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Case Study (Delegate) FS203001ENGX v3.0 Apr 2023 ©The British Standards Institution 2023 38 of 49 Nonconformity Report From 04/01/1X Nonconformity Report #FSMS-NCR Issue 1 - 11/23/05 AUDIT NONCONFORMITY REPORT Corporation: GalaRade Incident Number: 1 Area under Review: Pressing/Extraction ISO 22000 Clause Number: 8.2 Requirement: The organization shall establish, implement and maintain PRP(s) to assist in controlling the likelihood of introducing food safety hazards to the product through the work environment. Nonconformity: Staff working in the pressing/extraction area was observed to not be washing hands nor consistently wearing protective clothing as per the GalaRade SOP 8.2.4 Personnel Hygiene. When asked, unclad staff was not aware of the requirement to wash hands prior to entering the working area nor were they aware proper attire and head coverings were required as they had just started working at GalaRade last week. Auditor: Yuri Buzov Auditee: Production, Extraction Area staff

FS203001ENGX v3.0 Apr 2023 ©The British StanFacilities Inspection Checklist Checklist: II. GENERAL SANITATION: 1 Fruit for processing is kept in cold storage or in an enclosed area. 2 Storage area is free of flies, insects and rodent activity. (Cats, birdetc. are prohibited.) 3 Processing area is free of flies, insects and rodent activity. (Cats, banimals, etc. are prohibited.) 4 Processing is done in an enclosed area. 5 The processing plant and equipment are clean and in good repair.6 Fruit is handled and stored in clean containers. 7 Filter cloths. A Filter cloths designed for this purpose. B During processing, filter cloths are handled in a sanitary manner. (C When not in use, cloths stored off the floor in an enclosed area. D Filter cloths are cleaned, rinsed and sanitized at the end of each dE If filter cloths are dried by spreading them on a clean line in a well-area, away from flies and vermin. (The alternate method is to use

Case Study (Delegate) ndards Institution 2023 39 of 49 Yes No With Conditions s, dogs wild animals, birds, dogs wild (Kept off the floor) ay’s operation. -ventilated, enclosed a dryer.)

FS203001ENGX v3.0 Apr 2023 ©The British Stan8 Press Racks. A Press racks are made of food-grade plastic (or hardwood which hacoated with a food-approved coating). B Press racks are kept off the floor during pressing. C Press racks are cleaned and sanitized at the end of each day theyD Press racks are allowed to dry (off the floor) in a well ventilated en9 Tubing. A Tubing carrying juice/cider is made of material approved for food uB When present, plastic tubing is made of a transparent material, apand in good repair. C Tubing is protected from abrasion and breakage. D If the tubing passes through spaces that are not readily accessiblepiece and easily cleaned. E Tubing is continuous as possible with couplings kept to a minimumF Tubing, clamps, couplings and connections are periodically disassG Tubing must be positioned so that no pockets of liquid remain wheH Tubing is cleaned and sanitized after each day’s run.

Case Study (Delegate) ndards Institution 2023 40 of 49 as been properly y are used. nclosed area. use. pproved for food use e, the tubing is one m. sembled and cleaned. en the tubing is rinsed.

FS203001ENGX v3.0 Apr 2023 ©The British Stan10 Equipment is disassembled (as far as possible) cleaned and san11 Equipment is air-dried off the floor. 12 Press pomace properly disposed of away from the facility. 13 Juice/cider is properly labeled (IRQ, ingredients, use-by-date, ‘Ke‘Fresh Un-pasteurized’. 14 Toilet facilities present and in good condition. 15 Hand washing facility present and in good repair. III. EMPLOYEE PRACTICES: 1 No smoking, eating, or drinking in the processing facility. 2 Hair restraints (hat or hairnet) worn at all times. 3 Workers maintain a high degree of cleanliness. 4 Workers wear clean outer garments. 5 Workers clean their hands thoroughly before starting work, after working area and between operations. IV. EQUIPMENT AND SUPPLIES: 1 Whenever possible equipment should be made of food-grade ma2 Utensils and equipment are properly cleaned, sanitized, dried anthe floor.

