PJLA Blog

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PJLA has gathered data from the ISO/IEC 17025 assessments held in 2023 for both testing and calibration laboratories. Here were the Top Ten Common Findings observed throughout the year:

10. 8.8 Internal Audits

9. PL-3 Uncertainty

8. 6.5 Metrological Traceability

7. 7.6 Evaluation of Measurement Uncertainty

6. 8.3 Control of Management System Documents

5. SOP-3 & The Use of Accreditation Symbols and References to Accreditation

4. PL-1 Proficiency Testing

3. 7.8 Reporting of Results

2. 6.4 Equipment

1. 7.2 Selection, Verification, and Validation of Methods

To watch our recent webinar with Michael Kramer, PJLA Calibration/Inspection Program Manager, where he goes into detail on each finding, please CLICK HERE.

For more information, please email [email protected] or call (248) 519-2603.

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Measurement Uncertainty refers to the doubt or range of values associated with a measurement result. It’s crucial for understanding the reliability of measurements. One approach that is used by calibration laboratories, and may be used for testing laboratories, includes these steps:

1. Identify the Measurement Process: Define the measurement process, including the instrument used, the quantity being measured, the measurement procedure, and any relevant environmental factors.
2. List Sources of Uncertainty: Identify all potential sources of uncertainty that can affect the measurement result. These can include instrument limitations, calibration errors, environmental conditions, operator skill, etc.
3. Classify Uncertainties: Categorize uncertainties into two main types: Type A and Type B.
• Type A: These are evaluated statistically based on a series of repeated measurements. Calculate the standard deviation or standard error of the mean to estimate uncertainty due to random fluctuations.
• Type B: These are assessed using other information sources like calibration certificates, manufacturer specifications, expert opinions, etc. They’re typically evaluated using probability distributions.
4. Quantify Type A Uncertainties: Perform multiple measurements of the same quantity under similar conditions. Calculate the mean and standard deviation of these measurements. The standard deviation represents the Type A uncertainty.
5. Quantify Type B Uncertainties: For each identified source of uncertainty, gather relevant data or information. Estimate the uncertainty contribution from each source using appropriate statistical methods or available information.
6. Combine Uncertainties: Combine Type A and Type B uncertainties to calculate the combined standard uncertainty. This is often done using the root-sum-square (RSS) method. Square each uncertainty component, sum them up, and take the square root of the sum.
7. Coverage Factor: Introduce a coverage factor (usually denoted as k) to account for the confidence level. For a Gaussian distribution (which is often assumed), a coverage factor of 2 corresponds to a 95% confidence level.
8. Expanded Uncertainty: Multiply the combined standard uncertainty by the coverage factor to obtain the expanded uncertainty. This provides a range within which the true value is likely to lie.
9. Report Uncertainty: Present the measurement result along with the expanded uncertainty. This communicates the reliability of the measurement to others.
10. Iterative Process: Measurement uncertainty assessment is not a one-time task. It should be periodically reviewed and updated as new information or data becomes available, or if the measurement process changes.
11. Documentation: Keep comprehensive records of the measurement process, sources of uncertainty, calculations, and any assumptions made during the assessment. This documentation is crucial for traceability and repeatability.

Testing laboratories often find this approach is not practical. Testing laboratories may choose to use a variety of data-driven approaches using laboratory data from calibrations, quality controls, or validation.

Some of the common approaches using laboratory data include:

• NORDTEST NT TR 537 – “Handbook for calculation of measurement uncertainty in environmental laboratories”
• ISO 21748 – “Guidance for the use of repeatability, reproducibility and trueness estimates in measurement uncertainty estimation”
• ISO 11352 – “Water quality – Estimation of measurement uncertainty based on validation and quality control data”

There are two points for testing laboratories to note: 1) These approaches do not identify the major sources of error, as required by the standard and 2) That single value may not define the uncertainty of a method when using one of these approaches. To address the first point, consider listing or using a fishbone diagram to identify the major sources or error. The considerations in addressing the second include the evaluating the impact over the range of the test and the understanding the impacts of different sample preparations of the items or matrices involved.

Remember that measurement uncertainty assessment is both a scientific and mathematical process. It requires a thorough understanding of the measurement process, statistical methods, and relevant data sources.

For more information, please email [email protected] or call (248) 519-2603.

Want more information on Measurement Uncertainty? Join PJLA and Dr. Susan Audino for a complimentary webinar on Tuesday, February 20, 2024 – 1:00pm ET. She will be presenting Measurement Uncertainty and Decision Rules: Why Do They Matter?

