Give the salient features of : 2×10=20

(i) ISO 14001

(ii) OHSAS 18001

I'll provide information on the salient features of ISO 14001 and OHSAS 18001:
ISO 14001: Environmental Management Systems
 Focus: Reducing an organization's environmental impact and promoting sustainability.
 Framework: Provides a structured approach for establishing, implementing, and
maintaining an environmental management system (EMS).
 Key Elements:
o Environmental Policy: A public declaration of an organization's commitment to
environmental protection and continual improvement.
o Planning: Identifying environmental aspects, impacts, legal and other requirements,
setting objectives and targets.
o Implementation and Operation: Implementing controls, procedures, and resources to
achieve objectives.
o Checking and Corrective Action: Monitoring performance, conducting audits, and
taking corrective actions for nonconformities.
o Management Review: Regularly evaluating the EMS's effectiveness and making
necessary improvements.
 Benefits:
o Reduced environmental impact
o Improved resource efficiency (e.g., energy, water)
o Cost savings through waste reduction
o Enhanced compliance with environmental regulations
o Increased brand reputation and stakeholder trust

o OHSAS 18001: Occupational Health and Safety Assessment Series (Important

Note: OHSAS 18001 is no longer being updated and will be fully withdrawn in 2023.
Organizations are encouraged to transition to ISO 45001 for occupational health and
safety management.)
 Focus: Protecting employees' health and safety in the workplace.
 Framework: Provided a framework for establishing, implementing, and maintaining an
occupational health and safety management system (OHSMS).
 Key Elements: Similar to ISO 14001, with a focus on workplace hazards, risks,
controls, and continual improvement of OH&S performance.
 Benefits:
o Reduced workplace injuries and illnesses
o Improved employee safety culture
o Enhanced compliance with occupational health and safety regulations
o Lower insurance costs
o Increased employee morale and productivity
While OHSAS 18001 is no longer being updated, understanding its principles can be
helpful in transitioning to ISO 45001.

(a) Explain the important features of the clause-5–managing an audit program under
ISO 19011. 10
(b) What are the personal attributes required for the role as an auditor ? 5
(c) List the elements of audit report.

(a) Important Features of Clause 5 - Managing an Audit Program (ISO 19011)

ISO 19001 Clause 5 focuses on establishing and managing an effective audit program.
Here are its key features:
 Planning the Program:
o Defining objectives: Establishing clear and achievable goals for the audit program,
aligned with organizational needs.
o Risk evaluation: Identifying and assessing risks associated with the activities being
audited.
o Scope and extent: Determining the breadth and depth of the audit program based on
risk and objectives.
o Responsibilities: Assigning roles and responsibilities for program management, audit
execution, and reporting.
o Resources: Ensuring adequate resources (personnel, time, budget) are available for
successful audits.
 Implementing the Program:
o Audit procedures: Establishing documented procedures for conducting audits within
the program.
o Audit team selection: Choosing qualified and competent auditors to conduct the
audits.
o Audit methods: Determining appropriate methods (interviews, document reviews,
observations) for gathering evidence.
o Audit program records: Maintaining accurate documentation of the audit program and
individual audits.
 Monitoring and Improvement:
o Monitoring program effectiveness: Regularly evaluating the program's performance
against its objectives.
o Internal audit follow-up: Ensuring corrective actions are implemented for identified
nonconformities.
o Review and improvement: Periodically reviewing the audit program and making
necessary improvements to maintain its effectiveness.

(b) Personal Attributes Required for an Auditor

Effective auditors possess a combination of hard and soft skills:

 Technical Skills:
o Knowledge of relevant standards (e.g., ISO 19011, specific industry standards)
o Understanding of auditing principles and methodologies
o Ability to interpret regulations and compliance requirements
 Soft Skills:
o Integrity and Objectivity: Maintaining an unbiased and ethical approach during audits.
o Analytical and Problem-Solving Skills: Identifying and evaluating audit findings.
o Communication Skills: Effectively conveying audit results and recommendations in
written and verbal formats.
o Interpersonal Skills: Building rapport and trust with auditees, fostering open
communication.
o Time Management Skills: Meeting deadlines and efficiently managing audit timelines.

(c) Elements of an Audit Report

A well-structured audit report typically includes the following elements:

 Title: Clearly identifies the audit program, audit activity, and date.
 Introduction: Provides context about the audit objectives and scope.
 Audit Methodology: Describes the methods used to conduct the audit (e.g., interviews,
document reviews).
 Findings: Presents the results of the audit, including any identified nonconformities.
 Conclusions: Summarizes the overall assessment of the audited activity or system.
 Recommendations: Provides suggestions for corrective actions or improvements.
 Appendix: May include supporting documentation such as interview notes or data
tables.

(a) Elaborate ‘quality management’ principles given in ISO : 9000. 8

(b) Explain fundamentals of quality management systems as given in ISO : 9000.

(a) Quality Management Principles in ISO 9000

ISO 9000 outlines eight core quality management principles that organizations can
adopt to achieve excellence:

1. Customer Focus: Organizations depend on their customers, so understanding current

and future customer needs is crucial. Strive to meet customer requirements and exceed
expectations through continuous improvement.
2. Leadership: Leaders establish unity of purpose and direction, creating an environment
where people are engaged in achieving organizational objectives. Leaders set clear
goals, empower employees, and foster a culture of quality.
3. Engagement of People: People at all levels are the essence of an organization, and
their full involvement enables their abilities to be used for the organization's benefit.
Motivate and empower employees to contribute their skills and knowledge.
4. Process Approach: Effective results are achieved more efficiently when activities are
managed as interconnected processes. Identify, define, manage, and improve these
processes for consistent quality output.
5. Improvement: There is always room for improvement. Organizations should
continuously seek opportunities to improve their performance in all areas, including
quality, efficiency, and effectiveness.
6. Evidence-Based Decision Making: Effective decisions are based on the analysis of
data and information. Collect and analyze relevant data to support informed decisions
about quality and improvement initiatives.
7. Relationship Management: The success of an organization depends on the
relationships it maintains with key stakeholders, including suppliers, partners, and
communities. Foster mutually beneficial relationships that contribute to overall quality.
8. Relationship Management: (Yes, it's listed twice in ISO 9000! Some interpretations
combine these into "Relationship Management with External Providers" emphasizing
collaboration with suppliers and partners.)

(b) Fundamentals of Quality Management Systems in ISO 9000

ISO 9000 doesn't prescribe a specific quality management system (QMS) but provides
a framework for establishing one. Here are the fundamental elements:

 Customer Focus: Integrate customer requirements throughout the QMS, from

understanding needs to designing products/services and measuring satisfaction.
 Process Management: Identify, document, and manage key processes that impact
quality. This includes defining process inputs, outputs, controls, and performance
measures.
 Continual Improvement: Establish a culture of continuous improvement where
processes and the QMS itself are regularly evaluated and enhanced.
 Commitment of Management: Top management must demonstrate leadership and
commitment to the QMS by providing resources, setting quality objectives, and
promoting quality awareness.
 Documentation: Develop and maintain documented procedures, policies, and work
instructions to ensure consistent implementation of the QMS.
 Control of Records: Maintain accurate and up-to-date records to demonstrate
conformity with the QMS and provide evidence of quality performance.
 Internal Audit: Conduct periodic internal audits to assess the effectiveness of the QMS
and identify areas for improvement.
 Nonconformity and Corrective Action: Establish a system for identifying,
documenting, and correcting nonconformities (issues where processes or products don't
meet requirements).

(a) Explain the clause resource management and clause product realization of ISO : 9001.
10
(b) List any five mandatory records to be maintained as per 9001 : 2000. 5
(c) List out five SOPs which are generally maintained as per ISO 9001.

(a) ISO 9001 Clauses: Resource Management and Product Realization

Clause 7.1: Resource Management

This clause focuses on ensuring the organization has the necessary resources to
achieve conforming products and services. It covers:
 Human Resources: Competence, training, and awareness of personnel.
 Infrastructure: Buildings, workspace, and supporting services.
 Work Environment: Conditions that affect product quality and employee well-being.
 Monitoring and Measuring Resources: Equipment needed for product realization and
monitoring.
 Organizational Knowledge: Capturing and applying knowledge for continuous
improvement.
Clause 8.5: Product Realization
This clause deals with all activities involved in creating products or delivering services. It
emphasizes:
 Planning of Product Realization: Defining the processes, resources, and controls
needed for product/service provision.
 Customer Related Processes: Communication with customers to understand and
manage requirements.
 Design and Development: Processes for designing and developing products that meet
customer requirements.
 Control of Production and Service Provision: Implementing controls to ensure
products and services conform to specifications.
 Validation of Processes for Production and Service Provision: Verifying that
processes can produce conforming outputs.
 Identification and Traceability: Tracking products and materials through the
production process.
 Customer Property: Protecting and safeguarding customer-owned property entrusted
to the organization.
 Preservation of Product: Handling and storing products to maintain their quality and
prevent damage.
 Control of Monitoring and Measuring Devices: Calibrating and maintaining
measuring equipment for accurate results.
 Control of Changes: Managing changes to products, processes, or documentation to
ensure continued effectiveness.

