Implementation of HACCP based procedures. Tom Kennedy
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1 Implementation of HACCP based procedures Tom Kennedy
2 HACCP Art 5 Regulation 852/2004 Food business operators shall put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles.
3 HACCP system = Food Safety Management System = The FBO s HACCP related activities including training, pre-requisite programme and HACCP plan. HACCP Plan Product / Process Pre-requisite Programme Processing Environment HACCP Training HACCP Team
4 HACCP Plan Is a written document based on the principles of HACCP which outlines procedures to be following to assure control of a specific product or specific process Followed by whom? The HACCP plan essentially informs an operative how to do his job
5 Responsibility of FBO HACCP system Written pre-requisite programmes Write SOPs Adequate training HACCP Team Monitorers Verifiers Records to demonstrate compliance Conduct reviews? When? Verification / Validation
6 Responsibility of Competent Authority Initial evaluation of HACCP plan Ongoing evaluation of HACCP plan
7 Pre-requisite programme Basic conditions and activities that are necessary to maintain a hygienic environment throughout the food chain suitable for the production, handling and provision of safe end products and safe food for human consumption
8 Examples?
9 Verification Confirmation, through the provision of objective evidence that specified requirements have been fulfilled
10 Validation Obtaining evidence that the control measures managed by the HACCP plan and the prerequisite programmes are capable of being effective
11 Discussion Validation v Verification
12 Essentially... Safe food CCP 1 CCP 2 CCP 3 Pre-requisite 1 Pre-requisite 2 Pre-requisite 3 MANAGEMENT COMMITTMENT
13 Management Comittment
14 12 Steps / 7 Principles Step Logical Sequence Principle 1 Assemble the HACCP Team 2 Product / Process description 3 Intended use and end user 4 Process Flow Diagram 5 Confirm accuracy of flow diagram 6 Conduct a Hazard Analysis 1 7 Identify the Critical Control Points 2 8 Establish Critical Limits 3 9 Establish Monitoring Procedures for each CCP 4 10 Establish Corrective / Preventative actions 5 11 Establish Verification Procedures 6 12 Documented working instructions for each CCP and records to demonstrate compliance 7
15 Step 1 - Assemble the HACCP Team Food Safety Team Leader Manage Team TNA Established, Implements and oversees the FSMS Reports to Management Food Safety Team Multidisciplinary Production Maintenance Technical R&D
16 Step 2 - Product / Process Description Product characteristics Raw materials, ingredients, food contact materials Characteristic of end product
17 Step 3 Intended Use Must consider the intended use Unintended but reasonably expected mishandling / misuse of the product must be identified Groups of users / end users to be identified
18 Exercise - Intended Use / End User Crumbed raw chicken goujons to be cooked prior to consumption. Product Intended Use Potential Abuse Action by HACCP Team End Use / End user Potential Abuse Action by HACCP Team Raw chicken strips coated in bread crumbs Retail Poor stock rotation. Temperature abuse. Loss of traceability. Batch numbers. Dates of minimum durability. Labelling Restaurant ; home use. All ages. Persons prone to allergens Poor stock rotation. Undercooking. Cross contamination in kitchen. BBD / UBD Cooking instructions. Labelling ALLERGENS.
19 Step 4 Construct a flow diagram. Flow diagrams must be prepared for the product or processes covered by the FSMA and must include: The sequence and interaction of all steps Any outsourced processes or subcontracted work Where the raw materials, ingredients and intermediate products enter / leave the flow Rework / recycle End-products, intermediate products, by products or waste are removed
20 Step 5 Confirm accuracy of PFD Food safety team Onsite checking Walk the process Sign off
21 Step 6 Hazard Analysis Each step Determine which hazards need to be controlled All hazards that are reasonably expected to occur shall be identified and recorded Each hazard must be evaluated according to the possible severity of adverse health effects and the probability of their occurrence. RISK
22 RISK Article 3 178/2002 Risk means the function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard.
23 Qualitative analysis Risk Assessment A typical approach is to use a P x S matrix describing the probability and the severities of the risk associated with each hazard. P = level of probability S = level of severity Each sell within the matrix represents a simple combination of probability and severity.
