3 Determination of critical limits for critical control points
Principle 4Establish a system to monitor control of the CCP
Establish a monitoring system for each CCP
Step 9 7.6.4 System for the monitoring of critical control points
Principle 5 Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control.
Establish corrective actions
Step 10 7.6.5 Action when monitoring results exceed critical limits
Principle 6Establish procedures for verification to confirm that the HACCP system is working effectively.
Establish verification procedures
Step 11 7.8 Verification planning
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FOOD SAFETY MANUAL Revision Number: FSSC
Principle 7Establish documentation concerning all procedures and records appropriate to these principles and their application.
Establish documentation and record keeping
Step 12 4.2
7.7
Documentation requirementsUpdating of preliminary information and documents specifying the PRPs and the HACCP plan
Clauses reference: ISO 9001:2008, ISO 22000:2005 & PAS-220:2008
It is essential that each copy of the Food Safety management system Manual contains a
complete record of amendments. This amendment page should be updated with each
set of revised/new pages of the FSSC manual. An acknowledgement slip will be
included for signatures and return by all holders of controlled copies confirming the
receipt of amendments and returning the obsolete pages.
INTRODUCTION Dabur was founded in 1884 A.D. by a visionary physician of Bengal Dr. S. k. Burman with a philosophy of “what is that life worth which cannot bring comfort to others”. It was first indulged in preparing natural cures for killer diseases which spread as epidemic and endemic in those days like cholera, plague, malaria, leprosy, etc. Soon, he became a renowned person and people in their local ascent called him ‘Daktar’ (Doctor) and hence Dabur got its name from Daktar Burman. Now, as we all know it is
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DABUR NEPAL PVT. LTD.RAMPUR, TOKANI, BARA (NEPAL)
FOOD SAFETY MANUAL Revision Number: FSSC
not only a fledging medicine manufacturer in a small Calcutta house Dabur also produces health care and food items and is a trustworthy and a rising company that at once evokes trust and reliability.
Unit Description
Dabur Nepal Pvt. Ltd.…
The Plant has Six Tetra line:-
1. Tetra line Number 1(TBA 22) is capable of producing 20000 packs per hr.
2. Tetra line Number 2(TBA 8 Slim) is capable of producing 5400 packs per hr
3. Tetra line Number 3(TBA 8 Squire) is capable of producing 5400 packs per hr
4. Tetra line Number 4(TBA 19 (10V) is capable of producing 7500 packs per hr
5. Tetra line Number 5(TBA 19 (20V) is capable of producing 7500 packs per hr
6. Tetra line Number 6(A3 Flex) is capable of producing 7000 packs per hr.
The basic Quality system of the unit follows. All the documents of the Food Safety
System are available as read-only electronic documents.
Plant Quality System
This FSSC manual defines the Food safety Management System adopted by DNPL Unit.
These manual lists down the procedures and measures stipulated for ensuring the
quality of product and services provided by the company. The Quality System of the
company uses DRDC as its basis.
The Food safety management system also part of DRDC. It fits in to the program
structure of DRDC except the structure of this manual.
Status of Quality and Food Safety Management Systems
The unit certified for HACCP (Food Safety Management System)
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DABUR NEPAL PVT. LTD.RAMPUR, TOKANI, BARA (NEPAL)
FOOD SAFETY MANUAL Revision Number: FSSC
INTRODUCTION TO FOOD SAFETY MANAGEMENT SYSTEM:
Food Safety Management System is an International Standard (ISO 22000:2005) as
systematic and preventive approach to achieve food safety standards.
The FSSC approach can be used by all segments of the Food Processing Industry and
can be tailored to any individual product or process line. The advantage of using the
HACCP system lies in the planning it provides at all times over food safety in the
processing plant, from receiving raw materials to shipping the final products &
complete traceability of end products.
For the food processor, producing a safe product will be structured around critical
control points (CCPs). CCPs are designed to control potential significant hazards that
are biological, chemical or physical in nature and that may pose a food safety risk.
The key element of a FSSC based on food safety system is its preventive nature with an
emphasis to exercising better control along with manufacturing process, at critical
steps called critical control points.
By doing so, defects which could impact on the safety of the food can be readily
detected and Corrected at specific points in the manufacturing process instead of
relying on end product inspection and testing through monitoring & control.
By applying FSSC, manufacturing facilities can better control hazards, and thus provide a higher and more consistent assurance of the safety of their products. This document will allow a bottling plant to create their HACCP plan, however, it is important that all steps to implementation of the FSSC system as detailed in the standards, the process flowcharts are modified to match the plant processes, and PRPs, OPRPs and HACCP plans identified for respective plants by their FSSC teams. The final plans must be implemented, personnel trained, records maintained, and verification carried out as per the guidelines of FSSC standards.
Structure of FSSC Manual
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DABUR NEPAL PVT. LTD.RAMPUR, TOKANI, BARA (NEPAL)
FOOD SAFETY MANUAL Revision Number: FSSC
This FSSC manual is structured as shown in the content pages of the Manual. Different
sections are arranged sequentially as per clause number of ISO 22000. The title of
each head is given in the header, while the main clause number of ISO 22000 has also
been indicated in the each Section. For all Sections, relevant sub-clause numbers under
the main clause of ISO 22000 have been indicated in the text there under. FSSC Manual
pages are numbered serially head wise with page number indication. All pages of
Master Copy of each Section of manual bear signature(s) of Approving Authority and
Issuing Authority of manual in original. The current Issue number and amendment
number on each page is also indicated. Issue No. 01 has been given to the first issue
and forms a part of the document number. Amendment / Revision No. ”00” has been
given to first issue of the Section. This manual is available in English Language only.
Issuance of the FSSC Manual
The FSSC coordinator in consultation with Vice President (Management Representative)
is authorized to carry out the activities of preparing, issuing, maintaining and updating
of this FSSC Manual. Management Representative approves the FSSC Manual in
consultation with all concerned functions. The manual is approved by the Head of
operation (MR) prior to its distribution.
The Master Copy bears the signature of the approving and issuing authority in original.
The Master Copy bears stamp of CONTROLLED COPY on reverse page. All controlled
copies issued to the controlled copy holders as per distribution list are legibly
photocopied from original Copy and bear stamp of “CONTROLLED” in blue color on
the face of each page of the manual.
Additional copies of the Manual, required by external agencies, if any, are issued by
CORDINATOR and such copies of the Manual issued are stamped "UNCONTROLLED".
These uncontrolled copies do not come under the purview of document amendment
procedure and are not used within the Company.
The distributions of the Manual and the amendment(s)/Revision are controlled and this
activity is carried out by Coordinator. The Coordinator maintains a record of the
distribution list of the FSSC Manual in consultation with Vice President (Management
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Representative). This list is used as reference for updating of the respective controlled
copies. .
Revision, Updating and Amendment of FSSC manual
The FSSC CORDINATOR in consultation with MR & the related departments reviews the
FSSC Manual periodically. No revision is implemented unless it has been approved and
formally issued. Revision in the manual may be generated consequent upon changes
in the policies and objectives of the company, its internal structure and the FSSC
standard. The revision may also be necessitated due to new developments,
standardization activities, technological advancements and changes in procedures or
systems.
