Validation and Verification of HACCP Plans - Webinar Presentation


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Validation and Verification of HACCP Plans - Webinar Presentation

  1. 1. Validation and Verification of HACCPPlansAndrew Nash23rd April, 2013
  2. 2. General DisclaimerOpinions expressed by or on behalf of SAI Global published throughMyTutor or presented during MyTutor live webinars is provided as generalguidance only and does not amount to formal legal or other professionaladvice. SAI Global does not warrant the accuracy or completeness ofinformation given or its fitness for any particular purpose. To the extentpermitted by law SAI Global accepts no liability for any claims for loss ordamage whether caused by its negligence (or that of any of its agents oremployees) or otherwise. For full terms and conditions of use, please
  3. 3. How it all worksWebinar 60 minsQ & A 30 minsAsk questions via the Chat / Questions function in theside panelDidn’t get your questions answered?A discussion board will be open to answer anyquestions not covered in the webinar. These will beposted in Ask MyTutor.
  4. 4. Session Agenda• Introduction (10 min)• Details of the topic (30 min)• Q&A (45 min)
  5. 5. Definitions and Key Terminology• Validation: confirmation and provision of objectiveevidence that the requirements for a specificintended use have been fulfilled• Verification: confirmation and provision ofobjective evidence that specified requirementshave been metISO 9000: 2005 - QMS Fundamentals and Vocabulary
  6. 6. Definitions• Objective evidence: data supporting theexistence, or truth, of something• Monitoring: maintaining regular surveillance over(something)• Validate - before the event• Monitor - during the event• Verify - after the event
  7. 7. Food Safety Program Requirements
  8. 8. Elements of a Food Safety Program• HACCP focuses on “on-line” activities• Needs “support” to function effectively– “support” programs now known as “pre-requisiteprograms” (PRPs)• Needs appropriate premises, facilities andequipment
  9. 9. Food Safety Programs• Why are they necessary?– meet regulatory requirements– to demonstrate safe food controls– statement of commitment to produce safe food– evidence of reasonable precautions taken– evidence of due diligence– customer requirement– basis for auditing process– training aid for staff
  10. 10. Customers SpecificationsProcessCapabilityHazard AnalysisHACCP Audit TableID & TraceabilityTrainingCalibrationPest ControlCleaning/SanitationDocument ControlMaintenanceGood Hygiene PracticesApproved SuppliersLabelingRecall ProtocolsSafe, Quality FoodRecordsFlow Chart= FSP$$$
  11. 11. Customer Requirements for Validation andVerificationSQF - Validation• – Validation of raw and packaging materials toensure product safety. Validation shall include C of C;• C of A; or sampling and testing.• – Validation and verification activities shall be theresponsibility of the SQF practitioner.• – The methods, responsibility and criteria forensuring the effectiveness of pre-requisite programs, andvalidating critical food safety and quality limits to ensurethey achieve their intended purpose shall be documentedand implemented.• – Records of all validation activities shall bemaintained.• 2.8.2 – Allergen Management. See clause viii
  12. 12. Customer Requirements for Validation andVerificationSQF – Verification• Validation and verification activities shall be theresponsibility of the SQF practitioner.• The frequency and methods used to validate andverify food safety fundamentals, critical limits, and otherfood safety and quality controls shall be documented andimplemented.• Records of all verification activities shall bemaintained.• A schedule outlining the verification activities,frequency and the person responsible for each activity shallbe prepared and implemented.• 2.8.2 – Verify Allergen based cleaning
  13. 13. Customer Requirements for Validation andVerification• WQA – Validation is specified throughout the WQAStandard. For example:• Chapter 3 – Process Control Manufactured Foods– Establish Critical Limits– Product and Process validation– Shelf Life• Chapter 7 – Risk Assessment– Transfer of raw material into a high care facility without atransfer heat treatment must be validated.• Chapter 8 – Premises / Facility– Where high risk / care requirements not in place, theVendor to demonstrate validated methods– Suitability and Sufficient Refrigeration and cooling– Validation of transfer systems into high care (sanitisingtunnels and baths)
  14. 14. Customer Requirements for Validation andVerification• Chapter 10 – Laundry– The process used in laundries supplying high careenvironments shall be validated• Chapter 12 – Management of Allergens– Cleaning methodologies shall be validated as effective atremoving allergenic material and preventing crosscontamination.– Products labelled as ‘free from’ or ‘made without’ (orsimilar) an ingredient known to cause allergy, sensitivity orintolerances in the population require specific validatedprocedures to support the on pack claim.– The procedures of the allergen management plan shall befully validated and included on the internal audit program
  15. 15. Customer Requirements for Validation andVerification• Chapter 13 – Management of Cleaning– The frequency of cleaning shall be based on experience,validation and verification data and the equipmentmanufacturers’ recommendations.– Cleaning and disinfection chemicals shall be validated onsite for the use in which employed.– CIP operations shall be established, validated and verifiedas for manual cleaning– Traditional microbiological and allergen swabs shall beused as part of the validation of cleaning methods• Chapter 15 – Validation and Verification of processes• Chapter 18 – Product Validation– All data and product information on pack shall be treated asa claim and shall be validated.
