Food Safety - HACCP and Codex

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Food Safety (HACCP) Foundation Course1Course Agenda What & why of food safety The Pre-requisite programHACCP Preliminary stepsHACCP Principles System Maintenance 22What will you learn? Introduction of HACCP Understand the common best practices, such as GHP and GMPUnderstand 7 HACCP principles and their implementation

Slide 3, rev 1

3How this course is built up Slide 4, rev 1Introduction of HACCP,

Group activitiesTheoretical inputReflectionBrainstormingPre-requisite Program & HACCP Principles System Maintenance 4How to contribute today Slide 5, rev 1Learning new things is demanding, but funActive participationNo stupid questionsBenefit from sharing experiencesIllustration comingIllustration comingIllustration comingIllustration coming

5 Slide 6, rev 1Lets get started!6Introduction to HACCP Development of HACCP7What will you learn? Understand why product safety is importantHow HACCP is developed and its benefits What are various legislations

88Food safety

99Legislative RequirementConsumers awarenessConsequences - unrecoverable market lossLimitations of quality inspectionMore complex processes / food operationsExternal pressure

Why Food Safety Safety ?

1010Structure of Food Safety Management SystemFood Safety ElementsSystem ElementsISO 9001 or general principles on management system requirements

e.g.: Management Review, Internal Audits, Corrective-Preventive Actions, Document control etcHACCP Principles

PrerequisitesGMP, GHP, others121111Beginning of journey- HACCP system

1212HACCP- Origin and Milestones OriginPilsbury, NASA and US Army LAB (Natick) - Principal object was to develop safe food for astronautsBased on engineering system - Failure Modes and Effect Analysis (FMEA)

Milestones NACMCF guidelines for USA Defined terminology HACCPImplementation of EU DirectiveUSDA/FDA prescribe industry specific HACCP guidelines - shellfish, meat, horticultureWhite paper on Food Safety published in Jan 2000 - Farm-To-Fork concept was introduced

1313Development of HACCP Codex Alimentarius CommissionFAOs and WHOs joint Food Standards ProgrammeExecutive body: Codex Alimentarius CommissionDocument Recommended Code of Practice General Principles of Food Hygiene and Hazard Analysis and Critical Control Point (HACCP) system and guidelines for its application 1414BenefitsPreventative SystemSystematic ApproachEffective use of ResourcesCost Effective Control SystemHelps Demonstrate Due DiligenceInternationally AcceptedComplements Quality Management SystemsFacilitates regulatory inspectionDemonstrates Management CommitmentProduct Quality Bonus

1515Legal requirements

1616Group workWhat are applicable statutory & regulatory requirement related to your industry.

1717For presenting group work

Pre-requisite ProgramGAP, GMP, GHP, GLP 18What will you learn? What is Pre-requisite program What are elements of pre-requisite program

FSSAI Schedule IV Part II and V requirements 1919The Foundation to HACCP- pre-requisite program

2020Implementation of Food Safety SystemFood Safety Management System2121Pre requisite ProgramWhat is Prerequisite Program?

Slide 2222Definition of Pre-requisites universal steps or procedures that control the operational conditions within a food establishment allowing for environmental conditions that are favourable for the production of safe food Codex Alimentarius Commission (food safety) basic conditions and activities that are necessary to maintain a hygienic environment throughout the food chain, suitable for production, handling and provision of safe end product and safe food for human consumption.2323Elements of GHP, GMP2. Scope, Use and Definition3. Primary Production4. Establishment: Design and Facilities1. Objectives 5. Control of Operation6. Establishment: Maintenance and Sanitation7. Establishment: Personal Hygiene9.Product Information and Consumer Awareness8. Establishment: Transportation10. TrainingAs defined in CAC-Basic Code of Hygiene

2424Case StudyDefine a pre-requisite program for the company for your companyGroup I: Production Group II: Storage requirementsGroup III: Packing area Group IV: Staff facilities

2525HACCP Implementation 26What will you learn?12 steps of HACCP ImplementationMaintenance of the system Group Work and Case study

Slide 2727HACCP so farGHPGMPothersPrerequisitespreparation7 HACCPprinciplesImplementationMaintenanceHACCP MethodSystem Elements2828HACCP Steps Preparatory Step 0Management Commitment Step 1Assemble HACCP Team Step 2Describe the ProductStep 3Identify Intended Use Step 4Construct a flow diagram Step 5On Site verification of flow diagram 2929HACCP Steps Principles Step 6Principle 1 Identification of hazards, hazard assessment and establish control measuresStep 7Principle 2 Determine Critical Control Point (CCP) Step 8Principle 3 Establish Critical Limit Step 9Principle 4 Determine a monitoring system for CCPStep 10Principle 5 Determine Corrective Actions Step 11Principle 6 Establish a verification system Step 12Principle 7 Establish a documentation and record system 3030Preparatory steps of HACCP

