The Significance of Quality Control

The surprising truth about quality management: It's not just about ticking boxes, it's about building a quality mindset.👇 In my years as a QA consultant and employee, I’ve worked on hundreds of projects. I’ve seen how quality management impacts companies. But here’s a surprising truth: Quality management is more transformative than most people realize. Most times people think quality management is: 1. 𝗧𝗶𝗰𝗸𝗶𝗻𝗴 𝗕𝗼𝘅𝗲𝘀: ↳ They think it’s just about passing audits and meeting regulations. ↳ While important, it’s just the baseline. 2. 𝗙𝗶𝗻𝗱𝗶𝗻𝗴 𝗙𝗮𝘂𝗹𝘁𝘀: ↳ They assume it’s all about identifying defects. ↳ But identifying issues is just the starting point. 3. 𝗜𝗻𝘀𝗽𝗲𝗰𝘁𝗶𝗻𝗴 𝗙𝗶𝗻𝗮𝗹 𝗣𝗿𝗼𝗱𝘂𝗰𝘁𝘀: ↳ They see it as simply testing the end product. ↳ However, true quality starts much earlier in the process. But quality management actually is: 1. 𝗘𝗺𝗽𝗼𝘄𝗲𝗿𝗶𝗻𝗴 𝗧𝗲𝗮𝗺𝘀: ↳ It’s about involving and trusting your team in the quality process. ↳ This fosters ownership and accountability. 2. 𝗦𝗶𝗺𝗽𝗹𝗶𝗳𝘆𝗶𝗻𝗴 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻: ↳ It’s about creating clear, accessible procedures. ↳ This ensures consistency without overcomplication. 3. 𝗕𝘂𝗶𝗹𝗱𝗶𝗻𝗴 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗖𝘂𝗹𝘁𝘂𝗿𝗲: ↳ It’s about embedding quality in every aspect of the organization. ↳ This leads to sustainable, long-term success. 4. 𝗣𝗿𝗼𝗮𝗰𝘁𝗶𝘃𝗲 𝗥𝗶𝘀𝗸 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁: ↳ It’s about identifying and mitigating risks before they become issues. ↳ This helps prevent costly mistakes. 5. 𝗔𝗻𝗮𝗹𝘆𝘇𝗶𝗻𝗴 𝗗𝗮𝘁𝗮 𝗨𝘀𝗮𝗴𝗲 𝗮𝗻𝗱 𝗗𝗮𝘁𝗮 𝗤𝘂𝗮𝗹𝗶𝘁𝘆: ↳ It’s about using data to drive informed decisions. ↳ This ensures you’re constantly improving based on real insights. 6. 𝗙𝗼𝗰𝘂𝘀 𝗼𝗻 𝗧𝗿𝘂𝗲 𝗖𝘂𝘀𝘁𝗼𝗺𝗲𝗿 𝗡𝗲𝗲𝗱𝘀: ↳ It’s about aligning quality with what the customer actually values. ↳ This builds loyalty and satisfaction. 7. 𝗔𝗹𝗶𝗴𝗻𝗶𝗻𝗴 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 𝘄𝗶𝘁𝗵 𝗕𝘂𝘀𝗶𝗻𝗲𝘀𝘀 𝗚𝗼𝗮𝗹𝘀: ↳ It’s about ensuring compliance supports, not hinders, business objectives. ↳ This keeps quality and strategy in sync. 8. 𝗖𝗼𝗻𝘁𝗶𝗻𝘂𝗼𝘂𝘀 𝗜𝗺𝗽𝗿𝗼𝘃𝗲𝗺𝗲𝗻𝘁: ↳ It’s about always seeking ways to enhance processes and outcomes. ↳ This drives innovation and excellence. What are your thoughts on any of these? 💬 Remember, Quality management isn’t just a task. It is a mindset you must nurture as your business grows. P.S. ♻️ Share this to help your network understand the real value of quality management. ➕ Follow Harsh Thakkar for more on building quality into your process and systems.