To download this QuickStart Guide to Measurement Uncertainty, please CLICK HERE.

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Embarking on your first accreditation assessment can be a daunting task, much like stepping into the kitchen to prepare a new and complex dish. However, with the right ingredients and a well-thought-out recipe, success is possible. In this guide, we will outline the step-by-step recipe to ensure smooth and successful preparation for your first accreditation assessment.

Ingredients:

1. Knowledge Base: Gather all relevant information about the accreditation process. Understand the standards, criteria, and expectations set by the accrediting body.
2. Documentation: Ensure all necessary documentation is in order. This may include policies, procedures, and evidence of compliance. Proper documentation is the foundation of a successful accreditation assessment.
3. Team Collaboration & Training: Establish a cohesive team. Assign responsibilities to team members based on their expertise. Ensure that your team is well-trained and up to date on relevant skills.
4. Action Plan: Develop an action plan based on the findings from mock assessments. Your organization should strive for continuous enhancement of processes and procedures.

Instructions:

1. Start Early: Begin preparations well in advance of the assessment date. Give yourself ample time to address any unforeseen challenges.
2. Gather Information & Documentation: Collect all necessary information about the accreditation process from your chosen accreditation body. Understand the expectations and requirements thoroughly. Ensure all required documentation is complete and organized, which is crucial for a strong foundation during the assessment.
3. Develop an Action Plan: Develop an action plan based on the lessons learned from mock assessments.
4. Foster Team Collaboration: Assign roles and responsibilities to team members based on their strengths.
5. Invest in Training and Development: Devote time for training and development to enhance the skills of your team. A well-prepared team is essential for accreditation success.
6. Review and Reflect: Review your preparations, reflect on the process, and make any necessary adjustments. Ensure everything is in order for the assessment.

By following this step-by-step recipe, you are well on your way to preparing for a successful accreditation assessment. Bon appétit to your accreditation journey!

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In the dynamic world of accreditation, the significance of outstanding customer service cannot be overstated. A stellar example of this is Sean Donnellan, a National Project Manager at Perry Johnson Laboratory Accreditation, Inc. (PJLA).

Accreditation is more than just a procedural checklist; it’s a collaborative journey between the accreditation body and the organization seeking recognition. Sean Donnellan understands this well, bringing a human touch to the often technical and complex process of accreditation.

Darlene Collis, Vice President of Quality at LINDFAST Solutions Group, shares her experience, highlighting the pivotal role Sean played in their accreditation journey. “I wanted to send a quick note to let you know how much we appreciate your National Project Manager, Sean Donnellan. He is a true asset to your organization,” expresses Collis.

LINDFAST Solutions Group recently faced the challenge of choosing an accreditation body (AB) for their lab’s ISO/IEC 17025 accreditation. Despite considering multiple ABs, Sean’s exceptional customer service set PJLA apart. “Sean’s customer service made my decision incredibly easy. Even after we signed our contract to proceed with PJLA, Sean was there anytime myself or our Lab Manager called, and that is a huge deal to us,” Darlene notes.

Exceptional customer service goes beyond individual transactions; it establishes a foundation for long-term partnerships. PJLA’s commitment to providing this level of service contributes to the overall success and reputation of our accreditation body.

In the world of accreditation, PJLA continues to stand out as a beacon of exceptional customer service. Our Program Managers and support staff are the definition of dedication, providing prompt responsiveness and a collaborative approach that make PJLA shine. Through Darlene Collis’s testimonial, we can witness firsthand the profound impact that outstanding customer service can have on an organization’s accreditation journey.

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Matthew Sica, a Technical Program Manager at Perry Johnson Laboratory Accreditation, Inc. (PJLA), recently hosted an informative webinar focused on the integration of Department of Energy Consolidated Audit Program – Accreditation Program (DOECAP-AP) with existing Department of Defense Environmental Laboratory Accreditation Program (DoD ELAP) accreditation. The session aimed to help laboratories understand the specific requirements of DOECAP-AP and determine suitability for pursuing accreditation.

PJLA plays a major role in various accreditation domains, including testing, calibration, medical laboratories, reference material producers, and inspection bodies. PJLA’s accreditations also extend to government programs like the FDA Laboratory Accreditation for Analyses of Food (LAAF), FDA Accreditation Scheme for Conformity Assessment (ASCA), along with DoD ELAP and DOECAP-AP.

The presentation delved into specific DOECAP-AP requirements, elucidating areas where the program differs from DoD-ELAP. Notably, Sica highlighted the alignment between DOECAP-AP and the TNI 2016 standard, indicating that over 90% of DOECAP-AP criteria overlap with DoD ELAP accreditation. Sica outlined specific clauses unique to DOECAP-AP, focusing on proficiency testing, technical and quality management responsibilities, safety inspections, record-keeping, and hazardous material management.

Key points included the necessity for a proficient technical and quality management team, safety inspection protocols, detailed record-keeping with customer notifications, documentation of deviations from procedures, and stringent waste management and health & safety practices. These points ensure compliance with federal and state regulations, minimize risks, and guarantee the maintenance of a safe working environment.

The presentation concluded with a PowerPoint slide breaking down DOECAP-AP’s unique requirements. A PDF version of that slide is available upon request via email ([email protected]). Acknowledgments were also extended to Steve Clark and Alyssa Wingard from the U.S. Department of Energy for the review of our presentation and for giving PJLA the opportunity to present on this topic.

Want more information on bridging the gap between DoD ELAP and DOECAP-AP? Reach out to PJLA today! Let us help evaluate your readiness and suitability for pursuing DOECAP-AP. Email us at [email protected] or call (248) 519-2603.

To watch the full webinar, head over to the PJLA YouTube channel here: https://www.youtube.com/watch?v=xqFCEkW0VKk

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In the realm of food safety, the discourse surrounding Rapid Microbiological Methods (RMM) has been both progressive and contentious. The debate centers on whether these methods, once hailed for their efficiency in pathogen detection, remain indispensable. The landscape has transformed significantly over the years, with an increasing reliance on outsourcing pathogen samples due to safety concerns inherent in in-plant food laboratories.

The growth of RMM has been remarkable, evolving over the past two decades to offer quicker turnaround times, enhancing production efficiency. As highlighted in a recent survey of 250+ global food processors, the adoption of RMM has surged, with PCR, immunoassays, and automated bioburden testing becoming commonplace. This paradigm shift allowed microbiology tests, once taking several days, to be completed in mere hours, reducing holding times and enhancing logistics.

However, despite this growth, there’s been a substantial move towards outsourcing pathogen samples, stemming from the inherent risks associated with in-house analysis. This trend, particularly pronounced in North America and Europe, cites both the availability of qualified labs and risk mitigation as driving factors. The cost differential between in-house and outsourced analysis, although higher, underscores the prioritization of risk reduction over expense.

Notably, this shift has led to a decline in the number of in-plant laboratories, with many companies choosing to outsource non-pathogen microbiology testing as well. The survey data revealed that a majority of U.S. companies no longer operate in-house labs, and those that do often outsource their pathogen samples to meet customer demands for third-party results. In contrast, international companies with in-house labs often outsource fewer samples, primarily for verification purposes or when encountering uncommon pathogens beyond their analytical capabilities.

The ever-evolving technology of RMM continues to shape the narrative of food safety practices. Contact PJLA today to get started on your journey to accreditation. Email us at [email protected] or call (248) 519-2603 to speak to a Program Manager in your area.

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Perry Johnson Laboratory Accreditation, Inc. (PJLA) joyfully welcomed assessors back to Troy, Michigan, for our first in-person Annual Training since December 2019. The gathering, held on December 7th and 8th, marked a pivotal moment, fostering an atmosphere for teamwork and professional growth.

Tracy Szerszen, Tamara Norris, Doug Berg, Matthew Sica, Julie Snelling, Leeza Akimenko, and Mike Kramer diligently educated PJLA’s core group of assessors on a diverse array of topics, ranging from common findings and program changes to the latest updates on relevant standards and programs.

One of the highlights on the agenda was an enlightening FDA LAAF update, shedding light on critical developments in the field. Additionally, the discussion on Lessons Learned from the DoD/DOE Annual Meeting provided valuable insights into best practices and emerging trends. The session on The Future of Cannabis Testing offered a glimpse into what is happening in this rapidly evolving sector, igniting discussions on improvement and compliance within the cannabis testing accreditation domain.

Amidst the training sessions, PJLA took a moment to honor two of its shining stars, Tamara Norris, and Eddie Clemmons, by presenting them with Employee of the Year and Assessor of the Year. Their dedication, tireless efforts, and exceptional service has left an indelible mark on our company. Their commitment to excellence serves as an inspiration to their peers and stands as a testament to PJLA’s core values.

Overall, the return to in-person gatherings not only facilitated an exchange of new ideas but also rekindled the sense of community among PJLA managers, staff, and assessors. The camaraderie during this event will undoubtedly contribute to further collaboration and advancement within PJLA in 2024 and beyond.

Contact PJLA today to get started on your journey to accreditation. Email us at [email protected] or call (248) 519-2603 to speak to a Program Manager in your area.

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In the constantly evolving landscape of the laboratory industry, staying attuned to current trends and foreseeing future developments is paramount for success. Today, we’ll explore five prominent shifts shaping the industry and how they impact the dynamics of hospital-based laboratories.

1. Consolidation of Systems: The trend of smaller healthcare entities merging into larger systems is reshaping the industry. This consolidation streamlines operations and serves as a lifeline for struggling independents, paving the way for dominant health systems.
2. Increase in Employed Providers: More healthcare providers are affiliating with larger systems, altering traditional business models. This shift grants them access to integrated support systems, influencing their engagement with laboratory services.
3. Staffing Shortages and Innovative Solutions: Shortages in lab personnel prompt creative solutions such as automation and upskilling programs for existing staff, maximizing efficiency without significantly expanding the workforce.
4. Digital Pathology and AI: Integrating digital pathology with AI offers hospitals specialized expertise and advanced analysis tools for better patient outcomes. Investing in these technologies proves beneficial for future healthcare practices.
5. Patient Consumerism: Patients increasingly engage in at-home testing for various health screenings. Offering user-friendly apps for result viewing and streamlining access to records and scheduling enhances patient satisfaction and loyalty.

To thrive in this dynamic environment, laboratories must adapt by embracing patient-centric approaches. Establishing a presence on electronic medical record portals, enabling convenient scheduling, registration, and result access are crucial steps toward enhancing patient satisfaction and loyalty. Beyond merely observing trends, adaptability and creativity are indispensable traits for effective laboratory leadership in today’s dynamic healthcare landscape.

Contact PJLA today to get started on your journey to accreditation. Email us at [email protected] or call (248) 519-2603 to speak to a Program Manager in your area.

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Call For Presenters: TNI Hosting PFAS Virtual Workshop
Wednesday, February 7, 2024, 10:00am – 4:00pm ET

Guidance published by the US EPA, the Department of Defense, and several states indicate many precautions should be taken when collecting samples and field blanks are an essential component of the analytical workflow. Now that thousands of field blanks have been analyzed, is there any data to support this costly endeavor? The NELAC Institute (TNI) is holding this virtual workshop to explore best practices for sampling drinking water and wastewater for PFAS and the analysis of the associated field blanks.

TNI is soliciting speakers to address topics such as:

• How prevalent are PFAS in field blanks?
• Is there any evidence that shows such precautions are not required?
• How do laboratories analyze their work flows to process field blanks in the most expeditious manner?
• Is there any evidence that all of the precautions such as clothing, makeup, sunscreen, and food are required to minimize false positive results?

Following the presentations, the presenters will come back together as a panel to continue discussions. The presentations and summary of the panel discussion will be provided to key regulators to give them input into modifying their guidance.

If you are interested in presenting, please RSVP by December 18, 2023 to Ilona Taunton making sure to include your time preference as well as your name and title.

Important Dates:

• RSVP by Monday, December 18, 2023
• Abstracts due Friday, January 12, 2024
• Final presentations due Wednesday, January 31, 2024

You can contact Ilona Taunton or Tracy Szerszen – NEFAP Executive Committee Chair with any questions.

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The holiday season is a time for joy, togetherness, and of course, delicious meals shared with loved ones. As you embark on creating culinary delights, it is crucial to prioritize safety in the kitchen. Here are some tips to keep in mind for a safe and stress-free cooking experience during the season.

1. Practice Fire Safety: Keep flammable items such as kitchen towels, oven mitts, and wooden utensils away from the stove. Install a smoke alarm nearby and have a fire extinguisher on-hand in case of emergencies.
2. Proper Food Handling: Food safety is vital during holiday meal preparations. Thaw frozen foods safely in the refrigerator or under cold running water to prevent bacterial growth. Use separate cutting boards for raw meats and vegetables to avoid cross-contamination, and wash hands frequently when handling different food items.
3. Educate and Involve Everyone: If you’re cooking with family or friends, brief them on kitchen safety guidelines. Encourage open communication about safety measures to ensure everyone is on the same page.
4. First Aid Preparedness: Have a stocked first aid kit readily available in the kitchen. Familiarize yourself with basic first aid procedures for minor burns, cuts, or other kitchen-related injuries.

By prioritizing safety measures in the kitchen, you can create a secure environment for everyone. Embrace the joy of entertaining family while keeping safety at the forefront of your holiday festivities.

Wishing you a safe and delightful holiday season!

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