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Case Study (Delagate) FS203001ENGX v3.0 Apr 2023 ©The British Standards Institution 2023 1 of 49 GalaRade Incorporated Case Study This section contains the Case Study information for a fictitious organization called ‘GalaRade Incorporated.’ Please note that the documents included in this Case Study contain errors for training purposes only. These documents should not be used as guides for developing management system documentation. Whilst the organization is fictitious, the documentation behind this Tab has been adapted from existing organizations implementing a food safety management system. GalaRade is in the process of developing a food safety management system to FSSC 22000. GalaRade’s accompanying procedures are organized as shown by the contents list below. These materials should be referenced to complete the activities involving the Case Study. ***ASSUME THE CURRENT MONTH IS NOVEMBER FOR THE PURPOSE OF YOUR AUDITS AND DOCUMENTED INFORMATION INSPECTION*** Contents Foreword ............................................................................................................................... 4 Scope of the Manual.............................................................................................................. 4 Company Background ........................................................................................................... 5 Structure of FSMS ................................................................................................................. 5 FS Context............................................................................................................................. 6 GalaRade Inc. Food Safety Policy ....................................................................................... 11 Organization chart (Version 3 Jul 20xx) ............................................................................... 12 Organizational roles, responsibilities, accountabilities and authorities.................................. 13 GalaRade Inc. HACCP Programme..................................................................................... 15 Corrective Action Procedure (SOP 8.9.3)............................................................................. 30 Management Review Procedure (CP-9.3)............................................................................ 32 Recall Procedure (SOP 8.9.5).............................................................................................. 34 Food Contact Surfaces (SOP 8.2.1)..................................................................................... 36 Nonconformity Report From 04/01/1X.................................................................................. 38 Facilities Inspection Checklist .............................................................................................. 39 Training and Awareness Procedure (SOP7.3) ..................................................................... 44 Emails.................................................................................................................................. 46 Training Record Log (F7.3.2)............................................................................................... 48 Management Review Minutes.............................................................................................. 49

Case Study (Delegate) FS203001ENGX v3.0 Apr 2023 ©The British Standards Institution 2023 2 of 49 Food Safety Manual Stamp box IMPORTANT Copies of any document, made in accordance with the controlled distribution list, will be identified by a red ‘CONTROLLED COPY’ stamp inside of the ‘stamp box’ located above. All other copies shall be considered uncontrolled. The revision level of an uncontrolled document should be checked prior to using the document. The user is responsible for having the most current revision. The current revision of any document is always available on the GalaRade Intranet, and can be printed out for individual use. GalaRade inc.

Case Study (Delegate) FS203001ENGX v3.0 Apr 2023 ©The British Standards Institution 2023 3 of 49 Revision History and Approval TITLE: GalaRade Food Safety Manual ISSUE CR NO. DATE ORIGINATOR DESCRIPTION OF CHANGE 1 N/A 25/11/17 Created FS manual following the requirements of FSSC 22000 Distribution: Referenced Documents: Approved Change Request on file in Document Control.

Case Study (Delegate) FS203001ENGX v3.0 Apr 2023 ©The British Standards Institution 2023 4 of 49 [As an Internal Auditor (of the case study organization) you would already be familiar with the first twelve pages.] Foreword This FSMS Manual describes the GalaRade business processes and systems in support of the company Food Safety Policy. It is the ‘what and why’ of all our systems on the mission of food safety commitment. This is a total FSMS Manual, representing the entire organization, from its top management throughout the whole organization. Internal customers, those inside the organization who receive work from any part of GalaRade, must be served as well as the end user, our external customers. Every GalaRade employee is at once both a customer and supplier. Each employee has the responsibility to ensure that all work coming in and going out from every workstation meets the established requirements, and that at all times they are following the procedures set in place to ensure the safety of our products. These systems are consistent and in compliance with the requirements of FSSC 22000, Juice HACCP and other related customer and regulatory requirements. Scope of the Manual This policy manual describes the food safety system at GalaRade and meets the requirements of the FSSC 22000 International Standard which includes GMP and HACCP requirements. The manual is a reference to the processes in the company, as well as directing the reader to the system or process that addresses the requirements of FSSC 22000. This policy manual is subject to revision at any time. Revisions are maintained as described in the FSMS Support Method: Control of Documents. The manual is subject to review every two years beginning at its release in April, 20xx. Reviews will also be noted in the FSMS Policy – Revision History, the third page of this document.

Case Study (Delegate) FS203001ENGX v3.0 Apr 2023 ©The British Standards Institution 2023 5 of 49 Company Background GalaRade is a producer of high quality apple juices. Our primary product is GalaRade, a pasteurized juice made from gala apples. Our secondary product is Red Cascade made from a blend of several apple varieties and red cascade pears. Our primary markets are retail shops in the US and Canada, though we are seeking to expand our exports into Mexico by 20XX. The company was founded in 1943 in Newport, VA. What started out as two stubborn brothers, a family orchard and a hand-cranked cider press turned into an enterprise encompassing 25 acres of the finest fruit in the tri-state area. In 1985 we added a 4,000 square-foot processing facility with a new Maximizer press and a Microflash Pasteurizer to triple our production volume and enable us to produce a safe and flavorful product. GalaRade prides itself on delivering the finest safe product and to this end we have implemented a food safety management system that meets the requirements of the FSSC 22000 standard. Structure of FSMS The basic structure of the food safety management system is in a four tier system, with the top three tiers being documents describing necessary processes including controls for the processes, and the bottom or fourth tier indicating the records of the organization. Procedures Work Instructions/Forms Records Food Safety Policy