(b) Mandatory Records in ISO 9001:2000 (Note: ISO 9001 has been revised since
2000)
 While ISO 9001:2000 is no longer the current version, here are some examples of
mandatory records it required:
1. Control of documents: Records of document approval, revision, and distribution.
2. Control of records: Records of record creation, approval, storage, and disposition.
3. Internal audit: Records of internal audit planning, conducting, reporting, and corrective
actions.
4. Customer complaints: Records of customer complaints, investigations, and
resolutions.
5. Customer satisfaction: Records of customer satisfaction surveys and feedback.
Important Note: The specific mandatory records may differ in the current version of
ISO 9001 (2015). It's recommended to consult the latest standard for accurate
information.

(c) Common Standard Operating Procedures (SOPs) in ISO 9001

While ISO 9001 doesn't mandate specific SOPs, organizations typically develop them to
ensure consistent implementation of the QMS. Here are some common examples:
1. Document Control SOP: Defines procedures for creating, approving, revising, and
distributing documents.
2. Control of Records SOP: Outlines the process for creating, maintaining, storing, and
disposing of records.
3. Nonconformance and Corrective Action SOP: Establishes procedures for identifying,
documenting, investigating, and addressing nonconformities.
4. Internal Audit SOP: Defines the process for planning, conducting, reporting, and
following up on internal audits.
5. Calibration and Maintenance SOP: Describes the procedures for calibrating and
maintaining measuring and monitoring equipment.
These are just a few examples, and the specific SOPs needed will vary depending on
the organization's size, industry, and complexity.

(a) Explain the key features of ISO 22000. 10

 (b) Explain the clause “Food Safety Management System” and “Validation, Verification and
Improvement” as per ISO : 22000.

(a) Key Features of ISO 22000: Food Safety Management Systems

ISO 22000 outlines a framework for establishing, implementing, and maintaining a Food
Safety Management System (FSMS) across the entire food supply chain. Its key
features include:
 Process Approach: Emphasizes managing food safety through interconnected
processes, ensuring consistent safe food production.
 Risk-Based Thinking: Organizations identify, assess, and control potential food safety
hazards throughout the food chain.
 Interactive Communication: Promotes open communication within the organization
and with external stakeholders (suppliers, customers, regulators) for better risk
management.
 HACCP Principles Integration: Incorporates the Hazard Analysis and Critical Control
Points (HACCP) methodology for identifying and controlling critical food safety hazards.
 Continual Improvement: The FSMS is constantly evaluated and improved based on
monitoring data, corrective actions, and new knowledge.
 Alignment with ISO 9001: Shares core principles with ISO 9001 (quality management),
allowing for easier integration of both systems.
These features, when implemented effectively, contribute to:
 Enhanced food safety: Reduced risk of foodborne illnesses and improved consumer
confidence.
 Compliance with regulations: Demonstrates adherence to relevant food safety
regulations.
 Improved efficiency and cost savings: Minimizes food spoilage and waste.
 Stronger brand reputation: Demonstrates commitment to food safety and quality.

(b) Clauses in ISO 22000:

1. Food Safety Management System (Clause 4):

 This clause defines the requirements for establishing, implementing, maintaining, and
continually improving a Food Safety Management System (FSMS). It covers:
 Scope of the FSMS: Defining the organization's activities within the food chain and the
products/services included.
 Food Safety Policy: A documented declaration of the organization's commitment to
food safety.
 FSMS Planning: Identifying hazards, establishing food safety objectives, and outlining
processes for achieving them.
 Operational Control: Implementing controls like prerequisite programs (PRPs) and
HACCP principles to ensure food safety throughout production.
 Monitoring and Measurement: Monitoring critical control points, verifying system
effectiveness, and performing internal audits.
 Nonconformity, Corrective Action, and Preventive Action: Addressing any
deviations from food safety requirements and taking steps to prevent recurrence.
 Continual Improvement: Regularly reviewing the FSMS for effectiveness and making
necessary improvements.
2. Validation, Verification and Improvement (Clause 8):
This clause focuses on ensuring the effectiveness of the FSMS and its ability to
consistently deliver safe food. It addresses:
 Validation: Demonstrating that the chosen controls (e.g., HACCP plan) are capable of
achieving the intended food safety objectives.
 Verification: Evaluating if the FSMS is implemented effectively and meets planned
arrangements. This includes internal audits and independent external audits.
 Improvement: Continually reviewing and enhancing the FSMS based on monitoring
results, audits, customer feedback, and new knowledge.
By implementing these clauses effectively, organizations can ensure their FSMS is
robust and contributes to consistently safe food production.

(a) List ten constituents of the food chain to which ISO 22000 is applicable. 5
(b) Give the main five clauses of ISO 17025.
 (c) Write down the suggested contents of quality manual under ISO 17025.
(d) List the quality parameters for agricultural products (raw and processed).

(a) Constituents of the Food Chain under ISO 22000 (5)

ISO 22000 applies to a wide range of organizations within the food chain. Here are ten
examples:
1. Primary Producers: Farmers, growers, ranchers raising animals for food production.
2. Food Processing: Companies that process raw ingredients into finished food products.
3. Manufacturers of Food Contact Materials: Producers of packaging materials and
equipment that come into contact with food.
4. Food Wholesalers and Distributors: Organizations that distribute food products to
retailers and businesses.
5. Retailers: Stores and supermarkets that sell food products directly to consumers.
6. Food Service Providers: Restaurants, cafes, and other businesses that prepare and
serve food to customers.
7. Catering Companies: Organizations that provide food services for events or
gatherings.
8. Transportation and Storage: Companies that transport or store food products
throughout the supply chain.
9. Cleaning and Sanitation Services: Organizations that clean and sanitize food
production facilities and equipment.
10. Testing Laboratories: Labs that analyze food samples for safety and quality.

(b) Main Clauses of ISO 17025 (5)

ISO 17025 focuses on the competence of testing and calibration laboratories. Here are
five key clauses:
1. Management Requirements: Defines organizational structure, quality policy,
impartiality, and confidentiality.
2. Technical Requirements: Covers testing and calibration methods, equipment, and
personnel competence.
3. Quality Management System: Outlines requirements for a documented quality
management system.
4. Technical Records: Specifies recordkeeping procedures for test/calibration data,
equipment calibration, and customer complaints.
5. Audits: Defines requirements for internal audits and management reviews to maintain
system effectiveness.

(c) Suggested Contents of Quality Manual under ISO 17025

A quality manual for ISO 17025 should document the laboratory's quality management
system. Here are some suggested contents:
 Quality Policy: Statement of the laboratory's commitment to quality and customer
satisfaction.
 Management Structure: Organization chart outlining roles and responsibilities for
quality management.
 Technical Procedures: Documented procedures for conducting tests and calibrations.
 Equipment Management: Procedures for equipment selection, calibration, and
maintenance.
 Personnel Qualifications: Requirements for education, training, and competence of
laboratory personnel.
 Uncertainty Measurement: Procedures for estimating uncertainty in test and
calibration results.
 Control of Records: Procedures for managing test/calibration records, customer
complaints, and nonconformities.
 Internal Audits: Procedures for planning, conducting, and reporting on internal audits.
 Management Review: Procedures for reviewing the quality management system and
making improvements.
 (d) Quality Parameters for Agricultural Products (Raw and Processed)

The specific quality parameters for agricultural products can vary depending on the
product itself. However, here are some general categories:
Raw Agricultural Products:
 Safety: Absence of harmful contaminants (e.g., pesticides, heavy metals).
 Freshness: Visual appearance, firmness, absence of spoilage.
 Maturity: Ripeness, sugar content, color.
 Size and Shape: Consistency with market standards.
 Nutritional Value: Vitamin, mineral, and protein content.
Processed Agricultural Products:
 Safety: Compliance with food safety regulations and absence of pathogens.
 Sensory Characteristics: Taste, aroma, texture, color.
 Nutritional Composition: Vitamin, mineral, and protein content after processing.
 Chemical Composition: Moisture content, fat content, acidity.
 Shelf Life: Expected spoilage time under storage conditions.
 Packaging Integrity: Container strength, seal quality, and proper labeling.
Remember, these are just general examples. Specific quality parameters will be
determined by regulatory requirements, industry standards, and customer expectations.

