Validation and Verification of HACCP Plans - Webinar Presentation

1. Validation and Verification of HACCP
Plans
Andrew Nash
23rd April, 2013

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3. How it all works
Webinar 60 mins
Q & A 30 mins
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4. Session Agenda
• Introduction (10 min)
• Details of the topic (30 min)
• Q&A (45 min)

5. Definitions and Key Terminology
• Validation: confirmation and provision of objective
evidence that the requirements for a specific
intended use have been fulfilled
• Verification: confirmation and provision of
objective evidence that specified requirements
have been met
ISO 9000: 2005 - QMS Fundamentals and Vocabulary

6. Definitions
• Objective evidence: data supporting the
existence, or truth, of something
• Monitoring: maintaining regular surveillance over
(something)
• Validate - before the event
• Monitor - during the event
• Verify - after the event

7. Food Safety Program Requirements

8. Elements of a Food Safety Program
• HACCP focuses on “on-line” activities
• Needs “support” to function effectively
– “support” programs now known as “pre-requisite
programs” (PRPs)
• Needs appropriate premises, facilities and
equipment

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. Customers Specifications
Process
Capability
Hazard Analysis
HACCP Audit Table
ID & Traceability
Training
Calibration
Pest Control
Cleaning/Sanitation
Document Control
Maintenance
Good Hygiene Practices
Approved Suppliers
Labeling
Recall Protocols
Safe, Quality Food
Records
Flow Chart
= FSP
$$$

11. Customer Requirements for Validation and
Verification
SQF - Validation
• 2.3.2.4 – Validation of raw and packaging materials to
ensure product safety. Validation shall include C of C;
• C of A; or sampling and testing.
• 2.5.1.1 – Validation and verification activities shall be the
responsibility of the SQF practitioner.
• 2.5.2.1 – The methods, responsibility and criteria for
ensuring the effectiveness of pre-requisite programs, and
validating critical food safety and quality limits to ensure
they achieve their intended purpose shall be documented
and implemented.
• 2.5.2.2 – Records of all validation activities shall be
maintained.
• 2.8.2 – Allergen Management. See clause viii

12. Customer Requirements for Validation and
Verification
SQF – Verification
• 2.5.1.1 Validation and verification activities shall be the
responsibility of the SQF practitioner.
• 2.5.1.2 The frequency and methods used to validate and
verify food safety fundamentals, critical limits, and other
food safety and quality controls shall be documented and
implemented.
• 2.5.1.3 Records of all verification activities shall be
maintained.
• 2.5.3.1 A schedule outlining the verification activities,
frequency and the person responsible for each activity shall
be prepared and implemented.
• 2.8.2 – Verify Allergen based cleaning

13. Customer Requirements for Validation and
Verification
• WQA – Validation is specified throughout the WQA
Standard. 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 a
transfer heat treatment must be validated.
• Chapter 8 – Premises / Facility
– Where high risk / care requirements not in place, the
Vendor to demonstrate validated methods
– Suitability and Sufficient Refrigeration and cooling
– Validation of transfer systems into high care (sanitising
tunnels and baths)

14. Customer Requirements for Validation and
Verification
• Chapter 10 – Laundry
– The process used in laundries supplying high care
environments shall be validated
• Chapter 12 – Management of Allergens
– Cleaning methodologies shall be validated as effective at
removing allergenic material and preventing cross
contamination.
– Products labelled as ‘free from’ or ‘made without’ (or
similar) an ingredient known to cause allergy, sensitivity or
intolerances in the population require specific validated
procedures to support the on pack claim.
– The procedures of the allergen management plan shall be
fully validated and included on the internal audit program

15. Customer Requirements for Validation and
Verification
• Chapter 13 – Management of Cleaning
– The frequency of cleaning shall be based on experience,
validation and verification data and the equipment
manufacturers’ recommendations.
– Cleaning and disinfection chemicals shall be validated on
site for the use in which employed.
– CIP operations shall be established, validated and verified
as for manual cleaning
– Traditional microbiological and allergen swabs shall be
used 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 as
a claim and shall be validated.

16. Customer Requirements for Validation and
Verification
• 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. Customer Requirements for Validation and
Verification
• 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 documentation
including audit reports and certificates to demonstrate
compliance to the approved supplier animal welfare
programs.