  16. 16. Customer Requirements for Validation andVerification• Verification is also specified throughout the WQA standard• Chapter 15 – Validation and Verification– Product Assessment– Product Testing– Food Safety Criteria– Retention Samples– Internal Audits• Chapter 16 – Corrective Action– Verification of
  17. 17. Customer Requirements for Validation andVerification• Chapter 17 – Incident Management– Verify effectiveness of established procedures – recall,withdrawal• Chapter 18 – Product Validation– Verify accuracy of product claims• Chapter 19 – Animal Welfare– Vendors shall maintain copies of relevant documentationincluding audit reports and certificates to demonstratecompliance to the approved supplier animal welfareprograms.
  18. 18. ANY QUESTIONS ?
  19. 19. Hazard Analysis Critical Control Point
  20. 20. HACCP• Hazard Analysis and Critical Control Point• Food Safety and Quality Management Tool• Identifies hazards and how they can be controlled• Imposes discipline on an organisation
  21. 21. The Seven Principles of HACCP1. Conduct a hazard analysis2. Determine the Critical Control Points3. Establish critical limit(s)4. Establish a system to monitor control of the CCP5. Establish the corrective action to be taken whenmonitoring indicates that a particular CCP is not undercontrol.6. Establish procedures for verification to confirm that theHACCP system is working effectively.7. Establish documentation concerning all procedures andrecords appropriate to these principles and theirapplication
  22. 22. Principle 1• Done in 3 parts:– Identify all potential hazards at each step in theprocess– Work out the significance of the hazards• What hazards are most likely to occur?• What hazards will cause the greatestproblems?– Develop control measures for all significanthazards
  23. 23. Hazard Identification: The Enemies!• Biological hazards• Chemical hazards− Allergens• Physical hazards• Quality Hazards
  24. 24. Control Measures• A Control Measure is an activity that prevents, eliminatesor reduces a hazard to an acceptable level• Where a significant hazard has been identified, a controlmeasure must be developed and implemented• More than one control measure may be applied to eachhazard
  25. 25. Principle 2 - CCPs• Determine the Critical Control Points (CCPs)• Step/operation/practice that:– must be done to prevent, eliminate or reduce ahazard– if not done then there is a high probability thatthe hazard will enter food
  26. 26. Principle 3 – Critical Limits• Establish critical limit(s).• Have to establish critical limits for each CCP– boundary of acceptability/unacceptability• Usually relate to the control measure• Critical limits– easily measurable– (ideally monitored continuously)• Must be validated / justified
  27. 27. Principle 4 - Monitoring• Establish a system to monitor control of the CCP• The 5 keys of monitoring– What– How– Where– When– Who
  28. 28. Principle 5 – Corrective Action• Establish the corrective action to be taken whenmonitoring indicates that a particular CCP is notunder control.• Corrective action procedures must include– what must be done with potentially unsafeproduct– what adjustments must be made to the processto get it back under control– who has responsibility for both activities
  29. 29. Principle 6 - Verification• Establish procedures for verification to confirm thatthe HACCP system is working effectively.• These procedures demonstrate that the HACCPplan– being followed and;– is effective
  30. 30. Principle 7 - Records• Establish documentation concerning allprocedures and records appropriate to theseprinciples and their application
  31. 31. Records• Very important– Made at the time– Accurate– Identify who made them• Verified by supervisor• Evidence that procedures were followed
  32. 32. ANY QUESTIONS ?