❗⚠️ Why You Should Never Take a COA at Face Value: Lessons from a Recent FDA Warning Letter ⚠️❗ I want to highlight a critical takeaway from the recent US FDA warning letter issued to Dyno Manufacturing Inc. The letter underscores a recurring issue in our industry: relying solely on a Certificate of Analysis (COA) from a supplier without independently verifying the data. The FDA found that Dyno Manufacturing accepted COAs from their raw material suppliers without conducting their own identity testing or verifying the accuracy of the supplier’s results. This practice is explicitly called out as inadequate. 🤔 Why is this a problem? A COA is only as trustworthy as the processes and controls of the supplier issuing it. Without verification, you risk incorporating substandard or contaminated raw materials into your products. Regulatory agencies like the FDA expect manufacturers to independently verify the identity and quality of each batch of raw materials, not just rely on a piece of paper. 👍 What should you do instead? Implement a robust incoming material testing program-at minimum, verify the identity of each lot of raw material. Audit and qualify your suppliers regularly and test for additional quality attributes beyond identity. Treat the COA as a starting point, not the final word. Use it to inform your risk assessment, but always back it up with your own data. Quality assurance is not about paperwork-it’s about evidence. The FDA’s warning to Dyno Manufacturing is a stark reminder: trust, but always verify. Your brand’s reputation and consumer safety depend on it. #CosmeticChemist #CosmeticSafety #CosmeticScience #QualityControl #QualityAssurance #BusinessofBeauty US FDA Warning Letter to Dyno Manufacturing, Inc. - 700785 - 04/09/2025

Leveraging the Pareto Principle to Optimize Quality Outcomes: 1. Identifying Core Issues: Conduct a thorough analysis of defect trends and recurring quality challenges. Prioritize the 20% of issues that account for 80% of quality failures, focusing efforts on resolving the most impactful problems. 2. Root Cause Analysis: Go beyond mere symptomatic observation and delve deeper into underlying causes using advanced tools such as the "Five Whys" and Fishbone Diagrams. Target the critical few root causes rather than dispersing resources on peripheral issues, ensuring a concentrated approach to problem resolution. 3. Process Optimization: Streamline operational workflows by pinpointing and addressing the most significant process inefficiencies. Apply Lean and Six Sigma methodologies to systematically eliminate waste and optimize processes, ensuring a more effective production cycle. 4. Supplier Performance Management: Identify the 20% of suppliers responsible for the majority of defects and operational disruptions. Enhance supplier oversight through rigorous audits, stricter compliance checks, and fostering closer collaboration to elevate overall product quality. 5. Targeted Training & Development: Tailor training programs to address the most prevalent quality challenges faced by frontline workers and engineers. Ensure that skill development efforts are focused on equipping teams to handle the most critical aspects of quality control, thus driving tangible improvements. 6. Robust Monitoring & Control Mechanisms: Utilize real-time data dashboards to closely monitor key performance indicators (KPIs) that have the highest impact on quality. Implement automated alert systems to detect and address critical deviations promptly, reducing response time and maintaining high standards of quality. 7. Commitment to Continuous Improvement: Cultivate a Kaizen mindset within the organization, where small, incremental improvements, focused on key areas, result in significant long-term gains. Leverage the Plan-Do-Check-Act (PDCA) cycle to facilitate ongoing, iterative process enhancements, driving continuous refinement of operations. 8. Integration of Customer Feedback: Systematically analyze customer feedback and complaints to identify recurring issues that significantly affect satisfaction. Prioritize improvements that directly address the most frequent customer concerns, ensuring that product enhancements align with consumer expectations. Maximizing Results through Focused Effort: By concentrating efforts on the critical 20% of factors that drive 80% of outcomes, organizations can significantly improve efficiency, reduce defect rates, and elevate customer satisfaction. This targeted approach allows for the optimal allocation of resources, fostering sustainable improvements across the quality process. Reflection and Engagement: Have you successfully applied the Pareto Principle in your quality management systems?

