Built-In-Quality is achieved through the use and implementation of lean manufacturing principles. Dr. Joseph M. Juran, a pioneer in modern quality management principles, created the Juran Trilogy. The Juran Trilogy focuses on long-term quality improvement through quality planning, quality control and continuous improvement. This presentation will focus on how effectively applying the Juran Trilogy can help an organization achieve the objective of Built-In-Quality.
The document discusses moving quality inspections earlier in the production process to reduce costs. It presents a model showing the distribution of quality costs throughout production, from development to after sales. The goal is to shift from a reactive, trust-based quality system to a proactive, fact-based one by building quality into decision making, supplier qualifications, and development processes. A five-level quality system maturity model ranges from local and random inspections to an intelligent system that integrates quality across the business through data-driven decision making, supplier audits, and clear quality performance goals.
Advanced Product Quality Planning (APQP) is a structured approach to product and process development that aims to ensure suppliers understand customer requirements and are able to meet them. It involves 5 phases - planning and defining the program, product design and development, process design and development, product and process validation, and feedback and assessment. The key goals of APQP are up-front quality planning, satisfying the customer, and supporting continual improvement. Common roadblocks to effective APQP implementation include a lack of management commitment, unclear responsibilities, and insufficient resources or knowledge.
The document discusses quality management systems and ISO 9001 standards. It outlines the key aspects of a quality management system including quality objectives, processes, reviews, facilities, documentation, training, and audits. It also describes how the company manages its quality management system through its quality policy statement, quality manual, and procedures like document control, record control, internal audits, non-conforming product control, corrective action, and preventive action. The benefits are highlighted as doing work safely, correctly, and within time limits through continuous improvement.
Six Sigma is a data-driven methodology for improving processes by reducing variation. It was developed by Motorola in the 1980s to help address quality issues that were causing them to lose market share to Japanese competitors. Motorola found that the Japanese companies had much lower variation in their production processes, allowing them to produce higher quality products at a lower cost. By implementing Six Sigma, Motorola was able to improve their processes, lower defects, and increase customer satisfaction, leading to billions of dollars in savings over time. The core of Six Sigma is reducing defects to 3.4 per million opportunities through the DMAIC process of Define, Measure, Analyze, Improve, and Control. It has now been adopted by many major companies
The document provides an overview of quality, including its history and importance. It discusses the evolution of quality practices from the Industrial Revolution through modern approaches like Total Quality Management and Six Sigma. Key figures who advanced quality concepts are also highlighted. The document then covers quality certifications, dimensions of quality, costs of quality, and problem-solving methodologies like the PDCA cycle.
The document provides an introduction and overview of the QC Story methodology, which is a 9-step problem solving technique used to examine facts and data around quality, productivity, cost, logistic, safety and other problems. It involves selecting a theme, justifying the choice, understanding the current situation, setting targets, analyzing causes, implementing corrective measures, confirming effects, standardizing solutions, and planning future actions. Each step is then described in more detail, outlining the key elements and process to be followed at that stage of the QC Story.
Advanced product quality planning (APQP) is a framework for developing new products with a focus on meeting customer requirements. It involves 5 phases - planning, product design, process design, validation, and feedback. Key aspects of APQP include establishing cross-functional teams, using tools like FMEAs to prevent issues, designing control plans and statistical process control methods, conducting validation trials, and promoting continuous improvement. APQP aims to standardize quality planning processes for increased collaboration with suppliers.
The document discusses moving quality inspections earlier in the production process to reduce costs. It presents a model showing the distribution of quality costs throughout production, from development to after sales. The goal is to shift from a reactive, trust-based quality system to a proactive, fact-based one by building quality into decision making, supplier qualifications, and development processes. A five-level quality system maturity model ranges from local and random inspections to an intelligent system that integrates quality across the business through data-driven decision making, supplier audits, and clear quality performance goals.
Advanced Product Quality Planning (APQP) is a structured approach to product and process development that aims to ensure suppliers understand customer requirements and are able to meet them. It involves 5 phases - planning and defining the program, product design and development, process design and development, product and process validation, and feedback and assessment. The key goals of APQP are up-front quality planning, satisfying the customer, and supporting continual improvement. Common roadblocks to effective APQP implementation include a lack of management commitment, unclear responsibilities, and insufficient resources or knowledge.
The document discusses quality management systems and ISO 9001 standards. It outlines the key aspects of a quality management system including quality objectives, processes, reviews, facilities, documentation, training, and audits. It also describes how the company manages its quality management system through its quality policy statement, quality manual, and procedures like document control, record control, internal audits, non-conforming product control, corrective action, and preventive action. The benefits are highlighted as doing work safely, correctly, and within time limits through continuous improvement.
Six Sigma is a data-driven methodology for improving processes by reducing variation. It was developed by Motorola in the 1980s to help address quality issues that were causing them to lose market share to Japanese competitors. Motorola found that the Japanese companies had much lower variation in their production processes, allowing them to produce higher quality products at a lower cost. By implementing Six Sigma, Motorola was able to improve their processes, lower defects, and increase customer satisfaction, leading to billions of dollars in savings over time. The core of Six Sigma is reducing defects to 3.4 per million opportunities through the DMAIC process of Define, Measure, Analyze, Improve, and Control. It has now been adopted by many major companies
The document provides an overview of quality, including its history and importance. It discusses the evolution of quality practices from the Industrial Revolution through modern approaches like Total Quality Management and Six Sigma. Key figures who advanced quality concepts are also highlighted. The document then covers quality certifications, dimensions of quality, costs of quality, and problem-solving methodologies like the PDCA cycle.
The document provides an introduction and overview of the QC Story methodology, which is a 9-step problem solving technique used to examine facts and data around quality, productivity, cost, logistic, safety and other problems. It involves selecting a theme, justifying the choice, understanding the current situation, setting targets, analyzing causes, implementing corrective measures, confirming effects, standardizing solutions, and planning future actions. Each step is then described in more detail, outlining the key elements and process to be followed at that stage of the QC Story.
Advanced product quality planning (APQP) is a framework for developing new products with a focus on meeting customer requirements. It involves 5 phases - planning, product design, process design, validation, and feedback. Key aspects of APQP include establishing cross-functional teams, using tools like FMEAs to prevent issues, designing control plans and statistical process control methods, conducting validation trials, and promoting continuous improvement. APQP aims to standardize quality planning processes for increased collaboration with suppliers.
The document provides an overview of Advanced Product Quality Planning (APQP) based on the AIAG reference manual. It discusses the objectives of APQP, which is a structured method for new product development to ensure customer satisfaction. The presentation outlines the 5 phases of APQP: 1) Plan and define program, 2) Product design and development, 3) Process design and development, 4) Product and process validation, and 5) Feedback, assessment and corrective action. Breakout sessions provide examples of applying APQP methodology to a new product development project. Key terms and an overview of the relationship between APQP and ISO/TS 16949 are also summarized.
The Seven Basic Tools of Quality (also known as 7 QC Tools) originated in Japan when the country was undergoing major quality revolution and had become a mandatory topic as part of Japanese’s industrial training program. These tools which comprised of simple graphical and statistical techniques were helpful in solving critical quality related issues. These tools were often referred as Seven Basics Tools of Quality because these tools could be implemented by any person with very basic training in statistics and were simple to apply to solve quality-related complex issues.
The document provides an overview of 7 quality control tools: Pareto diagram, stratification, scatter diagram, cause and effect diagram, histogram, check sheet, and control chart/graph. It describes each tool, including what they are, when they are used, and the typical results obtained from each tool. The tools are used to collect and analyze data, identify root causes, measure results, and help solve problems in quality control.
The document provides an overview of value stream mapping (VSM) process. It discusses defining the current state and future state maps which involve mapping the material and information flows, identifying value-added and non-value added activities, calculating metrics like cycle time and takt time, and developing an implementation plan to eliminate waste and create flow. The future state aims to optimize processes, improve flow, implement pull systems, and achieve continuous improvement through periodic reviews.
Poka Yoke refers to mistake-proofing methods used to eliminate human errors in manufacturing processes. It was developed in Japan in the 1960s as part of the Toyota Production System. There are various types of Poka Yoke including contact, counting, and motion-sequence methods. Poka Yoke aims to simplify processes, provide real-time feedback, and make it impossible to make mistakes. It can be implemented at any step where errors may occur and provides benefits such as low cost, quick feedback, and minimal supervision needs once established.
Quality in Manufacturing for Production & ManufacturingTimothy Wooi
This 1 day training program on the “Soft” TQM Concepts focus on Manufacturing Staff and Operators to equip Participants with a better understanding TQM and its practices and to understand why being responsible for Quality is so important as a mechanism to safe guard to Customer for receiving a Defect as well as to comply to Quality procedures..
The document describes the 8D Problem Solving process for addressing problems in organizations. The 8D process involves 8 disciplines (D0-D8) for defining the problem, identifying root causes, developing and verifying solutions, implementing corrective actions, and preventing recurrence. It aims to understand customer needs, gather details of issues, protect the customer, obtain management support, and recognize the project team upon completion. Following the 8D process can help organizations systematically solve problems and improve systems and processes.
This document discusses the concept of zero defects in manufacturing. It begins with an introduction to zero defects as a stretch goal to have no defects rather than just reducing defects over time. It then discusses some examples of companies that have achieved low defect rates. Several tools for achieving zero defects are mentioned, including mistake-proofing, statistical process control, design of experiments, and poka-yoke systems. The document argues that achieving very high quality levels like 99.99% defect-free can provide significant financial benefits in terms of reduced rework costs and increased profitability and competitiveness. It concludes that a zero defects approach adds value for customers and the business.
This document provides an overview of continuous improvement strategies like Kaizen, 5S, and the Toyota Production System (TPS). It discusses key aspects of each including:
- The 5 pillars of TPS: JIT, Jidoka, Kaizen, Heijunka, and respect for people.
- Components and benefits of 5S including sort, set in order, shine, standardize, and sustain. 5S aims to create a clean and organized workplace.