Case Study (Delegate) ndards Institution 2023 41 of 49 itized after use. eep Refrigerated’ and each absence from the aterial. d stored on racks off

FS203001ENGX v3.0 Apr 2023 ©The British Stan3 A source of pressurized potable running water is available in the cleaning equipment and the interior of the facility. 4 Supplies of juice/cider containers are stored off the floor in a cleaand vermin. 5 Juice/cider containers are stored in their original plastic bags unt6 Plastic bags which are partially used will be resealed in plastic baenclosed area. V. BUILDINGS AND GROUNDS: 1 Grounds clean around building 2 Processing equipment enclosed 3 Windows intact, closed or screened. 4 Doors with curtains. 5 The processing room walls and ceilings are impervious. 6 Floors are continuous concrete. 7 Adequate floor drains. 8 Processing facility adequately screened to eliminate insect and ro9 Adequate lighting is provided in the processing facility. 10 Interior lights are shielded.

Case Study (Delegate) ndards Institution 2023 42 of 49 processing room for an area free of insects il use. ags or in a screened or odent entry.

FS203001ENGX v3.0 Apr 2023 ©The British Stan11 Cold storage entry doors should be covered with plastic curtains.12 Toilet facilities are conveniently located near the processing facil13 The lavatory has hot and cold running potable water and soap fodisposable towels. 14 Trash containers are covered.

Case Study (Delegate) ndards Institution 2023 43 of 49 . ity. or hand washing with

Case Study (Delegate) FS203001ENGX v3.0 Jul 2021 ©The British Standards Institution 2023 44 of 49 Training and Awareness Procedure (SOP7.3) 1.0 PURPOSE GalaRade recognizes that awareness and training regarding food safety issues is important to the success of the FSMS. This procedure defines the process for identifying and planning food safety training and awareness at GalaRade. 2.0 OBJECTIVES The objective for this procedure is to protect the safety of consumers and improve the FSMS by ensuring proper training and awareness of food safety issues is provided to all GalaRade employees. 3.0 DEFINITIONS AND ABBREVIATIONS None 4.0 RESPONSIBILITIES 4.1 The Human Resources department shall maintain the current copy of the training needs analysis and training schedule 4.2 The Human Resources department shall maintain records of the food safety training which individuals have received 4.3 The food safety team leader and the Human Resources department shall maintain data/records that together comprise a food safety training programme 5.0 REQUIREMENTS 5.1 Training 5.1.1 A training needs analysis (TNA) schedule will be completed and maintained by the Human Resources department to identify the level of instruction needed by personnel whose job may create a significant impact on the safety of the product 5.1.2 The TNA and training schedule will be reviewed and updated where necessary at least annually and when requested by a Manager/Supervisor/Director in consultation with the Human Resources department 5.1.3 New and part-time employees, as well as permanent on-site contractors, shall be included in the food safety training programme 5.1.4 The Human Resources Department will maintain records of each individual’s food safety training 5.1.5 Triggers for employee training may include, but are not limited to: • Changes in equipment • New products • Regulatory requirements • Changes in job descriptions • Changes in procedures • New employee

Case Study (Delegate) FS203001ENGX v3.0 Jul 2021 ©The British Standards Institution 2023 45 of 49 • Accidents • Feedback from audits or reviews 5.2 Competence 5.2.1 Personnel performing tasks that can affect the safety of the product shall be competent on the basis of appropriate education, training and/or experience 5.2.2 Employee competence relevant to the FSMS is determined through applicable training and through observation of performance by the employee’s supervisor. 6.0 REFERENCE 6.1 Training Record Log (F7.3.2) 6.2 Food Safety Management System (FSMS) 6.3 21 CFR 110 (FDA) 6.4 21 CFR 120 (FDA) 6.5 Guidance for Industry: Juice HACCP Hazards and Controls Guidance - First Edition March 3, 2004 7.0 APPROVAL This procedure will take effect upon the signature by those individuals listed below. _________________________________________________________________ General Manager Date _________________________________________________________________ Training Representative Date