Case Study (Delegate) FS203001ENGX v3.0 Apr 2023 ©The British Standards Institution 2023 6 of 49 FS Context 1. Organization’s purpose and strategic direction Purpose To continue to be one of the USA’s and Canada’s premier leading brands and providers of ‘high quality apple juices’. Our primary product is GalaRade, a pasteurized juice made from gala apples and our secondary product is Red Cascade made from a blend of several apple varieties and red cascade pears. Our reason for ‘being’ is a combination of our vision, mission, and values. What is our vision? To become the most trusted provider of high quality apple juices within the USA, Canada and Mexico. What is our mission? To expand our operations by consistently meeting customer's expectations, and our statutory and regulatory requirements; which includes the enhancement of customer satisfaction, provision of legal, technological, competitive, market, cultural, social, economic environments, cyber security, prevention of food fraud, enhanced food defence and protection against intentional contamination, knowledge and performance of the organization, whether international, national, regional or local, through the effective application of our management system processes for continual improvement. What are our values? Sustainable business practices taking into account our, social, economic and environmental impacts, responsible governance and the protection of all our products. These are re-enforced through sustainability principles and workforce integrity throughout all of our food safety business operations. Strategic Direction To maintain our current customer base of provision of product to retail shops in the USA and Canada with a view to expand our exports into Mexico by 2020. To implement and gain accredited certification to ISO 14001 and FSSC 22000 in all activities, within two years of the new standard being published. To employ a motivated workforce that will embrace the organization’s values, and complement the cooperation and collaboration needed to achieve the effective application of our processes for continuous improvement. 2. Organization’s intended results of its FSMS [relevant to 1.] From the ‘1 Scope’ of the Standard: • To plan, implement, operate, maintain and update a food safety management system aimed at providing products that, according to their intended use, are safe for consumers • To demonstrate compliance with applicable statutory and regulatory food safety requirements • To evaluate and assess food safety customer requirements and demonstrate conformity with those mutually agreed customer requirements that relate to food safety • To effectively communicate food safety issues to interested parties within the food chain • To ensure that the organization conforms to its stated food safety policy • To demonstrate conformity to relevant interested parties; and to seek certification or registration of its food safety management system by an external organization, or make a self‐assessment or self‐declaration of conformity to FSSC 22000

Case Study (Delegate) FS203001ENGX v3.0 Apr 2023 ©The British Standards Institution 2023 7 of 49 3. External issues [relevant to 2.] extracts The intent here is to provide a high level, conceptual understanding of the important issues that can affect, either positively or negatively, the way an organization manages its Food Safety responsibilities to achieve intended results of its food safety management system. • Legal – To be compliant to FDA, CFIA and COFEPRIS enforced applicable food safety laws • Technological – To be sufficiently advanced to current technology and innovation • Competitive – Other international apple juice brands particularly, infiltration from Europe • Market – Knowing the international market and the potential of the introduction of new products regarding a variety of fruit blended combinations • Cultural – Understanding culturally what is expected from our products in the future by our current customers and particularly in the new export target market of Mexico • Social – In Mexico it is custom to buy products from Mexico, rather than the United States • Economic – To produce a high quality product that is affordable when pitched against new infiltrating multinational brands from within the US, from Europe and with established Mexican brands already present in Mexico • Environment – Sourcing our own sustainable apples and pears from our own orchards • Cyber security – Protection of our recipes, methodology, processes and flow diagrams of how we do what we do, and the information security management of our valued customer database, their order spends and sensitive data • Food fraud – Being ever vigilant, in investigating any forms of food fraud that relates or could relate to our prestigious brand • Food defence and intentional contamination – Being ever diligent in the potential of breaches in food safety production, with legal pursuance of individuals intentionally putting our customers and business reputation at risk, combined with litigious action where the targeted consumers country and US legislation has been breached • Knowledge and performance of the organization whether international, national, regional or local – Monitoring, measuring, analysing, evaluating and reviewing the products processes, HACCP’s, PRP’s, ORP’s and overall performance of the organizations food safety management systems; whilst being ever aware of how our brand is progressing in the market place and what the current and speculated future consumer demands may be • [continued] 4. Internal issues [relevant to 2.] extracts • Organizational structure – Very flat, with most of the workers being either contractors, or the work outsourced. This introduces issues around food safety control • Roles and accountabilities – Are loosely defined due to the flat structure • Resource capabilities - Knowledge and competence, relating to food safety, is still very poor with only superficial training provided, and only general competence in food safety within the organization to do so • Relationships with, and perceptions and values of workers – Command and control, work comes first, food safety is the responsibility of the worker. Seasonal worker perception is food safety becomes a luxury when time allows and may rely on downstream processes

Case Study (Delegate) FS203001ENGX v3.0 Apr 2023 ©The British Standards Institution 2023 8 of 49 or personnel to ensure food safety, as it is seen as, transferring responsibility to full time employees who are perceived to have a higher responsibility • The form and extent of contractual relationships, including for example outsourced activities – hourly rates, or package price based on a defined output. No robust contractual arrangements in place relating to food safety, which do not clearly outline the duty of care owed by everyone to produce food safe product fit for human consumption • Working time arrangements – Generally work until the job is completed, or for as much time as GalaRade is prepared to pay them for, this puts enormous stress on the workers, tiredness, and mistakes relating to food safety have the potential to escalate • [continued] 5. Needs/expectations of interested parties [relevant to 2.] extracts (An organization is expected to gain a general (i.e., high-level, not detailed) understanding of the expressed needs and expectations of workers and other interested parties that are FS relevant) The workers, and other interested parties, with expectations relevant to the FS have been determined below, with their individual needs and expectations (requirements). These have been determined through a mixture of contract/tender requirements, disclosed voluntarily, phone contact, electronic surveys, operational meeting and top management focus. External Parties Example Needs/Expectations Legal and Regulatory Authorities 1) Identification of statutory and regulatory requirements for the FS activities under our control/influence, understanding of the requirements, application within our FS, update/maintenance of them, compliance to them, prompt responses to investigations and enquiries, prompt reporting of applicable incidents Customers 2) Demostrable ISO conformance/Legal compliance 3) Value for money (esp. for higher –ve risk activities) 4) Maintained levels of product provision times 5) Socially and ethically responsible Citizens 6) Legal compliance 7) Absence of FS incidents 8) Meeting policy commitments 9) Socially and ethically responsible Media 10) Fast, accurate information concerning FS related impacts/incidents to the local/national press 11) Openness/transparency to everyone Banks 12) Meeting repayment terms 13) Compliance with loan conditions 14) Good risk management 15) Legal compliance