- Guidelines for implementing the different elements of 5S like sorting unnecessary items, clearly labeling storage areas, and establishing cleaning procedures and responsibilities.
- Using a PDCA approach for continuous 5S implementation including planning, doing, checking
The document discusses five core quality tools: APQP (Advanced Product Quality Planning), FMEA (Failure Modes and Effects Analysis), PPAP (Production Part Approval Process), MSA (Measurement Systems Analysis), and SPC (Statistical Process Control). It provides a brief overview of each tool, noting that APQP is used to develop products that satisfy customers, FMEA ensures potential problems are considered, PPAP ensures products meet specifications, MSA assesses measurement systems, and SPC enables process control and improvement. The document emphasizes that these five tools are considered core tools for quality management.
The document discusses Lean methodology which focuses on eliminating waste to produce high quality products faster and at lower cost. Lean aims to streamline processes through techniques like single piece flow, just-in-time production, and eliminating non-value added activities to improve throughput, quality, and customer satisfaction. Key aspects of Lean covered include value stream mapping, reducing the seven wastes, line balancing, managing bottlenecks, setup reduction, pull systems, and visual management.
This document provides an introduction to statistical process control (SPC). It discusses the limitations of inspection and why SPC is better. It explains that SPC allows monitoring of processes to detect changes before defective products are produced. Various control chart templates are shown and key SPC concepts are defined, including sources of variation, the central limit theorem, and using average and range to monitor process behavior over time. Examples are provided to illustrate variability, distributions, and how control charts can be used.
This document summarizes a seminar report on Six Sigma's DMAIC methodology and a case study on improving liquid metal yield at Ispat Industries Limited. [1] The report defines DMAIC as Six Sigma's five-step approach to drive variation out of processes. [2] It then details a case study where the team aimed to increase liquid metal yield from a baseline of 86.1% to a target of 87.88% through the DMAIC framework. [3] Key factors analyzed included hot metal percentage, scrap percentage, and arcing oxygen levels, with a test restricting oxygen leading to a 0.4% yield improvement.
The document discusses quality circles (QCC), which are voluntary groups of workers that work to identify and solve work-related problems in order to improve organizational performance. Quality circles were first established in Japan in 1962 and involved workers volunteering to improve processes. The document then provides an example of a quality circle registration form and theme selection criteria used by Procon Engineering to establish a quality circle focused on preventative maintenance of key machines.
This document discusses the cost of poor quality (COPQ) and how measuring quality costs can help businesses. It defines COPQ and outlines the different types of quality costs including prevention, appraisal, internal failure, and external failure costs. Measuring COPQ exposes hidden costs and provides a tool to prioritize issues, measure improvements, and maximize profits by reducing waste. The benefits of using quality cost metrics include aligning quality goals, prioritizing problems, and incentivizing doing tasks right the first time.
The document is a presentation on lean manufacturing principles from the website ReadySetPresent.com. It covers topics such as the Toyota Production System house model, the five S system, the two main focuses of lean being continuous improvement and respect for people, the seven types of waste, kanban pull systems, stopping problems to get quality right the first time, becoming a learning organization through reflection and improvement, and Japanese lean terms. The presentation provides over 300 slides on lean foundations and principles.
The document provides an overview of the Production Part Approval Process (PPAP), including:
- PPAP is a standardized process used to approve new or changed parts and ensure they meet requirements before production.
- It originated in the automotive industry but has spread to many industries. An approved PPAP package is required for new parts or when changes are made.
- A PPAP package contains extensive documentation like design records, process flow diagrams, inspection results and more to fully validate the part and manufacturing process. The goal is to reduce risks for customers and ensure conforming parts are delivered.
This document outlines the 8D problem solving process used by Ford Motor Company to continuously improve quality and prevent issues from reoccurring. The 8D process involves 8 disciplines: 1) Define the problem/failure, 2) Establish an interim containment action, 3) Determine the root cause(s), 4) Choose a permanent corrective action, 5) Implement and validate the corrective action, 6) Implement actions to prevent recurrence, 7) Recognize the problem-solving team, and 8) Document lessons learned. Each discipline involves defining objectives, collecting data, verifying solutions, and ensuring the problem is fully resolved before progressing to the next step. The goal is to take a structured, cross-functional team approach
7 QC Tools are simple statistical tools used for problem solving. Nilesh Arora presented basics of 7 QC Tool training and details about Pareto Diagram.
How to Make Postmarket Surveillance More Cost EffectiveApril Bright
When it comes to postmarket surveillance (PMS), it’s common for the costs to outweigh the value. But, by working with the right team, you’ll be able to execute a study that maximizes return on investment and minimizes the financial impact of conducting further observational research. Postmarket study challenges that must be addressed include enrollment delays, patient attrition, long-term follow-up, resourcing demands and global payor requirements. This session will provide a case study of one orthopaedic company’s seamless transition between postmarket approval and post-approval studies.
As UDI deadlines roll out, OEMs are left with many questions on implementation and compliance, including:
How does FDA recommend we direct mark screws and small implants?
How should we proceed as we await the guidance on the Convenience Kit exemption?
What are best practices for entering submissions to GUDID?
How is FDA enforcing UDI?
FDA officials will speak on UDI adoption and UDI data quality. Bring your questions. Ample time will be saved for Q&A.
The document provides an overview of Advanced Product Quality Planning (APQP) based on the AIAG reference manual. It discusses the objectives of APQP, which is a structured method for new product development to ensure customer satisfaction. The presentation outlines the 5 phases of APQP: 1) Plan and define program, 2) Product design and development, 3) Process design and development, 4) Product and process validation, and 5) Feedback, assessment and corrective action. Breakout sessions provide examples of applying APQP methodology to a new product development project. Key terms and an overview of the relationship between APQP and ISO/TS 16949 are also summarized.
The Seven Basic Tools of Quality (also known as 7 QC Tools) originated in Japan when the country was undergoing major quality revolution and had become a mandatory topic as part of Japanese’s industrial training program. These tools which comprised of simple graphical and statistical techniques were helpful in solving critical quality related issues. These tools were often referred as Seven Basics Tools of Quality because these tools could be implemented by any person with very basic training in statistics and were simple to apply to solve quality-related complex issues.
The document provides an overview of 7 quality control tools: Pareto diagram, stratification, scatter diagram, cause and effect diagram, histogram, check sheet, and control chart/graph. It describes each tool, including what they are, when they are used, and the typical results obtained from each tool. The tools are used to collect and analyze data, identify root causes, measure results, and help solve problems in quality control.
The document provides an overview of value stream mapping (VSM) process. It discusses defining the current state and future state maps which involve mapping the material and information flows, identifying value-added and non-value added activities, calculating metrics like cycle time and takt time, and developing an implementation plan to eliminate waste and create flow. The future state aims to optimize processes, improve flow, implement pull systems, and achieve continuous improvement through periodic reviews.
Poka Yoke refers to mistake-proofing methods used to eliminate human errors in manufacturing processes. It was developed in Japan in the 1960s as part of the Toyota Production System. There are various types of Poka Yoke including contact, counting, and motion-sequence methods. Poka Yoke aims to simplify processes, provide real-time feedback, and make it impossible to make mistakes. It can be implemented at any step where errors may occur and provides benefits such as low cost, quick feedback, and minimal supervision needs once established.
Quality in Manufacturing for Production & ManufacturingTimothy Wooi
This 1 day training program on the “Soft” TQM Concepts focus on Manufacturing Staff and Operators to equip Participants with a better understanding TQM and its practices and to understand why being responsible for Quality is so important as a mechanism to safe guard to Customer for receiving a Defect as well as to comply to Quality procedures..
The document describes the 8D Problem Solving process for addressing problems in organizations. The 8D process involves 8 disciplines (D0-D8) for defining the problem, identifying root causes, developing and verifying solutions, implementing corrective actions, and preventing recurrence. It aims to understand customer needs, gather details of issues, protect the customer, obtain management support, and recognize the project team upon completion. Following the 8D process can help organizations systematically solve problems and improve systems and processes.
This document discusses the concept of zero defects in manufacturing. It begins with an introduction to zero defects as a stretch goal to have no defects rather than just reducing defects over time. It then discusses some examples of companies that have achieved low defect rates. Several tools for achieving zero defects are mentioned, including mistake-proofing, statistical process control, design of experiments, and poka-yoke systems. The document argues that achieving very high quality levels like 99.99% defect-free can provide significant financial benefits in terms of reduced rework costs and increased profitability and competitiveness. It concludes that a zero defects approach adds value for customers and the business.
This document provides an overview of continuous improvement strategies like Kaizen, 5S, and the Toyota Production System (TPS). It discusses key aspects of each including:
- The 5 pillars of TPS: JIT, Jidoka, Kaizen, Heijunka, and respect for people.
- Components and benefits of 5S including sort, set in order, shine, standardize, and sustain. 5S aims to create a clean and organized workplace.
- Guidelines for implementing the different elements of 5S like sorting unnecessary items, clearly labeling storage areas, and establishing cleaning procedures and responsibilities.
- Using a PDCA approach for continuous 5S implementation including planning, doing, checking
The document discusses five core quality tools: APQP (Advanced Product Quality Planning), FMEA (Failure Modes and Effects Analysis), PPAP (Production Part Approval Process), MSA (Measurement Systems Analysis), and SPC (Statistical Process Control). It provides a brief overview of each tool, noting that APQP is used to develop products that satisfy customers, FMEA ensures potential problems are considered, PPAP ensures products meet specifications, MSA assesses measurement systems, and SPC enables process control and improvement. The document emphasizes that these five tools are considered core tools for quality management.
The document discusses Lean methodology which focuses on eliminating waste to produce high quality products faster and at lower cost. Lean aims to streamline processes through techniques like single piece flow, just-in-time production, and eliminating non-value added activities to improve throughput, quality, and customer satisfaction. Key aspects of Lean covered include value stream mapping, reducing the seven wastes, line balancing, managing bottlenecks, setup reduction, pull systems, and visual management.
