INTRODUCTION TO HACCP NINA G. PARKINSON NGP CONSULTING NOVEMBER 12, 2014 NGP Consulting Nov 2014 1 COMMENTS FROM 2013 Waaay too much information! Didn t even get to the end with FSMA stuff! Basic, but still several people present, some had nooooo idea what HACCP or GMPs were! In general, well received, but need to taper it down some! NGP Consulting Nov 2014 2 HACCP What is it? SECTION SUMMARY Program designed to assure the production of a safe food How to develop a plan? Why you need to know about it! Audits Food Safety Modernization Act (FSMA) and HARPC NGP Consulting Nov 2014 3 11/1 11/12/14 1
THE US REGULATORY AGENCIES USDA jurisdiction over meat and poultry products, including slaughter and processing and liquid, frozen and dried egg products FSIS Food Safety and Inspection Services FDA jurisdiction over all other foods, including seafood, juice, dairy and shelled eggs CFSAN Center for Food Safety and Applied Nutrition NGP Consulting Nov 2014 4 WHAT IS HACCP? Program designed to assure the production of a safe food A system based on scientific concepts The objective is to prevent problems A system separate and different from Quality Control Color Texture Taste Biological Hazards Chemical Hazards Physical Hazards NGP Consulting Nov 2014 5 H IS FOR HAZARDS A biological, chemical or physical agent that is reasonably likely to cause illness or injury in the absence of its control NGP Consulting Nov 2014 6 11/1 11/12/14 2
BIOLOGICAL HAZARDS = PATHOGENS Bacteria Salmonella spp. E. coli 0157:H7 Listeria monocytogenes Viruses Hepatitis A Norwalk virus or Norovirus Parasites Cryptosporidium spp. Cyclospora spp. Affect different foods/ingredients Have different growth needs and resistances Growth vs Survival Illness may affect consumers differently NGP Consulting Nov 2014 7 POTENTIAL CONTROLS FOR BIOLOGICAL HAZARDS Heating time and temperature (blanching, pasteurizing, thermal process) Refrigeration/Freezing ph control (formulation, processing) Residual sanitizer levels Cross contamination prevention NGP Consulting Nov 2014 8 Mycotoxins CHEMICAL HAZARDS OCCURRING NATURALLY By-product of mold growth on some foods Allergens = Big 8 Peanuts, tree nuts, wheat, soy, fish, shellfish, dairy and eggs Different in other countries Intolerances and Sensitivities Lactose Gluten NGP Consulting Nov 2014 9 11/1 11/12/14 3
CHEMICAL HAZARDS ADDED INTENTIONALLY Colors and flavors Preservatives Nutrients NGP Consulting Nov 2014 10 CHEMICAL HAZARDS ADDED INADVERTENTLY Environmental contaminants Pesticides Radiological Hormones, antibiotics Sanitation chemicals Maintenance chemicals NGP Consulting Nov 2014 11 POTENTIAL CONTROLS FOR CHEMICAL HAZARDS Ingredient and materials specifications Controlled raw material and ingredient sourcing Controlled storage of raw material Allergen control programs Employee training CGMPs NGP Consulting Nov 2014 12 11/1 11/12/14 4
PHYSICAL HAZARDS Any potentially harmful extraneous matter not normally found in food Usually associated with injury like cuts, broken teeth, choking Reaction is immediate NGP Consulting Nov 2014 13 POTENTIAL PHYSICAL HAZARDS IN FOODS METAL WOOD GLASS PLASTIC STONES BONES COMPLIANCE POLICY GUIDE 555.425 HARD OR SHARP OBJECTS 7-25 MM FOR GENERAL PUBLIC (1/4 TO 1 INCH) GUIDELINE NOT A RULE 14 NGP Consulting Nov 2014 POTENTIAL CONTROLS FOR PHYSICAL HAZARDS Raw material contract stipulations Metal detectors Will the control measure be Magnets effective for: X-ray equipment the hazard the product Screens/Sieves the container Manual removal of contaminants NGP Consulting Nov 2014 15 11/1 11/12/14 5
SUPPORT PROGRAMS Good Manufacturing Practices (21CFR110) Prerequisite Programs (PRPs) Education and training programs Preventive maintenance Pest control Chemical control Supplier controls MUST BE FORMALIZED!! HACCP Prerequisite Programs Good Manufacturing Practices NGP Consulting Nov 2014 16 HOW TO DEVELOP A HACCP PLAN How many already have a HACCP Plan? How many are trying to develop one? How many are trying to figure out how to transition to HARPC? NGP Consulting Nov 2014 17 PRELIMINARY STEPS (TO DEVELOP OR REVIEW A HACCP PLAN) HACCP 1. Assemble the HACCP Team 2. Describe the food and its distribution 3. Describe the intended use and consumer (different applications and sensitivities) Ingredients Mix Thermal Process 4. Develop flow diagram 5. Confirm flow diagram Packaging Ship NGP Consulting Nov 2014 18 11/1 11/12/14 6