Case Study (Delegate) FS203001ENGX v3.0 Apr 2023 ©The British Standards Institution 2023 9 of 49 External Parties Example Needs/Expectations 16) Absence of FS incidents/legal costs/public liabilities Contractors/Suppliers 17) Clear statement of FS requirements in tenders/contracts 18) Consistent approach to contract variations involving FS practices 19) Adherence to agreements 20) Level playing field for all FS requirements 21) Reasonably practical FS demands Workers’ (labor) representatives (external) 22) Terms and conditions for workers – FS related 23) Employee FS consultation/participation on work changes Internal Parties Example Needs/Expectations Workers, including management 24) Good FS reputational image 25) Wider focus than just profit 26) Formal externally recognized training for all workers 27) Occupationally safe and healthy working conditions 28) Continuity of employment 29) Opportunities for dialogue/improvement/changes Workers’ (labor) representatives (internal) 30) Terms and conditions for workers – FS related 31) Employee FS consultation/participation on work related changes 32) Suitable and sufficient training for their role, and other workers whom they represent 6. Work related activities planned or performed The company operates from a single site at the Newport, VA location, with three buildings where operations exist. Our FSMS has been designed to ensure that food safety hazards that may be reasonably expected to occur in relation to our products are identified, evaluated and controlled so that our products are safe and do not harm consumers either directly or indirectly. In order to achieve this, GalaRade communicates important information about our products throughout the food chain and within GalaRade. Primary concern within GalaRade is that our employees know and understand our FSMS, including its development, implementation and updating of the food safety management system so that they are aware of the role of the FSMS to assure the safety of our products. We understand the changing nature of our industry, processes and potential food safety hazards and how these changes can impact our operations. We evaluate and update GalaRade’s FSMS to ensure it reflects our operations, incorporating the most recent scientific information on the food safety hazards we need to control. GalaRade outsources calibration services, network maintenance services, pest control monitoring maintenance and, as necessary, testing requested by customers, are the only outsourced activities. The sources of services are managed under purchasing agreements

Case Study (Delegate) FS203001ENGX v3.0 Apr 2023 ©The British Standards Institution 2023 10 of 49 ensuring adequate control of quality of those services and their availability to the company. No outsourcing of product handling or storage is done at this time and none is planned. 7. Determined scope [considering 3, 4, 6 and 7.] The scope of the food safety management system includes all activities involved in producing the main products of the company and in supporting the maintenance and improvement of the FSMS. PRP design, as required by the FSSC 22000 standard follows the Design and Development methodology, and results in processes and controls developed and implemented to manage food safety.

Case Study (Delegate) FS203001ENGX v3.0 Apr 2023 ©The British Standards Institution 2023 11 of 49 GalaRade Inc. Food Safety Policy As one of the USA’s and Canada’s premier leading brands and providers of ‘high quality apple juices’. GalaRade will embrace the organization’s commitment to food safety of its products in this policy which is believed to be fulfilling and appropriate regarding the purpose and context of GalaRade. This includes: • Providing a framework for setting and reviewing the objectives of food safety management system • Commitment to satisfy applicable food safety requirements including statutory and regulatory requirements and mutually agreed customer requirements related to food safety • Addressing internal and external communication • Commitment to continual improvement of the food safety management system • Is reviewed for continued suitability Review of the FS policy will take place at least annually, to ensure it remains relevant and appropriate. This will be in conjunction with workers and relevant interested parties, where they exist. President and CEO John Applebie

FS203001ENGX v3.0 Apr 2023 ©The British StanOrganization chart (Version 3 Jul 20xx) X3 President John ApContracts Manager Hank Roba Plant MHughQuality Assurance Director Kevin Applebie Sales Director William Ross MaintenanceRonald MaintenanFood Safety Team x 4 Quality control Supervisor Gene Lean

Case Study (Delegate) dards Institution 2023 12 of 49 and CEO pplebie Manager h Trent Purchasing Manager Gloria Frugal OH&S and ENV Advisor Chester Payne Human Resources Director Irma Smartt Orchard and Juice Mill Director Perrie Crusher e Supervisor Cooke ce staff x 6 Production Staff x 15 Production Supervisor Stephanie Applebie

Case Study (Delegate) FS203001ENGX v3.0 Apr 2023 ©The British Standards Institution 2023 13 of 49 [ Organizational roles, responsibilities, accountabilities and authorities Roles Responsibilities Accountabilities Authorities Managing Director Management System(s) owner, overall responsibility for the protection of food safety and the FSMS, improving FS culture in the organization, providing the resources as necessary For the protection of Food Safety and the FSMS All authorities granted Quality Assurance Director Maintenance of the FSMS including: • The FSMS conforming to the standard • Keeping up-to-date with legal and other requirements • Actions to ensure compliance • Assessing risks and opportunities to the FSMS • FSMS performance reporting to top management • FS Team Leader FSMS internal audit process • Planning of audit programme • Undertaking audits and monitoring progress Reporting on objective conformance to: The organization’s own requirements for its food safety management system, including the FSMS policy and FSMS objectives Quality, Food safety production, profitability, the effective implementation of the overall FSMS To update, change, improve any aspect of the FSMS To change audit programme(s), to recruit new FSMS internal auditors, raise audit findings (as appropriate), escalate matters Production Manager For site FS performance, including: • Maintenance of risk treatment action plans and opportunities • FS discipline • Timely incident investigations • FS Regulator interactions • Undertaking audits and monitoring progress For the effective implementation of safe systems of work, and the controls according to the hierarchy. Accountable to Regulator on any incidents and inspection notices To deviate from safe systems of work if required