This document provides an introduction to statistical process control (SPC). It discusses the limitations of inspection and why SPC is better. It explains that SPC allows monitoring of processes to detect changes before defective products are produced. Various control chart templates are shown and key SPC concepts are defined, including sources of variation, the central limit theorem, and using average and range to monitor process behavior over time. Examples are provided to illustrate variability, distributions, and how control charts can be used.
This document summarizes a seminar report on Six Sigma's DMAIC methodology and a case study on improving liquid metal yield at Ispat Industries Limited. [1] The report defines DMAIC as Six Sigma's five-step approach to drive variation out of processes. [2] It then details a case study where the team aimed to increase liquid metal yield from a baseline of 86.1% to a target of 87.88% through the DMAIC framework. [3] Key factors analyzed included hot metal percentage, scrap percentage, and arcing oxygen levels, with a test restricting oxygen leading to a 0.4% yield improvement.
The document discusses quality circles (QCC), which are voluntary groups of workers that work to identify and solve work-related problems in order to improve organizational performance. Quality circles were first established in Japan in 1962 and involved workers volunteering to improve processes. The document then provides an example of a quality circle registration form and theme selection criteria used by Procon Engineering to establish a quality circle focused on preventative maintenance of key machines.
This document discusses the cost of poor quality (COPQ) and how measuring quality costs can help businesses. It defines COPQ and outlines the different types of quality costs including prevention, appraisal, internal failure, and external failure costs. Measuring COPQ exposes hidden costs and provides a tool to prioritize issues, measure improvements, and maximize profits by reducing waste. The benefits of using quality cost metrics include aligning quality goals, prioritizing problems, and incentivizing doing tasks right the first time.
The document is a presentation on lean manufacturing principles from the website ReadySetPresent.com. It covers topics such as the Toyota Production System house model, the five S system, the two main focuses of lean being continuous improvement and respect for people, the seven types of waste, kanban pull systems, stopping problems to get quality right the first time, becoming a learning organization through reflection and improvement, and Japanese lean terms. The presentation provides over 300 slides on lean foundations and principles.
The document provides an overview of the Production Part Approval Process (PPAP), including:
- PPAP is a standardized process used to approve new or changed parts and ensure they meet requirements before production.
- It originated in the automotive industry but has spread to many industries. An approved PPAP package is required for new parts or when changes are made.
- A PPAP package contains extensive documentation like design records, process flow diagrams, inspection results and more to fully validate the part and manufacturing process. The goal is to reduce risks for customers and ensure conforming parts are delivered.
This document outlines the 8D problem solving process used by Ford Motor Company to continuously improve quality and prevent issues from reoccurring. The 8D process involves 8 disciplines: 1) Define the problem/failure, 2) Establish an interim containment action, 3) Determine the root cause(s), 4) Choose a permanent corrective action, 5) Implement and validate the corrective action, 6) Implement actions to prevent recurrence, 7) Recognize the problem-solving team, and 8) Document lessons learned. Each discipline involves defining objectives, collecting data, verifying solutions, and ensuring the problem is fully resolved before progressing to the next step. The goal is to take a structured, cross-functional team approach
7 QC Tools are simple statistical tools used for problem solving. Nilesh Arora presented basics of 7 QC Tool training and details about Pareto Diagram.
How to Make Postmarket Surveillance More Cost EffectiveApril Bright
When it comes to postmarket surveillance (PMS), it’s common for the costs to outweigh the value. But, by working with the right team, you’ll be able to execute a study that maximizes return on investment and minimizes the financial impact of conducting further observational research. Postmarket study challenges that must be addressed include enrollment delays, patient attrition, long-term follow-up, resourcing demands and global payor requirements. This session will provide a case study of one orthopaedic company’s seamless transition between postmarket approval and post-approval studies.
As UDI deadlines roll out, OEMs are left with many questions on implementation and compliance, including:
How does FDA recommend we direct mark screws and small implants?
How should we proceed as we await the guidance on the Convenience Kit exemption?
What are best practices for entering submissions to GUDID?
How is FDA enforcing UDI?
FDA officials will speak on UDI adoption and UDI data quality. Bring your questions. Ample time will be saved for Q&A.
Defining Your Leadership Style in a Performance-Based OrganizationApril Bright
To be an effective leader, you must learn to recognize that in different organizational situations, the style of leadership may need to change to be successful. This presentation discusses what defines a performance-based organization and how to improve accountability and responsibility. Attendees receive guidance on how to set expectations, how to achieve continued efficiency from a highly-focused group, how to push an underperforming group to productivity and how to be an effective leader to tenured vs. millennial employees.
What Is It? Product Development vs. Product Management April Bright
This session will focus on the respective roles and responsibilities of the Product Manager vs. the Development Engineer from a product’s inception through its lifecycle maintenance. Attendees will learn how to leverage the cross-functional product team to deliver results, business vs. technical aspects of product development, putting the customer first and navigating the organization in order to get things done.
Unique Device Identification or UDI is a forever project. What's the best way for orthopaedic device companies to receive return on their investment? What best practices can be learned for a continually-smooth process? How can the data be leveraged to enhance your company’s value proposition? The true value of UDI is not in the identification number, but in the data that can be generated as a result of UDI. This session will provide attendees with an outline of the opportunities that manufacturers can leverage beyond implementation.
OEMs and suppliers see promise in the ability of manufacturing and software to expand the use of custom implants in orthopaedics. Multiple companies are focused on the custom market. This session provides the surgeon perspective on these devices. What are the benefits? When should and shouldn't they be used? Will the market take off?
Steps to Compliance with the European Medical Device RegulationsApril Bright
The document summarizes proposed changes to the European Medical Device Regulations (MDR). It discusses expanding the regulations to cover clinical investigations in Europe and adverse incident reporting. It outlines the classification system for medical devices and conformity assessment procedures. Key aspects include new definitions, unique device identification requirements, essential safety and performance standards, and requirements for economic operators, notified bodies, and identification/traceability of devices. The European database EUDAMED is also mentioned.
Orthopaedic Device Industry Business Models: 2020 and BeyondApril Bright
During last year’s closing keynote, Dr. Wael Barsoum underscored the importance of producing transformational, innovative products to stay competitive and maintain a strong company and a healthy supply chain. This year, Dr. Bill Tribe will shine the “innovation lens” on the value of transforming your business.
Dr. Tribe co-authored the often-cited “Medical Devices: Equipped for the Future?” study in which the orthopaedics sector is called out specifically as facing an extreme combination of forces — none of which come as a surprise or are new, but when viewed holistically (as in the image below), paint a rather obvious picture of the need for companies to respond. As you can see, orthopaedics is the only sector with 4 of 5 “hot” areas…and in this case, the odd one out (regulatory scrutiny) is still marked “critical.”
From a top-down view, the five “disruptors” listed above are acute (power shift to payors, regulatory scrutiny, unclear sources of innovation, new healthcare delivery models, need to serve lower socio-economic classes). They impact the overall orthopaedic industry intensely – but how are they impacting you? Dr. Tribe’s Keynote Address will take into account the uniqueness of the OMTEC audience: large and small OEMs, Suppliers and Service Providers.
As stated in the A.T. Kearney study, “Each company faces a different set of headwinds…while the macro-factors held true, individual experiences and prioritization depended on factors such as market geography, product life cycles and go-to-market strategies. The most effective strategies are therefore likely to be company specific.”
What will be your business model in 2020? 2025?
Will you be considering cost-structure, deployment of inventory, commercial logistics, quality and regulatory frameworks, R&D, innovation and data collection?
Dr. Tribe will break down the issues and share potential approaches to help you navigate toward a more relevant and lucrative business model – regardless of where you are in the process.
Disposable instruments and procedural kits undergo comprehensive product development and testing to meet quality and regulatory requirements. Extensive validation and verification testing is performed on packaging, sterilization methods, aging, and the instruments themselves to ensure clinical robustness. This includes testing instruments through simulated clinical reprocessing cycles to validate they can withstand repeated cleaning, sterilization, and use over their intended lifetimes. Understanding how instruments will perform after many reprocessing cycles is important for material selection, design, and establishing appropriate cleaning and sterilization instructions.
Packaging Solutions that Improve Time to MarketApril Bright
This session will discuss packaging solutions designed to improve time to market and lower costs for OEMs. Kelly Lucenti will discuss challenges imposed from the research and development phase to production, as well as trending issues with packaging design and validations. The presentation will highlight the importance of OEMs engaging their packaging groups early in the design phase, and ways that leveraging existing validations can speed time to market and cut major costs.
Design for Manufacturability Rapid Fire April Bright
Design for manufacturability (DFM) is a broadly-implemented step in today’s development process to ensure that a designed product can actually be manufactured. While the concept sounds simple, there are nuances to every supplier relationship and every new process.
Three suppliers—a contract manufacturer, additive manufacturer and plastics company—will each spend 15 minutes answering the following question: With orthopaedic customers, our greatest DFM pain point is ___ and the best strategy to change that is ___.
OEMs will learn best practices and ways to approach DFM with their supplier partners.
Coatings for implants and instruments continue to evolve as manufacturers seek the best surface for their devices. Attendees will leave this session with knowledge of new coating research and manufacturing techniques. Three suppliers will speak on the benefits, applications and manufacturing processes of three different coatings. A Q&A with all three presenters will follow.
Surgeon Perspective on Additive Manufacturing April Bright
As additive manufacturing gains popularity as a production process, it’s important to understand the perspective of surgeons engaged with the technology. Nirav Shah, M.D., has consulted with device companies on additively-manufactured implants and is involved in the research of 3D-printed tissue. He will share his perspective and research on the current state of additive manufacturing in orthopaedics, and provide ideas on how the technology could be used in the future.
Strategies for Device Approval in China, India, South Korea and AustraliaApril Bright
This session will describe the orthopaedic device regulatory and registration requirements in Asia Pacific markets. Regulatory steps and strategies will be presented for each of these countries. The discussion will also cover ways to gain regulatory information about competitors already selling in these markets. Attendees will leave the session with an understanding of timelines, costs and complexity for approval.