  33. 33. Verification and Verification Activities
  34. 34. Validation Activities• Planning• Data collection• Assessment of effectiveness• Reporting
  35. 35. Validation Planning• What needs to be validated?– Critical limits associated with CCPs e.g.specified sterilisation temperatures– Foreign object removal equipment e.g. metaldetector and removal units– Filtration processes– Key processing equipment e.g. divert valves– Cleaning effectiveness– Pest control effectiveness– Training effectiveness
  36. 36. Validating CCPs• The critical limits associated with each CCP musthave a scientific reference or experimental datasubstantiating its use– regulations– Codes of Practice– published scientific evidence– soundly devised experiments• Refer to Food Safety Standards– alternate methods of compliance fortemperature/times for heating/cooling
  37. 37. Validating CCPs• Where the critical limits relate to microbialdestruction, it is very good practice to know thetarget organism and the expected destruction:– cooking chicken at 70°C for 2 minutes• Listeria monocytogenes - 6 log reduction– Cooking at 83° C for 60 minutes and 9 seconds• Non proteolytic Clostridium botulinum - 6 logreduction
  38. 38. Validating CCPs• Reference information should be included into apage titled “CCP Critical Limit Validation” (RTEprocessed meat example) E.g.– CCP step 6 (Cooking): 65° for 10 minutes– CCP step 7 (Cooling):– Uncured products 52oC to 12oC in 6 hours and12oC to 5oC within 24 hours.– Cured products 52oC to 12oC in 7.5 hours and12oC to 5oC within 24 hoursREF: ‘Australian Standard for the Hygienic Production andTransportation of Meat and Meat Products for Human Consumption.AS4696, 2007’
  39. 39. Validating Shelf Life• Shelf Life will need to be Validated for new products orwhen changes to existing products occur.• Shelf life Validation will also include “Challenge Testing”
  40. 40. ANY QUESTIONS ?
  41. 41. Pre-Requisite Programs
  42. 42. Pre-Requisite Programs• HACCP focuses on “on-line” activities• Needs “support” procedures and systems tofunction effectively (also known as “pre-requisiteprograms”)• The Food Safety Standards 3.2.2 and 3.2.3identifies that appropriate premises, facilities andequipment are also required
  43. 43. Good Manufacturing Practice (GMP)• Now used as an “umbrella” term• “GMP is the combination of manufacturing andmanagement practices aimed at ensuring that foodproducts are consistently produced to meetspecifications and customer expectations”NZIFST 1999
  44. 44. Good Manufacturing Practices• Traditional HACCP pre-requisite programs areeffectively a subset of GMPs• Support programs focus on those activities thatdirectly impact on the manufacture of safe food– aspects such as Good Laboratory Practices,building design and equipment design may notnecessarily be support programs but are part ofGMP (and need to be considered!)
  45. 45. Good Manufacturing Practices• Document Control• Design of Premises• Design of Equipment• Cleaning/Sanitation• Purchasing• Approved Suppliers• Training• Good Lab Practices• Maintenance• X-contamination Control• Good Hygiene Practices• Pest Management• Calibration• Foreign Object Control• Allergen Control• Waste Management• Reworking of Food• Warehousing Controls• Customer Complaints• Potable WaterManagement• Recall Program• Internal Auditing
  46. 46. Pre-Requisite Programs• Calibration• Cleaning• GHP• GMP - food processing• Pest control• Training• Approved suppliers• Document control & 4(c)• Preventative maintenance
  47. 47. Pre-Requisite Programs• Requirements of any pre-requisite programprocedure:– documented - all aspects written down (what,how, where, when, who)– implemented - supervised and monitored– assessed for effectiveness– corrective action provided– records kept of monitoring and correctiveactions
  48. 48. Calibration• Documented procedure– identify equipment, method, frequency, +/-• Monitoring– calibration checks• Corrective action– action taken when equipment found to be out ofcalibration (product and equipment)• Records– confirmation of required accuracy– product disposition and equipment repair
  49. 49. Validation and Verification• Validation activities– identifying required accuracy– ensuring appropriate reliability– check to determine whether any calibrationactivities are likely to create any food safetyissues, e.g. Mercury-in-glass reference• Verification activities– confirmation of required accuracy– evaluation of frequency of recalibration
  50. 50. Cleaning / Sanitation• Documented procedures– areas, methods, chemicals & frequency• Monitoring– correct concentrations and contact times• Corrective action– re-cleaning, changes to cleaning methods• Records– monitoring and corrective action
  51. 51. Validation and Verification• Validation activities– challenge testing (micro. and physical)– detailed assessment of the program– risk assessment of possible residues• Verification activities– pre-operational start-up checks– surface swabbing/ATP rapid methods– rapid colour change surface checks– revalidation if the program changes
  52. 52. Good Hygienic Practices (GHP)• Documented policies on– clothing, staff hygiene, illness, smoking, eating,waste bins handling, jewellery, gloves• Monitoring– Inspections• Corrective action– re-training, changes to the system• Records– audit reports and corrective actions
