Food Safety Manual - ECCL

Doc. No.
FSM
EDNA CHOCOLATES CEYLON (PVT) LTD Issue No. 05
Issue Date 2015.06.23
Food Safety Manual
No. 00
Abbreviations
ECCL - Edna Chocolates (Ceylon) Pvt Ltd

FSMS - Food Safety Management System
HACCP - Hazard Analysis and Critical Control Points
PRP - Pre-requisite Programs
GAP - Good Agricultural Practices
GMP - Good Manufacturing Practices
GHP - Good Handling Practices
SOP - Standard Operation Procedure
SSOP -Standard Sanitary Operation Procedure
CCP - Critical Control Point
CL - Control Limit
OPRP - Operational Pre-requisite Program
CAR - Corrective Action Report
MRM - Management Review Meeting
IA - Internal Audits
FSTL - Food Safety Team Leader
FST - Food Safety Team
GM/HOM - General Manager/Head of Manufacturing
PLM - Plant Manager
QAE - Quality Assurance Executive
PM - Production Manager
SE - Stores Executive
MM - Maintenance Manager
PE - Production Executive
QAA - Quality Assurance Assistant
Prepared by Reviewed by: Approved by:

Quality Assurance Plant
Executive Manager GM/HOM
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I. Introduction
The Food Safety Management System established at EDNA CHOCOLATE (CEYLON) PVT LTD.
(ECCL) with reference to requirements of ISO 22000:2005 Food Safety Management System is
comprehensively presented in this manual.
II. Distribution Control
The Food Safety Team Leader is responsible for distribution control of this document and distribution
of the controlled copies of this manual will be carried out in accordance with the procedure for
document control (Refer FSP/01- Procedure for Control of Document). Distribution list of controlled
copies is as follows.
.
Distribution list
COPY HOLDER’S
CONTROLLED COPY
DESIGNATION
Chairman/CEO Controlled Hard Copy
GM/HOM Controlled Soft Copy & Hard Copy
Food Safety Team Leader Master Soft Copy & Hard Copy
Plant Manager Controlled Hard Copy
Maintenance Manager Controlled Hard Copy
Stores Executive Controlled Hard Copy
Certification body Uncontrolled hard copy
The copies issued to outside parties like certification bodies, customers will become ‘Uncontrolled
Copies’ and such copy shall be issued only on prior approval of the top management.
III. Review and Approval
This Manual is
- Prepared by FSTL/QAE-ECCL
- Reviewed by the Plant Manager(PLM)and Approved by GM/HOM
This manual is a controlled document within the company and when distributed outside it will
become an uncontrolled document
IV. Revision

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This Manual will be periodically reviewed for its adequacy, adherences and effectiveness and
revised. Revision will be carried out in accordance with the procedure for document control (Refer
FSP/01- Procedure for Control of Document). Revision shall be finally approved by the General
Manager/HOM prior to application.
V. COMPANY PROFILE
Name of the Organization – EDNA CHOCOLATE (CEYLON) PVT LTD.

Address – Uthuwankanda, Mawanella.
Telephone – 0094 035 224 1660/ 0094 0352241670
Fax – 0352241669
Email – mawanella.tally@edna.lk
Today EDNA group is headed by its present chairman Mr. B.R.S.T Edirisinghe son of late Mr.
Wimaladasa Edirisinghe.
The Edna group is one of the largest diversified conglomerates specializing in many areas. E I&M
(pvt) Ltd is the key subsidiary of Edna Group and is the marketing arm of chocolate, confectionary
and pharmaceuticals which has a work force of over 300.
Today Edna is one of the leading chocolate & confectionary brands in Sri Lanka. It boasts a well
established island-wide distribution network and an extensive product portfolio which includes
chocolates, confectionaries and wafer biscuits. E I&M (pvt) Ltd is also the marketer of world
renowned SMA Nutritional brands of Wyeth Nutritional USA.
Awards and Achievements: Super Brand Award, ISO 22000:2005, GMP
 Product Range
ECCL manufacture varies types & flavors of chocolate in vary weight range retail packs & wafer
biscuits under the brand name of “EDNA” and “BUNTY”.
 Management
The GM/HO is overall responsible for the total operation and Plant Manager head the whole operation
in the plant with the assistance of the Heads of Production, Maintenance, and Quality Assurance,
Stores and Accounts and their teams of Supervisors/Assistants reporting them.
The organization chart is annexed – Annexure iv
1.0 SCOPE

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FSMS is applicable to the entire operation from the point of receiving raw materials, converting those
raw materials into Chocolates, Coated Chocolates, Wafer Biscuits and Chocolate Enrobes and dispatch
of the finished goods complying with statutory and regulatory requirements governed under Sri
Lankan conditions.
2.0 NORMATIVE REFERENCES
ISO 22000:2005 – Food Safety Management System

ISO 9001:2008 – Quality Management System
SLS 143:1999 – General Principles of Food Hygiene
Codex Standard for Chocolate & Chocolate Products(Codex Stan 87-1981,Rev.1-2003)
Food Act No 26 of 1980 Regulation Food(Tea, Coffee, Cocoa & their Products)
3.0 TERMS AND DEFINITIONS
3.1 Food Safety

Concept that food will not cause harm to the consumers when it is prepared and/or eaten according to
its intended use.
3.2 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.
3.3 Food Safety Hazard

Biological, chemical or physical agent in food, or condition of food, with the potential to cause an
adverse health effect.
4.0 FOOD SAFETY MANAGEMENT SYSTEM

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Edna Chocolates Ceylon (pvt) Ltd, has established, documented, implemented and maintain an
effective food safety management system and update it when necessary in accordance with the
requirements ISO 22000:2005 International Standard.
The scope of the food safety management system has covered the reception of raw materials including
packaging, the manufacturing processes, storage & dispatched of the finished products for sales, It also
fulfill all the requirements that are specified in ISO 22000 : 2005 FSMS. Food safety management
system has covered the product and process starting from the supplier, raw materials to finished
products.
4.1 General Requirement

Under this ISO 22000 Food Safety Management System manual has covered all the activities within
ECCL.
EDNA CHOCOLATE CEYLON (Pvt) LTD (ECCL) has been;

a) Ensured that food safety hazards that may be reasonably expected to occur in relation to
product within the scope of the system are identified, evaluated and controlled in such manner that
the product of the organization do not, directly or indirectly, harm the consumer,
b) Communicated appropriate information throughout the food chain regarding safety issues
related to its products,
c) Communicated 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 ISO 22000 International Standard.
d) Evaluated periodically and updated when necessary, the food safety management system to
ensure that the system reflects the organization's activities and incorporates the most recent
information on the food safety hazards subjected to control.