The entire manual is replaced by a new version of the manual after certain numbers of
revisions have been affected or major changes have been enforced due to policy
decisions as envisaged in the documented procedure.
All revisions are furnished to only control copy holders and an acknowledgement is
taken. It is the responsibility of the controlled copy holder to maintain the
Amendment/Revision Record Sheet and update as and when revisions to any provision
of the manual takes place.
The Coordinator ensures prompt withdrawal of obsolete copies of the manual. The
Coordinator & Management Representative retain one copy of the earlier version of the
Section(s) / Page(s) duly marked as “OBSOLETE” in archives, for future references, if
any.
The controlled copy is freely accessible to all personnel in the department for their use.
What is FSSC?
It is a structured management system essentially provides a framework around which
people can operate in order for the organization to achieve its desired outcomes in an
effective and efficient manner.
A food safety management system comprises of three elements
Pre requisite program
Food safety
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DABUR NEPAL PVT. LTD.RAMPUR, TOKANI, BARA (NEPAL)
FOOD SAFETY MANUAL Revision Number: FSSC
Management system requirements
In order for a management system to be effective, the organization must:
Check that it is achieving and maintaining the appropriate levels of performance
and
Review progress to ensure continual suitability & sustainability.
Need for FSSC
The standard specified the requirements for a food safety management system that
combines the following key elements to ensure food safety along the food chain, till
final consumption
Pre-requisite program
FSSC/HACCP principles
System management
Interactive communication
Continual Improvement
Advantages of Food Safety Management System
Systematic approach
Compliance with the customer, statutory & regulatory requirements
Organized and targeted communication among trade partners
Facilitate better Business process
Increased due diligence
Systematic management of pre requisite program
Better planning and less post process verification
More efficient and dynamic food safety hazard control
Reduce liability and risk
Widely applicable as focused on end result
LEGAL AND STATUTORY REQUIREMENTS:
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DABUR NEPAL PVT. LTD.RAMPUR, TOKANI, BARA (NEPAL)
FOOD SAFETY MANUAL Revision Number: FSSC
The unit operations and Production process complies the following Legislations / rules by Government of India / State
Government
DNPL-GOV--FRM-1 Legal Requirements MatrixBureau of Indian Standards (BIS)
Standard Description
IS – 14543 Treated water used for beverage must confirm the
specifications for packaged drinking water
IS 10500 Raw water specifications to meet potability requirements
Finish Product Havey Metals & Pesticide
Raw Material Physical, Chemical & Pesticide
SCOPE
The FSSC system of Dabur Nepal Pvt.Ltd. enables in receiving, storage of raw
material & manufacturing of ready to serve sweetened and in TETRA PACK.
Planning, implementation, operation, maintenance and updating of Unit’s Food
Safety Management System aimed at providing products that, according to their
intended use, are safe for the consumer, demonstrating compliance with
applicable statutory and regulatory food safety requirements, Evaluation and
assessment of customer requirements (in terms of intra/inter department/unit
product requirements i.e. Internal communication) and demonstration of
conformity with those mutually agreed customer requirements that relate to food
safety, in order to enhance customer satisfaction, Effective communication of
food safety issues to their suppliers, customers and relevant interested parties
including statutory & regulatory authorities in the food chain through time to
time written/verbal updating (external communication).
Ensuring that the organization conforms to its stated food safety policy, and
demonstrating such conformity to relevant interested parties, and
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FOOD SAFETY MANUAL Revision Number: FSSC
Certification or registration of its Food Safety Management System by an
external organization, and/or conducting a self-assessment in terms of Internal
Audit or self-declaration of conformity to this International Standard.
3.0 TERMS AND DEFINITIONS:
FSSC Specific:
FSSC: Food Safety Management Systems requirements in line with the international
standard of ISO22000:2005
Food safety: Concept that food will not cause harm to the consumer when it is
prepared and/or eaten according to its intended use.
Food chain: Sequence of the stages and operations involved in the production,
processing, distribution, storage and handling of a food and its ingredients, from
primary production to consumption
Food safety hazard: biological, chemical or physical agent in food, or condition of
food, with the potential to cause an adverse health effect
Food safety policy: Overall intentions and direction of an organization related to food
safety as formally expressed by top management
End product: Product that will undergo no further processing/rework or transformation
by the organization.
Flow diagram: schematic and step by step sequential interaction of control of process.
Control measure: Any action or activity that can be used to prevent or eliminate a
food safety hazard or reduce it to an acceptable level
PRP prerequisite programme: Basic conditions and activities those are necessary to
maintain a hygienic environment throughout the food chain suitable for the production,
handling and provision of safe end products and safe food for consumption.
Operational prerequisite programme: Identified by the hazard analysis as essential
in order to control the likelihood of introducing food safety hazards to and/or the
contamination or proliferation of food safety hazards in the product(s) or in the
processing environment.
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FOOD SAFETY MANUAL Revision Number: FSSC
CCP critical control point: Any step at which control can be applied and is essential
to prevent or eliminate a food safety hazard or reduce it to an acceptable level
Critical limit: criterion which separates acceptability from unacceptability
Target Value: The value of the product or process parameters to be monitored
targeted with in action limit values and certainly with in critical limit values thus
securing a safe product.
Monitoring: Conducting a planned sequence of observations or measurements to
assess whether control measures are operating as intended
Correction: Action to eliminate a detected nonconformity
Corrective action: Action to eliminate the cause of a detected nonconformity or
other undesirable situation
Validation: obtaining evidence that the control measures managed by the HACCP plan
and by the operational PRPs are capable of being effective
Verification: Confirmation, through the provision of objective evidence, that specified
requirements have been fulfilled
Updating: Immediate and/or planned activity to ensure application of the most recent
information
Plant Specific:
Brix: Percentage solids (Sugar) by W/W (10 0Brix means 10 grams of Sugar in 100 gm
of Beverage).
CIP: Cleaning In Place, A system that enables to clean and sanitize all inner surfaces
(Food contact) of equipment without dismantling.
ACIDITY:
4 Food Safety Management Systems
4.1General requirements
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DABUR NEPAL PVT. LTD.RAMPUR, TOKANI, BARA (NEPAL)
FOOD SAFETY MANUAL Revision Number: FSSC
Dabur Nepal Pvt. Ltd. has established, documented, implemented and maintains a
Food Safety Management System and continually improves its effectiveness in
accordance with the requirements of this Standard.
The Scope of this Food Safety management system is defined above (1.0 Scope)
It will maintain a Food Safety Management System manual that includes
a) The scope of the FSSC, including details of and justification for any exclusions
b) References to the documented procedures established for the Food Safety
Management system;
c) The identified, evaluated food safety hazards that may be reasonably expected
to occur in relation to products within the scope of the system. A set of
processes & control measures are identified ,implemented and evaluated for
efficacy in order to control the potential Food safety hazards such a manner
that the products of the organization do not, directly or indirectly, harm the
consumer,
d) Communication procedures established for appropriate information throughout
the food chain regarding safety issues related to its products,
e) Communication procedures established for information concerning development,
implementation and updating of the food safety management system
throughout the organization, to the extent necessary to ensure the food
safety required by this International Standard, and
f) Evaluation & updating on the food safety hazards when necessary , procedure
through validation/verification, audits & periodic review methodology,
By virtue of operation Dabur Nepal Pvt. Ltd. had not outsourced any process of
Beverage manufacturing which would directly affect the product conformity.
