QUALIFICATIONS PACK - OCCUPATIONAL STANDARDS FOR FOOD PROCESSING

Contents
1. Introduction and Contacts……[1]
2. Qualifications Pack………………..[2]
3. Glossary of Key Terms…………[3]
4. OS Units……………………………[5]
5. Annexure: Nomenclature for QP and NOS…[25]
 OS describe what
6. Assessment Criteria…………[27]
individuals need
to do, know and
understand in
order to carry out
a particular job Introduction
role or function
Qualifications Pack – Food Regulatory Affairs Manager
 OS are
performance
ces SECTOR:
Helpdesk Attendant
FOOD PROCESSING

standards that SUB-SECTOR: Fruit and vegetable, food grain milling (including oilseeds), dairy products,
individuals must meat and poultry, fish & sea food, bread and bakery, alcoholic beverages, aerated
achieve when water/soft drinks, soya food, packaged foods
carrying out OCCUPATION: Quality Assurance
functions in the
workplace, REFERENCE ID: FIC/Q9002
together with
specifications of ALIGNED TO: NCO-2004/NIL
the underpinning
Brief Job Description: A Food Regulatory Affairs Manager is responsible for designing,
knowledge and developing, implementing and changing food regulatory systems in the organisation.
understanding S/he acts as a liaison between organisation and government regulatory agencies and
authorities to ensure that the products produced and distributed comply with regulatory
standards.
Food Industry
Capacity & Skill Personal Attributes: A Food Regulatory Affairs Manager must have the ability to read,
write, communicate, mathematical ability to calculate, organizational & analytical skills,
Initiative
ability to plan, organize and prioritize, concentration, physical stamina, handling
FICCI office pressure, team work, mechanical aptitude and trouble shooting skills, understanding on
1, Federation House food safety standards and requirements, personal and professional hygiene.
Tansen Marg
New Delhi-110001
91-11-23738760-70
E mail: Page | 1
ceo.ficsi@ficci.com
 Qualifications Pack For Food Regulatory Affairs Manager

Qualifications Pack Code FIC/Q9002

Job Role Food Regulatory Affairs Manager
Credits (NSQF) TBD Version number 1.0
Sector Food Processing Drafted on 26/11/2015
Job Details

Fruit and Vegetable, Food Grain

Milling (Including Oilseeds), Dairy
Products, Meat and Poultry, Fish &
Sub-sector Sea Food, Bread and bakery, Last reviewed on 03/08/2018
Alcoholic beverages, Aerated
water/soft drinks, Soya food,
Packaged foods
Occupation Quality Assurance Next review date 02/08/2021
NSQC clearance on 03/08/2018

Job Role Food Regulatory Affairs Manager

A Food Regulatory Affairs Manager is responsible for designing,
developing, implementing and changing food regulatory
systems in the organisation. S/he acts as a liaison between
Role Description
organisation and government regulatory agencies and
authorities to ensure that the products produced and
distributed comply with regulatory standards.
6
NSQF level
Bachelor’s degree in Food Technology / food science,
Minimum Educational Qualifications
preferably
Maximum Educational Qualifications
Not applicable

1. Food Safety Standards and Regulations (as per FSSAI)

2. Total Quality Management
Training 3. Occupational Health & Safety Advisory Services
(Suggested but not mandatory) 4. Environmental Management System

Minimum Job Entry Age 30 years

Experience 8-10 years in a food processing unit in a food regulatory role

Compulsory:
1. FIC/N9011 Design, develop and implement regulatory
Applicable National Occupational system
2. FIC/N9012 Manage change in food regulatory system
Standards (NOS)
3. FIC/N9013 Prepare representations to regulatory
authorities and new product registrations

Performance Criteria As described in the relevant OS units

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 Qualifications Pack For Food Regulatory Affairs Manager

Keywords /Terms Description

Sector Sector is a conglomeration of different business operations having similar

Definitions

businesses and interests. It may also be defined as a distinct subset of the

economy whose components share similar characteristics and interests.
Sub-sector is derived from a further breakdown based on the characteristics
Sub-sector
and interests of its components.
Occupation is a set of job roles, which perform similar/related set of
Occupation functions in an industry.
Function is an activity necessary for achieving the key purpose of the sector,
occupation, or area of work, which can be carried out by a person or a
Function
group of persons. Functions are identified through analysis and form the
basis of OS.
Job role defines a unique set of functions that together form a unique
Job Role
employment opportunity in an organization.
OS specify the standards of performance an individual must achieve when
carrying out a function in the workplace, together with the knowledge and
OS
understanding they need to meet that standard consistently. Occupational
Standards are applicable both in the Indian and global contexts.
Performance Performance Criteria are statements that together specify the standard of
Criteria performance required when carrying out a task.
NOS NOS are Occupational Standards which apply uniquely in the Indian context.
Qualifications Pack Qualifications Pack Code is a unique reference code that identifies a
Code qualifications pack.
Qualifications Pack comprises the set of OS, together with the educational,
Qualifications Pack training and other criteria required to perform a job role. A Qualifications
Pack is assigned a unique qualification pack code.
Unit Code is a unique identifier for an Occupational Standard , which
Unit Code
is denoted by an ‘N’
Unit Title gives a clear overall statement about what the incumbent should
Unit Title
be able to do.
Description gives a short summary of the unit content. This would be helpful
Description to anyone searching on a database to verify that this is the appropriate OS
they are looking for.
Knowledge and Understanding are statements which together specify the
Knowledge and
technical, generic, professional and organizational specific knowledge that
Understanding
an individual needs in order to perform to the required standard.
Organizational Context includes the way the organization is structured and
Organizational
how it operates, including the extent of operative knowledge managers
Context
have of their relevant areas of responsibility.
Technical Technical Knowledge is the specific knowledge needed to accomplish
Knowledge specific designated responsibilities.
Core Skills or Core Skills or Generic Skills are a group of skills that are key to learning and
Generic Skills working in today's world. These skills are typically needed in any work
environment. In the context of the OS, these include communication related
skills that are applicable to most job roles.
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 Qualifications Pack For Food Regulatory Affairs Manager

