Tag Archives: laboratory

Best Practices for ISO 17025 Accreditation: Preparing for Your Food Laboratory Audit (Part II)

By Joy Dell’Aringa
2 Comments

In Part I of this article, we explored the considerations a laboratory should initially evaluate when pursuing accreditation, as well as guidance from leading industry experts on how to prepare for an ISO 17025 audit. Here we will review what comes after the on-site assessment and provide practical user-based advice for preparing a response, common areas of non-conformance, and future changes to the ISO 17025 Standard.

The Response

Once the assessor has completed the audit, they will typically hold a closing meeting on-site where they present their findings, also referred to as deficiencies or non-conformances. For each finding they will document a specific reference to the standard as evidence and provide opportunity for questions and discussion. Most assessors will be open and conversational during this final portion of the assessment; laboratories are well suited to take advantage of this time. Some assessors will even brainstorm possible responses and corrective actions while onsite; this is valuable insight for the laboratories quality team and can help them get a jump on the response.

Depending on the accrediting body, the laboratory will have a certain amount of time to respond to the findings, usually 30–60 days. The anatomy of a well-assembled response will include a full corrective action report, complete with root cause analysis. Often, the assessor will also request supporting documents and records to show the effectiveness of a corrective action. Most laboratories will have forms to help guide users through the corrective action and root cause process. It is important to have a systematic approach to ensure your corrective action is thorough and balanced.

Determining root cause is a critical part of this exercise. Erin Crowley, CSO of Q Laboratories shares their approach. “We use a variety of root cause analysis techniques, but have found for our operation the principle of the ‘5 Why’s’ is very effective,” she says. “Don’t simply answer the singular deficiency. Accrediting bodies will want to know that you have addressed all variables that might be associated with a finding. For example, if a specific incubator was out of range on a specific date, don’t just indicate that someone fixed it and move on. Assess how they addressed the issue, any impact on data, what they did to react to it, and how they are putting systems in place to prevent it from happening in the future on any other incubator. You have to show the full process.”

Implementing procedures as an outcome of a corrective action can also bring challenges to an operation. As a national multi-site reference lab, Eurofins Quality Manager Peter Dragasakis must work with other departments and locations to deploy new or changed systems for compliance. “Sometimes the most challenging part of the entire audit process is coordinating internal stakeholders across other departments such as IT or complimentary analytical departments,” he says. “Coordinating a response in a timely manner takes full organizational cooperation and support.” Communication throughout the quality and operational arms of an organization is critical to a successful response. Often, accrediting bodies and laboratories may shuttle a response back and forth a few times before everyone is satisfied with the outcome.

Common Areas of Non-Conformance: Pro-Tips

While all areas of the standard are important to a conformant operation, there are a few key areas that are frequently the focus of assessments and often bare the most findings.

Measurement Uncertainty. Depending on the laboratories Field of Testing (FOT), Measurement Uncertainty (MU) can be captured in a multitude of ways. The process aims to systematically and quantifiably capture variability in a process. For chemical analysis this is typically well defined and straightforward. For microbiological analysis the approach is more challenging. A2LA’s General Manager, Accreditation Services, Adam Gouker says the reason many labs find themselves deficient in this area is “they don’t consider all of the contributors that impact the measurement, or they don’t know where to begin or what they need to do.” Fortunately, A2LA offers categorical guidance in documents P103a and P103b (for the life sciences laboratories, two of the of many guidance documents aimed at helping laboratories devise systems and protocols for conformance.

Traceability. There are several requirements in the ISO 17025 standard around traceability. In terms of calibration conformance, which accrediting bodies seem to have emphasized in the last few years, Dragasakis offers this tip: “When requesting [calibration] services from a vendor, make sure you’re requesting 17025 accredited service. You must specify this, as several levels of service may be available, and “NIST Traceable” certificates are usually no longer sufficient.” He also advises that calibration certificates be scrutinized for all elements of compliance closely. “Some companies will simply state that it is ‘ISO 17025 compliant’, [and] this does not mean it is necessarily certified. Look for a specific reference to the accrediting body and the accreditation certificate number. Buyer beware, there is often a price difference between the different levels of calibration. Always practice due diligence when evaluating your calibration vendor and their services, and contact the calibration service if you have any questions.”

