Designing Manufacturing Processes: Defect-Free Approach
Dev Raheja, MS, CSP, author of the books Design for Reliability and Safer Hospital Care, is international risk management, reliability, durability, and system safety consultant for the government, commercial, and aerospace industry for over 30 years.
His clients include Army, Navy, Air Force, NASA, Siemens, Eaton, Boeing, Lockheed, Northrup Grumman, General Motors, Prior to becoming a consultant in 1982 he worked at GE as Supervisor of Quality Assurance/Manager of Manufacturing Engineering, at Cooper Industries as Chief Engineer, and at Booz-Allen & Hamilton as Risk Management consultant for a variety of industries.
He teaches Design for Reliability courses at the University of Maryland for degree programs in Mechanical Engineering and Reliability Engineering. He is a Fellow of the American Society for Quality and recipient of its Austin Bonis Award for Reliability Education Advancement, and former chair of the Reliability Division. He is a Senior Member of IEEE. He is a former National Malcolm Baldrige Quality Award Examiner in the first batch of examiners. He served as Vice president of the International System Safety Society where he received the Scientific Achievement Award and the Educator-of-the-Year Award. He served on the Board of Directors for the Annual Reliability and Maintainability Symposium for more than 10 years.
Most manufacturing problems can be eliminated by better design of components and assemblies. One can call this approach the Design for Manufacturability, meaning the ability to produce the assembly without known defects. Then none or very little inspection is required, no rejects, no rework, no warranty costs, and therefore high quality at low cost!
The tool of understanding production-related defects overlooked in design is the Process FMEA. In this FMEA we analyze what can go wrong in each step of the production process, and brainstorm with production employees to see if we can design out the production problems. This author’s experience shows that employees can easily come up with design solutions 90% of the time. If unable to design out the problems, then manufacturing and quality assurance engineers should design an early warning system as a part of the process design or develop automated inspections. This may require a minor investment but the benefits are many such as no defects, no rework, no warranty costs, etc., besides increased customer satisfaction.
No individual had more influence on quality management than Dr. W. Edwards Deming. Shortly after World War II, he was invited to help Japan. He defined quality as: A product or a service possesses quality if it helps somebody and enjoys a good and sustainable market. This definition is a win-win value proposition for the user as well as for the manufacturer. It meets the intent of regulations. He taught that management is responsible for 85% of quality problems. He communicated to management by saying that mistakes in production are a symptom of a troubled system, not the cause. Today we have competition from many countries. Our ability to keep the company healthy depends on this knowledge. He implemented his doctrine with the so-called Theory of Profound Knowledge.
- Understanding Key Design Features Related to Defect-Free Production
- Understanding the Theory of Profound Knowledge for Superior Quality
- Conducting HAZOP analysis to identify Latent Hazards in Manufacturing Process
- Using ISO 14971 HACCP Analysis to identify Critical Steps in a Process
- Assuring Conformance to Key Design Features without 100% Inspection or Testing
- Auditing to Identify Unacceptable Variation before Defects are Produced
- Taking Corrective and Preventive Actions using the FDA System
- Training Production Operators to Identify Incidences that may Result in Device Defects
- Production Validation Testing
Course Level - Beginner and Intermediate levels.
Who Should Attend
- Design managers and engineers
- Manufacturing managers and engineers
- Production managers and engineers
- Quality Assurance staff
- Marketing staff
- Product Safety staff
Why Should You Attend
To prevent product recalls and high warranty costs, we need to conduct a special audit of critical dimensions and other features (such as chemical properties, the strength of the solder joints, surface finish, and contamination) on new processes. Identification of critical features should come from the Failure Mode and Effects Analysis, and Fault Tree Analysis. As a minimum, the Six Sigma quality is required on these features. The concept of Six Sigma is the all parts must be within the middle half of the engineering tolerances and the process should able to maintain this level of quality over time in all three shifts with different operators.
Understanding variation means knowing how much variability is inherently internal to the production process and how can it be coming from the external causes called special causes. If the internal variation is high, it usually means the process is unacceptable. If the external cases are frequent, we must eliminate the source of the problem.