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Root Cause Analysis data received in September 2021

Summary of Food/Feed Safety Incident Root Cause Analysis (RCA) information

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Incident Reference Number Date RCA Received Incident Type Hazard Type Product Type Why 1 Why 2 Why 3 Why 4 Why 5 Root Cause Corrective Actions ALPHA TEST: FSA RCA Categorisation
I-001-566 02/09/2021 Allergens Milk Cereals & Bakery Products Blank Blank Blank Blank Blank Source: People - Procedures not followed A one off operator error – The baker made a one off mistake. Procedure at the time allowed baker to obtain further ingredients if they ran out. On this occasion the choc chips ran out and the baker obtained more from storage, but selected the incorrect choc chip for the recipe. The Company, at the time, used 2 types of Choc chip. One was a dairy free milk choc alternative chip. This is the one that should have been selected, but instead the choc chip (containing traces of milk) was selected and used. Source: Environment - Inadequate space / layout Choc chips were stored at supplier. Source: Method - Work instructions - absent or inadequate We have improved the work instructions Source: Material - Composition – incorrect ingredients / substitution Dairy free milk choc chip alternative for branded product were stored, alongside another brand of choc chips. The other brand wa selected in error. Source: People - Procedures not followed A new stock procedure has been implemented – this prevents any operator obtaining further stock ingredients, without prior management authorisation. A new baker’s sign off sheet has been implemented before any baking takes place and the customer baking sheets and baking production sheets have also been update. All staff have been made aware of this mistake and the consequences of this mistake.Training has been given for the new procedures and documentation. The Company now only uses one type of choc chip – the dairy free milk choc alternative. Source: Environment - Inadequate space / layout All milk choc chips are now stored at alterantive supplier. They DO NOT store any other choc chips for any other customer on site. Source: Method - Work instructions - absent or inadequate We have implemented and improved new procedures for Stock procedure, daily baking production sheets, bakery sign off sheet and the customer baking sheet. Source: Material - Composition – incorrect ingredients / substitution The root cause was operator error in selecting the incorrect ingredients. We now only store one type of choc chip. No other choc chips are allowed on site for any other customer. Environment: Ingredient / Product Storage Controls - inappropriate Method: Work Instructions - inadequate
I-001-368 03/09/2021 Pathogenic Microorganisms Salmonella Meat & Meat Products (other than poultry) Salmonella ssp detected inside of product on regular planned finished product testing Problem could have happened due to either: introduction with raw material ingredient (raw pork or fresh dill) or introduced by production staff (hygiene standard not followed correctly) Raw meat is delivered Vac packed and minced up to the standard within temperature contraints of production, Dill is washed in clorine before chopping and introducing into the product filling. Staff is compelled to follow hand washing procedure and wearing gloves at all times when inside of factory. Most probably introduced with ingredients. Product is raw there is no microbacterial elimination stage at any of the stages of manufacture. Product has cooking instruction that exceeds minimum of cooking to reach 72 for 2 minutes in order to bring out correct taste. Blank Salmonella was found in product after introducing with the ingredients. Source: People - Procedures not followed There is a possibility that the microorganism has been introduced through personnel. It seems a plausible explanation as the ingredients have a good history of micro stability. Source: Material - Contaminated product Microorganism introduced with one of the ingredients, there is no other history of bacteria in the area. All equipment is thoroughly cleaned every day. Reviewed process, ingredients and staff working on the product to ensure no reccurence. Staff briefed about Incident Source: People - Procedures not followed Hygiene practices are enforced daily on entrance of staff into the areas. All staff receives initial training and a supervising body ensuring that they follow the hygiene requirements correctly. Hand swabs and environmental swabbing planned, specifically for Salmonella presence. Source: Material - Contaminated product Notified meat supplier, who believes it should be okay as the product will be cooked before consumption, they also stated their test results from qualifying period were to standard and there was no issues with them reported. Process of Washing and Rinsing veg in 50ppm chlorine solution has also been reviewed and confirmed to be followed correctly. Material: Ingredient Cross-contamination
