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Recall Team – mock recall test: possible malicious contamination

The last in our series of mock recall scenario’s which will provide you with a withdrawal and recall test. You can read the previous test scenario on water contamination here if you want to try it out with your team.
This scenario may provide a situation where:
  • Product may have been affected and therefore may need to be withdrawn or recalled
  • Traceability will be required to establish affected product (meaning you can use this as a combined recall and traceability test if you wish)
  • An emergency situation (business continuity) is involved
Try not to disregard the scenario if you feel that it does not apply to you. Get the team together anyway, to review the situation.  To really challenge yourself, play devil’s advocate and prove that it would not put you at risk. You may find there are still lessons to be learnt – or if some of the detail needs amending to suit your product or your business, then do that.

The situation…

Scenario detail
Instructions
Results

Friday 9:30am:

The complaints come in for the week.  One of the complaints is a metal foreign body in product _____________ from customer __________, use by/best before date_____________. The description of the foreign body says that the product contained a number of small metal screws.  A photograph of the foreign bodies have been attached to the complaint.

This information should be provided to the technical manager at the next step, as this is background information and one complaint would not instigate a recall situation. N/A

Friday afternoon, at 4:30pm:

The technical manager gets a call from a customer to say that they have had a second complaint, in the same product, of a number of small metal screws. The product in question has been taken back to a store in Sheffield by the customer. No photos have been provided at this stage.

The customer has asked for an investigation to be conducted immediately, to establish if this is a wider issue.

The product is the same as the previous complaint; ____________, the use by/best before date is from a different batch; _________.

This information should be provided to the Technical Manager by a nominated person acting as the customer.

 

(Because a real-life scenario like this would involve a great deal of customer contact, it would be beneficial for the team to include the customer.  The member of the team who looks after customer communications should contact the customer and inform them that they are carrying out a test. If you have a good relationship and the customer is willing, it would a useful to get their opinion on the way in which the test was handled at the end, or even better still, at points during the investigation.)

Does the Technical Manager pull the recall team together?

Is the information relayed to the recall team members correctly?

Is a traceability carried out on both batches of product to establish where the product has gone?

Does the team put any product within their control in the supply-chain on hold to contain it?

Is an investigation carried out of the plant to establish if the small metal screws could have come from the process?

Does the team organise to pick up the product from the store?

Does the team agree what actions (and who is responsible for making sure they happen) should be taken when the foreign bodies and the product arrive back at site?

Does the team analysis to have the product and the foreign bodies sent away for analysis?

Is malicious contamination investigated?

Friday, 6pm:

The Technical Manager gets another call from the customer, to say that a store operative has noticed something sticking out of one of the packed products in a store in Worksop. On opening the product, they found a small screw. The product is a different product to the previous 2 complaints, as it is _________.

As the store operative has opened the product, it is not clear if the packaging had been tampered with at this stage.

The customer requests that their product be withdrawn and production stopped until the source of the problem can be established.

This information should be provided to the Technical Manager by a nominated person acting as the customer.

Does the team look to pick up the product from Worksop, and speak to the store operative who found the issue, to establish what condition the packaging was in?

Does the team look to compare the production records for all 3 products for similarities, including personnel who were involved in the production of the product?

Where possible do they view CCTV of the 3 production runs?

Does the team know how to withdraw the product and ensure that any product in the supply-chain is contained and confirmed as contained?

Do they carry out a mass balance to ensure that all the product in the supply-chain has been contained?

Does the team put in place specific plans to highlight immediately if any further complaints are received?

Do they review any necessary additional interim actions that are required to ensure that any other product is not affected over the weekend?

Saturday 10am:

The foreign bodies from the complaint are received by site.  They are found to be detected when they are passed through the metal detector.

This information should be provided to the Technical Manager by a nominated person.

Does the team review the information (in person or virtually) and record their findings?

Do they agree further actions?

Do they inform the customer of the new information and record this?

Monday 9am:

No further complaints have been received.

This information should be provided to the Technical Manager by a nominated person.

Does the team establish a start-up plan with the customer?

Does the team identify weaknesses in the production process for malicious on-site contamination?

I’d be really keen to hear how you get on if you use this scenario. Or, if there is anything that you would add to it or change?  It would be good to include your suggestions to make it better for those that try it in the future. Please get involved and add your thoughts in the comments section below.

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