Keywords /Terms Description

CIP Clean In Place
Acronyms

COP Clean Out Of Place

ERP Enterprise Resource Planning
FIFO First In First Out
FEFO First Expiry First Out
FSSAI Food Safety and Standards Authority of India
GMP Good Manufacturing Practice
GHP Good Hygiene Practices
HACCP Hazard Analysis and Critical Control Point
NOS National Occupational Standard
NSQF National Skill Qualification Framework
OS Occupational Standard
PC Performance Criteria
QP Qualification Pack
SSC Sector Skill Council
SOP Standard Operating Procedure
QMS Quality Management System

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FIC/N9011 Design, develop and implement regulatory system

---------------------------------------------------------------------------------------------------------------------------------------

Overview

This OS is about designing, developing and implementing food regulatory systems for food
products produced in the organisation.

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 FIC/N9011 Design, develop and implement regulatory system

Unit Code FIC/N9011

Unit Title
National Occupational Standard

Design, develop and implement regulatory system

(Task)
This OS unit is about designing, developing and implementing regulatory systems in
Description food processing units to ensure product compliance to national and international food
regulatory system.
This unit/task covers the following:
 Design and develop regulatory system for the organisation (for food products
produced)
Scope  Develop, monitor and audit regulatory system in the organisation (for food
products produced)
 Provide training on regulatory system (for food products produced)

Performance Criteria(PC) w.r.t. the Scope

Element Performance Criteria
Design and develop To be competent, the user/individual must be able to:
regulatory system for PC1. understand food safety regulations and develop regulatory policies for the
the organisation (for organisation with clear definitions to increase consistency, legal security and
food products
to provide high level of food safety
produced)
PC2. design regulatory system with focus on risk reduction, risk-based priorities,
reflect integrated and economically feasible initiatives, and ensure high
quality and transparency
PC3. design and develop regulatory system with intuitive approach to food safety
such that problem are recognized, understood, dealt, and checked to ensure
problem has been dealt efficiently and effectively
PC4. design regulatory system with contingency planning like product traceability
and product recall in case of problems, procedures for handling containment,
with clear attribution of roles like lines of authority and co-ordination
mechanism across food chain (from procuring raw materials, production until
product reaching consumers)
PC5. design regulatory system with improved communication on food safety
information in marketing materials, product labels etc, providing science
based information to clear up the unjustified fear among consumers
PC6. set food safety system involving food producers, processors, distributors,
retailers and consumers to recognize their primary responsibility and to share
a common goal of ensuring food safety at all stages
PC7. design food regulatory system involving GMP, GHP, and monitoring systems
like HACCP
PC8. design regulatory system that improve efficiency and compliance, build
consumer confidence in the safety and quality of food products produced,
processed, marketed, distributed and sold
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FIC/N9011 Design, develop and implement regulatory system

PC9. design and develop regulatory system ensuring food and health standards are
followed in each stage of production and produce food products that meet
national and international regulatory standards and protect the health of
consumers
PC10. design regulatory system including provisions for the right of consumers to
have access to accurate and sufficient information and make adequate
choices
PC11. provide strategic advice and cost effective strategies on regulatory
aspects/requirements to senior management and project managing teams
throughout the development of a new product

Develop, monitor and To be competent, the user/individual must be able to:

audit regulatory PC12. interpret regulatory standards and develop organisation standards meeting
system in the national and international food safety regulations like FSSAI, FDA, EU food
organisation (for
safety regulations, codex alimentarius etc for products produced, exported
food products
and imported, and labels of products packed by the organisation
produced)
PC13. develop and review standard operating procedures (SOPs) and ensure that
they are in compliance with current regulatory requirements and provide
regulatory support for corporate quality assurance efforts
PC14. develop organisation standards for labels of food products produced and
packed, promotional marketing materials, products imported and exported
by the organisation to meet national and international food regulatory
PC15. evaluate labels of packed food products to ensure it meets national and
international food regulatory standards and provide approval or recommend
changes
PC16. evaluate promotional and materials for regulatory impact and provide
approval
PC17. provide support for review of essential documents, development and review
of consent forms for submission to regulatory authorities for clearance
PC18. initiate and contribute to process improvements which have an impact on
regulatory affairs, quality assurance and other departments
PC19. conduct audits on food processing unit for compliance with regulatory, safety
and hygiene standards implemented and followed in the organisation
PC20. conduct periodic audits to evaluate haccp plans and their implementation in
the organisation and ensure it meets the regulatory standards
PC21. review internal and external audit reports to check the effectiveness of the
present regulatory system and recommend necessary changes in the policies
and procedures to reduce failures in the future
PC22. identify reason for consumer cases in court related to non-compliance of food
products to regulatory standards, collect relevant information’s and
documents transmitting evidence to produce in court to assist prosecution

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FIC/N9011 Design, develop and implement regulatory system

PC23. monitor company progress toward fulfillment of regulatory commitments

Provide training on To be competent, the user/individual must be able to:

regulatory system PC24. provide training to department managers on organisation policies on food
(for food products and safety regulations, national and international food laws and regulations,
produced)
methods and procedures for implementing regulations for procuring raw
materials, producing food products, marketing and selling quality products to
the consumers
PC25. provide training to all department managers on the importance of food
regulatory standards and need for its compliance, statutory and regulatory
requirements for the products produced, labels of packed products and
promotional materials, and the consequences for not following the
regulatory requirements
PC26. provide training on procedures for collecting evidence in case of
problems/consumer complaints/consumer cases in court and handling them
with technical and scientific approach
PC27. provide training to all department managers on methods to implement and
monitor regulatory system in their area of function, writing reports with
relevant information and data to present to local food regulatory authorities
for any concerns raised / clarification required, methods to approach and
maintain relationship with food regulatory authorities
PC28. provide training on upgradation and changes in the food regulatory system
and methods to implement, monitor and achieve them