Write short notes on any four of the following :

5×4=20
(a) Micro-organisms that may contaminate water, food of animal origin and fruits
and vegetables.
(b) Quality control measures available to a chemical laboratory for monitoring of
analytical performance.
(c) BRC global standard.
(d) SQF 1000.
(e) Mandatory procedures under ISO 22000.
(a) Micro-organisms in Food and Water Contamination

 Water:
o Bacteria (e.g., E. coli, Salmonella) causing gastrointestinal illnesses.
o Protozoa (e.g., Giardia) causing diarrhea.
o Viruses (e.g., Hepatitis A) affecting liver function.
 Food of Animal Origin (Meat, Poultry, Seafood):
o Bacteria (e.g., E. coli, Salmonella, Listeria) causing foodborne illnesses.
o Parasites (e.g., Trichinella) affecting muscle tissue.
o Viruses (e.g., Avian Influenza) impacting respiratory and other systems.
 Fruits and Vegetables:
o Bacteria (e.g., E. coli) causing foodborne illness.
o Molds (e.g., Aspergillus) producing toxins and spoilage.
o Viruses (e.g., Hepatitis A) transmitted through contaminated water used for irrigation.
Note: This is not an exhaustive list, and specific risks can vary depending on the source
and processing of food and water.

(b) Quality Control Measures in Chemical Laboratories

 Blanks: Analyzing samples with no analyte present to detect potential contamination

from reagents or glassware.
 Spiked Samples: Adding a known amount of analyte to a sample to assess analytical
accuracy.
 Standards: Using reference materials with known concentrations to calibrate
instruments and verify measurement accuracy.
 Duplicates: Repeating analyses on the same sample to assess precision and
consistency of results.
 Method Validation: Demonstrating that an analytical method is reliable and suitable for
the intended purpose.
 Participation in Proficiency Testing: Comparing laboratory performance with other
labs by analyzing the same samples.
 Control Charts: Monitoring trends in analytical data to identify potential biases or drifts
in measurements.
 Regular Calibration and Maintenance of Equipment: Ensuring instruments are
functioning correctly and producing reliable results.
 (c) BRC Global Standard for Food Safety

The BRC Global Standard (British Retail Consortium) is a leading food safety
certification program for retailers, manufacturers, and food service organizations. It
focuses on:
 Hazard Analysis and Critical Control Points (HACCP): Implementing HACCP
principles to identify and control critical food safety hazards.
 Quality Management System: Establishing a documented system for managing food
safety throughout the supply chain.
 Site Standards: Meeting specific requirements for premises, hygiene, and pest control.
 Product Safety and Quality: Implementing controls to ensure product quality and
prevent contamination.
 Traceability: Maintaining records to track products through the supply chain for efficient
recalls if needed.
BRC certification demonstrates a company's commitment to food safety and helps gain
access to global markets.

(d) SQF 1000 Food Safety Code

The SQF (Safe Quality Food) Program is a comprehensive food safety and quality
management system recognized by retailers and food service providers worldwide. It
incorporates elements of:
 Good Manufacturing Practices (GMPs): Implementing hygienic practices and proper
food handling procedures.
 HACCP principles: Identifying and controlling critical food safety hazards.
 Food Safety Culture: Promoting a culture of food safety awareness and responsibility
throughout the organization.
 Supplier Management: Ensuring suppliers meet food safety and quality standards.
 Continual Improvement: Regularly reviewing and enhancing the food safety
management system.
 SQF certification demonstrates a company's commitment to food safety and quality
across all food industry sectors.

(e) Mandatory Procedures under ISO 22000

ISO 22000 outlines several mandatory procedures for establishing and maintaining a
Food Safety Management System (FSMS). Here are some key ones:
 Documented Food Safety Policy: A clear statement of the organization's commitment
to food safety.
 Scope Definition: Identifying the organization's role in the food chain and the
products/services covered by the FSMS.
 Hazard Analysis: Identifying potential food safety hazards associated with raw
materials, processes, and finished products.
 HACCP Plan Development: Establishing a plan to control critical food safety hazards
identified through the hazard analysis.
 Prerequisite Programs (PRPs): Implementing basic hygiene and sanitation programs
to support HACCP.
 Monitoring and Measurement: Regularly monitoring critical control points (CCPs) in
the HACCP plan and verifying system effectiveness.
 Nonconformity, Corrective Action, and Preventive Action (CAPA): Addressing any
deviations from food safety requirements and taking steps to prevent recurrence.
 Internal Audits: Regularly evaluating the FSMS for effectiveness and identifying areas
for improvement.
 Management Review: Periodically reviewing the overall performance of the FSMS and
making necessary changes.

Write short notes on any four of the following :

4×5=20
(a) QCI
(b) Customer focus
 (c) Resource Management
(d) Mandatory Procedures for ISO-22000
(e) Types of Formats and Records

(a) QCI (Quality Council of India)

The Quality Council of India (QCI) is a national body established by the Government of
India to promote and facilitate quality in all spheres of economic activity. Its functions
include:
 Accreditation: Granting accreditation to certification bodies, laboratories, and inspection
agencies.
 Recognition: Recognizing conformity assessment schemes and training bodies.
 Standards Development: Facilitating the development of national and international standards.
 Promotion of Quality: Raising awareness about the importance of quality in various sectors.
 Training and Development: Providing training programs on quality management systems and
related topics.
QCI plays a vital role in enhancing the quality of Indian products and services,
promoting international competitiveness, and protecting consumer interests.

(b) Customer Focus

Customer focus is a core principle of quality management that emphasizes

understanding and meeting customer requirements to achieve their satisfaction. Here's
a breakdown:
 Understanding Customer Needs: Organizations actively seek to understand current and
future customer needs through surveys, feedback mechanisms, and market research.
 Meeting Customer Requirements: Products and services are designed and delivered to meet
or exceed customer expectations for quality, functionality, and value.
 Exceeding Expectations: Organizations strive to go beyond basic requirements by providing
exceptional customer experiences.
 Continuous Improvement: Customer feedback is used to continuously improve products,
services, and processes to enhance customer satisfaction.
By focusing on customers, organizations can build stronger relationships, achieve
loyalty, and gain a competitive edge.

(c) Resource Management

Resource management is a crucial aspect of quality management, ensuring the

organization has the necessary resources to achieve its goals effectively. Key aspects
include:
 Human Resources: Competent and qualified personnel are recruited, trained, and motivated to
perform their tasks effectively.
 Infrastructure: Suitable buildings, workspace, and supporting facilities are available to enable
quality operations.
 Work Environment: A safe, healthy, and positive work environment is created to promote
employee well-being and productivity.
 Monitoring and Measuring Resources: Equipment and tools needed for production and
quality control are properly maintained and calibrated.
 Organizational Knowledge: Knowledge and expertise within the organization are captured,
shared, and applied for continuous improvement.
Effective resource management ensures efficient utilization of resources, reduces
waste, and contributes to achieving quality objectives.

(d) Mandatory Procedures for ISO 22000

ISO 22000 outlines several mandatory procedures for establishing and maintaining a
Food Safety Management System (FSMS). Here are some key ones:
 Documented Food Safety Policy: A clear statement of the organization's commitment to food
safety.
 Scope Definition: Identifying the organization's role in the food chain and the products/services
covered by the FSMS.
 Hazard Analysis: Identifying potential food safety hazards associated with raw materials,
processes, and finished products.
 HACCP Plan Development (if applicable): Establishing a plan to control critical food safety
hazards identified through the hazard analysis. HACCP may not be mandatory for all situations
under ISO 22000.
 Prerequisite Programs (PRPs): Implementing basic hygiene and sanitation programs to
support HACCP.
 Monitoring and Measurement: Regularly monitoring critical control points (CCPs) in the
HACCP plan and verifying system effectiveness.
 Nonconformity, Corrective Action, and Preventive Action (CAPA): Addressing any
deviations from food safety requirements and taking steps to prevent recurrence.
 Internal Audits: Regularly evaluating the FSMS for effectiveness and identifying areas for
improvement.
 Management Review: Periodically reviewing the overall performance of the FSMS and making
necessary changes.