24 Qualitative Probability Levels Level of probability of the hazard getting to the market place if the control fails. Probability High Medium Low Definition Likely to happen, often, frequent May happen but not frequent Unlikely to happen, rare remote
25 Qualitative Severity Level Level of severity if the consumer ingests the hazard. Severity Significant Moderate Negligible Definition Death or serious injury Reversible of minor injury Will not cause injury or will only slightly injure
26 3 x 3 Matrix Qualitative Severity Level Qualitative Probability Levels Negligible Moderate Significant High Unacceptable Unacceptable Unacceptable Medium Acceptable Acceptable Unacceptable Low Acceptable Acceptable Acceptable
27 e.g. Milk Pasteurisation Step Milk Pasteurisation Hazard Pathogenic Survival What is the severity? Significant What is the probability? Medium What is the risk? Unacceptable
28 Hazard Analysis Carry out a hazard analysis (at each process step) by identifying and listing all potential hazards and list the measures to control the identified hazards. Biological Contamination, growth, survival Chemical Residue, cleaning chemicals, medicines, herbicides Physical People, premises, plant, packaging, pests Intrinsic Allergens
29 Hazard Analysis Step Cooking Product : Cooked ready to eat deli meats Author Decision Tree Date Page of Hazard Cause Control Measure Biological Hazards Pathogen Survival Chemical Hazards Cleaning residue Physical hazards Equipment Inadequate Time Inadequate Temp Poor rinsing procedure Inadequate maintenance Maintenance Services Calibration SOP Sanitation pre-requisite programme Maintenance programme P S Risk Q1 Q2 CCP Y/N S S UA M M A L N A Comment
30 Step 7 Identification of CCPs Critical control points are those where a specific hazard must be controlled to protect the consumer, on the basis that no further process will deal adequately with that hazard.
31 Simplified decision tree! Q1 Would a loss of control at this point result in a realistic risk of illness of injury? YES NO Q2 Is there a later step (under your control) at which this hazard is or can be controlled Not a CCP CCP NO YES Not a CCP
32 Warning! Never put pre-requisites through the decision tree. If you do you will unnecessarily create CCPs
33 Hazard Analysis Step Cooking Author Joe Bloggs Hazard Cause Control Measure Biological Hazards Pathogen Survival Chemical Hazards Cleaning residue Physical hazards Equipment Inadequate Time Inadequate Temp Poor rinsing procedure Inadequate maintenance Maintenance Services Calibration SOP Product : Cooked ready to eat deli meats Decision Tree Date Page of P S Risk Q1 Q2 CCP Y/N S S UA Yes No Yes Comment Pre-req Pre-req Pre-req Sanitation M M A Pre-req Maintenance programme L N A Pre-req
34 Step 8 Determine Critical Limits Rationale for chosen limits should be documented Validation Time / Temperature combinations Presence / Absence Validation sources Industry guidelines R&D Trials Legislative requirements Scientific publications Supported by work instructions, specifications, education and training.
35 Step 9 Monitoring Schedules A monitoring schedule should be established for each CCP to demonstrate that the CCP is under control It should consist of the relevant procedures, instructions and records What has to be done? Who will do it? When (how often) has it to be done? How (with what) will it be done?
36 Step 10 Corrective action Corrective action will be taken when there is a deviance for the critical limit. Preventative element Disposition of the product
37 HACCP Plan Step Hazard Cause Control measure PRODUCT Cooked Deli Meats Critical Limits Author Date Rev Page of Monitoring Corrective Action Doc Ref Verification What can go wrong? Why did it go wrong? What can I do about it? What? Who? When? What can I do about it? How do I prove it? Cook -ing Pathogen Survival Inadequate time temperature combination Maintenance Services Calibration SOP > 72 o C for 2 minutes Core meat temp of one chicken from each tray in cooker Trained operative Each cook Rework Recook Divert Repair ovens Retrain operative Recalibrate Process control charts Weekly check on monitoring activities
38 Step 11 - Records The FSMS should include Documented procedures Records Written for whom??operator v Auditor?
39 Step 12 - Verification Paperwork verification Operational verification of CCPs Microbiological verification of product Which one?
40 Exercises
41 Thank you!
COMPANY NAME Title: Document: Effective Date: Supersedes Date: Reason For Revision:
Page 1 of 7 1. PURPOSE 1.1 To create an organized FSMA PC Rule risked- base Food Safety Plan for Company Name ensuring all Food Safety Plan Hazards are identified and Preventive Controls are maintained,
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