MARCH 16, :30-10:30 AM

Transcription

1 MARCH 16, :30-10:30 AM

2 Welcome PAUL BENSON Chair, Product & Tort Liability FaB Council Member FaBsafe Leader

3 Forming the FaBsafe Committee Watch for 1 st meeting notice

4 Welcome SHELLEY JUREWICZ Executive Director

5 We believe in feeding our own, and the world better, together.

6 Cleaner, closer safer, bolder, better food and beverage

7 FaB Wisconsin is raising industry awareness and capacity for growth, advancement and attraction with a strategic focus on

8 PAT WERNER Senior Director of Quality Assurance & Compliance Co-Founders SWATI SHARMA VIVEK SHARMA

9 FSMA 2016 Food Safety Modernization Act

10 Introduction About Chr. Hansen The Road to FSMA FSMA Key Elements Preparing for the Deadline Q&A 10

11 Chr. Hansen Founded in 1874 in Copenhagen by Danish pharmacist Christian D.A. Hansen A global supplier of bioscience based ingredients to the food, health, pharmaceutical and agricultural industries Production facilities on five continents 11

12 Chr. Hansen - Our Products Food and Beverage Dairy cultures, enzymes and probiotics Wine and meat cultures Natural colors Human Health and Animal Health Probiotics for dietary supplements, infant formula and pharmaceuticals Probiotics for feed and silage inoculants

13 2009: The Road to FSMA The Evolution of Quality, Food Safety and Regulatory Consumers and Regulators want to be certain of the food safety of our products As a result, our customers are looking more closely at their supply chain Globally Driven by the Food Industry GFSI: Global Food Safety Initiative Locally Driven by the FDA FSMA: Food Safety Modernization Act GFSI 13

14 2009 Deep Dive: It s all about the Programs Audit Ready Plants Supplier Management Program HACCP Program Allergen, Environmental, Sanitation, Pest Control Internal Audits, Tracker CC/CAR/PAR Programs Product Mock Recall: < 2 hours/quarterly 2010 Training: Allergens, GMPs, Safety, Auditing, Crisis Management, etc., conducted annually 1 st CH plant 3 rd US Company FSSC certification Certifications FSSC 22000, ISO 22000, FAMI-QS

15 Key Elements of FSMA Signed into law January 4, 2011 Science based system to address hazards farm to table HACCP and HARPC Allergen Control & Labeling Foreign Supplier Verification Program (FSVP) Comprehensive Food Safety Plan Qualified Individual (QI)/Team 3rd Party Accreditation Transportation 15

16 What is the Difference?? HACCP vs HARPC 1. Identify Hazards 2. Establish Risk-based Preventive Controls (PCs) to mitigate CCPs 3. Monitor the Effectiveness 4. Apply Corrective Actions 5. Verification of PCs, monitoring, CAs, emerging risks 6. Recordkeeping and Documentation (including training); Proof 7. Requirement to Reanalyze every 3 years Hazard Analysis Risk-based Preventive Controls

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18 Foreign Supplier Verification Program (FSVP) Importers must establish and follow written procedures to ensure they import foods only from approved foreign suppliers Supplier/Raw Material Management Procedures Use of these procedures must be documented RM Compliance Review, Hazard Analysis Supplier Verification Activities Evaluations Audits Corrective Actions Periodic Assessment Documentation, Record-keeping

19 Food Safety Plan HACCP Team Food Safety Team SQM Team Food Safety Team MAJOR CHANGE: NO LONGER THIS IS WHAT YOU SHOULD DO NOW THIS IS WHAT YOU MUST DO Crisis Management Team

20 Qualified Individual (QI)/Team Qualified Individual (QI) Production employees must have documented training Preventive Control QI (PCQI) HACCP/HARPC Preventive Controls Programs, including Supplier Management; monitors compliance to procedures, recordkeeping, training, facilitates improvements QI/Food Safety Team Oversees the entire food safety plan 20

21 3 rd Party Accreditation Transportation: March/April

22 Preparing for the Deadline Food Safety Plan, Food Safety Team US Food Safety Team (Qualified Individual/s) Global QA, US Regulatory, Local QA Oversees the entire FS program for US, monitors for compliance to Chr. Hansen procedures and FSMA, facilitates improvements HACCP vs. HARPC, Preventive Controls Programs Supplier/Raw Material Management Programs Recordkeeping, Documentation, Training 22