In the pharmaceutical and medical device industries, ensuring the highest quality standards is not just a priority; it's a necessity. Quality assurance professionals play a pivotal role in maintaining these standards, and one of their most important tools is auditing. Quality audits can contribute to business performance in the following ways: 1. Ensuring Compliance: Quality audits verify that operations adhere to regulatory requirements. Compliance minimizes legal risks, ensuring business continuity. 2. Enhancing Product/Service Quality: Audits identify areas for improvement in manufacturing and production processes. Improved product/service quality leads to higher customer satisfaction and ensures patient safety. 3. Risk Mitigation: Audits uncover potential risks and vulnerabilities. Addressing these risks proactively prevents costly disruptions and higher costs later. 4. Process Optimization: Auditors identify inefficiencies and bottlenecks in operations. Optimized processes lead to cost savings and improved productivity. 5. Continuous Improvement: Audits foster a culture of continuous improvement. Regular assessments can drive innovation and better business practices. 6. Supplier Relationships: Audits assess the performance of suppliers and contractors. Strong supplier relationships ensure a consistent supply of high-quality materials and services. 7. Data-Driven Decision Making: Audits provide data and insights for informed decision-making. Data-driven strategies lead to better resource allocation and risk management. In a sector where lives depend on the highest standards, quality audits are not just a regulatory requirement; they are a strategic imperative. What are some other benefits you can think of? Please share your thoughts and ideas in the comments. #qualityassurance #regulatorycompliance #auditing

I can’t stress this enough: In the CPG world, quality isn't just important—it's absolutely crucial! 🌟 As a food entrepreneur, diving deep into quality through GFSI frameworks like BRCGS isn't merely ticking a box for compliance—it's a game changer. Here are couple of reasons why embracing these standards is so pivotal: - Compliance and Leadership: We are certified by BRCGS, which means we meet high standards, we only work with GFSI suppliers and lead the way in making excellent products. 🌟🌟 -Proactive and Responsive Systems: Our quality systems help us quickly fix any problems and prevent them from happening again. -Consistency and Trust: Each product we create is of the highest quality, which builds trust and loyalty with our customers. -Sustainability and Efficiency: Our approach to quality helps us use less and do more, which is good for both our business and the Earth. 🌍 -Community Impact: Our high standards do more than just help us sell products; they improve the lives of people in our community and encourage good practices. -Smooth Operations: Our strong quality systems create a smooth workflow, which helps our company operate better every day. How do you manage your quality systems at your company? Are you leveraging BRCGS or exploring other standards? Let’s exchange insights and drive our industries toward sustainable success!

What do ISO and Six Sigma mean in a global sourcing company? For most companies, ISO 9001 becomes a symbolic act A certificate on the wall A checklist passed during audits But rarely something woven into the daily rhythm of the business In a global sourcing company, that mindset is risky Why? Because we are managing 🌍 distributed execution Suppliers across regions Parts with tight tolerances Deadlines under constant time pressure Documentation accuracy for international buyers And layered risks, not all visible at first glance At FRIGATE, we decided early. If we treat ISO or Six Sigma as a paper exercise We will collapse under the complexity of global buyer demands So we went back to the ground level ☑️ Building CTQ trees based on real buyer expectations ☑️ Mapping SIPOC across every BU - Sales, Sourcing, KAM, Quality, Expediting ☑️ Embedding control points into supplier evaluation, monitored over time ☑️Using root cause tools like 5 Whys and Fishbone on non-conformances ☑️Designing registers that track live execution data, not static files ☑️Training teams to understand why each SOP exists, not just how to follow it And yes, I am running many of these trainings myself Not because a founder should micromanage, But I am already a certified lean, ISO and WPM auditor which I don't want to outsource. Also because as a systems company If we do not respect the system layer We risk making promises globally that we cannot deliver operationally 💡 Six Sigma teaches us Small variations left uncontrolled become large-scale failures 📋 ISO teaches us Document, monitor, improve or risk hidden blind spots In global sourcing, execution is no longer local It is multi-country, multi-standard, multi-stakeholder The companies that survive that complexity They are the ones doing the hard, detailed systems work that most others skip. That's the difference between a ok company, a good company and a great company. #ISO9001 #SixSigma #GlobalSourcing #SupplierManagement #ProcessImprovement #QualityControl #RootCauseAnalysis #SupplyChainExecution #ManufacturingSystems #OperationalExcellence