Case Study (Delegate) FS203001ENGX v3.0 Apr 2023 ©The British Standards Institution 2023 14 of 49 Roles Responsibilities Accountabilities Authorities OH&S and Env. Advisor OHS&E MS internal audit process: • Planning of audit programme • Undertaking audits and monitoring progress Reporting on objective conformance to: The organization’s own requirements for its OHS&E management system, including the OH&S policy and OH&S objectives. The requirements of ISO 14001 is effectively implemented and maintained To change audit programme(s), to recruit new OHS&E internal auditors, raise audit findings (as appropriate), escalate matters Members of the Food Safety Team FS performance improvement: • Ensuring that information on changes that can have an effect on the FSMS is included in updating of the FSMS • Conducting Hazard Analysis • Planning and implementing validation processes for control measures • Evaluating the results of verification • Analysing results of verification • Evaluating the Food Safety Management System at planned intervals To the Food Safety Team Leader, Food Safety Interpretation and understating of critical control point and ORP, data /action criteria To devise and control HACCP plans stop production, investigate incidents take sample data Inspect Process and functions and audit the FSMS All personnel Conformance with the FSMS, and reporting deficiencies in FS arrangements and new hazards Their own DoC related to FS contributions and their actions on others, whom also owe a DoC and may also be affected To raise FSMS improvement requests, deficiencies, and new hazards HR Director The provision of FS information and communication, FS competence provision and evaluation All workers have been informed and communicated on pertinent FS matters relating to their role. All workers are competent relating to their activities affecting FS Devise FS training, knowledge provision and experience, relating to FS. Assess the above through appropriate evaluation methods with line management

Case Study (Delegate) FS203001ENGX v3.0 Apr 2023 ©The British Standards Institution 2023 15 of 49 GalaRade Inc. HACCP Programme Step 1 - The HACCP team GalaRade has assembled a multi-disciplinary Food Safety/HACCP Team drawn from internal and external expertise. All members have been trained in accordance with SOP 6.2.2.1 Training. Members of the Team, their roles and expertise are defined in the table below. Role in Team Name of Member Position at GalaRade Expertise Leader (Food Safety Team/HACCP) Kevin Applebie Quality Assurance Director Juice processing Member Ronald Cooke Maintenance Supervisor Equipment, preventive maintenance Member Sheryl Janes HACCP consultant Microbiologist Member Stephanie Applebie Production Supervisor Operations, scheduling Steps 2 and 3. - Product Description and Intended Use, Verified Table 2. Description and Intended Use of Product Name of Product GalaRade, Red Cascade Description GalaRade: 13° Brix apple juice with added sugar, preservative (sodium metabisulphite) and water. Filtered through 5 micron filter, pasteurized at 90°C for 2 minutes Red Cascade: 13° Brix apple + pear juice with added sugar, preservative (sodium metabisulphite) and water. Filtered through 5 micron filter, pasteurized at 90°C for 2 minutes Storage conditions Bulk tank at 8°C until processed. Ambient temperature after processing Shelf Life Six months on store shelves/consumer home at ambient temperatures Intended use Consumed without further heat treatment or filtration. Packaging TetraPack - 1 liter, TetraPack Minis with packaged straw – 0.25 liter. Secondary packaging in stadium cut laminated cardboard shipper Customer specification Within microbiological and mycotoxin guidelines, within product acid level Distribution Ambient transport, sealed truck. No refrigeration required during transport. Thermal blankets used in summer/winter to protect product. Target Consumer Local consumption and export market (Canada). Sensitive populations None, consumption by all. Labeling requirement Chill before serving. Consume within 4 days once opened

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Case Study (Delegate) FS203001ENGX v3.0 Apr 2023 ©The British Standards Institution 2023 17 of 49 Step 4 - Flow diagram Receipt Apple Bulk Storage, apple Sort Wash Bulk storage whole fruit Press/extraction process Filtration Pasteurization Aseptic Filling Storage and dispatch Receipt: Sodium metabisulphite, sugar solution, packaging materials 1 2. 3. 4. 5. 6. 7. 8. 9. 10. Dry Storage: Sodium metabisulphite, sugar solution, packaging materials

FS203001ENGX v3.0 Apr 2023 ©The British Standards Step 5. Flow diagram approved and verified by: Kevin Applebie Date: April 5, 201X Food Safety Team Leader Step 6 (Principle 1) - Hazard analysis Firm Name: GalaRade, Inc. Firm Address: 3562 Orchard Lane Newport, VA 24063 Product(s): Pa Ga RedApproved by: 1 Ingredient/ processing step 2 Identify potential hazards introduced, controlled or enhanced at this step (1) 3 Are any potential FS hazards significant? (Y/N) 4 JustcoluReceipt of apples Biological - Vegetative and protozoan enteric pathogens(E.coli O157:H7, Cryptosporidium parvum, Salmonella sp. filth Yes HistappChemical - Pesticides Yes ProdpestfreqimpaChemical - Patulin Yes Mayeffe

Case Study (Delegate) Institution 2023 18 of 49 asteurized apple juice: alaRade d Cascade John Applebie Date: 04/09/XX tify your decisions for umn 3. 5 What preventative measures can be applied to prevent the significant hazards? 6 Is this step a critical control point? (Y/N) tory of outbreaks for le juice Pasteurization No duce unapproved ticide residues not uent, public health act typically not severe (Apples from GalaRade orchard, use of unapproved pesticides controlled by GAPs) No y have adverse health cts Orchard’s guarantee to exclude fallen fruit, cull or trim apples to remove rotten, Yes

FS203001ENGX v3.0 Apr 2023 ©The British Standards 1 Ingredient/ processing step 2 Identify potential hazards introduced, controlled or enhanced at this step (1) 3 Are any potential FS hazards significant? (Y/N) 4 JustcoluReceipt of apples [continued] Physical - Sticks, stones, large bugs Yes CouchokReceipt of packaging materials (Tetrapack, shippers) Biological - None Chemical - None Physical - None Dry storage packaging materials Biological - None Chemical - None Physical - None Bulk Storage – apple Biological - Growth of pathogens (Salmonella spp and E. coli O157:H7) from temperature abuse No pH opathChemical - Patulin Yes Patuin stPhysical - None * Patulin is a mycotoxin that can occur on rotten, moldy, bruised or damamake juice