Knowledge and Understanding (K)

A. Organizational The user/individual on the job needs to know and understand:
Context KA1. principles and processes of organization
(Knowledge of the KA2. organisaiton goals and policies
KA3. business processes of the organisation
company /
KA4. food regualtory system related to the process and products produced in the
organization and
organisation
its processes) KA5. policies and proecdures for designing regulatory system for the organisaiton
KA6. training system in the oganisation for implenting food regulatory system
KA7. research and project management techniques
KA8. code of business conduct
B. Technical The user/individual on the job needs to know and understand:
Knowledge KB1. risk and information management
KB2. national and international legal and regulatory systems like FSSAI, FDA,
CODEX Alimentarius, EU food safety regulations etc, and GMP, GHP, HACCP,
OHSAS etc
KB3. policies and procedures to be followed to meet the national and international
regulatory requirements like GMP, GHP, HACCP etc
KB4. relevant legal requirements related to the products produced in the
organisation
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FIC/N9011 Design, develop and implement regulatory system

KB5. food microbiology and its standards and regulations for products produced in
the organisation
KB6. current and emerging regulatory concerns and expectations on the
organisation
KB7. methods to deal with current and emerging social concerns and expectations
KB8. processes for maintaining relevant policies and procedures and methods to
ensure sustainability and effectiveness
KB9. methods to meet the consequence due to failure in policies and procedures
and methods to review and take corrective action on people and policies
KB10. reporting and reviewing system to understand the effectiveness of the
regulatory system implemented
Skills (S)
A. Core Skills/ Writing Skills
Generic Skills The user/ individual on the job needs to know and understand how to:
SA1. note the information communicated
SA2. note the raw materials used for production and the finished products
produced
SA3. note the readings of the process parameters and provide necessary
information to fill the process chart
SA4. note down observations (if any) related to the process
SA5. write information documents to internal departments/ internal teams
SA6. note down the data for online ERP or as per applicability in the organization
Reading Skills
The user/individual on the job needs to know and understand how to:
SA7. read and interpret the process required for producing various types of
products
SA8. read and interpret and process flowchart for all products produced
SA9. read equipment manuals and process documents to understand the
equipments operation and process requirement
SA10. read internal information documents sent by internal teams
Oral Communication (Listening and Speaking skills)
The user/individual on the job needs to know and understand how to:
SA11. discuss task lists, schedules and activities
SA12. effectively communicate with team members
SA13. question in order to understand the nature of the problem and to clarify
queries
SA14. attentively listen and comprehend the information given by the speaker
SA15. communicate clearly on the issues being faced
B. Professional Skills Decision Making
The user/individual on the job needs to know and understand how to:
SB1. analyse critical points in day to day tasks through experience and observation
and identify control measures to solve the issue
SB2. handle issues in case the manager is not available (as per the authority matrix
defined by the organization)
Plan and Organize
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FIC/N9011 Design, develop and implement regulatory system

The user/individual on the job needs to know and understand how to:
SB3. plan and organize the work order and jobs received
SB4. organize raw materials and packaging materials required for all products
SB5. plan and prioritize the work based on the instructions received
SB6. plan to utilise time and equipment's effectively
SB7. organize all process/ equipment manuals so as to access information easily
SB8. support the manager in scheduling tasks for helper(s)
Customer Centricity
The user/individual on the job needs to know and understand how to:
SB9. understand customer requirements and their priority and respond as per
their needs
Problem Solving
The user/individual on the job needs to know and understand how to:
SB10. support manager in solving problems by detailing out problems
SB11. discuss the possible solutions with the manager for problem solving
Analytical Thinking
The user/individual on the job needs to know and understand how to:
SB12. apply domain information about maintenance processes and technical
knowledge about tools and equipment
Critical Thinking
The user/individual on the job needs to know and understand how to:
SB13. use common sense and make judgments on day to day basis
SB14. use reasoning skills to identify and resolve basic problems
SB15. use intuition to detect any potential problems which could arise during
operations
SB16. use acquired knowledge of the process for identifying and handling issues

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FIC/N9011 Design, develop and implement regulatory system

NOS Version Control

NOS Code FIC/N9011

Credits (NSQF) TBD Version number 1.0

Industry Food Processing Drafted on 26/11/2015
Fruit and Vegetable, Food
Grain Milling (Including
Oilseeds), Dairy Products,
Meat and Poultry, Fish &
Industry Sub-sector Sea Food, Bread and Last reviewed on 03/08/2018
bakery, Alcoholic
beverages, Aerated
water/soft drinks, Soya
food, Packaged foods

Occupation Quality Assurance Next review date 02/08/2021

Back to Top

Page | 11
FIC/N9012 Manage change in food regulatory system

----------------------------------------------------------------------------------------------------------------------------- ----------

Overview

This OS unit is about managing change in food regulatory system in food processing unit

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 FIC/N9012 Manage change in food regulatory system

Unit Code FIC/N9012

Unit Title
National Occupational Standard

Manage change in food regulatory system

(Task)
This OS unit is about managing change in regulatory system in food processing unit to
Description
ensure product compliance to national and international food regulatory system.
This unit/task covers the following:
 Plan change in regulatory system (for food products produced)
 Lead to implement changes in regulatory system (for food products produced)
Scope
 Monitor changes implemented in regulatory system(for food products
produced)

Performance Criteria(PC) w.r.t. the Scope

Element Performance Criteria
Plan change in To be competent, the user/individual must be able to:
regulatory system PC1. identify procedures, systems, structures that need to be changed for effective
(for food products implementation of food regulatory system
produced)
PC2. assess gaps in the current policies and procedures and analyze the future
requirements
PC3. identify and assess barriers to change in regulatory system, develop strategies
and plans to overcome those barriers
PC4. assess risks and benefits associated with the strategies and plans, and
develop contingency arrangements
PC5. design new work processes, procedures, systems, structures and roles to
achieve planned changes in regulatory system
PC6. ensure plan for change in regulatory system include short-term as well as
longer-term deliverables
PC7. develop system for monitoring and assessing regulatory system to assess
progress in changes implemented
PC8. develop reporting and communicating system to review the effectiveness of
the changes in regulatory system and to obtain feedback
PC9. provide training and support to implement changes planned in regulatory
system