Let me tell you about the time I bought a one-way ticket to Shenzhen, China on a mission to save my startup. Here’s what happened: A few years into building my consumer brand, Syde, I began to run into several supply chain problems. Our defect rates were out of control and the flawed products were making their way into the hands of our customers. That couldn’t happen. When we attempted to get to the root of the problem, I quickly realized that our manufacturing relationships were a black box. There was no way we would be able to fix this issue without having a better understanding of our supplier’s relationship to the rest of our supply chain. So, I decided to do something crazy — I bought a one-way ticket to Shenzhen, China to figure things out. Once I arrived, I found an apartment, hired a translator, and then immediately got to work visiting all of our suppliers. Here’s what I learned: 🏭  The factories with more equipment, better processes, and systems could consistently produce higher quality products than those lacking these aspects. 🔎  The quality of a product depends on a few different facets: 1. Product development and specification: How the product is made, the process for manufacturing, and the product specification. 2. How the product is manufactured on the production line: A typical production line involves a series of spots, each one representing a small step in the manufacturing process. For each step, there are instructions for the workers detailing exactly what they need to do and the quality level expected. 👷  In the production line, there should be designated QC checkpoints that perform various tests and checks throughout the manufacturing process (QC can be costly, so many manufacturers often skimp on these processes). 🚧  The final inspection is the most important step in a QC process. This ensures that everything is packed right, labeled properly, and no mistakes have been made. 📋  Many workers doing QC are not familiar with the buyer's standards. They are simply given internal instructions. This means that the quality of the inspection becomes entirely dependent on the quality of the checklist. If the instructions are ever unclear, the inspector can make simple, yet crucial, mistakes (like misplacing labels). That’s why it's important to have an accountability layer *on top of* the internal instructions. It didn’t take long for me to identify the common denominator across all of the problems we were having back home — It all came down to quality. A great product is defined by an effective quality control process and consistent inspections. All it took was a few weeks in China for me to figure that out!

A January 23, 2025 article on Quality Magazine’s website entitled “Embedded Quality: Create Competitive Advantage and Customer Delight” includes excellent perspectives on companies’ relationships with their quality organizations, the importance of working closely with business partners from the earliest stages of product development and the quality function operating as a success-enabling partner. Author Nils Nugteren writes, “For chief quality leaders the main objective is to partner effectively with business leaders and help them not just build quality into what they’re trying to achieve, but also help them achieve their business outcomes.” Nugteren also points out how expectations for those in our profession have changed, saying “…quality leaders can impact not just compliance, but deliver results to shareholders, other stakeholders and most importantly to customers,” as well as facing dual “…pressure to reduce both the cost of poor quality and the cost of good quality.” The need to develop quantifiable metrics to ensure quality systems are performing as intended and are on a trajectory of continuous improvement is also emphasized in the article as a way to ensure an organization is enabling business success. The Quality & Regulatory Affairs (Q&RA) professionals at Thermo Fisher Scientific continue to strengthen what the article describes as a “culture where quality is not an afterthought or a checkbox but an intrinsic part of daily operations that contributes directly to business success.” #thermofisher #QualityProfessionals #QualityAssurance #RegulatoryAffairs #QARA #Regulatory #Quality #Compliance