Nicole Cotta (00:03):
Hello everyone, and thank you for joining us today for our fourth webinar in our PFAS series. Today we will be joined by a few of our team members, where we will be talking about how laboratories can demonstrate PFAS excellence through a quality assurance mindset. So our speaker for today is Dr. Christy Abbas, and then I'm moderating, and then we've got Matt Graves and Brian Stringer who are members of our proficiency testing and technical teams, and they'll be with us during the Q&A portion. So you see on your dashboard here, you've got the presentation on the left and then you've got your other capabilities on the right. So there is a Q&A section where you can submit your questions during the webinar and we've allocated a lot of time to answer these questions, so we will get to as many as we can. And anything we don't have time to get to, we will follow up after the webinar.

(01:14):
Also, after the webinar, we'll send a follow-up email that'll have a link to today's recording. It'll have a link to some of the resources we think may be helpful, and you can also register for any of the webinars you missed and you can watch them on demand. And then also at the very end, after the Q&A session, we will be sending out a survey. So we would really love to get your feedback on what you liked during the webinar, what you would like to see more of in the future. That way, we can plan out future topics that we know are of interest to all of you.

(01:56):
So first off, I'm going to start with a question here, and so everyone should be able to click on the slide here and answer this question, but the question is why do you use certified reference materials? So I'll go ahead and give everyone a little bit of time to pick their favorite answer. I'm sure you might use them for more than one, but you can pick which one you use certified reference materials for most often, and I will share the results of the poll after everyone has a moment to select their answer. Give it like 10 or 15 more seconds.

(03:29):
All right, let me go ahead and share the results. All right, so number one, the most common use is to document and establish standards of traceability. That was a clear winner at over 50%. I see some people use it for corrective action, for documenting analyst capabilities. Some labs don't currently don't use CRMs. All right, thanks very much for participating and there is going to be another poll question at the end.

Dr Christy Abbas (04:16):
Hello everyone. Excited to have you all with us today for the webinar, Demonstrating PFAS Excellence Through a Quality Assurance Mindset. Again, I am Christy and in the course of the following slides, I would like to go over some of the areas that may be causing you additional challenges in your laboratory outside of method development, sample collection and prep of PFAS samples. To that end, I will give an overview of how proficiency testing and QC samples can aid in validating your processes, demonstrating analyst competency, adding to your scope of accreditation and documenting your commitment to quality for the new PFAS methods. And I will introduce you to the Waters ERA PFAS product line.

(05:04):
But before we get into the meat of the webinar, I would like to introduce you to ERA. ERA was founded in 1977, and our first PTs were offered in 1992. We were acquired by Waters Corporation in 2006. Our manufacturing occurs in Golden, Colorado and Wexford, Ireland. We are the leading environmental PT and CRM provider with 50 PT studies per year in eight matrices. I've included a link to a video that gives more information about our environmental products. We are also providers of process water consumables, so I've also included a link to that video. Shown here is the outline for today's talk. We'll go over accreditation and then certified reference materials.

(05:58):
We'll talk extensively about how CRMs can be used in your laboratory. Then we'll go into proficiency testing and the PFAS product portfolio at Waters ERA and we'll conclude with a summary. As a laboratory, whether a testing lab, government lab, in-house lab or PT provider, we are all faced with these drivers. We need to demonstrate how we provide accurate and defensible data. We need to maintain client data security. We need to turn samples around quickly. We need to offer competitive pricing. We need to protect our reputation and brand quality and we need to adhere to regulatory compliance. And paramount to all of this is the data we surface. The best way to defend that data is to be accredited.

(06:52):
What does accreditation mean? Well, for ISO 17025, it means that labs are held accountable for the green bubbles represented on this slide from managing risk and documentation to addressing nonconformities and implementing effective quality control measures. The environmental testing industry is based on regulation, and governments are charged with protecting the environment and supporting human health, and this is enforced through laws and rulemaking. But why be accredited? Because all stakeholders depend on quality data. Accrediting bodies are charged with ensuring labs have the quality management system and technical capabilities required to perform the methods satisfactorily and meeting the requirements of a standard. The accreditation process is in place to require labs to generate data of known and recorded quality.