Lead to implement To be competent, the user/individual must be able to:

changes in regulatory PC10. communicate reasons, importance and benefits of implementing change in
system (for food regulatory system, future that can be achieved through implementing and
products produced)
following the change, to management and concerned employees
PC11. make the management and employees welcome change in regulatory system
as an opportunity to deliver products of national and international quality

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FIC/N9012 Manage change in food regulatory system

PC12. make the management and employees understand the need and importance
for change in regulatory system, result expected out of change and its effect
on the organisation
PC13. implement the strategies and plans for change in regulatory system with
available resources
PC14. make the managers responsible for implementing change in regulatory
system understand their responsibilities and commitment, and use their
influence and power over employees to implement change
PC15. set and prioritize objectives for the change in regulatory system, identify and
deal with obstacles to change, and support employees through the change
process
PC16. communicate progress achieved thorough change in regulatory system to
everyone involved, and make them understand and enjoy achievement

Monitor changes To be competent, the user/individual must be able to:

implemented in PC17. review reports on total quality management system to evaluate effectiveness
regulatory system(for of changes implemented in regulatory system of the organisation
food products
PC18. organize internal and external audit on total quality management system to
produced)
evaluate effectiveness of the changes implemented in regulatory system
PC19. monitor changes implemented in regulatory system , document and
communicate the outcome of implemented change to the management
PC20. recognize and reward employees and teams for implementing regulatory
system and achieving results thorough new policies and procedures
PC21. monitor and ensure changes implemented in regulatory system are effective
and meet the requirements of the organisation and regulatory system laid by
national and international regulatory bodies

Knowledge and Understanding (K)

A. Organizational The user/individual on the job needs to know and understand:
Context KA1. organisation goals and policies
(Knowledge of the KA2. organisation vision for future
KA3. food regualtory system related to the process and products produced in the
company /
organisation
organization and
KA4. critical activies related to food regulatory system of the organisation
its processes) KA5. strategy, policies, procedures and standards that need to be changed
B. Technical The user/individual on the job needs to know and understand:
Knowledge KB1. national and international legal and regulatory requirements related to the
products produced in the organisation like FSSAI, FDA, CODEX Alimentarius,
EU food safety regulations etc
KB2. changes in the legal and regulatory standards for products produced in the
organisation

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FIC/N9012 Manage change in food regulatory system

KB3. current and emerging political, economic, social, technological,

environmental and legal developments and their effect on the food
regulatory system
KB4. methods to analyze strengths and weaknesses of the system for planning
changes
KB5. methods for making and managing change effectively
KB6. analyzing strategy, procedures, policies and structure that need to be
changed
KB7. reason for implementing changes, risks and benefits expected out of changes
planned and implemented
KB8. methods to assess the benefits and risks associated with strategies and plans
KB9. methods to influence change process in the management
KB10. analyzing employee’s knowledge, skill and attitude to implement change
KB11. culture of the organization and its implication to change process
KB12. methods and procedures to monitor change
Skills (S)
A. Core Skills/ Writing Skills
Generic Skills The user/ individual on the job needs to know and understand how to:
SA1. note the information communicated
SA2. note the raw materials used for production and the finished products
produced
SA3. note the readings of the process parameters and provide necessary
information to fill the process chart
SA4. note down observations (if any) related to the process
SA5. write information documents to internal departments/ internal teams
SA6. note down the data for online ERP or as per applicability in the organization
Reading Skills
The user/individual on the job needs to know and understand how to:
SA7. read and interpret the process required for producing various types of
products
SA8. read and interpret and process flowchart for all products produced
SA9. read equipment manuals and process documents to understand the
equipments operation and process requirement
SA10. read internal information documents sent by internal teams
Oral Communication (Listening and Speaking skills)
The user/individual on the job needs to know and understand how to:
SA11. discuss task lists, schedules and activities
SA12. effectively communicate with team members
SA13. question in order to understand the nature of the problem and to clarify
queries
SA14. attentively listen and comprehend the information given by the speaker
SA15. communicate clearly on the issues being faced
B. Professional Skills Decision Making
The user/individual on the job needs to know and understand how to:

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FIC/N9012 Manage change in food regulatory system

SB1. analyse critical points in day to day tasks through experience and observation
and identify control measures to solve the issue
SB2. handle issues in case the manager is not available (as per the authority matrix
defined by the organization)
Plan and Organize
The user/individual on the job needs to know and understand how to:
SB3. plan and organize the work order and jobs received
SB4. organize raw materials and packaging materials required for all products
SB5. plan and prioritize the work based on the instructions received
SB6. plan to utilise time and equipment's effectively
SB7. organize all process/ equipment manuals so as to access information easily
SB8. support the manager in scheduling tasks for helper(s)
Customer Centricity
The user/individual on the job needs to know and understand how to:
SB9. understand customer requirements and their priority and respond as per
their needs
Problem Solving
The user/individual on the job needs to know and understand how to:
SB10. support manager in solving problems by detailing out problems
SB11. discuss the possible solutions with the manager for problem solving
Analytical Thinking
The user/individual on the job needs to know and understand how to:
SB12. apply domain information about maintenance processes and technical
knowledge about tools and equipment
Critical Thinking
The user/individual on the job needs to know and understand how to:
SB13. use common sense and make judgments on day to day basis
SB14. use reasoning skills to identify and resolve basic problems
SB15. use intuition to detect any potential problems which could arise during
operations
SB16. use acquired knowledge of the process for identifying and handling issues

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FIC/N9012 Manage change in food regulatory system

NOS Code FIC/N9012

Credits (NSQF) TBD Version number 1.0

Industry Food Processing Drafted on 26/11/2015
Fruit and Vegetable, Food
Grain Milling (Including
Oilseeds), Dairy Products,
Meat and Poultry, Fish &
Industry Sub-sector Sea Food, Bread and Last reviewed on 03/08/2018
bakery, Alcoholic
beverages, Aerated
water/soft drinks, Soya
food, Packaged foods

Occupation Quality Assurance Next review date 02/08/2021

NOS Version Control

Back to Top

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FIC/N9013 Prepare representations to regulatory authorities and for
new product registrations

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Overview
This OS is about preparing representation documents to regulatory authorities, liasioning
with food regulatory authorities and new product approval from food regulatory authorities.

