Optimizing Manufacturing Performance

𝐈𝐒𝐀-𝟗𝟓 has been the longstanding defacto model for how information flow between enterprise and control systems within a manufacturing environment. This standard sets a baseline for terminology, hierarchy models, functional data flow models, object models, and even operational models. As technology has changed, so must our models. Today's Industry 4.0 technologies (most notably IIoT in this case) have created an entirely different way of networking mostly based on publication & subscription instead of the traditional point-to-point communication. This allows every device to be able to communicate directly with every other device, changing the infrastructure away from “hierarchical layers”. However, the idea of functional layers is still very relevant! 𝐖𝐡𝐞𝐫𝐞 𝐚𝐫𝐞 𝐭𝐡𝐢𝐧𝐠𝐬 𝐠𝐨𝐢𝐧𝐠? A “Flatter” version of the ISA-95 model with more connection options.  This allows for new levels of process integration across production and business functions, but unfortunately can cause friction between IT and OT teams if not properly addressed, governed, and managed. For more information, check out CESMII’s Conrad Leiva' article in the Journal of Advanced Manufacturing and Processing on the first principles of smart manufacturing addressing this very topic: https://lnkd.in/g7EDMKXx How are you seeing the ISA-95 model be modified to meet the needs of Industry 4.0? #Industry40 ******************************************** • Follow #JeffWinterInsights to stay current on Industry 4.0 and other cool tech trends • Ring the 🔔 for notifications!

Transformation thrives when people are empowered to make the most of technology. 🚀 My recent visit to the Bosch production facility for automotive and eBike drives in Miskolc, Hungary, showcased this perfectly. I was deeply impressed to see firsthand how their progress in digitalization and the implementation of the Bosch Manufacturing and Logistics Platform (BMLP) is reshaping their manufacturing operations. BMLP is a globally standardized, open IT platform that connects all stages of production and logistics. During an insightful plant tour, I observed a successful example of how the platform leads to significant improvements in efficiency, quality, and data transparency across the plant. What stood out most was seeing the passionate and enthusiastic team at Miskolc leverage this technology in action and achieving great results towards operational excellence. Here are three key areas where BMLP is contributing to the plant’s digital transformation success, powered by our NEXEED IAS: 1️⃣ Enhanced Efficiency & Reduced Downtime: The module Shopfloor Management enables a closed PDCA cycle in production by consequent integration of all relevant information in one system. This leads to quick reaction in case of deviations to minimize downtimes and safeguard the daily performance targets.   2️⃣ Improved Product Quality: Continuous monitoring throughout production stages helps the team identify issues early, ensuring top-tier quality while driving process improvements.   3️⃣ Change Management: Change management plays a crucial role in digital transformation within a plant. As seen in Miskolc, effectively managing change ensures that the workforce is engaged, and equipped to embrace new technologies, driving sustainable success. In Miskolc we have seen solutions using gamification that help to involve all associates, making the transition both engaging and effective.   I was also excited to see AI in action with a live demo of 8D Analysis using GenAI, cutting failure analysis time by half. By automating the root cause analysis process, engineers are now spending less time on administrative tasks and more on proactive problem-solving – a great example of how technology empowers people. Beyond the production lines, the most rewarding part of the visit was engaging with the team. Their passion for digitalization, commitment to upskilling, and their drive for innovation truly brought home the message: technology is only as strong as the people behind it. A special thank you to the entire Miskolc team for the inspiring discussions and warm welcome – along with Volker Schilling, Klaus Maeder, Joerg Klingler, Volker Schiek, Norbert Jung, Stephan Brand, Aemen Bouafif, and everyone who joined us on this great trip. I’m excited to see what’s next on this incredible digitalization journey!