Modernize the Orthopaedic Supply Chain: A Surgeon’s ViewApril Bright
This document discusses modernizing the orthopedic supply chain from a surgeon's perspective. It describes current issues with the supply chain that can lead to medical errors and waste, including complex compatibility rules between implant systems, small labels, and time pressure in the operating room. The author outlines a new system called OrthoSecure that uses barcodes and electronic displays to efficiently check implant compatibility and prevent errors. A study found this system prevented all errors in over 4,600 joint replacements and reduced wasted implants. The document advocates expanding this approach and using supply chain data to further increase efficiency and cost savings.
CAPA: Using Risk-Based Decision-Making Toward ClosureApril Bright
Implementing a risk‐based CAPA process within a QMS is a necessity in the improvement of controls aligned with product and process non-conformances, adverse events, audit findings, complaints, etc. Making decisions concerning scope and extent about these “defectives” is a modern and cost-saving approach to improvement and compliance. Every non-conformity does not force you to open a corrective action. While almost every problematic issue needs at least a correction, the biggest payback is to use corrective actions on systemically-driven problems that are repetitive and recurring.
Applying the methods of determining risk to the device’s complete life cycle will give your company a complete look at all of the device’s risks—including those relative to processes. Manufacturers should be able to justify that they have reduced the risks as far as possible as part of their risk management plan and ongoing corrective and preventive actions.
Significant changes are underway that impact the quality and regulatory systems of medical device companies and their suppliers. ISO 13485:2016 adds new requirements to address risk management and to better align the standard with global regulatory requirements (FDA, MDD, JPAL, etc.). With the release of ISO 9001:2015, the ISO 9001 and ISO 13485 standards are no longer integrated. A new single audit MDSAP program will be in effect beginning 2017 that incorporates applicable FDA, Canadian, Brazilian, Australian and Japanese quality system requirements into the annual ISO 13485 audit cycle. The presentation will provide an overview of these changes and the steps required to incorporate these changes into existing quality management systems.
Design controls are not an easy subject to address during and after the design of medical devices and manufacturing processes. Design controls should drive the device design process, not be an afterthought. This session focuses on treating design as a separate entity within the quality management system, user needs vs. design inputs, continuation of design controls after the transfer process, design review and more.
Orthopaedic Care Shifts to Outpatient and Urgent Care ClinicsApril Bright
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Attendees gain more insight into this shift, and learn how it will affect demands on manufacturers from a product design and delivery standpoint.
This document discusses smart and innovative machining processes. It begins by describing various machining operations like turning, milling, grinding, and wire EDM. It then shows how collaboration between designers, buyers, and manufacturers can lead to design for manufacturing practices that streamline processes. For example, modifying a part design reduced the cost per part from $178 to $37.40 for a lot size of 1,000 parts. The document also covers metal injection molding, noting its suitability for complex small parts in high volumes, and outlines design considerations and capabilities for the process.
This document discusses driving a built-in quality culture. It begins with an overview of lean manufacturing principles and establishing a quality culture through leadership commitment, employee engagement, and communication. It then covers built-in quality concepts like process validation and quality feedback. The document outlines topics to be discussed including visiting a built-in quality plant and leadership's role. It emphasizes that quality and safety are top priorities driven by a leadership-led quality culture.
Training effectiveness-ISO ProspectiveSAROJ BEHERA
The document discusses training effectiveness and evaluation from an ISO perspective. It provides an overview of ISO models and Kirkpatrick's model for training evaluation. Kirkpatrick's 4-level model includes reaction, learning, behavior, and results. While widely known, higher levels are rarely evaluated due to difficulties in measurement and the perception they are beyond the scope of most trainers.
This document discusses defining and tracking productivity metrics for an organization. It proposes identifying key metrics across teams to measure productivity gaps. It suggests developing a framework to collect data, analyze gaps, and deliver a report with optimization recommendations. Sample metrics are provided for engineering, development, sustainment, and quality assurance. Case studies demonstrate defining complexity-weighted productivity comparisons between global teams and addressing constraints impacting productivity.
Qm0026 quality concepts, tasks and development methodsStudy Stuff
Dear students get fully solved assignments by professionals
Send your semester & Specialization name to our mail id :
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Qm0026 quality concepts, tasks and development methodssmumbahelp
This document provides information about getting fully solved assignments for the MBA semester 4 Quality Management subject. It includes the subject code, credit hours, and 6 questions related to quality concepts such as PDCA cycle, quality planning phases, critical path method, supplier certification, supplier rating, and the Toyota Production System framework. Students are instructed to send their semester and specialization details to the provided email or call the phone number to receive solved assignments.
Business Process Improvement - Doing the right things effectively and efficie...Simon Misiewicz
Optimise-GB provides you with a presentation on business process improvement. This presentation focuses on customer’s needs, also known as Voice of the Customer (VoC). The presentation’s approach pulls on knowledge and methods from systems thinking (focusing on failure demand and doing the right things by the customer), lean (having an efficient process), six sigma (focusing on quality and reducing failure demand and defects) and Theory of constraints (ToC –reducing bottlenecks and constraints). It has been considered that business process improvement cannot be approached in the same way as manufacturing. This is true for many reasons. One, the complex tools and levels of perfection is simply not required or even feasible for the service sector, given that most service organisations have near 50-80% defect rates across the entire organisation, so why focus on the 1% accuracy? Pareto’s 80/20 approach will yield significant results. The presentation guides you through the formation of teams and people to be involved, identifying objectives, problems and needs. The presentation then takes you through the documentation of each business process through workshop events and how to use data and issues logs. Finally we will look at how solutions are identified and evaluated and then implemented using the top 3 ideas. If you have any questions on simon@optimise-gb.com and visit www.optimise-gb.com for more details. Many thanks Simon Misiewicz
The document provides an overview of 15 different question types that may appear on the PMI Project Management Professional (PMP) certification exam, along with examples and tips for answering each type. It discusses questions that are based on inputs, tools and techniques, and outputs (ITTOs); definitions; situations; excessively wordy phrasing; formulas; interpretation; specific techniques; those with multiple right answers; those with extraneous information; those using made-up terms; those requiring understanding; those with a new approach; those with multiple items per option; those based on PMBOK Guide knowledge; and negative questions. The document aims to help exam takers understand the various question formats and how to approach each effectively.
How to create a strong team that is constantly trying to impriove processes and productivity.
Enables teams to determine how they would want to begin and maintain the journey.
An easy read plus descriptive materials to help teams setup strong improvement culture within the company and also within departments.
This document defines the deliverables for a project to improve the computer delivery time process. Deliverable 2 involves defining the project boundaries, which includes writing a problem statement identifying the defect as computers being delivered in 11 days on average versus the 10 day goal, drafting a project charter with details of the scope, timeline and benefits, and setting a goal of decreasing the delivery time to 9 days by a target date. It provides guidance on tools to use for each deliverable such as a SIPOC, inclusion/exclusion list, and elevator speech.
Chaplin School of Hospitality and Tourism ManagementInternship Lea.docxcravennichole326
Chaplin School of Hospitality and Tourism ManagementInternship Lean 6σ Process Improvement Project
Improving the Speed, Accuracy, Reliability, Cost Effectiveness and Flow of the (Y) process.
A picture of you in front of your company here.
Executive Summary
Executive Summary
Please describe your project in this box. If it does not fit in the box, it is too long, and you must shorten it. Shoot for the 5W’s and the H, but be brief. (Who, what, when, where, why, how)
Please describe your project in this box. If it does not fit in the box, it is too long, and you must shorten it. Shoot for the 5W’s and the H, but be brief. (Who, what, when, where, why, how)
Table of Contents
i
Executive Summaryi
Message from the Professoriii
Why we are using this method in the advanced internship classiii
About Lean 6σiii
Criteria for the Projectiii
Define1
1.1Project Charter and Financial Estimate1
1.2 Current State Process Map2
Measure3
2.1 Data Collection Plan3
2.2 Collection Results4
Analyze5
3.1 Voice of the Customer5
3.2 Voice of the Business5
3.3 Voice of the Employee (WIFM)5
3.4 Waste Analysis – DOWNTIME6
4.1 Addressing gaps in VOC needs7
Improve
4.2Addressing gaps VOB needs7
4.3 Addressing VOE concerns/ Alternate WIFM7
4.4Reduction of Waste8
4.5 Summary of Recommended
Solution
s8
Control9
5.1 Modification to Procedures Manuals (Or Establishment of Internal Controls)9
Lessons Learned10
Supervisor’s Critique11
Message from the Professor
Why we are using this method in the advanced internship class
Our internship students are within a semester or two of entering the workforce as managers. FIU’s Hospitality and Tourism Management School has included a structured internship as part of the curriculum for over a decade to assist students with this transition into management. A substantial part of the course has always included a project where the students were to improve the host company’s operations in a meaningful and lasting way.About Lean 6σ
This project is a scaled down Lean 6σ ( six sigma) project designed to be completed within the term of the semester. Lean 6σ is a continuous process improvement method which has grown in use in U.S. and international corporations since the 1970’s. Employed to great success at companies like Motorola, this method aims to refine a company’s existing processes through data based analysis and evidence based decision making.
U.S.-based quality professionals who complete any Six Sigma training earn on average $12,642 more than those without it. 2011 QP Salary Survey*Criteria for the Project
· The project must be based on a real need in the company, and have the support of the student’s supervisor.
· Must be able to be completed to in 10 weeks or (40 hours)
This template is the intellectual property of Jason L. Stiles, Ph.D. All rights reserved.
2
Define
A description of the current process and proposed financial benefits
1.1 Project Charter and Financial Estimate
Project Charte ...
This document discusses improving quality when partnering with customers. It describes a case study where phase 1 of a project went poorly, experiencing delays, cost overruns, and defects due to incomplete requirements and lack of transparency. Phase 2 applied lessons learned with improved requirements gathering, testing processes, and communication. These changes strengthened the partnership and led to on-time delivery with few defects. The key is being open about challenges, willing to modify processes, understanding the client's metrics and culture, and having oversight to avoid getting lost in details.
