FSSC Food Safety & Quality Management System Audit Report

Transcription

1 FSSC Food Safety & Quality Management System Audit Report NAME OF Client: Chicago Processed Fruit Group Address: 6280 W. Howard St., Niles, IL Audit Type Initial Certification - Stage 1 Stage 2 Annual Surveillance Re-certification Business Sector Fruit Juice, concentrates, Food manufacturing Food Categories purees, essences and - CII essential oils No Employees: 40 No Shifts: 1 production shift Additional Team N/A Martin Fowell Lead Auditor Member(s) Audit Commencement Date September 26, 2017 Audit Conclusion Date September 27, 2017 Date of last audit October 6, 2016 Previous CB Mérieux NutriSciences Certification LLC Description of last audit Previous audit was the initial surveillance audit. All corrective actions were completed and submitted. Current certificate issue Current certificate expiry November 19, 2015 date date November 19, 2018 Any Other Certificates Held Kosher, Organic Scope of Audit: Processing (Blending and/or pasteurization) of fruit products (juices, purees and concentrates) and fruit by-products (essential oils, essences). Any scope exclusions are appropriate and justified: been excluded. No areas or products have Yes No NA Facility Summary (including overview of relevant changes to documentation, requirements, processes, and products since last audit) Chicago Processed Fruit Group (a unit of Greenwood Associates) is a small private company, established in The company is involved in processing of fruit products (juices, purees and concentrates), fruit by-products (essential oils, essences), as well as importation and distribution of fruit based products. The company is located in a 59,0000 square foot facility that was constructed in Oct The facility employs approximately 35 full time employees, working 1 production shift over 5 days per week. Fruit and fruit by-products are either blended, and pasteurized (single strength juices), and packaged for frozen distribution. There are also some products that are received, warehoused, and distributed without further processing. Since the previous surveillance audit there have been changes in regulatory requirements (FSMA related) and management staff. The previous Director of Food Safety and Quality is no longer with the company and there have been several changes in the responsibilities of key staff. The core food safety team has remained the same and demonstrated a strong knowledge of food safety principles. List Recalls in past 12 months as well as any complaints or reports that have been registered with the government.

2 This facility has not had any recalls over the past 12 months and has not received any regulatory warning letters. List of Key Personnel present at Andre Molina Emma Peterson Brian McDonough Michael Hansche Suraya Gabel Chris Reed Caroline Kuehn Eric Michalak Douglas Boxmann Matt Martens Mark Scholtz Tiffany Chan Audit Objectives: audit (name and title) Quality Lab Manager Product Application and Marketing Specialist Regulatory Specialist General Manager (GreenWood) Director of Procurement and Supplier Relationships Production Manager Production Process Engineer Maintenance Engineer Maintenance Coordinator General Manager (CFPG) Warehouse Senior Lab Technician To confirm that the food safety management system conforms with all the equirements of FSSC To confirm that the Food Safety & Quality Management system has been effectively implemented To confirm that the facility is capable of meeting the Food Safety & Quality Management system requirements To provide feedback to the organization to facilitate continual improvement Audit Recommendation The audit team concludes that the organization: 1. Has Has not established a Food Safety & Quality Management system in accordance with FSSC Has Has not implemented and/or maintained its Food Safety & Quality Management system in accordance with FSSC Has Has not demonstrated the ability of the food safety & quality system to systematically achieve agreed requirements for products or services within the scope and the organization policy objectives. Based on the results of this audit and the client s Food Safety & Quality Management system demonstrated state of development and maturity, it is recommended that certification be