( very Important Topic CIP VS SIP ) 🧼 CIP vs. SIP – What’s the Difference in Pharma Manufacturing? hashtag #ThePharmaUniversity hashtag #PharmaUni hashtag #CIP hashtag #SIP hashtag #GMPCompliance hashtag #SterileManufacturing In pharmaceutical production, equipment must be both clean and sterile. But cleaning and sterilization are NOT the same — and each plays a critical role. Let’s break it down: ⸻ ✅ CIP – Cleaning-In-Place CIP stands for Cleaning-In-Place. It’s an automated method to remove product residues and contaminants from internal surfaces like tanks, piping, and bioreactors. • Uses water and chemical detergents • Focuses on physical cleanliness • Typical cycle: Pre-rinse → Detergent wash → Final rinse • Validation checks: Visual inspection, rinse sample analysis ⸻ ✅ SIP – Steam-In-Place SIP means Steam-In-Place. It’s the process of sterilizing cleaned equipment by injecting saturated steam — without disassembly. • Uses clean steam at high temperatures (~121°C or higher) • Targets microbial destruction (bacteria, spores) • Typical cycle: Preheat → Steam exposure → Controlled cooling • Validation checks: Temperature mapping, Biological Indicators (BIs) ⸻ 🧠 Simple Way to Remember It: • CIP = Clean the dirt. • SIP = Kill the germs. You can have equipment that’s clean — but not sterile. That’s why both CIP and SIP are critical for GMP and aseptic manufacturing. ⸻ ⚡ Why It Matters: Poorly executed CIP can leave residues → affecting product quality. Poorly executed SIP can leave viable microbes → risking patient safety. Both must be validated independently to meet FDA, EMA, and Annex 1 expectations.

Frantic SKU proliferation bleeds profit and cash. This is how to do SKU optimization in 7 steps: 1️⃣ Collect and Clean Data ↳ Compile accurate sales, inventory, and profitability data to ensure a solid start for analysis & decision-making 2️⃣ Run Portfolio Segmentation ↳ Segment SKUs based on performance, profit, volume, and value to prioritize efforts on the most impactful products 3️⃣ Identify Non-Performing & Low-Value SKUs ↳ Find SKUs that overlap, cannibalize sales, have low turnover or gross margin for potential elimination 4️⃣ Align with Sales, Marketing, and Finance ↳ Discuss and align with sales, finance & marketing during S&OP to ensure critical customer SKUs aren’t impacted during rationalization 5️⃣ Reach Consensus & Assess Impact ↳ Align with all stakeholders in that product footprint. Ensure that rationalization doesn't create any bottlenecks or disruptions 6️⃣ Communicate the changes proactively ↳ Ensure all teams and key customers are informed about SKU changes and provide alternatives where necessary 7️⃣ Rationalize SKUs ↳ Eliminate or consolidate underperforming SKUs to streamline your portfolio and reduce complexity Any others to add?

Manufacturing processes are often plagued by inefficiency.   Here's why:   Manufacturers cling to old batch habits. ___   Batch Production is a traditional manufacturing method where identical or similar items are produced in batches before moving on to the next step.   Some manufacturers argue that large batches balance workloads and minimize changeovers.   But data often shows otherwise.   Overlong production runs cause overproduction. Operators lose focus working on large batches while equipment drifts out of standards between changeovers.   Main drawbacks:   -Piles of WIP inventory waiting for the next step -Defects hide among the batches -Inefficient space management -Uneven workflow -Long lead times   Those lead to:   -Some stations being overloaded, others waiting -Low responsiveness to customer demand -More scrap and rework -Higher carrying costs -Facility costs up   Switching to One-Piece Flow can bring relief.    Workstations are arranged so that products can flow one at a time through each process step, making changeovers quick and routine.   Main advantages:   +High customer responsiveness +Minimal work-in-process inventory +Quality issues are detected immediately +Reduced wasted space and material handling +Easy to level load production to match takt time   The selection between batch processing and one-piece flow can significantly impact quality, productivity, and lead time in a manufacturing process.   P.S. Some case studies show improvements in labour productivity of 50% or more. Lead times can drop by 80%. And quality can approach Six Sigma.

