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Quality by design
- 1. Quality By Design By: HUMAYOON AKHTAR
- 2. Definition of: Quality by Design is “The practice of using a multidisciplinary team to conduct conceptual thinking, product design, and production planning all at one time.”
- 3. QbD definition A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.
- 4. The Easy Definition!!! With a team to simultaneously design and develop products that have Ease of Producibility Customer Satisfaction
- 5. Essential elements in Qbd Quality Target product profile Determine critical quality attributes (CQAs) Risk assessment: Link raw material attributes and process parameters to CQAs Develop a design space.(Optional not required) Design and implement a control strategy Manage product lifecycle, including continual improvement
- 6. People to Include on Your Quality by Design Team Specialist From Business Engineering Production The Customer Base and at appropriate times Suppliers of Equipment, Purchased Parts and Services
- 7. SIGNIFICANCE OF QbD : Quality by Design means –designing and developing formulations and manufacturing processes to ensure a predefined quality Quality by Design requires – understanding how formulation and manufacturing process variables influence product quality . Quality by Design ensures – Product quality with effective control strategy
- 8. BENEFITS OF QBD: QbD is good Business Eliminate batch failures Minimize deviations and costly investigations Avoid regulatory compliance problems Organizational learning is an investment in the future QbD is good Science Better development decisions Empowerment of technical staff
- 9. Product Development Flow Diagram
- 10. Benefits of Quality by Design Significant decrease in time to market Faster product development Better quality Less work in progress Fewer engineering change orders Increased productivity Reduced labor costs Increased profits for the company
- 11. Team s Must have a variety of backgrounds and expertise. Must communicate!! Must think outside the box-stay flexible!! Quality by Design
- 12. Traditional Communication Flow Model
- 13. Quality by Design Communication Model
- 14. Advantages of QbD Benefits for Industry: Better understanding of the process. Less batch failure. More efficient and effective control Return on investment / cost savings. Allows for implementation of new technology to improve manufacturing Improves interaction with FDA –deal on a science level instead of on a process level Allows for continuous improvements in products and manufacturing process.
- 15. Implementation
- 16. Why Implement Budgets are more critical today than in past 1970’s Fewer brands to choose from Price = Cost + profit amount Today Design changes in product development creates higher costs.
- 17. Why Implement Control cost by designing at the start of a project Increased time in the design stage Changes in design stage cost 10 times more than in testing stage Spending 10 times more creates the need for development software EX: CAD/CAM
- 18. Why Implement More time designing results in a more complete final product Less Rework Less waste of Materials
- 19. Why Implement Fewer Design Changes + Shorter Lead Times = Quicker Response to Customer’s Needs Lower Rejects and Scraps = Increased Profits Customer Returns decrease Profit Margins increase
- 20. Key Concepts Look at the whole product life cycle Agree that organization has internal and external customers and suppliers Commitment to quality for the entire process of making the product
- 21. Preparation for Implementation Principles - Statement of principles that the company operates on Assessment - How the company currently operates and the changes that will be made Work Process - Define procedures for the new process
- 22. Preparation (continued) Internal Organizational Changes - Define how reporting and management will change Supply Chain - Define how the supply chain will participate in development of the project People Systems - Define reward systems, goals and objectives Technology - What new technology needs to be in place to complete the project
- 23. Implementation Start A Meeting with everyone involved. Communication between everyone involved. Some companies start with a “Pilot”.
- 24. Implementation Benefits of Meetings Project members meet face to face and develop personal relationships with internal and external customers and suppliers. Everyone understands goals. Clear up misconceptions Answer questions
- 25. Implementation Meetings Regular meeting should be set for reviewing the project Exchange ideas and resolve complaints Time between meeting should be long enough for questions to arise and short enough to make design decisions
- 26. Implementation Dedicated Project Teams Have a sense of togetherness Communication is established Each member knows the capabilities of team members
- 27. Implementation Flaws of Dedicated Project Teams Sense of stability and settling occurs Tend not to look for better ways to solve problems and rely on past practices
- 28. Implementation Co-Location Placing team members in same location Team stimulated to continuously find solutions to problems with the project Increased communication and continuous improvements
- 29. Implementation Disadvantages of Co-Location Cost of moving and providing for project team members Team members lose communication with the department they came from Product in that department may suffer
- 30. Implementation Computer Networks Allow team members to communicate with the department they came from Communication with resources and applications
- 31. Implementation Advantages of Computer Networks Eliminates cost of Co-Location Communication between team members and outside consultants Records progress for managers and accounting department
- 32. Implementation Cost Increases Time and Money have to be considered before applying the design Cultural Changes Solutions require cultural changes before becoming effective Through meetings, managers can slowly change the culture of the organization After cultural changes, project facilitator may be hired
- 33. Implementation Implementation of Quality by Design is a way to true quality by design.