The document discusses project management for new product development. It outlines the key phases of product generating including market surveys, product definition, development, marketing, customer support and continuous improvement. It then provides details on project planning including defining work breakdown structures, milestones, activities, critical paths, buffers and allocating resources. An example case study of developing a new semiconductor metrology tool is also discussed.
Agile Framework based on PMBOK 6th Edition.pdfAliAfrazAjmal
The document provides an overview of agile concepts and practices. It begins by describing the four values of the Agile Manifesto: individuals and interactions over processes and tools, working software over comprehensive documentation, customer collaboration over contract negotiation, and responding to change over following a plan. It then discusses agile planning cycles and the relationship between product vision, release planning, and iteration planning. Other topics covered include Scrum roles, defining Scrum, Scrum ceremonies like daily stand-ups and retrospectives, user stories, estimation techniques like planning poker and story points, and calculating estimated velocity.
The document provides information about getting fully solved assignments for the MBA semester 4 Project Quality Management course. It includes 6 sample questions and answers on topics like data mining tools, communities of practice, the project management initiative process, forces involved in quality project management, and inspection planning and quality necessity. Students can email their semester and specialization details to get the solved assignments or call the provided number for assistance.
The document defines the Define phase of a Lean Six Sigma project. It includes templates for key Define activities like developing a project charter, scope statement, voice of the customer, SIPOC diagram, CTQ tree, schedule, business case, communication plan, current status report, issue log, and sign-off sheet. The Define phase establishes the foundation for a project by understanding the problem, customers, processes, metrics and goals.
The document discusses several Lean manufacturing concepts including PDCA, SMED, Kanban, and Poka-Yoke. It provides descriptions and examples of each concept. PDCA refers to the Plan-Do-Check-Act cycle used for continuous improvement. SMED focuses on reducing changeover times by converting internal setup steps to external steps. Kanban uses visual cards to schedule production. Poka-Yoke uses mechanisms to prevent mistakes from occurring in processes. The document aims to explain these key Lean tools and concepts.
BUSN350Week 3 Business Problem and RequirementsBusiness.docxhumphrieskalyn
BUSN350
Week 3: Business Problem and Requirements
Business Analysis
The basic idea of business analysis is simple. It is the practice of identifying and clarifying a problem or issue within a company, then working with the various stakeholders to define and implement an acceptable solution. However, actually conducting a business analysis can be quite complex and time-consuming.
Starting Point
The first step in the process is to identify a problem, an issue, or some other business need. Let's say that you are the owner of a small motorcycle dealership. In addition to selling bikes, your store does repairs and maintenance, sells riding gear, and custom orders parts for your customers. You have received numerous complaints from the staff and customers about the accuracy of your inventory system. The problem is the inventory system often shows parts and merchandise as being in stock, when none are actually available. This often means that a repair job is not finished on schedule, which really irritates your customers.
Milestone 1 Assignment Requirements
In a 5-8 page paper using APA format, please describe the following:
1. Introduction– Briefly describe the organization and business process to provide contextfor your project.
2. Business problem– Identify and describe a business problem for your project.
a. Create a flowchart of the current business process using Visio.
b. If you do not have Visio installed on your computer, you can access this application via the iLab tab in the Course Home unit.
3. Identify stakeholders– Provide a stakeholder tracking matrix based on eachstakeholder’s position and responsibilities, the level of their involvement and their importance to the project.
Example of a stakeholder matrix:
Role
Responsibilities
Level of Involvement
Importance
Project Manager
(Business)
Project Manager
(Implementation partner)
Business Analyst
Page 1 of 4
BUSN350
Role
Responsibilities
Level of Involvement
Importance
Department Manager
Work Group Supervisor
External Business Partner
SME 1
SME 2
SME 3
Level of Involvement – What level of involvement and how much time will be expected of each stakeholder?
Importance – How important is the stakeholder in the requirements elicitation process? Are they required in order to document all of the critical project requirements, or are they optional in that they can add clarity to processes that may further refine requirements?
4. Conduct elicitationusing one of the methods listed and provide the documented resultsfrom your activity in the Appendix of your paper:
Surveys – develop a set of 5-8 multiple choice questions pertaining to the business problem that will enable you to document a list of requirements for your project, administer the survey to elicit responses from 10 participants
Interviews – develop a set of 5-8 open-ended questions pertaining to the ...
This document summarizes Malcolm Sanders' submission for Lean Practitioner accreditation. It details his experience implementing Lean tools at Waltham Cross and Linford sites, including performance meetings, continuous improvement, 5S, process mapping, and encouraging staff involvement. It then describes a project to streamline the R&A management information process at Linford, which involved process mapping, identifying duplication and non-value-added steps, and implementing a revised process that reduced the time spent on the task by 30 minutes per day.
Николай Алименков "Геймификация в аутсорсинговых компаниях: практический отчет"Fwdays
Большинство привыкли слышать слово "Геймификация" только в контексте привлечения конечного пользователя в процесс использования программы. Кто-то знает о применении данного подхода в продуктовых компаниях с целью влияния на процесс разработки. Но мало кто верит, что подобные практики можно внедрять и в аутсорсинговых компаниях.
В данном докладе будут представлены практический отчет о подобном внедрении, рассмотрены детальный фреймворк для повторного использования в проектах различного типа. Если вы хотите добавить интереса и привлечь команду в свой проект, то этот доклад для вас.
Top success factors for successful agile deliveryWipro
The key factors for successful Agile project delivery according to survey respondents are:
1. Experience and training in Agile methods for all roles, along with proper coaching for new practitioners.
2. A Product Owner who fulfills requirements like prioritizing the backlog, making decisions, and being available to the team.
3. Commitment from senior stakeholders and customers, who understand Agile and provide support.
Additional important factors include having a self-organizing team, co-locating the team in a project space, an empowering Scrum Master, and involving customers in reviews and testing. Factors that can lead to failure include vague requirements, changing stories during a sprint, and
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Psychological safety in teams is important; team members must feel safe and able to communicate and collaborate effectively to deliver value. It’s also necessary to build long-lasting teams since things will happen and relationships will be strained.
But, how safe is a team? How can we determine if there are any factors that make the team unsafe or have an impact on the team’s culture?
In this mini-workshop, we’ll play games for psychological safety and team culture utilizing a deck of coaching cards, The Psychological Safety Cards. We will learn how to use gamification to gain a better understanding of what’s going on in teams. Individuals share what they have learned from working in teams, what has impacted the team’s safety and culture, and what has led to positive change.
Different game formats will be played in groups in parallel. Examples are an ice-breaker to get people talking about psychological safety, a constellation where people take positions about aspects of psychological safety in their team or organization, and collaborative card games where people work together to create an environment that fosters psychological safety.
Achieving Built-in-Quality: Actions and Implementation
1.
2. Achieving Built – In – Quality
Through
The Juran Trilogy
Joe Mazzeo
Integrated Lean and Quality Solutions, LLC
June 16, 2016
1
3. Achieving BIQ Through the Juran Trilogy
2
Topics of Discussion
• Lean Manufacturing Overview
• Built-In-Quality Refresher
• The Juran Trilogy
• Applying the Juran Trilogy to BIQ
• Leadership Roles and Responsibilities
• Summary
4. Presentation Take-Aways:
• An understanding of what the concept of Built-In-Quality is and how
to apply it to your business environment
• How BIQ fits within Lean Manufacturing Principles
• Basic understanding of the Juran Trilogy
• How applying the Juran Trilogy can make implementing BIQ successful
• Think about the concepts:
- How can I apply this idea to my business?
- How can I make this work for my business?
• Everything discussed can be scaled to fit different organizations
3
Achieving BIQ Through the Juran Trilogy
5. Achieving BIQ Through the Juran Trilogy
4
Topics of Discussion
• Lean Manufacturing Overview
• Built-In-Quality Refresher
• The Juran Trilogy
• Applying the Juran Trilogy to BIQ
• Leadership Roles and Responsibilities
• Summary
7. • The key to
eliminating waste
is to identify it
• LM categorizes
waste into seven
types
6
8. Lean Manufacturing Principles
An effective Lean Manufacturing System is:
• A single, common manufacturing system
• Integrated / Inter-dependent principles
• Scalable to fit the needs and size of the
organization
7
10. People Involvement
Author:
(Group Leader)
Job
Number
1 2 3 4 5 6
Group:
ACE AREA Dept
156 Maching
Issue
Date:
Jan-11
Group
Leader
Shift
Leader
Shift Req'd Act.
Jan
J.M J.W.
1 J.Doe (T/L)
Feb
1 T.White
Mar
1 T.LaCourse
Apr
1 J.Wing
May
1 C.Persall
June
1 T.Bellant
July
Aug
Sep
Oct
Nov
Dec
Plan 3 3 3 3 2 2 Knows steps (in training)
Actual 2 3 2 3 3 2 Can perform job to quality & safety but not in takt time
X X X X Can perform job to quality & safety in takt time with no help
Can teach job with Job Element Sheets
# of people at 3/4 circle per job to meet
coverage requirements
% of group that reached Persons/Job target (%
of boxes checked)
______ %
Check here if target is met
_____ %
SIGN-OFF
Evaluation (O,
, X)
J
o
b
N
a
m
e
Name (Write position if not T/M)
# of 3/4 circle
Jobs per
Person to meet
rotation plan
Check
here if
target is
met
% of
group that
reached
Jobs/
Person
target (%
of boxes
checked)
O
p
1
0
O
p
2
0
O
p
3
0
O
p
4
0
W
h
e
e
l
C
h
a
n
g
e
T
o
o
l
S
e
t
u
p
FLEXIBILITY CHART Ref-2C
Verify quadrants filled in have
supporting documentation to
match in JIT binder.
If the Actual does not meet the Plan, ensure
the team has countermeasures written to close
the training gap.
Ensure monthly reviews and sign
offs are occuring between TL &
Elements - Engagement
- Communication
- Team concept
- Health and safety
Communication Board Job Flexibility Chart
9
12. Short Lead Time
cart will contain 13 rows with 6 housings in each
(78 pcs) total.
