GFSI FSMA HARPC & FUTURE OF AUDITS

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2 GFSI FSMA HARPC & FUTURE OF AUDITS Presented at the North American Millers Association May 14, 2015 Peoria, IL Walter P. Saraniecki, MS, LDN, LEHP, REHS/RS Food Safety Auditor, SGS North America

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4 WHAT MAKES A FOOD SAFER THAN OTHERS? n A great food safety management system n A certified HACCP plan that is properly followed n Attention to allergens n Verification n Validation n A trusted and respected food safety auditing firm n Great employees 4

5 JUST A FEW NOTABLE FOOD BORNE DISEASE OUTBREAKS & RECALLS n Spinach outbreaks n 500,000 eggs recalled n Peanut butter outbreak n Cantaloupe outbreak n China s food safety woes now a global concern n E. coli outbreaks n Raw cookie dough outbreaks n Navajo Pride Bleached Flour recall n Cornmeal recall 5

6 WHY WAS GFSI NEEDED? n Large food manufacturers and retailers had/have little faith in any government s ability to ensure the quality and/or safety of the food supply they were buying or selling n Nearly all of them had either their own food safety/quality inspection teams or utilized third party inspectors (auditors) to inspect not only their own facilities but also their suppliers and their suppliers suppliers (farm to fork for real) n There are hundreds of different inspection (audit) schemes currently in use across the globe 6

7 SUPERFLUOUSLY REDUNDANT INSPECTIONS n This resulted in each supplier of food or food grade packaging being audited by almost everyone of their customers inspection teams annually! n Superfluously redundant inspections resulted in: Waste of time, money, and productivity Wide variations in the quality & effectiveness of audits Wide variations in the competency of the auditor False sense of security that the inspections/audits were actually accomplishing added food safety and quality 7

8 THE EFFECT OF REDUNDANT AUDITS 8

9 VERIFYING AND NOT VALIDATING n Many audits were only verifying and not validating that the food safety program was reducing or eliminating the hazard identified in the HACCP plan n The large buyers, suppliers, government, academia, audit certification bodies, accreditation bodies, scheme owners, retailers, and others got together and said enough of this redundancy! n Too many recalls and FBDOs 9

10 ONCE CERTIFIED ACCEPTED EVERYWHERE n If your facility is certified by a GFSI certified body then all (most) other companies have to accept the facility as meeting the benchmarked standard n Redundancy is dead and gone therefore food safety, quality and efficiency is improved (allegedly) 10

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13 PROVEN VALUE FROM GFSI AUDITS n Walmart: University of Arkansas Study shows safer food for consumers n Walmart: 31% reduction in product recalls n Metro: 90% decrease of recalls in Germany n Migros: 50% reduction of audits n Cargill: $5mm/year in reduced redundant audit costs. Estimated $15mm/year savings once fully implemented n Danone: 4 million in reduced redundant audit costs in the first year Source: 13

14 GFSI APPROVED AUDIT SCHEMES n FSSC October 2011 Issue (5K worldwide) n SQF CODE 7TH Edition Level 2 (5K worldwide) n BRC Global Standard For Food Safety Issue 6 (18K) n 11 total schemes + 2 in progress including China HACCP 14

15 GFSI & FSMA n FSMA requires that Importers give the FDA prior notice for all high risk foods entering the US. n FSMA places the burden of proof on foreign food IMPORTERS that their imported foods are safe n FSMA states that this safe food certification can be performed by foreign governments or THIRD PARTY Certifying Bodies (CB) n Once fully implemented there will be a great demand for auditors in foreign countries 15

16 FSMA MANDATED INSPECTION FREQUENCY From the date of the President signing the law: n High Risk Domestic Facilities: Once in the first 5 years Once every 3 years after n Non-High Risk Domestic Facilities: Once in the first 7 years Once every 5 years after n vs GFSI Audits: Minimum once every year; more if high risk 16

17 FSMA MANDATORY PREVENTIVE CONTROLS FOR FOOD FACILITIES Proposed Rules: n Evaluating hazards that could affect food safety n Specifying what preventive steps, or controls, will be put in place to significantly minimize or prevent the hazards n Specifying how the facility will monitor these controls to ensure they are working n Maintaining routine records of the monitoring n Specifying what actions the facility will take to correct problems that arise 17

18 FDA S NEW TOOLS FROM FSMA n Mandated inspection frequency n Mandatory recalls n Expanded records access n Expanded administrative detention n Suspension of registration n Enhanced product tracing n Third party laboratory testing 18

19 FUTURE DIRECTIONS IN AUDITING n Better qualified auditors n Standardizing auditors n Higher benchmarks of audit schemes n Risk based audits n Attention to backflow prevention n Attention to cross connections of potable water n Targeted customer audits of GFSI certified facilities n Sanitary transport of food and packaging n Protection against intentional adulteration 19

20 NEHA S CCFS CREDENTIAL CERTIFIED in COMPREHENSIVE FOOD SAFETY 20

21 HARPC PROVISIONS OF FSMA OR HACCP ON STEROIDS Hazard Analysis Risk-Based Preventative Controls n HACCP will be required of all types of food processing facilities with a few exceptions Having total sales of less than $1 million Less than 500 employees must comply in 2 years USDA facilities n Prevention is the cornerstone n HA will now encompass radiation (P, B, C & R) n Requirement to Reanalyze Any significant change at the facility that might increase a known hazard or introduce a new one or At least every three years 21

22 HARPC PREVENTIVE CONTROLS EXAMPLES n Sanitation procedures at food surface contact points n Sanitation of utensils and equipment n Staff hygiene training n Environmental monitoring program (for pathogen controls) n Food allergen control program n Recall plan n Current Good Manufacturing Practices (cgmps) n Supplier verification activities 22

23 THANK YOU FOR YOUR ATTENTION. LUNCH OR QUESTIONS?