18. ANY QUESTIONS ?

19. Hazard Analysis Critical Control Point

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. The Seven Principles of HACCP
1. Conduct a hazard analysis
2. Determine the Critical Control Points
3. Establish critical limit(s)
4. Establish a system to monitor control of the CCP
5. Establish the corrective action to be taken when
monitoring indicates that a particular CCP is not under
control.
6. Establish procedures for verification to confirm that the
HACCP system is working effectively.
7. Establish documentation concerning all procedures and
records appropriate to these principles and their
application

22. Principle 1
• Done in 3 parts:
– Identify all potential hazards at each step in the
process
– Work out the significance of the hazards
• What hazards are most likely to occur?
• What hazards will cause the greatest
problems?
– Develop control measures for all significant
hazards

23. Hazard Identification: The Enemies!
• Biological hazards
• Chemical hazards
− Allergens
• Physical hazards
• Quality Hazards

24. Control Measures
• A Control Measure is an activity that prevents, eliminates
or reduces a hazard to an acceptable level
• Where a significant hazard has been identified, a control
measure must be developed and implemented
• More than one control measure may be applied to each
hazard

25. Principle 2 - CCPs
• Determine the Critical Control Points (CCPs)
• Step/operation/practice that:
– must be done to prevent, eliminate or reduce a
hazard
– if not done then there is a high probability that
the hazard will enter food

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. Principle 4 - Monitoring
• Establish a system to monitor control of the CCP
• The 5 keys of monitoring
– What
– How
– Where
– When
– Who

28. Principle 5 – Corrective Action
• Establish the corrective action to be taken when
monitoring indicates that a particular CCP is not
under control.
• Corrective action procedures must include
– what must be done with potentially unsafe
product
– what adjustments must be made to the process
to get it back under control
– who has responsibility for both activities

29. Principle 6 - Verification
• Establish procedures for verification to confirm that
the HACCP system is working effectively.
• These procedures demonstrate that the HACCP
plan
– being followed and;
– is effective

30. Principle 7 - Records
• Establish documentation concerning all
procedures and records appropriate to these
principles and their application

31. Records
• Very important
– Made at the time
– Accurate
– Identify who made them
• Verified by supervisor
• Evidence that procedures were followed

32. ANY QUESTIONS ?

33. Verification and Verification Activities

34. Validation Activities
• Planning
• Data collection
• Assessment of effectiveness
• Reporting

35. Validation Planning
• What needs to be validated?
– Critical limits associated with CCPs e.g.
specified sterilisation temperatures
– Foreign object removal equipment e.g. metal
detector and removal units
– Filtration processes
– Key processing equipment e.g. divert valves
– Cleaning effectiveness
– Pest control effectiveness
– Training effectiveness

36. Validating CCPs
• The critical limits associated with each CCP must
have a scientific reference or experimental data
substantiating its use
– regulations
– Codes of Practice
– published scientific evidence
– soundly devised experiments
• Refer to Food Safety Standards 3.2.2.25
– alternate methods of compliance for
temperature/times for heating/cooling

37. Validating CCPs
• Where the critical limits relate to microbial
destruction, it is very good practice to know the
target 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 log
reduction

38. Validating CCPs
• Reference information should be included into a
page titled “CCP Critical Limit Validation” (RTE
processed meat example) E.g.
– CCP step 6 (Cooking): 65° for 10 minutes
– CCP step 7 (Cooling):
– Uncured products 52oC to 12oC in 6 hours and
12oC to 5oC within 24 hours.
– Cured products 52oC to 12oC in 7.5 hours and
12oC to 5oC within 24 hours
REF: ‘Australian Standard for the Hygienic Production and
Transportation of Meat and Meat Products for Human Consumption.
AS4696, 2007’

39. Validating Shelf Life
• Shelf Life will need to be Validated for new products or
when changes to existing products occur.
• Shelf life Validation will also include “Challenge Testing”

40. ANY QUESTIONS ?

41. Pre-Requisite Programs

42. Pre-Requisite Programs
• HACCP focuses on “on-line” activities
• Needs “support” procedures and systems to
function effectively (also known as “pre-requisite
programs”)
• The Food Safety Standards 3.2.2 and 3.2.3
identifies that appropriate premises, facilities and
equipment are also required

43. Good Manufacturing Practice (GMP)
• Now used as an “umbrella” term
• “GMP is the combination of manufacturing and
management practices aimed at ensuring that food
products are consistently produced to meet
specifications and customer expectations”
NZIFST 1999

44. Good Manufacturing Practices
• Traditional HACCP pre-requisite programs are
effectively a subset of GMPs
• Support programs focus on those activities that
directly impact on the manufacture of safe food
– aspects such as Good Laboratory Practices,
building design and equipment design may not
necessarily be support programs but are part of
GMP (and need to be considered!)

