Traceability of a Breakthrough Food Science Technology Russ Miller - PowerPoint PPT Presentation

Traceability of a Breakthrough Food Science Technology Russ Miller & Hilary Taylor, SCM 2018 Advisor : : Bruce Arntzen Sponsor Company: Apeel Sciences

The Team Before MIT, Russ was a Before MIT, Hilary was a su supply Process Engineer in biotech. ems project lead for a Pr chain system ch He has experience with FD FDA Canadian retailer. She has regulations , as well as a deep re experience in bus busine iness pr process Good Manufacturing Practices engineer en eering , change (GMP) knowledge in the management and te technology industry . ion . phar pharmac maceut utic ical al indus im imple plementatio Russ Miller Hilary Taylor

Agenda Introduction § Apeel’s Supply Chain § Recommendations § Q&A §

Sponsor Company - Apeel Sciences 45% of produce is wasted due to spoilage - $750B 750B annually § 45% § Food science st start-up up § Founded in San Santa B a Bar arbar ara, a, C Cal alifornia a in 2012 2012

Co Company Mission Co Company Purpose Company Vision Co Apeel uses na natur ural pl plant- This means we will wa waste In the future, less food will based ba ed tec echno hnologies es to less food, water and energy, le be wasted, we will use protect crops and smarter, more natural helpi hel ping ng to pr pres eser erve e our ur harvested produce, helping na natur ural ec ecosystems ems while methods for growing and to el elimi mina nate e food d spo poilage e creating economic protecting crops, and there and re reduce re reliance on opportunities for the 500 will be an an ab abundan ance of f chemicals ch million small family farms fr fresh food for everyone worldwide Source: http://apeelsciences.com/apeel-mission.html

Introducing… Edipeel TM UN UNTREATED TED with Edipeel TRE TREATE

Edipeel TM § Edible, natural, odorless, flavorless § Produced as a powder and reconstituted with water re § Mimics the protection of the plant’s natural peel § DO DOUBLES the viable shelf-life of harvested produce Source: http://apeelsciences.com/edipeel.html

Project Purpose – Lot Traceability of Edipeel § Ensure Apeel’s lot traceability program is co compliant from a re regulatory sta tandpoint and sc scalable § Apeel must identify the origin & location of all Edipeel inventory - cu current and historic c - upo upon n reques equest § Cr Critical data points from production to applying Edipeel are lo logged & lin linked Avocados are the current commercial Edipeel product § Av § La Lack o of s standardization for collecting and communicating data along the supply chain

Regulatory Environment Code of Federal Regulations Co Bioterrorism Preparedness & Response Act 2002 Bi § Companies must maintain a record of: § Establish a re recall plan “immediate previous sources and the § Packaging requirements – include: lot #, immediate subsequent recipients of food” commodity name, date/time, operator § One u up / on / one d down traceability signature, supervisor review Fo Food & Drug Amendments Act of 2007 Fo Food Safety Modernizat ation Act (FS FSMA) of 2011 § Shifts focus from reactive to preventative Built upon one up / one down § Bu § Written recall plan, re respond within 4 hours § Reportable Food Registry (RFR) § Initiated Track ckin ing & & T Tracin cing P Pilot ilots

Agenda Introduction § Apeel’s Supply Chain § Recommendations § Q&A §

Edipeel Supply Chain EDIPEEL TM FINISHED GOODS INVENTORY MANAGEMENT RECONSTITUTION & APPLICATION RAW MATERIALS & MANUFACTURING MANUFACTURING RECONSTITUTION APPLICATION RECEIVING INVENTORY (APEEL) INVENTORY (CUSTOMER) SUPPLY SHIP TO RETAILER 1kg 1kg 1kg COMPONENT 1 SUPPLIER 1kg 1kg LOT #A1 A 1kg 1kg 1kg CONTAINER 1 Edipeel TM Reconstituted 1kg 1kg Lot #1 Batch Data #1 1kg 1kg 1kg 1kg 1kg 1kg 1kg 1kg Sales COMPONENT 2 SUPPLIER Order 1 LOT #B1 B CONTAINER 1

Edipeel Supply Chain EDIPEEL TM FINISHED GOODS INVENTORY MANAGEMENT RECONSTITUTION & APPLICATION RAW MATERIALS & MANUFACTURING MANUFACTURING RECONSTITUTION APPLICATION RECEIVING INVENTORY (APEEL) INVENTORY (CUSTOMER) SUPPLY SHIP TO RETAILER 1kg 1kg 1kg COMPONENT 1 SUPPLIER 1kg 1kg LOT #A1 A 1kg 1kg 1kg CONTAINER 1 Edipeel TM Reconstituted 1kg 1kg Lot #1 Batch Data #1 1kg 1kg 1kg 1kg 1kg 1kg 1kg 1kg Sales COMPONENT 2 SUPPLIER Order 1 LOT #B1 B CONTAINER 1 Apeel’s Service Model: Integrate into customer pa packing ng ho hous use § Own inventory on customer’s site § Manage reconstitution and application § Inventory ti titl tle tr transfer upon applicati tion §