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 FIC/N9013 Prepare representations to regulatory authorities and for
new product registrations

Unit Code FIC/N9013

Unit Title
National Occupational Standard

Prepare representations to regulatory authorities and for new product registrations

(Task)
This OS unit is about preparing representations to regulatory authorities on existing
Description food products and for new product registrations, liaison with food regulatory
authorities, industrial and trade associations
This unit/task covers the following:
 Prepare representation documents to regulatory authorities (for food
Scope products produced)
 Liaise with regulatory authorities (for food products produced)
 New product registrations (for food products produced)
Performance Criteria(PC) w.r.t. the Scope
Element Performance Criteria
Prepare To be competent, the user/individual must be able to:
representation PC1. prepare simple and complex regulatory documents in accordance with
documents to applicable FSSAI regulations by collecting, collating and evaluating scientific
regulatory data that has been well researched on relevant aspects
authorities (for food
PC2. review regulatory guidance and requirements pertaining to products
products produced)
produced in the organisation and prepare documents providing thoughtful
and accurate comments
PC3. prepare regulatory documents to authorities that translate regulatory
requirements into practical, workable plans with timelines for development
and implementation
PC4. coordinate with food regulatory authorities to review disputed matters,
negotiation and finalization on products and projects, and for comments and
formal approvals
PC5. prepare documents that include check lists created and maintained to
implement regulatory requirements, technical data, and declarations of
conformity
PC6. interface with consultants, research organizations, partners, co-
manufacturers etc for preparation, review, compilation, finalization and
submission of documents for regulatory approvals
PC7. prepare responses to communications and other requests from government
food regulatory authorities
PC8. prepare safety reports and documents on raw materials, ingredients,
additives, flavours etc used in the products produced and marketed by the
organisation, for regulatory submissions and clearance
PC9. identify reasons related to non-compliance of food products to regulatory
standards, collect relevant information’s and data, prepare technical
documents with scientific facts and supporting evidence, and submit to
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FIC/N9013 Prepare representations to regulatory authorities and for
new product registrations

relevant authorities, respond to communications from government

authorities, and follow up regularly to revoke product ban

Liaise with regulatory To be competent, the user/individual must be able to:

authorities (for food PC10. interact with various regulatory authorities during concept, development and
products produced) industrialization stages of projects for clarification and approvals
PC11. interact with the notified bodies and competent authorities for developing
and reviewing regulatory standards
PC12. coordinate with regulatory authorities for reporting, to comment on
proposed regulations, and to represent company’s interest in the
development of standards and guidelines
PC13. discuss on the differences that exist in the regulations laid down by different
governments and their interpretation by the regulatory agencies and ensure
that efficient and economical regulatory standards are planned
PC14. identify possible threats or opportunities from upcoming regulations under
fssai, consumer affairs, other government food policies and regulations and
liaise with industry associations to tackle/manage them effectively
PC15. participate in seminar, workshops, conferences and meetings organised by
fssai and other industry association, representing the organisation to
maintain, strengthen and expand contacts
PC16. work closely with regulatory and trade associations like cii (confederation of
indian industries), ficci (federation of indian chambers of commerce and
industries), cifti (confederation of indian food trade and industry), aifpa (all
india food processors association), assocham(the associated chambers of
commerce of india) etc on national and international regulatory changes and
challenges that have impact on food products produced in the organisation
and to manage them proactively

New product To be competent, the user/individual must be able to:

registrations (for PC17. develop and write clear arguments and explanations for new product license
food products PC18. prepare and present registration documents to regulatory authorities and
produced)
notified bodies for new product approvals
PC19. present written representation for new products and carry out negotiations
with regulatory authorities to obtain necessary approvals for new product
production and marketing
PC20. evaluate, prepare and submit new product registration applications and
follow through the application during the evaluation phase to achieve
favorable outcome
PC21. prepare responses to letter/e-mail communications and other requests from
government food regulatory bodies on new product approval

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FIC/N9013 Prepare representations to regulatory authorities and for
new product registrations

PC22. provide regulatory and product compliance report in the area of advertising
and label claims for new products

Knowledge and Understanding (K)

A. Organizational The user/individual on the job needs to know and understand:
Context KA1. food regualtory system related to the process and products produced in the
(Knowledge of organisation
KA2. government food regualtory authorities and other regulatory bodies
the company /
KA3. national and internation relationship maintenance strategy with food
organization and
regulatory authorities
its processes) KA4. formal procedures for handling legal and food regulatory requirements of the
organisation

