FSMA compliance update

Transcription

1 FSMA compliance update November 2017 Chris Milan, VP, NexTec Richard Ross, Owner Pathtracer Laboratory & Consulting Services

2 Agenda FSMA compliance an update for the food industry Why FSMA? Who must comply? What are the rules? Where are the benefits? How is a food safety culture created? Questions? 2

3 Why FSMA? Why the US established the Food Safety Modernization Act Annual estimate of preventable foodborne illness outbreaks in the US¹ 48 million sickened 1 in 6 Americans 128,000 hospitalized 3,000 die ¹ 3

4 Recently deadly outbreaks Salmonella contaminated peanut products 700 sickened in 46 states, 9 deaths 398 products recalled from 361 companies Salmonella tainted eggs 1900 sickened, 500 million eggs recalled Listeria contaminated cantaloupe 147 sickened, more than 30 deaths 4

5 Costs The cost of food contamination to US businesses is enormous $77B $15.6B $1B Annual economic losses to food industry from recalls 1 Annual loss in medical expenses, lost wages and death 2 Estimated loss to peanutproduct producers 3 ¹ ² ³ 5

6 FDA paradigm shift A new approach FSMA mandates a new approach to food safety Focus on risk-informed and preventative Establishes prevention-oriented standards Gains industry compliance with the standards through inspections and other verification activities (e.g. sampling) FDA enhances its risk-informed models for inspection frequencies, and develops sampling programs and resource deployment strategies to align with the expanded responsibilities 6

7 Who must comply? Must comply by Sep 2018 Bullet point Bullet point Bullet point Food producers Food processors Packers Transporters Distributors Foreign suppliers / importers Food contact packaging 7

8 What are the rules? Preventative measures Preventive controls for human food Preventive controls for animal food Produce safety Foreign supplier verification Sanitation Preventive Controls Food defense Third-party audits 8

9 Preventive controls for human and animal food Rules 1 and 2 cgmps HACCP HARPC PCQI Sanitation Environmental Monitoring Allergens Cross-contamination Recalls mock and real Employee training Recordkeeping 9

10 Testing environmentals & products Rule 1a Test all products for pathogens Determine areas of facility to be tested Establish baseline for testing and scientifically set procedures for frequency Set corrective actions based on results 10

11 Produce safety Rule 3 Agricultural water Treated and untreated soil Worker health and hygiene Equipment, tools, buildings, sanitation Domesticated and wild animals Growing, harvesting, packing and holding Sprouts 11

12 Foreign supplier verification Rule 4 Importers are required to Conduct a hazard analysis FDA will evaluate and approve based on analysis Conduct supplier verification activities Take corrective action, if needed Maintain records 12

13 Sanitary transportation Rule 5 Vehicle and equipment must be cleanable and adequately cleaned Adequate temperature control Protection from contamination Employee training Recordkeeping 13

14 Food defense Rule 6 Prevention of intentional adulteration Vulnerability assessment Mitigation strategies Employee training Recordkeeping 14

15 Third-party audits Rule 7 Consultative and regulatory audits report Deficiencies that pose risk Corrective actions for addressing deficiencies Sampling and laboratory testing History of recalls and changes to facility Certifications issued within last 2 years 15

16 When to report to the FDA New responsibilities FDA registered facilities are required to report a reasonable probability that, the use of or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals, a SAHCDHA event Facilities must report the receipt of contaminated ingredients from suppliers when the receiving facility cannot remove the hazard and supplier was required to do so 16

17 FSMA rules Punishment or Reward? 17

18 Where are the benefits? FSMA regulations Profit Food Safety Food Quality 18

19 Safety and quality The difference Safety Know your suppliers Know your production processes Identify hazards Take corrective action Know where your product is shipped Have security procedures in place Quality Reduce processing waste Reduce packaging waste Increase efficiency Improve consistency Control costs Increase employee commitment Develop customer and consumer trust 19

20 How to create a food safety culture? It all starts at the top! Develop standard operating procedures Create a food safety plan Involve employees Communicate with suppliers Develop receiving and shipping procedures Record activities Be inspection prepared 24/7 20

21 Aspen Foods refused to recall chicken and the complaint vanished Recall of 1.9 M lbs. in July, 2015 Company scientifically enhanced testing to reduce salmonella FSIS found more of the same strain of salmonella two months after initial recall FSIS directed staff to detain products found in commerce because the company refused the recall Company stated that their scientific protocols and cooking instructions are enough warning to consumers of potential pathogens 21

22 About NexTec Group 22

23 About NexTec An award-winning business technology consultancy ERP, CRM, BI, Cloud and On-premise solutions to small and mid-sized businesses Specialize in working closely with clients to find the right solution for their business the first time Industries: Manufacturing (process and discrete) Food and beverage Pharmaceuticals/nutraceuticals Chemicals Medical devices Distribution / Supply chain management Professional services Agriculture / Cannabis 23

24 Some of our Sage X3 process customers 24

25 About the NexTec Sage X3 team Helping our customers for over 20 years Biggest and most experienced Sage X3 team in the industry Over 40 full-time Sage X3 consultants 80+ Sage X3 clients 20 years of implementing Sage ERP solutions Working with Sage X3 since the product s introduction Emphasis on continuous improvement and optimization of ERP use 25

26 NexTec & Sage X3 Standard capabilities Bullet point Bullet point Bullet point Regulatory compliance (HACCP) Quality assurance Traceability for ingredients and end-items Product recall management Batch continuous flow processing Powerful formula & recipe management engine Allergen and product constraints designation Multiple packaging units per product Shelf-life management Product & processing costing Strong order fulfillment

27 Questions?

28 Richard Ross PathTracer Laboratory & Consulting Services Chris Milan NexTec Group

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