3 Granted Granted following satisfactory resolution of Non Conformances Maintained Re-certified Suspended Future Audit Scheduling Your next scheduled audit activity is a Intial Certification Stage2 audit Surveillance At the present time this activity is tentatively scheduled for September 2018 Re-certification Thank you for your ongoing support of Merieux NutriSciences Certification as your Certification Service Provider. Should you have any queries, comments or questions pertaining to the content of this report including the classification of any non conformity raised at this audit, feel free to contact our certification office at certification@mxns.com Lead Auditor Name Martin Fowell Signature Date October 19, 2017 Explanation of Audit Report contents: Addendum 1 Addendum 2 Addendum 3 Addendum 4 Addendum 5 Addendum 6 Summary of Findings ISO Requirements Summary of Findings - FSSC Requirements Non-Conformity Schedule (Corrective Action Requests) Observations for Continuous Improvement Verification of Closure of Identified Non Conformities (by Assessor) Certification Status Summary: NB- This report will be updated and presented after each audit activity to assist in reviewing the overall health of the FSSC Certification

4 Addendum 1 Summary of findings for ISO requirements Conforms Clause Yes No Remarks 4 Food Safety Management System 4.1 General requirements 4.2 Documentation requirements Summary Clause 4: A food safety and quality management program has been implemented and well maintained. The document control procedure (Doc-1004) outlines the requirements for controlling documents and managing changes to those documents. All records that were requested were readily available and well organized. Records from various dates were reviewed include production dates of Dec 5 9, 2016; May 1 5, 2017; and Sep 11 15, Records are maintained for the shelf life of the product plus a minimum of 2 years. The facility manufactures different products each day depending upon sales and customer needs. 5 Management responsibility Management commitment 5.2 Food safety policy MINOR: The organization is not currently in compliance with the FSMA required preventive controls based food safety program for the finished products that are not regulated under the existing juice HACCP regulations. Most of the products that are manufactured are regulated under juice HACCP, but there are some that are not. The sanitary transport requirements have not been clearly identified and implemented for applicable products. 5.3 Food safety management system planning 5.4 Responsibility and authority An organizational chart from Sep 22, 2017 was available. Job descriptions for the Director of Food Safety and Quality, Production Supervisor, and Quality Lab Manager were available.

5 5.5 Food safety team leader The food safety team has undergone transitions in the past several months. The previous Director of Quality and Food Safety is no longer with the company (left the company 3 4 weeks previously) and the responsibilities are being covered by the Quality Manager. The Quality Manager The Food safety team meeting from September 7, 2017 included a review of the changes that have been occurring. Form 1026 is used for the agenda for the food safety team meetings. The meetings include follow up from previous meetings, changes, new product/specifications, contracted services, verifications, and KPIs. HACCP training certificates were available for Andre Molina (general HACCP March 23 24, 2015) and Michael Hansche (Juice HACCP Sep 12 13, 2017). 5.6 Communication (including registered complaints and reports to concerning government) 5.7 Emergency preparednes ss response 5.8 Management review Customer complaint process includes review during food safety team meeting and in the CAPA. The Crisis Control program (Policy 005 Aug 15, 2016) includes the processes use for emergency situations. The crisis coordinator is currently identified as the Director of Food Safety and Quality. The contact lists are in the process of being updated because of changes in management staff. The management review was completed on May 11, The output from the management review meeting was not well documented. One output from the meeting resulted in bi-weekly clean breaks being implemented for sanitation. Summary Clause 5: The food safety team has undergone transitions in the past several months. The previous Director of Quality and Food Safety is no longer with the company (left the company 3 4 weeks previously) and the responsibilities are being covered by the Quality Manager. The Quality Manager The Food safety team meeting from September 7, 2017 included a review of the changes that have been occurring. Form 1026 is used for the agenda for the food safety team meetings. The meetings include follow up from previous meetings, changes, new product/specifications, contracted services, verifications, and KPIs. HACCP training certificates were available for Andre Molina (general HACCP March 23 24, 2015) and Michael Hansche (Juice HACCP Sep 12 13, 2017). MINOR: The organization is not currently in compliance with the FSMA equired preventive controls based food safety program for the finished products that are not regulated under the existing juice HACCP regulations. Most of the products that are manufactured are regulated under juice HACCP, but there are some that are not. The sanitary transport requirements have not been clearly identified and implemented for applicable products.