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4.2 Documentation Requirements

4.2.1. General Requirements
The food safety management system documentation included:
a) Documented statements of a food safety policy and related objectives
b) Documented procedures and records
c) Documents for the effective development, implementation and updating of the food safety
management system
4.2.2. Control of Documents
ECCL ensures that documents required by the FSMS are controlled and records are kept according to
the requirements specified in 4.2.3 of this Food Safety manual and has established a documented
procedure to define controls that are needed for;
a) Approving documents prior to issue.
b) Reviewing and updating as necessary and to re-approve documents,
c) Ensuring that changes and the current revision status of documents are identified
d) Ensuring that relevant versions of applicable documents are available at points of use
e) Ensuring that documents remain legible and readily identifiable,
f) Ensuring that documents of external origin are identified and their distribution controlled,
and
g) Preventing the unintended use of obsolete documents, and applying suitable identification
to them if they are retained for any purpose.
Reference:
Procedure for Control of Documents (FSP/01)
Master List of Documents (QA/L-01)
4.2.3. Control of Records
ECCL has established and maintains all records to provide evidence of conformity to requirements and
of the effective operation of the FSMS. Records are maintained in a manner that they remain legible,
readily identifiable and retrievable. A documented procedure has been established to define the
controls needed for the identification, storage, protection, retrieval, retention time and disposition of
records. List of Records is maintained to establish the traceability of all records.
Reference Procedure for Control of Records (FSP/02)

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List of Records (QA/L-02)

5.0 MANAGEMENT RESPONSIBILITIES
5.1 Management Commitment
Top Management of ECCL shall provide evidence of its commitment to the development and
implementation of the food safety management system and to continually improving its effectiveness
by
a) Showing food safety is supported by business objectives
b) Communicating to the organization the importance of meeting the requirements of this international
standard, any statutory and regulatory requirements, as well as customer requirements relating to
food safety
c) Establishing the food safety policy
d) Conducting management reviews
e) Ensuring the availability of resources
5.2 Food Safety Policy

Edna Chocolates Ceylon (Pvt) Ltd makes every effort to ensure That the Chocolates, Coated
Chocolates, Wafer Biscuits and Chocolate Enrobes Supplied to our customers is Free of all potential
biological, chemical and physical hazards, by manufacturing in an environment where ISO
22000:2005/HACCP principles have been established while complying to all the applicable legal
requirements.
We believe that the continual improvement of our consumer safety approach is based on the
commitment and contribution of our employees towards food safety and on upgrading their knowledge
and skill on food safety.
This policy has been communicated to all employees by displaying at the premises and reviewed at the
management meeting to ensure compatibility with the company policy, values and objectives to
achieve continual improvement.

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5.3 Food Safety Management System Planning

Top management GM/HOM ensures that,
a) Planning and review of the food safety management system is carried out to meet requirements
given in 4.1 as well as the objectives organization that support Food safety Management
system and,
b) The integrity of the FSMS is maintained when changes to the food safety management system
are planned and implemented.
5.4 Responsibility, Authority

Responsibility and authority of each position of the management hierarchy is described throughout
this manual. Managers and supervisors who involve in different stages of the vinegar manufacturing
process should have an adequate knowledge of food hygiene principles and practices to be able to
judge potential risks, take appropriate preventive and corrective action, and ensure that effective
monitoring and supervision takes place.
Reference Organization chart (Annexure - iv)
Food safety team (Annexure - v)
5.5 Food Safety Team Leader

Quality Assurance Executive is the food safety team leader and, Irrespective of other responsibilities,
shall have the responsibility and authority
a) to manage a food safety team and organize its work.
b) To organize relevant training and education programs of Food Safety Team members,
c) to ensure that the food safety management system is established, implemented, maintained and
updated,
d) to report to the organization's top management on the effectiveness and suitability of the food
safety management system and internal audit findings.
Reference Food safety team (Annexure - v)

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5.6 Communication
5.6.1. External Communication
The GM/HOM and PLM is overall responsible for ensuring the establishment of an appropriate and
effective communication processes with
a. Suppliers
b. Customer/s
c. Statutory and regulatory authority/s
d. Other organization that have an impact on or will be affected by , the effectiveness or updating
of the FSMS
By the means of enquiries, contracts or order handling including amendments, customer feedback
includes complaints.
5.6.2. Internal Communication
The Plant Manager is responsible for ensuring the establishment of processes for communication with
personnel including Food Safety Team of the organization on issues having an impact on food safety,
by means of meetings with the Food Safety Team, departmental meetings, notices and management
review meetings, electronic and telecommunication means ensuring the effectiveness of the FSMS.
5.7 Emergency Preparedness and Response

The potential emergency situations and accidents that can impact on food safety and which are
relevant to the role of the ECCL are handled according to planned arrangements.
Top management (GM/HOM) has established separate emergency preparedness team and action plan
to manage potential emergency situations and accidents that can impact food safety
Reference Emergency Manual (EM)
5.8 Management Review

5.8.1. General
The food Safety Management System of ECCL, is reviewed by the Management Review Committee
during management review meetings held at an approximate interval of six months, in order to ensure
its continuity, suitability, adequacy and effectiveness and to assess the need and opportunities for
continually improve the FSMS including the Food Safety Policy and objectives.

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5.8.2. Review Input
Food safety team reviews included the followings:
a) Follow-up actions from previous Food safety team meeting and way forward,
b) Analysis of results of verification activities and action to be taken,
c) Changing management,
d) Management of Emergency situations, accidents and withdrawals and training.
e) Review of communication activities and customer feed-back including positive comments.
f) Result of external audits or inspections reports and corrective actions to be taken.
g) Required information for Top management review.
5.8.3. Management Review Output
The output from the management reviews included the followings,

a) Assurance of food safety and way forward
b) Improvement of the effectiveness of the food safety management system
c) Resource allocation
d) Revisions of the organization's food safety policy
Reference Procedure for Management Review (FSP/08)

Management Review Meeting Minutes (QA/M/01)
6.0 RESOURCE MANAGEMENT
6.1 Provision of Resources
The Top management of ECCL provides adequate resources for establishment, implement, maintain &
update of the ISO 22000:2005/ FSMS.
6.2 Human Resources
6.2.1 General
Food safety team is assigned and responsibilities defined in the Food Safety management system
should be competent on the basis of appropriate education, training, skills and experience due to all the
personnel activities having an impact on the food safety.
Reference Organizational chart (Annexure - iv)
Food Safety Team (Annexure - v)
6.2.2 Competence, Awareness and Training

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Competency development and training of ECCL employees are carried out according to planed
arrangements in order to ensure that all the employees are aware of the relevance and importance of
their role within the Food Safety Management System and are competent enough to execute their job.
All personnel involve in the Chocolates, Coated Chocolates, Wafers & Chocolate Enrobes
manufacturing process should have the necessary knowledge and awareness on their role and
responsibility and on caring out the manufacturing process in a hygienic manner protecting
Chocolates, Coated Chocolates, and Wafers & Chocolate Enrobes from contamination and
deterioration.
Reference Food safety Team (Annexure v)
Training Plan (QA/SHL/04)
Training Attendance Record (QA/RE/12)
Training Effectiveness Record (QA/RE/13)
6.3 Infrastructure
The Top Management of ECCL provides the resources for the establishment and maintenance of the
infrastructure needed to implement the FSMS.
6.4 Work Environment
The Top Management of ECCL shall provide the resource for the establishment, management and
maintenance of the work environment needed to implement the requirements of this FSMS.
7. PLANNING AND REALIZATION OF SAFE PRODUCTS