Case Study (Delegate) Institution 2023 19 of 49 tify your decisions for umn 3. 5 What preventative measures can be applied to prevent the significant hazards? 6 Is this step a critical control point? (Y/N) moldy, bruised and damaged fruit uld present king/injury hazard Press and filtration will remove large particles No of apples low, growth of hogens unlikely Cull/trim bruised, rotten, moldy apples No ulin levels may increase torage aged apples. May occur at hazardous levels if such apples are used to

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FS203001ENGX v3.0 Apr 2023 ©The British Standards HAZARD-ANALYSIS (continued) 1 Ingredient/ processing step 2 Identify potential hazards introduced, controlled or enhanced at this step (1) 3 Are any potential FS hazards significant? (Y/N) 4 JustcoluSort Biological - None Chemical - Patulin Yes RedremappPhysical - None Wash Biological - Contamination with pathogens from water No SOPcontcontChemical - None Physical - None Grind Biological - None Chemical - None Physical - Metal fragments Yes WorbreaPress / Extraction Process Biological - None Chemical - None Physical - None Filtration Biological - None Chemical - None Physical - Metal fragments Yes Undcontfrag

Case Study (Delegate) Institution 2023 21 of 49 tify your decisions for umn 3. 5 What preventative measures can be applied to prevent the significant hazards? 6 Is this step a critical control point? (Y/N) duce patulin levels by oving moldy, damaged les Cut/trim moldy, bruised apples. Cull-out rotten apples Yes P for water quality trols biological tamination issues rn/damaged blades can ak off into slurry Screen will remove metal particulates No damaged screen will tinue to filter out metal ments Screen will remove metal particulates Yes

FS203001ENGX v3.0 Apr 2023 ©The British Standards 1 Ingredient/ processing step 2 Identify potential hazards introduced, controlled or enhanced at this step (1) 3 Are any potential FS hazards significant? (Y/N) 4 JustcoluBulk Storage (juice) Biological - None Chemical - Sanitizing chemicals from CIP system No Not cleakeepnot Physical - None Pasteurization Biological - Vegetative and protozoan enteric pathogens (E. coli O157:H7 and Cryptosporidium parvum are the pertinent microorganisms Yes MicrincoChemical - None Physical - None Aseptic Filling Biological - None Chemical - Hydrogen peroxide No Not occucommaxperoby r178watethe Physical - None

Case Study (Delegate) Institution 2023 22 of 49 tify your decisions for umn 3. 5 What preventative measures can be applied to prevent the significant hazards? 6 Is this step a critical control point? (Y/N) likely to occur, SOP for aning and sanitizing will p residues to low levels likely to cause illness robial contamination on oming apples Pasteurization for proper time and temperature Yes reasonably likely to ur. SSOP to ensure mpliance with the ximum level of hydrogen oxide residual allowed egulation (21 CFR .1005; of 0.5 ppm in er filled and packaged in system.) SSOP No

FS203001ENGX v3.0 Apr 2023 ©The British Standards 1 Ingredient/ processing step 2 Identify potential hazards introduced, controlled or enhanced at this step (1) 3 Are any potential FS hazards significant? (Y/N) 4 JustcoluStorage and Dispatch Biological - None Chemical - None Physical - None

Case Study (Delegate) Institution 2023 23 of 49 tify your decisions for umn 3. 5 What preventative measures can be applied to prevent the significant hazards? 6 Is this step a critical control point? (Y/N)

FS203001ENGX v3.0 Apr 2023 ©The British Step 7 HACCP Plan HACCP Plan Form Firm Name: GalaRade, Inc. Firm Address: 3562 Orchard Lane Newport, VA 24063 Pr Ap(1) Critical Control Point (2) Significant Hazards (3) Critical Limits for each Preventive Measure Monitoring (4) (5) (6) What How FrequeCCP 1 Receipt of apples Patulin Filth Guarantee from Orchard - shipment does not include fallen fruit Orchard guarantee exists for each incoming shipment of fruit Guarantee is visually confirmed Each incomifruit shipme

Case Study (Delegate) Standards Institution 2023 24 of 49 roduct(s): Pasteurized apple juice: GalaRade Red Cascade pproved by: John Applebie Date: 04/09/XX (8) Corrective Actions (9) Verification (10) Records (7) ency Who ing ent Receiving manager Reject fruit if not accompanied by guarantee Review monitoring corrective action and verification records within one week of preparation. Periodic audits of Orchard for adherence to guarantee. Periodically test juice for patulin levels. Orchard guarantee Receiving log Orchard audit report Patulin test results

FS203001ENGX v3.0 Apr 2023 ©The British (1) Critical Control Point (2) Significant Hazards (3) Critical Limits for each Preventive Measure Monitoring (4) (5) (6) What How Freque(1) Critical Control Point (2) Significant Hazards (3) Critical Limits for each Preventive Measure Monitoring (4) (5) (6What How FrCCP 2 Sort Patulin Undamaged apples Moldy, rotten, bruised or otherwise damaged apples Visual inspection CoCCP 3 Filtration Metal fragments Screen is intact and in place Integrity of screen Visual inspection Da

Case Study (Delegate) Standards Institution 2023 25 of 49 (8) Corrective Actions (9) Verification (10) Records (7) ency Who (8) Corrective Actions (9) Verification (10) Records 6) (7) requency Who ontinuous Sorting personnel Stop belt and remove damaged fruit Review monitoring, corrective action, and verification records within one week of preparation. Periodically test juice for patulin levels Sorting log Patulin test results aily Production personnel Segregate product and rework to eliminate metal pieces, run product through metal detector, divert to nonfood use, or destroy Replace screen Calibrate screen to ensure metal pieces 7 mm or greater do not pass screen, semiannually. Review monitoring corrective action and verification records within one Screen integrity log Screen calibration log