Safety Ergonomics Quality K Knack CriticalSymbol Legend (SYM):
4 Load or unload the buggy.
Doc. No.: DP-785
area for download/upload.
uploaded out of with minimal walking distance.
Stack the housings in stacks of 6 per row. A full
C
machined surface
Will reduce and minimize nicks on the
Select a green buggy for Gen IV. Choose a
B Will help ensure FIFO.
machined surface to a machined surface method.
When loading the cart stack the housings using a
to the line so the parts can be loaded into or
C Will help minimize waste in motion.
the current date before you begin to load.
JOB ELEMENT SHEET Page: 1 of 2
Control
Block
Shift 154 / Truck Oil Pump
Rev. 2
1 FIFO for buffer after Op50
3 Place the buggy into the identified staging Move the cart into the identified staging area next
2 Fill out and attach "O.K. for Use" tag to the Identify on the tag Gen III or Gen IV, and fill in
SYM
downloaded parts into. blue buggy for Gen III.
SEQ
Helps prevent the bodies from being mixed.1 Select the proper colored buggy to buffer the
N/A
A
Department No. / Name:
Op. No. / Mach. Mfg./ Process:
Job Element or Task Name:
Element Numbers(s):
buggy.
- STEP (What) -
Initial Review & Update Signatures
(Final Review & Update - See Training Signature Sheet or Training M atrix)
Group Leader
Team Leader
and/or
Lead Technician
Date
10/22/10
10/20/10Deanna McKay
- KEY POINT (How) -
B.Berry1
REF - REASON (Why) -
C
A B C
REF 12A
Elements
- Simple process flow
- Supply chain management
- Scheduled shipping/receiving
- Lean containerization
Material Delivery Rack Locations
Job Element Sheet – Showing Color-coded Part-Cart
Locations
11
13. Continuous Improvement
Dept/Group: 140 PISTON PINS
PACK OFF INSPECTION
Reviewer: ______________________________ Date: ______________ Shift: _______ RATING
X orO
1. PPE sheet: present onworkstationboard, current, andsignedoff. (Ref 1Aor 1B)
2. PPE Sheet: beingadheredtobytheoperator. (safetyglasses, gloves, nofinger rings, non-slipshoes, etc) (Ref 1C)
3. WalkieTruckPre-OpInspectioncompletedif applicabletoarea. (Ref 1D)
4. Takeshelterevacuationmap: needs tobevisuallylocatedintheworkarea. (team room) (Ref 1E & 1F)
5. VerifyLockout Placardis postedonoperation, is current, (reviewedonanannual basis) andis understoodbytheoperator. ( Ref 1G)
6. Verifyif SOP's arebeingusedat theworkstation, arelistedonthePPE, andarepostedat thejob. (Ref 1H & 1I)
1. Verifythereis JIT documentationfor eachteam member that supports theinformationpostedontheflexchart (Ref 2A, 2B, 2C)
2. Does theJIT havetherequiredsignatures: safety, quality, andproduction (Ref 2B)
3. Flexchart: sign-offs validatingmonthlyreviews; bottom quarter of sheet filledin(target vs plan) (Ref 2C)
MANUFACTURING LAYERED AUDIT
CHECKSHEET
Workstation:
Team Member Name:
PRIORITYCHECKS (Performed by alllevels ofthe organization)
Is theteam member (TM) followingthepostedPPE requirements?
Has theTMbeenqualifiedtorequirements of thejob, documentedthroughJIT, identifiedontheFlexChart androtatingintheteam?
4. Verifyif thereareanycountermeasures writtenunder "People" onthelevel 5boardif trainingplans (target vs actual) arenot achieved
accordingtotheflexchart. (Ref 2C)
5. Verifytraining(BayCityspecific) has occurredfor thosepeoplewithfull Harveyquadrants (documentationlocatedwithJITP sheets)
1
PI
2
X
J.Craig 1/26/11 1st
Elements
- Problem-solving
- Process Verification
- Andon - call for help
- Layered Audits
- Business Plan
Deployment
Manufacturing Layered Audit
12
14. Built-In-Quality
Elements
- Process and product validation
- Quality standards
- Quality management system
- Quality feedback and feed forward
Process Control Plan
Product Sample Retention Boards / Tables
13
15. Topics of Discussion
• Lean Manufacturing Overview
• Built-In-Quality Refresher
• The Juran Trilogy
• Applying the Juran Trilogy to BIQ
• Leadership Roles and Responsibilities
• Summary
Achieving BIQ Through the Juran Trilogy
14
17. Do not
Accept
Build
Ship
a Defect!
16
For the Purposes of Today’s Discussion:
Defects Do Not Leave the Team
Focus is on the workstation
What is the definition of Built-In-Quality ?
19. Defects
don’t leave the plant
Protect customer
from ‘obvious defects’Goal
Definition
BIQ
Vision
(Avoid errors)
Built-In-Quality Level I - V
II
V
ILevels
Defects
don’t leave the
team
Defects
don’t leave the shop
Defects
don’t leave the station
(Containment)
Inspection-
Based
Process
BIQ
Basic
(Detection &
Containment)
BIQ
Intermediate
(Prevention &
CIP)
BIQ
Advanced
(Avoid error flow)
Minimize disruption to
downstream processes
Eliminate in-process
repair
III
IV
Defects are not
created
(Avoid errors)
Zero
in-process waste
Improve
up-stream quality
18
20. Defects
don’t leave the plant
Protect customer
from ‘obvious defects’Goal
Definition
BIQ
Vision
(Avoid errors)
II
V
ILevels
Defects
don’t leave the
team
Defects
don’t leave the shop
Defects
don’t leave the station
(Containment)
Inspection-
Based
Process
BIQ
Basic
(Detection &
Containment)
BIQ
Intermediate
(Prevention &
CIP)
BIQ
Advanced
(Avoid error flow)
Minimize disruption to
downstream processes
Eliminate in-process
repair
III
IV
Defects are not
created
(Avoid errors)
Zero
in-process waste
Improve
up-stream quality
19
Built-In-Quality Level I - V
21. Defects
don’t leave the plant
Protect customer
from ‘obvious defects’Goal
Definition
BIQ
Vision
(Avoid errors)
II
V
ILevels
Defects
don’t leave the
team
Defects
don’t leave the shop
Defects
don’t leave the station
(Containment)
Inspection-
Based
Process
BIQ
Basic
(Detection &
Containment)
BIQ
Intermediate
(Prevention &
CIP)
BIQ
Advanced
(Avoid error flow)
Minimize disruption to
downstream processes
Eliminate in-process
repair
III
IV
Defects are not
created
(Avoid errors)
Zero
in-process waste
Improve
up-stream quality
20
Built-In-Quality Level I - V
22. Defects
don’t leave the plant
Protect customer
from ‘obvious defects’Goal
Definition
BIQ
Vision
(Avoid errors)
II
V
ILevels
Defects
don’t leave the
team
Defects
don’t leave the shop
Defects
don’t leave the station
(Containment)
Inspection-
Based
Process
BIQ
Basic
(Detection &
Containment)
BIQ
Intermediate
(Prevention &
CIP)
BIQ
Advanced
(Avoid error flow)
Minimize disruption to
downstream processes
Eliminate in-process
repair
III
IV
Defects are not
created
(Avoid errors)
Zero
in-process waste
Improve
up-stream quality
21
Built-In-Quality Level I - V
23. Defects
don’t leave the plant
Protect customer
from ‘obvious defects’Goal
Definition
BIQ
Vision
(Avoid errors)
Built-In-Quality Level I - V
II
V
ILevels
Defects
don’t leave the
team
Defects
don’t leave the shop
Defects
don’t leave the station
(Containment)
Inspection-
Based
Process
BIQ
Basic
(Detection &
Containment)
BIQ
Intermediate
(Prevention &
CIP)
BIQ
Advanced
(Avoid error flow)
Minimize disruption to
downstream processes
Eliminate in-process
repair
III
IV
Defects are not
created
(Avoid errors)
Zero
in-process waste
Improve
up-stream quality
22
24. Defects
don’t leave the plant
Protect customer
from ‘obvious defects’Goal
Definition
BIQ
Vision
(Avoid errors)
Built-In-Quality Level I - V
II
V
ILevels
Defects
don’t leave the
team
Defects
don’t leave the shop
Defects
don’t leave the station
(Containment)
Inspection-
Based
Process
BIQ
Basic
(Detection &
Containment)
BIQ
Intermediate
(Prevention &
CIP)
BIQ
Advanced
(Avoid error flow)
Minimize disruption to
downstream processes
Eliminate in-process
repair
III
IV
Defects are not
created
(Avoid errors)
Zero
in-process waste
Improve
up-stream quality
23
25. Defects
don’t leave the plant
Protect customer
from ‘obvious defects’Goal
Definition
BIQ
Vision
(Avoid errors)
Built-In-Quality Level I - V
II
V
ILevels
Defects
don’t leave the
team
Defects
don’t leave the shop
Defects
don’t leave the station
(Containment)
Inspection-
Based
Process
BIQ
Basic
(Detection &
Containment)
BIQ
Intermediate
(Prevention &
CIP)
BIQ
Advanced
(Avoid error flow)
Minimize disruption to
downstream processes
Eliminate in-process
repair
III
IV
Defects are not
created
(Avoid errors)
Zero
in-process waste
Improve
up-stream quality
24
Used BIQ III –
Defects Don’t leave the Team
as example to explain the process
27. 26
Talk focused on:
Defining what a BIQ culture is
How to Establish a BIQ culture
Steps required to achieve BIQ Level III
Defects
don’t leave the
plant
Protect customer
from ‘obvious
defects’
Goal
Definition
BIQ
Vision
(Avoid errors)
II
V
ILevels
Defects
don’t leave the
team
Defects
don’t leave the
shop
Defects
don’t leave the station
(Containment)
Inspection-
Based
Process
BIQ
Basic
(Detection &
Containment)
BIQ
Intermediate
(Prevention &
CIP)
BIQ
Advanced
(Avoid error flow)
Minimize disruption
to downstream
processes
Eliminate in-
process repair
III
IV
Defects are not
created
(Avoid errors)
Zero
in-process waste
Improve
up-stream quality
OMTEC 2015
Driving a Built - In - Quality Culture
28. 27
Talk did not discuss:
How to structure quality improvement
The quality processes and procedures
in support of BIQ
Defects
don’t leave the
plant
Protect customer
from ‘obvious
defects’
Goal
Definition
BIQ
Vision
(Avoid errors)
II
V
ILevels
Defects
don’t leave the
team
Defects
don’t leave the
shop
Defects
don’t leave the station
(Containment)
Inspection-
Based
Process
BIQ
Basic
(Detection &
Containment)
BIQ
Intermediate
(Prevention &
CIP)
BIQ
Advanced
(Avoid error flow)
Minimize disruption
to downstream
processes
Eliminate in-
process repair
III
IV
Defects are not
created
(Avoid errors)
Zero
in-process waste
Improve
up-stream quality
OMTEC 2015
Driving a Built - In - Quality Culture
29. Topics of Discussion
• Lean Manufacturing Overview
• Built-In-Quality Refresher
• The Juran Trilogy
• Applying the Juran Trilogy to BIQ
• Leadership Roles and Responsibilities
• Summary
Achieving BIQ Through the Juran Trilogy
28
32. Dr. Joseph M. Juran (1904 - 2008)
World-wide recognized management leader /
consultant / teacher / researcher
A contemporary of Dr. W. Edwards Deming
Juran focused on managing for quality
- Concept of quality management extended outside the walls of
the factory to encompass non-manufacturing processes
For Juran, resistance to change was the root cause of quality issues
Deming to Japan in 1952 / Juran in 1954
Japan’s economic rise in 1980’s directly attributed to these two men
31
33. 32
Significant Works:
Quality Handbook
First published in 1951 is considered the “bible”
for all things quality.