6 Conforms Clause Yes No Remarks 6 Resource management 6.1 Provision of resources 6.2 Human resources 6.3 Infrastructure 6.4 Work environment Summary Clause 6: Job descriptions and equired competencies have been identified and implemented. Training is tracked to ensure all employees have received the applicable topics. The training records indicated that training had been conducted in English and Spanish. Specific training records were reviewed for HACCP, GMPs, CCP #5, and new employee requirements. Adequate resources have been provided for ongoing training and the work environment is maintained in a safe manner. 7 Planning and realization of safe products 7.1 General 7.2 Prerequisite programs (PRPs) 7.3 Preliminary steps to enable hazard analysis 7.4 Hazard analysis (including description of the assessment of the identification of food safety hazards). The hazard analysis for the receiving step (non tankers frozen ph<=4.6) is not clear. The same risk level and likelihood have been identified for different pathogens, with some resulting in CCPs and some not resulting in CCPs. The hazard analysis that was available for the pear and apple juice did not include identification of patulin as a hazard. The hazard analyses were last updated July 14, 2017 by the previous Director of Quality and were not being properly maintained (as identified in 8.5.2).

7 7.5 Establishing the operational PRPs 7.6 Establishing the HACCP plan The HACCP program has been divided into plans that cover 13 products/processes. HACCP plan #3 covers most products produced and the concentrated juice (non- ph<4.6, and apple/non-pear), frozen. CCPs have been identified for Product Receiving Tankers (ph >= 4.6), Product Receiving Frozen, Shipping Tankers, and Empty Tanker Arrival. CCP1 is for E. Coli 0157:H7, Listeria Monocytogenes, and Salmonella in incoming materials. CCP2 is for allergen cross contamination and tampering in ingredients received in tankers. CCP 3 is for allergen and tampering in tankers. 7.7 Updating of preliminary information and documents specifying the PRPs and the HACCP Plan 7.8 Verification planning Conforms Clause Yes No Remarks 7.9 Traceability system 7.10 Control of nonconformity The non-conforming product program (i.e. hold program) was not effectively implemented. A barrel of product with a hold tag was observed in the cooler area (unclear if the product was actually on hold). There were several different pails of product on a pallet in the hold area of the cooler that were not identified with hold stickers. One pail on the pallet was identified but not several others.

8 Summary Clause 7: The HACCP program has been divided into plans that cover 13 products/processes. HACCP plan #3 covers most products produced and the concentrated juice (non-apple/non-pear), ph<4.6, and frozen. CCPs have been identified for Product Receiving Tankers (ph >= 4..6), Product Receiving Frozen, Shipping Tankers, and Empty Tanker Arrival. CCP1 is for E. Coli 0157:H7, Listeria Monocytogenes, and Salmonella in incoming materials. CCP2 is for allergen cross contamination and tampering in ingredients received in tankers. CCP 3 is for allergen and tampering in tankers. The critical limits had been identified using regulatory requirements, scientific literature, and testing. The hazard analysis for the receiving step (non tankers frozen ph<=4..6) is not clear. The same risk level and likelihood have been identified for different pathogens, with some resulting in CCPs and some not resulting in CCPs. The hazard analysis that was available for the pear and apple juice did not include identification of patulin as a hazard. The hazard analyses weree last updated July 14, 2017 by the previous Director of Quality and were not being properly maintained (as identified in 8.5.2). The traceability program was well documented and the results of the trace exercise/mock recall were acceptable. MINOR: The non-conforming product program (i.e. hold program) was not effectively implemented. A barrel of product with a hold tag was observed in the cooler area (unclear if the product was actually on hold). There were several different pails of product on a pallet in the hold area of the cooler that were not identified with hold stickers. One pail on the pallet was identified but not several others. 8 Validation, Verification and improvement of the FSMS 8.1 General 8.2 Validation of control measure combinations 8.3 Control of monitoring and measuring

