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Root Cause Analysis data received in November 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-002-113 02/11/2021 Allergens Nuts Confectionery A limited amount of dark chocolate bars with hazelnuts were wrapped with a wrapper of dark chocolate with raisins and almonds 1.1. dark choc with hazelnuts present at the line 2.1. Checklist change over/start up barline: check line clearance was ok on checklist, but not in reality. 3.1. During currative maintanance interventions on the packaging machine, products are collected on another conveyer belt and put into grey bins. Products of the previous run were not put back on the line in the same run or have not been labelled after the production run. There was no communication towards the next shift or Teamleaders about this in the shiftbook on the shift. 1.2. Products of previous production were not used within the same production run (due to too many technical issues during this shift) as described in the procedure. If this is not possible these products should be identified and put away. 2.2. Grey bins with rest products of the bars dark choc with hazelnuts were overlooked at the start of the production run of the bar dark choc almonds and raisins 3.2. Grey bins with rest products of the bars dark choc with hazelnuts were overlooked 1.3.Grey bins with rest products of the bars dark choc with hazelnuts were overlooked 2.3.Unlabelled bins containing product of previous production run may be mistaken with empty bins. 3.3.Training manual of the operators, which includes how to stop on the end of a working day, does not describe the place where the grey bins were left. 1.4.There is a checklist for start up of production which includes checks for line clearance, which was completed. There is no written acknowledgement on a checklist when stopping the line at the end of the day. 2.4.Because the bins have been left unlabelled by the previous production shift. STEP 6: 1.5. There wasn't a prompt on checklist for stop production. There is no written acknowledgement on a checklist when stopping the line at the end of the day. 1. There wasn't a prompt on checklist for stop production 2. Because the bins have been left unlabelled by the previous production shift. 3. Training manual of the operators, which includes how to stop on the end of a working day, does not describe the place where the grey bins were left. 1. Revision of checklist change over/start up to include stopping the production run at the end of a working day 2. Training personnel how to use the revised checklist which includes stopping the production run at the end of a working day 3. Retraining personnel for how to use the shift book correctly 4. Retraining personnel for communication of the status of the production run towards the teamleaders. 5. Upgrade training manual to include the place were the grey bins were left when stopping the production run at the end of a shift/working day Retraining personnel according to upgraded training manual. Environment: Ingredient / Product Storage Controls - inadequate Method: Work Instructions - inadequate
I-002-132 03/11/2021 Pathogenic Microorganisms Not Determined / Other Poultry Meat & Poultry Meat Products Failure of physical checks. Sensory checks failure. Smelly, slimy product. This is under investigation at the moment. The first checks do not show any problem during production We have maintained our internal process checks and stringent desptach checked and do not find any further issues. We have made sure that all dolvas are less than 400kg with a target of around 350. The product is now probed thoughout the filling of the dolavs which takes around 25 minutes The root cause has being identified that regular temperature checks should take place throughout the process as top, middle bottom. We also communicate to despatch if any isssues are found to carry out further checks. Despatch, before loading, do now a top, middle and bottom temperature checks with a long nose probe as the final check Blank Product had deteriorated by the time it had reached the border. When it arrived back to FBO it was evident it had undergone some degree of temperature abuse. After extensive traceability and review of temperature control already in the process the data showed control whilst in process and desptach with temperatres on despatch at -1c to 2.5 c+. Source: Method - Work instructions - absent or inadequate Temperatures of the dolavs of product were not recorded when they were filled . All product was not checked at point of filling the dolav and went on earlier temperature checks before deboning, allowing potential increase of temperature if not monitored . Source: Equipment - Weighing machine – inaccurate calibration No probe was used whilst filling dolavs and various weights could be filled On return of stock, it was evident, as highlighted at Border authorities, that sticky ,slimey and putrification in some product was present. We then reviewed the whole process and realised that the