- 34. Overview Organizational Tools Improve communication and understanding Product Development Tools Decrease product development time Production Tools Improve quality of manufactured parts and decreases production time Statistical Tools Allow studying and targeting of variables effecting design, testing, and production
- 35. Who Uses the Tools Organizational Tools Everyone Product Development Tools Engineering and Design Professionals Production Tools Production Engineers Statistical Tools Quality Engineers and Others when needed
- 36. Organizational Tools TQM Philosophy Computer Networks ISO 9000 and ISO 14000 Total Productive Maintenance Quality Function Deployment Electronic Data Interchange
- 37. Product Development Tools Computer-aided drafting software Solid modeling software Finite element analysis software Parametric analysis software Rapid prototyping techniques Design for manufacture and assembly techniques Failure mode and effect analysis
- 38. Production Tools Computer-aided Manufacturing Computer numerical controlled tools Continuous process improvement Just-in-time production Virtual manufacturing software Agile manufacturing
- 39. Statistical Tools Design of Experiments Statistical Process Control
- 40. Other Considerations Training is a must Requires money and time Using the tools increases employee retention and satisfaction
- 41. Misconceptions of Quality by Design It is NOT simultaneous design and production. ALL designs are finalized BEFORE production begins. It is NOT a quick fix or magical formula for success. It does NOT require multiple testing of products. Should NOT be confused with TQM inspection techniques.
- 42. Pitfalls to Avoid Don’t eliminate the old type sequential engineering system too quickly. Avoid having an unobtainable schedule. Better to be done early (longer predicted time) than to be late (shorter predicted time). Avoid using tight tolerances and stringent requirements. Avoid changing the product specs during the design phase. Avoid using the low bidder. Avoid automating the product development phase before it is simplified.
- 43. THANK YOU
Notes de l'éditeur
- TQM - all employees must understand these principles in order to understand the organization’s goals and strive to achieve them. Networks - allow for sharing of information both locally and globally ISO’s - set standards QFD - matches/relates customer requirements with engineering characteristics and production processes. Deployed through product planning, design, engineering production, assembly and field service. Results of QFD are measured with the number of design and engineering changes, time to market, cost, and quality. EDI - provides a standard mode for companies, departments, suppliers, and competitors to share information on products, parts, components, inventory, analysis, specifications, etc.. Uses the internet. Companies are able to communicate very efficiently, allowing the growth of and in the global marketplace.
- CAD - produces engineering production drawings. Allows for quick and easy engineering changes. Easily used with other software used for computer-aided manufacturing, design for manufacture, and CNC machines. Solid modeling software - Creates a visual verification of a component or a system. FEA - analyzes and optimizes the response of a system prior to prototype development and testing. Helps detect problems early, allows design team to implement alternative changes instantly, test the changes and see the effect on quality and performance. Parametric Analysis Software - expands the capabilities of solid modeling and FEA software by including parametric modeling from parts libraries and design optimization. Automates changes in design by programming the software to make decisions based on specified functions, variables, and other analysis criteria. Rapid Prototyping techniques - quickly produces a physical model of a product. Techniques include - stereolithography, solid ground curing, selective laser sintering, fused deposition modeling, direct shell production casting, and laminated object method. Prototypes do not have realistic mechanical characteristics. DFMA - design philosophy that identifies production and assembly problems prior to production. FMEA - identifies failure modes of a product or process before they happen and plans for their elimination.Includes a group of activities that recognize and evaluate potential failure of a product or process and its effects; identify actions that could eliminate or reduce the chance of failure, documents the process. Requires a team effort.
- CAM - software that identifies machine tool paths and other production parameters to optimize the machining of a part. Includes parameters such as machine tool feed rates, stock required, bit size and optimum tool path. CNC - Controls mills, lathes, and presses using a computer. CPI - systematic year after year study to improve the production processes by eliminating waste and rework, reducing scrap and cycle time, eliminating activities that do not increase product value, and eliminating non-conformities JIT - a process control method and production philosophy that provides parts, components, and assemblies to production at the exact time they are needed, resulting in less inventory of raw materials and parts, less work in process, and shorter lead times. One problem with JIT is the reduction of inventory to critically low levels. Suppliers with excellent quality products and services as well as a knowledge of production lead and process times must be used. Virtual Manufacturing Software - enables production engineers to create a factory on their desktop computer. Engineers can analyze and debug production facilities prior to the capital equipment investment. Agile Manufacturing - A manufacturing environment that responds quickly to marketplace demands by quickly incorporating new technologies into products and easily adapts to many different customer needs.
- DOE - a numerical study that identifies and studies many variables in a process or product at once that are the critical parameters or cause significant variation in the process. Three approaches to DOE are classical, Taguchi, and Shainin. A mix of the three approaches is often a wise choice. SPC - “The primary TQM tool.” It is a charting technique used to monitor process variations and correct problems before they occur. Because DOE identifies the variables, it should be used before SPC. Otherwise the wrong variables may be monitored by SPC.