Quality By Design Total Quality Management

Quality By Design Total Quality Management

1. Zunaira Zaman 015 Aqsa Shahzadi 009 Aleena Qureshi 030 Amna Asif 156 1

2. Quality By Design Quality The suitability of either a drug substance or a drug product for its intended use. This term includes such attributes as the identity, strength, and purity Quality by Design 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. Producing product within process capabilities will increase the level of customer satisfaction. So customer returns decrease and cost on rework also decrease. As a result, profit margin become larger because the time that was previously used to rework and customer return can now be used to inspect a new products to produce a it within process capabilities

3. History of QbD  ”Joseph M. Juran ” believed that quality could be planned, and that most quality crises and problems relate to the way in which quality was planned . While Quality by Design principles have been used to advance product and process quality in products manufacturing's.  Failures in features create dissatisfactions, so removing failures is the purpose of quality improvement, while creating features is the purpose of quality by design

4. Quality By Design Benefits Faster product development Better Quality Less work in progress Fewer engineering changes orders Increase productivity Reduce labor costs Increased profit for the company Significant decrease in time to market Communication Model

5. 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. 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.

6. Implementation Dedicated Project Teams Have a sense of togetherness. Communication is established. Each member knows the capabilities of team members Implementation. Disadvantages 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.

7. 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 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.

8. Implementation Computer Networks Allow team members to communicate with the department they came from. Communication with resources and applications. Benefits of Computer Networks Eliminates cost of Co-Location. Communication between team members and outside consultants. Records progress for managers and accounting department.

9. Organizational Tools The primary organizational tools for a quality by design environment are: Total Quality Management Philosophies Computer Networks ISO 9000 ISO 14000 Total productive maintenance Quality function deployment’ Information Technology Electronic meeting software Enterprise resource planning software

10. Organizational Tools Total Quality Management : -All employees must understand these principles so they can understand organizational goals and achieve them. Computer Networks : -consists of both LAN and WAN, to share information within an organization or miles away. ISO 90000 : -the ISO 9000 definition is a description of a quality management system. The object of the ISO 9000 family of standards is to provide organizations with the guidance and tools needed to ensure that their products and services meet external requirements and drive consistent quality improvement.

11. Organizational Tools ISO 14000 : - ISO 14000 is a set of rules and standards to help companies reduce industrial waste and environmental damage. ISO 14000 is a framework for better environmental impact management. Total Productive Maintenance : -TPM emphasizes proactive and preventative maintenance to maximize the operational efficiency of equipment. It blurs the distinction between the roles of production and maintenance by placing a strong emphasis on empowering operators to help maintain their equipment. -The implementation of a TPM program creates a shared responsibility for equipment that encourages greater involvement by plant floor workers. In the right environment this can be very effective in improving productivity (increasing up time, reducing cycle times, and eliminating defects).

12. Organizational Tools Quality Function Deployment : -relates customer requirements with engineering characteristics and production processes. It is considered as Perfect blueprint by design experts. Electronic meeting software : -a means for individuals to communicate their opinions within a group in a structured and creative environment. Enterprise Resource Planning : -ERP unites separate systems under umbrella of one software database of a company.

13. Product Development Tools CAD Solid modeling software Finite element analysis software Parametric analysis software Rapid prototyping techniques Design for manufacturing and assembly techniques Design for maintainability and serviceability Design for reliability Failure mode and effect analysis

14. Product Development Tools CAD : - CAD, or computer-aided design and drafting (CADD), is technology for design and technical documentation, which replaces manual drafting with an automated process. Solid Modelling software : - it is used to create a visual verification of a component or a system of components. By viewing 3D model, problems between part interactions can be defined easily. FEA : -The advantage of finite element analysis lies in its power to analyse and optimise the response of a system prior to prototype development and testing.

15. Product Development Tools Parametric Analysis Software : -It expands the capabilities of solid modeling and FEA software to include parametric modeling from parts libraries and design optimization. Rapid prototyping techniques : -to quickly produce a physical “one piece” model of a component or product . DFMA : -it identifies the production and assembly problems before design effort continuous. Recently, DFMA has evolved to include design for service and design for environment. Design for Reliability : -it is a philosophy of assuring that reliability is built into the design Reliability is the probability that a product will perform its intended function for a given time under specified conditions.