Now in 6th printing (2010)
Managerial Breakthrough (1964)
Focused on the need for an enterprise-wide
approach to quality improvement
Role senior leaders must play to accomplish
improvement and change. Updated 1994
Dr. Joseph M. Juran (1904 - 2008)
186-035300716297i509D46F0ATVPDKI0283155A2R2RITDbooks283155glance186-0353186-035300716297i509D46F0ATVPDKI0283155A2R2RITDbooks283155glance186-0353
34. 33
Dr. Joseph M. Juran (1904 - 2008)
Juran Institute established in 1979
Located in Southbury, Connecticut
Purpose:
- Conduct quality related research
- Teach Quality Management Principles
- Provide broader consulting services
Juran Institute becomes Juran Global
186-035300716297i509D46F0ATVPDKI0283155A2R2RITDbooks283155glance186-0353186-035300716297i509D46F0ATVPDKI0283155A2R2RITDbooks283155glance186-0353
35. 34
1950 1960 1970 1980 1990
QUALITYOFPRODUCT
Dr. Juran Accurately Predicted Japan Overtaking the West in Quality*
* American Management Associations Management Review
Product Quality – A Prescription for the West
Dr. J.M. Juran – July 1981
36. 3
5
Full Disclosure:
Studied under Juran for four years (1982 - 1986)
Co-authored and published:
“Deming, Juran, Crosby – Three Preachers, One Religion”
Quality Magazine, September 1986
Critiqued draft editions of:
- Juran Quality Handbook, 4th edition (1988)
- Juran on Quality by Design Quality (1992)
before publication
Significant influence in developing personal
beliefs and theories on quality management
Dr. Joseph M. Juran (1904 - 2008)
37. 3
6
Dr. Joseph M. Juran (1904 - 2008)
*
* The Juran Trilogy
Juran on Planning for Quality
Free Press Enterprise - 1988
38. 37
* The Juran Trilogy Juran on Planning for Quality Free Press Enterprise - 1988
Juran Trilogy
39. 38
* The Juran Trilogy Juran on Planning for Quality Free Press Enterprise - 1988
• Establish quality goals
• Identify who the
customers are
• Determine the needs
of the customer
• Develop product
features that respond
to the customers needs
• Develop processes able
to produce the product
features
• Establish process
controls: transfer the
plans to the operating
forces
Quality Planning
Juran Trilogy
40. 39
* The Juran Trilogy Juran on Planning for Quality Free Press Enterprise - 1988
• Establish quality goals
• Identify who the
customers are
• Determine the needs
of the customer
• Develop product
features that respond
to the customers needs
• Develop processes able
to produce the product
features
• Establish process
controls: transfer the
plans to the operating
forces
Quality Planning
• Evaluate the actual
performance
• Compare actual
performance with
quality goals
• Act on the difference
Quality Control
Juran Trilogy
41. 40
* The Juran Trilogy Juran on Planning for Quality Free Press Enterprise - 1988
• Establish quality goals
• Identify who the
customers are
• Determine the needs
of the customer
• Develop product
features that respond
to the customers needs
• Develop processes able
to produce the product
features
• Establish process
controls: transfer the
plans to the operating
forces
Quality Planning
• Prove the need
• Establish the
infrastructure
• Identify the
improvement projects
• Establish project teams
• Provide the teams with
resources, training and
motivation to:
• Diagnose the
causes
• Stimulate
remedies
• Establish the controls to
hold the gains
Quality Improvement
• Evaluate the actual
performance
• Compare actual
performance with
quality goals
• Act on the difference
Quality Control
Juran Trilogy
42. Topics of Discussion
• Lean Manufacturing Overview
• Built-In-Quality Refresher
• The Juran Trilogy
• Applying the Juran Trilogy to BIQ
• Leadership Roles and Responsibilities
• Summary
Achieving BIQ Through the Juran Trilogy
41
43. Measurement & Feedback
Voice of Process and Voice of Customer
0 1 2 3 Product Program Management
Quality Plan for Each Part Manufacturing System Variation Reduction
Quality / Reliability Growth
Quality ControlQuality Planning Quality Improvement
World Class Quality
Start of Production
6s Capability
Common Processes
QS-9000 Certified Systems
Lean Manufacturing System Foundation
Dr. Joseph Juran’s Quality Trilogy
42
Continuous Improvement
44. Measurement & Feedback
Voice of Process and Voice of Customer
0 1 2 3 Product Program Management
Quality Plan for Each Part Manufacturing System Variation Reduction
Quality / Reliability Growth
Quality ControlQuality Planning Quality Improvement
World Class Quality
Start of Production
6s Capability
Common Processes
QS-9000 Certified Systems
Lean Manufacturing System Foundation
Dr. Joseph Juran’s Quality Trilogy
43
Continuous Improvement
45. Measurement & Feedback
Voice of Process and Voice of Customer
0 1 2 3 Product Program Management
Quality Plan for Each Part Manufacturing System Variation Reduction
Quality / Reliability Growth
Quality ControlQuality Planning Quality Improvement
World Class Quality
Start of Production
6s Capability
Common Processes
TS / QS-9000 Certified Systems
Lean Manufacturing System Foundation
Dr. Joseph Juran’s Quality Trilogy
44
Continuous Improvement
46. 45
Driving Quality Processes into the Entire Organization
PRODUCT
ENGINEERING
MANUFACTURING
ENGINEERING
PROGRAM
MANAGERS
MANUFACTURINGQUALITYPURCHASING
47. Driving Quality Processes into the Entire Organization
PRODUCT
ENGINEERING
MANUFACTURING
ENGINEERING
PROGRAM
MANAGERS
MANUFACTURINGQUALITYPURCHASING
PRODUCT ENGINEERING
1. Design Failure Modes & Effects Analysis
2. Key Characteristic Designation System
3. Pre-Prototype and Prototype Process
4. Design For Six Sigma
48. Driving Quality Processes into the Entire Organization
PRODUCT
ENGINEERING
MANUFACTURING
ENGINEERING
PROGRAM
MANAGERS
MANUFACTURINGQUALITYPURCHASING
PURCHASING
1. External Production Part Approval Process (PPAP)
2. Advanced Product Quality Planning (APQP)
3. Supplier Run@Rate
49. Driving Quality Processes into the Entire Organization
PRODUCT
ENGINEERING
MANUFACTURING
ENGINEERING
PROGRAM
MANAGERS
MANUFACTURINGQUALITYPURCHASING
PROGRAM MANAGERS
1.Lessons Learned
2.Production Launch Process
3. Pro-Active Containment
50. Driving Quality Processes into the Entire Organization
PRODUCT
ENGINEERING
MANUFACTURING
ENGINEERING
PROGRAM
MANAGERS
MANUFACTURINGQUALITYPURCHASING
MANUFACTURING ENGINEERING
1. Control Plans
2. Machine/Assembly Run Off
3. Evaluation of Measurement System
4. Process Failure Modes & Effects Analysis
5. Functional Testing
6. Internal PPAP
7. Internal Run at Rate
8. Traceability
51. Driving Quality Processes into the Entire Organization
PRODUCT
ENGINEERING
MANUFACTURING
ENGINEERING
PROGRAM
MANAGERS
MANUFACTURINGQUALITYPURCHASING
QUALITY
1. Business Plan Deployment
2. Quality Valve Process
3. Current Product Improvement Process
4. Statistical Engineering
5. Customer/plant Feedback
6. Process Monitoring
7. Quality Systems Monitoring
8. Problem Solving
52. Driving Quality Processes into the Entire Organization
PRODUCT
ENGINEERING
MANUFACTURING
ENGINEERING
PROGRAM
MANAGERS
MANUFACTURINGQUALITYPURCHASING
QUALITY
1. Fast Response
2. Quality Gates
3. Error Proofing Verification
4. Process Verification
5. Production Trial Run
6. Standardized Work/Op Training
7. Process Capability
53. Measurement & Feedback
Voice of Process and Voice of Customer
0 1 2 3 Product Program Management
Quality Plan for Each Part Manufacturing System Variation Reduction
Quality / Reliability Growth
Quality ControlQuality Planning Quality Improvement
World Class Quality
Start of Production
6s Capability
Common Processes
QS-9000 Certified Systems
Lean Manufacturing System Foundation
Dr. Joseph Juran’s Quality Trilogy
52
Continuous Improvement
54. Measurement & Feedback
Voice of Process and Voice of Customer
0 1 2 3 Product Program Management
Quality Plan for Each Part
• Program Quality Management
- Robust Designs
- KPCs / PQCs
- DFMEA / PFMEA
- Effective Validation
• Production Readiness Process
• Quality Valve Process
• Supplier Quality Improvement Process
Manufacturing System
• Product Quality Standards
• Manufacturing Process Verification
• In Process Control & Verification
• Quality Feedback / Feed Forward
• Quality System Management
Variation Reduction
• Current Product Improvement Process /
Problem Solving
• RPN Reduction Process
• Quality Gates
• Advanced Problem Solving
- Statistical Engineering (Red X)
- Six Sigma
• Supplier Quality Improvement Process
QRD Growth
Quality ControlQuality Planning Quality Improvement
World Class Quality
S.O.V.P.
6s Capability
Common Processes
QS-9000 Certified Systems
Lean Manufacturing System Foundation
Dr. Joseph Juran’s Quality Trilogy
53
55. Quality Plan for Each Part
• Program Quality Management
- Robust Designs
- KPCs / PQCs
- DFMEA / PFMEA
- Effective Validation
• Production Readiness Process
• Quality Valve Process
• Supplier Quality Improvement Process
Manufacturing System
• Product Quality Standards
• Manufacturing Process Verification
• In Process Control & Verification
• Quality Feedback / Feed Forward
• Quality System Management
Variation Reduction
• Current Product Improvement Process /
Problem Solving
• RPN Reduction Process
• Quality Gates
• Advanced Problem Solving
- Statistical Engineering (Red X)
- Six Sigma
• Supplier Quality Improvement Process
Measurement & Feedback
Voice of Process and Voice of Customer
0 1 2 3 Product Program Management
Manufacturing System
Quality / Reliability Growth
Quality ControlQuality Planning Quality Improvement
World Class Quality
Start of Production
6s Capability
Common Processes
QS-9000 Certified Systems
Lean Manufacturing System Foundation
Dr. Joseph Juran’s Quality Trilogy
54
Continuous Improvement
•Program Quality Management
- Robust Designs
- KPCs / PQCs
- DFMEA / PFMEA
- Effective Validation
•Production Readiness
Process
•Quality Valve Process
•Supplier Quality Improvement
Process
Quality Plan for Each Part
56. Quality Plan for Each Part
• Program Quality Management
- Robust Designs
- KPCs / PQCs
- DFMEA / PFMEA
- Effective Validation
• Production Readiness Process
• Quality Valve Process
• Supplier Quality Improvement Process
Manufacturing System
• Product Quality Standards
• Manufacturing Process Verification
• In Process Control & Verification
• Quality Feedback / Feed Forward
• Quality System Management
Variation Reduction
• Current Product Improvement Process /
Problem Solving
• RPN Reduction Process
• Quality Gates
• Advanced Problem Solving
- Statistical Engineering (Red X)
- Six Sigma
• Supplier Quality Improvement Process
Measurement & Feedback
Voice of Process and Voice of Customer
0 1 2 3 Product Program Management
Manufacturing System
Quality / Reliability Growth
Quality ControlQuality Planning Quality Improvement
World Class Quality
Start of Production
6s Capability
Common Processes
QS-9000 Certified Systems
Lean Manufacturing System Foundation
Dr. Joseph Juran’s Quality Trilogy
55
Continuous Improvement
•Product Quality Standards
•Manufacturing Process Verification
•In Process Control & Verification
•Quality Feedback / Feed Forward
•Quality System Management
Manufacturing System
57. Quality Plan for Each Part
• Program Quality Management
- Robust Designs
- KPCs / PQCs
- DFMEA / PFMEA
- Effective Validation
• Production Readiness Process
• Quality Valve Process
• Supplier Quality Improvement Process
Manufacturing System
• Product Quality Standards
• Manufacturing Process Verification
• In Process Control & Verification
• Quality Feedback / Feed Forward
• Quality System Management
Variation Reduction
• Current Product Improvement Process /
Problem Solving
• RPN Reduction Process
• Quality Gates
• Advanced Problem Solving
- Statistical Engineering (Red X)
- Six Sigma
• Supplier Quality Improvement Process
Measurement & Feedback
Voice of Process and Voice of Customer
0 1 2 3 Product Program Management
Manufacturing System
Quality / Reliability Growth
Quality ControlQuality Planning Quality Improvement
World Class Quality
Start of Production
6s Capability
Common Processes
QS-9000 Certified Systems
Lean Manufacturing System Foundation
Dr. Joseph Juran’s Quality Trilogy
56
Continuous Improvement
•Current Product Improvement
Process / Problem Solving
•RPN Reduction Process
•Quality Gates
•Advanced Problem Solving
- Statistical Engineering (Red X)
- Six Sigma
•Supplier Quality Improvement
Process
Variation Reduction
58. Quality Process to Enable Product
Improvement
Quality
Deliverables
Defined &
Executed at each
Phase
Quality
Performance
Create/Develop Robustly Control
Passionately
Flawless
Launches
Solve Problems
Aggressively
Prior to Product Launch New Product in Hands of Customer
Launch
ProblemsExperienced
Few
Many
Time
57
60. Casting Machining Assembly
Application of Quality Process Across Different
Manufacturing Environments
59
Process Capability Monitoring
PFMEA RPN Reduction
Support Systems:
Fast Response
Quality Alerts
Layered Audits
Enhance Supplier Engagement Cleanliness Management
Start-up / Shutdown Process
Mfg ByPass
COMMON
TO ALL
61. Casting Machining Assembly
Application of Quality Process Across Different
Manufacturing Environments
60
Process Capability Monitoring
FMEA RPN Reduction
Support Systems:
Fast Response
Quality Alerts
Layered Audits
Enhance Supplier Engagement Cleanliness Management
Start-up / Shutdown Process
Mfg ByPass
COMMON
TO ALL
PFMEA by Operation
Control Plan by Operation
JES by Operation
Final Inspection
Quality Gate
Scrap Alarm & Escalation
62. Casting Machining Assembly
Application of Quality Process Across Different
Manufacturing Environments
61
Process Capability Monitoring
FMEA RPN Reduction
Support Systems:
Fast Response
Quality Alerts
Layered Audits
Enhance Supplier Engagement Cleanliness Management
Start-up / Shutdown Process
Mfg ByPass
COMMON
TO ALL
FMEA by Operation
Control Plan by Operation
Job Element Sheets by Operation
Final Inspection
Quality Gate
Scrap Alarm & Escalation
PFMEA by Operation
Control Plan by Operation
JES by Operation
Gage Stations
Leak Test
Trace Marking
Pass Thru Feature Check
Scrap Alarm & Escalation
End of Line Final Inspection
Quality Gate
63. Casting Machining Assembly
Application of Quality Process Across Different
Manufacturing Environments
62
Process Capability Monitoring
FMEA RPN Reduction
Support Systems:
Fast Response
Quality Alerts
Layered Audits
Enhance Supplier Engagement Cleanliness Management
Start-up / Shutdown Process
Mfg ByPass
COMMON
TO ALL
PFMEA by Operation
Control Plan by Operation
JES by Operation
Final Inspection
Quality Gate
Scrap Alarm & Escalation
PFMEA by Operation
Control Plan by Operation
JES by Operation
Gage Stations
Leak Test
Trace Marking
Pass Thru Feature Check
Scrap Alarm & Escalation
End of Line Final Inspection
Quality Gate
PFMEA by Operation
Control Plan by Operation
JES by Operation
Error Proofing Verification
Leak Test
Final Functional Test
Product Traceability
Quality Gate
64. Casting Machining Assembly
Application of Quality Process Across Different
Manufacturing Environments
63
Built-In-Quality concept applies across all industries
65. Topics of Discussion
• Lean Manufacturing Overview
• Built-In-Quality Refresher
• The Juran Trilogy
• Applying the Juran Trilogy to BIQ
• Leadership Roles and Responsibilities
• Summary
Achieving BIQ Through the Juran Trilogy
64
66. What would you expect to see when visiting
a BIQ Level III plant
• Evidence of robust designs and processes in place
• An effective team structure
• Plant staff has a strong focus and approach to quality
• Plant quality results (metrics) are a result of BIQ actions
- Time does not allow for detailed discussion
65
Achieving BIQ Through the Juran Trilogy
67. 66
• A Quality Culture which drives all plant behavior
in support of quality, second only to safety.
• Effective Team concept in place
• Team members capable of supporting
shop floor processes
• Standardized work is established and followed throughout the process
• Defect prevention is achieved through strong team based problem
solving
• Daily review and reaction to critical plant performance quality metrics to
help identify issues which are aggressively contained and resolved
• Leadership is very knowledgeable of their internal / external product
quality issues and aggressively pursuing resolution
Leadership Requirements For Successful BIQ
Implementation
68. Topics of Discussion
• Lean Manufacturing Overview
• Built-In-Quality Refresher
• The Juran Trilogy
• Applying the Juran Trilogy to BIQ
• Leadership Roles and Responsibilities
• Summary
Achieving BIQ Through the Juran Trilogy
67
69. Achieving BIQ Through the Juran Trilogy
68
Summary
Built-In-Quality is a key principle of lean manufacturing
The Juran Trilogy of Quality Planning/Control/Improvement
is still relevant today
The Juran Trilogy operationalizes the implementation
of BIQ
The Juran Trilogy and BIQ applies to all industries
Implementation of BIQ leads to long term sustainable
quality improvement
72. Thank You!
About Joe Mazzeo
• Owner of Integrated Lean and Quality Solutions, LLC
• Broad global experience in manufacturing and quality
• Providing Leadership, Lean Manufacturing and Quality Management services
• Member of: ASQ / SME / SEMA
VISIT www. http://ILQSolutions.com for additional information
71