Tag Archives: sampling

FDA

E. Coli Outbreaks Linked to Salinas-Grown Romaine Lettuce Over, Deputy Commissioner Yiannas Releases Statement

By Food Safety Tech Staff
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FDA

Yesterday the CDC reported that the E.coli outbreak linked to romaine lettuce grown in the Salinas, CA growing region is over. The contaminated lettuce should no longer be available, and FDA states that consumers do not need to avoid romaine lettuce from Salinas. The agency will continue its investigation into the potential factors and sources that led to the outbreak.

The FDA did identify a common grower link to the E.coli O157:H7 contamination as a result of its traceback investigation. However, a statement released yesterday by FDA Deputy Commissioner for Food Policy and Response Frank Yiannas points out that “this grower does not explain all of the illnesses seen in these outbreaks.”

To be specific, the FDA, CDC and other public health agencies were tracking three outbreaks involving three separate strains of E.coli O157:H7 linked to romaine lettuce. During the course of the investigation FDA, CDC, the California Department of Food and Agriculture and the California Department of Public Health conducted sampling of the water, soil and compost of several of the fields in the lower Salinas Valley that were connected to the outbreak. “So far, sample results have come back negative for all of the three outbreak strains of E. coli O157:H7. However, we did find a strain of E. coli that is unrelated to any illnesses in a soil sample taken near a run-off point in a buffer zone between a field where product was harvested and where cattle are known to occasionally graze,” Yiannas said in the agency statement. “This could be an important clue that will be further examined as our investigation continues. However, this clue does not explain the illnesses seen in these outbreaks.”

Finding the contamination source(s) is critical, as it will aid romaine growers in putting safeguards in place to help prevent future contamination.

As for the final case count (with last illness onset on December 21, 2019) of this outbreak, there were 167 total illnesses and 85 hospitalizations across the United States. No deaths were reported.

Recall

Almark Foods Expands Hard Boiled Egg Recall As Listeria Outbreak Continues

By Food Safety Tech Staff
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Recall

Today FDA provided an update about its outbreak investigation of Listeria monocytogenes linked to hard-boiled eggs manufactured by Almark Foods’ facility in Gainesville, Georgia. On December 23, Almark expanded its recall to include all eggs manufactured at the Gainesville plant. In addition, the company is not producing products at this facility.

Thus far, four companies have recalled products containing the eggs from Almark Foods, as they have the potential to be contaminated with Listeria monocytogenes:

As of December 17, seven infections were reported, with four hospitalizations and one death across five states. The hard-boiled eggs were sold both in bulk pails to food processors, restaurants and retailers, as well as directly to consumers at the retail level, and have “Best If Used By Dates” through March 2, 2020.

FDA used whole genome sequencing to find a genetic match in the outbreak strain from samples collected at Almark’s facility during agency inspections in February and December of this year.

The agency investigation is ongoing.

magnifying glass

FDA Report on E. Coli Outbreak in Romaine Lettuce Points to “Significant” Finding of Strain in Sediment of Water Reservoir

By Maria Fontanazza
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magnifying glass

The November 2018 outbreak of E.coli O157:H7 infections linked to romaine lettuce caused 62 illnesses across 16 states. The FDA zeroed in on the Central Coast growing regions of northern and Central California as being responsible for the contamination. The outbreak was declared over on January 9 and yesterday FDA released the report, “Factors Potentially Contributing to the Contamination of Romaine Lettuce Implicated in the Fall 2018 Multi-State Outbreak of E.Coli O157:H7”, which provides an overview of the investigation.

The report states that a sediment sample coming from an on-farm water reservoir in Santa Maria (Santa Barbara County, California) tested positive for the outbreak strain of E. coli O157:H7. Although this particular farm was identified in several legs of the Fall 2018 traceback investigations that occurred in the United States and Canada, as well as being a possible supplier of romaine lettuce in the 2017 traceback investigations, the FDA said that the farm is not the single source of the outbreak, as there is “insufficient evidence”. The traceback suggests that the contaminated lettuce could have come from several farms, because not all tracebacks led to the farm on which the contaminated sediment was found.