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7.1 General
The approach of ECCL, towards planning and manufacturing of Chocolates which is safe for human
consumption by formulating requirements with respect to raw materials and processing, implementing,
monitoring and reviewing effective control systems is comprehensively described in Hazard analysis,
PRP’s and HACCP plan of this manual.
7.2 Prerequisite Programs (PRP’S)
Pre requisite programs are provide basic condition and activities that are necessary to maintain
hygiene environment through the food chain suitable for production handing and provision of safe
product for human consumption.
This basically includes good maintaining previous (GMP) and good hygienic practice (GHP). ECCL
has identified following area when establishing PRP Program.
1. Design and facilities
A) Location and surroundings
The company has considered following criteria in order to avoid threats encountered in chocolates
processing and storage.
 Flooding
 Surrounding environment pollution
 Infestation of Pest
 Waste disposal facilities.
The suitability of environment in periodically by Food safety team leader and if required effective
protective measures should be taken.
B) Design and lay out

Design and layout should permit implementation of good hygienic proactive and should prevent cross
contamination during processing of chocolates. The place and the flow of raw material, work in
progress, finished product and equipment identified. Raw and packing material and production area is
adequately segregated from the production area to avoid cross contamination. All operatives enter the
factory by specific entrance to dedicated changing area where showing, hand washing and drying and
toilets facilities area available.
C) Drainage and waste disposal

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Adequate drainage and wasted disposal system and facilities are provided. Waste materials are not
allowed to accumulate in the food handing food storage, and other area. The solid waste removal
storage /garbage room is located well away from production area in closes area.
Reference: Waste Disposal Records (PR/RE/17)
D) Sitting of equipment
All machinery has positioned to give easy access to all parts of cleaning. Equipments are beat least
50cm from the adjacent walls and set on elevated floor for easy cleaning. Equipments are made of
material with no toxic effect or reaction on the products manufactured. Equipments are movable or
capable of being dissembled to allow for maintenance and cleaning. For every equipment and
machinery, cleaning instruction, schedule with maintenance are available.
E) Condition of floor
Floor is maintaining in good condition and laid using impervious materials with an even, easily
cleaned surface to minimize the accumulation of dust, grease and substance that could become feeding
materials for microorganisms. There is no entry point for insects from drains to floor surfaces. There is
non-slip surface minimizing the risk of accidents.
F) Condition of walls, doors and windows

All interior wall are in good condition with no cracks, pores and easy to clean. All wall-wall and wall-
floor junctions are curved for easy cleaning. All external opening doors are kept closed and all doors
to production area is self-closed. All windows are kept closed, where openings are screened with a
small size mesh.
G) Condition of ceiling and lights

Adequate natural and artificial lighting to enable the processing to be carried out in a safe
environment. Lighting fixtures area protected to ensure that the food is not contaminated when
breakage. Throughout production and inspection area, good artificial lighting is provided. Fluorescent
lights (Insecticuters unit) are protected by shatterproof stickers in production area. The lights area
fixed to the ceiling tightly.
H) Ventilation

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Adequate means of natural or mechanical ventilation is provided to minimize the air born
contamination of food, control ambient temperature, control odours which might affect the quality of
food and control humidity, where necessary to ensure the safety and suitability of food. The
Thermometers & humidity meters are set in production area to monitor the temperature and humidity.
Exhaust fans provided to give adequate ventilation and minimize condensation.
2. Storage facilities
Adequate facilities for the storage of raw, packaging materials and Finished Goods are provided.
Separate facilities to the other cleaning and lubricating chemicals. Storage products are maintained in
first in first out basis and required training are provided for the personnel who working in the stores.
Storage products are clearly labeled and arranged in an order to facilitate the easy accessibility. The
temperature and humidity levels are monitored within the storage area. When necessary, the laboratory
tests are carried out to establish fitness for use. Stocks of raw materials and ingredients are subjected
to effective stock rotation. All materials are stored off the floor on clean pallets to facilitate adequate
cleaning, pest control and product ventilation. Incoming materials and finished products are clearly
identified and stored in separate designated areas of the factory. Loading area is kept cleaned.
Cleaning and pest control system of the storage area are in place.
3. Distribution facility
Prior to loading all Lorries are internally inspected by the Store Keeper to ensure that they are clean,
free from moisture, foreign objects and pests that cause product contamination and damage to the
packages. Delivery of products always in closed vehicles to prevent contamination from external
sources.
Reference: Vehicle cleaning Check List (QA/CL/07)
4. Cleaning and Sanitizing

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A well organized cleaning system is established. A cleaning schedule is documented and available for
every section within the factory. It is clear, legible and easy to follow. The cleaning schedule indicates
the place/area/equipment, method of cleaning, frequency, when, and the responsible person.
The cleaning inspection checklist is maintained at each production and storage areas to ensure that the
every single area or equipment used for production process has been appropriately cleaned Cleaning
evaluation audit is done on daily basis by Quality assurance executive in order to maintain consistent
hygienic environment inside the processing area.
Cleaning equipments and chemical are stored in separate area and cleaning operatives are adequately
trained to do their job properly. The entire cleaning process is monitored by quality supervisor. Within
the production area, the food debris levels are maintain in a minimum consistent with the process and
practice “Clean as You Go” principle. Floor debris is removed by designated hygiene operatives rather
than online process workers. All staff facilities including toilets, rest rooms, canteen, lockers are
regularly cleaned throughout the day.
Reference: Outside cleaning check list (QA/CL/01)
Inside cleaning check list (QA/CL/02)
5. Pest Control

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Access of pest, harborage and infestation should be prevented and potential breeding sites should be
eliminated by
a.Keeping building in good repair condition
b. Keeping factory premises in clean to avoid pest infestation and rubbish bins are totally enclosed
and regularly emptied to prevent over spill.
c.Sealing of drains, holes, other and place where pest are likely to gain access (avoiding of pest entry
point)
d. Installing mesh screens on open windows, doors and ventilators
e.Exclude animal from the premises
f. Potential food sources are stored insect proof containers
g. Ensuring waste materials are stored in covered and located in a manner that prevents breeding
Pest control system is outsourced by an approved and well trained pest control organization and all the
chemicals used are food grade. The pests that covering the pest control is Rats, Ants, Cockroaches
Cocoa moth. They have executed for the regular inspection and treatment of the premises to deter and
destroy infestation by pests. The pest treatments are carried out once a month (last week of the month)
at regular intervals and visited the factory when the requirement is arises.
Quality Assurance Executive has responsible for pest control system and maintained records.
Reference: Pest control check list (QA/CL/05)
6. Personal hygiene

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All production and Quality Assurance personnel are fully trained in the principles of Good
Manufacturing Practices and competent the task assigned to them. ‘On the Job’ training is given to
staff to fully understand their responsibilities and the need to follow written instructions and
procedures. Training records are maintaining and effectiveness of training is monitored by Human
Resources Unit.
All operatives enter the factory by a specific entrance, to a dedicated changing area where hand
washing, showering, foot bathing, exchanging of outer garments are available.
Adequate lockers are provided for all operation personnel for safe storage of personnel effects. A
separate rest room and canteen are provided for operatives to take their meals and breaks. Water drink
dispensers are available at production floor as well as canteen. All toilets are adequately lit and
ventilated and separated from production area. Toilet areas are of good hygienic design and the floors,
walls, ceilings and sanitary equipments are clean.
The all employees are provided with suitable uniforms, protective cloth, head coverings, masks and
gloves whenever necessary. To prevent foreign body contamination, the all employees are restricted to
wear jewelry, wrist watch, necklace, rings and bangles. The employees are subjected personnel
hygienic inspection on daily basis prior to entrance of processing area by well fare officer.
A company has provided the services of a fully trained First Aid group and a First Aid room with
adequate equipments for first aid treatment of illness or injury. First aid equipments are kept securely
and issued by a Well Fare Officer. All treatments are fully recorded in the medical record book and
records are maintained by well fare officer. Person suffering from any infectious illness is not be
permitted to work & Food handlers with cuts and wounds should be permitted to work in the food
handling area only after proper covering or dressing of those cuts and wounds. All injuries and
diseases are reported to Well Fare Officer and suitable treatments are done by Well Fare Officer.
Food handles should wash their hands at the starts of food handling activities, immediately after using
toilets, after having meals or after handling any material that can contaminate food items by using
suitable antibacterial hand wash.