Validation vs. Verification. One of the more nuanced areas of the standard lies in determining when a test requires validation, verification, or an extension, specifically when there is a modification to a method or a sample type not previously validated by an internationally recognized organization (AOAC, AFNOR, etc.). Certified Laboratories Director Benjamin Howard reminds us, “think of validation and verification as existing on a spectrum. The more you stray away from an existing validation, the more validation work is required by the analyzing laboratory.” For example, analyzing Swiss cheese for Salmonella by a method that has already been validated for soft queso cheese may require only minimal verification or matrix extension. However, a laboratory that is altering a validated incubation time or temperature would require a much more robust and rigid validation process. Howard cautions, “Accredited laboratories must be transparent about modifications, not only on their scope of accreditation but on their reports [or CofA’s] as well. Under FSMA, companies are now accountable to the data that their laboratories generate. If you see a “modification” note on your report, perform due diligence and discuss this with your laboratory. Ensure a proper validation of the modification was performed. “Additionally, the ISO 17025 standard and accrediting bodies do not mandate how a validation or verification should be done. Laboratories should have a standalone SOP that outlines these procedures using scientifically supported justification for their approach.

CAPA / Root Cause. A good corrective action / preventive action (CAPA) and root cause (RC) analysis program is at the heart of every sound quality system. “Corrective and preventive action (CAPA) processes can either add value or steal time away from the organization according the quality of the root cause analysis,” says Vanessa Cook, quality systems manager at Tyson Foods Safety & Laboratory Services. “CAPA might be the single greatest influence on an organization’s ability to continuously improve and adapt to change if diligence is given to this activity.” Investing in resources such as ongoing training in CAPA/RC programs and techniques are key components to ensuring a robust and effective CAPA / RC program.

Continue to page 2 below.

Palmer Orlandi, FDA, Food Labs conference

FDA Pushing Proactive, Real-Time Analysis

By Maria Fontanazza
No Comments
Palmer Orlandi, FDA, Food Labs conference

Over the past year, FDA has been emphasizing the level of collaboration necessary with industry to drive a more preventive culture of food safety.  Much of these efforts surround closely integrated partnerships between federal, state and local stakeholders, including a larger role that laboratories will play in FSMA implementation.

Palmer Orlandi, FDA, Food Labs conference
“We can’t test our way to food safety. It’s just not possible,” said Orlandi. He added that industry can work together to develop a testing program that leads to safer foods.

There will be greater reliance on the responsibilities and capabilities of laboratories as a result of the proactive movement in finding points of contamination, before they invade the home of the consumer, in real time. With the convergence of more laboratory analysis and the responsibilities that the FSMA regulations warrant, industry will be relying on the establishment of uniform and standardized lab-related processes and policies in order to bring uniformity and trust to the quality of data being generated and shared, according to Palmer Orlandi, Ph.D., acting chief science officer and research director at FDA’s Office of Food and Veterinary Medicine. Orlandi, speaking at the Food Labs Conference last week, said that FDA is moving in this direction. “The oversights we’re mandating moving forward for data sharing, data reporting and data acceptance are completely equivalent across the board,” he said. FDA is working toward providing more transparency in terms of laboratory oversight and how it intends on working with industry.

Within the five published final FSMA rules there is at least some component of lab support that is necessary. The rule that deals the most with lab involvement, especially laboratory accreditation, is the foreign supplier verification program, because the responsibility falls on the importer to assure and verify safety of the commodity, and this requires the submission of laboratory analysis, said Orlandi.

Palmer Orlandi, FDA, Food Safety Consortium
Palmer Orlandi discusses FSMA and laying the groundwork for data acceptance in lab partnerships at the Food Safety Consortium. WATCH NOW

Currently the majority of FDA’s work effort in the laboratory category falls under compliance program driven sampling, with domestic activities (i.e., inspections) and import activities coming in second and third respectively. Moving forward, environmental driven sampling will play a much larger role, as FSMA places greater emphasis on a risk-based approach and finding issues in real time, directly in the environment.

“We don’t want to be the agency that is just is responding to foodborne outbreaks or responding to problems with industry or farms or any of the commodities,” said Orlandi. “We want to work and become less of an enforcement agency and one of a partner so we can stop problems where they may occur. That involves making partners and leveraging our resources.”

