Thursday, April 2, 2015

Case study of a Management and Recordkeeping Failure

Back in the fall of 2012 I watched a meat recall with interest. You might remember this one; it involved a large meat packing plant called XL foods located in southern Alberta. I was alerted when the company failed to respond promptly for a request for records. My "records radar" was activated, and I just knew that part of the issue had to be poor record-keeping and perhaps a failure of management as well.

The affected meat was identified and recalled within days, and the incident quickly faded from public interest. An independent review of the incident was quietly published many months later.

I finally got around this week to confirming if my instincts were right, and the review indeed validates my first instinct. It turns out this failure is a good lesson on the importance of not only following the letter of the law but the spirit as well. Good record-keeping and alert quality practices are evidence of a quality culture that can't be faked. Management and personnel throughout the organization must be committed to the principles behind our regulations, to prevent these sorts of incidents from re-occurring.

Internal Defect Phase

For two weeks leading up to the first failed test at the US border, internal tests at XL foods found four positive tests for e-coli. Quality Assurance protocols were followed, and the batches of tainted meat were removed. However, these tests (High Event Periods or HEP) should also have alerted the company that there was a systemic issue, requiring resolution. This would have been evidence of Quality Management at work. Testing and reporting are not only for compliance but for analysis and action. Perhaps there was action taken, but there are no records to indicate that there were. An alert company intent on excellence would have acted on these results internally and would have protected the company from the public embarrassment and losses that followed. They would have also documented their actions as evidence of their accountability.

External Incident

The next few weeks are marked by increasing external evidence of the failure, caught by watchdogs both at the US border and by the Canadian inspection agency. This led to increasing demands for action and information from XL foods. The XL Foods Quality Manager was ill-prepared to meet the increasing demands and was not able to produce information in a timely manner to the Canadian Food Inspection Agency (CFIA).

Public Shame

Finally on September 16, thirteen days after the first tainted meat result caught by the US customs officials, the CFIA made public the failure and ordered a recall.

Failed Recovery

Over the weeks that followed, XL foods struggled to implement all the demands of the CFIA. In the meantime, production is slowed then shut down, employees are laid off, and any meat left in production is rendered safe (cooked) and disposed of. Finally on October 18, management of the plant is turned over to IBS foods which eventually takes ownership.

Management that values their reputation for quality will demonstrate their values by not only making sure that all those activities and reporting required by regulation are done, but by following up on any irregularities. If there is a testing and reporting protocol, analyse those results and follow up on any defects. Conduct root cause analysis on re-occurring problems. Keep current and careful records, and make sure plant staff have the information required to quickly locate batches in process.

Support teams do not operate in isolation. When an emergent issue arises, include key personnel throughout the company to build a team to help the Quality Manager to respond.

Once an emergency protocol is developed, have regular and effective drills to test that protocol and train staff in how to implement it. This could have prevented the chaos that followed and perhaps allowed the company to recover more quickly.

Independent Review of XL Foods Inc. Beef Recall 2012 Ronald John Lewis, DVM - Excerpts

(Chair) André Corriveau MD
W. Ronald Usborne, PhD
May 2013

We found a relaxed attitude towards applying mandatory procedures – clearly outlined in some documents, less so in others. Again, a shortcoming shared by both plant and [Canadian Food Inspection Agency] CFIA staff....In short, we found a weak food safety culture at the Brooks plant, shared by both plant management and CFIA staff.

The company's Quality Assurance Manager confirmed that turnover was some 30% each year at the Brooks plant.

Sampling spreadsheets studied by the Panel show high event periods (HEPs) very clearly. We found no indication that the company was identifying and analyzing those results for trends during the time leading up to the identification of the E. coli O157:H7 contamination; consequently, it was unable to make any efforts to establish and correct the root cause of the problem.

...the Panel reviewed sampling data as far back as January 2012, and noted a number of HEPs that should have resulted in root cause analyses by XL Foods Inc., but we have no evidence to suggest any analysis actually occurred. The company had established action limits at 10%, 20%, but there was no indication of how the action limits were linked to the sampling program.

XL Foods Inc.'s recordkeeping of monitoring activities and its validation of procedures and equipment maintenance were found to be deficient. In addition, sampling techniques were inconsistent. These shortcomings should have been identified by CFIA inspectors before the contamination event occurred.

The information first handed to CFIA was coded and could therefore not be acted upon by the regulator; product distribution information was kept at the company's corporate offices off site, which was slow to arrive at the plant. The company did not follow the recall section of the [Food Safety Emergency Protocol] FSEP Manual, which would have made the retrieval of records timely. During this lost time, contaminated product continued to be sold and eaten, unnecessarily exposing additional consumers to a potentially serious health risk.