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All operatives are completed an appropriate medical questionnaire prior to commencing work. Annual
medical inspection is done by The company doctor has assigned for once in two weeks to teat the
employees and all the records are maintained at Human Resources Department by company Safety
Officer.
Reference: Employee Hygiene check list (QA/CL/03)
7. Quality Assurance
The company has sufficient, properly trained Quality Assurance Department to execute the system to
ensure the consistent production of safe, legal product in compliance with the agreed specification.
The quality Assurance personnel are properly trained to maintain agreed quality standards, with
clearly defined responsibilities covering all aspects of the operation. Quality Assurance Department is
operational at all times when production is in progress. Adequate resources and facilities are available
for the Quality Assurance Department to fulfill its tasks.
Chemical, Physical and sensory analysis of raw materials and finished product is inspected at Quality
Assurance Department and accepting of raw materials within the agreed standard and returns the rest.
The laboratory personnel are competently trained to understand the analysis, interpret the results. All
laboratory equipments and instruments used are clean, well maintained, serviced and calibrated at
regular intervals to ensure its accuracy and the information kept on record. The calibration of
laboratory equipments is carried out by either Industrial Technology Institution (ITI) or Sri Lanka
Standards Institute (SLSI).
The results of the calibration is formally documented and signed and the next due calibration date give
to ensure accuracy of all measuring equipments.
The company has a formalized, written complaint procedure, detailing the person responsible.
All quality complaints are recorded when received, investigated within a given time scale according to
their urgency and a report prepared as the basis for correction action

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7.3 Preliminary Steps to Enable Hazard Analysis
7.3.1 General
All relevant information needed to conduct the hazard analysis has been collected, maintained,
updated and documented. Records have been maintained.
7.3.2 Food Safety Team

The food safety team has a combination of multi-disciplinary knowledge and experience in developing
and implementing the food safety management system.
Reference Annexure v-Food Safety Team
7.3.3 Product Characteristics
Chocolate is the generic name for the homogenous products obtained by an adequate manufacturing
process from cocoa materials which may be combined with milk products, sugars and/or sweeteners,
and other additives. Chocolate shall contain, on a dry matter basis, not less than 35% total cocoa
solids, of which not less than 18% shall be cocoa butter and not less than 14% fat-free cocoa solids.
7.3.3.1 Raw Materials, Ingredients And Product Contact Materials

Hazard analysis carried out based on, All Raw materials, Ingredients and Product-contact materials are
described in the document to the extent needed to conduct the hazard analysis including the following,
a. Biological, chemical and physical characteristics
b. Composition of formulated ingredients, including additives and processing aids
c. Origin
d. Method of production
e. Packaging and delivery methods
f. Storage conditions and shelf life
g. Preparation and handling before use or processing
h. Food safety – related acceptance criteria or specifications of purchased materials and
ingredients appropriate to their intended use.
Reference Supplier Specifications

Product Certification/Test reports (MSDS, Food Grade Certifications)
Specification for Raw Material (QA/SPC/01)
Specification for Packing Material (QA/SPC/02)

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7.3.3.2 Characteristics Of End Products
The characteristics of end products are described in documents to the extend needed to conduct the
hazard analysis including information on the followings
a) Product name or similar identification
b) Composition
c) Biological , chemical and physical characteristics relevant for food safety
d) Intended shelf life and storage conditions
e) Packaging
f) Labeling related to food safety and / or instructions for handling, preparation and usage
g) Methods of distribution
Reference Specification for Finished Goods (QA/SPC/03)
7.3.4 Intended Use

Chocolates are used as a staple food, snack, luxury gifts, dietary products, etc.
Even though the Chocolates in general is consumed by all age groups including risk groups special
types of Chocolates are tailor made for the consumption of specific risk groups (light/sugar free
chocolates)
Information regarding addition of nut ingredients is mentioned in the ingredient list and therefore any
nut allergy risk group can retrain from eating of those chocolate
7.3.5 Flow Diagrams, Process Steps And Control Measures

7.3.5.1 Flow Diagram
Flow diagrams are prepared for the production process covered by the food safety management system
including the followings
a) The sequence and interaction of all steps in the operation;
b) Any outsourced processes and subcontracted work;
c) Where ingredients and intermediate products enter the flow;
d) The end product.
All these flow diagrams are verified by the food safety team
Reference Process flow Diagram (Annexure i)
7.3.5.2 Description of Process Steps and Control Measures

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Hazard analysis carried out for the existing control measures, process parameters which they may
influence food safety.
7.4 Hazard Analysis

 Hazard Analysis and Determination of Critical Control Points (CCPS)
Identification of all potential biological, chemical and physical hazards encountered together with the
control measures and control points of such identified hazards and
Evaluation and analysis of such hazards to assess the impact of the risk involved the following criteria
is used for the hazard assessment
Severity
5. Can cause fatality
4. Can lead to serious illness/ injury
3. Can cause product recall
2. Can generate customer complaint
1. Non significant
Likelihood of occurrence (LOC)

5. Common occurrence
4. known to occur (has happened at our premises)
3. Could occur (evidence in published material)
2. Not likely to occur
1. Practically impossible to occur
Risk Level = Probability x Severity
When the risk level of hazard is higher than 9 it becomes significant
7.4.1 General
The Food Safety Team conducted a hazard analysis to determine which hazards need to be controlled
and the degree of control required to ensure food safety, and which combination of control measures is
required.
7.4.2 Hazard Identification and Determination of Acceptable Levels

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 The Hazard Identification Carried Out Based On

a. The preliminary information and data
b. Experience
c. External information including, to the extent possible, epidemiological and other historical data,
Information from the food chain on food safety hazards that may be of relevance for the safety of
the end products, intermediate products and the food at consumption.
 When Identifying The Hazards, Consideration Given To
a. The steps preceding
b. The process equipment, utilities/services and surroundings
c. The preceding and following links in the food chain.
 Determination Of The Acceptable Level Of The Food Safety Hazard
For each of the food safety hazards identified, the acceptable level of the food safety hazard in the
end product has been determined.
7.4.3 Hazard Assessment

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HACCP Plan – Identification and control of hazard – Raw Material and Process steps
Raw Material / Food Control and Hazard Analysis Significant/

