Tag Archives: pathogen testing

How to Use FMEA to Risk Assess Pathogen Testing Methods

By Maria Fontanazza
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All methods are not equal, and companies must understand the testing methods used on a Certificate of Analysis.

A Certificate of Analysis (COA) can provide a company with a level of confidence in the quality and purity of its product.  However, the company should be able to take the document and understand how the results were gathered, says Maureen Harte, President and CEO at HartePro Consulting, and Lean Six Sigma Master Black Belt. Using Failure Modes and Effects Analysis (FMEA) can help a company identify, quantify and assess risks associated with pathogen detection methods, and should be integrated into a HACCP strategy.

Food Safety Tech: What are the challenges a company faces when assessing results on a Certificate of Analysis (COA)?

Maureen Harte: [Companies] lack the background information to really understand what goes into a COA, and they trust that what is coming to them is the highest quality.

FST: What questions should a company ask?

Harte: They need to consider everything that goes into the testing method itself.

•    What is the origin of the COA?
•    Who’s doing the testing?
•    What’s the complexity of the method?
•    What is the overall quality of the method?
•    How traceable is it?
•    How well can I trust that this result is the true result (are there false negatives)?

FST: How is FMEA used to evaluate pathogen testing methods?

Harte: FMEA helps us understand the differences between testing methods by individually identifying the risks associated with each method on its own. For each process step [in a test method], we ask: Where could it go wrong, and where could an error or failure mode occur? Then we put it down on paper and understand each failure mode.

For example, most methods have an incubation step. A simple failure mode would be that the incubator isn’t at the correct temperature, or that it has been incubated too long or not long enough. You go across the board for each step, identifying potential failures and the severity. Is there potential that we wouldn’t identify the pathogen? If so, what would happen to the customer? You also rate how often it might happen with the test method. What’s the frequency of it? The last thing we rate is detection. With or without controls, how easy would it be for the personnel in the lab to identify or detect that this problem occurred?

We rate these three factors: severity, frequency and detection, and whether we detect [the pathogen] before it goes out to the retailer or consumer. Then we multiply the ratings and come up with a risk priority number (RPN).  We add all RPNs for each step and figure out risk, and the potential for error, for each test methodology.

 Image courtesy of Roka Bioscience

FST: How does using FMEA integrate into a HACCP strategy?

Harte: It could be integrated into the HACCP strategy. HACCP deals with identifying potential safety risks, and the key to identifying the risks and proactively trying to eliminating them. That’s what the FMEA is doing as well. I think the integration of FMEA could help identify the critical control points and where the failures will occur. That would be the most streamlined approach.

Harte’s Tips

•    Don’t fully trust the COA unless you understand what the result means.
•    Get involved with the labs that are providing the testing to ensure you have the most comprehensive information surrounding the COA.

Harte is presenting “Behind the Certificate of Analysis: Risk Assessment in Pathogen Testing Methods” at the Food Safety Summit on Thursday, April 30, 12:30-1:00 pm.

 

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FSQA Enabling Technologies as a Food Safety and Quality Assurance Game Changer

Environmental Monitoring Programs and The Cost of Failure

What happens when a food company does not have an effective environmental monitoring program in place? The cost of failure can be significant, warns Prof. Ann Draughon, ranging from placing contaminated food in the markets, to managing product recalls, and businesses getting shut down.

Effective Environmental Monitoring, Sampling and Testing (EMS) Programs are absolutely necessary to protect our consumers, and make safe food, and are also required from a regulatory and food safety point of view, and to verify that our food safety programs are working.

In a recent webinar, Prof. Ann Draughon offered some insights on what happens when such an EMS program is not set in place – the cost of failure is much greater, and the repercussions can be severe, she warns.

What is on the horizon with EMS given the new regulatory landscape under the Food Safety Modernization Act and the proposed rules? Prof. Draughon talked about the Mandatory Preventive Controls described in Section 103 of the Act that lists the following controls that FDA will require:

  • Environmental monitoring programs;
  • Sanitation and cleaning requirements;
  • Allergen control;
  • Mitigation of hazards; and
  • Supplier verification.

How will FSMA affect FDA’s regulatory sampling of food facilities and products? The volume of environmental samples will increase at a much higher rate than sampling for allergens or ingredients, she adds. And in order to meet such a high demand for environmental inspection and sampling, it will be important to have in place effective EMS programs. Prevention will be cost-effective and give companies the ability to detect and destroy the microorganism before they cause any issues. Prof. Draughon provided the following numbers as cost of reinspection: $224 per hour for domestic inspections, $325 per hour for foreign inspections, and cost of FDA reinspection in FY 2012 estimated to be around $21,000.

She described two case studies of companies that suffered bankruptcy, and business losses due to massive food safety related recalls, caused by inadequate or lack of environmental monitoring programs.

3M-Envi-Monitoring_March2015-1

“This company is currently bankrupt due to a massive recall. While they had a great food safety plan, they did not back it up with a strong EMS program,” Prof. Draughon explained.

Speaking about the second company, she explained that the strong and capable leadership had done everything right for the company, but what went wrong? “There was a:

  • 3M-Envi-Monitoring_March2015-2Lack of trend analysis of environmental data;
  • Lack of communication within company about any positives Listeria results;
  • Sporadic Listeria positives occurred – while the problem was fixed, they continue to reoccur and the source was never detected or fixed;
  • The company had a reactive EMS, but not proactive,” she explained.

What are some of the recurring problems due to ineffective EMS programs? Prof. Draughon listed these as:

  • Increased risk of recall;
  • Increase loss of product;
  • Increased liability exposure;
  • Build-up of pathogens and spoilage agents or chemicals in environment;
  • Lack of regulatory compliance; and
  • Reaction to problems, not prevention.