FS203001ENGX v3.0 Apr 2023 ©The British Signature of Company Official: Kevin Applebie Page 1 of ____ (1) Critical Control Point (2) Significant Hazards (3) Critical Limits for each Preventive Measure Monitoring (4) (5) (6) What How Freque

Case Study (Delegate) Standards Institution 2023 26 of 49 Date: 04/09/20XX (8) Corrective Actions (9) Verification (10) Records (7) ency Who week of preparation

FS203001ENGX v3.0 Apr 2023 ©The British # (Food safety Risk Assessments) All U1 Receipt of apples Apples are not fallen fruit and free from patulin and filth Persodelivewithouguaraeach fshipm2 Apple sort process Apples are undamaged and free from patulin, filth, mold, not rotten, bruised or otherwise damaged Persoapplefilthy, bruisedamato visu

Case Study (Delegate) Standards Institution 2023 27 of 49 Uncertainty Risks (-ve) (Effect) Opportunities (+ve) (Effect) onnel receiving eries of apples ut an orchard antee exist for full incoming ment There is no orchard’s guarantee, fallen fruit is present, damaged apples are not culled or trimmed to remove rotten, moldy, bruised and damaged fruit which contaminates other apples within the process Clear instruction guidance and supervision combined with training competency and awareness that food safety comes before production and profit for safety, ethical and litigious reasons. Reject fruit if not accompanied by guarantee. Implement a food safety sorting log. Ensure that orchard has been audited and an audit report is kept as retained documented information onnel sorting s may miss moldy, rotten, ed or otherwise ged apples due ual inspection Damaged apples are, at present, not culled or trimmed to remove rotten, moldy, bruised and damaged fruit which contaminates other apples within the process Clear instruction guidance and supervision combined with training competency and awareness that food safety comes before production and profit for safety, ethical and litigious reasons. Ensure employees stop conveyor belts and remove damaged fruit. Implement a food safety sorting log and Patulin test

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FS203001ENGX v3.0 Apr 2023 ©The British # (Food safety Risk Assessments) All U3 Filtration Products are free form any physical contaminant especially metal If filterdamametal breacand pthe prthe fin4 Etc. ………………. ………

Case Study (Delegate) Standards Institution 2023 29 of 49 Uncertainty Risks (-ve) (Effect) Opportunities (+ve) (Effect) r screens are ged there may particulate ching the filters progressing in rocess and on to nal product Large metal particulate contaminate in product Calibrate screen to ensure metal pieces 7 mm or greater do not pass screen, semi-annually. Review monitoring corrective action and verification records within one week of preparation. Implement a food safety integrity log and food safety screen log …………. ………………. ……………….

Case Study (Delegate) FS203001ENGX v3.0 Apr 2023 ©The British Standards Institution 2023 30 of 49 Corrective Action Procedure (SOP 8.9.3) 1.0 PURPOSE To define the responsibilities for and the process of eliminating the cause of nonconformities. The procedure is designed to satisfy the requirements of FSSC 22000 and other customer and regulatory requirements. The procedure is also used to resolve customer complaints. 2.0 SCOPE This procedure applies to all nonconformities raised through internal audits, registration audits, regulatory audits, customer audits, internal complaints, and customer complaints. 3.0 RESPONSIBILITY 3.1 Anyone in GalaRade can initiate a corrective action. To do so, they may document the nonconformity, customer complaint, or internal complaint on the Corrective Action Request Form (F8.9.3) and present the form to the Quality Assurance Director who is then responsible for signing and dating the form upon receipt. 3.2 The Quality Assurance Director is responsible for resolving nonconformities or delegating other GalaRade employees to resolve nonconformities. 3.3 The Quality Assurance Director is responsible for monitoring the progress of all corrective actions. 3.4 The Quality Assurance Director and the CEO are both responsible for accepting and signing off on any completed corrective actions. 4.0 DEFINITIONS AND ABBREVIATION Corrective Action: Action to eliminate the cause of a nonconformity and to prevent recurrence (ISO 22000, Clause 3.10). Nonconformity: Non-fulfillment of a requirement (ISO 22000, Clause 3.29) Objective Evidence: Data supporting the existence or verity of something (ISO 9000:2015, Clause 3.8.3) 5.0 CORRECTIVE ACTION PROCESS 5.1 All GalaRade employees are responsible for completing ‘Section 1.0’ of the Corrective Action Request Form (F8.9.3) when they receive a customer complaint or observe a nonconformity. 5.2 The Quality Assurance department is responsible for receiving the Corrective Action Request Form (F8.9.3) and completing ‘Section 2.0.’ The Quality Assurance Director must sign all received forms and assign a unique number to the corrective action request. 5.3 The Quality Assurance Director must delegate responsibility for ‘actioning’ the corrective action request. This may be someone in the Quality Assurance department, the Food Safety Team or another employee at GalaRade. The Quality Assurance department must record the appropriate data on the Correction Action Log (LG8.9.3.4) to show who is responsible for resolving the corrective action, and the form is then passed to the ‘Actioner’ for recording of the corrective action process. 5.4 The ‘Actioner’ must take the following steps within 60 days of when the corrective action is recorded on the Corrective Action Log (LG8.9.3.4)

Case Study (Delegate) FS203001ENGX v3.0 Apr 2023 ©The British Standards Institution 2023 31 of 49 5.4.1 Determine and document the appropriate actions to resolve the nonconformity or complaint on ‘Section 3.0’ of the Corrective Action Request Form (F8.9.3) 5.4.2 Implement the actions 5.5 The Quality Assurance Director must review the corrective action and the objective evidence before signing the Corrective Action Request Form (F8.9.3) 5.5.1 If the completed corrective action is acceptable to the Quality Assurance Director, the form is sent to the Plant Manager for review who must also sign the form If the completed corrective action is unacceptable to the Quality Assurance Director, the form is sent back to the ‘Actioner’ to begin the process again. This failure is recorded on ‘Section 4.0’ of the Corrective Action Log (LG-006). If the completed corrective action is unacceptable to the Plant Manager, the form is sent back to the ‘Actioner’ to begin the process again. This failure is recorded on the Corrective Action Log (LG-006) 5.6 The Quality/Regulatory Affairs department must keep all Corrective Action Request Forms (F8.9.3) for at least 3 years 5.7 If the corrective action results in a change to a procedure or work instruction, all affected personnel must be trained to the new procedure or work instruction 6.0 COMMUNICATION AND TRAINING 6.1 The Quality Assurance Director is responsible for communicating the corrective action to all affected parties within GalaRade. If the corrective action directly affects the quality of the product, the appropriate customers must be notified 6.2 The Quality Assurance Director is responsible for posting an updated printout of the Corrective Action Log (LG-006) in the break room weekly 7.0 REFERENCE Corrective Action Request Form (F8.9.3) Corrective Action Log (LG-006) Control of Records (SOP7.5.3) 8.0 APPROVAL ______________________________________________ Quality Assurance Director Date ______________________________________________ CEO Date