3131HACCP Steps Preparatory Step 0Management Commitment Understands benefits and impacts Policy and Objectives Provides resources

3232HACCP Steps Preparatory Step 1Assemble HACCP Team Multidisciplinary with a HACCP Team LeaderSize can vary depending upon the companyConducts a gap analysis before start Adequate training to the HACCP Team

3333HACCP Steps Preparatory Step 2Describe the Product Full description of the product describing Raw Material Ingredients and composition in final product Physical Chemical Microbiological characteristics of end product Preservation Method Packaging details Shelf life Labeling requirements Handling , Preparatory , Storage requirements Distribution method

3434HACCP Steps Preparatory Step 3Identify Intended Use Identify potential usersSafe storage, preparation and serving describedUnintended handling and potential abuse of the productSpecification for the final product based on info from customers, internal expertsDetermine sensitive consumers (Allergens - YOPI) Young Old Pregnant Immuno-disordered 3535Case Study I : Product Description Using Step 2 & 3, describe your product

3636HACCP Steps Preparatory Step 4Construct a flow diagramA flow diagram is A systematic representation of the sequence of steps or operations used in the production or manufacture of a particular food item.all steps in manufacturing process includedindicated where raw materials join flow where reworking and recycling takes placewhere intermediates, by-products and waste are removedFlow diagrams sufficiently clear and detailed for potential hazards to be identifiedincludes relevant process data3737

Flow diagram - Example3838HACCP Steps Preparatory Step 5On site verification flow diagramThe ready flow diagram compared with the operation and layout.

All team members visit on the site to confirm- the diagram is complete- is valid trough all operational period3939Case Study II Flow Diagram Construct a flow diagram

4040HACCP Principles

4141HACCP Steps HACCP Principles Step 6Principle 1 - List all potential hazards associated with each step,conduct a hazard analysis, and consider any measures to control identified hazardsContent principle 1:Identify all existing and potential hazards associated with each process stepEvaluate the risk of each hazardEstablish control measures

4242DefinitionsHazard A biological, chemical or physical agent in, or condition of, food with potential to cause an adverse health effect.Codex Alimentarius CommissionBiological E. Coli (0157:H7)SalmonellaClostridium perfringens Listeria monocytogens Staphylococcus aureus Camphylobacter

Chemical Naturally occurring toxinsFood Additives in excessPesticide residues Antibiotic residues Environmental contaminantsChemical contaminants from packaging Allergens

PhysicalGlass Metal, Machine fillingsPaper PlasticDead InsectsJewellery

4343Some considerations .pH best grow values : 6.6-7.5Molds > Yeasts > BacteriaSalmonella spp. 3.5 - 9.5Clostridium botulinum : 4.5 - 8.5 Moisture / Water activity (aW)The ratio of the vapour pressure of food substrate to the vapour pressure of pure water, at the same temperature aw= p/p0Gram- have higher requirements than Gram+Most spoilage bacteria dont grow below aw= 091Nutrient Content watersource of energysource of nitrogenvitamins, minerals

Oxidation-Reduction Potential The O/R potential of a substrate the ease with which the substrate loses or gains electronsanaerobic (e.g.: Clostridium spp.) - Ehaerobic (e.g.: Bacillus spp.) + Eh4444The sources of the informationInternal and External Experts Epidemiological dataCustomer Complaints Results of internal and external auditsRegulatory guidelines Use of flow diagram Literature Basic practices in the industryScreening Analysis (SPC)4545Instruc to trainers are these the same for all tpyes of audits? where is the emphasis? What it this course focused on?DefinitionsLikelihood / ProbabilityConsequences / SeverityLow Medium HighLow Significant Medium Significant SignificantHighSignificant Significant Hazard / Risk analysis: The process of collecting and evaluating information on hazards and conditions leading to their presence to decide which are significant for food safety RISK = PROBABILITY*SEVERITY Slide 4646DefinitionsControl Measure Control Measures are those systems in place at a process step that eliminate hazards or reduce their impact or occurrence to acceptable levels.Codex Alimentarius CommissionControl measure examples:Pre-requisite program e.g. GMP, GHP, GAP etc. Training Additional controls e.g. Metal detector More than one control measure may be required to control a specific hazard (s) and more than one hazard may be controlled by a specified control measure.