(e) Types of Formats and Records

In quality management systems, various formats and records are used to document
processes, maintain traceability, and demonstrate system effectiveness. Here are some
common types:
 Procedures: Detailed instructions outlining how specific tasks or processes are to be
performed.
 Work Instructions: Step-by-step instructions for specific activities within a process.
 Forms: Standardized formats for collecting data, recording observations, or completing tasks.
 Specifications: Defined requirements for products, materials, or processes.
 Calibration Records: Documentation of equipment calibration dates, methods used, and
calibration results.
 Training Records: Records of employee training programs completed, topics covered, and
attendance.
 Internal Audit Reports: Documentation of internal audit findings, corrective actions taken, and
follow-up activities.
 Customer Complaints: Records of customer complaints received, investigations conducted,
and resolution actions.
 Meeting Minutes: Documentation of key decisions, action items, and responsible parties from
meetings related to quality management.
The specific formats and records used will vary

2. Differentiate between the following : 5×4=20

(i) SQF 1000 and SQF 2000
(ii) India GAP and Global GAP
(iii) Error and Uncertainty
(iv) Critical limit and Control measures
(v) Internal audit and third party audit

Differentiating Key Concepts:

(i) SQF 1000 vs. SQF 2000

Feature SQF 1000 SQF 2000

Target Primary producers (farms, Food manufacturing, distribution, and

Audience growers) storage

Food Safety Fundamentals Comprehensive Food Safety & Quality

Focus
(HACCP principles) Management

Complexity Less complex, entry-level More complex, comprehensive

Focuses on Good Agricultural Includes HACCP plan development,

Requirements Practices (GAPs), basic prerequisite programs (PRPs), and
hygiene, and traceability stricter quality management

Demonstrates commitment to Enhances food safety, improves quality

Benefits basic food safety, facilitates consistency, strengthens brand
market access reputation

(ii) India GAP vs. Global GAP

 Feature India GAP Global GAP

National standard developed by

Origin Internationally recognized standard
India

Applicability Primarily used in India Widely accepted globally

Rigor Less stringent than Global GAP More comprehensive and demanding

Addresses specific Indian

Caters to a broader range of agricultural
Focus agricultural practices and
products and international markets
regulations

Improved farm management, Enhanced market access, consumer

Benefits compliance with Indian confidence, and international
regulations recognition

(iii) Error vs. Uncertainty

Feature Error Uncertainty

The difference between a measured The doubt that exists about a

Definition
value and the true value measured value

Mistakes, biases in measurement Inherent variability, limitations of

Cause
methods, instrument malfunction measurement techniques

Represented as a range or
Expression Usually expressed as a single value
probability distribution

Provides a confidence interval for

Impact Can lead to incorrect conclusions
the true value

(iv) Critical Limit vs. Control Measure

Feature Critical Limit Control Measure

A specific boundary
Any action taken to prevent, eliminate, or
Definition separating safe and unsafe
reduce a food safety hazard
food
 Defines the acceptable range Encompasses all actions to control a hazard,
Focus for a critical control point including monitoring, corrective actions, and
(CCP) record keeping

Minimum internal
Maintaining proper cooking time and
Example temperature for cooked
temperature, monitoring internal temperature
chicken (165°F)

Ensures the effectiveness of Prevents hazards from exceeding acceptable

Importance
the HACCP plan levels

(v) Internal Audit vs. Third-Party Audit

Feature Internal Audit Third-Party Audit

Conducted
Organization's own employees Independent certification body
by

Evaluate the effectiveness of the Verify compliance with external

Purpose
organization's management system standards (e.g., ISO 22000)

Frequency Scheduled at regular intervals Typically conducted annually

Leads to certification (if

Improves internal systems, identifies
Outcome successful) or corrective action
areas for improvement
plans

Objective and impartial

Preventive, identifies potential
Focus assessment against defined
problems
criteria
(i) Enlist the compulsory documents for implementation of ISO-9000. 12
(i) What is meant by a product in context of FSMS ? How is a food product
characterized ?

(i) Compulsory Documents for ISO 9001:

While ISO 9001 doesn't mandate specific documents, it requires a documented Quality
Management System (QMS). Here are the four core mandatory documented elements:
1. Scope of the Quality Management System: Defines the organization's activities, products,
and services covered by the QMS.
2. Quality Policy: A documented statement outlining the organization's commitment to quality and
customer satisfaction.
3. Quality Objectives: Measurable objectives set at departmental or process levels to achieve the
quality policy.
4. Criteria for Selection and Evaluation of Suppliers: Documented procedures for selecting and
evaluating suppliers to ensure they meet quality requirements.
Important Note: The current version of ISO 9001 is 2015. For historical reference, ISO
9000:2000 did have specific mandatory records, but these are not applicable to the
current standard.

(i) Product in FSMS and Food Product Characterization:

(a) Product in FSMS:

In a Food Safety Management System (FSMS) based on ISO 22000, a "product" refers
to anything intended for human consumption that the organization handles throughout
the food chain. This can include:
 Raw Materials: Unprocessed agricultural products (fruits, vegetables, meat, grains), ingredients
used in processing.
 In-Process Products: Partially processed or intermediate products during food production.
 Finished Products: Ready-to-eat or ready-to-cook food products intended for consumers.
 Food Contact Materials: Packaging materials and equipment that come into direct contact with
food.
(b) Food Product Characterization:
Food products can be characterized based on various factors that influence their safety
and quality. Here are some key aspects:
 Biological: Presence of microorganisms, allergens, and potential for spoilage.
 Chemical: Composition (fats, carbohydrates, proteins), presence of contaminants (pesticides,
heavy metals), and additives.
 Physical: Size, shape, texture, color, and any physical hazards (foreign objects).
 Sensory: Appearance, taste, aroma, and texture as perceived by consumers.
 Shelf Life: The expected period during which the product remains safe and maintains
acceptable quality under specified storage conditions.
Understanding these characteristics helps identify potential food safety hazards and
implement appropriate controls throughout the food chain.

(i) Discuss the importance and types of proficiency testing for laboratories. 12
(ii) How important is the role of top management for implementation of QMS in any
industry ?

(i) Importance and Types of Proficiency Testing for Laboratories

Importance of Proficiency Testing:

Proficiency testing (PT) plays a crucial role in ensuring the accuracy and reliability of
laboratory results. Here's why it's important:
 Independent Verification: PT provides an independent assessment of a laboratory's
performance compared to other labs using the same methods.
 Early Warning of Problems: Participation in PT can reveal potential issues with laboratory
methods, equipment, or analyst competence before they impact client results.
 Improved Quality Control: PT helps identify areas for improvement in laboratory procedures
and data analysis.
 Enhanced Customer Confidence: Demonstrates a laboratory's commitment to quality and
reinforces the validity of its results for clients.
 Meeting Regulatory Requirements: Many accreditation bodies and regulatory agencies
require participation in PT programs for certain tests or measurements.
Types of Proficiency Testing:
There are two main types of PT programs:
1. Interlaboratory Comparisons (ILCs): Laboratories analyze the same test samples and
compare their results with each other. This helps identify systematic biases or inconsistencies
within a laboratory or across participating labs.
2. Performance Assessment Proficiency Testing (PTAs): Laboratories receive samples with
known or certified values and analyze them using their usual methods. The organizer then
evaluates the performance of each lab against these known values.
 Beyond these main types, PT programs can be designed to target specific tests,
matrices (e.g., food, water), or analytical techniques.

(ii) Importance of Top Management for QMS Implementation

Top management plays a critical role in the successful implementation and ongoing
effectiveness of a Quality Management System (QMS) within an organization,
regardless of the industry. Here's why:
 Leadership and Commitment: Top management sets the tone for the organization's
commitment to quality. Their active involvement and support are essential for driving continuous
improvement through the QMS.
 Resource Allocation: Top management is responsible for allocating necessary resources
(financial, human) to develop, implement, and maintain the QMS effectively.
 Strategic Alignment: The QMS should be aligned with the organization's overall strategy and
objectives. Top management ensures the QMS supports organizational goals and enhances
competitiveness.
 Communication and Awareness: Top management communicates the importance of the
QMS to all employees and fosters a culture of quality within the organization.
 Management Review: Regular reviews of the QMS by top management are crucial for
identifying areas for improvement and ensuring the system remains effective.

(i) Give the benefits of adopting ISO-22000. 5

(ii) What additional features does ISO-22000 bring over HACCP ? 5
(iii) Give an overview of audit activities.

(i) Benefits of Adopting ISO 22000:

 Enhanced Food Safety: Implementing a robust FSMS based on ISO 22000 minimizes the risk
of foodborne illnesses and product recalls.
 Improved Regulatory Compliance: Demonstrates adherence to food safety regulations and
facilitates market access for exports.
 Increased Customer Confidence: Certification under ISO 22000 signifies commitment to food
safety and builds trust with customers.
 Streamlined Supply Chain: Establishes clear communication and control measures throughout
the food chain, improving overall efficiency.
 Cost Savings: Reduced waste due to spoilage and recalls, leading to improved cost control
and profitability.

(ii) Additional Features of ISO 22000 over HACCP:

 Process Approach: Focuses on managing food safety through interconnected processes,

ensuring consistent safe food production.
 Risk-Based Thinking: Organizations identify, assess, and control potential food safety hazards
throughout the entire food chain, not just at critical control points (CCPs).
 Continual Improvement: The FSMS is constantly evaluated and improved based on
monitoring data, corrective actions, and new knowledge.
 Alignment with ISO 9001: Shares core principles with ISO 9001 (quality management),
allowing for easier integration of both systems.
 Communication Emphasis: Promotes open communication within the organization and with
external stakeholders (suppliers, customers, regulators) for better risk management.
While HACCP remains a core element within ISO 22000, the standard provides a
broader framework for managing food safety across the entire food chain.