Case Study (Delegate) FS203001ENGX v3.0 Apr 2023 ©The British Standards Institution 2023 46 of 49 Emails Irma, As expressed in our Food Safety Policy, the business of GalaRade is based on consistently producing juice that meets or exceeds customer expectations as well as meeting all standards and regulations for food safety. This means that individually and as a team member, each employee is responsible for food safety. To help us meet this commitment, we must undertake an assessment of employee training needs. We must recognize that not every employee needs to be trained in every aspect of GalaRade’s operations and requirements, but that training needs to encompass general awareness and must also include components specific to the job each employee is undertaking. Relevant training might include: 1. GMP training a) Plant Cleaning and Sanitation b) Personnel Hygiene 2. HACCP training a) Extensive for Food Safety Team Members b) General Awareness for rest of employees c) CCP monitoring 3. Awareness of FSMS 4. Internal Auditor training 5. Juice HACCP regulation 6. Guidance for Industry: Juice HACCP Hazards and Controls Guidance - First Edition March 3, 2004 GMP and FSMS training is to be part of the orientation training each employee receives within the first week of hire. Please distribute the attached training needs assessment form to all managers and supervisors and have them each complete one. These forms will then be used for the development of the identification of training needs and we can move forward with scheduling training. Stephanie Production Supervisor To: Irma Smartt Human Resources Director From: Stephanie Applebie Production Supervisor CC: Subject: Food Safety Training Needs

Case Study (Delegate) FS203001ENGX v3.0 Apr 2023 ©The British Standards Institution 2023 47 of 49 Irma, As per your request, here is a copy of the attendance list of staff who attended the last Juice HACCP training session held last year. If you require more information, please call me at ext. 1234. Kevin Date: March 21, 20XX Employee Juice HACCP Regs. Applebie, John Applebie, Stephanie Smartt, Irma X Buzov, Yuri X Campbell, Earl X Chabot, Nada Christie, Pat Doyle, Paul X Jenson, Barb X Johnson, Sally X Jones, Bill X McCain, Ernie X Peart, Steve Ransom, Meg Simpson, Laura Srangi, Erin X Trent, Hugh X To: Stephanie Applebie Production Supervisor From: Kevin Applebie Quality Assurance Director CC: Subject: Food Safety Training

Case Study (Delegate) FS203001ENGX v3.0 Apr 2023 ©The British Standards Institution 2023 48 of 49 Training Record Log (F7.3.2) Last updated, 1-22-05 Employee Department FSMS Awareness Plant Cleaning & Sanitation HACCP Emergency Preparedness Chemical Management Production Practices Regulatory Requirements Corrective Action Applebie, John Management X X Applebie, Kevin Management X X X Applebie, Stephanie Management X X Smartt, Irma Management X X X X Buzov, Yuri Production X Campbell, Earl Production Chabot, Nada Production X Christie, Pat Production X Doyle, Paul Production X X Jenson, Barb Production X Johnson, Sally Production X Jones, Bill Production McCain, Ernie Production X X X Peart, Steve Management X X Ransom, Meg Warehousing X Simpson, Laura Production Srangi, Erin Production Trent, Hugh Management X X Weinberger, Doug Warehousing X Willis, Mark Production Wilson, Mara Production

Case Study (Delegate) FS203001ENGX v3.0 Apr 2023 ©The British Standards Institution 2023 49 of 49 Management Review Minutes MINUTES FROM MANAGEMENT REVIEW MEETING Management Review Minutes (dated 6/01/201X) Attendees: • John Applebie • Stephanie Applebie • Kevin Applebie 1.1.1. Agenda: • Policy Statement • Issues and updates • Summary of Internal Audit Results • Summary of Progress against Objectives 1.1.2. 1.1.3. Minutes: • The GalaRade Policy Statement is adequate and effective – no changes needed • Legislative change made in March - According to a newsletter received from the FDA in November 2005 there have been changes in directives related to food recall and maximum pesticide levels. In the same newsletter the FDA stated that significant changes are expected in the labeling directive • Legal requirements do not address testing of recall so we have never carried it out. The statement in the SOP 8.9.5 relates to the requirement of one of our customers who does not purchase from us anymore • Latest internal audit was a success! • 3 nonconformities identified during the latest internal audit Attachments: None