“The finding of the outbreak strain in the sediment of the water reservoir is significant, as studies have shown that generic E. coli can survive in sediments much longer than in the overlying water. It’s possible that the outbreak strain may have been present in the on-farm water reservoir for some months or even years before the investigation team collected the positive sample. It is also possible that the outbreak strain may have been repeatedly introduced into the reservoir from an unknown source,” stated FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Frank Yiannas in a press announcement.

(left to right) Stic Harris, FDA; Matt Wise, CDC; Dan Sutton, Pismo Oceano Vegetable Exchange; Scott Horsfall, California Leafy Greens Marketing Agreement discuss the first E.coli outbreak involving romaine lettuce during a panel at the 2018 Food Safety Consortium. Read the article about the discussion.

Although the exact route of contamination cannot be confirmed, the FDA hypothesizes that it could have occurred through the use of agricultural water from an open reservoir, which has increased potential for contamination.

The investigation teams also found evidence of “extensive” wild animal activity and animal burrows near the contaminated reservoir, as well as adjacent land use for animal grazing, all of which could have contributed to the contamination.

Although FDA did not directly name the farm in the report, it provided a link about the recall that was initiated by the farm, Adam Bros. Farming, Inc., in December.

Considering the significant effect that the past two E.coli outbreaks involving romaine lettuce have had on both the public as well as the produce industry, FDA made several recommendations on preventive measures that leafy greens growers and industry can take to avoid such pathogenic contamination, including:

For growers:

  • Assessing growing operations to ensure they are in line with compliance to FSMA and good agricultural practices
  • Making sure that any agricultural water that comes into direct contact with the harvestable portion of the crop, food contact surfaces and harvest equipment is safe and sanitary
  • Address and mitigate risks associated with agricultural water contamination that can occur as a result of intrusion by wild animals
  • Address and mitigate risks associated with the use of land near or adjacent to agricultural water sources that can lead to contamination
  • Conduct root cause analysis whenever a foodborne pathogen is identified in the growing environment, agricultural inputs like water or soil, raw agricultural commodities, or “fresh-cut” ready-to-eat produce

For the broader industry:

  • The development of real-time procedures that enable rapid examination of the potential scope, source and route of contamination
  • All leafy green products should have the ability to be traced back to the source in real time, and information include harvest date. In November, FDA requested voluntary labeling [https://foodsafetytech.com/news_article/cdc-alert-do-not-eat-romaine-lettuce-throw-it-out/] to help consumers identify products affected during an outbreak
  • The adoption of best practices in supply chain traceability

Resources

  1. FDA report: “Factors Potentially Contributing to the Contamination of Romaine Lettuce Implicated in the Fall 2018 Multi-State Outbreak of E.Coli O157:H7”
  2. FDA statement from Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Frank Yiannas
  3.  FDA investigation of source of E.coli O157:H7 outbreak linked to romaine lettuce
Sprouts

FDA Releases Sampling Report on Sprout Contamination

By Food Safety Tech Staff
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Sprouts

In an effort to determine the prevalence of Salmonella, Listeria and E. coli O157:H7 in sprouts, FDA conducted a large sampling study of sprouts, the results of which were released last week.

The agency collected 825 samples from 37 states, Puerto Rico and the District of Columbia and found 14 positive samples at eight of the 94 growers (10 samples came from four growers). Samples were collected from three production process points: Seeds, finished product and spent irrigation water, and tested for contamination. FDA found the following contamination:

  • Salmonella on 2.35% of seed samples, 0.21% in finished sprouts and 0.53% in spent irrigation water
  • Listeria monocytogenes on 1.28% of finished sprouts
  • No positive E. coli O157:H7 results in finished sprout or spent irrigation. Due to limitations of the test method, FDA didn’t test seed samples.

“Sprouts are especially vulnerable to pathogens given the warm, moist and nutrient-rich conditions needed to grow them. From 1996 to July 2016, there were 46 reported outbreaks of foodborne illness in the United States linked to sprouts. These outbreaks accounted for 2,474 illnesses, 187 hospitalizations, and three deaths.” – CFSAN

In the event that contaminated sprout samples were uncovered, FDA worked with the firms that own or released the affect sprouts to conduct voluntary recalls or destroy them. FDA inspections also followed.

The full report, FY 2014 – 2016 Microbiological Sampling Assignment, is available on FDA’s website.

Reduce Foodborne Illness Causing Microorganisms through a Structured Food Safety Plan

By James Cook
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In 2011 three U.S. government agencies, the CDC, the FDA and the USDA’s Food Safety Inspection Service (FSIS) created the Interagency Food Safety Analytics Collaboration (IFSAC). The development of IFSAC allowed these agencies to combine their federal food safety efforts. The initial focus was to identify those foods and prioritize pathogens that were the most important sources of foodborne illnesses.

The priority pathogens are Salmonella, E. coli O157:H7, Listeria monocytogenes and Campylobacter. To research the most important product sources, the three agencies collaborated on the development of better data collection and developed methods for estimating the sources of foodborne illnesses. Some of this research was to evaluate whether the regulatory requirements already in effect were reducing the foodborne pathogens in a specific product matrix. The collection, sharing and use of this data is an important part of the collaboration. For example, when the FDA is in a facility for routine audit or targeted enforcement, they will generally take environmental swabs and samples of air, water and materials, as appropriate, which are then tested for the targeted pathogens. If a pathogen is found, then serotyping and pulsed-field gel electrophoresis (PFGE) fingerprinting is performed, and this is compared to the information in the database concerning outbreaks and illnesses. This data collection enables the agencies to more quickly react to pinpoint the source of foodborne illnesses and thereby reduce the number of foodborne illnesses.

The IFSAC strategic plan for 2017 to 2021 will enhance the collection of data. The industry must be prepared for more environmental and material sampling. Enhancement of data collection by both agencies can be seen through the FSIS notices and directives, and through the guidance information being produced by the FDA for FSMA. Some examples are the raw pork products exploratory sampling project and the FDA draft guidance for the control of Listeria monocytogenes in ready-to-eat foods.

Starting May 1 2017, the next phase of the raw pork products exploratory sampling project will begin. Samples will be collected and tested for Salmonella, Shiga-toxin producing E. coli (STECs), aerobic plate count and generic E. coli. In the previous phase, the FSIS analyzed 1200 samples for Salmonella for which results are published in their quarterly reports. This is part of the USDA FSIS Salmonella action plan published December 4, 2013 in an effort to establish pathogen reduction standards. In order to achieve any objective, establishing baseline data is essential in any program. Once the baseline data is established and the objective is determined, which in this situation is the Health People 2020 goal of reducing human illness from Salmonella by 25%, one can determine by assessment of the programs and data what interventions will need to take place.

The FDA has revised its draft guidance for the control of Listeria monocytogenes in ready-to-eat food, as per the requirement in 21 CFR 117 Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Foods, which is one of the seven core FSMA regulations. Ready-to-eat foods that are exposed to the environment prior to packaging and have no Listeria monocytogenes control measure that significantly reduces the pathogen’s presence, will be required to perform testing of the environment and, if necessary, testing of the raw and finished materials. Implementing this guidance document helps the suppliers of these items to cover many sections of this FSMA regulation.

The purpose of any environmental program is to verify the effectiveness of control programs such as cleaning and sanitizing, and personnel hygiene, and to identify those locations in a facility where there are issues. Corrective actions to eliminate or reduce those problems can then be implemented. Environmental programs that never find any problems are poorly designed. The FDA has stated in its guidance that finding Listeria species is expected. They also recommend that instead of sampling after cleaning and/or sanitation, the sampling program be designed to look for contamination in the worst-case scenario by sampling several hours into production, and preferably, just before clean up. The suggestion on this type of sampling is to hold and test the product being produced and to perform some validated rapid test methodology in order to determine whether or not action must be taken. If the presence of a pathogen is confirmed, it is not always necessary to dispose of a product, as some materials can be further processed to eliminate it.

With this environmental and product/material testing data collected, it is possible to perform a trends analysis. This will help to improve sanitation conditions, the performance of both programs and personnel, and identity the need for corrective actions. The main points to this program are the data collection and then the use of this data to reduce the incidence of foodborne illness. Repeated problems require intervention and resolution. Changes in programs or training may be necessary, if they are shown to be the root cause of the problem. If a specific issue is discovered to be a supply source problem, then the determination of a suppliers’ program is the appropriate avenue to resolve that issue. Generally, this will mean performing an audit of the suppliers program or reviewing the audit, not just the certificate, and establishing whether they have a structured program to reduce or eliminate these pathogens.

Continue to page 2 below.

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

Are You Ready for an FDA Inspection?

By Shawn K. Stevens
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Shawn K. Stevens, Food Industry Counsel

Don’t miss the Plenary Mock Food Safety Trial: Sam I Am who made Green Eggs and Ham is represented by Shawn Stevens vs. Food Safety victims represented by Bill Marler. Judged by Steve Sklare | November 30 at the 2017 Food Safety Consortium | Learn moreWith FSMA regulations coming into effect, food companies must prepare for the arrival of FDA investigators, as the agency has made it a priority to inspect U.S. food facilities, and they won’t always show up announced. Prior to an investigator’s arrival, it’s important to iron out several details in order to be adequately prepared. The following are 10 questions that every company should add to its pre-inspection checklist and make sure they are addressed before the inspection.

  1. Where will you meet? Pinpoint a place where you will host the FDA investigators. It should be a space that has enough room for them to review records, but it should not provide access to records (paper or digital) that could be viewed unsupervised.
  2. Who are the Designated Individuals? Assign a primary and secondary Designated Individual (DI) for each facility. This person serves as the liaison with the FDA investigators and should coordinate vacation time to ensure that one DI will always be available if FDA arrives. Although not required, the DI should also complete Preventive Control Qualified Individual Training.
  3. Has the written food safety plan been finalized? And, do the primary and secondary DIs know its components (i.e., GMPs, Sanitation Programs, Preventive Control Plan, Recall Plan, Environmental Monitoring Program, Foreign Supplier Verification Plan, Sanitary Transportation Plan, Food DefensePlan, and Produce Safety Plan)?
  4. Are records readily accessible? The DI should be able to immediately access any supporting records from the past three months for FDA review (FDA requires that most records are maintained for at least two years, but investigators usually ask to review the preceding three months).
  5. Have corrective actions been documented? When a deviation occurs, you must document all corrective actions. These actions should identify the deviation’s root cause and actions to prevent recurrence. If product safety is not affected, this should include a written conclusion that the deviation “does not create an immediate or direct food safety issue.”
  6. Have you conducted environmental monitoring and environmental sampling? If your company processes ready- to-eat food products that are exposed to the environment prior to packaging, FDA will require you to have an environmental monitoring program. In addition, the agency will collect 100–200 microbiological samples from your facility, so you need to know exactly what FDA will find before it arrives. By conducting your own FDA-style facility swabbing, you’ll be able to identify and immediately correct any hidden problems. It’s also important to develop your swabbing and testing plan with the help of legal counsel so that  the final testing results are confidential.
  7. Do you have a “No Photographs” policy? If not, you should. FDA Investigators will often insist on taking photographs while inspecting the processing environment. If your corporate policy prohibits visitors from taking photographs, you may in some cases be able to prevent FDA from taking pictures as well.
  8. Do you have a “Do Not Sign” policy? Sometimes, FDA Investigators will insist that a company representative sign a statement or affidavit during an inspection. You’re not legally obligated to do sign such a document. You should develop a policy stating you will neither sign nor acknowledge any written statements presented by FDA Investigators.
  9. Have you identified a suitable “on call” food industry lawyer? Add a food industry lawyer familiar with the inspection process to the company’s emergency contact list. This lawyer should be notified and remain “on call” during the inspection and serve as a resource to help answer any regulatory or investigator-related questions that arise during the process.
  10. Did you conduct a mock FDA inspection? One of the most effective ways to prepare for an FDA visit is to conduct a mock inspection. Food industry consultants and/or lawyers can visit your facility and play the role of the Investigator. Ask them to review your programs to identify possible regulatory shortfalls, and work with you to implement strategies that will strengthen your programs and reduce your regulatory exposure.

There are several more points to add to your pre-inspection checklist. To get the rest, attend the webinar, FDA Inspection Readiness Checklists, on March 28.

Maria Fontanazza, Zephyr Wilson, Food Safety Consortium

Encourage Employees to Find Listeria

By Food Safety Tech Staff
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Maria Fontanazza, Zephyr Wilson, Food Safety Consortium

Building the right food safety culture around environmental monitoring requires a realistic approach to your processes. “Culture starts with understanding your process,” Zephyr Wilson, product manager at Roka Bioscience told Food Safety Tech at the 2016 Food Safety Consortium. “You need to ask questions—a lot of questions.”

In the following video, Wilson talks about food safety culture in the context of environmental monitoring and how companies should approach environmental monitoring. “Understand all of your processes,” she said. “Take an honest look at your metrics and make sure you’re encouraging your employees to find the Listeria.”

She also reviews the steps a company should take when undergoing self-auditing, and encourages companies to work under the direction of an attorney to ensure that all results are confidential.

Food lab testing

Infographic: Who Outsources Pathogen Testing?

By Maria Fontanazza
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Food lab testing

Pathogen testing of food samples, whether in-plant or outsourced, is a critical task. Although some companies find it more cost-effective (and they have the capabilities) to conduct testing in-house, other companies don’t want to touch it due to cost and potential risk.

“Food processors are far more comfortable analyzing samples for nutritional parameters, contaminants and routine microbiology in an in-plant lab, but fewer are comfortable running pathogen tests in-plant,” stated Bob Ferguson of Strategic Consulting in the Food Safety Tech article, Changing Landscape for Selecting a Food Safety Contract Laboratory.

According to Ferguson, some of the factors that lead food processors to outsource pathogen testing include:

  • Need for skilled analysts (including recruiting and maintaining accreditations
  • Lab accreditation (just 20% of food company labs are accredited)
  • Analytical methods require complex equipment, which can be expensive to maintain
  • Risk of in-house pathogen contamination
  • Company size

The below infographic reveals some of the findings, discussed at the 2016 Food Safety Consortium, of a survey conducted of more than 100 food processing customers of food contract laboratories.

 

Food contract labs
Information gathered as part of Strategic Consulting’s survey of food processing customers of food contract labs. Graphics courtesy of Strategic Consulting.
Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

FDA’s Tactics to Reduce Outbreaks and Recalls

By Shawn K. Stevens
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Shawn K. Stevens, Food Industry Counsel

The advent of PulseNet in the late 1990s enabled more effective identification of outbreaks, even as many of them overlapped. The database brought to light the fact that many of the products sold in commerce nationwide contained ingredients that were at risk of contamination with dangerous pathogens. In many instances, these ingredients were in products from a single lot or batch and then sold by a single supplier to dozens of customers. From there, they were used in hundreds of products that would be distributed into thousands of retail locations.

Attend Food Safety Tech‘s Listeria Detection & Control Workshop | May 31–June 1 in St. Paul, MN | LEARN MOREFDA created the Reportable Food Registry (RFR) as a way to prevent the shipment of contaminated ingredients into the food supply. If received ingredients or products test positive for contaminants, the RFR requires that the company inform FDA. The agency uses the reports to take regulatory action against the original supplier and requires that all ingredients or products from all potentially affected lots be recalled from commerce. Because the RFR allows FDA to immediately begin tracking and containing ingredients testing positive for pathogens, its introduction in 2009 resulted in a significant spike in recalls.

Driven by the recalls triggered by PulseNet and the RFR, a national perception about an extremely unsafe U.S. food supply began to emerge. The public and media demanded that Congress take action, and so FSMA was born. The regulations require all FDA-regulated food companies to develop and implement written preventative control programs designed to control pathogens and other hazards in food. As a result, food companies will face heightened regulatory risk, scrutiny and exposure.

To further decrease the incidence of outbreaks and recalls, FDA is implementing regulatory enforcement initiatives that include sampling food products at retail for the presence of pathogens; conducting microbiological profiling of food processing facilities during routine inspections; and exploring criminal sanctions against companies that have been linked to positive samples in food products or production facilities associated with an outbreak or foodborne illness.

Microbiological Sampling in Retail

FDA is sampling products intended for human consumption as well as those for animal consumption. As testing continues at the retail level, the likelihood of more food products testing positive for the presence of pathogens is much higher. When positive product samples are found, FDA will take immediate action against the company that processed the product and require the company to recall all affected product. The agency will also demand access to the production facility at issue and conduct extensive environmental sampling, including from drains, floors, walls, production equipment, and finished products, in an effort to find the same strain as the sample testing positive at retail.  If product or environmental samples test positive, FDA will perform genetic DNA testing on the isolates and compare the DNA fingerprints against those of the isolates collected from sick case patients in PulseNet over the past 15 years. If a match between the DNA fingerprint and an illness(es) in PulseNet is found, the agency will presume that these illnesses were caused by product originating from that particular facility. FDA will also demand access to all food production and microbiological testing records from previous months, or years, and critique those records.

Microbiological Sampling in Food Production Facilities

In accordance with FSMA, FDA will inspect all food production facilities (drains, floors, walls, food processing equipment, and finished products) that process high-risk ingredients or food products within the next three years (lower risk facilities will be inspected within the next five years). The agency is also performing extensive microbiological profiling of the food processing environment in all production facilities during routine inspections. If a positive sample is found, FDA may require the company to recall the affected product. It is expected that the level of sampling will intensity in the coming months and years as a result of FSMA mandates. And as the extensive microbiological sampling in food production facilities continues, FDA will perform genetic DNA testing on any positive samples collected, once again comparing the DNA fingerprints of samples against those of sick case patients over the last two decades. If a match is found, FDA will take the same course of action as in retail and presume all illnesses were caused by a food product originating from that specific facility. When that occurs, in addition to the potential recalls that may be required, the food companies at issue may become the target of a criminal investigation as well.

My next column will cite recent examples of FDA’s criminal offensive against food companies.

Laboratory Information Management System

How LIMS Facilitates ISO 17025 Certification in Food Testing Labs

By Dr. Christine Paszko
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Laboratory Information Management System

In order to ensure that a food testing laboratory maintains a quality management system that effectively manages all aspects of laboratory operations that affect quality, there are numerous records, reports and data that must be recorded, documented and managed.

Gathering, organizing and controlling all the data that is generated, managed and stored by food testing laboratories can be challenging to say the least. As the ISO Standards and regulatory requirements for food testing laboratories evolve, so does the need for improved quality data management systems. Historical systems that were very efficient and effective 10 years ago, may no longer meet the demanding requirements for ISO 17025 certification. One way to meet the challenge is to turn to automated solutions that eliminate many of the mundane tasks that utilize valuable resources.

There are many reasons for laboratories to seek this certification, including to enhance reputation, gain a competitive advantage, reduce operational costs, and meet regulatory compliance goals. A major advantage for food testing laboratories to obtain ISO 17025 Certification is that is tells prospective clients that the laboratory has a strong commitment to quality, and they hold the certification to prove it. This certification not only boosts a laboratory’s reputation, but it also demonstrates an organization’s commitment to quality, operational efficiency and management practices. Proof of ISO 17025 Certification eliminates the need for independent supplier audits, because the quality, capability and expertise of the laboratory have been verified by external auditors. Many ISO Certified laboratories will only buy products (raw materials, supplies and software) and services from other ISO-certified firms so that they do not need to do additional work in qualifying the vendor or the products.

There are many areas in which a LIMS supports and promotes ISO 17025 compliance. Laboratories are required to manage and maintain SOPs (standard operating procedures) that accurately reflect all phases of current laboratory activities such as assessing data integrity, taking corrective actions, handling customer complaints, managing all test methods, and managing all documents pertaining to quality. In addition, all contact with clients and their testing instructions should be recorded and kept with the job/project documentation for access by the staff performing the tests/calibrations. With a computerized LIMS, laboratory staff can scan in all paper forms that arrive with the samples (special instructions, chain of custody (CoC), or any other documentation). This can be linked to the work order and is easy assessable by anyone who has  the appropriate permissions. The LIMS provides extensive options for tracking and maintaining all correspondence, the ability to attach electronic files, scanned documents, create locked PDFs of final reports, COAs (Certificate of Analysis), and CoCs.

Sample Handling and Acceptance

Laboratories are required to have a procedure that defines all processes that a sample is subjected to while in the possession of the laboratory. Some of these procedures will relate to sample preservation, holding time requirements, and the type of container in which the sample is collected or stored. Other information that must be tracked includes sample identification and receipt procedures, along with acceptance or rejection criteria at log-in. Sample log-in begins and defines the entire analysis and disposal process, therefore it is important that all sample storage, tracking and shipping receipts as well as sample transmittal forms (CoC) are stored, managed and maintained throughout the sample’s analysis to final disposal. To summarize, the laboratory should have written procedures around the following related to sample preservation:

  • Preservation
  • Sample identification
  • Sample acceptance conditions
  • Holding timesShipping informationStorage
  • Results and Reporting
  • Disposal

The LIMS must allow capture and tracking of data throughout the sample’s active lifetime. In addition, laboratories are also required to document, manage and maintain essential information associated with the analytical analysis, such as incubator and refrigerator temperature charts, and instrument run files/logs. Also important is capturing data from any log books, which would include the unique sample identifier, and the date and time of the analysis, along with if the holding time is 72 hours or less or when time critical steps are included in the analysis, such as sample preparations, extractions, or incubations. Capturing the temperature data can be automated such that the data can be directly imported into the LIMS. If there is an issue with the temperature falling outside of a range, an email can automatically be spawned or a message sent to a cell phone to alert the responsible party. Automation saves time and money, and can prevent many potential problems via the LIMS ability to import and act on real-time data.

If any instrumentation is used in the analysis, the following information must also be recorded in the instrument identification (to ensure that it is in calibration, and all maintenance and calibration records are current), operating conditions/parameters, analysis type, any calculations, and analyst identification. In addition to analyst identification, laboratories must also keep track of analyst training as it relates to their laboratory functions. For example, if an analyst has not been trained on a particular method or if their certification has expired, the LIMS will not allow them to enter any result into the LIMS for the method(s) that they have not been trained/certified to perform. The LIMS can also send automated alerts when the training is about to expire. Figure 1 shows a screen in the LIMS that manages training completed, scheduled, tests scores, and expiration dates of the training, along with the ability to attach any training certificates, exams, or any other relevant documentation. Laboratory managers can also leverage the LIMS to pull reports that compare analyst work quality via an audit report. If they determine that one analyst has a significant amount of samples that require auditing, they can then investigate if there is a possible training issue. Having immediate access to data allows managers to more rapidly identify and mitigate potential problems.

Laboratory Information Management System
LIMS manages a variety of aspects in training, including when it has been completed, scheduled, tests scores, and expiration dates. (Click to enlarge)

Another major area that a LIMS can provide significant benefit is around data integrity. There are four main elements of data integrity:

  1. Documentation in the quality management system that defines the data integrity procedure, which is approved (signed/dated) by senior management.
  2. Data integrity training for the entire laboratory. Ensures that the database is secure and locked and operates under referential integrity.
  3. Detailed, regular monitoring of data integrity. Includes reviewing the audit trail reports and analyzing logs for any suspicious behavior on the system.
  4. Signed data integrity documentation for all laboratory employees indicating that they have read and understand the processes and procedures that have been defined.

The LIMS will enhance the ability to track and manage data integrity training (along with all training). The LIMS will provide a definition of the training, the date, time, and topic (description); instructor(s); timeframe in which the training is relevant, reminders on when it needs to be repeated; along with  certifications, quiz scores, copies of quizzes, and more. With many tasks, the LIMS can provide managers with automated reports that are sent out at regular time intervals, schedule training for specific staff, provide them with automatic notification, schedule data integrity audits, and to facilitate FDA’s CFR 21 part 11 compliance (electronic signatures). The LIMS can also be configured to automatically have reports signed and delivered via fax or email, or to a web server. The LIMS manages permissions and privileges to all staff members that require access to specific data and have the ability to access that data, along with providing a secure document control mechanism.

Laboratories are also required to maintain SOPs that accurately reflect all phases of current laboratory operations such as assessing data integrity test methods, corrective actions and handling customer complaints. Most commercial LIMS provide the ability to link SOPs to the analytical methods such that analysts can pull down the SOP as they are doing the procedure to help ensure that no steps are omitted. Having the SOPs online ensures that everyone is using the same version of the locked SOPs, which are readily available and secure.

Administrative Records, Demonstration of Capability

Laboratories are required to manage and maintain the following information on an analyst working in the laboratory: Personal qualifications and experience and training records (degree certificates, CV’s), along with records of demonstration of capability for each analyst and a list of names (along with initials and signatures) for all staff that hold the responsibility to sign or initial any laboratory record. Most commercial LIMS will easily and securely track and manage all the required personnel records. Individuals responsible for signing off on laboratory records can be configured in the LIMS to not only document the assignment of responsibility but also to enforce it.

Reference Standards and Materials

Because the references and standards that laboratories use in their analytical measurements affect the correctness of the result, laboratories must have a system and procedures to manage and track the calibration of their reference standards. Documentation that calibration standards were calibrated by a body that can prove traceability must be provided. Although most standards are purchased from companies that specialize in the creation of reference standards, there are some standards that laboratories create internally that can also be traced and tracked in the LIMS. Most commercial LIMS will also allow for the creation, receipt, tracking, and management of all supplies in an inventory module, such that they document the reference material identification, lot numbers, expiration date, supplier, and vendor, and link the standard to all tests to which it was linked.

The ISO 17025 Standard identifies the high technical competence and management system requirements that guarantee your test results and calibrations are consistently accurate. The LIMS securely manages and maintains all the data that supports the Quality Management System.

Key advantages of food testing laboratories that have achieved ISO 17025 Certification with a computerized LIMS that securely and accurately stores all the pertinent data and information:

  • Proof of ISO 17025 Certification eliminates the need for supplier audits, because the quality, capability and expertise of the laboratory have been demonstrated by the certification.
  • Knowledge that there has been an evaluation of the staff, methods, instrumentation and equipment, calibration records and reporting to ensure test results are valid.
  • Verification of operational efficiency by external auditors that have validated the quality, capability and expertise of the laboratory.
  • Defines robust quality controls for the selection and authentication of methods, analyzing statistics, controlling and securing data.
  • Clearly defines each employee’s roles, responsibilities and accountability.
  • Confidence that the regulatory and safety requirements are effectively managed and met in a cost efficient-manner.