This Food Safety Management System Manual is designed as per ISO 22000:2005
standards.
ISO22000:2005
Each document in this manual has its own unique identification code and revision
status. These documents are available to the employees of the organiasation. Hard
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DABUR NEPAL PVT. LTD.RAMPUR, TOKANI, BARA (NEPAL)
FOOD SAFETY MANUAL Revision Number: FSSC
copies of the documents are issued to the required personnel in accordance to the units
Document Management Procedure (DNPL)
4.2 Documentation requirements
4.2.1 General
Dabur Nepal Pvt. Ltd. has established the Food Safety Management System with the
food safety policy, objectives. The document was prepared as per the standards of ISO
22000:2005 standards to ensure the effective development, implementation and
updating of the Food Safety Management System.
4.2.2 Control of documents
Dabur Nepal Pvt. Ltd. will control all documents required as per the established
documented procedure that defines the:
a) Definition of the structure and numbering of the documentation system;
b) Procedure for creation and approval of documents prior to issue;
c) Review, updating as necessary, and re-approval documents;
d) Identification of changes and the current revision status;
e) Use of a master list for internal and external documents;
f) Procedure for distribution and retrieval of documents.
g) Assurance that relevant versions of applicable documents are available at the
location.
h) Assurance that documents remain legible and readily identifiable;
i) Assurance that external documents are identified and their distribution
controlled;
j) Prevention of the unintended use of obsolete documents; by retrieving &
collect from user and destroy.
Dabur Nepal Pvt. Ltd. has designed a communication strategy that ensures all
appropriate personnel have access to the current authorized requirements,
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FOOD SAFETY MANUAL Revision Number: FSSC
specifications, programs and procedures. This system is managed by the Document
Manager
Document control is a centralized function carried out by Document Manager at Dabur
Nepal Pvt. Ltd
Dabur Nepal Pvt. Ltd. had already implemented the HACCP system and
simultaneously the Document management program was established. During the
transition from HACCP to ISO22000:2005, the DNPL SOP procedure remained as it is
and all the Doc Management requirements of HACCP systems are also prevalent for
ISO22000 system except the change is standard’s identification name.
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DNPL SOP Document Management
DABUR NEPAL PVT. LTD.RAMPUR, TOKANI, BARA (NEPAL)
FOOD SAFETY MANUAL Revision Number: FSSC
4.2.3 Control of records
The Dabur Nepal Pvt. Ltd. has established and maintains appropriate records to
achieve the following:
1. Traceability and protection of the Dabur Nepal Pvt. Ltd., assets.
2. Evidence of conformity to requirements and of the effective operation of The
Food Safety Management System.
3. Evidence of conformity to applicable regulatory requirements, where ever
records are required to be maintained
Records are legible, identifiable, and readily retrievable. Records may be kept in paper,
physical form. Retention samples are considered records within the scope of the
system. A documented procedure has been established that includes:
1. The controls needed for the identification, storage, protection, retrieval, retention
time, and disposition of records.
2. Compliance with the Food Safety Management System requirements and/or Local
Applicable regulations which ever is stringent.
3. Appropriate backup and storage of electronic records to avoid loss and to
protect confidentiality. Regular challenges to the backup system have been
carried out to confirm that retrieval of data is possible when required.
4. Secure storage of paper records and physical samples to protect from damage
and to ensure integrity over the life of the record.
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DABUR NEPAL PVT. LTD.RAMPUR, TOKANI, BARA (NEPAL)
FOOD SAFETY MANUAL Revision Number: FSSC
5. Management responsibility
5.1 Management Commitment
Top management of Dabur Nepal Pvt. Ltd. will demonstrate its support and
commitment to the development, implementation, and continual improvement of the
FSSC by:
a) Establishing a Food Safety Management System Policy and ensuring that key
FSSC objectives are established in line with the Business continuity of the
organization;
b) Ensuring the availability of appropriate resources;
c) Communicating to the organization the importance of meeting the FSSC
standard’s requirements, customer requirements for food safety as well as
statutory and regulatory requirements;
d) Ensuring Food Safety Management System programs are developed,
implemented and maintained in manufacturing operations;
e) Conducting planned management reviews;
5.2 Food safety policy
Dabur Nepal Pvt. Ltd.. Food Safety Policy
Dabur Nepal Pvt. Ltd... Food Safety Objectives
Dabur Nepal Pvt. Ltd. Responsibility & Authority
5.3 Food Safety Management System planning
Management ensure that Planning of food safety management system requirements
and objectives that support food safety.
Maintain integrity of the system when changes to the food safety management system
are planned and implemented
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DABUR NEPAL PVT. LTD.RAMPUR, TOKANI, BARA (NEPAL)
FOOD SAFETY MANUAL Revision Number: FSSC
FSSC requirements are identified during the Business planning process which is an
exhaustive analysis of the present year scenario and a projection of the forthcoming
allocations. This process includes all the Business perspective of the unit.
Dabur Nepal Pvt. Ltd. has developed a Business plan that addresses its objectives,
and which promotes continual improvement of the organization and the effectiveness
of all the management systems. This includes the determination of metrics that allow
for the monitoring of performance against objectives. Objectives and metrics are
documented.
The Annual Operation Plan (AOP) at Dabur Nepal Pvt. Ltd. takes place on an annual
basis and includes the top management team. A documented Business plan is
produced, along with a plan for implementation and communication. All associates are
responsible for understanding the, its objectives and metrics in order to assist with the
achievement of the plan. Progress against the objectives and metrics is communicated
to all associates on a routine basis through one or more of the following: staff meetings,
monthly performance reviews, emails, posted charts and graphs, and other means.
Progress against objectives and metrics are a key input to our Business review
meetings.
The Business planning procedure considers the following at minimum:
a) Determination of factors of success;
b) An assessment of financial, economic, food safety, environmental & safety,
and other current factors that bear on success;
c) An assessment of the risks posed by internal and external factors that could
impact our ability to meet objectives and the assets that we manage;
d) Human resource capabilities and needs;
e) Quality capabilities and needs, including resource availability. Also if any
specific food safety related issues or product recall situations.
f) Objectives and metrics.
Top management of Dabur Nepal Pvt. Ltd. will ensure that objectives and metrics,
including those needed to meet requirements for food safety, are established and
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FOOD SAFETY MANUAL Revision Number: FSSC
communicated to relevant functions and levels within the organization. The objectives
have been measurable and consistent with the FSSC policy statement.