16. Product Development Tools Design for Maintainability or serviceability : -It has strong relationship with the design for assembly. Some underlying principles includes: low fastener count, low tool count, predictable maintenance schedules, one-step service functions and provide diagnostics and monitoring facilities. Failure mode and Effect Analysis (FMEA) : -a technique to identify foreseeable failure modes of a product or service and plan for their elimination.

17. Production Tools These are used to improve the quality of manufactured parts and decreasing the production cycle time requires for high powered computer programs integrated with computer controlled machine tools and modern facilities. 1.Robotics : They are capable of operating in the open architecture personal computers and can interact with CAD/CAM software packages. Now robots are developed as autonomous systems. 2.Computer aided manufacturing is used to identify machine tool path and other production parameters to optimize the machining of a part. It identifies critical machining parameters based on part geometry , size , dimensions and tolerances. 3.Computer numerical controlled tools Machine tools such as mills, lathes and presses they are completely controlled by a microprocessor called computer numerical control machine tools. Advanced CNC machines and modern facilities also can automate material handling.

18. Production Tools 4.Continuous process improvement is a systematic year after year study to improve the production processes involved in production. This process involves eliminating waste and rework, reducing scrap and cycle time and eliminating nonconformities wherever they occur. 5.Just in time production Is a process control method and production philosophy that provide parts ,components and assemblies to production at the exact time they are needed. its result is less inventory of raw materials , smaller inventories of parts, less work in process and shorter lead times. 6.Virtual manufacturing software It enable to create a factory on their desktop computers. It allows production engineers to analyze and debug production facilities prior to the capital equipment investment. They can simulate a production facility and operations in a virtual setting.

19. Production Tools 7.Agile manufacturing It helps organization thrive in a rapidly changing, competitive marketplace by incorporating verstility into the manufacturing environment. It responds quickly to marketplace demands and customer needs. 8.Advanced measurements and verification It brought together the worlds of computer-oriented product development tools and computer-oriented manufacturing tools. The newer systems are capable of defining part shapes automatically with extremely high precision.

20. Statistical Tools Quality engineers are the primary users of statistical tools associated with a quality by design environment. However all employees should be able to use statistical tools where appropriate. The primary statistical tools that cover all the facets of design ,testing and production are: 1 . Statistical tolerance stack-up analysis. It is performed to prevent any functional or assembly problems due to incorrect tolerances. Simulation is performed to anticipate problems if any ,before physical manufacturing of the parts. 2. Reliability and life data analysis It is performed to estimate measures such as Mean Time Between Failures (MTBF) or B10 Life. Reliability data is most often incomplete which is the data of failures and survivals.

21. Statistical Tools 3. Design of experiments It is a numerical study that identifies the variables in a process or product that are the critical parameters or cause significant variation in the process. There are 3 approaches to DOE :Classical , Taguchi and Shainin . 4 . Response surface methods It is used to optimize the solution obtained through DOE when the response in nonlinear . 5. Statistical process control It is the primary TQM tool. It is a Charting technique used to monitor process variation and correct problems before producing scrap.

22. Misconceptions and Pitfalls of quality by design: Some organizations claims to have been using quality by design for quite sometimes, but most possibly they have redefined quality by design to fit their methods rather then changing their present management style. Following are some misconceptions that should be understood by those claiming to have used quality by design . Quality by design is not a quick fix or magical formula for success, it's a way of thinking . People involved in group must be specialist before engaged in a group. Quality by design is often confused with inspection techniques used in TQM. It highly dependent upon a TQM environment but the same inspection methods are not required , incorporates repeatability in products rather than automatically or manually. Quality by design is not simultaneous design and production . Nothing is produced until all designs are agreed upon between all the producers required to fabricate the product.

23. Cont … The following is a list of some of the common pitfalls to avoid if an organization is considering implementation quality by design. 1. Team members should be assigned to functional departments , as in sequential engineering; however, their primary loyalty lies with quality by design team. Don't eliminate the sequential engineering process and should work in a team by improved communication. Build product incrementally, don't complete at a time. 2. Avoid promising to meet an unobtainable schedule, because missing it ,carries a more severe penalty than meeting a longer one. Should lead time for anticipated or uncontrolled design changes.

24. C ont ... 3. Avoid using tight tolerances and stringent requirements to obtain a one-pass designing. 4. Avoid changing definition and specifications during the design phase as it leads to increase in cost. 5. Avoid “business as usual” parts vendoring by using the low bidder. 6. Avoid automating the product development phase before it is simplified. so, these are some possible pitfalls, and the manner in which an organization implements quality by design depends on its size , structure and product line.