actual dolav filling was not getting checked as much as we would like going forward. From a week review we added long tip probes to reach bottom, middle and top of the dolavs Now regular check and record are being carried out while filling the dolavs. If any temperature concerns, we highlight with signage for temperature control and storage until the required temperature is met. We are also looking to reduce the micron of the liners which currently is 30 micron which is thick.We have had these measure in place for 2 weeks and feel we have solved our unfortunate failure. Source: Method - Work instructions - absent or inadequate A new procedure is in place and trained out such that a minimum of 3 product temperatures per date of kill are taken prior to moving to despatch where holding chill is set at -2c Loading levels are also regulated to an average of 350 kg , no batch ticket will be able to print if over 400kg Despatch also double check for due diligence with a long nose probe on all despatch of dolavs to ensure consistency of temperatures Source: Equipment - Weighing machine – inaccurate calibration Long nose probes are now in use. Temperature checks at top, middle and bottom of dolavs for consistency We now regulate an average of 350 kg per dolav. If over 400kg , the batch ticket will not be printed and stock will need removing from dolav Process: Quality Control Checks - inadequate Equipment: Calibration - inaccurate
I-002-206 03/11/2021 Allergens Cereals (containing gluten) Confectionery As a result of an error during the manufacturing process, some packs of confectionery bars contain a different flavoured bar. We believe that between 5 and 80 bars are affected. The affected packs therefore are incorrectly labelled, and in particular do not refer to an allergen - wheat (gluten). This means the product is a possible health risk for anyone with an allergy to or intolerance of wheat or gluten. Error during changeover - after experiencing technical problem on one of the wrapping lines, line in question was not cleaned out properly from the leftovers from the previous production. Packing changeover checklist (one document for all 4 packing/wrapping lines) was signed off as completed even though information for the affected line was missing. Quality ‘’cut’’ test, necessary to ensure correct product is being wrapped in a correct packaging was conducted according to the procedure, but not the very first bar from the new production was checked. Blank Blank Blank Error during production changeover, when remnants from the previous production on one of the four packing lines, were not completely removed and were wrapped into alternative/incorrect packaging and went into the first pallet of the new production, which was shipped to the UK. At the time of the incident, the affected packing line was experiencing minor technical problem, which has resulted in few minutes delay in start-up. The quality ‘’cut’’ test, necessary to ensure correct product is being wrapped in a correct packaging was conducted few minutes after starting the line (not the very first bar was checked). Corrective actions: - cross- disciplinary internal team has been formed to coordinate the investigation - any remaining product from the relevant batch within FBO control has been placed on hold - FBO has informed the affected retailers of the issue asking them to withdraw from shelves any remaining stock from the relevant batch - point-of-sale recall notification was issued for retailers Preventive actions: - Introduction of separate clean out check lists for each wrapping line - Ensuring the relevant quality checks are conducted immediately after product change-over - Introduction of more robust process for handling potential technical/ equipment issues - Briefing and re-training production staff in the factory Environment: Ingredient / Product Storage Controls - inadequate Process: Assembly Error
I-002-225 03/11/2021 Allergens Sulphur dioxide / Sulphites Dietetic Foods / Food Supplements / Fortified Foods Product had incorrect label due to substitute lime juice being delivered by supplier. Substitute lime juice wa supplied and assumption made it was same. This resulted in allergens not being highlighted on label. Blank Blank Blank Incorrect labelling due to use of substitute lime juice SOURCE: PEOPLE – Procedures not followed One off error in not checking ingredients on substituted product SOURCE: MATERIAL – Composition - incorrect ingredients Substitution product wasn’t checked SOURCE: MATERIAL – Composition – labelling absent / incomplete / incorrect Substitution resulted in incorrect labelling Notes made on stock order forms + delivery records stating no substituted items to be accepted. SOURCE: PEOPLE – Procedures not followed Substitute lime juice resulted in incorrect labelling. Notes have been made on order forms + delivery records not to accept substitute product in future. SOURCE: MATERIAL – Composition - incorrect ingredients Notes made to check each delivery. Non- acceptance of substituted products.