(iii) Overview of Audit Activities:

Audits are systematic evaluations of a system or process to ensure it meets defined

criteria. Here's an overview of different types of audits relevant to quality management:
 Internal Audit: Conducted by the organization's own employees to evaluate the effectiveness
of its QMS or FSMS in meeting its stated objectives.
 First-Party Audit: An audit conducted by the organization itself, but utilizing external auditors
who may not be accredited.
 Second-Party Audit: An audit conducted by an organization in its supply chain to assess their
supplier's QMS or FSMS.
 Third-Party Audit: An independent audit conducted by an accredited certification body to
determine if the organization's QMS or FSMS meets the requirements of a specific standard
(e.g., ISO 22000).
 Certification Audit: A specific type of third-party audit conducted to assess an organization's
readiness for certification against a specific standard.
The specific audit activities will vary depending on the type of audit, but generally
involve:
 Document Review: Reviewing documented procedures, policies, and records related to the
QMS or FSMS.
 Interviews: Interviewing personnel at various levels to understand their roles and
responsibilities within the system.
 Observation of Activities: Observing actual practices on the production floor or within relevant
departments to assess compliance with procedures.
 Nonconformity Identification: Identifying any deviations from the documented system or the
relevant standard.
 Reporting: Compiling a report summarizing the findings, including any nonconformities and
recommendations for improvement.

(i) Describe the important features of the IFS.

12
(ii) What considerations are kept while handling non-conforming or potentially unsafe
food products under FSMS ?

(i) Important Features of the IFS Food Standard:

The IFS (International Featured Standards) Food Standard is a globally recognized food
safety and quality certification program specifically designed for food manufacturers.
Here are some of its key features:
 Focus on Food Safety and Quality: Combines elements of Hazard Analysis and Critical
Control Points (HACCP) with Good Manufacturing Practices (GMPs) and additional quality
management principles.
 Process Approach: Emphasizes managing food safety and quality throughout the entire food
production process, from receiving raw materials to finished product distribution.
 Risk-Based Thinking: Encourages identifying and mitigating potential food safety hazards at
all stages of the food chain.
 Continual Improvement: Promotes ongoing evaluation and improvement of the food safety
and quality management system.
 Customer Focus: Addresses customer requirements and expectations for product quality,
safety, and consistency.
 Supplier Management: Provides a framework for evaluating and managing risks associated
with suppliers.
 Traceability: Requires robust traceability systems to track food products through the supply
chain.
 Audits and Certification: Certification is granted after successful completion of an audit by an
accredited IFS certification body.
Benefits of IFS Certification:
 Enhanced Food Safety: Reduces the risk of foodborne illnesses and product recalls.
 Improved Quality Management: Leads to more consistent product quality and reduces waste.
 Increased Customer Confidence: Demonstrates commitment to food safety and quality,
strengthening customer relationships.
 Global Market Access: Facilitates access to new markets that recognize IFS certification.
 Supply Chain Efficiency: Promotes better communication and collaboration throughout the
food chain.

(ii) Handling Non-Conforming or Potentially Unsafe Food Products under FSMS

A Food Safety Management System (FSMS) based on ISO 22000 outlines clear
procedures for handling non-conforming or potentially unsafe food products. Here are
some key considerations:
1. Identification and Segregation:
 Implement procedures to identify non-conforming or potentially unsafe products through
monitoring, inspections, customer complaints, or testing.
 Segregate these products from conforming products to prevent further contamination or
distribution.
2. Evaluation and Risk Assessment:
 Evaluate the severity of the non-conformance and the potential food safety risk associated with
the product.
 Conduct a risk assessment to determine the likelihood of harm if the product is consumed.
3. Corrective Actions:
 Based on the evaluation and risk assessment, take appropriate corrective actions:
o Rework: If the product can be made safe through reprocessing or rectification.
o Release: If the product meets safety requirements after corrective actions and risk assessment
confirms safety.
o Restriction: If the product is safe for specific uses with clear labeling and controls.
o Recall: If the product poses a serious health risk and needs to be retrieved from the market.
4. Documentation and Traceability:
 Document all actions taken, including the identification of the non-conforming product, the
corrective action chosen, and the rationale behind the decision.
 Maintain traceability records to track the movement of the non-conforming product throughout
the supply chain.
5. Communication:
 Communicate the issue and corrective actions to relevant personnel within the organization,
including production, quality control, and management.
 If a recall is necessary, communicate effectively with customers and regulatory authorities.
6. Preventive Actions:
 Analyze the root cause of the non-conformance to identify potential weaknesses in the FSMS.
 Implement preventive actions to prevent similar incidents from occurring in the future.

(i) Write about the structure of Standard India GAP. 12 [ 3 ]

(ii) What are the benefits of accreditation for a testing laboratory ?

(i) Structure of Standard India GAP (India GAP)

 Standard India GAP (India GAP) is a national certification scheme developed by the
Quality Council of India (QCI) to promote Good Agricultural Practices (GAP) among
Indian farms. It is designed to address the needs of both domestic and international
markets. Here's a breakdown of its structure:
1. Tiers of Certification:
 India GAP Basic: Aimed at small and marginal farmers. It focuses on basic hygiene practices,
pre-harvest and post-harvest handling, and basic record-keeping.
 India GAP Premium: For larger farms and group farming operations. It builds upon India GAP
Basic and includes stricter requirements for traceability, integrated pest management (IPM), and
environmental management.
2. Modules Covered:
India GAP certification covers various modules encompassing different aspects of farm
management:
 Farm Management: Land use planning, soil health management, water management, waste
management.
 Crop Production Practices: Selection of planting materials, fertilizer and pesticide
management, weed control, harvesting practices.
 Post-Harvest Handling and Storage: Proper handling techniques to minimize spoilage and
maintain quality.
 Worker Health, Safety, and Welfare: Ensuring safe working conditions for farm workers and
addressing social responsibility aspects.
 Traceability and Record Keeping: Maintaining records to track product movement throughout
the supply chain.
3. Compliance with Regulations:
India GAP considers relevant Indian regulations on food safety, pesticide use, and
environmental protection. It ensures farms comply with these regulations to promote
safe and sustainable agricultural practices.
4. Certification Process:
 Farms undergo a gap analysis to identify areas where current practices may not meet India
GAP standards.
 They implement corrective actions to address identified gaps.
 An accredited certification body conducts an audit to assess compliance with India GAP
requirements.
 Upon successful completion of the audit, the farm receives India GAP certification.
Benefits of India GAP Certification:
 Improved farm management practices
 Enhanced product quality and safety
 Increased market access, both domestic and international
 Potential for premium prices for GAP-certified produce
 Improved brand reputation for farmers

(ii) Benefits of Accreditation for a Testing Laboratory

Accreditation by a recognized national accreditation body offers several benefits for a

testing laboratory:
 Enhanced Credibility and Reputation: Accreditation signifies a laboratory's competence and
adherence to international standards for testing and calibration. This builds trust with clients and
stakeholders.
 Improved Technical Competence: The accreditation process involves a rigorous evaluation of
the laboratory's technical capabilities, personnel qualifications, and quality management system.
This promotes continuous improvement in laboratory practices.
 Wider Market Access: Accreditation to internationally recognized standards allows laboratories
to participate in global testing programs and service clients worldwide.
 Increased Client Confidence: Clients are assured that test results produced by an accredited
laboratory are reliable and accurate, leading to better decision-making.
 Meeting Regulatory Requirements: Many regulations and industry standards require testing
to be performed by accredited laboratories. Accreditation ensures compliance with these
requirements.
 Competitive Advantage: Accreditation can be a differentiating factor in a competitive testing
market, attracting clients who value high-quality testing services.
Overall, accreditation demonstrates a laboratory's commitment to providing reliable and
accurate testing services, fostering trust, and enhancing its overall competitiveness in
the market.