NOTE: Top management at Dabur Nepal Pvt. Ltd. is defined as the AVP OPERATION
and Functional heads
5.4 Responsibility and authority:
Responsibilities and authorities are defined as Job descriptions and communicated up to Supervisory level. The prime responsibilities are defined as below:
Dabur Nepal Pvt. Ltd. Responsibility & Authority
Also – the entire workmen, associates, are responsible for communication of any Food
safety related issues, which would directly or indirectly affect the product conformity, to
either the FSSC Team leader or any of the top management associates. Once these are
collated, the same will be discussed among the FSSC team members for suitable
corrective actions or can be taken up through the Crises Management procedure
(situation dependent).The detailed responsibility & authority of FSSC team members
are enlisted in the attachment:
Dabur Nepal Pvt. Ltd FSSC Organization Structure
Dabur Nepal Pvt. Ltd. FSSC team members- Responsibility & Authority
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DABUR NEPAL PVT. LTD.RAMPUR, TOKANI, BARA (NEPAL)
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5.5 Food Safety Team Leader:
Food safety team leader Mr. S. Mukherji trained under DNV for Lead Auditor Course of
ISO 22000:2005 is knowledgeable about Food safety management system and hence
would coordinate the development, implementation and maintenance of the system at
our unit. He will coordinate the development, implementation, maintenance and
updating of the FSSC system, be the leader to manage Food safety team and ensure
relevant training and education of the food safety team members. He will report to the
top management on the effectiveness and suitability of the food safety management
system.
Team members and Staff members are trained by FSSC team leader. Workmen and all
process related personnel are trained by FSSC team leader / FSSC Team member’s
internally. In addition to formal training individual function supervisors are instructed to
train respective area people on OPRPs and CCP s of the respective locations. The
content of these training programs have emphasis on GHP, GMP, GLP and their
applications in their respective departments. The training of staff & operators ensures
that they understand their specific functions, duties, and how these are to be
performed under a FSSC system.
5.6 COMMUNICATION
5.6.1 External communication
Management ensures that proper external communication procedures as follows:
Food safety requirements are communicated to suppliers like Auxiliary materials,
packaging materials cleaning agent’s etc along with Purchase Order.
DRDC communicates the details of authorized suppliers to Beverage Plant. The
Suppliers are communicating material testing results along with materials to the
plant through the Certificate of Analysis.
All other contractors dealing with Products/Processes-which will be
directly/indirectly affecting the end product-are communicated about the food
safety related requirements by the user department through the unit’s supply
chain- before finalizing any such purchase order.
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Consumer information including instructions regarding intended use, specific
storage requirements and, as appropriate, shelf life etc are communicated through
labeling practices, which are mentioned in product description.
Customer contacts.
Food safety issues between organizations are communicating through
E-mails/telephonic conversation.
Statutory and regulatory requirements communication through media, E-mails,
Internet.
For the control of unsafe products _ Product Recall Procedure
Responsibility & Authority of External Communication.
1. In case of any unsafe products / unsafe activities related to safety
environmental affair & any other regulatory affair, media, pamphlets, posters
etc, HR manager is authorized to carry out the same & to retain the evidence.
2. In case of non-conforming & unsafe products QAM is authorized to carry out the
same and retain the evidence.
3. Technical & non technical issues related to development/production/new
packaging materials/Modification of process/Redesigning/ development of
machineries/ Logistic development/modification etc for new products/ concerned
to particular department, respective HODs are responsible to communicate with
vendors, warehouse, C & F agent, Distributors, Agencies etc.
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Interactive Communication
Food safety team is responsible for the information obtained through external
communication will be included as input to system updating and management review.
This External communication will be captured in every possible ways. Either through
the Visitor’s registers(kept at security where all suggestions related to Food safety &
other plant requirements will be captured), or by any written letters, or by e-mails, or
by nonverbal communication methods will be captured by the Food Safety Team
Leader, time to time and will be discussed during management review/FSSC team
meetings. The inputs from all these will be taken in consideration during MRM, Risk
Analysis and FSSC updating.
5.6.2 Internal Communication
Top management of Dabur Nepal Pvt. Ltd. has ensured that appropriate
communication processes are established within the organization and that
communication takes place regarding the effectiveness of the Food Safety Management
System. Examples of these communication processes include our intranet site, staff
meetings, bulletin board postings, emails, and other means.
To maintain the effectiveness of the Food Safety Management System, the food safety
team will conduct the meetings at regular intervals.
Food safety team is responsible for updating the information as input to the system updating and Top management is responsible for inclusion of information as input to the Management Review.
Products change or New Products after receiving the communication a review meeting
is called by MR involving HODs & food safety team and plan for raw & packaging
material. Proceed for qualification round as per DRDC. In case of TETRA PACK approval
from packaging dept of DABUR to is obtained. Commercial production will take place
only after getting approval from Dabur India. Raw materials, ingredients, packaging
materials needed to be segregated from old & properly identified. All the specifications
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of raw materials, packaging materials and services should be procured from Dabur
India & verify. Issuance through information slips from store & approval slip (material
status) from user to store Production system and equipment up gradation as per Dabur
India design & approval from Dabur India to be obtained. Production planning needed
to be displayed in production board. All the information related to product, equipment &
location GMP, GHP & food safety aspects, environmental aspect with relevant
information to be communicated to respective dept. cleaning and sanitation
programmes along with GMP, GHP to be monitored & recorded. New products are
packed with Dabur India approved & verified Packaging, materials containing all
regulatory/statutory requirements identified & stored separately from rest of the
finished goods. Distribution system with complete traceability up to dealer point with
display of posters, hoarding & through media also information to regulatory bodies like
PFA.FPO,BIS health authority, pollution control board etc. where applicable.
Personal qualification level & allocation of responsibility & authority Refer…
Statutory & regulatory requirement relevant to product & package and other is dully
communicated through interoffice memo, email & notice to respective responsible
person.
Awareness & Refresh Training related to FSSC is being conducted internal as well as
from external source.
Plant tour of families of employees is being conducted with prior information & any
relevant information related to product, planning & organization is dully communicated.
Also visitor’s guide is being communicated to security. ( ####-MR-5.6.2-SOP-1 )
Product related information by conducting the Plant tour of institutions & other bodies.
Food safety hazard displayed at location with precaution, procedure, control measure,
control point & impact on food safety for each significant process in FSSC.
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DNPL-MR-5.7-SOP-2 Product Recall
5.7 Emergency preparedness and response :
Dabur Nepal Pvt. Ltd. has developed and implemented a Crises Management
procedure and Emergency Action Plan to manage potential emergency situations and
accidents that can impact food safety, protects our consumers, assets, and the image
and trademarks of The Dabur Nepal Pvt. Ltd. Company.
The Emergency Action/Food safety Plan is a multifunctional procedure led by the H O
Operation. The Dabur India Quality System requires the existence of an effective
Emergency Action Plan procedure that is to be reviewed (Safety Audit) in every six
months.
Each level of the organization maintains a key contact list, which includes 24-hour per
day phone numbers. The key contact list is current and includes interfaces to the next
level up and down within the Company system.
DNPL-MR-5.7-SOP-1 Emergency Response Plan
5.8 Management review
5.8.1 General
Management reviews FSSC implementation, continuing suitability, adequacy and effectiveness. The review
includes assessing opportunities for improvement and the need for change to the Food Safety Management System,
including the food safety policy.