Even after the regulator formalized its request in writing the following day, CFIA staff repeatedly extended deadlines for receiving the required data. Each day that passed before contaminated products were recalled allowed them to make their way further along the supply chain and into consumers' food baskets.

The XL Foods Inc.'s Quality Assurance Manager may have been unsure about which request was the most pressing, or was overwhelmed with the volume of information requested. It appears that he did not establish a team to assist with the work, and was determined to address these requests singlehandedly while continuing to perform his regular duties.

It is the Panel's view that equipment maintenance and sanitation were significant problems at the plant.

The fact that the company did not pay attention to increasing E. coli O157:H7 positive tests of beef trim had several consequences: it did not identify a high event period (HEP), it did not bracket product adequately, it missed contaminated products, and these then left the establishment. In addition, because plant staff was not reviewing sampling data, the HEP was not identified. Consequently, there was no attempt to determine a root cause, and the contamination continued unchecked until it was picked up outside the plant at Ginger Beef Choice Ltd. and the US border.

XL Foods Inc.'s Hazard Analysis and Critical Control Point system was neither applied nor managed properly. This is evidenced by the absence of detailed documentation, inconsistent trend analysis, insufficient record keeping on monitoring and validating processes and equipment maintenance, inconsistent sampling, etc. Annual quality verifications of inspection activities (a component of CFIA's Quality Management System) indicated that these were not delivered with scheduled regularity.

The six-day delay in providing this information – while the plant remained in operation and no root cause had been identified – meant that contaminated product continued to be produced and shipped from the plant.

3. Inspectors should devote proportionately less time to evaluating specimens for pathology and more time training on protocols that have maximum impact on food safety.
To improve the effectiveness of inspectors, CFIA should assess the specific duties their inspectors perform, with a view to evaluating the direct impact of these duties on food safety. More effort should be committed to evaluating trends, and assisting plant staff with root cause analysis when contamination is detected. They should also spend more time evaluating the thoroughness of cleaning and sanitation before shift start-ups.

5. The CFIA must enforce its oversight responsibilities at the plant.

Examples of these responsibilities include, among several others:
  • ...
  • As also required under FSEP, in the event of a recall, the plant must provide the Agency with distribution records for the recalled products that are complete and in a format that is accessible.
  • Also in accordance with FSEP, the plant must include all of its standard operating procedures and good manufacturing practices in its own food safety plan.


2009 -  XL Foods bought Lakeside Packers from its U.S. parent company Tyson Foods[3]
2012, August 24, 27, 28, 29 and September 5 - the five dates where E Coli outbreak occurred.
2012, September 3 -  E Coli found in a shipment of beef to the US.
2012, September 4 - Canadian inspectors found E Coli during routine testing.
2012, September 7, XL Foods Inc. was formally requested in writing to produce detailed information related to product details, distribution, sampling results, and information on the effectiveness of the plant's preventative controls as soon as possible but no later than September 8.
2012, September 10, 1 - Pursuant to CFIA requests to XL Foods Inc. on September 6 and 7, information from XL Foods Inc. was provided to the CFIA in a series of submissions over two days.
2012, September 12 -  more E Coli is found.
2012, September 14  -The CFIA team completes review and reports that XL Foods Inc. must improve its trend analysis on high event days (periods when positive sampling tests are higher than normal) and follow documented procedures.
2012 September 16 - recall of tainted meat and public announcement.
2012, September 27 -  the plant is shut down because of the outbreak, until company officials “..have demonstrated that they have fully implemented CFIA’s required corrective action,”  Problems identified in a “corrective action” notice include employees touching contaminated meat without cleaning their hands properly and “water nozzles clogged in the primary carcass wash area.”
2012, October 18 - it was announced that the XL Lakeside plant was to be taken over by JBS USA for 60 days with "an exclusive option to buy the Canadian and U.S. operations of XL Foods".
2012, October 19 - The CFIA receives test results for the carcasses that the company processed between October 12 and October 17. Both CFIA and XL Foods Inc. test results for these carcasses are negative for E. coli.
2013, January 14 JBS Foods, Brazil, buys XL foods
2013, May - the Canadian Food Agency publishes an independent review of the XL Foods incident

CFIA Review panel:

They include Ronald Lewis, former chief veterinary officer for British Columbia; Dr. Andre Corriveau, chief public health officer for the Northwest Territories; and Ronald Usborne, a former executive with Caravelle Foods.

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