I-001-800 03/09/2021 Pathogenic Microorganisms Salmonella Meat & Meat Products (other than poultry) Salmonella was detected in one of the five composite samples taken from batch. There was an additional commercial Salmonella sample taken from the same batch which was also negative. Environmental factors are extremely unlikely due to the number of samples tested from this small batch and all other results were returned negative. In relation to process records around this production, all mince was produced as per our HACCP system. Raw material must have been contaminated. Cross contamination most likely took place on the slaughter line due to the manual dressing process involved It is probable that an infected animal that was not showing any symptoms came on site and passed through the process. Some form of cross contamination either from the gut or hide has allowed this to be transferred to the meat Cleaning and process records reviewed for the affected dates with no issues or finding recorded. A member of staff involved in the dressing process will have transferred the Salmonella unto the carcase. A number of staff are training on different jobs currently due to COVID. A member of staff involved in the dressing process will have transferred the salmonella unto the carcase The transfer took place due to the manual nature of the dressing process. We have have been having to move staff and retrain some staff due to COVID issues. Review of the lairage and HACCP plan carried out. The transfer took place due to the manual nature of the dressing process. We have gone back to all staff concerned and highlighted this issue and the importance of the avoidance of cross contamination. Recognizing that we need to eliminate the possibility of environmental contamination several swabs were tested from the mince room, all with negative results. Also recognising that there has to be an ultimate source of the Salmonella we have identified a number of potential farmers and have undertaken stool sample in some other animals from their farms. All these have been negative up until the present time. All product continues to be labelled as thoroughly cook prior to consumption with the commercial cooking process used by the customers being a retort cook well above the thermal threshold for salmonella. Method: Cleanliness or Sanitation - failure
I-001-599 07/09/2021 Allergens Crustaceans Prepared Dishes & Snacks Allergen labelling error. The allergen ‘Crustaceans’ was not declared for the ingredient Shrimp on the product labels imported. The product labels declared Shrimp as an allergen but under EU Regulation 1169/2011 Crustaceans must be declared as the specific allergen on the product labels to indicate to customers that the allergen Crustaceans is present in the product. The supplier declared the allergen as “ Shrimp “ on the product label and not the specific name of the allergen ‘Crustaceans’. The supplier misunderstood the requirement to label the allergen Crustaceans on the product label and deemed declaring ‘Shrimp’ as the allergen to be adequate and meet regulatory requirements. Allergen declared was not correctly compliant with EU Regulation 1169/2011 Misunderstanding/misintpretratation by supplier to declare the allergen ingredient as Shrimp and not Crustacean. There was a training gap by the supplier to understand the definition of Crustacean and to declare Crustacean as the allergen on the product label. This product is imported and there was a miscommunication between the supplier and the importing FBO to review the product label Incorrect allergen declaration of the ingredient Shrimp and not Crustaceans which did not follow EU Regulation 1169/2011 Incorrect allergen declaration which did not comply with EU Regulation 1169/2011 All product labels supplied by this supplier have been reviewed to comply with EU regulation 1169/2011. New products sourced from this supplier will be undergoing a full label and product specification review to ensure product labels are complaint with all regulatory labelling requirements. FBO has invested in a new Product Information Management System and all products being listed will be subject to a full label and specification review as part of the approval process. FBO Product Regulatory Officer conducts label audits each month and will be focused on the review of foreign products in the business to ensure full compliance. The supplier has been made aware of the non-conformance and now fully aware of the labelling requirements under EU Regulation 1169/2011. Corrective actions: • For stock already produced - Over labelling is going to take place, The full list of ingredients will be over labelled ensuring that the allergen indication is clear” labels will be fully compliant with FIR – these labels will be approved by FBO QA. • For NEW stock – New labels will be created labels and will be fully compliant with FIR – the Art work will be summited and these labels will be approved by FBO QA. Method: Labelling Declaration - incomplete