Case Study (Delegate) FS203001ENGX v3.0 Apr 2023 ©The British Standards Institution 2023 32 of 49 Management Review Procedure (CP-9.3) 1.0 PURPOSE To define the responsibilities for and the process of conducting management reviews of GalaRade’s Food Safety Management System (FSMS) at defined intervals to ensure its continuing suitability and effectiveness in satisfying the requirements of FSSC 22000 and GalaRade’s food safety policy, goals and objectives. 2.0 OBJECTIVES AND TARGETS This procedure applies to all activities that have a direct bearing on food safety management at GalaRade. The objective of the management review process is to provide the necessary direction, commitment and resources required to achieve continuous improvement in GalaRade’s Food Safety Management System. 3.0 RESPONSIBILITY 3.1 The President and CEO of GalaRade is responsible for convening a meeting of top management and the Food Safety Team to discuss the suitability, adequacy and effectiveness of the company’s FSMS. 3.2 The Quality Assurance Director is responsible for coordinating and chairing the management review and related meetings, and for providing the resources necessary to respond to any new initiatives that result from management review. 3.3 The Quality Assurance Director is responsible for preparing information for the management review meeting regarding the FSMS. 3.4 All managers and supervisors are responsible for making available all relevant information regarding the suitability, adequacy and effectiveness of the FSMS in those areas for which they are responsible, including information about opportunities for further improvement in the FSMS. 4.0 DEFINITIONS AND ABBREVIATION None. 5.0 REQUIREMENTS The FSMS at GalaRade shall be reviewed at least once in each twelve-month period. 5.2 The President and CEO shall advise the Quality Assurance Director of the date and time of an upcoming management review, and shall direct the QA Director to prepare specified materials for review by management in advance of the meeting. 5.3 The Quality Assurance Director shall determine who will be required to attend the meeting, will notify attendees of the meeting time, and shall prepare a meeting agenda in advance of the meeting. 5.4 The agenda for the meeting shall include, but not be limited to, the following items: 5.4.1 The status of actions from previous management reviews; 5.4.2 Changes in external and internal issues that are relevant to the food safety management system including changes in the organization and its context; 5.4.3 Information on the performance and the effectiveness of the food safety management system, including trends in: a. Result of system‐updating activities; b. Monitoring and measurement results;

Case Study (Delegate) FS203001ENGX v3.0 Apr 2023 ©The British Standards Institution 2023 33 of 49 c. Analysis of the results of verification activities related to PRPs and the hazard control plan (see nonconformities and corrective actions); d. Audit results (internal and external); e. Inspections (e.g. regulatory, customer); f. Performance of external providers; g. Review of risks and opportunities and of the effectiveness of actions taken to address them; ‐ Extent to which objectives of the food safety management system have been met; 5.4.4 The adequacy of resources; 5.4.5 Any emergency situation, incidents or withdrawal/recall that occurred; 5.4.6 Relevant information obtained through external and internal communication, including requests and complaints from interested parties; 5.4.7 Opportunities for continual improvement. 6.0 COMMUNICATION AND TRAINING 6.1 A report on the management review shall be produced by the Quality Assurance Director, for approval by the President and CEO. Copies shall be distributed to all delegates in the meeting. 6.2 The Quality Assurance Director shall keep a copy of the management reports on file, and shall use the results to assist in the preparation of annual plans, programmes and budgets. 7.0 EVALUATION 7.1 Delegates in the management review meeting shall critique the meeting and management review. The results of the critique will be made a part of the minutes and meeting report. 8.0 REFERENCE None. 9.0 APPROVAL ______________________________________________ Quality Assurance Director Date ______________________________________________ President Date

Case Study (Delegate) FS203001ENGX v3.0 Apr 2023 ©The British Standards Institution 2023 34 of 49 Recall Procedure (SOP 8.9.5) 1.0 PURPOSE To define the responsibilities for and the process of enabling and facilitating the complete and timely withdrawal of product lots that have been identified as unsafe. The procedure is designed to satisfy the requirements of FSSC 22000 and other customer and regulatory requirements. 2.0 SCOPE This procedure applies to any product identified as unsafe. 3.0 RESPONSIBILITY 3.1 All the employees have the authority to advise the Quality Assurance Director of occurrences which may contribute to an unsafe product. 3.2 The Quality Assurance Director is responsible for initiating a recall. 3.3 The sales manager is responsible for handling the communication required in the event of a recall. 3.4 The Production Manager is responsible for executing the recall. 3.5 The Quality Assurance Director is responsible for scheduling and testing the recall system. 4.0 DEFINITIONS AND ABBREVIATION None 5.0 RECALL PROCESS 5.1 Information from employees or production records regarding potentially unsafe products is brought to the attention of the Quality Assurance Director 5.2 In consultation with the rest of the Food Safety Team, the Quality Assurance Director determines whether a recall is necessary 5.3 The Food Safety Team classifies the recall as Class 1-3 in accordance with the following criteria: Class I recalls are for dangerous or defective products that predictably could cause serious health problems or death. Class II recalls are for products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Class III recalls are for products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing regulations. 5.4 Quality Assurance Director notifies sales to execute the recall. 5.5 Sales works with Production Supervisor to identify the affected product lots and identify any corresponding product still within GalaRade’s control/property. 5.6 Sales identifies final location of all affected product. 5.7 Sales contacts customers who received affected product, informs them of recall and instructs them to pull affected product off shelves and ship back to GalaRade. 5.8 Affected product is isolated and identified as ‘RECALLED’ (marked with red recall tag and date) at receipt.

Case Study (Delegate) FS203001ENGX v3.0 Apr 2023 ©The British Standards Institution 2023 35 of 49 5.9 Samples of affected product are sent to the Quality Assurance Laboratory for testing. 5.10 Affected product is isolated until destroyed, reworked, or used for purposes other than originally intended and determined to be safe for the same (or other) intended use. 5.11 The cause of the withdrawal is determined. 5.12 The cause, extent and result of a withdrawal are recorded and reported to top management as input to the management review. 5.13 The recall procedure is tested through mock recalls every 6 months. 5.14 Records of mock recalls are maintained and reported to top management as input to the management review. 6.0 COMMUNICATION AND TRAINING 6.1 The Quality Assurance Director is responsible for communicating the Recall to all affected parties within GalaRade. If classified as a Class 1 or 2 recall, the FDA must be notified. Customers are notified in the event of any type of recall. 6.2 The Quality Assurance Director presents the results of recalls and results of testing the recall procedure at the Quarterlies to top management. 7.0 REFERENCE Recall Detail Form (F8.9.5.1) Recall Log (F8.9.5.2) 8.0 APPROVAL ______________________________________________ Quality Assurance Director Date ______________________________________________ CEO Date ______________________________________________ Production Supervisor Date

Case Study (Delegate) FS203001ENGX v3.0 Apr 2023 ©The British Standards Institution 2023 36 of 49 Food Contact Surfaces (SOP 8.2.1) 1.0 PURPOSE To ensure food surfaces of plant equipment and utensils are kept in a sanitary condition 2.0 SCOPE This procedure covers all food-contact surfaces of plant equipment and utensils, including gloves and outer garments worn by employees. 3.0 RESPONSIBILITY 3.1 Orders to purchase minor equipment and utensils used in the process will be reviewed by the line supervisor placing the order and the quality assurance department. 3.2 If necessary, the supervisor of the contracted cleaning company will be contacted to consider the impact of present methods of cleaning and sanitizing plant equipment and utensils. The results of these evaluations will be kept on file. 3.3 The quality control supervisor will evaluate the condition of plant equipment and utensils monthly. The results of these evaluations will be recorded on the monthly sanitation audit form. 3.4 The quality control representative will conduct a pre-operational sanitation inspection at the beginning of each day. 3.5 The quality control representative will check the concentration of the chlorine sanitizer before it is used. 3.6 The line supervisor will ensure that his or her employees are issued personal gear including aprons and gloves. 4.0 PROCEDURE 4.1 Equipment the product will come in contact with must be designed of such material and workmanship to be easily cleaned and maintained in a sanitary condition. Such surfaces will be constructed of nontoxic materials and designed to withstand the environment of its intended use and the action of the cleaning compounds and sanitizing agents. 4.2 All utensils and surfaces of equipment that contact food during processing will be cleaned and sanitized with effective cleaning and sanitizing preparation before the day’s operations begin. Before the production day begins, the facility, equipment and utensils will be sanitized using a 100 ppm chlorine rinse. The concentration of the chlorine sanitizer will be checked by the quality control representative before it is used. The results will be recorded on the facilities checklist. The quality control representative will conduct a pre-operational sanitation inspection. A representative of the cleaning crew will be present and if necessary immediately eliminate any discrepancy noted. The observations will be recorded on the facilities checklist. 4.3 GalaRade will issue line workers rubber aprons and work gloves. The line supervisor will ensure that his or her employees are issued this gear. Employees are not allowed to use personal gear in place of these items unless authorized by the line supervisor

Case Study (Delegate) FS203001ENGX v3.0 Apr 2023 ©The British Standards Institution 2023 37 of 49 and foreman. Employees are required to maintain this gear in a sanitary and operable condition and, if necessary, must replace it through the line supervisor. Gloves and outer garments that contact food or food-contact surfaces are made of an impermeable material and must be kept clean and sanitary. Supervisors require all employees to comply. In addition, the quality control representative will check this gear at the beginning of each day's operations as part of the facilities checklist. Observations will be recorded on the facilities checklist. 4.4 All utensils and surfaces of equipment that contact food during processing will be cleaned and sanitized with effective cleaning and sanitizing at the end of the day’s operations. All process lines, regardless of the intended purpose, will be cleaned and sanitized at the end of the day's operation, at the end of the production day. GalaRade employees will remove all build-up of debris or other materials from the facility. In addition GalaRade employees will clean and sanitize all equipment, utensils and the facility. A food-grade alkaline detergent will be used for cleaning, followed by a 100 ppm chlorine rinse. The concentration of the chlorine sanitizer will be checked by the quality control representative before it is used. The results will be recorded on a daily sanitation audit form. 4.5 Issues noted with equipment will be monitored on the facilities checklist. If a problem is noted with any piece of equipment in regards to sanitation, it must be recorded, and reported to the quality control representative. Based on the nature of the problem, corrective action may need to be requested by the quality control representative. 4.6 If equipment cannot be cleaned and requires a replacement, prior to replacing any major piece of equipment, the quality assurance, production and maintenance departments will meet to evaluate the equipment. The evaluation will determine whether replacing the equipment will impact adjacent processing steps. Specifications of all equipment will be reviewed to ensure it is capable of withstanding the intended use and can be easily cleaned. The same evaluation will be conducted on materials used in the modification of the physical plant. 5.0 COMMUNICATION AND TRAINING 5.1 All GalaRade employees will take part in basic sanitation training within the first 2 weeks of employment. 5.2 Periodic reviews of sanitization performance will take place and refresher training will occur every 2 years. 5.3 Records of training for sanitation must be kept with the HR department.