DEVIATION REPORT NGR No.: SOFdev00T Date and je: 20 October 2023 Initiator Name and Title: D.Mistry (Interial Auditor) Initiator Signature and Date: D.Mistry (20 October 2023) Product Name: Frozen Shrimp Product Cod FSHRPORS Lot # FSHRP 19_10_23 ‘Supplier Name: StarFisheries ‘Quantity: 30 kgs Recelpt inv. 1977023 Description of the Deviation ‘A major non-conformance in the Allergen Management Program was observed as SOF requirements in Clause 2.8.1 (Section 2.8) were not implemented. The sanitation of the conveyor belt (allergen-contact surface) was not done after processing the tuna. There is no evidence! record showing that the changeover of sanitation is propery done, and the validation report of cleaning methods (ATP allergen test kits) were not found Root Cause(s) What is the issue? Where did the deviation arise? And where does it impact? Who found the deviation? When was the issue found? Why is this a problem? How severe is it? The cleaning and sanitation of the conveyor belt canying raw tuna fish(allergen) was not done, and the same conveyor belt was utilized for carrying raw shrimp(allergen). This deviation was observed at the Raw Material Belt no, and Belt no,2 by S, Jane (raw material supervisor), The issue was observed on 19 October 2023 at 21:00 p.m., during the shift rotation. The raw material conveyor line, as well as further processing of the raw material, was Stopped for 45 minutes. According to S. Jane, the raw material handler on lines 1 and 2 was anew hire and failed to follow Allergen management procedures (SOP 18 lineChangeoverSani). Time segregation for sanitation and cleaning was not applied bétween the production of fish and shrimp. Consequently, 30 Kgs shrimp were cross-contaminated with tuna fish. Impact assessment to product quality, safely andlor efficacy (describe) ‘> The primary safety concem is the risk of severe allergic reactions in individuals allergic to shrimp or tuna due to even minor allergen cross-contamination. This can lead to a range of responses, from mild rashes to life-threatening anaphylaxis, ‘+ 30 Kg of frozen shrimp were contaminated by an allergen product (tuna fish), making it necessary to discard it. The product quality was damaged, and reworking the shrimp is impossible. ‘+ a consumer is expecting pure shrimp and receives a product contaminated with tuna, it may not meet their expectations. This could lead to dissatisfaction and affect the product's reputation and brand image. Corrective Action Taken ‘+ olate and quarantine the 30 Kgs of cross-contaminated shrimp to prevent them from reaching the production line. ‘+ immediately stopped further processing of the shrimp, until the sanitation and cleaning of the conveyor belts 1 and 2 was not performed.; followed by detailed inspection and assurance that the cleaning is in accordance with established Allergen Management Procedures (SOP18_lineChangeoverSan)) + Enhancing shift handover procedures to ensure effective communication of critical information, including sanitation status, between shifts. Form: SQFdev001 Date: October20, 2023 v:00DEVIATION REPORT = Moritoring the new hire’s performance closely and ensuring strict adherence to procedures. + Documenting the entire incident, including details of cross-contamination. Preventative Actions Taken > Reviow, update, and standardize allergen management procedures (SOP18_lineChangeoverSani) to make them clearer, more detailed, and in full compliance with SQF requirements. Ensure that these updated procedures are accessible to all relevant personnel ‘+ Develop a training and certification program for all employees involved in allergen management, including those handling allergenic materials. This program should encompass both theoretical and practical components to ensure complete understanding, ‘+ Establish a formal process to review and verify the effectiveness of corrective actions taken in response to non-conformances. ‘+ Standardize shift handover protocols for effective communication on equipment status, Cleanliness, and allergen control ‘+ Enhance supervisory oversight, with a focus on new hires during critical production phases. Implement regular allergen testing for equipment and product surfaces post- cleaning. + Maintain comprehensive records of cleaning validation, including ATP allergen test results, for easy review and verification, Investigation Summary and Conclusion This report underscores a major non-conformance within the Allergen Management Program due to SQF non-compliance (Clause 2.8.1). The primary issue centered on the improper sanitation of the conveyor belt post-tuna processing, and the absence of documented sanitation changeovers and validation of cleaning procedures using ATP allergen test kits. The issue was caused by a new hire's failure to follow procedures, resulting in cross-contamination of 30 Kgs of shrimp (Lot #FSHRP19_10_23) with tuna. The impact assessment identified severe safety concems, from mild allergies to anaphylaxis, Immediate actions isolated the contaminated shrimp, enhanced sanitation, and documented the incident. Praventative steps include procedure updates, training, standardized handovers, increased supervision, allergen testing, and thorough cleaning records to prevent future non-conformances and enhance compliance, Comments: As Lot #FSHRP19_10_23 shrimp was discarded, there will not be any recall and further handling of the product under strict Allergen Management Plan will be carried out. “Attach supporting documentation Investigation Conducted By: Name: D.Mistry Title: Intemal Auditor Signature: D. Mistry Date: 20 October 2023 Reviewed by: HACCP Coordinator Name: HH.M. Title: HACGP Coordinator Signature: H.H.M. Date: 21 October 2023, Form: SQFdev0o1 Date: October20, 2023 v:00DEVIATION REPORT Approved by: P. Robert ‘QA Manager Signature: P. Robert Date: 21 October 2023, Form: SQFdev0o1 Date: October20, 2023 v:00