DNPL-MR-5.8-SOP-1 Management review DNPL-IA-8.4-SOP-1 Internal Audit
DNPL-MR-7.10.2-SOP-1 Corrective Action
HACCP-FRM-06 FSSC Verification Compliance ReportDNPL-MR-5.8-FRM-1.1 MRM review FormDNPL-VAL 8.0-GHK-1 FSSC Validation Report
5.8.2 Review input
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The management review includes the
a) Follow-up actions from previous management reviews,
b) Analysis of results of verification activities
c) Changing circumstances that can affect food safety,
d) Emergency situations, accidents, recall and withdrawals
f) Review of communication activities, including customer feed-back and
g) External audits or inspections.
5.8.3. Review out put
The management review output has the decisions and actions related to
a) Assurance of food safety
b) Improvement of the effectiveness of the food safety management system
c) Resource needs and
d) Revisions of the organization's food safety policy and related objectives
6. Resource Management
6.1 Provision of resources
Top management of Dabur Nepal Pvt. Ltd. will determine and provide the resources
and information needed to:
a) Effectively achieve the organization’s objectives, as defined in the Business
Plan;
b) Establishment, implement, and maintain the Food Safety Management
programs in manufacturing operations;
c) Ensure updating the changes of the Food Safety Management System.
6.2. Human resources
6.2.1 GeneralThe Food Safety Management System team formed to develop the FSSC plan
Implement and maintain the FSSC in the unit. The FSSC team comprising of people
from various functions to accommodate the knowledge of different fields and work
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environments so that the FSSC implementation includes all process steps right from
receiving of materials (Refer DNPL-PRP-7.2-SOP-2 Material Receiving) to
manufacturing to storage of products at shipping. (Refer-Warehouse)
DNPL-HR-6.2.2-SOP-1 Personnel Training6.2.2 Competence, awareness and training
The organization has developed and implemented a documented procedure of training
with the requirement of
Team Leader was trained by the Food Safety Management System by expert
agency (SGS – INDIA)
Team members and other Staff members and the personal monitoring,
corrections and corrective actions of the system are trained by team
leader/members
Workmen and all process related personnel are trained by FSSC Team Leader or
other trained members
The Management has been encouraging & supportive in ensuring that all the
associates are adequately trained to facilitate FSSC system development,
implementation and maintenance.
Records of training are available with HR Department along with other training
records. The implementation and effectiveness of the training are evaluated by
the HR Department.
DNPL-HR-6.2.2-SOP-1 Personnel Training
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6.3 Infrastructure:
Dabur Nepal Pvt. Ltd. will determine, provide, and maintain the infrastructure
needed to achieve conformity to product and service requirements. Maintenance
procedures, including routine, preventive, and corrective maintenance, needed to
achieve product and/or process requirements has been documented. Records of
maintenance have been maintained.
Infrastructure includes, as applicable:
a) Buildings, workspace, and associated utilities; Refer to Maintenance program.
b) Process equipment (including hardware, software, production equipment,
vending and dispensing equipment); Refer to Maintenance program…
c) Supporting services (such as transport or communication). Refer Inbound &
outbound vehicle checklist
d) Organization chart: DNPL-HR-6.3-CHRT-01
6.4 Work environment
Dabur Nepal Pvt. Ltd. will determine and manage the work environment needed to
achieve conformity to this standard requirement.
Medical checkup & facility of employees
Good Manufacturing Practices
Good Hygiene Practice
Pest Control
Cleaning & Sanitation
Personal Safety
Environment Safety
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7.0 Planning and realization of safe products
7.1 General
Dabur Nepal Pvt. Ltd. controls commercialization to ensure effective manufacture,
distribution, and merchandising of new products, packages and other process outputs.
This includes PRP(s) as well as operational PRP(s) and/or the HACCP plan.
There are no special processes / technology introduced by the Unit. Any new process /
Product / technology will be first tested and validated. The new products / process will
be implemented under the close observation of technical experts / technical experts
nominated by the Dabur India. Data regarding the complete trails including raw
materials, Process monitoring and control etc will be maintained. The out put / finished
products will be retained in the warehouse till all the product conformity tests
completed and satisfactory.
The top management ensures effective communication among different departments
such as Production, Quality, Shipping, Sales and marketing
Quality will coordinate with Dabur India to receive New Product Formulation (Beverage
Document) specifications and other details. New pack launch details are collected from
package division. QA shares relevant information with Technical team in plant
Unit to get legal clearance from appropriate authorities and concerned statutory bodies
to comply with applicable laws where ever required
The distribution and marketing of newly launched product will be as per the specific
guidelines by Dabur India and other marketing related requirements. Sales identify the
distribution system and plans retail strategies. Develops Marketing strategies and
Launch criteria are planned and implemented in coordination with sales team and
required merchandizing practices will be put in place.
Unit conducts surveys on the new product / package based on the DABUR requirement
and shares the information with DABUR.
Unit reconfirms and determines changes which require verification and validation
Records of test market validation and any changes during the commercialization
process are maintained
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Technical Service Manager (DABUR) is responsible for the new product realization in
general and Plant manager and QA manager are responsible for Production process.
7.2 Prerequisite programmes (PRPs)
7.2.1 Dabur Nepal Pvt. Ltd. has identified & established, to implement and maintain
PRP(s) to assist in controlling
a) The likelihood of introducing food safety hazards to the product through the work
environment,
b) Biological, chemical and physical contamination of the product(s), including cross
contamination between products or intermittent process out puts, and
c) Food safety hazard levels in the product and product processing environment.
The PRPs are primarily outlined in line with the Codex Alimentarius requirements as
referred to CAC/RCP 1-1969, Rev 3 (1997) Amended 1999
Refer – Annexure C of ISO/FDIS 22000:2005(E)
7.2.2 The PRP(s)
Dabur Nepal Pvt. Ltd. have the PRPs appropriate to the products manufactured and
to the whole set of operation within the organization. These PRPs are approved the
safety team and will periodically be reviewed during the half yearly verification process
of the FSSC Manual or as & when changed/updated. The team identified the applicable
statutory and regulatory requirements as the mandatory PRPs in FSSC.
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DNPL-HK-7.2-SOP-3 PERSONAL PRACTICES & HYGIENE
DNPL-HR-6.2.2-SOP-1 PERSONNEL TRAINING
DNPL-RET-4.2.3-SOP-1 RETENTION SAMPLES
DNPL-IA-8.4-SOP-1 INTERNAL AUDIT
DNPL-MR-7.10.2-SOP-1 CORRECTIVE ACTION
DNPL-HK-7.2-SOP-1 HOUSEKEEPING
DNPL-SAN -7.2.3-SOP-1 CLEANING & SANITATION
DNPL-PRP-7.3.5-SOP-1 MICROBIOLOGY MONITORING
DNPL-HK-7.2-SOP-2 PEST CONTROL
DNPL-DOC-4.2-SOP-1 DOCUMENT MANAGEMENT
DNPL-CAL-8.3-SOP-1 EQUIPMENT CALIBRATION
DNPL-MR-5.8-SOP-1 MANAGEMENT REVIEW
DNPL-MR-5.7-SOP-1 EMERGENCY PREPARDNESS
DNPL-MR-5.7-SOP-3 HANDLING OF OVERAGE PRODUCTS
DNPL-PRP-7.2-SOP-4Handling, Storage, Control and Distribution of Materials &
Products
DNPL-PRP-7.2.3-SOP-1 Waste Management
DNPL-GOV--FRM-1 Legal compliance
HACCP/FLC/TETRA PACK /6 Process Flow Chart PROCESS
HACCP/FLC/TETRA PACK /7 Process Flow Chart Soda PET & RGB
HACCP/ACH/1 Plant Lay Out _ Material Flow PET & RGB
HACCP/ACH/3 Plant Lay Out _ Hygiene Zones
DNPL-PRP-7.2DNPL-PRP-7.2
PAS-220 (TS/ISO 22002-1)
Food Defense
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7.2.3 Dabur Nepal Pvt. Ltd. has established the PRPs considering the layout of
Building construction layout of premises, work spaces and constructing the utilities.