9 8.4 Food safety management S y s t e m verification The verification and other analysis is included as a line item in the management review meetings The analysis of the results of the verification planning does not appear to be complete. There were multiple instances of actions not being taken as a result of nonnoted during verification conformities activities. Examples include: (1.) Thermometer calibration records indicated a 30+ degree difference in a non-critical recording device, but there was no evidence available to show that this discrepancy had been investigated to ensure product manufactured with this equipment was acceptable. (2.) The monthly glass and brittle plastic inspections for July had identified additional potential sources of glass/brittle plastic, but these items had not been inspected or included on the August glass inspections. 8.5 Improvement The food safety plan has not been properly maintained, reviewed, and verified on an ongoingg basis. There were several instances of information that did not appear to be correct and complete. Examples include: (1.) The documentation for HACCP #1 did not include the CCP summary information. (2.) The hazard analysis for the receiving step is not clear. The same risk level and likelihood have been identified for different pathogens, with some resulting in CCPs and some not resulting in CCPs. (3.) The hazard analysis that was available for the pear and apple juice did not include identification of patulin as a hazard. The hazard analyses were last updated July 14, 2017 by the previous Director of Quality. (4.) The allergen statement thatt was posted on the company website was not correct. Red Grape Juice was identifiedd on the list of non-allergen products, even though the HACCP program indicated that it contained sulfites which have been identified as an allergen for Canada.

10 Summary Clause 8: Verification procedures have been established for the CCPs and the prerequisite programs that include product testing, calibrations, and internal inspections and audits. However, there were some instances that indicated the results of the verification programs were not being analyzed and that the food safety plan was not being reviewed to ensure complete and correct updates. The analysis of the results of the verification planning does not appear to be complete. There were multiple instances of actions not being taken as a result of non-conformities noted during verification activities. Examples include: (1.) Thermometer calibration records indicated a 30+ degree difference in a non-critical recording device, but there was no evidence available to show that this discrepancy had been investigated to ensure product manufactured with this equipment was acceptable. (2.) The monthly glass and brittle plastic inspections for July had identified additional potential sources of glass/brittle plastic, but these items had not been inspected or included on the August glass inspections The food safety plan has not been properly maintained, reviewed, and verified on an ongoing basis. There were several instances of information that did not appear to be correct and complete. Examples include: (1.) The documentation for HACCP #1 did not include the CCP summary information. (2.) The hazard analysis for the receiving step is not clear. The same risk level and likelihood have been identified for different pathogens, with some resulting in CCPs and some not resulting in CCPs. (3.) The hazard analysis that was available for the pear and apple juice did not include identification of patulin as a hazard. The hazard analyses weree last updated July 14, 2017 by the previous Director of Quality. (4.) The allergen statement that was posted on the company website was not correct. Red Grape Juice was identified on the list of non-allergen products, even though the HACCP program indicated that it contained sulfites which have been identified as an allergen for Canada.

11 Addendum 2 Summary of Findings - FSSC Requirements Conforms Clause Yes No Remarks 4. Construction and layout of buildings 4.1 General requirements 4.2 Environment 4.3 Locations of establishments Summary Construction and layout of buildings: The FDA facility inspection report from March 9, 2017 was available. Corrective actions had been implemented for the process for pasteurizing finished product instead of pasteurizing the concentrate and then diluting. The registration was completed October 7, 2016 for the FDA bio- is used. CPFG maintains terrorism regulations. An agreement was available for a contracted warehouse that ownership of the product through the entire warehousing. 5. Layout of premises workspace 5.1General requirements 5.2 Internal design, layout and traffic patterns 5.3 Internal structures and fittings 5.4 Location of equipment 5.5 Laboratory facilities 5.6 Temporary/mobile premisess and vending machines 5.7 Storage of food, packaging materials, ingredients and non food chemicals Summary Layout of premises workspace: The facility is designed and organized in a manner that allows for safe production of food. Most of the process is fully enclosed and equipment was maintained in good condition. Space is maintained around equipment to allow for inspection and sanitation. No temporary or mobile premises or vending machines are used. The laboratory is located in a designated room thatt is physically separated from the production areas. All materials were observed to be properly stored and kept in containers that protected the integrity of the product. 6. Utilities air, water, energy 6.1 General requirements 6.2 Water supply 6.3 Boiler chemicals 6.4 Air quality and ventilation 5 micron filtration is used for process water.