  53. 53. Validation and Verification• Validation activities– interviews after induction training• Verification activities– audits by observation and interview– review of customer complaints for hair,jewellery, tools, and pens (etc) - anything thatcomes from staff– refresher training with Q’s and A’s– review of documented program
  54. 54. Pest Control• Document procedures– target pests, chemicals, frequency, location• Monitoring– observation/audits• Corrective action– product disposition, and review of program• Records– assessment, corrective action– action taken in regard to product
  55. 55. Validation and Verification• Validation activities– high intensity sticky boards, appropriateness oftraps, IR sensing, chemical applications• Verification activities– sticky boards review for effectiveness– review of consumer complaints– audit of the pest controller’s operations– trend analysis of activity
  56. 56. Training• Documented procedure– training plan, critical activities undertaken byappropriately trained operators• Monitoring– regular reviews• Corrective action– re-training• Records– training records and reviews
  57. 57. Validation and Verification• Validation activities– “buddy” review, interviews, competency checks,training effectiveness• Verification activities– observations and interviews– review of customer complaints e.g. incorrectlabels, missing ingredients, incorrect product– review of training program content
  58. 58. Approved Suppliers• Documented procedures– suppliers approved on the basis of their ability tosupply safe material - criteria for selection• Monitoring– approval/certification status, test results (C of A)• Corrective action– rejection, letters of warning, deletion• Records– receival inspection, C of A’s, corrective actions
  59. 59. Validation and Verification• Validation activities– questionnaires, on-site audits to determine status– analysis of pre-delivery samples– inspection during production runs• Verification activities– re-audits– updates of appropriate certifications– trend analysis of delivery accuracy– review of customer complaints
  60. 60. Document Control• Documented procedures– policies on document and forms management• Monitoring– issue status, correct location, correct users• Corrective action– replacement, retraining• Records– document, record, and amendment regis
  61. 61. Validation and Verification• Validation activities– review of implementation• Verification activities– internal audit of currency, location, and users
  62. 62. Maintenance• Documented procedure– schedule of planned activities– procedures for unplanned repairs (foreign bits)• Monitoring– timeliness of activities• Corrective action– Reschedule• Records– completed works orders
  63. 63. Validation and Verification• Validation activities– not applicable• Verification activities– trends in breakdowns– downtime studies– review of customer complaint
  64. 64. Allergen Control• Documented procedures– policies on allergen management with linespecific clean-up procedures and change-overrules• Monitoring– pre-start up inspections (= “clear to go”)• Corrective action– reclean, reschedule production• Records– pre-start up checks
  65. 65. Validation and Verification• Validation activities– residue testing after clean-up– quantitative analysis used to supportassumptions and validation– challenge testing of surfaces• Verification activities– residue testing after clean-up– “clean” product analysis
  66. 66. Foreign Object Control• Documented procedure– policies on foreign object elimination (includingglass)• Monitoring– inspection and observation• Corrective action– remove objects, isolate product, retrain staff• Records– pre-start up checks, incident logs
  67. 67. Validation and Verification• Validation activities– interview of staff and supervisors• Verification activities– “hazard hunts”, and GMP audits– evaluation of foreign object complaints: where inthe process could they have originated– trend analysis of type of object– review of incident logs
  68. 68. Dropped Product• Documented procedure– clear policies on what to do if ingredients, work-in-progress, and finished product contacts theground• Monitoring– Observations• Corrective action– reject, and retrain• Records - incident logs
  69. 69. Validation and Verification• Validation activities– interview of staff after awareness training• Verification activities– GMP audits– observation by supervisors– review of incident logs– review of customer complaints (dirt etc)
  70. 70. Summary• Validation represents the data and references thatall key activities within the QA system are going todeliver the food safety and quality objectives thatour specifications demand• Verification represents those activities that needto be in place to ensure that we are delivering ourfood safety and quality objectives
  71. 71. Summary• Reasonable precautions can be demonstrated byhaving accurate and up-to-date HACCP plans andGMPs in place, that are understood by all staff• Validation and verification activities, together withthe internal audit process for the balance of the QAsystem, demonstrate that the company isexercising due diligence
  72. 72. ANY QUESTIONS ?
  73. 73. For more informationA recording of this webinar will beavailable on your MyTutor portal• Visit• Call 1300 727 444• Email training@saiglobal.comThank you for attending