7 HACCP PRINCIPLES 1. Conduct a Hazard Analysis (HA) 2. Determine Critical Control Points (CCPs) 3. Determine Critical Limits (CLs) 4. Establish monitoring procedures 5. Establish Corrective Actions (CAs) 6. Establish verification (and validation) procedures 7. Establish recordkeeping and documentation procedures NGP Consulting Nov 2014 19 1. CONDUCT A HAZARD ANALYSIS The process of collecting and evaluating information on hazards associated with the food under consideration to decide what hazards are significant (likelihood of occurrence and severity) and must be addressed in the HACCP plan. NGP Consulting Nov 2014 20 POTENTIAL HAZARDS TO CONSIDER Biological hazards Pathogens Chemical hazards Naturally occurring Intentionally added Unintentionally/Incidental Physical hazards Metal, glass, wood, stones, etc. Ingredients Mix Thermal Process Packaging Ship NGP Consulting Nov 2014 21 11/1 11/12/14 7
HAZARD ANALYSIS Evaluate each hazard listed for Likelihood of occurrence Severity of illness or injury Decide if the hazard needs to be controlled in the HACCP Plan or if it can be controlled adequately in a Prerequisite Program HACCP Can be difficult but Prerequisite Programs is VITAL to a good HACCP plan Nov 2014 Good Manufacturing NGP Consulting 22 Practices 2. DETERMINE CRITICAL CONTROL POINTS Critical Control Point (CCP) = point, step or procedure in a food process at which a control measure can be applied and at which control is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level. NGP Consulting Nov 2014 23 CRITICAL CONTROL POINTS (CCPs) Depend on: Formulation Process flow Equipment Ingredient selection Sanitation and other support programs Are specific to: Product Process Line Ingredients Mix Thermal Process Packaging Ship NGP Consulting Nov 2014 24 11/1 11/12/14 8
For each CCP. TEMP 3. Establish critical limits 4. Establish monitoring procedures 5. Establish corrective actions NGP Consulting Nov 2014 25 3. ESTABLISH CRITICAL LIMITS TIME A criterion which separates acceptability from unacceptability Process specifications (time/temp) Numerical value or yes/no decisions Based on science If appropriate limits are not well defined, need to generate data or change the process NGP Consulting Nov 2014 26 CRITICAL LIMITS VS. OPERATIONAL LIMITS Critical Limits Values or parameters necessary to make sure the hazard is being controlled Operational Limits Usually set for quality or production purposes; Usually more stringent than Critical Limits If there s a deviation usually make a process adjustment NGP Consulting Nov 2014 27 11/1 11/12/14 9
Process Temperature 190 Temperature ( o F) 180 170 160 150 Process Adjustment Needed Corrective Action Required Operating limit Critical limit 140 Time NGP Consulting Nov 2014 28 4. ESTABLISH MONITORING PROCEDURES Monitoring = a planned sequence of observations or measurements to assess whether the point, step or procedure is under control. NGP Consulting Nov 2014 29 MONITORING PROCEDURES What should be monitored Time, temperature, ph, etc. Make sure it matches the CL How it should be monitored Thermometer, recording chart, ph meter, visual observation, etc. Frequency Daily, hourly, continuously, etc. As it happens, not after the fact! Minimize hazards and product loss NGP Consulting Nov 2014 30 11/1 11/12/14 10
By whom MONITORING PROCEDURES Line operator, QC tech, etc. Must be properly trained Clearly defined responsibility and time available Initial responsibility for Corrective Actions Responsible for documentation (accurate, verifiable) NGP Consulting Nov 2014 31 5. ESTABLISH CORRECTIVE ACTIONS Procedures that must be taken when Critical Limits are not met, in order to eliminate an actual or potential hazard. NGP Consulting Nov 2014 32 CORRECTIVE ACTIONS Predetermined in HACCP Plan Procedures to be taken at each CCP Get production back on track Correct the problem Responsibility One person should be assigned to make decisions and everyone else must respect NGP Consulting Nov 2014 33 11/1 11/12/14 11
CORRECTIVE ACTIONS Disposition of affected product Divert Reprocess Segregate until evaluated (Release/Destroy) Documentation Records showing exactly what happened at every step, including product disposition Reassess the HACCP Plan Minimize/Eliminate recurrence! NGP Consulting Nov 2014 34 For each CCP For the HACCP System 6. Establish verification (and validation) procedures 7. Establish recordkeeping and documentation procedures NGP Consulting Nov 2014 35 6. ESTABLISH VERIFICATION (AND VALIDATION) ACTIVITIES Verify that we are following the Plan we developed ( compliance ) Validate that what we re doing is truly providing a safe food NGP Consulting Nov 2014 36 11/1 11/12/14 12