Write the full form of the following abbreviations : 20×1=20

(i) IEC (ii) OHSAS
(iii) PDCA (iv) EMS
(v) SOP (vi) OPRP
(vii) FSMS (viii) AOAC
(ix) LCMS (x) ILAC
(xi) CRM (xii) NABL
(xiii) BRC (xiv) IFS
(xv) ICP (xvi) LOD
(xvii) SQF (xviii) APEDA
(xix) GMO (xx) TQM

(i) IEC - International Electrotechnical Commission

(ii) (ii) OHSAS - Occupational Health and Safety Assessment Series
(defunct standard)
(iii) (iii) PDCA - Plan-Do-Check-Act (cycle)
(iv) (iv) EMS - Environmental Management System
(v) (v) SOP - Standard Operating Procedure
(vi) (vi) OPRP - Operational Prerequisite Program (sometimes referred to
as PRP - Prerequisite Program)
(vii) (vii) FSMS - Food Safety Management System
(viii) (viii) AOAC - Association of Official Analytical Chemists
(ix) (ix) LCMS - Liquid Chromatography-Mass Spectrometry
(x) (x) ILAC - International Laboratory Accreditation Cooperation
(xi) (xi) CRM - Certified Reference Material
(xii) (xii) NABL - National Accreditation Board for Testing and Calibration
Laboratories (India)
(xiii) (xiii) BRC - British Retail Consortium (Global Standards for Food
Safety)
(xiv) (xiv) IFS - International Featured Standards (Food)
(xv) (xv) ICP - Inductively Coupled Plasma (spectrometry)
 (xvi) (xvi) LOD - Limit of Detection (xvii) SQF - Safe Quality Food
(certification program)
(xvii) (xviii) APEDA - Agricultural and Processed Food Products Export
Development Authority (India)
(xviii) (xix) GMO - Genetically Modified Organism
(xix) (xx) TQM - Total Quality Management

Write short notes on the following : 4×5=20

(i) ISO 14001
(ii) ISO 18001
(iii) PDCA model
(iv) Principles of auditing

Short Notes on Management System Standards:

(i) ISO 14001: Environmental Management Systems (EMS)

ISO 14001 is an international standard that specifies requirements for an organization to
establish, implement, maintain, and continually improve an Environmental Management
System (EMS). It helps organizations minimize their environmental impact, comply with
relevant regulations, and operate in a more sustainable manner.
Key elements of ISO 14001 include:
 Environmental Policy: A documented statement outlining the organization's commitment to
environmental protection.
 Environmental Aspects and Impacts: Identifying the organization's activities, products, and
services that have an impact on the environment (e.g., air emissions, waste generation,
resource consumption).
 Legal and Other Requirements: Identifying and complying with applicable environmental
regulations and industry standards.
 Objectives and Targets: Setting measurable environmental objectives and targets for
continuous improvement.
 Operational Controls: Implementing procedures and practices to control environmental
aspects and impacts.
 Monitoring and Measurement: Monitoring key environmental performance indicators (KPIs)
and measuring progress towards objectives.
 Nonconformity, Corrective Action, and Preventive Action (CAPA): Addressing any
deviations from environmental requirements and taking steps to prevent recurrence.
 Management Review: Regularly reviewing the EMS performance and making necessary
improvements.
By implementing an ISO 14001-certified EMS, organizations demonstrate their
commitment to environmental responsibility and can benefit from:
 Reduced environmental footprint
 Improved resource efficiency
 Lower waste disposal costs
 Enhanced brand image and reputation
(ii) ISO 18001: Occupational Health and Safety Management Systems (OHSMS)
ISO 18001 is an international standard that outlines requirements for establishing,
implementing, maintaining, and continually improving an Occupational Health and
Safety Management System (OHSMS). It helps organizations prevent workplace
injuries and illnesses, create a safe working environment for employees, and comply
with relevant health and safety regulations.
Key elements of ISO 18001 include:
 Occupational Health and Safety Policy: A documented statement outlining the organization's
commitment to employee health and safety.
 Hazard Identification and Risk Assessment: Identifying hazards in the workplace and
assessing the associated risks.
 Legal and Other Requirements: Identifying and complying with applicable occupational health
and safety regulations.
 Objectives and Targets: Setting measurable objectives and targets for continuous
improvement in employee health and safety.
 Operational Controls: Implementing procedures and practices to control identified hazards and
risks.
 Training and Awareness: Providing employees with appropriate training and awareness about
health and safety risks.
 Incident Investigation and Corrective Action: Investigating workplace incidents and taking
corrective actions to prevent recurrence.
 Management Review: Regularly reviewing the OHSMS performance and making necessary
improvements.
By implementing an ISO 18001-certified OHSMS, organizations show their dedication to
employee well-being and can experience:
 Reduced workplace accidents and illnesses
 Improved employee morale and engagement
 Lower workers' compensation costs
 Enhanced compliance with health and safety regulations

Continuous Improvement Model:

(iii) PDCA Model (Plan-Do-Check-Act)

The PDCA model (Plan-Do-Check-Act) is a continuous improvement cycle used in
various management systems, including ISO 14001 and ISO 18001. It provides a
structured approach for planning, implementing, evaluating, and improving processes or
systems.
 Plan: Define objectives, identify resources, and establish necessary procedures and controls.
 Do: Implement the planned activities according to documented procedures.
 Check: Monitor and measure progress towards objectives, analyze results, and identify any
deviations.
 Act: Take corrective actions to address deviations, implement improvements based on findings,
and revise the plan for future iterations.
The PDCA cycle is a continuous process, meaning organizations can use the results of
each cycle to refine their plans and achieve ongoing improvement.
 Auditing Principles:

(iv) Principles of Auditing

Auditing principles provide a framework for conducting effective and objective audits of
management systems. Here are some key principles:
 Integrity: Auditors should be honest, impartial, and avoid conflicts of interest.
 Confidentiality: Maintain confidentiality of information obtained during the audit.
 Competence: Auditors should possess the necessary skills and knowledge to conduct the audit
effectively.
 Objectivity: Audits should be based on evidence and objective criteria, not personal opinions or
biases.
 Due Professional Care: Auditors should exercise professional judgment and follow established
auditing procedures.
 Risk-Based Approach: Focus audit activities on areas with higher risk of nonconformities.
 Evidence-Based Approach: Gather

Which agency does the accreditation of laboratories ? Give the benefits, scope and
procedure of accreditation of laboratories.
15
(b) Give the name of five autonomous bodies working under QCI.

(a) Laboratory Accreditation in India

Agency: The National Accreditation Board for Testing and Calibration Laboratories
(NABL) is the autonomous body responsible for accrediting laboratories in India. It
functions under the Department of Science and Technology (DST), Government of
India.
Benefits of Accreditation:
 Enhanced Credibility: Accreditation demonstrates a laboratory's competence in performing
specific tests and calibrations, leading to increased trust from clients and stakeholders.
 Improved Technical Competence: The accreditation process involves a rigorous evaluation,
encouraging continuous improvement in laboratory practices and personnel qualifications.
 Wider Market Access: Accreditation to international standards allows laboratories to participate
in global testing programs and service clients worldwide.
 Meeting Regulatory Requirements: Many regulations and industry standards require testing
to be performed by accredited laboratories.
 Competitive Advantage: Accreditation can be a differentiating factor in a competitive market,
attracting clients who value high-quality testing services.
Scope of Accreditation:
NABL accreditation covers a wide range of testing and calibration activities, including:
 Chemical testing (e.g., food analysis, environmental testing)
 Biological testing (e.g., microbiology, toxicity testing)
 Physical testing (e.g., mechanical testing, electrical testing)
 Calibration (e.g., of measuring instruments and equipment)
Procedure for Accreditation:
1. Application: The laboratory submits a formal application to NABL.
2. Document Review: NABL reviews the laboratory's quality management system documentation.
3. Pre-assessment: An optional pre-assessment can identify potential gaps before the formal
audit.
4. On-site Assessment: NABL assessors conduct an on-site audit to evaluate the laboratory's
compliance with accreditation standards (ISO/IEC 17025).
5. Decision: Based on the audit findings, NABL issues an accreditation certificate or recommends
corrective actions.
6. Surveillance: NABL conducts periodic surveillance audits to ensure the laboratory maintains its
accredited status.

(b) Autonomous Bodies under QCI

The Quality Council of India (QCI) oversees several autonomous bodies, including:
1. National Accreditation Board for Testing and Calibration Laboratories (NABL): As
discussed previously, responsible for laboratory accreditation.
2. National Accreditation Board for Education and Training (NABET): Accredits educational
institutions and training programs.
3. National Accreditation Board for Certification Bodies (NABCB): Accredits certification
bodies that issue management system certificates.
4. National Accreditation Board for Hospitals & Healthcare Providers (NABH): Accredits
hospitals and healthcare organizations.
5. Agricultural & Processed Food Products Export Development Authority (APEDA): Not
directly under QCI, but an autonomous body under the Ministry of Commerce and Industry that
promotes exports of agricultural products and processed food items. (Note: APEDA focuses on
export promotion, not accreditation.)

