| I-000-911 |
01/12/2021 |
Foreign Body |
Glass |
Soups / Broths / Sauces & Condiments |
N/A |
N/A |
N/A |
N/A |
N/A |
A piece of glass has been found inside a jar of product, this was send towards producer. Upon arrival the jar was emptied and the content diluted and sieved with a 1 mm sieve to see if there were more pieces. None were found. Upon investigating the shard found by the customer, there seemed to be an embossed number or letter. A complete jar showed the same embossed codes at the bottom of the jar. This meant that somehow a part of another jar ended up inside this jar without it being detected.
A possible root cause might be that a jar fell without it being detected, the filler will probably crush that jar in that case and that in turn could cause the filler to be contaminated with a piece of glass.
Right after the notification: The jars arrive after being flushed to prevent the jars themselves being contaminated. This is in an enclosed space to prevent post-contamination The breakage procedure is that 50+ and 50- jars are destroyed when a breakage is detected. This is done to ensure no shards are in products nearby as the line is enclosed this was validated as far enough due to the physical distance. The X-Ray is tested by trained personnel and there was no registered breakage during the day of this incident. A video was provided of the X-Ray working.
The site had a visit from their food safety authority, they have send the full report from this that is included in this RCA folder as well.
Due to no registered incident the exact cause is not clear the possible root cause of a fallen jar has been deemed as the most likely cause and actions for prevention have been taken. |
A sensor to detect fallen (incorrect positioned) jars has been installed and been seen as effective during the audit of their authority.
A training has been done to raise the awareness among the employees.
The X-Ray was verified to be working with the detectors as well as on an actual piece of glass.
Company actions: The supplier is under review, with currently sharpened controls. Audit can be planed when the COVID situation allows it.
Audit on site was done. |
Process: Contamination - segregation failure |
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| I-002-258 |
01/12/2021 |
Pathogenic Microorganisms |
Listeria Monocytogenes |
Crustaceans & Products Thereof |
RCA 1 - How was the high risk area contaminated by listeria monocytogenes? Potentially caused from cross contamination of new foyer area.
RCA 2 - Introduction from Drains. Previously reported that drain had separated underneath unit. Waste product falling underneath unit instead of drains. Then re-attached following investigation. Not disinfected before re-attachment.
RCA 3 - Why was the listeria monocytogenes not contained/destroyed from the cleaning process? Areas of the unit in poor repair that may harbour listeria monocytogenes from usual cleaning process.
RCA 4 - Cleaning process not sufficient. Inspection of unit showed areas of the unit were not cleaned to an acceptable standard.
RCA 5 - Why was it not identified at an earlier stage? Listeria Monocytogenes identified in Testing. Previous testing completed 3 months earlier. Should have been completed monthly in accordance with HACCP. But not completed.
RCA 6 - Once identified, how effective/timely was the suspension of production? Initial out of spec pre-liminary report emailed on specified date. Production continued (Although meat from the date was not sold to public). Instruction to suspend production taken next day, after email confirming Listeria Monocytogenes had been identified in samples from the 10 days previously. This was then reported to the local Environmental Health Authority, following an extensive/extraordinary clean and swabs taken to see if contamination had been removed from high risk area. Swabs not clear. EHO unhappy with timescales of suspension and reporting of the contamination. |
RCA 1 - The foyer area is in the high risk area but is easily accessible from the exterior of the building and the low risk area without a hygiene barrier.
RCA 2 - Maintenance checks incomplete. Not identified immediately that there was drain collapse.
RCA 3 - Floor and drains in poor repair with holes and gaps no easy to clean and disturbance my result in aerosol effect of contaminated moisture from them.
RCA 4 - Staff not completing their daily cleaning activities, supervisors not identifying shortfalls. Majority of cleaning left to one person. No one checking standard of cleaning as supervisor was leaving at end of production, not when cleaning was finished. The cleaning only checked at the start of the packing shift, at this point too late to rectify.