Employee’s facilities were provided by the HR.
The unit has good source of ground water facilities and the required facilities like
energy, air, water and other utilities were provided to produce safe products.
The material generated while production are having proper services for the disposal of
waste and sewage. Plant is committed to minimize the environmental impacts due to
waste materials.
For the equipment that are used for production are having the accessibility for cleaning
and sanitation, maintenance. The unit is purchasing the materials from the approved
suppliers recommended by the DABUR INDIA. The disposal of the solid & other wastes
are through approved/authorized third party is under process – Refer Solidest
Management plan (DNPL-HK-7.2.3-SOP-1 & DNPL-HK-7.2.3-SOP-2). Implementation of
good storage practices, transportation practices are in place according to the guidelines
of DABUR INDIA.
Good storage practices are in place to prevent the cross contamination in the food
chain as per DABUR INDIA Guidelines.
\DABUR INDIA recommended cleaning and sanitizing material and procedures are in
place to produce safe food product.
Location follows an internal guideline of maintaining personnel hygiene at the highest
level which is verified in the scheduled frequency for its efficacy.
All the PRP are implemented and they have been updating basing upon the changes
and requirements. These documents are verified periodically and modifications will be
updated.
For PRP 7 other verification – refer 7.8 clause of this manual.
7.3 Preliminary steps to enable hazard analysis
7.3.1 General
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Dabur Nepal Pvt. Ltd. conducted the hazard analysis with the team members and
the concern area food handles. The details of analysis were documented.
7.3.2 Food Safety Team
The FSSC team formed to develop the FSSC plan Implement and maintain the FSSC
system at the location. The FSSC team comprising of people from various functions to
accommodate the knowledge of different fields and work environments so that the
FSSC implementation includes all process steps right from receiving of materials to
manufacturing to storage of products at shipping.
The eligibility criterion for an FSSC team member is Minimum educational graduation
(Biology / Microbiology / Engg / Commerce / Arts) and At least one year working in his /
her respective area.
The FSSC Team: DNPL-FSSC-5.5-TEAM-1
7.3.3 Product characteristics: DNPL-PRP-7.3.3-ACH-1
7.3.3.1 Raw materials, ingredients and product-contact materials
HACCP/TETRA PACK /1 Material Datasheet
Identification of key ingredients and raw materials, Packaging materials and their
description
7.3.3.2 Characteristics of end productsDNPL-PRP-7.3.3-ACH-1 Product Description
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Product description is for Carbonated & non carbonated Beverage includes the Basic
composition, Packaging and processing conditions, Intended use etc.
Dabur Co DABUR INDIA identified the related statutory and regulatory food safety
requirements for all the products. The descriptions will be updated when required
periodically.
7.3.4 Intended use
DNPL-PRP-7.3.3-ACH-1 Product DescriptionDNPL-MR-5.7-SOP-3 Handling Of Overage Products
7.3.5 Flow diagrams, process steps and control measures
7.3.5.1 Flow diagrams
HACCP/FLC/TETRA PACK /6 Process Flow Chart PROCESS
HACCP/FLC/TETRA PACK /7 Process Flow Chart soda PET & RGB
HACCP/ACH/1 Plant Lay Out _ Material Flow PET & RGB
HACCP/ACH/3 Plant Lay Out _ Hygiene Zones
* Drainage flow & Pest control diagrams are displayed at the entrance of the Lab corridor
7.3.5.2 Description of process steps and control measures
Dabur Nepal Pvt. Ltd. plans, implements, controls, monitors, measures (where
applicable), and analyzes its processes, and effectively ensures that new and existing
processes continuously produce material, product, and/or service within Company
specifications, and which meet applicable regulatory requirements and this standard.
Planning of processes is consistent with the overall requirements and objectives of the
food safety management system. The process monitoring and control procedure (or
components of the procedure) has been documented for processes that affect the
achievement of conformance by material, product, or service to applicable regulatory
or Company requirements.
Plant has been described the process steps and control measures are in the Hazard analysis.
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7.4 Hazard analysis
7.4.1, 7.4.2
Dabur Nepal Pvt. Ltd. identified the food safety hazards relation to the product,
process and actual processing facilities by gathering preliminary information of the
clause 7.3, experience, historical data and information relevance to the safety of end
products and intermediate products. All the steps preceding and following the specified
operation, process equipments and utilities/services and surroundings are considered
during identification of the hazards. Acceptable levels of the hazards are determined by
considering the division guidelines and Statutory & Regulatory requirements
7.4.3 Hazard assessment
HACCP/TETRA PACK /1 Hazard Analysis
Hazard analysis has been conducted by FSSC team based on the Flow charts.
Methodology followed for arriving a hazard is as follows
1. Verify each step of the flow chart for possible physical, Chemical and biological
Hazards.
3. Control Measures are identified for either eliminating or reducing the hazards up to an acceptable level.
HACCP/TETRA PACK /1 Hazard Analysis
7.4.4 Selection and assessment of control measures:
The organization developed methodology for Assessment of control measures
HACCP/TETRA PACK /1
HACCP/TETRA PACK /1
Categorization of Control Measures
7.5 Establishing the Operational Pre-requisite Programs
HACCP/TETRA PACK /1 Categorization of Control MeasuresHACCP/TETRA PACK /1 Hazard Analysis
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7.6 Establishing the HACCP Plan
7.6.1, 7.6.2, 7.6.3, 7.6.4
DNPL-FSSC--7.6-PLAN-1 FSSC Plan
HACCP plan includes the identification of critical limits based on company
specifications, past experiences and DABUR INDIA reference documents, Target limits
from where the actual corrective action initiates
HACCP plan also includes monitoring, Verification and corrective action (as per DNPL-
MR-7.10.2-SOP-1 Corrective action Procedure) mechanism for each CCP. Any deviation
in CCP critical limits, the process must be stopped, and the product produced during
that period must be identified. The product should be re-verified for the hazard and
release only if conform to specifications. In case of non-conformity the product will be
handled as per (Control of non-conforming Material)
7.7 Updating of preliminary information and documents specifying the PRP and HACCP PLAN
Dabur Nepal Pvt. Ltd. established the following information for the OPRPs and HACCP
plan and will be subsequently amend as and when these are updated.