B. Technical The user/individual on the job needs to know and understand:

Knowledge KB1. national and international legal and regulatory requirements related to the
products produced in the organisation like FSSAI, FDA, CODEX Alimentarius,
EU food safety regulations etc
KB2. policies and procedures to be followed to meet the national and international
regulatory requirements like GMP, GHP, HACCP, OHSAS etc
KB3. relevant legal requirements related to the products produced in the
organisation
KB4. food microbiology and its standards and regulations for products produced in
the organisation
KB5. methods and procedures to prepare regulatory documents
KB6. various government regulatory authorities and other relevant bodies handling
food safety regulations
KB7. various trade associations and procedures to obtain membership
KB8. formal procedures to approach and liaise with government regulatory
authorities and other relevant bodies
KB9. methods to evaluate and collect types and source of information required for
resolving food regulatory issues
KB10. legal communications and methods and procedures to respond to them
KB11. procedures that apply for participating in meetings organized by regulatory
authorities and trade associations
Skills (S)
A. Core Skills/ Writing Skills
Generic Skills The user/ individual on the job needs to know and understand how to:
SA1. note the information communicated
SA2. note the raw materials used for production and the finished products
produced
SA3. note the readings of the process parameters and provide necessary
information to fill the process chart
SA4. note down observations (if any) related to the process
SA5. write information documents to internal departments/ internal teams
SA6. note down the data for online ERP or as per applicability in the organization
Page | 21
FIC/N9013 Prepare representations to regulatory authorities and for
new product registrations

Reading Skills
The user/individual on the job needs to know and understand how to:
SA7. read and interpret the process required for producing various types of
products
SA8. read and interpret and process flowchart for all products produced
SA9. read equipment manuals and process documents to understand the
equipments operation and process requirement
SA10. read internal information documents sent by internal teams
Oral Communication (Listening and Speaking skills)
The user/individual on the job needs to know and understand how to:
SA11. discuss task lists, schedules and activities
SA12. effectively communicate with team members
SA13. question in order to understand the nature of the problem and to clarify
queries
SA14. attentively listen and comprehend the information given by the speaker
SA15. communicate clearly on the issues being faced
B. Professional Skills Decision Making
The user/individual on the job needs to know and understand how to:
SB1. analyse critical points in day to day tasks through experience and observation
and identify control measures to solve the issue
SB2. handle issues in case the manager is not available (as per the authority matrix
defined by the organization)
Plan and Organize
The user/individual on the job needs to know and understand how to:
SB3. plan and organize the work order and jobs received
SB4. organize raw materials and packaging materials required for all products
SB5. plan and prioritize the work based on the instructions received
SB6. plan to utilise time and equipment's effectively
SB7. organize all process/ equipment manuals so as to access information easily
SB8. support the manager in scheduling tasks for helper(s)
Customer Centricity
The user/individual on the job needs to know and understand how to:
SB9. understand customer requirements and their priority and respond as per
their needs
Problem Solving
The user/individual on the job needs to know and understand how to:
SB10. support manager in solving problems by detailing out problems
SB11. discuss the possible solutions with the manager for problem solving
Analytical Thinking
The user/individual on the job needs to know and understand how to:
SB12. apply domain information about maintenance processes and technical
knowledge about tools and equipment
Critical Thinking
The user/individual on the job needs to know and understand how to:

Page | 22
FIC/N9013 Prepare representations to regulatory authorities and for
new product registrations

SB13. use common sense and make judgments on day to day basis
SB14. use reasoning skills to identify and resolve basic problems
SB15. use intuition to detect any potential problems which could arise during
operations
SB16. use acquired knowledge of the process for identifying and handling issues

Page | 23
FIC/N9013 Prepare representations to regulatory authorities and for
new product registrations

NOS Version Control

NOS Code FIC/N9013

Credits (NSQF) TBD Version number 1.0

Industry Food Processing Drafted on 26/11/2015
Fruit and Vegetable,
Food Grain Milling
(Including Oilseeds),
Dairy Products, Meat
and Poultry, Fish & Sea
Industry Sub-sector Last reviewed on 03/08/2018
Food, Bread and
bakery, Alcoholic
beverages, Aerated
water/soft drinks, Soya
food, Packaged foods
Occupation Quality Assurance Next review date 02/08/2021

Back to Top

Page | 24
 Qualifications Pack for Food Regulatory Affairs Manager

Annexure

Nomenclature for QP and NOS

Qualifications Pack
9 characters
[ABC]/ Q 0101

[Insert 3 letter code for SSC] QP number (2 numbers)

Q denoting Qualifications Pack Occupation (2 numbers)

Occupational Standard

An example of NOS with ‘N’ 9 characters

[ABC] / N 0101

[Insert 3 letter code for SSC] OS number (2 numbers)

N denoting National Occupational Standard Occupation (2 numbers)

Back to top…

Page | 25
 Qualifications Pack for Food Regulatory Affairs Manager

The following acronyms/codes have been used in the nomenclature above:

Range of Occupation
Sub-sector
numbers
Fruit and Vegetable 01 – 09
Food Grain Milling (including Oilseeds) 10 - 19
Dairy products 20 - 30
Meat and Poultry 30 – 40
Fish and Sea Food 40 - 49
Bread and Bakery 50 - 59
Alcoholic Beverages
60 - 69
Aerated water/ soft drinks
Quality Analysis (involving physical and chemical lab
76 – 79
analysis)
Packaging, Refrigeration and Procurement 70 – 75
Soya Food 80 – 84
Packaged Foods 85 - 90
Miscellaneous 90 - 95

Sequence Description Example

Three letters Industry name FIC

Slash / /

Next letter Whether QP or NOS Q or N

Next two numbers Occupation code 01

Next two numbers OS number 01

Page | 26
 Assessment Criteria

CRITERIA FOR ASSESSMENT OF TRAINEES

Job Role Food Regulatory Affairs Manager

Qualification Pack FIC/Q9002
Sector Skill Council Food Processing

Guidelines for Assessment

1. Criteria for assessment for each Qualification Pack will be created by the Sector Skill Council. Each Performance Criteria
(PC) will be assigned marks proportional to its importance in NOS. SSC will also lay down proportion of marks for Theory and
Skills Practical for each PC
2. The assessment for the theory part will be based on knowledge bank of questions created by the SSC.
3. Assessment will be conducted for all compulsory NOS, as well as the selected elective NOS/set of NOS.
OR
4. Assessment will be conducted for all compulsory NOS, as well as the selected optional NOS/set of NOS.
5. Individual assessment agencies will create unique question papers for theory part for each candidate at each
examination/training center (as per assessment criteria below)
6. Individual assessment agencies will create unique evaulations for skill practical for every student at each
examination/training center based on this criteria
7. To pass the Qualification Pack , every trainee should score a minimum of 70% of aggregate marks to successfully clear the
assessment.
8. In case of unsuccessful completion, the trainee may seek reassessment on the Qualification Pack