Potential Category
Step Contact Material/ Preventive Non
Hazard (B/C/P) Risk
Process Step Measure Probability Severity significant
Level
[1] Receiving raw

materials
Cocoa (Cocoa Presence B Supplier 3 4 12 S

[1a] butter, Cocoa liquor, of guarantee
Cocoa Powder) pathogeni certificate is
c bacteria visually
Presence confirmed
of live
dead RH of the
insects/ store is
debris maintained
Presence C Raw 2 2 4 NS
of material
pesticides Inspection at
receiving
each
Presence P consignment
of dirt, (Moisture 2 2 4 NS
stone %)
particles,
iron FIFO at
particles, issue
polythene,
human
hair
[1b] Sugar Presence B Purchase 2 2 4 NS

of live from a
dead guaranty
insects/ supplier
debris
Raw Material / Food Potential Category Control and Hazard Analysis Significant/
Step Non
Contact Material/ Hazard (B/C/P) Preventive Probability Severity Risk

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Level
significant
Process Step Measure
[1b] Sugar Presence C Raw 2 1 2 NS

of material
Lubricants Inspection at
/chemical receiving
additives each
consignment
Presence P 5 1 5 NS
of iron
particles, Passing
sand, through a
polythene, sieve
human
hair Installing
metal traps
in the
process
[1c] Milk powder Presence B Supplier 2 4 8 NS

of guarantee
pathogeni certificate is
c bacteria visually
Presence confirmed
of live
dead Raw
insects/ material
debris Inspection at
receiving
each
Presence C consignment 2 4 8 NS
of
Melamine RH of the
store is
Presence P maintained 2 4 8 NS
of iron
particles, Adhere to
polythene, GMP
human
hair FIFO at
issue
Step Raw Material / Food Potential Category Control and Significant/

Hazard Analysis
Contact Material/ Hazard (B/C/P) Preventive Non
Process Step Measure Probability Severity Risk significant

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Level
[1d] Vegetable fat Presence B Supplier 2 4 8 NS

of live guarantee
dead certificate is
insects/ visually
debris confirmed
Presence C Raw 2 3 6 NS
of material
/chemical receiving
additives each
consignment
Presence P 2 3 6 NS
of stones RH of the
wooden store is
particles, maintained
polythene,
human Adhere to
hair GMP
[1e] Fillers (cashew nuts, Presence B Supplier 3 2 6 NS

pea nuts, sultana, & of moulds guarantee
rice crispy) and fungi certificate is
Presence visually
of live confirmed
dead
insects/ Raw
debris material
Inspection at
Presence C receiving 2 4 8 NS
of each
aflatoxin consignment
Roasting
Presence P pea nut up 3 2 6 NS
of stones, to 1500C for
polythene, 30mins
human
hair
Manual
Sorting
Hazard Analysis Significant/

Raw Material / Food Control and
Potential Category Non
Step Contact Material/ Preventive
Hazard (B/C/P) Probability Severity
Risk significant
Process Step Measure Level

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[1f] Chemical additives Presence B Supplier 2 4 8 NS

(Lecithin, Flavours of live guarantee
(Vanilla-Powder & dead certificate is
flavour, strawberry, insects/ visually
orange & rum ), debris confirmed
Antioxidants
,salt, malt extract, Presence C Raw 2 3 6 NS
sodium carbonate) of material
/chemical receiving
additives each
consignment
Presence P 2 3 6 NS
of stones RH of the
wooden store is
particles, maintained
polythene,
human Adhere to
hair GMP
[1g] Packing materials Presence B Supplier 2 4 8 NS

of live guarantee
dead certificate is
insects/ visually
debris confirmed
Presence C Raw
of material
Lubricants Inspection at 2 3 6 NS
/chemical receiving
additives each
consignment
Presence
of stones P 2 3 6 NS
wooden
particles, RH of the
polythene, store is
human maintained
hair
Adhere to
GMP

Risk significant

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[1h] Wheat flour Presence B Supplier 2 4 8 NS

of guarantee
c bacteria visually
Presence confirmed
of live
dead
insects/ FIFO at 2 4 8 NS
debris C issue
Presence
of
chemical P 2 4 8 NS
residue Flour
sieving
Presence trough a
of iron mesh
particles,
woods,
polythene
head
treads
[1i] Tapioca flour/ corn Presence B Supplier 2 4 8 NS

starch of guarantee
c bacteria visually
Presence confirmed
of live
dead
insects/
debris P Flour 2 4 8 NS
sieving
Presence trough a
of iron mesh
particles,
woods,
polythene
head
treads

Risk significant
[1j] Portable water Presence B Adhere to 2 4 8 NS

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of GMP daily
pathogeni
c bacteria Detail
Presence microbiologi
of live cal analysis
dead at every 3
insects/ months
debris
Filtering
before
addition
[3] Storing (RM and Growth of B Maintain the 2 4 8 NS

Packaging materials) vegetative temperature
pathogens sufficiently
low to
minimize
the growth
of
pathogens.
Clean the
storage
areas at
frequencies
Adhere to
GMP and
GHP at
stores
[4] Issuing (RM and Introducin P Adhere to 2 2 4 NS

PM) g dust, GMP
soil, sand
or
polythene
due to
poor GMP
Significant/
Raw Material / Food Control and Hazard Analysis
Hazard (B/C/P) Risk significant
Process Step Measure Probability Severity
Level
[5] Fat Melting Introducin P Filtering 3 2 6 NS

g after melting

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polythene
pieces
[6] Sugar grinding Introducin P Magnetic 5 2 10 S

g dust, screen to
iron remove
particles metal
foreign particles
materials
Or human
hair
Equipments
[7] Cocoa liquor Introducin B used for 2 4 8 NS
treating g addition is
pathogeni constructed
c bacteria to minimize
P product or 2 2 4 NS
Introducin ingredient
g exposure
impurities, Self
foreign inspection
particles of
from neutralizing
neutralizin agents.
g agents
Adhere to
[8] Manual sorting Introducin B GHP 2 4 8 NS
(cashew nuts, g (sanitizing
peanuts, sultana) pathogeni hands with
c IPA)
microbes
P Sorting area 4 3 12 S
is controlled
Introducin in hygiene
g conditions.
extraneous Adhere to
matters GHP

Step Contact Material/ Preventive Risk
Hazard (B/C/P) Probability Severity significant
[9] Weighing and Introducin B Pest 3 3 9 NS

mixing (chemical g controlling

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additives) live dead in the plant

insects/
debris
Contamin C Adhere to 2 1 2 NS
ation with GMP (using
lubricants food grade
chemicals)
Introducin
g extra C Recipe 3 4 12 S
amount of weight
additives controlling
Calibration
of scales
Introducin
g dust, P Adhere to 2 2 4 NS
foreign GMP -
materials Preventive
maintenance
[10] Refining Introducin B Adhere to 2 4 8 NS

g GMP
pathogeni
c bacteria
Use food
Introducin B grade 2 2 4 NS
g live / chemicals
dead
insects C Adhere to 2 1 2 NS
GMP
Introducin
g Pest
lubricants P controlling 2 2 4 NS
Introducin in the plant
g sand
Step Raw Material / Food Potential Category Control and Hazard Analysis Significant/
Contact Material/ Hazard (B/C/P) Preventive Non
Risk
Process Step Measure Probability Severity
Level
significant
[11] Transferring Introducin B Adhere to 3 2 6 NS

