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Root Cause Analysis data received in April 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-000-620	01/04/2021	Foreign Body	Rubber	Poultry Meat & Poultry Meat Products	We chose to use the Fishbone method.	Blank	Blank	Blank	Blank	Human error in the visual inspection of dolly bins before use, to ensure it is free of contamination i.e an o-ring. PEOPLE: Procedures not followed - one-off operator error - A human error ENVIRONMENT: Adequate lighting and space are provided throughout the whole process of production of the product. Adequate facilities for washing and hygiene are available too. Not a likely root cause. METHOD: Work instructions on checking the O-rings position and integrity during equipment assembly are in place. Visual product standards on the line for the line inspectors / graders are available. Procedure to cover with blue liner all meat containing vessels is strictly adhered to throughout. Not a likely root cause. PLANT: There were no stops for maintenance at the front end of the line (where the issue occurred) during this run. The machines are relatively new; the last PPM was completed with no issues related to O-rings. The forming machine and the relevant O-ring, must have been assembled and used correctly at the start of shift, or the subsequent loss of pressure would have resulted in urgent engineering intervention none recorded to have taken place. Not a likely root cause. MATERIAL: All raw materials are subject to documented sampling visual inspections upon arrival, no issues recorded pertaining to physical contamination. All raw materials were accepted as these were found to be within specification. All raw materials are 100% x-rayed the records showed no issues. Not a likely root cause.	Mixing Teams, Hygiene Teams and Line Graders / Inspectors all debriefed to be more vigilant. All Hygiene and Meat Mixing operators, as well as Line Graders / Inspectors have been debriefed to be vigilant. O-rings now kept locked and control issued (Old-for-New) by Engineering. Working with equipment manufacturers to procure metal detectable O-rings where possible.	PEOPLE: Procedures not followed - one-off operator error
I-000-843	05/04/2021	Allergens	Milk	Cereals & Bakery Products	Blank	Blank	Blank	Blank	Blank	Apparently the supplier verbally verified that there is no milk in the cookies and thought it was a clerical error!! However, I forwarded the PA laboratory report to the FBO and made it clear that it was not an error and that there was scientific evidence to substantiate this incident and that it was not a mistake. He contacted them again and they carried out an investigation and realised that the cookies contain small % Butter, hence the presence of lactose and casein!!. So the supplier is now producing new labels with butter (milk) declared on the label and in the ingredients list as per the EC Regulation 1169/2011 with the name of the actual allergen after its processed product. The FBO has sent labels to all of his customers to add a milk warning to all of the packets with the old labels and then any new stock will have the correct ingredients and allergen declaration direct from the supplier.	We applied an additional labels for dairy/milk allergen warning. Also sent the stickers to the shops we supplied and asked them to stop selling if the dairy allergen warning sticker is not applied. The new stock from the producer will be with full allergen warning including milk/butter warning.	Material: Ingredient Specifications - incorrect Process: Labelling Verification Checks - failure
I-000-729	06/04/2021	Allergens	Fish	Other Food Product / Mixed	Cooked materials are booked to the line via a batching sheet on the system. the product is assembled, metal detected and check weighed then transferred onto retort wires - every wire is labelled. After the transfer, the product is moved into pre retort segregated storage (see flow chart), then booked into retort cook. When the cook is complete its booked into high risk and every wire is relabelled. Next its transferred to the blast chiller to complete the chill cycle, then moved into high risk segregated chiller storage. the last step is to run down the high risk line into despatch and again metal detected and check weighed. product sleeved, date coded in line and packed into outer cases. the finished product then moves to chilled storage, QA checks completed on the product, plus a temperature check, end of line label and palletise ready for despatch.	From the investigation, it was established that products were put into baskets off the end of the production line, then decanted from here on to wire racks prior to retorting. The re-racking of both product types took place in the same production area, whereas they would normally be kept separated at all times prior to retort cook. Note: Both products pre-retort were produced in low care.	It is believed that the transfer from baskets to wires resulted in the issue. Lack of availability of wires was caused by the production schedule during this period, and increased demand for faster turnaround of retort wires.	Thermal Processing Retort Retort Oven operation While decanting/ double handling it is believed that the product was mixed.	Product A in baskets was wheeled into a different chill area to allow space to re-rack on to retort wires. This was then repeated for the next product (Product B).	Rank in order the factors considered responsible for the adverse event, beginning with the proximate cause, followed by the most important to less important contributory factors. 1.Putting into baskets and later decanting into Retort wires. It is believed that while decanting/ double handling product was mixed. 2.Decanting of different products in the same chiller area prior to retort, whereby normally they would be stored and handled separately throughout the entire process. 3: Lack of availability of wires was caused by the production schedule during this period. Root cause: Decanting from baskets to wires resulting in a product mix pre-retort.	Traying into baskets was stopped immediately Staff were briefed on the event that took place Additional audits throughout the process Any concession required to either run 2 similar products on the same day, or double handle products must be raised to and approved by one of the following. Site Director, Operations Manger, Technical Manager. 1. Move retort to 24 hour processing 2. Daily mass balance - Record and report daily 3. Change production schedules so that each product is made once per week with a day's gap between similar products. 4. Review the use of different coloured baskets, alongside any another possible solutions to make the product visually different. 5. Group auditor to visit site to review process and close out evidence.	Equipment: Other - insufficient availability for requirements
I-000-757	07/04/2021	Pathogenic Microorganisms	Not Determined / Other	Poultry Meat & Poultry Meat Products	Incorrect weight of product which invalidates the cooking instructions.	There was an operational decision taken to giveaway weight to fulfill the order but the cooking instructions were not considered and no adjustment was made to the cooking instructions.	This was an oversight by the production supervisor not to consider the cooking instructions.	Blank	Blank	Incorrect weight of product which invalidates the cooking instructions	?	Process: Formulation / Assembly Error People: Procedures not followed