Marks Allocation
Assessment outcomes Assessment criteria for outcomes Total Skills
Out Of Theory
Marks Practical
1. FIC/N9011 (Design, PC1. understand food safety regulations
develop and implement and develop regulatory policies for
regulatory system) the organisation with clear
4 1.5 2.5
definitions to increase consistency,
legal security and to provide high
level of food safety
PC2. design regulatory system with
focus on risk reduction, risk-based
priorities, reflect integrated and 100
4 1.5 2.5
economically feasible initiatives,
and ensure high quality and
transparency
PC3. design and develop regulatory
system with intuitive approach to
food safety such that problem are 4 1.5 2.5
recognized, understood, dealt, and
checked to ensure problem has

Page | 27
 Assessment Criteria

been dealt efficiently and

effectively
PC4. design regulatory system with
contingency planning like product
traceability and product recall in
case of problems, procedures for
handling containment, with clear
attribution of roles like lines of 4 1.5 2.5
authority and co-ordination
mechanism across food chain
(from procuring raw materials,
production until product reaching
consumers)
PC5. design regulatory system with
improved communication on food
safety information in marketing
materials, product labels etc, 4 1.5 2.5
providing science based
information to clear up the
unjustified fear among consumers
PC6. set food safety system involving
food producers, processors,
distributors, retailers and
consumers to recognize their 4 1.5 2.5
primary responsibility and to share
a common goal of ensuring food
safety at all stages
PC7. design food regulatory system
involving gmp, ghp, and monitoring 4 1.5 2.5
systems like haccp
PC8. design regulatory system that
improve efficiency and compliance,
build consumer confidence in the
4 1.5 2.5
safety and quality of food products
produced, processed, marketed,
distributed and sold
PC9. design and develop regulatory
system ensuring food and health
standards are followed in each
stage of production and produce
4 1.5 2.5
food products that meet national
and international regulatory
standards and protect the health
of consumers
PC10. design regulatory system including
provisions for the right of
consumers to have access to 4 1.5 2.5
accurate and sufficient information
and make adequate choices
Page | 28
 Assessment Criteria

PC11. provide strategic advice and cost

effective strategies on regulatory
aspects/requirements to senior
4 1.5 2.5
management and project managing
teams throughout the
development of a new product
PC12. interpret regulatory standards and
develop organisation standards
meeting national and international
food safety regulations like fssai,
fda, eu food safety regulations, 4 1.5 2.5
codex alimentarius etc for products
produced, exported and imported,
and labels of products packed by
the organisation
PC13. develop and review standard
operating procedures (sops) and
ensure sops are in compliance with
4 1.5 2.5
current regulatory requirements
and provide regulatory support for
corporate quality assurance efforts
PC14. develop organisation standards for
labels of food products produced
and packed, promotional
marketing materials, products 4 1.5 2.5
imported and exported by the
organisation to meet national and
international food regulatory
PC15. evaluate labels of packed food
products to ensure it meets
national and international food 4 1 3
regulatory standards and provide
approval or recommend changes
PC16. evaluate promotional and materials
for regulatory impact and provide 4 1 3
approval
PC17. provide support for review of
essential documents, development
and review of consent forms for 3 1 2
submission to regulatory
authorities for clearance
PC18. initiate and contribute to process
improvements which have an
3 1 2
impact on regulatory affairs, quality
assurance and other departments
PC19. conduct audits on food processing
unit for compliance with 3 1 2
regulatory, safety and hygiene

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 Assessment Criteria

standards implemented and

followed in the organisation
PC20. conduct periodic audits to evaluate
haccp plans and their
implementation in the organisation 3 1 2
and ensure it meets the regulatory
standards
PC21. review internal and external audit
reports to check the effectiveness
of the present regulatory system
3 1 2
and recommend necessary changes
in the policies and procedures to
reduce failures in the future
PC22. identify reason for consumer cases
in court related to non-compliance
of food products to regulatory
standards, collect relevant 3 1 2
information’s and documents
transmitting evidence to produce in
court to assist prosecution
PC23. monitor company progress toward
fulfillment of regulatory 3 1 2
commitments
PC24. provide training to department
managers on organisation policies
on food and safety regulations,
national and international food
laws and regulations, methods and
3 1 2
procedures for implementing
regulations for procuring raw
materials, producing food
products, marketing and selling
quality products to the consumers
PC25. provide training to all department
managers on the importance of
food regulatory standards and
need for its compliance, statutory
and regulatory requirements for
3 1 2
the products produced, labels of
packed products and promotional
materials, and the consequences
for not following the regulatory
requirements
PC26. provide training on procedures for
collecting evidence in case of
problems/consumer
3 1 2
complaints/consumer cases in
court and handling them with
technical and scientific approach
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 Assessment Criteria

PC27. provide training to all department

managers on methods to
implement and monitor regulatory
system in their area of function,
writing reports with relevant
information and data to present to 3 1 2
local food regulatory authorities for
any concerns raised / clarification
required, methods to approach and
maintain relationship with food
regulatory authorities
PC28. provide training on upgradation
and changes in the food regulatory
3 1 2
system and methods to implement,
monitor and achieve them
100 35 65
2. FIC/N9012 ( Manage PC1. identify procedures, systems,
change in food structures that need to be changed
5 1 4
regulatory system) for effective implementation of
food regulatory system
PC2. assess gaps in the current policies
and procedures and analyze the 5 1 4
future requirements
PC3. identify and assess barriers to
change in regulatory system,
5 1 4
develop strategies and plans to
overcome those barriers
PC4. assess risks and benefits associated
with the strategies and plans, and 5 1 4
develop contingency arrangements
PC5. design new work processes,
procedures, systems, structures 100
5 1 4
and roles to achieve planned
changes in regulatory system
PC6. ensure plan for change in
regulatory system include short-
4 1.5 2.5
term as well as longer-term
deliverables
PC7. develop system for monitoring and
assessing regulatory system to
5 2 3
assess progress in changes
implemented
PC8. develop reporting and
communicating system to review
the effectiveness of the changes in 5 2 3
regulatory system and to obtain
feedback