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a) Product characteristics
DNPL-PRP-7.3.3-ACH-1 Product Description
b) Intended use
DNPL-PRP-7.3.3-ACH-1 Product Description
C) Flow diagrams
HACCP/FLC/TETRA PACK /6 Process Flow Chart HACCP/FLC/TETRA PACK /7 Process Flow Chart HACCP/ACH/1 Plant Lay Out _ Material Flow HACCP/ACH/3 Plant Lay Out _ Hygiene Zones
d) Process steps – same as above
e) Control measures
HACCP/TETRA PACK /1 Hazard AnalysisIf necessary, the HACCP plan and the procedures and instructions specifying the PRP(s)
will be amended accordingly
7.8 Verification planningTo determine the compliance with specifications of the FSSC and to confirm that the
FSSC system is working effectively the following are verified. The Verification results
are communicated to the food safety team
a) The PRP(s) are implemented
b) Input to the hazard analysis is continually updated,
c) The operational PRP(s) and the elements within the HACCP plan are implemented
and effective,
d) Hazard levels are within identified acceptable levels and
e) Other procedures required by the organization are implemented and effective.
For individual Verification frequencies –
Refer
DNPL-FSSC--7.6-PLAN-1 FSSC PlanDNPL-PRP-7.2 PRP
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DNPL-VAL 8.0-GHK-1 FSSC Verification / validationHACCP-FRM-06 Verification compliance reportHACCP/TETRA PACK /1 Hazard AnalysisDNPL-IA-8.4-SOP-1 Internal Audit
7.9 Traceability system
Dabur Nepal Pvt. Ltd. has implemented a documented traceability procedure to
ensure that material, product and service effectively conform to all requirements. The
procedure prevents the inappropriate use of trademarked material and product in the
event of product withdrawal.
The documented procedure includes:
a) Coding and labeling of materials and products with operational status and
durability;
b) Demonstration of two-way traceability of material and product, and
maintenance of records that facilitate traceability
DNPL-TRC-7.9-FRM-0.2 Traceability of Mfg - (Backward)DNPL-TRC-7.9-FRM-0.1 Traceability of Mfg –products (Forward)
7.10 Control of nonconformity
7.10.1 Corrections
Dabur Nepal Pvt. Ltd. has implemented a documented procedure when critical limits
for CCP(s) are exceeded or there is a loss of control of operational PRP(s) to prevent the
use or distribution of nonconforming material and product. This includes nonconforming
trademarked material, product, or equipment.
The documented procedure includes:
a. Identification and assessment of affected end product;
b. Assignment of all responsibilities and authorities related to dealing with
nonconforming material and product;
c. Initiation of corrective action on nonconforming product, as appropriate;
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d. The causes and consequences for the non conformity with information needed
for traceability purpose
7.10.2 Corrective actions
The Dabur Nepal Pvt. Ltd. has implemented a corrective action procedure that
ensures action is taken to eliminate the cause of nonconformities in order to prevent
recurrence. The non conformances were evaluated by designated person with
knowledge in that activity and authorities were assigned to initiate the corrective
action. Corrective actions are appropriate to the effects of the nonconformities
encountered.
A documented procedure has been established that includes:
a) Review of nonconformities (including customer complaints);
b) Reviewing the trends in monitoring results that may indicate development
towards loss of control
c) Determining the causes of nonconformities;
d) Evaluating the need for action to ensure that nonconformities do not recur.
Not all deviations require action through the corrective action system. The
Dabur Nepal Pvt. Ltd. has established criteria to determine what deviations
require action;
e) Determining and implementing action needed;
f) Records of the results of action taken;
g) Reviewing effectiveness of corrective action taken;
When nonconforming material or product is detected after delivery or use has started,
the organization takes action appropriate to the effects, or potential effects, of the
nonconformity.
Records of the control of nonconforming material and product, including descriptions of
the nonconformity and disposition (including concessions, as applicable) are
maintained.
7.10.3 Handling of potentially unsafe products
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7.10.3.1 General
Dabur Nepal Pvt. Ltd. has implemented a documented procedure to prevent the use
or distribution of nonconforming material and product. This includes nonconforming
trademarked material, product, or equipment.
The documented procedure includes:
a. Food safety hazards of concern have been reduced to the defined acceptable
levels
b. Food safety hazards of concern will be reduced to identified acceptable levels
prior to entering into the food chain
c. Product still meets the defined acceptable levels of the food safety hazards of
concern despite the non-conformity
DNPL-TRC-7.9-FRM-0.2 Traceability of Mfg - TETRA PACK
DNPL-TRC-7.9-FRM-0.1 Traceability of Mfg –TETRA PACK ingredients - products
7.10.3.2 Evaluation for release
Dabur Nepal Pvt. Ltd. consider the nonconforming products will be released as safe
when
a) Evidence other than the monitoring system demonstrates that the control measures
have been effective;
b) Evidence shows that the combined effect of the control measures for that particular
product complies with the performance intended
c) The results of sampling, analysis and/or other verification activities demonstrate that the affected lot of product
complies with the identified acceptable levels for the food safety hazard(s) concerned.
5.6 Communication
DNPL-MR-5.7-SOP-3 Handling & Destruction of NC products
7.10.3.3 Disposition of nonconforming products
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DABUR NEPAL PVT. LTD.RAMPUR, TOKANI, BARA (NEPAL)
FOOD SAFETY MANUAL Revision Number: FSSC
Dabur Nepal Pvt. Ltd. has implemented a procedure to prevent the use or
distribution of nonconforming material and product. This includes nonconforming trademarked material, product, or
equipment.
DNPL-MR-5.7-SOP-3 Handling & Destruction of NC products
7.10.4 Withdrawals
The Dabur Nepal Pvt. Ltd. has implemented a procedure for monitoring consumer
contacts and withdrawals. The results of withdrawal are discussed in the Management
review. The consumer response and withdrawal procedure includes:
a) A mechanism with authority to initiate a withdrawal and for executing the
withdrawals
b) Handling of withdrawn products as well as affected lots of the products still in
stock
c) The sequence of actions to be taken
d) Maintenance of consumer contact records.
DNPL-MR-5.7-SOP-2 IM-Product RecallDNPL-TRC-7.9-FRM-0.2 Traceability of Mfg - TETRA PACK DNPL-TRC-7.9-FRM-0.1 Traceability of Mfg –TETRA PACK ingredients - products
8. Validation, verification and improvement of the food safety management system:
8.1 GeneralValidation a process where a separate validation team has been formed comprising
of FSSC team members and non team members in order to verify the completeness and accuracy of the Process flow
diagrams and Operational PRPs plan and HACCP plan documents, Methods of implementation and validates the OPRP
plan & HACCP plan for their completeness and effectiveness.
DNPL-MR-5.7-SOP-2 FSSC Validation
8.2 Validation of control measure combinations:
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DABUR NEPAL PVT. LTD.RAMPUR, TOKANI, BARA (NEPAL)
FOOD SAFETY MANUAL Revision Number: FSSC
The validation team is as follows
1. H.O. Operation Management Representative
2. QA Manager Independent
3. Production Manager Independent
4. Team Leader FSSC Coordinator
5. Maintenance Engg Independent
6 QA Executive Independent
Validation team goes through the Validation process that has to be done before
implementation of control measures to be included in operational PRP(s) plan and the
HACCP plan. After that if any changes had happened.