Slide 4747Case Study III: Principle 1 Identify potential hazards for at least 2 stepsConduct an hazard assessment Establish Control Measures (60 Min)Present your Hazard Analysis Worksheet (10 min each)

4848HACCP Steps HACCP Principles Step 7Principle 2 Determine Critical Control Points (CCP)A step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.

Aided by use of a decision tree:consider each step in the flow diagrammust be applied on each (significant) hazarduse common sense

4949HACCP Steps HACCP Principles Step 8Principle 3 Establish Critical LimitA criteria that separate acceptability from unacceptability.Limits associated with Temperature- time, pH, titratable acidity, concentrations, moisture level, water activity, available chlorine, viscosity, food additives quantitysensory parameters (texture, smell) etc.Consider National legislations Target Value and Action Value may also be defined.

5050Critical limits and control measuresLevel of controlstrictlowerControl measureall hazardsCritical LimitTarget LevelSafety Buffer Zoneall CCPs5151Step 9Principle 4 Establish Monitoring System The act of conducting a planned sequence of observations or measurements of control parameters to assess whether a critical control point (CCP) is under control.Purpose:to show the state of control at a CCPas a trigger for corrective actions when critical limits are exceededprovides data for trend analysisShould include:What, When, Where , How, WhoMonitoring Records 5252HACCP Steps HACCP Principles Step 10Principle 5 Establish Corrective ActionsAny action to be taken when the results of monitoring at the CCP indicate a loss of control.

Corrective actions but bring CCP back in control Procedure to describe handling of non-conforming products- Destroy the non-conforming product- Recycling in production process- satisfy another product specification of a less sensitive product.Responsibilities for information and action Notification and Recall procedures 5353Case Study IV: HACCP Plan Determine CCP Establish Critical limitDetermine a monitoring system for one CCP. Establish procedure for Corrective action

( Time : 45 min)

Slide 5454HACCP Steps HACCP Principles Step 11Principle 6 Establish Verification procedurePurpose of verification is to determine, if the HACCP system:

complies with the HACCP planis effectiveis appropriate for the current situation

Procedures for verification can include as a minimum:Purpose;Methods, standard operating procedures or tests applied;Tasks and responsibilities;Frequency;Records.Internal Audits can be a part of verification activity

5555DefinitionsValidation :Obtaining evidence that the elements of the HACCP plan are effective.Codex Alimentarius CommissionPrior to implementation of HACCP System Validation of Pre requisite program (as applicable) Critical LimitsHazard identification on sound scientific dataControl measures the parameters and methods used to monitor the control measures are appropriate

Slide 5656DefinitionsVerification :The application of methods, procedures, tests and other evaluations, in addition to monitoring to determine compliance with the HACCP plan. Codex Alimentarius CommissionExamples Review of the HACCP system documents and records;Analysis of (near) recalls and product dispositions;Verify control measures are effective Analysis of customer and consumer complaints related to hygiene and food safety;Review of analytical outcome of random sampling and analysis of products;Evaluation of conformity with applicable legislation and regulations Review of gaps competency gaps staff with respect to hygiene and food safety, resulting in effective (on-the-job) training sessions;

Slide 5757Validation Vs Verification

Our plans

LiteratureAre we doing the right things?Validation

Our plans

Our activitiesAre we doing things right?VerificationDifferent vocabulary to ISO 90015858HACCP Steps HACCP Principles Step 12Principle 7 Establish Documentation and Records Purpose:documentation to demonstrate that the HACCP system can be adequately understood and effectively and efficiently operatedrecords to demonstrate that the system operates effectively, and that processes have been carried out under hygienically conditionsExamples of Records Records of team meetingsRecords of product and process data and flow diagramsRecords of deviations and corrective actions takenAudit reportsTraining recordsExamples of DocumentsPolicyHazard Analysis & HACCP PlanInternal Audits Procedures describing pre-requisite programProduct Recall

5959Maintaining the HACCP system

6060HACCP Steps HACCP Principles On going activityMaintenance, Awareness and Training review of system may necessary:new product, new process, new ingredientsnew technology, machinery, etcnew legislation, discovery of new hazards Identify training needsTypically on functional or individual basisto be recorded, e.g. through matrix etcreviewed on regular basis Determine the training programPriority to be risk based Maintain comprehensive records6161