Luke Sansby’s Post

In the laboratory, quality is not about methods, instruments, or final results. A lot of it comes down to everyday habits. Simple things like: • checking labels carefully • keeping clear records • reviewing work before moving on • staying organised • asking when unsure These may seen small, but they make a big difference over time. Good quality systems are important, but daily habits are what bring those systems to life in real work. For me, building strong lab habits is one of the most practical ways to support consistency and quality. #QualityControl #LaboratoryLeadership #ProductionChemist #LaboratoryTraining #Quality #GoodLaboratoryPractice #QC

𝗬𝗼𝘂 𝗰𝗼𝗻𝘁𝗿𝗼𝗹 𝗽𝗮𝗿𝘁𝗶𝗰𝗹𝗲𝘀 𝘁𝗼 𝗜𝗦𝗢 𝟱. 𝗬𝗼𝘂 𝘃𝗮𝗹𝗶𝗱𝗮𝘁𝗲 𝗛𝗘𝗣𝗔 𝗳𝗶𝗹𝘁𝗲𝗿𝘀. But how many people are inside your 𝗮𝘀𝗲𝗽𝘁𝗶𝗰 𝗮𝗿𝗲𝗮 right now? 7? 9? 12? Most plants don’t know- not in real time. We monitor rooms, equipment, and environment with precision. Yet one of the biggest variables affecting cleanroom performance “𝗵𝘂𝗺𝗮𝗻 𝗼𝗰𝗰𝘂𝗽𝗮𝗻𝗰𝘆” is still tracked on paper logs or not tracked at all. What I’ve seen often: Operator enters. Supervisor follows. QA walks in. Maintenance steps in. Nobody is counting occupancy or duration. Then an 𝗘𝗠 𝗲𝘅𝗰𝘂𝗿𝘀𝗶𝗼𝗻 happens. The investigation starts: 𝗪𝗵𝗮𝘁 𝗰𝗵𝗮𝗻𝗴𝗲𝗱? Everything looks fine. HVAC is fine. Pressure differentials held. Gowning records complete. But then come the real questions: 𝗛𝗼𝘄 𝗺𝗮𝗻𝘆 𝗽𝗲𝗼𝗽𝗹𝗲 𝘄𝗲𝗿𝗲 𝗶𝗻 𝘁𝗵𝗲 𝗿𝗼𝗼𝗺 𝗱𝘂𝗿𝗶𝗻𝗴 𝘀𝗮𝗺𝗽𝗹𝗶𝗻𝗴? Open the logbook. Good luck. Entry times are there. Exit times are blank. Handwriting is unclear. Someone forgot to sign out. 𝗛𝗼𝘄 𝗹𝗼𝗻𝗴 𝗵𝗮𝗱 𝗲𝗮𝗰𝗵 𝗽𝗲𝗿𝘀𝗼𝗻 𝗯𝗲𝗲𝗻 𝗶𝗻𝘀𝗶𝗱𝗲? Most SOPs cap cleanroom stay at 4–5 hours. Beyond that, gown integrity and fatigue become risks. If someone entered at 6:00 AM and is still inside at 11:30 AM- that’s a deviation. Then comes the cycle: Deviation report. Impact assessment. CAPA. All because nobody 𝗳𝗹𝗮𝗴𝗴𝗲𝗱 a 5.5-hour stay in real time. The cleanroom doesn’t fail. The process of controlling who enters it and how long they stay does. #Pharma #AsepticManufacturing #Cleanroom #SterilityAssurance #EM #PharmaOperations #Compliance

This is Berlin Packaging's global commitment to our Quality Service Division (QSD) with our first Asia Pacific regional QC lab in Qingdao, China. This provides us with a fully staffed lab with the best equipment for both proactive and reactive quality services. This equipment is also use to help our New Product Development engineers work on developmental challenges to ensure that our customers globally get the right product in the right specification.

Inside the Lab: What Happens to Your Samples Once They Arrive? When you send samples to an ISO 17025 accredited testing laboratory, you are trusting that they will be handled with care, consistency and technical control from the moment they arrive. As specialists in RPE testing, we know that every sample represents more than just a product. It may form part of a compliance programme, product development project, quality investigation or customer assurance process. When samples arrive at the lab, the first step is identification, labelling and booking into our laboratory system. Each item is carefully labelled and formally logged, linking it to the customer, project, test requirements and any supporting information provided. This ensures clear traceability from receipt through to testing, reporting and return or disposal, where applicable. We then carry out a detailed inspection. This allows us to check the condition of the samples as received, confirm what has been supplied and identify anything that may need clarification before testing begins. Once the samples have been booked in and inspected, we notify the customer that they have been received, giving reassurance that the items are safely with us and that the laboratory process is underway. This step also allows us to communicate any questions or comments we might have, following the inspection. Before any testing is planned, our team takes time to familiarise themselves with the product and the Instructions for Use. For RPE, understanding the design, intended use, markings, components and user instructions is essential. It helps ensure that testing is approached in the correct context and that any observations are made with a full understanding of the product. It may sound simple, but these early stages are vital. Labelling, booking in, inspection and review all support traceability, impartiality and reliable testing outcomes. They are part of the disciplined laboratory approach that underpins confidence in every result we issue. At GCS, being trusted does not begin with the final report. It begins the moment your samples arrive. #ProductTesting #TypeApproval #SampleControl #Traceability

'Inside the Lab' is our behind-the-scenes series, designed to open the doors on what really happens in a laboratory. Its purpose is simple: to build trust and transparency by showing the processes, people, and standards that ensure accuracy, safety, and quality. By sharing real insights from within the lab environment, we aim to demystify complex procedures, challenge common misconceptions and give you a clearer understanding of how results are achieved.

🔬 Most people don't think about this — but it could save a life.In a rapid diagnostics laboratory, a result takes minutes to produce.But the work behind that result? That's hours of quality control.As a Quality Control Officer, here's what happens before a single patient result is ever reported: 1. Every new lot is tested against known controls before use. One bad reagent = dozens of false results.2. Calibration checks — Instruments don't stay accurate on their own. We verify, document, and recalibrate — every shift.3.  Internal Quality Controls (IQC) — We run high, normal, and low controls to confirm the assay is performing within acceptable limits. If they fail, the run stops. Full stop.4. Westgard Rules — These statistical rules aren't optional guidelines. They're our early warning system for detecting systematic errors before they reach clinicians.5. Proficiency Testing — We participate in external programs to benchmark our results against other labs globally. A rapid diagnostic test may take 15 minutes to run.The QC infrastructure behind it took years to build. 🧠 Quality is not a department. It's a culture. 👇 Drop it in the comments. Let's talk about it.#LaboratoryMedicine #QualityControl #RapidDiagnostics #MedicalLaboratory #LabLife #PatientSafety #IVD #ClinicalLaboratory #QualityManagement

What Is ISO 17025 Calibration? 📌 Read Full Guide: https://lnkd.in/gY3fAnMM Topic: What is ISO 17025 calibration? In this article, you’ll get: ✅ ISO 17025 calibration basics. ✅ Importance of traceability and competence. ✅ Practical understanding for calibration and quality systems. 🎯 Especially useful for: 👷 Calibration engineers 🏭 QA/QC teams 📚 Students learning calibration standards 💬 ISO 17025 supports confidence in calibration results and measurement quality. 👉 WhatsApp Channel: https://lnkd.in/gWWc92mk 👉 Telegram Channel: https://lnkd.in/gZFKyM6x 👉 LinkedIn Group: https://lnkd.in/g_vxxqzY 👉 Website: https://lnkd.in/g4YMbjZG #ISO17025 #Calibration #Traceability #QualityControl #Instrumentation #Metrology #IndustrialAutomation #ProcessIndustry #EngineeringGuide #TechnicalGuide #CalibrationLab #MeasurementAccuracy #QAQC #Standards #LaboratoryCalibration 📖 Read the full guide here: https://lnkd.in/gY3fAnMM

What Is ISO 17025 Calibration? 📌 Read Full Guide: https://lnkd.in/g5sGUgnu Topic: What is ISO 17025 calibration? In this article, you’ll get: ✅ ISO 17025 calibration basics. ✅ Importance of traceability and competence. ✅ Practical understanding for calibration and quality systems. 🎯 Especially useful for: 👷 Calibration engineers 🏭 QA/QC teams 📚 Students learning calibration standards 💬 ISO 17025 supports confidence in calibration results and measurement quality. 👉 WhatsApp Channel: https://lnkd.in/geca_TM8 👉 Telegram Channel: https://lnkd.in/guRD76dX 👉 LinkedIn Group: https://lnkd.in/g9C33tPT 👉 Website: https://lnkd.in/gX2XpRBj #ISO17025 #Calibration #Traceability #QualityControl #Instrumentation #Metrology #IndustrialAutomation #ProcessIndustry #EngineeringGuide #TechnicalGuide #CalibrationLab #MeasurementAccuracy #QAQC #Standards #LaboratoryCalibration 📖 Read the full guide here: https://lnkd.in/g5sGUgnu

How confident are you in the data coming out of your instruments? Most lab managers focus on keeping equipment running. Calibration gets scheduled, checked off, and forgotten until something goes wrong. But calibration isn't just a compliance checkbox; it's the foundation your data sits on. We've walked into labs where a pH meter hadn't been calibrated in over a year, or where a balance was drifting by a margin that quietly invalidated weeks of results. No alarms, no obvious failures. Just bad data building up in the background. The tricky part is that out-of-calibration equipment doesn't announce itself. Results look normal. Researchers trust the numbers. It takes a failed audit or a reproducibility problem to trace it back to the instrument. ISO 17025, GLP, and GMP all treat calibration traceability as non-negotiable for good reason. But you don't need a regulated environment to care about measurement integrity. If you're making decisions based on what your instruments tell you, those numbers have to be right. When was the last time you reviewed calibration intervals across your entire lab, not just the equipment your QA team flagged? #LabEquipment #Calibration #MeasurementIntegrity #LifeSciences #BridgePathScientific

 Importance of External Controls vs Local (Internal) Setups in Laboratories 🔹 What are External Controls? Also called External Quality Assessment (EQA) / Proficiency Testing (PT) Provided by independent organizations like College of American Pathologists or World Health Organization programs Lab receives unknown samples → tests them → results are compared with other labs 🔹 What are Local (Internal) Controls? Known as Internal Quality Control (IQC) Performed daily inside the lab using control materials Ensures instruments and reagents are working properly Why External Controls are CRITICAL ✅ 1. Inter-Laboratory Accuracy Confirms your results match national/international standards ✅ 2. Detect Hidden Errors Identifies: Calibration bias Method errors Technician mistakes ✅ 3. Accreditation Requirement Essential for ISO 15189 compliance ✅ 4. Builds Trust Doctors rely more on labs validated through EQA 🏥 Local Setup Reality (PHC / Small Labs) Many labs rely ONLY on IQC due to: Cost issues Lack of EQA access Limited infrastructure 👉 Result: Acceptable for basic testing BUT risk of undetected systematic errors 🧠 Best Practice (Golden Rule) ✔ IQC = Daily monitoring ✔ EQA = Periodic validation 👉 Both are essential, not optional 📊 Simple Concept IQC = “Is my machine working today?” EQA = “Are my results correct compared to the world?”