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 Assessment Criteria

PC9. provide training and support to

implement changes planned in
4 2 2
regulatory system

PC10. communicate reasons, importance

and benefits of implementing
change in regulatory system, future
that can be achieved through 5 2 3
implementing and following the
change, to management and
concerned employees
PC11. make the management and
employees welcome change in
regulatory system as an 4 1.5 2.5
opportunity to deliver products of
national and international quality
PC12. make the management and
employees understand the need
and importance for change in
5 2 3
regulatory system, result expected
out of change and its effect on the
organisation
PC13. implement the strategies and plans
for change in regulatory system 5 2 3
with available resources
PC14. make the managers responsible for
implementing change in regulatory
system understand their
responsibilities and commitment, 5 2 3
and use their influence and power
over employees to implement
change
PC15. set and prioritize objectives for the
change in regulatory system,
identify and deal with obstacles to 5 2 3
change, and support employees
through the change process
PC16. communicate progress achieved
thorough change in regulatory
system to everyone involved, and 4 1.5 2.5
make them understand and enjoy
achievement
PC17. review reports on total quality
management system to evaluate
effectiveness of changes 5 2 3
implemented in regulatory system
of the organisation

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 Assessment Criteria

PC18. organize internal and external audit

on total quality management
system to evaluate effectiveness of
5 2 3
the changes implemented in
regulatory system

PC19. monitor changes implemented in

regulatory system , document and
communicate the outcome of
5 2 3
implemented change to the
management

PC20. recognize and reward employees

and teams for implementing
regulatory system and achieving 4 1.5 2.5
results thorough new policies and
procedures

PC21. monitor and ensure changes

implemented in regulatory system
are effective and meet the
requirements of the organisation
5 2 3
and regulatory system laid by
national and international
regulatory bodies

100 35 65
3. FIC/N9013 ( Prepare PC1. prepare simple and complex
representations to regulatory documents in
regulatory authorities accordance with applicable FSSAI
and for new product regulations by collecting, collating
5 1 4
registrations) and evaluating scientific data that
has been well researched on
relevant aspects

PC2. review regulatory guidance and

requirements pertaining to
products produced in the
100
organisation and prepare 5 1 4
documents providing thoughtful
and accurate comments

PC3. prepare regulatory documents to

authorities that translate
regulatory requirements into
practical, workable plans with 5 1 4
timelines for development and
implementation

Page | 33
 Assessment Criteria

PC4. coordinate with food regulatory

authorities to review disputed
matters, negotiation and
finalization on products and 5 1 4
projects, and for comments and
formal approvals

PC5. prepare documents that include

check lists created and maintained
to implement regulatory
4 1.5 2.5
requirements, technical data, and
declarations of conformity

PC6. interface with consultants,

research organizations, partners,
co-manufacturers etc for
preparation, review, compilation,
4 1.5 2.5
finalization and submission of
documents for regulatory
approvals

PC7. prepare responses to

communications and other
requests from government food 4 1.5 2.5
regulatory authorities

PC8. prepare safety reports and

documents on raw materials,
ingredients, additives, flavours etc
used in the products produced and
4 1.5 2.5
marketed by the organisation, for
regulatory submissions and
clearance

PC9. identify reasons related to non-

compliance of food products to
regulatory standards, collect
relevant information’s and data,
prepare technical documents with
scientific facts and supporting
4 1.5 2.5
evidence, and submit to relevant
authorities, respond to
communications from government
authorities, and follow up regularly
to revoke product ban

PC10. prepare simple and complex

regulatory documents in
5 2 3
accordance with applicable fssai
regulations by collecting, collating

Page | 34
 Assessment Criteria

and evaluating scientific data that

has been well researched on
relevant aspects

PC11. review regulatory guidance and

requirements pertaining to
products produced in the
organisation and prepare 5 2 3
documents providing thoughtful
and accurate comments

PC12. prepare regulatory documents to

authorities that translate
regulatory requirements into
practical, workable plans with 5 2 3
timelines for development and
implementation

PC13. coordinate with food regulatory

authorities to review disputed
matters, negotiation and
finalization on products and 5 2 3
projects, and for comments and
formal approvals

PC14. prepare documents that include

check lists created and maintained
to implement regulatory 4 1.5 2.5
requirements, technical data, and
declarations of conformity

PC15. interface with consultants,

research organizations, partners,
co-manufacturers etc for
preparation, review, compilation,
4 1.5 2.5
finalization and submission of
documents for regulatory
approvals

PC16. prepare responses to

communications and other
requests from government food 5 2 3
regulatory authorities

PC17. develop and write clear arguments

and explanations for new product
5 2 3
license

Page | 35
 Assessment Criteria

PC18. prepare and present registration

documents to regulatory
authorities and notified bodies for 5 2 3
new product approvals

PC19. present written representation for

new products and carry out
negotiations with regulatory
authorities to obtain necessary 5 2 3
approvals for new product
production and marketing

PC20. evaluate, prepare and submit new

product registration applications
and follow through the application 4 1.5 2.5
during the evaluation phase to
achieve favorable outcome

PC21. prepare responses to letter/e-mail

communications and other
requests from government food 4 1.5 2.5
regulatory bodies on new product
approval

PC22. provide regulatory and product

compliance report in the area of
advertising and label claims for 4 1.5 2.5
new products

100 35 65

Page | 36