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 Water
Management
• Recall Program
• Internal Auditing

46. Pre-Requisite Programs
• Calibration 3.2.2.22
• Cleaning 3.2.2.19-20
• GHP 3.2.2.13-18
• GMP - food processing 3.2.2.5-11
• Pest control 3.2.2.24
• Training 3.2.2.3
• Approved suppliers 3.2.2.5
• Document control 3.2.1.3(c) & 4(c)
• Preventative maintenance 3.2.2.21

47. Pre-Requisite Programs
• Requirements of any pre-requisite program
procedure:
– 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 corrective
actions

48. Calibration
• Documented procedure
– identify equipment, method, frequency, +/-
• Monitoring
– calibration checks
• Corrective action
– action taken when equipment found to be out of
calibration (product and equipment)
• Records
– confirmation of required accuracy
– product disposition and equipment repair

49. Validation and Verification
• Validation activities
– identifying required accuracy
– ensuring appropriate reliability
– check to determine whether any calibration
activities are likely to create any food safety
issues, e.g. Mercury-in-glass reference
• Verification activities
– confirmation of required accuracy
– evaluation of frequency of recalibration

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. 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. 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. 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 that
comes from staff
– refresher training with Q’s and A’s
– review of documented program

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. Validation and Verification
• Validation activities
– high intensity sticky boards, appropriateness of
traps, 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. Training
• Documented procedure
– training plan, critical activities undertaken by
appropriately trained operators
• Monitoring
– regular reviews
• Corrective action
– re-training
• Records
– training records and reviews

57. Validation and Verification
• Validation activities
– “buddy” review, interviews, competency checks,
training effectiveness
• Verification activities
– observations and interviews
– review of customer complaints e.g. incorrect
labels, missing ingredients, incorrect product
– review of training program content

58. Approved Suppliers
• Documented procedures
– suppliers approved on the basis of their ability to
supply 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. 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. 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. Validation and Verification
• Validation activities
– review of implementation
• Verification activities
– internal audit of currency, location, and users

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. Validation and Verification
• Validation activities
– not applicable
• Verification activities
– trends in breakdowns
– downtime studies
– review of customer complaint

64. Allergen Control
• Documented procedures
– policies on allergen management with line
specific clean-up procedures and change-over
rules
• Monitoring
– pre-start up inspections (= “clear to go”)
• Corrective action
– reclean, reschedule production
• Records
– pre-start up checks

65. Validation and Verification
• Validation activities
– residue testing after clean-up
– quantitative analysis used to support
assumptions and validation
– challenge testing of surfaces
• Verification activities
– residue testing after clean-up
– “clean” product analysis

66. Foreign Object Control
• Documented procedure
– policies on foreign object elimination (including
glass)
• Monitoring
– inspection and observation
• Corrective action
– remove objects, isolate product, retrain staff
• Records
– pre-start up checks, incident logs

67. Validation and Verification
• Validation activities
– interview of staff and supervisors
• Verification activities
– “hazard hunts”, and GMP audits
– evaluation of foreign object complaints: where in
the process could they have originated
– trend analysis of type of object
– review of incident logs

68. Dropped Product
• Documented procedure
– clear policies on what to do if ingredients, work-
in-progress, and finished product contacts the
ground
• Monitoring
– Observations
• Corrective action
– reject, and retrain
• Records - incident logs

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. Summary
• Validation represents the data and references that
all key activities within the QA system are going to
deliver the food safety and quality objectives that
our specifications demand
• Verification represents those activities that need
to be in place to ensure that we are delivering our
food safety and quality objectives

71. Summary
• Reasonable precautions can be demonstrated by
having accurate and up-to-date HACCP plans and
GMPs in place, that are understood by all staff
• Validation and verification activities, together with
the internal audit process for the balance of the QA
system, demonstrate that the company is
exercising due diligence

72. ANY QUESTIONS ?

73. For more information
A recording of this webinar will be
available on your MyTutor portal
• Visit saiglobal-mytutor.com
• Call 1300 727 444
• Email training@saiglobal.com
Thank you for attending