RCA 5 - Production Manager left company, responsibility to get testing done falls to senior management General manager in this instance. Labs and samples not instructed as per HACCP plan.
RCA 6 - Senior Management should have suspended production immediately following Out of Spec email and notified EHO immediately. This was delayed by senior management.
Not had an out of spec listeria report before and although aware it was not good, due to not having experienced listeria contamination before, it was thought reasonable to wait until a confirmed result had been received. |
RCA 1 -Design and layout restrictions meant that for customer product collections and low risk employees to communicate with high risk, they were using the foyer area.
RCA 2 - Routine checks not completed by supervisors/management/employees.
RCA 3 - The floor is susceptible to wear and tear in high footfall areas. Floor not repaired for 3 years. Floor identified by EHO for repair/replacement. No action taken so floor in further disrepair.
RCA 4 - Movement to nightshift resulted in responsibility passed to one person to complete cleaning schedule. Staff too tired to stay. Desire from staff to finish shift after production. Request by a staff member for responsibility of the cleaning. They wanted to make sure that cleaning wasnt rushed and completed to a thorough/high standard. When all staff were cleaning, some would want to complete clean quicker than others with varying levels of thoroughness. No supervisor in place to ensure team did cleaning to sufficient standard.
RCA 5 - Other work activities prioritised over the instruction to get samples tested.
RCA 6 - Lack of understanding of the severity of listeria myocytogenes found in the samples, meant limiting commercial/reputational damage was prioritised over food safety. Management also assumed they could identify/contain/ destroy the contamination and resume production. Management was unaware of the severity of such actions and the implications of this decision. Training for senior management not refreshed, and without a food safety consultant in place, no sufficient understanding of the food safety procedures and laws. |
RCA 1 - Not identified as a high risk in the planning/subsequent use of the foyer area.
RCA 2 - No check list process in place - Not identified as an area of high risk/high monitoring
RCA 3 - Cost/time restrictions meant decision to repair floor not taken by senior management.
RCA 4 - Either supervisor did not want to stay to ensure cleaning done to sufficient standard.
No management available to monitor standards.
Management was working the day shift. Production on a night shift.
RCA 5 - No correct handover of responsibilities. No checklist in place to ensure monthly checks and verifications are complete.
RCA 6 - Had identified that a food Safety consultant was required in July 2020 but our previous consultant had retired and recommended another consultant. No response from the new consultant meant the issue was forgotten.
Other work commitments and no identifiable/urgent concerns at the time. New production manager installed. Technical responsibility passed to her. Issue of no food consultant not raised again.
Continued to get clear sampling results. No reports of unsafe products. Assumption from management that all was ok. |
RCA 1
- No use of food hygiene consultant that may have identified potential cross contamination. (Management)
- Un- authorised use of foyer area by staff and customers as next to new access point. (People)
- Lack of understanding of cross contamination by staff (Training).
RCA 2 - No use of food hygiene consultant that may have identified importance. (Management)
- Management team not identifying potential for contamination and re-introducing contaminated pipe into the high risk environment. (Management)
- Lack of cleaning underneath unit (Staff)
- Lack of/incomplete maintenance schedule (management)
RCA 3
- Lack of understanding as to severity of not replacing floor. (Management)
- Other areas of the overall business taken priority over floor. (Management)
RCA 4 - Management teams other duties required to be done on day shift. Resulting in disconnect/lack of communication between day/night shift. Lack of monitoring of standards (Management/People)
RCA 5 - Not considered necessary by senior management before to have in place. Importance of the sampling testing not high enough (management).
RCA 6
- No warning from qualified consultant that all wasnt ok (Management)
- Sampling results not consistently obtained so not sufficient evidence to be sure that all is ok. (Management)
- Technical manager left handover not adequate. (Staff/Management) |
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Process: Quality Control Checks - inadequate
Method: Cleanliness or Sanitation - inadequate
Environment: Ingredient / Product Storage Controls - inadequate
Equipment: Routine Maintenance - inadequate |
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