Edipeel Supply Chain – Scenario Review EDIPEEL TM FINISHED GOODS INVENTORY MANAGEMENT RECONSTITUTION & APPLICATION RAW MATERIALS & MANUFACTURING MANUFACTURING RECONSTITUTION APPLICATION RECEIVING INVENTORY (APEEL) INVENTORY (CUSTOMER) SUPPLY SHIP TO RETAILER PO#101 COMPONENT 1 1kg 1kg 1kg LOT #A1 CONTAINER 1 Reconstituted 1kg 1kg 1kg Sales Edipeel TM 1kg 1kg Batch Data #1 Order 1 Lot #1 1kg 1kg 1kg SUPPLIER 1kg 1kg A PO#102 1kg 1kg 1kg 1kg 1kg COMPONENT 1 LOT #A1 CONTAINER 2 1kg 1kg Sales SUPPLIER 1kg 1kg Order 2 B Reconstituted 1kg 1kg 1kg 1kg 1kg Batch Data #2 Edipeel TM PO#201 1kg 1kg 1kg Lot #2 COMPONENT 2 LOT #B1 1kg 1kg 1kg CONTAINER 1 1kg 1kg 1kg

Key Data Elements Raw Material Inventory Upon Receipt: § Raw Material § Supplier § Supplier Lot # § Date Edipeel Inventory § Quality Inspected = Container ID-01/02/2018 § Container ID-01/02/2018 § Work Order # § Production Date § Quantity Treated Product § Expiry Date = § Lot # CCO3-AVOCAD-001 Lot # CCO3-AVOCAD-001 § Sales order # § Reconstitution date § Quantity = 2017-1-ABC-180301-1172

Recall Traceback – example Raw Material Inventory Edipeel Inventory Treated Product A A A 1Kg 1Kg 1Kg 1Kg 1Kg issue identified A pallet pallet 1Kg 1Kg 2017-1-ABC-180301-1172 B B B pallet 1Kg 1Kg 1Kg 1Kg 1Kg 1Kg 1Kg pallet pallet pallet 1 identify batch data # 2 find sales order-line 3 identify Apeel Lot # 2017-1-ABC-180301-1172 2017-1-ABC-180301-1172 CC03-AVOCAD-001

Recall Traceback – example Raw Material Inventory Edipeel Inventory Treated Product A A A 1Kg 1Kg 1Kg 1Kg 1Kg A-12012016 A pallet pallet 1Kg 1Kg B B B pallet 1Kg 1Kg 1Kg 1Kg B-11012016 1Kg 1Kg 1Kg pallet pallet pallet identify raw material container IDs identify all Apeel lot #’s using 4 5 used to create CC03-AVOCAD-001 A-12012016 & B-11012016 A-12012016 B-11012016 CC03-AVOCAD-001 CB01-AVOCAD-001

Recall Traceback – example Raw Material Inventory Edipeel Inventory Treated Product Warehouse A A A 1Kg 1Kg 1Kg 1Kg 1Kg Customer Location ABC A pallet pallet 1Kg 1Kg Customer Location DCE B B B pallet 1Kg 1Kg 1Kg 1Kg In-transit 1Kg 1Kg 1Kg pallet pallet pallet identify all finished goods inventory of the CC03-AVOCAD-001 CB01-AVOCAD-001 6 identified lots: Warehouse In-Transit At Customer

Recall Traceback – example Raw Material Inventory Edipeel Inventory Treated Product Warehouse A A A 1Kg 1Kg 1Kg 1Kg 1Kg Customer Location ABC A pallet pallet 1Kg 1Kg Customer Location DCE B B B pallet 1Kg 1Kg 1Kg 1Kg In-transit 1Kg 1Kg 1Kg pallet pallet pallet identify any additional processed batches of the identified lots: 7 2017-1-ABC-180301-1172 2024-1-DCE-180228-1012 2024-1-DCE-180228-1011

Reporting Requirements Given: Identify: Any Additional Treatment Batch IDs Treatment Batch ID All relevant Apeel Lot #s All relevant Raw Material Container IDs Apeel Lot # All relevant Treatment Batch IDs Raw Material Container ID All relevant Apeel Lot #s

Agenda Introduction § Apeel’s Supply Chain § Recommendations § Q&A §

Recommendations and Considerations Recommendations Re Considerations for Operating at Scale Co § Reporting requirements – 5 reports § Vertical integration – consider raw material lot tracking § Minimize manually generating batch data number when applying Edipeel § Future customers – different inventory tracking processes must § Automate inventory reconciliation integrate with Apeel tracking after Edipeel is applied § Future products – may require § Address limitations of current ERP different steps system § Cost of Apeel Engineer applying Edipeel

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