(07:50):
To be accredited, quality management systems must be in place. Although QA and QC are closely related concepts and are both aspects of quality management, they're fundamentally different in their focus. QC is used to verify the quality of the output. QA is the process of managing for quality. The term quality management system or QMS covers the quality, technical and administrative system that governs the operations of the laboratory. The lab's QMS will have procedures for monitoring the validity of tests and calibrations undertaken in the lab. According to ISO standards, a QMS incorporates planning improvement initiatives, policies and objectives that will act as guidelines within an organization and QA/QC procedures. ERA adds value to our products and services by leveraging laboratory data to better serve the needs of you our customers. This is done by providing analytical tools that assist laboratories in improving their data quality and achieving a greater return on their investment in quality assurance.

(09:09):
Let's look briefly at accreditation process. It is the action or process of officially recognizing something as having a particular status or being qualified to perform a particular activity. Accreditation is a formal independent verification that a program or institution meets established quality standards and is competent to carry out specific tasks. To add to your lab scope of accreditation for PFAS, this process is followed. The accreditation process involves several steps as indicated on the slide, but critical to the process are proficiency testing and a corrective action plan, which includes CRMs. We'll talk about both of those in the course of this webinar. If starting from scratch, this entire accreditation process can take up to one year.

(10:04):
At ERA, we know the importance of accreditation and the requirements to obtain and maintain it. Listed here on the slide are ERA's quality accreditations. Using world-class materials and processes is an important way to inspire confidence in quality programs. All of ERA's proficiency testing and certified reference material products are covered by one or more independent and globally recognized accreditations. ISO 9001, 17025, 17034, 17043 and TNI. ISO 17025 requires traceability. So let's jump right into certified reference materials or CRMs, by dissecting the definition without reading the entire definition, I would like to highlight a few important points. ISO guides 34 and 35 amongst others provide guidance on what constitutes metrologically valid procedures.

(11:06):
Traceability is defined as the property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty and requires an established calibration hierarchy. Specification of the reference must include the time at which this reference was used in establishing the calibration hierarchy along with any other relevant metrological information about the reference such as when the first calibration in the calibration hierarchy was performed. A reference can be a measurement unit, a measurement procedure, a reference material, or a combination of such.

(11:50)
Basically, traceability equals history. Proper use of CRMs is essential for the establishment of metrological traceability of measurement results to international scales or other measurement standards. As stated in the definition, CRMs are accompanied with a certificate. Let's look at that on the next slide. ISO guide 31 provides guidance on the contents of certificates. The ISO committee on reference materials recognized the importance of the documentation that accompanies a reference material as early as 1981, when the first edition of ISO Guide 31 was published. The third edition of the guide that was published recently considers the appropriate accompanying documentation for all types of reference materials, whether it's a certified reference material or a non-certified reference material.

(12:47):
Shown on this slide is a certificate of analysis for PFAS in wastewater. Included is the certified value, the actual made to value verified by ERA analytical testing uncertainty, QC performance acceptance limits and PT performance acceptance limits, which are fixed per NELAC from the PT round. At ERA, all of the data from our PT studies is used to support our CRMs and ERA provides a summary of this data on our certificates of analysis. An assigned value from a provider is one thing, but an assigned value supported by data from dozens or hundreds of other labs is much more valuable.

(13:31):
Our certificates of analysis are compliant with ISO requirements, have an easy to use format, show unique performance, acceptance limits, uncertainty, expiration and instructions from the perspective of a reference material provider. The documentation that is provided with a CRM is the value adding component of the material. For the user, the document is critical for the correct implementation and use of the CRM in the measurement process. On this slide we have additional components of an ERA certificate of analysis, proficiency testing study results, which includes study mean recovery and number of participants per analyte. Also included is analytical traceability to a NIST standard reference material where available.

(14:28):
ISO 17025 accreditation is the single most important standard for calibration and testing laboratories around the world. ISO 17025-accredited laboratories have demonstrated that they are technically proficient and able to produce precise and accurate test and calibration data. Waters ERA maintains rigorous independent oversight of our internal processes, so you can be assured of the continuity, consistency, and predictability across our portfolio. In fact, we have amassed a comprehensive list of globally recognized accreditations as I showed earlier, which allows us to provide detailed documentation with your results and incorporate internationally recognized PT and CRM into your quality programs.

(15:21):
Now that we have looked at the official definition of a certified reference material and delved into the certificate of analysis, let's look to understand certified reference materials and their importance to your quality management system. In order to deliver more confidence, a lab needs to maintain a robust and sustainable QC program. Quality control generally applies to four basic functions of the analytical process: method development, staff training, ongoing performance, and corrective action.

(15:59):
Certified reference materials play a critical role in this and are often referred to as QC samples. To list some of the benefits or highlights of CRMs is that they have known concentrations of various analytes. We are an ISO 17034 accredited manufacturer of reference materials. Our CRMs are analytically verified by ERA's in-house laboratory. Values for analytes are assigned based on weights and measures. They're manufactured using NIST traceable balances and calibrated class A glassware, traceable to a SI unit established by means of an unbroken chain of calibrations or comparisons, linking them to relevant primary standards of the SI units of measurements.

(16:55):
We have multiple lots in stock and they are accompanied with a certificate of analysis. CRMs are a necessary component for validating your processes and training analysts for the evolving PFAS methods. And ERA offers several PFAS-certified reference materials amenable to multiple methods to help your lab with these challenges. CRMs are used to evaluate measurement accuracy on a routine basis. Additionally, listed here, are some of the common uses of CRMs. On the next slides, we will look at each of these more closely.

(17:37):
Let's look at uses of certified reference materials. Certified reference materials should be used when implementing a new method in the laboratory. They're helpful in determining the linear range of the method, the types of matrices that the method works with, as well as other conditions such as preservatives and hold times. If the laboratory is evaluating different columns for chromatography method or sample preparation procedures, CRMs play a critical role in these efforts.

(18:11):
Additionally, it's important to determine the ruggedness of the method. This involves making slight changes to the method criteria. For example, adjusting the drying temperature or time by varying amounts, using a slightly higher-lower concentration of acid during the preparation, things like that, to determine how critical each step is in the process. This allows the lab to write their procedures with the appropriate level of specificity. When a new method is being rolled out, a new analyst is being trained.

(18:45):
CRMs offer an opportunity to ensure successful training. An experienced analyst can walk a trainee through the analytical process using a CRM, and when the new analyst is ready to begin working on their own, a suite of different CRMs can provide valuable experience, once trained and functioning independently. Monitoring of CRM results during a probation can allow managers to identify and correct any bad habits before they become ingrained. Most laboratories are required to document the training effectiveness and capability of their analyst.

(19:25):
Using blind CRMs or PTs is an ideal way to do this. It provides an independent and traceable way to document this requirement. Each analyst should be tested upon training and annually after that. Records of the analyst's results, their certificates of analysis and an evaluation of their performance should be documented and kept on file. If the analyst does not pass the blind sample, corrective action should be performed, possibly including additional training and another demonstration of capability sample analyzed.

(20:03):
CRMs are great for monitoring ongoing performance. With so many variables involved in every analysis, only a CRM well-designed and taken through the entire analytical process provides the ability to monitor method performance in real time. CRMs are ideal for internal digestion and to determine extraction efficiency. By using a CRM, you can break down matrix components and recover analytes of interest. Without proper standards labs may report inaccurate measurements that wrongly quantify analyte concentrations. CRMs can be used routinely for calibration as the CRM is a trusted source and analytically traceable to a NIST standard reference material.

(20:52):
CRMs can be used for continuing calibration verification, as they can be the same source as calibration, are analyzed at routine intervals, and you can check for analytical drift. CRMs can also be used for independent calibration verification. They can be independent of the calibration source and are generally used for mid-calibration range. ICV recoveries can be used for control charting, where the percent recoveries are plotted over time and the results can be applied to preventative action or to implement corrective action.

(21:32):
This documentation is critical for corrective action and to monitor effectiveness. Let's take a closer look at control charting on the next slide. Ongoing performance can be monitored with control charting. On this slide, we are plotting how a process changes over time. Control charts, also known as process behavior charts are used to determine if a process is in a state of control. Basically a statistical process control tool. It is more appropriate to say that the control charts are the graphical device for statistical process monitoring.

(22:12):
On the X-axis, we have time, and on the Y-axis we have percent recovery. We show the upper warning limit, lower warning limit ,upper and lower control limits. Control limits, also known as natural process limits are horizontal lines drawn on a statistical process control chart, usually at a distance of plus or minus three standard deviations of the plotted statistic from the statistic's mean. Control limits define the area three standard deviations on either side of the centerline or mean of data plotted on a control chart.

(22:52):
Don't confuse control limits with specification limits. Control limits reflect the expected variation in the data. Warning limits define the area two standard deviations on either side of the mean. CRMs and control charting can help determine variations or if a process analyte instrument performance has changed over time and the need for corrective action. Another use of CRMs is corrective action. When a sample fails, time and money are lost. The use of CRMs can help mitigate this. We want to reduce reruns and maximize profitability.

(23:35):
Corrective action indicators can be anything from a failed PT to data outside the control chart limits. Once an indicator has been realized, the corrective action process is set into motion. This includes root cause analysis to determine the source of failure. Is it the machine, the method or the analyst? Once this has been identified, corrections are implemented. The best way to confirm if the corrections are appropriate and effective is to analyze CRMs along with long-term control charting.

(24:10):
Inconsistent laboratory results require error identification and remediation. CRMs are most effective for corrective action. Without CRMs, laboratory measurements cannot be benchmarked to certified values. CRMs allow laboratories to identify their source of error, free of internal bias and implement corrective action. PFAS analysis is not easy, therefore, the use of accredited CRMs and PTs is crucial in maximizing sample throughput and data reliability. The benefits of using CRMs is that CRMs provide the reference or traceability to a known value. The quality of the CRM directly affects the value of the data a laboratory provides, and a questionable CRM is a broken link. Without a quality CRM, any analysis is only an opinion.

(25:14):
Both CRMs and proficiency testing are critical for quality management systems and especially for maintaining accreditation and seeking new accreditation. So let's talk about proficiency testing and how it aids in validating methods and demonstrating your lab's competency for the new PFAS methods.

(25:35):
What is proficiency testing? Proficiency testing is the use of inter-laboratory comparisons as part of an assessment of performance. Proficiency testing programs require the laboratory to analyze unknown samples using a standard, national, or specified method within a specific timeframe. Participation in many cases is a requirement for license or accreditation of the laboratory and often required by customers of laboratory data. One of the primary uses of PT schemes is to assess laboratory's ability and competency to perform analytical tests.

(26:17):
PTs are globally recognized as a critical component to qualifying laboratory data quality and comparability. Credibility is key when it comes to laboratory performance. One of the best indicators of high laboratory quality is successful performance in an external PT program. It is also an integral component of laboratory accreditation and key to demonstrating your lab's expertise to customers. ERA'S experienced team with deep industry expertise is here to help you achieve and manage accreditation with our PFAS PT samples. Success in the next quarter of a century will be defined by those labs that can analyze and interpret data in a way in which it will add value to the products and services they provide. PT equals independent evaluation of performance and a way to demonstrate your lab's expertise.

(27:17):
Though CRMs are traditionally thought of first, when talking about quality management systems, PTs can be a valuable addition to the process. ERA has many tools on our eDATA informatics platform that allows labs to use PTs for more than just accreditation, from risk analysis to method optimization and performance monitoring. A well-designed PT gives data users greater confidence in a laboratory's analytical results. In comparison with other laboratories, can identify opportunities for continual improvement. PT allows a lab to differentiate themselves from others.

(28:00):
I would be remiss if I didn't mention Quik Response. Quik Response or QR is proficiency testing on demand. QRs return results within minutes of entering your study data. There's no waiting and no wondering and no worrying. Just results for critical evaluations. They're available anytime during the year. They do not have study open or close dates. Therefore, QRs are ideal for situations when you need a PT result in the middle of a study, or when you need to demonstrate corrective action.

 

(28:32):
We maintain a complete lineup of PFAS QRs to allow you to swiftly expand your scope of accreditation. Now that we have navigated through the accreditation process, the use of CRMs to validate your processes, demonstrate analyst competency, add to your scope of accreditation and document your commitment to quality for the new PFAS methods, I would like to introduce our PFAS product line. With these products, you can add to your scope of accreditation and accomplish the tasks outlined today. Shown here is the complete family of PFAS products offered by Waters ERA. Our soil, drinking water and wastewater product families.

(29:14):
We are geared up to help our customers navigate the ever-changing field of PFAS analysis with innovative and timely products to help them achieve accreditation. And in providing these products and services, our mission is to help analytical laboratories across the world improve the quality of their operations. Currently, there are no national or federal regulations in place for PFAS wastewater. Certain states, however, do require testing for PFAS and wastewater. The main focus thus far has been on drinking water, but that is expected to change. Emerging regulations are expected for PFAS testing, both drinking water and wastewater in the US, with the validation of EPA Method 1633 and ASTM method, DA-42121. With that in mind, Waters ERA's reformulated PFAS product portfolio is streamlined for these emerging methods and regulations.

(30:10):
The wastewater and drinking water products are available now. Our newest member to the family, PFAS in Soil, PT is available for the January soil 125 study beginning January 22, 2024. The CRM is available now and the QR will be available March 15, 2024. All PTs are available as quarterly studies. CRMs for quality assurance applications, and Quik Response for PT on demand. ERA will continue to add to our portfolio with other 1633 method matrices and routine use standards.

(30:53):
Before the summary slide to follow, I will wrap up today's talk with a few interesting facts on ERA's history with PFAS. ERA began manufacturing PFAS water supply and soil products in 2017, and PFAS wastewater in 2019. In the earlier years, participation was low as labs were just being introduced to PFAS. However, PFAS has increasingly become of concern for health reasons, therefore leading to calls for more stringent regulations and monitoring. And as you can see from the plot, study participation has grown because of it and we do not anticipate that changing, most notable, an uptick in wastewater testing in 2023, despite the lack of regulations to date.

(31:41):
Also, I need to mention that 2023 data is year-to-date. At the time of publication of this slide, our fourth quarter studies had not closed. When introduced the PTs were offered biannually, but that has since changed to quarterly to keep up with demand. In addition to our PFAS product portfolio, ERA manufactured the samples for the multi-lab validation of methods 1633. ERA has helped hundreds of labs navigate the PFAS, PT, and CRM world, and we are excited to partner with you.

(32:20):
In summary, the importance of good data cannot be overemphasized. Accurate measurements and defensible data are the drivers for any quality-conscious laboratory. And the use of CRMs and participation in PT can only help improve laboratory performance. And we are here to help laboratories achieve and manage accreditation and advance their quality management programs for the new PFAS methods. Waters ERA continues to expand our PFAS product line and study availability to keep pace with evolving analytical methods and needs of testing laboratories. With that, I thank you all for your time today and look forward to Q&A.

Nicole Cotta (33:10):
All right, thank you very much, Christy. And I will advance to our next question and then I'll give everyone a few minutes to answer it. This one is, does your laboratory use certified reference material? And there's only three options, so should be a pretty easy one. So I'll give everyone some time to think about that one and respond. And meanwhile also, if you have some questions you would like to submit in the Q&A, we have several of those in there already. So once I give some time for the poll question, we'll look at the results and then we'll move on to the Q&A section of the webinar.

(34:18):
All right, let's see what we got. So an even more dominant answer this time. So 72% of your laboratories always use CRMs for one of the various reasons that Christy just talked about. Very few don't today, but I'm sure there is probably some opportunity in the future.