23 Global Deadline US/Global implementation Gap analysis of all CH plants that import to US Each plant will complete self-assessment by April 1 Timeline for implementation of changes to comply with regulations Confirm who, when, how September 2016 Say What You Do, Do What You Say, Ensure it Works, Document it 23

24 New FSMA Regulations Any Questions?? Be Prepared for an Audit 365 Days a Year

25 The GFSI* Puzzle SQF 1998 British Retail Consortium 1994 Safe Quality Food Dutch HACCP GFSI 2000 BRC Food Safety System Certification Hazard Analysis Critical Control Points 2004 FSSC *Global Food Safety Initiative 2010

26 Food Safety Acronyms FS= Food Safety Q= Quality QM= Quality Management HACCP=Hazard Analysis Critical Control Points GFSI Global Food Safety Initiative SQF Safe Quality Food BRC British Retail Consortium Dutch HACCP FSSC Level 1-FS Low Risk Level 2-HACCP Certified Level 3-FS&QM Program Retailers, Brand owners Best Practice for FS&Q Standard Specific Guidelines for Operation International FS Systems HACCP Systems Includes ISO stds ISO British Standards PAS GFSI Requirements SQF, BRC, Dutch HACCP, FSSC others All systems include core GFSI FS standards KEY: Certification Against a Global Standard GFSI

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28 PAT WERNER Senior Director of Quality Assurance & Compliance Co-Founders SWATI SHARMA VIVEK SHARMA

29 FSMA Compliance with Quigistics FaBsafe Best Practice Session: Preparing and Tracking for FSMA 3/16/2016

30 About Quigistics Quigistics is an inventory management and traceability software for food processors It is scalable for processors with 5-10 to 200+ employees Our promise Quigistics makes FSMA compliance easy, so you can focus on your core business We are a FaBcap Accelerator Program Company We are based in Madison, WI

31 Vendors Customers Traceability is very complex Backward & Forward Traceability Retail Food Service Ingredients Intermediates Bulk Products Packaging Finished Goods

32 Our approach to FSMA compliance Improve operational efficiency and achieve FSMA compliance at the same time Achieve FSMA Compliance Save ingredient lot numbers Record audit-relevant information (CoA achieved, temperature, etc.) Standardize recipes for products and intermediates Record actual quantities and lot numbers of products produced & ingredients used Save process parameters Save lot numbers delivered to customers Record packaging information Procure Make Sell Improve Operational Efficiency Create and send purchase orders to suppliers electronically Receive materials Expedite material returns to vendors Scale recipes Create work orders to schedule and execute production Manufacture custom products Create sales orders Deliver orders to customers Substitute materials based on availability Invoice for actual deliveries

33 How does this all help in recalls? In actual or mock recall, backwards & forwards traceability records can be retrieved quickly. Total Purchased Purchase Orders Quality Parameters Total Used Production Records Where-Used Total Produced Production Records Process Parameters Inventory Balance 100 lbs Total Sold Sales Orders Packaging Details Total Contracted Out Purchase Orders Quality Parameters Total Wastage/Shrinkage Production Loss Yields Samples Enables surgical recalls with reduced response time

34 Our Software Quigistics supports all essential supply chain and manufacturing functions in food processing Go to to learn what each app can do

35 Quigistics Features Software as a Service (SaaS) Pay by use Reduce IT expenses and risk in IT investments Mobile Device Support Check inventory or create sales orders from anywhere Cycle counts inventory from your phone And more Cloud-Based Just log on to use Quigistics Let us sweat over software and hardware challenges

36 Cloud-based software is economic Costs of installing & maintaining in-house systems are very high However, food processors do need the benefits provided by these systems QuickBooks is for accounting; not traceability and inventory management Quigistics is offered on subscription Customers can scale subscription based on business needs No additional costs. Subscription includes hardware/software, automatic bug-fixes and updates, daily backup of data and support Historical data retained for contracted number of years

37 Contact Us Vivek Sharma Co-Founder, Quigistics (608)

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39 APRIL 12, :30-10:30 AM

40 MAY 10, :30-10:30 AM

41 JUNE 14, :30-10:30 AM

42 ANNUAL SPONSORS THANK YOU and

43 ANNUAL GOLD SPONSORS THANK YOU

44 ANNUAL FaBCAP SPONSORS THANK YOU

45 To all of you! THANK YOU