(refined powder) g GMP and
pathogeni GHP

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c bacteria
due to
manual
handling
B 2 2 4 NS
Introducin Pest
g dead controlling
live in the plant
insects or
debris
P 3 2 6 NS
Adhere to
Introducin GMP
g sand,
dust or
foreign
maters
[12] Conching Contamin B Using 2 4 8 NS

ate with equipments
vegetative meeting
pathogens sanitary
design
guidelines
Contamin C 3 1 3 NS
ation with Adhere to
lubricants GMP
Use food
grade
Introducin P chemicals 3 2 6 NS
g foreign
materials Preventive
maintenance
Filtering
Contact Material/ Hazard (B/C/P) Preventive Risk Non
Process Step Measure Probability Severity significant
Level
[14] Tempering ( cocoa Introducin B WIP 2 4 8 NS
butter chocolates) g Inspection
pathogeni temperature
c (batch wise)
microbes

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Adhere to
Contamin C GMP/ using 2 2 4 NS
ation with food grade
lubricants lubricants.
Introducin P Adhere to 3 2 6 NS
g foreign GMP
materials
Introducin Minimize 2 4 8 NS
[15] Filtering g B product
vegetative exposure to
microbes air
Frequent
Contamin P inspection to 4 3 12 S
ation with ensure free
physical of
impurities contaminati
on.
Contamin B WIP 3 4 12 S
[16] Roasting (cashew ation with inspection
nuts and pea nuts, pathogeni Roasting
rice crispy) c time
microbes /temperature 3 2 6 NS
Introducin P
g Adhere to
extraneous GMP and
matters GHP
[17] Oven Drying of Introducin B Heat up to 3 4 8 S

Sultana g relevant
pathogeni temperature
c
microbes
Contamin P Adhere to 2 2 4 NS
ation with GHP and
foreign GHP
matters
Contact Material/ Hazard (B/C/P) Preventive Risk Non
Probability Severity
Process Step Measure Level significant
[18] Cooling Introducin P Adhere to 3 2 6 NS

g foreign GMP
maters Passing
human through a
hair, metal metal

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particles detector
Contamin C 2 2 4 NS
ate with Using food
lubricants grade
lubricants
[19] De-moulding Contamin Adhere to 1 4 4 NS

ation with B GHP and
pathogeni GMP
c bacteria
Contamin C 2 2 4 NS
ation with Using food
lubricants grade
lubricants
Introducin P 3 2 6 NS
g foreign Adhere to
matters GMP and
GHP
[20] Contamin B Adhere to 3 2 6 NS

Melting of chocolate ation with GMP
(rework) pathogeni
c bacteria
and yeast
& mould
g foreign GMP
maters Passing
human through a
hair, metal metal
particles detector

Potential Category
Step Contact Material/ Preventive Risk Non
[22] Butter wash of fillers Introducin P Adhere to 3 2 6 NS

(rework) g foreign GMP
maters
Growth of B Reduce the 3 3 9 NS

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yeast and time of

mould keeping
after rework
[23] Metal detector Contamin P Well 3 2 6 NS

ation with cleaning of
foreign detector
materials surface
Passing P 2 4 8 NS
metals Calibrating
without detector
detecting with a 1mm
dummy
metal
practical
[24] Primary Packing Contamin B Packaging 2 4 8 NS

(Filling & sealing or ation with environment
Aluminum foil vegetative to be
wrapping & sealing) pathogens controlled
Introducin P 2 2 4 NS
g foreign Adhere to
materials GHP and
GMP
Introducin
[25] Secondary g foreign P Adhere to 1 2 2 NS
Packaging materials GMP
[26] Coding (printing of No
product information) Possible - - - - - -
hazards
[27] Chocolate FG stores Contamin P Adhere to 1 2 2 NS
ation with GMP
Foreign
Maters

Potential Category
Sugar syrup boiling Implementin
Introducin B g an insect- 4 2 8 NS
[29] g insects o-cutor
Contamin B Temperature 3 4 12 S
ation with and time
vegetative controlling

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pathogens
P
Introducin Filtering 3 2 6 NS
g foreign after
materials preparation
Introducin B Minimize 2 4 8 NS
g product
microbes air
P 3 2 6 NS
[30] Syrup filtering Contamin Frequent
ation with inspection to
physical ensure free
impurities of
contaminati
on.
Introducin
g B Adhere to 2 3 6 NS
pathogeni GMP
c bacteria
due to
manual
handling P Frequent 3 2 6 NS
[31] Syrup transferring
inspection to
Introducin ensure free
g sand, of
dust or contaminati
foreign on
maters
Contamin P Adhere to 2 2 4 NS
[32] ation with GMP
Adding colours
physical
impurities

Potential Category
Chocolate coating
[33] Introducin B Adhere to 3 2 6 NS
g GMP and
pathogeni GHP
c bacteria
due to
manual

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handling
Contamin B Preventive 3 2 6 NS
ated with maintenance
Microbes – Filter
presence cleaning of
[34] Cooling with blow in Air compressors
air
Contamin P 3 2 6 NS
ation with
physical
impurities
Contamin P Filtering 3 2 6 NS
ation with Sugar syrup
[35] Sugar coating physical prior to use
impurities
Contamin P Filtering 3 2 6 NS
ation with Sugar syrup
[36] Colour coating physical prior to use
impurities
Contamin
Polishing ation with
[37] physical P Adhere to 3 2 6 NS
impurities GMP/ GHP

Potential Category
[38] Weighing and Introducin B Pest 3 3 9 NS

mixing (batter and g live controlling
cream) dead in the plant
insects/
debris C Adhere to 2 1 2 NS
GMP (using

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Contamin food grade

ation with chemicals)
lubricants
Recipe
C weight 3 4 12 S
Introducin controlling
g extra
amount of Calibration
additives of scales
Introducin Adhere to 2 2 4 NS
g dust, P GMP -
foreign Preventive
materials maintenance
[39] Introducin B Minimize 2 4 8 NS

g product
microbes air
P 4 3 12 S
Filtering Batter Contamin Frequent
impurities of
contaminati
on.
[40] Introducin B Maintain 3 4 12 S

g time
vegetative temperature
Wafer Biscuit microbes combination
accurately
Baking

Potential Category
[40] Wafer Biscuit Contamin P Frequent 2 2 4 NS

Baking ation with inspection to
impurities of
contaminati

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on
[41] Cooling Wafer Contamin C Adhere to 2 4 8 NS

Biscuit ation with GMP
lubricants
g dust, GMP
foreign Preventive
materials maintenance
[42] Cream transferring Contamin P Frequent 2 2 4 NS

impurities of
contaminati
on
[43] Cream deposition Introducin P Adhere to 2 2 4 NS

g dust, GMP
foreign
materials
[44] Pressing of cream Introducin P Adhere to 2 2 4 NS

g dust, GMP
foreign
materials
Introducin
[45] Cooling g live B Frequent 3 2 6 NS
dead inspection to
insects/ ensure free
debris of
Introducin contaminati
g dust, on 2 2 4 NS
foreign
P Adhere to
materials
GMP

