UNIT-3

CRITICAL QUALITY CONTROL POINT IN DIFFERENT STAGES OF

PRODUCTION INCLUDING RAW MATRIALS AND PROCESSING MATRIALS

Critical Quality Control Points in Different Stages of Production:

Raw Materials:

1. Sourcing: Verify supplier credentials and material specifications.

2. Inspection: Check for visible defects, contamination or damage.

3. Testing: Analyze for chemical, physical and microbiological parameters.

4. Storage: Control temperature, humidity and pest management.

Processing Materials:

1. Receiving: Inspect packaging, labeling and documentation.

2. Storage: Maintain proper conditions (temperature, humidity).

3. Weighing/Metering: Ensure accurate measurement.

4. Mixing/Blending: Monitor uniformity and homogeneity.

5. Processing (heat treatment, pasteurization, sterilization): Control

temperature, time and pressure.

Production Stages

1. Primary Processing

1. Cleaning, sorting and grading.

2. Peeling, chopping, slicing.

3. Cooking, blanching.

4. Packaging.
2. Secondary Processing

1. Formulation, mixing.

2. Filling, sealing.

3. Labeling, packaging.

4. Sterilization.

3. Tertiary Processing

1. Assembly, packaging.

2. Quality inspection.

3. Packaging materials control.

Critical Control Points (CCPs)

1. Temperature control (storage, processing, transportation).

2. Moisture control (storage, processing).

3. Cross-contamination prevention.

4. Allergen management.

5. Foreign material detection (metal detection, X-ray inspection).

6. Microbiological testing (environmental, product).

7. Chemical testing (residues, contaminants).

8. Labeling and packaging verification.

Quality Control Measures

1. Good Manufacturing Practices (GMP).

2. Hazard Analysis Critical Control Points (HACCP).

3. Total Quality Management (TQM).

4. Statistical Process Control (SPC).

5. Supply Chain Management.

Regulations and Standards

1. Food Safety and Standards Authority of India (FSSAI).

2. US FDA regulations.

3. EU food safety regulations.

4. ISO 22000 (Food Safety Management System).

5. GMP, HACCP certifications.

Monitoring and Verification

1. Regular inspections.

2. Testing and analysis.

3. Corrective action implementation.

4. Continuous improvement programs.

5. Third-party audits.

Documentation

1. Material specifications.

2. Production records.

3. Quality control data.

4. Certificates of analysis.

5. Traceability records.

Food quality and quality control including the HACCP system

Food Quality and Quality Control, including HACCP:

Food Quality

1. Attributes: taste, texture, appearance, nutritional value.

2. Factors affecting quality: raw materials, processing, storage, handling.

3. Quality standards: regulatory requirements, industry specifications.

Quality Control

1. Inspection: raw materials, processing, finished products.

2. Testing: chemical, physical, microbiological analysis.

3. Certification: ISO 22000, HACCP, GMP.

4. Documentation: records, traceability.

Hazard Analysis Critical Control Points (HACCP)

1. Identify hazards: biological, chemical, physical.

2. Assess risks: likelihood, severity.

3. Determine Critical Control Points (CCPs).

4. Establish critical limits.

5. Monitor CCPs.

6. Corrective actions.

7. Verification.

HACCP Principles

1. Conduct hazard analysis.

2. Identify CCPs.

3. Establish critical limits.

4. Monitor CCPs.

5. Establish corrective actions.

6. Verify effectiveness.

7. Document.
HACCP System Components

1. Hazard analysis.

2. CCP identification.

3. Critical limit establishment.

4. Monitoring procedures.

5. Corrective action plans.

6. Verification procedures.

7. Record keeping.

Benefits of HACCP

1. Ensures food safety.

2. Reduces risk of contamination.

3. Improves quality.

4. Enhances consumer confidence.

5. Meets regulatory requirements.

6. Reduces recalls.

7. Improves traceability.

Food Safety Management System (FSMS)

1. ISO 22000.

2. Integrates HACCP, GMP, TQM.

3. Systematic approach to food safety.

Implementation Steps

1. Conduct hazard analysis.

2. Develop HACCP plan.

3. Train personnel.
4. Implement monitoring procedures.

5. Establish corrective actions.

6. Verify effectiveness.

7. Maintain records.

Regulations and Standards

1. Food Safety and Standards Authority of India (FSSAI).

2. US FDA regulations.

3. EU food safety regulations.

4. ISO 22000.

5. GMP, HACCP certifications.

Tools and Techniques

1. Flowcharts.

2. Hazard analysis tables.

3. CCP identification matrices.

4. Critical limit setting.

5. Monitoring forms.

6. Corrective action templates.

7. Verification checklists.

Training and Certification

1. HACCP certification.

2. Food safety training.

3. GMP training.

4. ISO 22000 certification.

5. Auditing and inspection training.

Challenges and Limitations

1. Complexity.

2. Cost.

3. Training requirements.

4. Continuous monitoring.

5. Verification challenges.

6. Regulatory compliance.

7. Supply chain management.

food inspection and food law

Food Inspection and Food Law:

Food Inspection

1. Visual inspection: checking for visible defects or contamination.

2. Physical inspection: checking texture, temperature, moisture.

3. Chemical inspection: testing for chemical contaminants.

4. Microbiological inspection: testing for bacterial, viral or parasitic

contaminants.

5. Sensory inspection: evaluating taste, smell, appearance.

Types of Food Inspection

1. Routine inspection: regular checks.

2. Complaint inspection: investigating consumer complaints.

3. Enforcement inspection: ensuring compliance with regulations.

4. Import/export inspection: verifying compliance with international

standards.
Food Law

1. Food Safety and Standards Act (FSSA) 2006 (India).

2. Federal Food, Drug, and Cosmetic Act (FDCA) (USA).

3. European Union Food Law.

4. Codex Alimentarius Commission regulations.

Key Aspects of Food Law

1. Food safety standards.

2. Labeling and packaging regulations.

3. Advertising and claims guidelines.

4. Import/export regulations.

5. Food additive and contaminant limits.

6. Hygiene and sanitation standards.

7. Traceability and recall procedures.

Regulatory Agencies

1. Food Safety and Standards Authority of India (FSSAI).

2. US Food and Drug Administration (FDA).

3. European Food Safety Authority (EFSA).

4. National Food Safety Control System (NFSCS).

Food Inspection Agencies

1. National Food Safety Inspection Service (NFSIS) (USA).

2. Food Safety and Inspection Service (FSIS) (Canada).

3. European Union's Food and Veterinary Office (FVO).

Food Testing Methods

1. Microbiological testing (e.g., PCR, ELISA).

2. Chemical testing (e.g., GC-MS, HPLC).

3. Physical testing (e.g., texture analysis).

4. Sensory evaluation.

Food Safety Certifications

1. ISO 22000 (Food Safety Management System).

2. HACCP (Hazard Analysis Critical Control Points).

3. GMP (Good Manufacturing Practices).

4. SQF (Safe Quality Food).

Challenges and Trends

1. Emerging contaminants (e.g., nanoparticles).

2. Food fraud and adulteration.

3. Climate change impacts on food safety.

4. Globalization and international trade.

5. Consumer awareness and expectations.

Resources

1. Food Safety and Standards Authority of India (FSSAI).

2. US FDA.

3. European Commission - Food Safety.

4. Codex Alimentarius Commission.

5. International Association for Food Protection (IAFP).

Microbial Risk Assessment:

Definition: Evaluating potential health risks associated with microbial

contamination in food.

Purpose:

1. Identify microbial hazards.

2. Assess risk of illness.

3. Prioritize control measures.

4. Inform risk management decisions.

Steps:

1. Hazard identification (e.g., Salmonella, E. coli).

2. Exposure assessment (e.g., contamination levels).

3. Dose-response assessment (e.g., illness severity).

4. Risk characterization (e.g., likelihood, severity).

5. Risk evaluation (e.g., prioritization).

Microbial Risk Assessment Tools:

1. Quantitative Microbial Risk Assessment (QMRA).

2. Microbial Hazard Identification and Critical Control Point (MHICCP).

3. Hazard Analysis Critical Control Points (HACCP).

4. Food Safety Objective (FSO) approach.

5. Risk-based inspection.

Factors Considered:

1. Microorganism characteristics (e.g., virulence).

2. Food characteristics (e.g., pH, moisture).

3. Processing and handling practices.

4. Storage and distribution conditions.

5. Consumer behavior.
Microbial Risk Assessment Models:

1. USDA's FSIS Pathogen Modeling Program.

2. FDA's iRISK tool.

3. European Food Safety Authority's (EFSA) risk assessment tools.

4. Codex Alimentarius Commission's risk assessment guidelines.

Applications:

1. Food safety policy development.

2. Regulatory decision-making.

3. Industry risk management.

4. Research prioritization.

5. Public health protection.

Benefits:

1. Informed risk management decisions.

2. Reduced foodborne illness.

3. Improved food safety.

4. Enhanced consumer confidence.

5. Economic benefits.

Challenges:

1. Data limitations.

2. Uncertainty in risk estimates.

3. Complexity of microbial systems.

4. Evolving microbial threats.

5. Resource constraints.

Regulatory Frameworks:

1. US FDA's Food Safety Modernization Act (FSMA).

2. EU's General Food Law Regulation.

3. Codex Alimentarius Commission guidelines.

4. National food safety regulations.

International Guidelines:

1. Codex Alimentarius Commission.

2. World Health Organization (WHO).

3. Food and Agriculture Organization (FAO).

4. European Food Safety Authority (EFSA).

Resources:

1. FDA's Risk Assessment webpage.

2. USDA's FSIS Risk Assessment webpage.

3. EFSA's Risk Assessment webpage.

4. Codex Alimentarius Commission publications.

5. International Association for Food Protection (IAFP).

Dose response and exposure response modelling

Dose-Response and Exposure-Response Modeling:

Dose-Response Modeling:

1. Defines relationship between pathogen dose and infection probability.

2. Quantifies health risks from microbial exposure.

Exposure-Response Modeling:

1. Evaluates relationship between exposure duration/intensity and health

outcome.

2. Assesses cumulative risk from repeated exposures.

Key Concepts:

1. Dose: Amount of pathogen ingested.

2. Response: Infection, illness or symptom severity.

3. Exposure: Duration, frequency and intensity of pathogen contact.

Dose-Response Models:

1. Probit model: Linearizes dose-response curve.

2. Logit model: Analyzes binary response data.

3. Weibull model: Accommodates variable susceptibility.

4. Beta-Poisson model: Incorporates dose-dependent variability.

5. Exponential model: Simplifies dose-response relationships.

Exposure-Response Models:

1. Time-to-event models: Analyze time to illness onset.

2. Survival analysis: Evaluates duration of illness.

3. Repeated measures models: Assess cumulative risk.

4. Dynamic models: Simulate exposure-response over time.

Data Requirements:

1. Human clinical trials.

2. Epidemiological studies.

3. Animal experiments.

4. In vitro assays.

Software Tools:

1. R (e.g., dose-response packages).

2. Python (e.g., scikit-learn, statsmodels).

3. SAS (e.g., PROC PROBIT).

4. MATLAB (e.g., Statistical Toolbox).

5. @RISK (Palisade Corporation).

Applications:

1. Food safety risk assessment.

2. Waterborne disease modeling.

3. Airborne pathogen transmission.

4. Vaccine efficacy evaluation.

5. Pharmaceutical risk-benefit analysis.

Challenges:

1. Data scarcity.

2. Model uncertainty.

3. Complexity of biological systems.

4. Variability in human susceptibility.

5. Interactions between pathogens.

Regulatory Guidelines:

1. US FDA's Guidance for Industry.

2. European Food Safety Authority (EFSA) guidelines.

3. World Health Organization (WHO) guidelines.

4. Codex Alimentarius Commission guidelines.

References:

1. FDA's Dose-Response Assessment webpage.

2. EFSA's Exposure-Response Modeling webpage.

3. WHO's Quantitative Microbial Risk Assessment manual.

4. "Dose-Response Modeling for Microbial Risk Assessment" (2017).

5. "Exposure-Response Modeling: Methods and Applications" (2020).

risk management

Risk Management:

Definition: Identifying, assessing and mitigating risks to minimize harm

and ensure safety.

Risk Management Process:

1. Risk Identification: Recognize potential hazards.

2. Risk Assessment: Evaluate likelihood and impact.

3. Risk Prioritization: Rank risks by severity.

4. Risk Mitigation: Implement control measures.

5. Risk Monitoring: Continuously evaluate effectiveness.

6. Risk Review: Update and refine risk management plan.

Risk Management Strategies:

1. Avoidance: Eliminate risk source.

2. Reduction: Minimize risk likelihood/impact.

3. Transfer: Shift risk to another party (e.g., insurance).

4. Mitigation: Implement controls.

5. Acceptance: Accept residual risk.

Risk Management Tools:

1. Risk matrices.

2. Decision trees.

3. Hazard analysis (HAZAN).

4. Failure mode and effects analysis (FMEA).

5. Bow-tie analysis.

6. Root cause analysis (RCA).

Risk Management Standards:

1. ISO 31000 (Risk Management).

2. ISO 22000 (Food Safety Management).

3. ISO 9001 (Quality Management).

4. OHSAS 18001 (Occupational Health and Safety).

5. COSO ERM (Enterprise Risk Management).

Risk Management Techniques:

1. Probability-consequence analysis.

2. Expected loss calculation.

3. Sensitivity analysis.

4. Scenario planning.
5. Monte Carlo simulations.

Risk Management Benefits:

1. Reduced risk of harm.

2. Improved safety.

3. Enhanced reputation.

4. Compliance with regulations.

5. Cost savings.

6. Increased stakeholder confidence.

Industry Applications:

1. Food safety.

2. Healthcare.

3. Finance.

4. Construction.

5. Manufacturing.

6. Transportation.

Regulatory Requirements:

1. Food Safety Modernization Act (FSMA).

2. Occupational Safety and Health Act (OSHA).

3. European Union's General Food Law Regulation.

4. Codex Alimentarius Commission guidelines.

Resources:

1. ISO website ((link unavailable)).

2. Risk Management Society (RIMS).

3. International Association for Food Protection (IAFP).

4. Food Safety and Standards Authority of India (FSSAI).

5. US FDA's Risk Management webpage.

Implementation of food surveillance system to monitor food
safety, risk communication

Implementation of Food Surveillance System for Monitoring Food Safety

and Risk Communication:

Food Surveillance System Components

1. Food sampling and testing

2. Risk-based inspection

3. Foodborne illness surveillance

4. Environmental monitoring

5. Supply chain tracking

6. Data analysis and reporting

7. Risk communication

Implementation Steps

1. Establish clear objectives and scope

2. Identify key stakeholders and their roles

3. Develop a risk-based sampling plan

4. Select appropriate testing methods

5. Establish data management and analysis protocols

6. Develop risk communication strategies

7. Train personnel and stakeholders

8. Monitor and evaluate system effectiveness

Risk Communication Strategies

1. Transparency: Share information openly

2. Consistency: Use clear, concise messaging

3. Proactivity: Anticipate and address concerns

4. Collaboration: Engage stakeholders

5. Cultural sensitivity: Tailor messaging

Food Safety Monitoring Parameters

1. Microbiological contaminants (e.g., Salmonella, E. coli)

2. Chemical contaminants (e.g., pesticides, heavy metals)

3. Physical contaminants (e.g., foreign objects)

4. Allergens

5. Nutritional content

Surveillance System Benefits

1. Improved food safety

2. Enhanced risk management

3. Increased consumer confidence

4. Reduced foodborne illnesses

5. Economic benefits (reduced recalls, improved trade)

6. Compliance with regulations

Challenges and Limitations

1. Resource constraints

2. Data quality and management

3. Complexity of food systems

4. Communication barriers

5. Stakeholder engagement

Regulatory Frameworks

1. Food Safety Modernization Act (FSMA)

2. European Union's General Food Law Regulation

3. Codex Alimentarius Commission guidelines

4. National food safety regulations

Technological Solutions

1. Food safety management software (e.g., HACCP, ISO 22000)

2. Data analytics platforms

3. Mobile apps for reporting and tracking

4. Blockchain technology for supply chain management

5. Sensor technologies for monitoring

International Collaboration

1. World Health Organization (WHO)

2. Food and Agriculture Organization (FAO)

3. Codex Alimentarius Commission

4. International Association for Food Protection (IAFP)

5. Global Food Safety Partnership (GFSP)

Resources

1. FDA's Food Safety Surveillance webpage

2. European Food Safety Authority (EFSA)

3. WHO's Food Safety webpage

4. FAO's Food Safety webpage

5. Codex Alimentarius Commission publications