Based on this high cost of compliance, Prof. Draughon strongly recommended establishing an effective EMS program, which has the following attributes:

  • Focus on having the appropriate indicators and hazards;
  • Ensure the best procedures selected and validated;
  • Strong sampling plan, which is well-designed and dynamic;
  • Data analysis and data management; and
  • Education and training.

Learn more by listening to the series of webinars on Environmental Monitoring, presented by 3M Food Safety. Click here for more details.

Thomas R. Weschler, Founder and President, Strategic Consulting, Inc (SCI)

Faster, Better, Cheaper… What’s Most Important in a Pathogen Test?

By Thomas R. Weschler
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Thomas R. Weschler, Founder and President, Strategic Consulting, Inc (SCI)

 TomWeschlerJan2015

For close to 20 years, Strategic Consulting Inc. (SCI) has been following the industrial microbiology market, and food safety testing applications in particular. As part of the data gathering for our most recent report, Industrial Microbiology Market Review, SCI interviewed 15 senior managers at major food companies and food contract labs (FCLs) to understand their priorities when choosing a pathogen diagnostic method. The interviews were roughly split between food companies and food contract labs.

SCI identified ten important attributes for evaluating a diagnostic method or instrument, and asked the interviewees to stack rank the top five items most important to them.

The three top-ranked choices were the same at both food companies and FCLs, with sensitivity/specificity the most important attribute. Second in importance was the ability of the method to be utilized in a broad range of food matrices. Ranking third was the cost-per-test for diagnostic reagents.

For food companies, time-to-results (TTR) was tied for third in the stack ranking, followed by ease-of-use (EOU)/automation in fifth place. Clearly food companies want quick results but only after they are assured that the pathogen diagnostic they are using provides accurate results and is able to work with a range of food types.

For food contract labs, the cost of the pathogen diagnostic instrument ranks fourth, and TTR is tied with the cost of labor per test for fifth. For FCLs, most of the key attributes in method selection are based on operational considerations, which makes perfect sense given testing is their business.

Salmonella – Most Expensive Pathogen

The top 15 pathogens, which includes Salmonella, Listeria monocytogenes, Campylobacter and E. coli O157:H7, make up 95 percent of illnesses and deaths from food in the U.S.

Salmonella ranks first among the top 15 most costly foodborne illnesses, raking up around $3.7 billion every year in medical costs for Americans.

According to the latest estimates from USDA’s Economic Research Service, the top 15 pathogens, which also include Listeria monocytogenes (ranked third), Campylobacter (ranked 5) and E. coli O157:H7 (ranked 9), make up 95 percent of illnesses and deaths from food in the U.S.

Salmonella’s cost is $3.7 billion, with 1,027,561 total cases, 19,336 hospitalizations and 378 deaths.

Listeria monocytogenes’s cost is $2.8 billion, with 1,591 cases, 1,173 hospitalizations and 306 deaths.

Campylobacter’s is $1.9 billion, with 845,024 cases, 8,463 hospitalizations and 76 deaths.

E. coli O157’s is $271 million, with 63,153 cases, 2,138 hospitalizations and 30 deaths.

Deaths tend to account for the bulk of the total costs. Death associated with salmonella, for example, cost nearly $3.3 billion, or almost 90 percent, of its $3.7 billion cost.

Click here to see more details.

California Apple Packing Facility Linked to Listeria Outbreak

The Centers for Disease Prevention and Control has confirmed that two strains of Listeria monocytogenes found at Bidart Bros. facility in Shafter, CA, are identical to those in an outbreak that has sickened 34 in the U.S. and Canada, and killed at least three in the U.S.

Another four people who had the outbreak strains have died, and one woman who had the outbreak strain had a miscarriage. However, officials at the Centers for Disease Control and Prevention said Jan. 12 they are waiting for confirmation from state authorities that listeria was the cause of death in those cases.

Initially the outbreak was only associated with caramel and candy apples from companies that Bidart had supplied.

However, three of the 32 sick people in the U.S. reported eating whole or sliced “green” apples before becoming ill, according to the CDC. All but one of the sick people in the U.S. had to be hospitalized.

As of Jan. 10, 25 of the 28 sick people interviewed by health officials reported eating caramel or candy apples before becoming ill.

Bidart Bros. officials recalled their entire 2014 crop of granny smiths and galas shipped from its Shafter, facility, notifying customers in a letter on January 6. A special website, www.bidartapplerecall.com, has been set up to help people and companies related to the recall and outbreak.

So far, no details have been revealed about who received the apples from Bidart or what volumes were shipped. “Bidart Bros. is contacting all of their retailers with specific instructions as to how to return those apples to Bidart Bros.,” according to a news release from Bidart Bros. that was posted on the FDA’s website Jan. 9.

Public health warnings and recalls are in effect in Canada and several brands of caramel and candy apples are under recall, as is the entire 2014 crop of granny smiths and galas from Bidart Bros., according to the Canadian food Inspection Agency. Sliced apples marketed by Scotian Gold Co-operative Ltd. are also now included in the Canadian recall. The Scotian Gold sliced apple products were distributed to retailers in New Brunswick, Newfoundland and Labrador, Nova Scotia and Prince Edward Island, according to the recall notice.

The CDC report shows the first confirmed illness in the U.S. began on Oct. 17. As of the agency’s Jan. 10 report, the most recent confirmed case started Dec. 12. More cases could be confirmed because listeria can take up to 70 days to develop into a detectable infection. The testing and reporting process takes an average of two to four weeks, further delaying the reports to CDC.