Bridging the "Manufacturing Valley of Death." If you're building a hardware startup, you already know: prototyping is hard, but scaling to production is where most ventures die. After helping dozens of hardware founders, I've seen one stage consistently kill great products: the transition from prototype to mass production. Why is this stage so so so brutal? You’re stuck in manufacturing no-man’s-land: ✅ Too big for prototype shops (their unit costs explode beyond 100 units). ✅ Too small for traditional contract manufacturers (they want 10,000+ units). ✅ Facing a 5–10x cost jump for tooling, molds, and compliance testing. ✅ Every delay cascades—supply chain hiccups, redesigns, and cash burn pile up fast. 1 day becomes 1 week becomes 1 month and so on... This is the "Valley of Death"—where startups hemorrhage money, time, and morale before reaching real customers. How to Survive (and Even Thrive, maybe): 1️⃣ Find a "Bridge" Manufacturer Look for CMs specializing in low-to-mid volume (500–10k units) with soft tooling or modular assembly. 2️⃣ Use Hybrid Prototyping Combine 3D printing, CNC, and hand assembly to defer expensive tooling until you validate demand. 3️⃣ Secure Flexible Funding Crowdfunding, pre-orders, or strategic investors who understand hardware’s scaling risks. 4️⃣ Design for Manufacturing (DFM) EARLY Involve manufacturing experts before your first prototype to avoid costly redesigns later. 5️⃣ Expect (and Budget For) Delays Assume your first production run will have 30% higher costs and 2x the timeline you planned. The Bottom Line: Crossing the hardware "Valley of Death" requires planning, partnerships, and patience. The startups that survive are the ones who: Treat scaling as a core risk (not an afterthought). Raise more capital than they think they’ll need (because they will). Build relationships with manufacturers before they’re desperate. If you’re in this phase now—keep pushing. The other side is worth it. What is your best tip for surviving the manufacturing valley of death? #Manufacturing #Electronics #Nearshoring #ContractManufacturing

Sustainability in the Value Chain 🌍 Sustainability needs to be integrated across the entire value chain to ensure long term business performance, risk management, and resilience. Addressing impacts stage by stage creates consistency and measurable outcomes. Design and R&D define the overall footprint of products. Integration of lifecycle assessments, durability, modularity, and recyclability ensures that innovation aligns with low carbon and regenerative pathways. Raw material sourcing requires sustainability criteria at the core. Renewable, recycled, and certified inputs combined with supplier due diligence on human rights, climate, and biodiversity reduce exposure to systemic risks. Production systems must embed sustainability through renewable energy deployment, water stewardship, waste minimization, and closed loop processes. Reliable labor, health, and safety standards are essential for operational stability. Logistics and distribution strategies benefit from sustainability integration through low carbon transport, optimized routing, and packaging solutions designed for reuse and resource efficiency. The use phase requires products built for efficiency, repairability, and extended lifecycles. Leasing, sharing, and product as a service models illustrate how sustainability principles extend value creation. End of life management integrates sustainability through take back programs, resale and repair channels, advanced recycling, and landfill alternatives such as composting and industrial reuse. Circular loops reinforce integration by closing resource flows, using recovered materials as feedstock, adopting secondary raw materials, and building industrial symbiosis partnerships supported by clear metrics. Cross cutting enablers such as governance structures, digital traceability, green finance, and workforce engagement ensure accountability and alignment with strategic priorities. Sustainability integrated across all phases of the value chain transforms operations from incremental measures into a comprehensive framework that drives competitiveness and long term value. #sustainability #business #sustainable #esg