1. The control measures are re-assessed if the result of the validation shows that
the elements cannot the confirmed
2. Modifications may include changes in control measures (i.e. process parameters,
or change in the raw materials, manufacturing technologies, and end product
characteristics, methods of distribution and/or intended use of the end product.
The validation team may go through the documents like, Microbiological monitoring
records, Process monitoring and control records and Consumer complaints records to
validate the HACCP Plan
Frequency: Beginning of the FSSC implementation and whenever there is a change in
the OPRP plan & FSSC Plan and at minimum not more than one year
For individual Validation frequencies –
Refer:
DNPL-OPRP-7.5-PDW-1 OPRP PlanDNPL-FSSC--7.6-PLAN-1 FSSC PlanDNPL-VAL 8.0-GHK-1 FSSC Validation Report
8.3 Control of monitoring and measuring
Dabur Nepal Pvt. Ltd. will identify the measuring and monitoring equipment used
(process and laboratory) to provide evidence of conformity of product and process to
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DABUR NEPAL PVT. LTD.RAMPUR, TOKANI, BARA (NEPAL)
FOOD SAFETY MANUAL Revision Number: FSSC
requirements. We uniquely identify each piece of equipment to facilitate traceability of
calibration and record keeping.
The documented calibration procedure(s) includes:
a) Determination of the accuracy required for each identified instrument and
device;
b) A calibration schedule that includes the calibration frequency;
c) Calibration over the full range of use of the equipment or device;
d) Readily identifiable calibration status;
e) Use of certified reference materials traceable through certificates retained on
file. Traceability has been to an appropriate standard (local, national or
international). When no reference material is available, a suitable consensus
material has been used;
f) Adjustment or readjustment of equipment, as necessary;
g) Identified to enable the calibration status to be determined
h) Removal of equipment from service when monitoring or verification results
indicate the equipment is out of calibration, until it is recalibrated and
deemed acceptable for use;
i) Assessment and recording of the validity of the previous measuring
results when the equipment is found not to conform to requirements; this
includes the taking of appropriate action on the equipment and any product
affected.
Measuring equipment has been safeguarded from adjustments that would invalidate
the measurement result, and has been protected from damage and deterioration
during handling, maintenance and storage.
Records of the results of calibrations and verifications are maintained.
Recalibration and/or verification takes place prior to first use and following repair
DNPL-CAL-8.3-SOP-1 Equipment Calibration
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DABUR NEPAL PVT. LTD.RAMPUR, TOKANI, BARA (NEPAL)
FOOD SAFETY MANUAL Revision Number: FSSC
8.4 Food safety management system verification
8.4.1 Internal audit
Dabur Nepal Pvt. Ltd. has implemented an audit procedure to monitor conformance
with this Food Safety Management System Standard and other relevant Company
requirements, and to assess the intent, implementation, and effectiveness of it’s the
system. Audits are conducted at planned intervals. Each organizational department
responsible for oversight of other organizations contracted to manufacture and
Distribution trademarked products must implement a procedure for performing external
audits on these same organizations.
The audit procedure includes:
a) Determination of persons responsible for conducting audit activities, including
required competency;
b) Auditors who are independent of the activity being audited. Auditors must not
audit their own work;
c) Documented schedule that defines audit frequency. The schedule takes into
consideration the results of previous audits and the status and importance of
the area or element being audited. For internal audits, the audit schedule
ensures that each element of the system is reviewed at least once per year;
d) A documented procedure that defines the responsibilities and requirements
for planning and conducting audits, and for reporting results and maintaining
records. The audit criteria, scope, and methods are also defined within the
documented procedure and the individual audit plans.
e) Investigation and corrective action by management on audit nonconformities
in a timely manner;
f) Verification of actions taken;
g) Management review of audit results and the resulting corrective actions.
Records of audits are maintained.
DNPL-IA-8.4-SOP-1 Internal Audit
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DABUR NEPAL PVT. LTD.RAMPUR, TOKANI, BARA (NEPAL)
FOOD SAFETY MANUAL Revision Number: FSSC
8.4.2 Evaluation of individual verification results
The verification team of Food Safety Management System evaluates the procedure to
monitor the results at planned intervals. The team verifies the conformity with the
system. It also verifies the
a) Existing procedures and communication channels
b) The conclusions of the hazard analysis, the established operational PRP(s)
and the HACCP plan
c) The PRP(s) and
d) The effectiveness of training activities
DNPL-VAL 8.0-GHK-1 Validation Report
HACCP-FRM-06 FSSC Verification Compliance Report
HACCP/TETRA PACK /1 Hazard Analysis
DNPL-FSSC-5.4.1-OBJ-1 FSSC Communication
DNPL-HR-SCH-01.4 Training Calendar
DNPL-HR-6.2.2-FRM-1.7 Skill Gap Analysis
8.4.3 Analysis of results of verification activities:
The food safety team analyses the results of the verification activities, internal audits
and external audits. These results are reviewed in the Management Review meetings.
The analysis includes
a) To confirm that the overall performance of the system meets the planned
arrangements and the food safety management system requirements established by
the organization,
b) To identify the need for updating or improving the food safety management system,
c) To identify trends which indicate a higher incidence of potentially unsafe products.
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DABUR NEPAL PVT. LTD.RAMPUR, TOKANI, BARA (NEPAL)
FOOD SAFETY MANUAL Revision Number: FSSC
d) To establish information for planning of the internal audit programme concerning the
status and importance of areas to be audited, and
e) To provide evidence that any corrections and corrective actions that have been
taken are effective.
HACCP-FRM-06 FSSC Verification Compliance Report
DNPL-IA-8.4-SOP-1 INTERNAL AUDIT
DNPL-MR-5.8-SOP-1 MANAGEMENT REVIEW
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Classified: Date: Page 46 of 47
DABUR NEPAL PVT. LTD.RAMPUR, TOKANI, BARA (NEPAL)
FOOD SAFETY MANUAL Revision Number: FSSC
8.5 Improvement
8.5.1 Continual improvement
Dabur Nepal Pvt. Ltd. Management ensure that the organization continually
improves the effectiveness of the food safety management system through the use of
communication, internal audit, evaluation of individual verification results, analysis of
results of verification activities, validation of control measure combinations, corrective
actions, management review and food safety management system updating.
8.5.2 Updating the food safety management systemDabur Nepal Pvt. Ltd. Management ensures that the food safety management
system is continually updated. In order to achieve this, the food safety team will
evaluate annually the food safety management system and to review the hazard
analysis, the established OPRPs and the HACCP plan. The updating activities will be
reviewed in the Management review meetings.
The evaluation and updating activities will be based on
a) Input from external and internal communication,
b) Input from other information concerning the suitability, adequacy and
effectiveness, of the food safety management system,
c) Output from the analysis of results of verification activities,
d) Output from management review
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Classified: Date: Page 47 of 47