Manual fsms final 181012

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

Prepared by: Approved by:

Signature: Signature:

Classified: Date: of 47



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






verification

Improvement

8.1

8.2

8.3

8.4

8.5

15 List of Manual

16 Regulatory document






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






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






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)






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






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






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






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:






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






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.






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






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






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,






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.




DNPL SOP Document Management



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.






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






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






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






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.






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.






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






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.






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






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






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






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






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






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.






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






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






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






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.






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.


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






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.






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






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.


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;






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






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.


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






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:






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






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






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






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


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.






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






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




Manual fsms final 181012

Food

Transcript of Manual fsms final 181012