Potential Category
[46] Wire cutting Introducin P Adhere to 2 2 4 NS

g dust, GMP and
foreign GHP
materials

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Introducin
g B Adhere to
pathogeni GMP and
c bacteria GHP
due to
manual Frequent
handling inspection to
ensure free
of
contaminati
on
[47] Biscuit WIP Storing Introducin P 2 2 4 NS

g dust,
foreign Adhere to
materials GMP and
GHP
Introducin
g B 3 2 6 NS
pathogeni
c bacteria
due to
storage
[48] Biscuit Feeding Introducin B Adhere to 3 2 6 NS

g GMP and
pathogeni GHP
c bacteria
due to
manual
handling
[49 Chocolate Enrobing Introducin P Adhere to 3 2 6 NS

& and Cooling g dust, GMP and
50] foreign GHP
materials

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7.4.4 Selection and Assessment of Control Measures

Based on the hazard assessment an appropriate combination of control measures has been selected
which is capable of preventing, eliminating or reducing these food safety hazards to defined acceptable
levels.
The selection and categorization carried out using a logical approach that includes assessments with,
a. Feasibility for monitoring

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b. Place within the system relative to other control measures

c. Likelihood of failure in the functioning of a control measure
d. Severity of the consequence(s) in the case of failure in its functioning
e. Control measure is specifically established and applied to eliminate or significantly reduce the
level of hazard
7.5 Establishing the Operational Prerequisite Program’s (OPRP’s)

The operational PRPs are documented and included the following information for each program
a. Food safety hazard to be controlled by the program
b. Control measure
c. Monitoring procedures
d. Corrections and corrective actions to be taken
e. Responsibilities and authorities
f. Record of monitoring
7.6 Establishing the HACCP plan
7.6.1 HACCP Plan

7.6.2 Identification of critical control points (CCPs)
HACCP Plan is documented and included the following information for each identified critical control
points
a. Food safety hazard to be controlled at the CCP
b. Control measure

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c. Monitoring procedures
d. Corrections and corrective actions to be taken
e. Responsibilities and authorities
f. Record of monitoring
7.6.3 Identification of CCP’s

CCPs are identified for each Hazard that needs to be controlled by the HACCP Plan for the
appropriate control measures that are already identified as per 7.4.4 with the help of “CCP Decision
Tree” approach.
7.6.4 Determination of Critical Limits (CL) for the Identified CCP’S

Critical Limits are established for each CCP identified to ensure the monitoring procedures are in
operation within the acceptable level of Food Safety.
Following guide lines are followed when determine and establish the CL’s
a) CL’s are measurable
b) Rationale of establishment of CL’s are documented
c) If subjective data (visual inspection of product/process, each CCP identified
handling, etc) are used for establishment of CL’s are supported by instruction/ specification and or
education and training.
Determination of Critical Control Points (CCP’S)

Raw Material / Decision Tree
OPRP/
Food Contact Significant
NO. Step
Material/ Process Hazard Q1 Q2 Q3 Q4 CCP
Step
01 [1a] Receiving raw Presence of
materials pathogenic
Y N Y N OPRP
Cocoa (Cocoa bacteria
Presence of live
butter, Cocoa
dead insects/

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liquor, Cocoa
Powder) debris
Introducing dust,
02 [6] Sugar grinding iron particles Y Y - - OPRP
foreign materials
Or human hair
Manual sorting Introducing
03 [8] (cashew nuts, extraneous matters Y N Y N OPRP
peanuts, sultana)
Weighing and Introducing extra
04 [9] mixing (chemical amount of Y N Y N OPRP
additives) additives
Contamination
05 [15] Filtering Y N Y N OPRP
with physical
impurities
Roasting (cashew Contamination
06 [16] with pathogenic Y Y - - OPRP
nuts and pea nuts)
microbes
Introducing
07 Oven drying of Y Y - - OPRP
[17] pathogenic
Sultana
microbes
Contamination
[29] Sugar syrup boiling with vegetative
08 Y N Y N OPRP
pathogens
Introducing
09 [40] Wafer Biscuit vegetative Y Y - - CCP
Baking microbes
7.6.5 Establishment of System for the Monitoring of CCP’s

Monitoring systems are established for each CCP to demonstrate that the CCP is in control.
The monitoring systems are included with following,

a) Measurement /Observation within a specific time frame
b) Monitoring method
c) Monitoring frequency
d) Responsibility & Authority
e) Reference records

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7.6.6 Actions When Monitoring Results Exceed Critical Limits

Planned corrections and corrective actions to be taken when critical limits are exceeded are specified
in the HACCP plan. The actions ensured that the cause of nonconformity is identified, that the
parameter controlled at the CCP is brought back under control.
Potentially unsafe products are handled according to the documented procedures to ensure that they
are not released until they have been evaluated

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7.7 Updating of Preliminary Information and Documents Specifying the PRP’s and the HACCP
Plan (CCP/OPRP’s)
When necessary following information is updated

a) Product characteristics
b) Intended use
c) Flow diagrams
d) Process steps
e) Control measures
If necessary, the HACCP plan and the procedures and instructions specifying the PRP(s) are
amended.
7.8 Verification Planning

The FSMS and its components are verified according to planned arrangements to determine
compliance of the system to its specifications and to confirm that the system is working effectively.
Verification can be conducted through either,
a. Internal auditing of the FSMS
b. Testing of random samples
c. Analysis and evaluation of data
d. Review of records
e. Comparing actual against documentation
Verification results were recorded and were communicate to the food safety team. Verification results
shall be provided to enable the analysis of the results of the verification activities.
Reference Procedure for Verification (SOP/01)

Verification Plan (Annexure ii)
7.9 Traceability System

A successful traceability system is established and implemented in order to identify Raw materials,
semi-finished products (Work In Progress-WIP) or finial products within the total manufacturing
process.
Traceability system reference data are kept for appropriate time period before disposition and recorded
in order to apply necessary correction/corrective actions and to implement effective withdrawal in
emergency situations.
Reference Procedure for Product Identification/Traceability & Product Recall ( FSP/05)
7.10 Control of Nonconformities

7.10.1 Correction

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Organization ensures that when critical limits for CCP is exceeded or there is a loss of control of
operational PRPs the products affected are identified and controlled with regard to their usage.
Organization established a documented procedure and implemented in order to identify,
a) The affected product is identified and handle(dispose) appropriately to avoid any risk for safety
of the products that are processed
b) Review the correction to ensure the safety of the products that are processed
Reference Procedure for Correction and Corrective Action (FSP/04)
7.10.2 Corrective Actions
Data derived from the monitoring of operational PRPs and CCPs were evaluated by FSTL and
discussed the main issues with Top Management
Corrective actions were initiated when critical limits are exceeded or when there is a lack of
conformity with operational PRP(s).
These actions include,
a. Reviewing nonconformities
b. Reviewing trends in monitoring results that may indicate development towards loss of control
c. Determining the cause of nonconformities
d. Evaluating the need for action to ensure that nonconformities do not reoccur
e. Determining and implementing the actions needed
f. Recording the results of corrective actions taken
Reference Procedure for Correction and Corrective Action (FSP/04)

7.10.3 Handling of Potentially Unsafe Products
7.10.3.1. General
All lots of products and materials that may have been affected by a nonconforming situation specially
when there is a loss of control of PRP are handled in a controlled manner ensuring appropriate
identification, segregation, evaluation and documentation.
Actions shall be taken to eliminate the root causes of the detected nonconformity to prevent the
recurrence.
7.10.3.2. Evaluation For Release