12 6.5 Compressed air and other gases 6.6 Lighting Summary Utilities air, water, energy: The maintenance department is responsiblee for managing the utilities. The water is sourced from the city. The boiler chemicals are approved for use in a food facility and are monitored daily. The boilers are also inspected by a contracted service provider. The compressed air that is used for flushing lines is filtered with a.01 micron point of use filter. The facility was well lit and the lights are shielded to prevent shattering. Conforms Clause Yes No Remarks 7. Waste disposal 7.1 General requirements 7.2 Containers for waste and inedible or hazardous substances 7.3 Waste management and removal 7.4 Drains and drainage Summary Waste disposal: Waste was properly handled and disposed. The waste containers are identified using a color coding system. Waste is removed from the premises by an approved contract service provider. The trash containers and drains appear to be clean and free from aged product residue and build up. 8. Equipment suitability, cleaning and maintenance 8.1 General requirements 8.2 Hygienic design 8.3 Product contact surfaces 8.4 Temperature control and monitoring equipment 8.5 Cleaning plant, utensils and equipment 8.6 Preventive and corrective maintenance

13 Summary Equipment suitability, Cleaning & Maintenance: Form 017 includes the master sanitation information. The program is organized according to room and tasks. The records for monthly and quarterly tasks were reviewed for The weekly tasks were reviewed for August and September 2017 and the daily tasks were reviewed for September The equipment was properly designed and maintained in a hygienic fashion. The process is mostly enclosed and product is transferred through a series of tanks, pumps, and fillers. The premises were very clean and maintained in excellent condition. 9. Management of purchased materials 9.1 General requirements 9.2 Selection and management of suppliers.3 Incoming material requirements (raw/ingredients/packaging) Summary Management of purchased materials: The supplier approval program (DOC 9001 Sep 20, 2017) includes identification of risk, process for approval, and requirements. The program for primary and secondary suppliers requires supplier approval information to be updated at least every 3 years, HACCP plans, Kosher certificate, food defense plan, allergen statement, GMO statement, third party audit certificate, organic certificate, pesticide residue test results, heavy metal test, example COA, corrective actions, Halal certificate, irradiation statement, recall procedure, Vegan statement, letter of guarantee, and label example. The program for packaging materials includes specifications, allergen statements, food grade statement, letter of guarantee, third party audit, and Kosher certificate. Specific equirements are also available for provisional suppliers. The information for the supplier of the pails and the cranberry juice concentrate were reviewed.

14 Conforms Clause Yes No Remarks 10. Measures for prevention of cross contamination 10.1 General requirements 10.2 Microbiological cross contamination 10.3 Allergen management 10.4 Physical contamination The glass inspection from July 2017 indicated several additional brittle plastic items (i.e. CTT 400 electrical cover and first aid kits) had been identified, but these items were not added to the glass brittle plastic inspection sheets for future dates. It did not appear that the information was being properly verified and maintained, as identified in clause Summary Measures for prevention of cross contamination: LAB 1023 (October 8, 2015) outlines the filter and screen requirements. The size of the screen is dependent upon the product being processed. Glass and brittle plastic is addressed in Policy 10 (Feb 21, 2017). Glass inspections are conducted monthly and were reviewed for July and August Microbiological cross contamination is controlled through GMPs, sanitation, and the pasteurization of single strength juices and purees. The glass inspection from July 2017 indicated several additional brittle plastic items (i.e. CTT 400 electrical cover and first aid kits) had been identified, but these items were not added to the glasss brittle plastic inspection sheets for future dates. It did not appear that the information was being properly verified and maintained, as identified in clause Cleaning and sanitizing 11.1 General requirements 11.2 Cleaning and sanitizing agents and tools 11.3 cleaning and sanitizing programmes 11.4 Cleaning in place (CIP) systems 11.5 Monitoring sanitation effectiveness Summary Cleaning and sanitizing: A master cleaning schedule has been developed and records are maintained for the daily and non-daily tasks. The employees responsible for sanitation have been trained and were able to answer questions regarding the CIP processes and manual cleaning. Chemical concentration records were reviewed for PAA/345. SOP 1025 was reviewed for the CIP system. There were some questions raised regarding the timing that is recorded for the cut in and cut out temperatures. It was determined that the cut out temperature is manual and was not appearing on the pasteurization chart (but could be determined in other areas). 12. Pest control 12.1 General requirements

15 12.2 Pest control programs 12.3 Preventing access 12.4 Harbourage and infestationsns 12.5 Monitoring and detection No CAPAs were available for Jul Sep when the number of insects exceeded the limits that have been identified in the program (i.e. results from blend room). Plant management explained that the automatic notifications were not working. The pest control map indicates there are 23 devices, but the reports indicate 24 are inspected. The pest control service reports for March 2017 indicated that a pesticide (Sygenta Ant Bait) had been used in the kitchen area. The pest control program does not allow for pesticides to be used inside of the facility Eradication Summary Pest control: The pest control program is managed by a contracted service provider. The pest control program includes a list of approved pesticides (August 7, 2017). Pesticides are only approved for use on the exterior of the building. The program includes 54 interior devices, 23 exterior devices, and 14 insect light traps. The entrances and windows to the facility were tightly sealed to prevent pest entry. MINOR: No CAPAs were available for Jul Sep when the number of insects exceeded the limits that have been identified in the program (i.e. results from blend room). Plant management explained that the automatic notifications were not working. The pest control map indicates there are 23 devices, but the reports indicate 24 are inspected. The pest control service reports for March 2017 indicated that a pesticide (Sygenta Ant Bait) had been used in the kitchen area. The pest control program does not allow for pesticides to be used inside of the facility. 13. Personnel hygiene and employee facilities 13.1 General requirements 13.2 Personnel hygiene facilities and toilets 13.3 Staff canteens and designated eating areas 13.4 Workwear and protective clothing 13.5 Health status 13.6 Illness and injuries 13.7 Personal cleanliness 13.8 Personal behavior

16 Summary Personnel hygiene and employee facilities: The employee break room and restrooms were clean and well maintained. The areas are segregated from the production and storage areas. Employees are provided with clean uniforms that are laundered by a contracted service provider. The employee GMP program and training includes topic that address health status and reporting illnesses. During the audit, the employees who were interviewed were aware of the requirements and were able to explain the requirements. GMP rules have been posted at the entrances to the production areas. 14. Rework 14.1 General requirements 14.2 Storage. identification and traceability 14.3 Rework usage Summary Rework: Per plant management, true rework is not used as all materials maintain the initial lot code. Partial pails are generated and are used as an ingredient in future production of product. When this process occurs, the partial pails are identified with the lot code information and product description. The partial pails are stored with other raw materials and are tracked in the inventory system. The lot code system includes using a w on the lot code to identify the product as a partial. 15. Product recall procedures 15.1 General requirements 15.2 Product recall requirements Summary Product recall procedures: A trace exercise was conducted using Cranberry 50 that had been produced on August 14, The production records indicated that 160 pails + 1 partial pail had been produced. The lot codes for each raw material (cranberry juice concentrate, lids, and pails) were identified along with the receiving records. The facility was able to identify all of the ingredients uses, as well as the finished product. The written recall procedures include internal and external contacts, communication requirements, and identification of the responsibilities. 16. Warehousing 16.1 General requirements 16.2 Warehousing requirements 16.3 Vehicles, conveyances and containers Summary Warehousing: The storage areas were clean and well maintained during the audit. Battery operated fork lifts and pallet jacks are used and were observed to be clean and in good condition. The products were stored in the appropriate temperature controlled areas and were kept in covered/sealed containers. The temperatures for the cooler and freezers are monitored continuously, with automatic notification when temperaturee limits are exceeded.

17 Conforms Clause Yes No Remarks 17. Product information/consumer awareness Summary Product information/consumer awareness: No product is currently manufactured for direct consumer sale. At this time, all products are sold to organizations that will further process. The products were labeled according to the customer requirements. 18. Food defence, biovigilance and bioterrorism 18.1 General requirements 18.2 Access controls Summary Food defence, biovigilance and bioterrorism: A food defense program has been documented and implemented. Access into the facility was controlled through locked doors that require key cards. Cameras are used in locations that have been identified as being critical. Employees are trained in regards to basic food defense requirements and reporting suspicious activities. Additional FSSC Requirements Specifications for services Supervision of personnel in application of food safety principles Specific regulatory requirements Service contracts are maintained for contracted services. All employees were properly trained and supervised. The facility has not implemented preventive controls based food safety plans for the products that are not regulated under the Juice HACCP regulations. Announced, but unscheduled audits of certified organisations Management of Inputs Other items required by applicable legislation, recognized sector codes and customer requirements. Facility is aware of requirements for proper usage of FSSC Logo. (refer to FSSC document No How to use the FSSC Logo ) The facility is not currently conducting unscheduled audits. All inputs were properly managed. The facility was aware of Juice HACCP requirements and have employees who have been formally trained. The company was also aware of the FSMA regulations, though still in the process of implementation. The FSSC logoo is used on the signature lines. The facility is also planning to use the FSSC logo on banners for marketing events. The logo is used in connection with the MNCertification logo. The facility has a copy of the requirements for using the logo and approval (May 2016).

18 Summary of Additional FSSC Requirements: With the exception of other applicable legislative requirements, the additional FSSCSC requirements have been met. A minor NCR has been raised in regards to the compliance with all FSMA requirements.

19 Addendum 3 Major Non-Conformities (Corrective Action Requests) - Resolution with supporting evidence must be submitted to the auditor within 14 working days of after completion of the audit. Minor Non-Conformities (Corrective Action Requests) - Resolution with supporting evidence must be submitted to the auditor within 30 working days after completion of the audit. CAR Major Minor Clause No Identified Issue The organization is not currently in compliance with the FSMA required preventive controls based food safety program for the finished products that are not regulated under the existing juice HACCP regulations. Most of the products that are manufactured are regulated under juice HACCP, but there are some that are not. The sanitary transport requirements have not been clearly identified and implemented for applicable products. The non-conforming product program (i.e. hold program) was not effectively implemented. A barrel of product with a hold tag was observed in the cooler area (unclear if the product was actually on hold). There were several different pails of product on a pallet in the hold area of the cooler that were not identified with hold stickers. One pail on the pallet was identified but not several others. 3 ISO The analysis of the results of the verification planning does not appear to be complete. There were multiple instances of actions not being taken as a result of nonconformities noted during verification activities. Examples include: (1.) Thermometer calibration records indicated a 30+ degree difference in a noncritical recording device, but there was no evidence available to show that this Resolution CAPA has been provided that includes evidence that two employees have been registered to take the PCQI training course (Feb 14, 2018). Additionally, a full assessment of the current HACCP plans will be conducted to determine deficiencies and to allow for the proper programs to be developed. CLOSED Oct 10, CAPA was provided that indicates production and dock employees are being retrained on the hold procedure (DOC The hold procedure is also being revised to include better signage of the hold areas. DOC 1001 (inspection form) has been updated to include specific inspections of the hold areas. CLOSED Oct 19, CAPA the verification and calibration tasks have been added as discussion points for the food safety team meetings (form 1026 to be updated). The KPIs will be revised and be part of the food safety team meetings. CLOSED Oct 10, 2017.