FDA is expanding its responsibility for testing and sampling in the area of surveillance, verification (i.e., preventive controls and import controls), and compliance (i.e., removing adulterated products from the market, enforcement actions, and environmental assessment). The agency is taking a risk-based approach to deploying its resources, and where it does not have the capacity it will be relying on partners for assistance. It is also investing more resources in import testing and the criteria that go into accepting data for import testing, and will be preparing guidance for submission of data.

FDA Vs. USDA: Who Regulates What?
FDA Responsibilities USDA Responsibilities
Manufacturers, processers, packers, holders, distributors, food transporters

Growers of fresh fruits and vegetables, tree nuts and sprouts

Dairy products

Plant products and spices

Grain-based products

Seafood (except catfish)

Beverages and bottled water

Food and color additives

Dietary supplements

Meat

Poultry

Frozen, dried and liquid eggs (FDA regulates whole eggs)

Catfish

FDA tests foods for the presence of pesticides, toxic elements, mycotoxins, chemotherapeutics in seafood, and microbial hazards (bacterial, parasitic, viral)
Palmer Orlandi, FDA, Food Safety Consortium

FSMA and Laying Groundwork for Data Acceptance in Lab Partnerships

By Food Safety Tech Staff
No Comments
Palmer Orlandi, FDA, Food Safety Consortium

Laboratories play a key role in FSMA, including providing data and analytical support, and assistance in surveillance and outbreak activities.

According to Palmer Orlandi, Ph.D., acting chief science officer and research director at FDA, success in the laboratory to support all the activity involving FSMA hinges on the following:

  • Mutual reliance on partners (federal, state and FDA)
  • Data-sharing capabilities (how data is generated and transmitted)
  • Acceptance of lab data

Establishing uniform standards of performance surrounding data quality and sharing, and ensuring that data has been verified and can be trusted lay the groundwork for data acceptance. Orlandi discussed the process of establishing data acceptance criteria at the 2015 Food Safety Consortium conference.

Microbiological Method Validation: The Elephant in the Lab

By Evan Henke, PhD, MPH
No Comments

Although commonly overlooked, microbiological method validation studies are the linchpins of entire quality programs, and method validations done without rigor are crippling our industry’s ability to truly ensure the quality and safety of foods on a daily basis.

Food quality managers, it is time we discussed the critical importance of validation studies in the quality lab. Although commonly overlooked, microbiological method validation studies are the linchpins of entire quality programs, and method validations done without rigor are crippling our industry’s ability to truly ensure the quality and safety of foods on a daily basis. This article discusses the purpose and importance of microbiological method validation studies and why the food industry should insist on validation study designs of maximum rigor and validity.

What is a microbiological method, and what exactly is a validation study?

A microbiological method, for the purposes of this discussion, is any microbiology test or assay used in the food industry. It may be a test for indicator organisms such as Coliforms or yeast and mold, pathogens such as Salmonella or E. coli O157, or toxins secreted by microorganisms such as Staphylococcal enterotoxin.

A validation study is a one-time study that food safety risk managers complete in order to assure themselves that a new microbiological method produces accurate results that will enable them to effectively measure and manage food safety risk. A validation study is conducted in the actual lab where testing will be performed, with current laboratory analysts, with the specific formulations of foods that are tested regularly.

Food industry regulators and certifying bodies such as SQF expect food producers to use microbiological test methods that are proven fit for use on specific foods. If we are to draw inferences about the fitness of a new test method on specific foods, then we must study how that new test method compares to an accepted reference method, or “gold standard” method. Reference methods are those written in the Food and Drug Administration’s Bacteriological Analytical Manual, the United States Department of Agriculture’s Microbiological Laboratory Guidebook, or ISO methods. Regulators and experts agree that these methods represent the standard to which all other tests should measure up. Methods certified by the Association of Analytical Communities (AOAC) are not considered reference methods and must be validated as fit for use on foods that are appreciably different from the matrices studied. Likewise, AOAC Performance Tested Method (PTM) and Official Methods of Analysis (OMA) certificates are not substitutes for internal validation studies in any given food plant.

In my experience working with quality labs across the United States, I have seen several different validation study designs used to evaluate alternative, more rapid and cost-effective microbiological methods. Some common validation study designs are shown in Table 1. Multiple alternative tests are available, however an internal validation study is needed regardless of the test kit manufacturer. Rarely does a validation study include a comparison to agar plates, which are required for almost every microbiological reference method. Material costs, labor costs, and emergency situations typically prohibit food labs from conducting a rigorous validation study that can speak to the performance of a new method in relation to the current gold standard.