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The details of the detected nonconforming situation shall be informed to the QCM to decide whether
the affected products/materials to be used it as it is, to be used after correction, to be reprocessed or to
be rejected.
7.10.3.3. Disposition of Nonconforming Products
If the lot of the product is not acceptable for release it shall be reprocess or further process to ensure
that
- Food safety hazard is eliminated or reduced to acceptable levels
- Destruction and/or disposal as waste.
7.10.4 Withdrawals
If any product found to be nonconforming after the product is released to the customer and if the
Quality Assurance manager’s decision is to rework or to reject, complete details of that particular
batch shall be immediately informed to the customer to hold the product at their storage or to enable
the customer to inform their customers to stop the use of those product and to take necessary actions
on batches that have already been used or to recall the product already being distributed.
All reworked products are inspected according to relevant documented instructions and against
relevant specifications.
The implementation of the Quality Assurance Manager’s recommendations on the nonconforming

product are verified and verification details shall also be recorded
Reference Procedure for Products identification, Traceability & Products withdrawal/Recall
(FSP/05)
Mock Withdrawal records
8. VALIDATION, VERIFICATION AND IMPROVEMENT OF THE FOOD SAFETY

MANAGEMENT SYSTEM
8.1 General
The FST has planned and implemented the processes needed to validate control measures and to verify
and improve the food safety management system

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8.2 Validation of Control Measure Combinations

Prior to implementation, the FSMS and its components are validated to ensure that the selected control
measures are capable of achieving the intended control of the food hazards originally identified by the
Food Safety Team are complete and correct and those hazards will be effectively controlled by the
planned arrangements established.
Whenever the operational changes take place in a manner that could adversely affect the safety of
Vinegar being manufactured the validation shall be up dated.
8.3 Control of Monitoring and Measuring

ECCL provides evidence that the specified monitoring and measuring methods and equipment are
adequate to ensure the performance of the monitoring and measuring procedures.
a. Where necessary to ensure valid results, the measuring equipment and methods used
b. Calibrated at specified intervals.
c. Adjusted or re-adjusted as necessary
d. Identified to enable the calibration status
e. Safeguarded from adjustments that would invalidate the measurement results
f. Protected from damage and deterioration.
Reference Procedure for calibration (SOP/03)

External /Internal Calibration records
8.4 Food Safety Management System Verification

8.4.1. Internal Audit
Internal audits are conducted at planned intervals to verify that the activities of the FSMS is complying
with planned arrangements, with the requirements of the international standard and with the
requirements of the system established by ECCL, and to determine the effectiveness of the system
being implemented and maintained.
Reference Procedure for internal audit
Internal Audit Plan
Internal Audit finding reports

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8.4.2. Evaluation of Individual Verification Results

The FST shall systematically evaluate the individual results of planned verification action to achieve
the required conformity.
Such action includes,
a) Existing procedures and communication channels
b) Conclusions of the hazard analysis - established operational PRP and the HACCP plan
c) Effectiveness of human resource management and of training activities.
Reference Verification schedule (annexure ii)
8.4.3. Analysis of Results of Verification Activities
The FST analyzed the results of verification activities, including the results of the internal audits and
external audits.
a) Confirm that the overall performance of the system meets the planned arrangements and the
food safety management system requirements established by the EDC.
b) Identify the need for updating or improving the food safety management system
c) Identify trends which indicate a higher incidence of potentially unsafe products
d) Establish information for planning of the internal audit program concerning the status and
importance of areas to be audited
e) Provide evidence that any corrections and corrective actions that have been taken are effective.
The results of the analysis and the resulting activities recorded and reported to top management as
input to the management review.
Reference Internal Audit Finding Reports
External Audit Records
Management Review meeting minutes
8.5 Improvement
8.5.1 Continual Improvement
The effectiveness of the FSMS is continually improved through the use of
a. Communication,
b. Management review,
c. Internal audit,
d. Evaluation of individual verification results
e. Analysis of results of verification activities
f. Validation of control measure combinations

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g. Correction and corrective actions

h. Analysis the established operational PRPs and the HACCP plan.
8.5.2 Updating the Food Safety Management System

Top Management GM/HOM of ECCL. ensures that the food safety management system is continually
updated in order to achieve this; the food safety team shall evaluate the FSMS by annually. The team
shall then consider whether it is necessary to review the hazard analysis the established operational
PRP(s) and the HACCP plan.
The evaluation and updating activities are based on
a. Input from communication, external as well as internal,
b. Input from other information concerning the suitability, adequacy and effectiveness of the FSMS
c. Output from the analysis of results of verification activities and
d. output from management review
System updating activities are recorded and reported in an appropriate manner, as input to the
management review.
Reference Internal /External Communication records

Verification records
Management Review meeting minutes

Page | 59

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ECCL - Edna Chocolates (Ceylon) Pvt Ltd

Prepared by Reviewed by: Approved by:

II. Distribution Control

III. Review and Approval

Prepared by Reviewed by: Approved by:

Name of the Organization – EDNA CHOCOLATE (CEYLON) PVT LTD.

Awards and Achievements: Super Brand Award, ISO 22000:2005, GMP

The organization chart is annexed – Annexure iv

Prepared by Reviewed by: Approved by:

2.0 NORMATIVE REFERENCES

ISO 22000:2005 – Food Safety Management System

3.0 TERMS AND DEFINITIONS

3.1 Food Safety

3.2 Food Chain

3.3 Food Safety Hazard

4.0 FOOD SAFETY MANAGEMENT SYSTEM

Prepared by Reviewed by: Approved by:

4.1 General Requirement

EDNA CHOCOLATE CEYLON (Pvt) LTD (ECCL) has been;

Prepared by Reviewed by: Approved by:

4.2 Documentation Requirements

4.2.3. Control of Records

Prepared by Reviewed by: Approved by:

List of Records (QA/L-02)

5.2 Food Safety Policy

Prepared by Reviewed by: Approved by:

5.3 Food Safety Management System Planning

5.4 Responsibility, Authority

5.5 Food Safety Team Leader

Prepared by Reviewed by: Approved by:

5.6.2. Internal Communication

5.7 Emergency Preparedness and Response

5.8 Management Review

Prepared by Reviewed by: Approved by:

5.8.2. Review Input

Food safety team reviews included the followings:

5.8.3. Management Review Output

The output from the management reviews included the followings,

Reference Procedure for Management Review (FSP/08)

6.0 RESOURCE MANAGEMENT

6.1 Provision of Resources

6.2 Human Resources

6.2.2 Competence, Awareness and Training

Prepared by Reviewed by: Approved by:

6.4 Work Environment

7. PLANNING AND REALIZATION OF SAFE PRODUCTS

Prepared by Reviewed by: Approved by:

7.2 Prerequisite Programs (PRP’S)

B) Design and lay out

C) Drainage and waste disposal

Prepared by Reviewed by: Approved by:

F) Condition of walls, doors and windows

G) Condition of ceiling and lights

Prepared by Reviewed by: Approved by:

4. Cleaning and Sanitizing

Prepared by Reviewed by: Approved by:

Prepared by Reviewed by: Approved by: