The Laboratory Results Reporting Pathway Based on ISO 17025 Accurate and reliable results are the lifeline of any professional laboratory. But how can this process be made transparent and standardized? Here’s a quick guide to the laboratory results reporting pathway aligned with ISO 17025 principles, highlighting the distinct roles of analysts and lab specialists: 🔹 1. Precise Documentation from the Start Unique Sample Coding: Every sample is assigned a unique identity to ensure full traceability. Role of the Analyst: Analysts are responsible for performing the initial tests, recording the raw data, and ensuring proper documentation at this stage. 🔹 2. Entry into the Software Analyst's Responsibility: The analyst enters test results into the system, ensuring accuracy by cross-checking the data with raw records. Lab Specialist's Role: The lab specialist reviews the data entered into the system, identifies potential inconsistencies, and prepares the report for further review. 🔹 3. Recording in the Logbook Logbook Documentation: The printed report is signed by both the analyst and the lab specialist to confirm accuracy and compliance for each unit. The logbook acts as a centralized record for audits and ensures traceability for every step in the process. 🔹 4. Supervisor Review The supervisor examines the logbook entries and corresponding reports to validate results. Any discrepancies or unusual findings are flagged for further investigation. 🔹 5. Submission to the Laboratory Manager The lab specialist prepares the final report, which is then submitted to the laboratory manager along with any relevant interpretations or recommendations. 🔹 6. Archiving and Data Security All signed reports and logbook entries are securely archived to ensure compliance with standards and accessibility for future reference. Why Does This Process Matter? ✅ Role Clarity: Analysts, lab specialists, and supervisors each play critical and distinct roles in ensuring quality and reliability. ✅ Transparency: The logbook serves as an official record, backed by signed approvals. ✅ Standardization: Full compliance with ISO 17025 enhances operational efficiency and credibility. How does your laboratory define and manage roles in the results reporting process? Share your experiences and insights with me! #VeterinaryLaboratory #LaboratoryManagement #PoultryLaboratory #PoultryVeterinarian #ISO17025 #ISOprinciples #LaboratoryStandards #Logbook #LaboratoryAudit #Qualitycontrol #PoultrySerology #Feedanalysis #MicrobiologyLab
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Hear from Faz Jalali on what led him to start EHO Consulting with Alex Thompson. Reflecting on my career journey, I often contemplate the twists and turns that led me to where I am today. Like everyone who becomes a hazardous materials consultant, I 'fell' into it! At first, I didn't see its value, so I tried to leave the industry by expanding my knowledge and gaining qualifications in three other fields. But, it became apparent that the demand for my skills lay in the hazardous materials domain. So, rather than resisting hazmat consulting, I embraced it by embarking on another course: an MSc in occupational hygiene and toxicology (Yes, I've spent a lot of money on education!). I often share the importance of our role as hazardous materials consultants and occupational hygienists with new trainees. We're not just practitioners but guardians of health at work, preventing potential illnesses among workers exposed to dangerous chemicals and contaminants. While the impact of our efforts may only sometimes be apparent, we are, in essence, saving lives. I'm so proud of what Alex Thompson and I started seven years ago with EHO Consulting. We're both excited to keep growing the business while retaining our core values.
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3 Essential Skills Every Microbiologist Should Have And Why I Use Them Every Day! In the world of microbiology, certain skills can make all the difference. Here are three skills that I believe are essential—and how I use them to make a positive impact as a Microbiologist 📍Analytical Thinking 🧪 Microbiology is all about the details! Being able to analyze data thoroughly and spot even the smallest anomalies is crucial. Whether it’s tracking a potential contaminant or making sure standards are met, analytical thinking keep things on track. I’ve seen firsthand how a careful analysis can stop a problem before it grows, and this is a skill I use every day with purpose and passion. 📍Problem-Solving 🔍 Our field is full of surprises, and not all of them are welcome! Quick and effective problem-solving means identifying issues right away and coming up with solutions that prevent bigger challenges. From handling unexpected lab results to finding creative ways to improve quality control, my experience has taught me to keep a calm head and think two steps ahead. 📍Hands-On Lab Skills 🧫 Knowing how to handle lab equipment is like having a second language. Familiarity with tools like Eosin Methylene Blue Agar (EMB) helps me detect microbes accurately and keep products safe. Precision and technical skills ensure every test yields reliable results, which is a top priority in protecting public health. As a Microbiologist in the quality assurance department, I'm passionate about preventing food products from getting contaminated. #MicrobiologyAndFoodScience #FoodSafety #day11of20
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Importance of Pipette Precision in Analytical and Microbiological Laboratories 🔹 In analytical laboratories, pipette precision and accuracy are crucial for highly sensitive analyses where small errors can impact results significantly. 🔹 In microbiological laboratories, while precision is important, the margin of error may be slightly higher due to larger sample volumes in some assays. 🔹 Both types of laboratories require pipettes with high precision and accuracy, tailored to the specific needs of the analyses being conducted. 🔹 Regular calibration and maintenance of pipettes are essential to ensure reliable and accurate results in both analytical and microbiological settings. #LaboratoryScience #PrecisionPipetting #AnalyticalLab #MicrobiologyLab #QualityControl #Quality 🔬🧪🔍
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I started my pharma/biotech career many years ago in a CAP/CLIA lab, eventually moving from operations into quality assurance management. One of the routine activities we would do when the College of American Pathologists (CAP) would release their updated checklists was to perform a gap analysis against any new requirements and revisit any others to ensure we reflected our current practices. Each discipline supervisor/manager was asked to go item by item and fill in how the laboratory complied with each requirement on their portion of the checklists. We would then review their checklists together to ensure consensus. I'm certain this was common practice at most CAP-accredited laboratories, but realizing the potential benefits was crucial so that it wasn't relegated to just another checkbox exercise. This served as our storyboard in a way as it helped each department to be able to tell the story of how each requirement was met at our facilities. This was tremendously helpful when it came to facing auditors who would visit. Knowing compliance requirements is one thing, while knowing specifically how your organization meets those requirements is another. Being able to succinctly and cohesively speak about your procedures and processes during audits is incredibly impactful. What are some audit readiness and training strategies that you've seen or used that were successful? I expect these will be varied as every organization is different culturally and dependent on the services you are providing as well. #qualityassurance #regulatorycompliance
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<1117> MICROBIOLOGICAL BEST LABORATORY PRACTICES DOCUMENTATION 1- Documentation should be sufficient to demonstrate that the testing was performed in a laboratory and by methods that were under control. This includes, but is not limited to, documentation of the following: Microbiologist training and verification of proficiency Equipment validation, calibration, and maintenance Equipment performance during test (e.g., 24-hour/7-day chart recorders) Media preparation, sterility checks, and growth-promotion and selectivity capabilities Media inventory and control testing 2- Critical components of test conducted as specified by a procedure 3- Data and calculations verified 4- Reports reviewed by QAU or a qualified responsible manager Investigation of data deviations (if needed) #documentation #Microbiologist #Instrumentvalidation #instrumentqualification #dataanylysis #QA
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Fishbone (Ishikawa) Diagram in Pharmacovigilance – Case Study 📝 Case Example: An increase in data quality issues was identified in Individual Case Safety Reports (ICSRs). Here’s how the Fishbone (Ishikawa) Diagram was used to identify and resolve the problem. Categories & Findings: 🔍 Process: Lack of consistent review steps in case processing led to errors and inconsistencies. 👥 People: Insufficient training on data entry and case validation contributed to misunderstandings and mistakes in handling ICSRs. 🛠️ Tools: Outdated safety database software resulted in data entry errors and limited functionality, hindering effective case processing. 🏢 Environment: High workload and pressure on PV staff caused oversights and lapses in ensuring case quality. 📋 Methods: Lack of standardization in case review procedures meant that data quality checks were inconsistent across teams. Solution: To address these root causes, the following actions were taken: Standardize Case Review Processes: Implement clear SOPs for each step of case processing to maintain data quality. Database Upgrades: Update to a more reliable and user-friendly safety database to reduce data entry errors and improve workflow efficiency. Training & Development: Enhance training programs to strengthen data entry skills, case validation, and understanding of safety database functionalities. Using the Fishbone Diagram allowed the team to systematically examine the different categories contributing to data quality issues and develop targeted corrective actions to improve the overall PV process. Have you used Fishbone Diagrams in your PV practice to solve complex issues? Share your experiences! 👇 #Pharmacovigilance #FishboneDiagram #IshikawaDiagram #RootCauseAnalysis #DrugSafety #QualityManagement #Healthcare #DataQuality #ProcessImprovement #RiskManagement
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📢 𝗔𝘁 #𝗙𝗮𝗴𝗿𝗼𝗻, 𝗼𝘂𝗿 𝗽𝗲𝗼𝗽𝗹𝗲 𝗮𝗿𝗲 𝗰𝗼𝗻𝘁𝗶𝗻𝘂𝗼𝘂𝘀𝗹𝘆 𝗶𝗺𝗽𝗿𝗼𝘃𝗶𝗻𝗴 𝗮𝗻𝗱 𝗱𝗶𝘀𝗰𝗼𝘃𝗲𝗿𝗶𝗻𝗴 𝗻𝗲𝘄 𝘀𝗼𝗹𝘂𝘁𝗶𝗼𝗻𝘀, 𝗯𝗿𝗶𝗻𝗴𝗶𝗻𝗴 𝗾𝘂𝗮𝗹𝗶𝘁𝘆 𝗺𝗲𝗱𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀 𝘁𝗼 𝗼𝘂𝗿 𝗰𝘂𝘀𝘁𝗼𝗺𝗲𝗿𝘀 𝗮𝗻𝗱 𝗽𝗼𝘀𝗶𝘁𝗶𝘃𝗲𝗹𝘆 𝗶𝗺𝗽𝗮𝗰𝘁𝗶𝗻𝗴 𝗽𝗲𝗼𝗽𝗹𝗲’𝘀 𝗹𝗶𝘃𝗲𝘀. Meet Teresa Spann, Manager, Quality Control, North America at FSS! 𝗦𝗵𝗮𝗿𝗲 𝗮 𝗰𝗮𝗿𝗲𝗲𝗿 𝗮𝗰𝗵𝗶𝗲𝘃𝗲𝗺𝗲𝗻𝘁 𝗼𝗿 𝗺𝗶𝗹𝗲𝘀𝘁𝗼𝗻𝗲 𝘆𝗼𝘂'𝗿𝗲 𝗽𝗿𝗼𝘂𝗱 𝗼𝗳 𝘀𝗶𝗻𝗰𝗲 𝗷𝗼𝗶𝗻𝗶𝗻𝗴 𝘁𝗵𝗲 𝗙𝗮𝗴𝗿𝗼𝗻 𝘁𝗲𝗮𝗺. I manage a small team of QC personnel that completed all In House testing for sterility with no failures for 2023. They are all trained to use aseptic technique. Their work was observed for an FDA audit with no issues and internal audit with positive comments for consistency. I'm so proud of the work they did; they make my job easy! 𝗪𝗵𝗮𝘁'𝘀 𝗼𝗻𝗲 𝗽𝗶𝗲𝗰𝗲 𝗼𝗳 𝗰𝗮𝗿𝗲𝗲𝗿 𝗮𝗱𝘃𝗶𝗰𝗲 𝘆𝗼𝘂'𝗱 𝗴𝗶𝘃𝗲 𝘁𝗼 𝘆𝗼𝘂𝗿 𝗽𝗮𝘀𝘁 𝘀𝗲𝗹𝗳? I would tell my past self that an advanced college education is important but is not the only path to advancement. 𝗪𝗵𝗮𝘁'𝘀 𝘁𝗵𝗲 𝗺𝗼𝘀𝘁 𝗲𝘅𝗰𝗶𝘁𝗶𝗻𝗴 𝗮𝘀𝗽𝗲𝗰𝘁 𝗼𝗳 𝘆𝗼𝘂𝗿 𝗷𝗼𝗯 𝘁𝗵𝗮𝘁 𝗺𝗼𝘁𝗶𝘃𝗮𝘁𝗲𝘀 𝘆𝗼𝘂 𝗱𝗮𝗶𝗹𝘆? Working in an industry that is growing and has lots of challenges, but knowing that what we do, at the end of the day, saves lives is so powerful because you never know who will need what we make. 𝗪𝗵𝗮𝘁 𝗶𝘀 𝘆𝗼𝘂𝗿 𝗳𝗮𝘃𝗼𝗿𝗶𝘁𝗲 𝗙𝗮𝗴𝗿𝗼𝗻 𝗖𝗼𝗿𝗲 𝗩𝗮𝗹𝘂𝗲 𝗮𝗻𝗱 𝗙𝗮𝗺𝗶𝗹𝘆 𝗥𝘂𝗹𝗲? 𝗪𝗵𝘆? Quality is my favorite Fagron Core Value because this empowers me to direct staff with purpose. Transparency is my favorite Fagron Family Rule because it is nice to know that there is nothing to hide nor be afraid to ask. #503B #Fagron #MotivationalMonday #WeAreFagron #medications #pharmacy #team
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𝟴𝟳. 𝗛𝗼𝘄 𝘆𝗼𝘂𝗿 𝗰𝗼𝗻𝗰𝗹𝘂𝗱𝗶𝗻𝗴 𝘁𝗵𝗲𝗿𝗲 𝗶𝘀 𝗻𝗼 𝗹𝗮𝗯𝗼𝗿𝗮𝘁𝗼𝗿𝘆 𝗲𝗿𝗿𝗼𝗿 𝗶𝗻 𝘁𝗵𝗲 𝗺𝗶𝗰𝗿𝗼𝗯𝗶𝗼𝗹𝗼𝗴𝘆? 𝗵𝗼𝘄 𝘆𝗼𝘂𝗿 𝗶𝗻𝘃𝗲𝘀𝘁𝗶𝗴𝗮𝘁𝗶𝗼𝗻 𝗺𝗶𝗰𝗿𝗼 𝗮𝗻𝗮𝗹𝘆𝘀𝘁? 1. Ensure the analyst followed SOPs, and verify the method’s validation for reproducibility. 2. Review environmental monitoring records (temperature, humidity, air quality) to rule out contamination. 3. Confirm that equipment and materials were sterilized to prevent cross-contamination. 4. Verify the analyst’s training and observe their technique if needed for any procedural errors. 5. Check that samples were handled and stored properly, and that the media used was validated. 6. Review calibration and maintenance records for all equipment used in testing. 7. Perform a retest or parallel study with control samples to confirm the results’ accuracy. 8.Ensure there is no microbial growth on the negative control plates, confirming that the media and environment are not contaminated. Note: This post is intended to share my experience, and I respect CBE Pty Ltd’s intellectual property. If requested, I will promptly remove or adjust the content to ensure compliance with their policies. Source: CBE #microbiology #pharma #vijaykumarh
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My work got contaminated after several trials 🥹 I thought I had done a good job, but little did I know that my work would get contaminated. I was wondering what could have happened. So, after the whole process to get a pure culture, I still got it wrong 😔 I was frustrated and didn't know what to do. Only for me to discover that I didn't swab my bench properly before starting the isolation. I thought my bench was already clean because I used water to clean it and not alcohol. Ahhh, so this little mistake caused me to lose resources 😲 I had no choice but to start all over again, but this time, I made sure to swab my bench aseptically before starting. I made sure never to forget using Ethanol first before placing my cultures on the workbench. Yes, in science, it's normal to make mistakes, especially when working in the laboratory as a microbiologist. Most times, you can't avoid making a mistake; you will definitely make one. Aseptically swabbing your bench with Ethanol helps your work area to be sterile before carrying out any research in the laboratory. If you have been making such mistakes, I hope this helps you remember that before you start your bench work, your research area needs to be sterilized. Have you had such experience before in your niche or discipline? I would love to read them in the comment section #MicrobiologyAndFoodScience #AsepticTechniqueSterilization #LabMistakes #day18of20
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Aastrid Lifesciences Pvt. Ltd : Safety Week 2024 – 04 to 08 Mar 2024! During Safety Week at Aastrid we conduct training sessions, workshops, drills, and awareness campaigns to educate individuals about potential hazards and how to mitigate risks effectively. The purpose of Safety Week is to emphasize the importance of prioritizing safety measures to prevent accidents, injuries, and fatalities. These initiatives aim to instill a culture of safety consciousness and responsibility among the employees. By fostering a proactive approach to safety, Safety Week contributes to creating safer environments and reducing the incidence of accidents and injuries. #aastridlifesciences #pharmaintermediates #specialitychemicals #apiintermediates #researchanddevelopment #innovation #CDMO #CRO #safetyweek24
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