VARIOUS TYPES OF VERIFICATION Verification of the CCPs Calibration of equipment Review of daily monitoring, Corrective Action and calibration records NGP Consulting Nov 2014 37 Continuous Monitoring Record Verification Record 2030 2100 2130 2200 2230 2300 2316 CCP Chart Recordings (Strip & Circulars) ok NGP Consulting Nov 2014 38 QA Manager s Signature VARIOUS TYPES OF VERIFICATION Verification of the CCPs Calibration of equipment Review of daily monitoring, Corrective Action and calibration records Verification of the HACCP System Review of the HACCP Plan is it being followed? Are the programs that support the HACCP Plan still working as intended? and AUDITS. NGP Consulting Nov 2014 39 11/1 11/12/14 13
AUDITS Verify that you re in compliance with a standard Regulation Customer Auditing company Your own plan! NGP Consulting Nov 2014 40 VALIDATION IS PART OF VERIFICATION Validate that what you re doing is truly producing a safe food Did you consider all the potential hazards? Are you controlling them properly? Is there anything new you need to consider? NGP Consulting Nov 2014 41 VALIDATION FREQUENCY Initially upon development of the HACCP Plan Make sure you can really do what you said you d do Annually (at least) Make sure everything is still valid -- there haven t been any changes or modifications that can affect the hazard analysis Whenever any of the following occurs Adverse findings Major failures Major changes NGP Consulting Nov 2014 42 11/1 11/12/14 14
CASE STUDY 2006 Peter Pan Peanut Butter recalled for Salmonella contamination 620 people ill, no deaths 2008 Peanut Corporation of America (PCA) recalls peanut butter and peanut paste Over 700 people ill, 9 people died 2011 Sunland inc. 42 people ill, 10 hospitalized, no deaths 2013 nspired natural foods NGP Consulting Nov 2014 43 7. ESTABLISH DOCUMENTATION AND RECORDKEEPING PROCEDURES Documentation is the basis of the HACCP Plan It must be written down, otherwise it didn t happen!! Provides opportunity to review trends, and possibly prevent problems Difficult at first, but then becomes routine NGP Consulting Nov 2014 44 DOCUMENTATION AND RECORDS HACCP Plan and support documentation used in developing the plan, including hazard analysis Documentation of CCP monitoring CCP deviation and Corrective Action records Verification audits Validation documents Prerequisite program documentation NGP Consulting Nov 2014 45 11/1 11/12/14 15
Data entry RECORDS Accurate, at the time it occurred!! No erasures, write-overs, etc. Corrections are made with single line over incorrect entry, new entry, initials, date Review Within prescribed period of time Trained individual Assure that procedures were followed, particularly CA s when deviations occurred NGP Consulting Nov 2014 46 RECORDS Use records to identify trends NGP Consulting Nov 2014 47 FOOD SAFETY MODERNIZATION ACT (FSMA) SIGNED IN 2011 Applies to FDA regulated foods Gives greater authority to FDA to control and regulate the food industry Access to company records Facility registration requirements Mandatory recall authority Risk-based inspections NGP Consulting Nov 2014 48 11/1 11/12/14 16
FOOD SAFETY MODERNIZATION ACT (FSMA) SIGNED IN 2011 Places more emphasis on: Preventing food safety problems Detecting and responding to problems Assuring the safety of imported products NGP Consulting Nov 2014 49 FSMA HIGHLIGHTS -- PROPOSED REGULATIONS Produce safety standards Foreign supplier verification Hazard Analysis and Risk-based Preventive Controls (HARPC) Will apply to all registered facilities Will require written food safety plan Will revise cgmp regulation Exemptions NGP Consulting Nov 2014 50 HARPC (HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS) Required written food safety plan: Hazard analysis Preventive controls for significant hazards Monitoring activities Corrective actions Verification/validation validation not required for allergen controls, sanitation controls and recall plan NGP Consulting Nov 2014 51 11/1 11/12/14 17
HACCP HARPC HACCP HAZARD ANALYSIS CRITICAL CONTROL POINTS 1. Hazard Analysis Likelihood of occurrence Severity 2. Critical Control Points (CCPs) 3. Critical limits 4. Monitoring activities 5. Corrective actions 6. Verification (and validation) 7. Documentation/ recordkeeping HARPC HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS Required written food safety plan: Hazard analysis Preventive controls for significant hazards Monitoring activities Corrective actions Verification/validation validation not required for allergen controls, sanitation controls and recall plan Nov 2014 NGP Consulting 52 ANY QUESTIONS OR COMMENTS?? NGP Consulting Nov 2014 53 11/1 11/12/14 18