20 discrepancy had been investigated to ensure product manufactured with this equipment was acceptable. (2.) The monthly glass and brittle plastic inspections for July had identified additional potential sources of glass/brittle plastic, but these items had not been inspected or included on the August glass inspections. 4 ISO The food safety plan has not been properly maintained, reviewed, and verified on an ongoing basis. There were several instances of information that did not appear to be correct and complete. Examples include: (1.) The documentation for HACCP #1 did not include the CCP summary information. (2.) The hazard analysis for the receiving step is not clear. The same risk level and likelihood have been identified for different pathogens, with some resulting in CCPs and some not resulting in CCPs. (3.) The hazard analysis that was available for the pear and apple juice did not include identification of patulin as a hazard. The hazard analyses were last updated July 14, 2017 by the previous Director of Quality. (4.) The CCP summary indicates that direct observations are conducted as part of the CCP verification. However, the frequency for direct observations were not identified and it was unclear how the direct observations were being recorded. (5.) The allergen statement that was posted on the company website was not correct. Red Grape Juice was identified on the list of non-allergen products, even though the HACCP program indicated that it contained sulfites which have been identified as an allergen for Canada. CAPA indicates a different employee was elevated to the Director of Quality and Food Safety to allow for program revision. The food safety team will also be involved in HACCP related updates. CLOSED October 27, 2017.

21 No CAPAs were available for Jul Sep when the number of insects exceeded the limits that have been identified in the program (i.e. results from blend room). Plant management explained that the automatic notifications were not working. The pest control map indicates there are 23 devices, but the reports indicate 24 are inspected. The pest control service reports for March 2017 indicated that a pesticide (Sygenta Ant Bait) had been used in the kitchen area. The pest control program does not allow for pesticides to be used inside of the facility. CAPA includes the minutes from meetings regarding the pest control program. The facility map is updated to include alll exterior bait stations. A member of the operations team has been tasked with oversight of the pest control program. CLOSED Oct 19, 2017 The above non-conformities were presented to the client Representative and discussed at the closing meeting Lead Auditor Name Martin Fowell Signature Date September 27, 2017 Verification of receipt of Non-Conformity Schedule (to be completed by the client representative) Name Andre Molina Signature See PDF version Date September 27, 2017

22 Addendum 4 Observations for Improvement Under the requirements of ISO 17021, Merieux NutriSciences Certification is not permitted to offer solutions or recommendations to clients, since this will establish a Conflict of interest. The following observations are offered to assist in the continual improvement of the Food Safety and Quality systems. As necessary, they could include minor anomalies in the current system, where raising a Corrective Action Request was not considered warranted or where further investigations may be warranted for continual improvement.

23 Appendix 5 Verification of closure of Identified Non Conformities (to be completed by the Auditor) I verify that the evidence submitted by the client has been reviewed and the action taken is sufficient to warrant closure of the identified non conformities. Evidence Sighted and Auditor Comments CAR Evidence & Comments No. 1 CAPA has been provided that includes evidence that two employees have been registered to take the PCQI training course (Feb 14, 2018). Additionally, a full assessment of the current HACCP plans will be conducted to determine deficiencies and to allow for the proper programs to be developed. CLOSED Oct 10, CAPA was provided that indicates production and dock employees are being retrained on the hold procedure (DOC The hold procedure is also being revised to include better signage of the hold areas. DOC 1001 (inspection form) has been updated to include specificc inspections of the hold areas. CLOSED Oct 19, CAPA the verification and calibration tasks have been added as discussion points for the food safety team meetings (form 1026 to be updated). The KPIs will be revised and be part of the food safety team meetings. CLOSED Oct 10, CAPA indicates a different employee was elevated to the Directorr of Quality and Food Safety to allow for program revision. The food safety team will also be involved in HACCP related updates. CLOSED October 27, CAPA includes the minutes from meetings regarding the pest control program. The facility map is updated to include all exterior bait stations. A member of the operations team has been tasked with oversight of the pest control program. CLOSED Oct 19, 2017 Additional Comments

24 Lead Auditor Name Martin Fowell Signature Date November 1, 2017 Addendum 6 Certification Status Report See Excel File Chicago Processed Fruit Audit Status Rep