𝗧𝗼𝘆𝗼𝘁𝗮'𝘀 𝗛𝗶𝗱𝗱𝗲𝗻 𝗦𝘁𝗿𝗲𝗻𝗴𝘁𝗵: 𝟵𝟱% 𝗼𝗳 𝗣𝗿𝗼𝗳𝗶𝘁𝘀 𝗗𝗲𝘀𝗶𝗴𝗻𝗲𝗱 𝗶𝗻 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 Why can't other automakers surpass Toyota despite mastering its production system? Since 1980s, manufacturers worldwide have benchmarked Toyota Production System (TPS). Production lead times now match Toyota's, and TPS elements became global standards. Yet Toyota maintains overwhelming advantage. Why? 𝗦𝗮𝗸𝗮𝗶'𝘀 𝗕𝗿𝗲𝗮𝗸𝘁𝗵𝗿𝗼𝘂𝗴𝗵 𝗗𝗶𝘀𝗰𝗼𝘃𝗲𝗿𝘆 Takao Sakai reveals: "95% 𝘰𝘧 𝘛𝘰𝘺𝘰𝘵𝘢'𝘴 𝘱𝘳𝘰𝘧𝘪𝘵𝘴 𝘢𝘳𝘦 𝘥𝘦𝘵𝘦𝘳𝘮𝘪𝘯𝘦𝘥 𝘪𝘯 𝘵𝘩𝘦 𝘱𝘳𝘰𝘥𝘶𝘤𝘵 𝘥𝘦𝘷𝘦𝘭𝘰𝘱𝘮𝘦𝘯𝘵 𝘱𝘩𝘢𝘴𝘦, 𝘯𝘰𝘵 𝘱𝘳𝘰𝘥𝘶𝘤𝘵𝘪𝘰𝘯." This challenges everything we thought about Toyota's success. Toyota's philosophy: "𝗽𝗿𝗼𝗱𝘂𝗰𝗶𝗻𝗴 𝘀𝗲𝗹𝗹𝗮𝗯𝗹𝗲 𝗽𝗿𝗼𝗱𝘂𝗰𝘁𝘀 𝗶𝗻 𝘁𝗵𝗲 𝗿𝗶𝗴𝗵𝘁 𝗼𝗿𝗱𝗲𝗿, 𝗾𝘂𝗮𝗻𝘁𝗶𝘁𝘆, 𝘁𝗶𝗺𝗶𝗻𝗴." -𝗧𝗣𝗗 (𝗧𝗼𝘆𝗼𝘁𝗮 𝗣𝗿𝗼𝗱𝘂𝗰𝘁 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁) creates "sellable products" -𝗧𝗣𝗦 handles "producing efficiently" Since 1970, TPD's profit contribution exceeded TPS. By late 1980s, Toyota achieved 48-month development lead times—12 months shorter than competitors, developing twice as many models with half the engineering hours. The Prius's 12-month development exemplified this mastery. 𝗧𝗵𝗲 𝟵𝟱% 𝗥𝘂𝗹𝗲: 𝗗𝗲𝘀𝗶𝗴𝗻 𝗗𝗲𝘁𝗲𝗿𝗺𝗶𝗻𝗲𝘀 𝗘𝘃𝗲𝗿𝘆𝘁𝗵𝗶𝗻𝗴 Toyota's Chief Engineers are "product presidents" responsible for consumer value, profit margins, and the technology to realize both—like Steve Jobs, designers in the broadest sense. Sakai's key insight: Value and cost are determined in early design stages. Later changes become impossible—like changing Christmas dinner after chopping ingredients. Companies like Sharp (acquired by Foxconn) and Toshiba (accounting scandals) lost humility to learn, mirroring American auto industry's decline. Jeffrey Liker identified Toyota's advantage: treating development as a standardized process with PDCA cycles and waste elimination. 𝗧𝗵𝗲 𝗨𝗹𝘁𝗶𝗺𝗮𝘁𝗲 𝗟𝗲𝘀𝘀𝗼𝗻 Prius chief engineer Takeshi Uchiyamada brought all teams together in "Obeya" for transparency and speed—contributing to 12-month development success. Old Mikawa* saying: "Making things that don't sell is a crime." 𝗦𝗮𝗸𝗮𝗶'𝘀 𝗰𝗼𝗻𝗰𝗹𝘂𝘀𝗶𝗼𝗻:  𝗧𝗣𝗦 𝘄𝗶𝘁𝗵𝗼𝘂𝘁 𝗧𝗣𝗗 𝗹𝗲𝗮𝗱𝘀 𝗻𝗼𝘄𝗵𝗲𝗿𝗲. When 95% of profits are determined before production begins, real competitive advantage lies in superior product development systems, not manufacturing efficiency. 𝗤𝘂𝗲𝘀𝘁𝗶𝗼𝗻 𝗳𝗼𝗿 𝗿𝗲𝗳𝗹𝗲𝗰𝘁𝗶𝗼𝗻:  -What percentage of your organization's resources and leadership attention goes to product development versus production optimization? -Are you designing tomorrow's success or just perfecting yesterday's processes? *Mikawa: historical region in eastern Aichi Prefecture where Toyota is headquartered #Takao_Sakai #Toyota_Product_Development_System #Lean_Product_Process_Development