3. Give the genesis, main sections/clauses, benefits and steps for implementation of
ISO 9000

ISO 9000: Genesis, Structure, Benefits, and Implementation

Genesis of ISO 9000

The ISO 9000 family of standards emerged in the late 20th century driven by several
factors:
 Need for Consistency: Companies in different countries lacked a common quality
management framework, hindering global trade and collaboration.
 Rise of International Trade: Globalization increased demand for standardized quality
assurance practices across borders.
 Focus on Quality Improvement: Manufacturing practices were shifting towards a focus on
continuous improvement and customer satisfaction.
Roots: While the first publication of ISO 9000 was in 1987, its foundation can be traced
back to the 1950s with:
 Government Procurement Standards: National governments like the US with MIL-Q-9858
established quality standards for military equipment.
 British Standards BS 5750: A pioneering standard for quality management systems in the UK,
later adopted as the basis for ISO 9000.
 Main Sections/Clauses of ISO 9001 (Core Standard)

ISO 9001 outlines the requirements for a Quality Management System (QMS). It's
currently structured into 10 clauses:
 Context of the Organization: Defines the organization's external and internal environment,
relevant stakeholders, and the scope of the QMS.
 Leadership: Emphasizes leadership commitment to quality and the importance of a customer
focus.
 Planning: Addresses planning for the QMS, including defining quality objectives, identifying
risks and opportunities, and resource allocation.
 Support: Covers the provision of necessary resources (human, infrastructure) and maintaining
a quality culture within the organization.
 Operation: Focuses on the operational processes for product and service creation, including
control of nonconforming outputs.
 Performance Evaluation: Defines how the organization monitors and measures the
performance of the QMS and associated processes.
 Improvement: Addresses continuous improvement of the QMS through corrective actions,
preventive actions, and innovation.
Note: Clauses 1-3 are introductory, while Clauses 4-10 outline specific requirements for
the QMS.

Benefits of Implementing ISO 9001

 Enhanced Customer Satisfaction: Improved quality management leads to consistent

product/service quality, meeting customer expectations.
 Increased Efficiency: Streamlined processes and focus on eliminating errors can lead to cost
savings and improved operational efficiency.
 Improved Market Access: Certification to ISO 9001 demonstrates commitment to quality and
can facilitate access to new markets.
 Stronger Brand Reputation: Certification enhances brand image and instills confidence in
customers and stakeholders.
 Improved Employee Engagement: A documented QMS promotes clarity in roles and
responsibilities, leading to better employee engagement.

Steps for Implementing ISO 9001

1. Gap Analysis: Assess the current state of your quality management practices compared to ISO
9001 requirements.
2. Develop a QMS Documentation: Create documented procedures, policies, and records as per
the standard's requirements.
3. Train Employees: Train employees on the QMS principles, procedures, and their roles within
the system.
4. Implement the QMS: Integrate the documented QMS into your daily operations.
5. Internal Audit: Conduct internal audits to identify any nonconformities and areas for
improvement.
6. Management Review: Top management reviews the QMS performance and makes necessary
adjustments.
7. Certification Audit: An accredited certification body conducts an audit to assess compliance
with ISO 9001 for certification.
8. Continuous Improvement: Continuously monitor, evaluate, and improve the QMS based on
performance data and feedback.
By implementing ISO 9001, organizations establish a robust framework for quality
management, leading to improved customer satisfaction, increased efficiency, and a
competitive edge in the global marketplace.

(a) Discuss the importance and types of reference materials for compliance to ISO
17025. 12
(b) Write about traceability and calibration for measurement in a chemical analysis
laboratory.

(a) Importance and Types of Reference Materials for ISO 17025 Compliance

Importance of Reference Materials (RMs):

 Reference materials (RMs) are crucial for laboratories complying with ISO 17025, the
standard for laboratory competence in testing and calibration. They play a vital role in
ensuring the accuracy and reliability of test results by:
 Method Validation: Used to validate new testing methods or verify existing ones, ensuring they
produce reliable results.
 Calibration: Used to calibrate measuring instruments and equipment, guaranteeing their
accuracy against a known standard.
 Quality Control (QC): Used to monitor the performance of analytical methods throughout
routine testing, identifying potential deviations.
 Traceability: Establishing a traceable link between measurements made by the laboratory and
internationally recognized standards.
Types of Reference Materials:
ISO 17025 recognizes two main types of RMs:
1. Certified Reference Materials (CRMs): The highest level of RMs, issued by accredited
producers. They have well-defined and documented property values with associated
uncertainties, ensuring the highest level of confidence in the reference values.
2. Reference Materials (RMs): Materials with sufficiently homogeneous and well-established
property values, but with less stringent certification compared to CRMs. They are often used for
internal QC purposes or when CRMs are unavailable.
Additional Considerations:
 Selection of RMs: Laboratories should select RMs appropriate for the specific tests being
performed and with a matrix (e.g., water, soil) similar to the samples they analyze.
 Storage and Handling: Proper storage and handling of RMs are crucial to maintain their
integrity and validity.
 Uncertainty of RMs: The uncertainty associated with the reference value of the RM should be
considered when evaluating measurement results.

(b) Traceability and Calibration for Measurement in a Chemical Analysis

Laboratory

Traceability:
 Traceability is a critical concept in chemical analysis laboratories, ensuring
measurements can be linked back to internationally recognized standards. It establishes
a chain of comparisons through a hierarchy of calibrations, ultimately connecting the
laboratory's measurements to a well-defined primary reference material.
Benefits of Traceability:
 Confidence in Results: Traceability enhances confidence in the accuracy and reliability of
analytical data, allowing for comparison with results from other laboratories.
 Meeting Regulatory Requirements: Many regulations and standards require laboratories to
demonstrate traceability of their measurements.
 Reduced Risk of Errors: Regular calibration and traceable measurements minimize the risk of
systematic errors in analytical results.
Calibration:
Calibration is the process of comparing a measuring instrument or equipment with a
known reference standard to establish a relationship between the readings. This
relationship allows for correction of any deviations and ensures the instrument provides
accurate measurements.
Calibration Process in a Chemical Analysis Laboratory:
1. Selection of Calibration Standards: Selecting appropriate calibration standards with certified
values traceable to national or international standards.
2. Calibration Procedure: Following a documented calibration procedure using the chosen
standards.
3. Data Recording and Analysis: Recording calibration data and analyzing it to assess
instrument performance and calculate any necessary corrections.
4. Calibration Certificate: Issuing a calibration certificate documenting the date, reference
standards used, and any corrections applied.
Frequency of Calibration:
The frequency of calibration depends on various factors, including:
 Stability of the Instrument: Instruments prone to drift may require more frequent calibration.
 Frequency of Use: Instruments used frequently may need calibration more often.
 Manufacturer's Recommendations: Manufacturers often specify recommended calibration
intervals.

(a) Write about the structure of food safety team. 5

(b) Which segment of industry can benefit from adopting ISO 22000 ? 5
(c) Write the elements of structure of ISO 22000 documentation.

(a) Structure of a Food Safety Team

The structure of a food safety team can vary depending on the size and complexity of
the food business. However, some common roles and reporting lines are:
 Food Safety Team Leader: Leads the overall food safety program, oversees documentation,
training, and ensures compliance with regulations and standards like ISO 22000. May report
directly to senior management.
 Quality Assurance (QA) Specialists: Conduct internal audits, manage non-conformance
procedures, and monitor adherence to food safety protocols. May report to the Food Safety
Team Leader.
 Quality Control (QC) Specialists: Perform laboratory testing of raw materials, finished
products, and monitor the environment for potential hazards. May report to the Food Safety
Team Leader or the laboratory head (if separate).
 Production Personnel: Implement food safety practices on the production floor, following
SOPs (Standard Operating Procedures) for sanitation, handling, and storage. May report to
production supervisors.
 Sanitation Team: Responsible for cleaning and disinfecting food contact surfaces and
equipment to prevent contamination. May report to the production supervisor or facilities
manager.
Additional Roles (depending on the company):
 HACCP Coordinator: Develops and maintains the Hazard Analysis and Critical Control Points
(HACCP) plan, a core element of ISO 22000. May be part of the Food Safety Team Leader's
responsibilities or a separate role.
 Regulatory Affairs Specialist: Keeps the team updated on relevant food safety regulations
and ensures compliance. May be a standalone role or part of the QA function.
 (b) Segments Benefiting from ISO 22000 Adoption

 Food Manufacturers: Demonstrates commitment to food safety, improves internal controls,

and facilitates access to new markets.
 Food Processors: Enhances control over raw materials, processing steps, and finished
product quality, reducing risks.
 Food Distributors and Retailers: Provides assurance of supplier food safety practices and
strengthens brand reputation.
 Food Service Providers: Ensures safe food handling throughout the preparation and service
chain, minimizing foodborne illness risks.
 Primary Producers: Improves farm hygiene practices, pre-harvest and post-harvest handling,
and traceability for safer produce.
By adopting ISO 22000, organizations across the entire food supply chain can benefit
from a robust food safety management system, leading to increased consumer
confidence and improved business performance.

(c) Elements of ISO 22000 Documentation Structure

ISO 22000 follows a high-level structure similar to other ISO management system
standards. Here's a breakdown of the key documentation elements:
 Food Safety Policy: A documented statement outlining the organization's commitment to food
safety and its continuous improvement.
 Food Safety Management System Manual: Describes the overall FSMS framework, its scope,
and key elements.
 Standard Operating Procedures (SOPs): Detailed instructions for specific food safety
procedures, including sanitation, handling, and maintenance activities.
 Work Instructions: Supplemental documents providing specific step-by-step instructions for
tasks within SOPs.
 Hazard Analysis and Critical Control Points (HACCP) Plan: Identifies potential food safety
hazards, establishes critical control points (CCPs) for monitoring, and defines corrective actions.
 Records: Maintain documented records of all relevant activities, including training, audits, non-
conformance reports, and corrective actions taken.
 Forms: Standardized forms for data collection, reporting, and record-keeping related to food
safety activities.
Additional Documents (may vary):
 Prerequisite Programs (PRPs): Documents outlining procedures for essential hygiene
practices and operational controls that support HACCP.
 Traceability Procedures: Describe how the organization tracks and documents the movement
of food products through the supply chain.

(a) Discuss the benefits and give principles of BRC/IOP packaging standard. 14
(b) What types of documents are required to support HACCP pre-requisite steps ?

(a) Benefits and Principles of BRC/IOP Packaging Standard

Benefits of BRC/IOP Packaging Standard:

The BRC/IOP Global Standard for Packaging Materials provides several advantages for
packaging manufacturers and suppliers:
 Enhanced Food Safety: Focuses on hazard analysis and risk management to minimize the risk
of packaging materials contaminating food products.
 Improved Quality Management: Promotes consistent product quality and adherence to
customer specifications.
 Increased Market Access: Certification demonstrates compliance with high food safety
standards, facilitating entry into new markets.
 Strengthened Customer Confidence: Provides assurance to customers of a commitment to
safe and reliable packaging materials.
 Operational Efficiency: Identifies and addresses potential issues proactively, minimizing
production disruptions and costs.
 Enhanced Brand Reputation: Demonstrates a dedication to quality and food safety, boosting
brand image.
Principles of BRC/IOP Packaging Standard:
The BRC/IOP standard is built upon several key principles:
 HACCP-based Approach: Applies the Hazard Analysis and Critical Control Points (HACCP)
methodology to identify and control hazards associated with packaging materials.
 Risk Management: Assesses risks throughout the packaging supply chain, from raw material
procurement to finished product delivery.
 Traceability: Ensures the ability to track packaging materials through the supply chain for
efficient recalls and incident management.
 Continuous Improvement: Promotes a culture of continuous improvement in food safety
practices and quality management systems.
 Documentation and Record Keeping: Requires comprehensive documentation of procedures,
policies, and records to demonstrate compliance.
By adhering to these principles, companies can establish robust quality and food safety
management systems for packaging materials, ultimately contributing to safer food
products for consumers.

(b) Documents Required for HACCP Prerequisite Steps

HACCP Prerequisite Programs (PRPs) are the foundation of a HACCP plan, outlining
essential hygiene practices and operational controls that support food safety.
Documents required to support these programs can include:
General:
 Food Safety Policy: A documented statement outlining the organization's commitment to food
safety and its continuous improvement.
 Food Safety Management System Manual: Describes the overall FSMS framework, its scope,
and how it incorporates PRPs.
 Management Review Records: Documentation of periodic reviews of the FSMS, including
evaluation of PRPs.
 Training Records: Records of employee training on food safety practices and specific PRPs
relevant to their roles.
Specific PRP Documents:
 Cleaning and Sanitation Program: Detailed procedures for cleaning and sanitizing facilities,
equipment, and utensils.
 Pest Control Program: Outlines procedures for preventing and managing pest infestations.
 Waste Management Program: Describes procedures for proper waste handling and disposal
to prevent contamination.
 Water Treatment Program: Defines procedures for ensuring the safety and suitability of water
used in food production.
 Personnel Hygiene Program: Establishes guidelines for employee hygiene practices to
minimize the risk of contamination.
 Product Labeling and Recall Procedures: Documents processes for labeling products
accurately and conducting effective recalls if necessary.
 Calibration and Maintenance Procedures: Outlines procedures for calibrating and
maintaining equipment used in food production.
 Allergen Control Program: Describes procedures for managing allergens to prevent cross-
contamination.

 Give the considerations in managing the audit program for the following : 20
 (a) Audit program objectives
 (b) Audit program resources
 (c) Audit program implementation
 (d) Audit program monitoring and review
Considerations in Managing an Audit Program:

Here's a breakdown of key considerations for each stage of an audit program:

(a) Audit Program Objectives
 Alignment with Organizational Strategy: Ensure audit program objectives directly support the
organization's overall goals and objectives.
 Risk-Based Approach: Focus audit activities on areas with higher risk of non-conformities or
areas with significant impact.
 Stakeholder Needs: Consider the needs of internal and external stakeholders when defining
audit objectives.
 Clarity and Specificity: Set clear, specific, and measurable objectives for each audit to ensure
focused evaluation.
 Compliance with Regulations: Include audits to assess compliance with relevant regulations
and standards.
(b) Audit Program Resources
 Auditor Competence: Ensure auditors possess the necessary skills, knowledge, and
experience for the specific audits they will perform.
 Availability of Auditors: Plan the audit schedule considering the availability of qualified
auditors to avoid resource constraints.
 Financial Resources: Allocate sufficient budget for auditor training, travel, and other program
expenses.
 Access to Information: Provide auditors with access to necessary documents, records, and
information to conduct effective audits.
 Technology and Tools: Consider utilizing appropriate technology and tools to support audit
planning, execution, and reporting.
(c) Audit Program Implementation
 Audit Scope and Criteria: Clearly define the scope of each audit and establish appropriate
audit criteria for evaluation.
 Audit Schedule: Develop a detailed audit schedule outlining the timeframe and sequence of
audits planned.
 Audit Methodology: Select the appropriate audit methodology (e.g., internal audit, supplier
audit) based on the scope and objectives.
 Communication: Effectively communicate the audit program and schedule to relevant
stakeholders (auditees, management).
 Audit Conduct: Perform audits in accordance with established procedures and maintain
objectivity and independence.
(d) Audit Program Monitoring and Review
 Internal Audit Function Effectiveness: Evaluate the effectiveness of the internal audit function
in achieving program objectives.
 Audit Findings Follow-Up: Monitor the implementation of corrective actions taken in response
to audit findings.
 Management Review: Regularly review the audit program performance and make necessary
improvements based on feedback and findings.
 Performance Indicators: Establish key performance indicators (KPIs) to track the program's
effectiveness and efficiency.
 Benchmarking: Benchmark program performance against industry best practices to identify
areas for improvement.
Additional Considerations:
 Confidentiality: Maintain confidentiality of sensitive information obtained during audits.
 Continuous Improvement: Foster a culture of continuous improvement within the audit
program based on lessons learned.

8. Write the full form of the following abbreviations : 20×1=20

(i) IAF (ii) OHSAS (iii) QCI (iv) EMS (v) SOP (vi) PRP (vii) FSMS (viii) AOAC (ix)
HACCP (x) TQM (xi) SRM (xii) GAP (xiii) BRC (xiv) IFS (xv) ICP (xvi) LOD (xvii) SQF
(xviii) APEDA (xix) GMO
(xx) UKAS
(i) IAF - International Accreditation Forum (ii) OHSAS - Occupational Health and Safety
Assessment Series (No longer actively promoted, but some certifications may still be
valid) (iii) QCI - Quality Council of India (iv) EMS - Environmental Management System
(v) SOP - Standard Operating Procedure (vi) PRP - Prerequisite Program (HACCP) (vii)
FSMS - Food Safety Management System (viii) AOAC - Association of Official
Agricultural Chemists (ix) HACCP - Hazard Analysis and Critical Control Points (x) TQM
- Total Quality Management (xi) SRM - Standard Reference Material (xii) GAP - Good
Agricultural Practices (xiii) BRC - British Retail Consortium (Global Standards for Food
Safety) (xiv) IFS - International Featured Standards (Food Safety & Quality) (xv) ICP -
Inductively Coupled Plasma (spectrometry) (xvi) LOD - Limit of Detection (xvii) SQF -
Safe Quality Food Institute (Food Safety Certification) (xviii) APEDA - Agricultural &
Processed Food Products Export Development Authority (xix) GMO - Genetically
Modified Organism (xx) UKAS - United Kingdom Accreditation Service