Table 1: Scientific Questions Inherent in Food Microbiology Method Validation Study Designs 

 Validation Study Design  Inherent Scientific Question  Does Study Explain Performance
of New Test?
 
Test positive or spiked samples side by side on reference method and the new test  Does the test perform comparably to the reference method on my food? Yes 
Test positive or spiked samples on the new test  Regardless of accuracy, can the test detect certain or specific bacteria in my food?   No, but may be useful to understand workflow
Test any samples side by side on current AOAC certified method and new test  How do the new test’s results compare to my current AOAC certified method on my food?  No, but may be useful to understand workflow 
Test any positive or negative samples on the new test  Will the new test’s workflow improve my lab’s efficiency?  No, but may be useful to understand workflow 
This table presents several validation study designs common in the food industry and the scientific questions that are addressed by each design.

It is in the best interests of food producers and the public’s health to conduct rigorous validation studies that give food safety risk managers good information to make correct risk management decisions. In theory, some percentage of unsolved epidemiological foodborne illness clusters must be due to incorrect risk management decisions that allowed contaminated products to reach the market. At the same time, some percentage of all food lot rejections and recalls must be made incorrectly. A portion of these events must be related to food matrix interference that yielded incorrect microbiological results and caused the wrong risk management decision. As they say, “Garbage in, garbage out.”

In addition, including a comparison to agar reference methods in your microbiological method validation study is critical, as it reduces your chances of making an incorrect risk management decision.

Look at things this way: Plants certified with a GFSI accredited quality scheme have already put in effort to ensure analytical equipment such as thermometers and scales are calibrated. Similarly, validating microbiological methods against a reference method is equally if not more important. Finished product microbiology results inform decisions made every day that affect your profits and losses, and those results are likely a primary metric you use to study the effectiveness of your prerequisite programs and preventative controls.

Consider a quality lab that is using an alternative microbiological method that has not been rigorously validated with the plant’s specific foods. Unknown to the lab, the test results every day are twice as variable as the reference agar method and are frequently inaccurate relative to the plant’s product specifications. A rigorous method validation would demonstrate that results on the current method vary widely, while the same samples are consistent with a reference method. This well-intentioned plant is unknowingly making incorrect risk management decisions not just multiple times per year, but multiple times per week, either accidentally releasing contaminated product, reworking product that is acceptable, or disposing of perfectly good product. For the millions of dollars the food producer invests in prerequisite programs, preventative controls, quality personnel, and testing, the plant is unable to optimize their food safety risk management simply due to an unknown and overlooked incompatibility of the microbiological method with the plant’s product.

In my estimation, the costs of rigorously validating a microbiological method on all of your food products outweigh the potential hidden costs that could result from method incompatibility. The business case justifying the costs of a validation study are strong and compelling. And learning how to apply current microbiological methods specific to your foods is not as hard as you might think, considering the large host of test manufacturers, third-party labs, consultants, food safety extensions, and industry groups available to regularly provide study design education and services.

LIMS: Overwhelmed by Lab Data?

By Food Safety Tech Staff
No Comments

Thermo Fisher Scientific’s LIMS expert, Colin Thurston, explains how laboratory informatics can help food labs cope with large amounts of data as well as regulatory compliance.

The real challenge for food safety labs now is the amount of data that they are generating. “As analytical techniques have evolved, and instrumentation methods have become more sensitive, you can now process more and more information from a single sample. That kind of information becomes extremely difficult for a lab manager to process and to sift,” says Colin Thurston, Product Director, Informatics, for Thermo Fisher Scientific.

The big challenge for food processors is not the quality of the food but the brand. If something goes wrong with the food product, the consumer is going to remember it. So it is really critical for the lab to able to get the results to verify that the food is safe to eat, that too within a short time. 

What role does Laboratory Information Management System or LIMS play? “With the right LIMS solution, we can have the ability to automate, highlight the outliers, know which samples we have to go back and recheck, and which ones they have to reprocess because of challenges with the data. 

“Labs now are facing challenges around regulatory compliance. Regulations are changing and the food chain is becoming extended. Labs have to process a particular sample against many regulations as food companies want that product to be shipped to the U.S., consumed in Japan, Europe and so on. LIMS can store multiple sets of checks, carry out that process, and validate that product against all these requirements,” explains Thurston.