In an automobile manufacturing industry, maintaining the Cost of Quality (CoQ) involves a balanced approach between preventing defects, monitoring quality during production, and addressing any failures as efficiently as possible. Here are strategies tailored to an automobile manufacturing setting like HMCL Niloy Bangladesh Ltd(Hero Motorcycle Manufacturing plant). 1. Invest in Prevention to Minimize Failures Prevention is the most cost-effective way to maintain quality. This focuses on avoiding defects from occurring by designing robust processes and systems. a. Supplier Quality Management for development strong relationships. b. Process Design for use advanced quality planning (AQP) and design for manufacturability(DFM). c. Employee Training for continuous training for employees on quality standards. d. Preventive Maintenance and Regular maintenance of machines and equipment to prevent breakdowns and increase efficiency. 2. Efficient Appraisal Systems Automated Inspection Systems: Use AI-driven or computer-vision inspection systems to monitor components for defects in real-time, reducing manual inspection costs. Statistical Process Control (SPC): Use SPC tools to monitor production processes and detect any variances early, allowing for corrective action before defects occur. In-Line Quality Control: Implement in-line inspections, testing, and gauging to identify defects as they occur, rather than at the end of production, saving rework costs. 3. Minimize Internal Failure Costs Internal failure costs arise from defects identified before the product reaches the customer. Root Cause Analysis: Use methods like the 5 Whys to identify and eliminate the root cause of defects, preventing recurrence. Lean Manufacturing Techniques: Implement lean methods such as Six Sigma, 5S, or Kaizen to reduce waste, optimize workflows, and eliminate non-value-adding activities that lead to defects. 4. Control External Failure Costs External failure costs occur when a defective product reaches the customer Product Testing and Validation: Ensure comprehensive final testing of vehicles, including endurance and environmental testing, before they are shipped to customers Field Data Collection and Analysis: Use data from warranty claims, customer complaints, and field failures to identify trends and areas for improvement in future production runs. Proactive Customer Service: A strong customer service system can quickly address complaints, reduce the impact of defects, and preserve brand reputation. 5. Utilize Data-Driven Quality Management Quality Management system (QMS): Implement a robust QMS to track quality data across the product lifecycle, in-process inspections, and customer feedback. 6. Cross-functional Collaboration Quality management is not the responsibility of the quality control team alone. Collaborate across departments—R&D, production, procurement, and customer service—to ensure that quality is embedded throughout the product lifecycle.

PROCESS AUDIT CHECKLIST (COMMON POINTS) IN MANUFACTURING SECTOR: 1. Process Control Are standard operating procedures (SOPs) available and followed? Is process capability (Cp, Cpk) monitored and within acceptable limits? Are control charts used for critical process parameters? Is there evidence of regular calibration of equipment and gauges? Are process changes documented and approved through change control? 2. Material Handling & Storage Are materials labeled correctly (name, batch, status)? Is FIFO (First-In-First-Out) or FEFO (First-Expiry-First-Out) followed? Are storage conditions (temp, humidity) monitored and maintained? Are rejected or non-conforming materials segregated and labeled? 3. Operator Competency & Safety Are operators trained and certified for the tasks they perform? Are safety PPEs being worn and used correctly? Are safety instructions and emergency procedures visible? Is there a system for reporting and investigating near-misses and incidents? 4. Equipment Management Is there a preventive maintenance schedule and is it being followed? Are breakdowns recorded and analyzed for recurrence? Are start-up and shutdown procedures standardized? Are critical spare parts available and tracked? 5. Quality Assurance Are in-process inspections conducted as per the control plan? Are inspection tools calibrated and used properly? Are quality issues tracked using root cause analysis tools (5 Why, Fishbone)? Are quality records complete and traceable? 6. Production & Planning Is actual vs planned production tracked? Are downtimes recorded with reasons? Is the takt time, cycle time, and lead time monitored? Are WIP levels controlled and visualized (kanban, signage)? 7. Waste Management & 5S Is workplace organization (5S) maintained? Are waste bins labeled and segregated? Are daily 5S audits conducted and actioned? Are there visible signs of lean practices (kaizen, visual boards, etc.)? 8. Tooling & Fixtures Are tools and fixtures stored properly with visual controls? Are they identified and logged for use and maintenance? Is there a system for tool calibration and wear tracking? 9. Documentation & Records Are process-related documents current and controlled? Are logs (production, quality, maintenance) filled accurately? Are version-controlled work instructions available at workstations? 10. Environmental & Regulatory Compliance Are emissions, effluents, and noise levels monitored and controlled? Is compliance with environmental regulations documented? Are MSDS (Material Safety Data Sheets) available and up-to-date?