Tests using a range of technologies were conducted in these two labs and all of the tests definitively confirmed that the recalled WPC80 contained a harmless strain of C. sporogenes and was clear of C. botulinum. As soon as clear and definitive test results were received, the MPI proactively released these results to the public on August 28, 2013, 26 days after the recall was initiated.
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Manufacturing Trace Back
The MPI documented its actions in response to the Fonterra WPC80 recall and on August 28, 2013 published a Whey Protein Concentrate Incident Tracing and Verification Report dated August 25, 2013.
The 61-page report includes the following details.
- The dairy material for reworking was reconstituted, chilled, and then processed as usual. Equipment for reconstituting (rehydrating) dairy material had been decommissioned, so temporary (non-standard) equipment was introduced into the plant to facilitate this processing aspect.
- All equipment was subject to cleaning in place (CIP) prior to use and after each day’s manufacture.
- Immediately prior to and following manufacture of the WPC80, the plant also manufactured a protein called hydrolysate. While there was common processing equipment used for both WPC80 and hydrolysate, the temporary equipment associated with the contaminated WPC80 was not used for the hydrolysate. This helped to identify the likely source of contamination.
- The rework was completed using manufacturing equipment common to the hydrolysate and fresh WPC80 manufacturing processes, with the exception of food grade flexi-hoses and the microfiltration line.
- The equipment operator’s investigation concluded that the cause was either within the product lines used to deliver the reconstituted product to the routine process or within a microfiltration line.
- The data suggested that either the reconstituted product line or the microfiltration line contained a protein deposit/biofilm. This is likely to have harbored Clostridia spores and may not have received the full effect of the CIP. The majority of the evidence pointed to the reconstituted product line being the cause of the problem.
- So it was determined that Clostridia contamination occurred during this reprocessing. To complete the reprocessing, an item of nonstandard equipment was used, namely a transfer pipe.
- Although standard cleaning procedures were followed, including those for the transfer pipe, before and during reprocessing, subsequent analysis of the plant by the MPI shows that the source of Clostridia was likely to have been this transfer pipe. The pipe has since been decommissioned.
On August 12, the Fonterra board of directors established the WPC80 Inquiry Committee, and charged them to oversee an independent review of the circumstances that led to the WPC80 recall and the subsequent chain of events. “The review is due to conclude at the end of October 2013,” says Maury Leyland, Fonterra’s group director of strategy.
Soon after initiating the precautionary recall, Spierings commissioned an inhouse Operational Review to enable the cooperative to understand the cause of the contamination and evaluate how the business handled the incident and precautionary recall. The Operational Review team was also tasked with making recommendations on how Fonterra could prevent an event like this from happening again.
Led by Leyland, the Operational Review team presented its findings and recommendations to Spierings on August 30.
The Operational Review of Fonterra’s WPC80 concluded that no single occurrence led to the precautionary recall and the events that ensued, and that no single issue was the sole contributor.
“The WPC80 incident was the result of a number of separate and unrelated events occurring in an unforeseen sequence,” Leyland says. “One of those events was the decision to reprocess the original WPC80 and not downgrade the product, in combination with the use of an item of non-standard equipment, which was the cause of the contamination.”