Industrial Regulation and Quality CHMG 751

1. Industrial Regulation and Quality CHMG 751 Manhattan College Fall 2012 Class 2

2. Agenda • Review Homework Assignment No. 1 30 min • Review Homework Assignment No. 2 GMO Case Study 30 min • Product Quality 30 min • Break 15 min • Product Lifecycle 30 min • Quality Function Deployment 30 min • Concurrent Engineering 15 min

3. Homework Assignment No. 1 • Describe the major U.S. regulations influencing that area? • Select one other country or region and cover its regulations? • What government agencies are involved? (hint: maybe more than one) • How does it impact the product? • How does it impact the manufacturing process?

4. Homework Assignment No. 1

5. Homework Assignment No. 2: GMO Case Study • What were the main takeaways? • Did you agree or disagree? Why? • How would you improve the author(s) points? • Are there alternative rationales? • How can you broaden or expand the case study?

6. Product Quality • Some Recent News • 2012: Salmonella in Cantaloupes in the US • 2012: Fine Chemical Manufacturer pays $1 million for air contamination • 2011: Microbiological contamination in facial and eyelash cosmetics • 2011: Vaginal Mesh Implants in the US • 2008: Heparin Scare in China • 2007: Water Pollution in India

7. Product Quality • What is quality? • Who defines quality? • What is the cost of quality or lack of it • How do we use quality to drive product design and process design • What is the relationship between product quality and regulations? • Is meeting regulations part of quality? • Is it separate from regulations?

8. Product Quality • History of Quality • Ancient Times • Items made at home or in local markets • One piece at a time • Driven by artisans such as blacksmiths, masons, etc. • Pride of the craftsman • 19th Century • Industrial Revolution created concept of providing products to mass quantities of people • Transfer of Knowledge from experts to management structures/concept of workers • Quality issues began to rise substantially

9. Product Quality • History of Quality • 20th Century • Mass produced products lacked “quality” • Management focused on Quality and became a science borrowing concepts from probability/statistics, industrial engineering and management principles • Juran: Cost of poor quality, application of Pareto rule, the application of acceptance sampling, inspection and control charts, • Deming: went to Japan to teach quality concepts, credited with the TQM movement • Feigenbaum: Concept of Total Quality Control, the Hidden Plant and Quality Costs • Crosby: Price of nonconformance, Zero Defects • Ishikawa: Root Cause Analysis, Fishbone Diagram

10. Product Quality • Definition of Quality • Joseph Juran said “Fit for use” • Philip Crosby said “Conformance to requirements” • International Organization for Standardization (ISO) defines it as • The “totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs” • Customer Satisfaction and loyalty • Customer is anyone affected by the product or process • External Customers (Actual user of the product, buyer, regulatory bodies) • Internal Customers (downstream users of the intermediates within the manufacturing operation or supply chain) • Some folks say • It is something we feel or know by our gut instinct?

11. Product Quality • Components that seem to be implied in the definition • Product Features (included) • Freedom of Defects (excluded)

12. Product Quality • Components that seem to be implied in the definition • Product Features (included) • Safety • Physical • Chemical • Microbiological • Energy Level • Toxicological • Freedom of Defects (excluded) • Could be defined as a too much or too little of the desired features • Introduction of some new feature not requested

13. Product Quality • Quality Relationships • Productivity • Measured Output of Units/Input of Effort • When the quality of the input requires more labor, material, energy etc productivity goes down • Product Costs: • When defects are experience in the manufacturing of the product, typically costs increases due to rework, additional material • When defect are experience by the customer (user) of the product and defects occur, cost will increase if recalled, fixed in the field and possibly future sales are lost • Cycle time • Customer typically wants products with minimal waiting time. • Delays are perceived as low quality • Value: • Value = Quality /Price • If product quality improves at the same price, the value perceived by the customer increases

14. Product Quality • Views of Quality in Organizations • Internal • Compare product (individual or batches) to specifications • Passes Inspection • Internal quality measures • Viewed as a technical matter • Efforts coordinated by a quality manager • External • Compare product to competition • Provide satisfaction over product life • Meets customer needs • Viewed as a business issue • Efforts directed by senior management

15. Product Quality • Cost of Poor Quality • Monetary loss of products and processes that are not achieving their quality objectives • Reasons for calculating cost of poor quality • Quantifying improves communication to management • Opportunities for improvement can be indentified • Opportunities for reducing customer dissatisfaction • Ability to evaluating progress on quality improvements

16. Product Quality • Cost of Poor Quality • Categories of Quality Costs • Internal Failure Costs • Failure to meeting Customer requirements and need • Cost of Inefficient Processes • External Failure Costs • Appraisal Costs (Inspection, Documentation Review) • Prevention Costs • Hidden Quality Costs

17. Product Quality • Relationship between Quality and Regulations • Quality is driven by the customer need • Regulations driven by the government needs • But are the government needs representing the customer needs or are the separate? • They should be similar or the same… or • When the customers needs are better represented by the government Industry Regulations supports the capability of defining and managing product quality

18. Break 15 minutes

19. Product Life Cycle (PLC) • Product Life Cycle Curve • Development • Introduction • Growth • Maturity • Decline

20. Product Life Cycle (PLC) • Key product characteristics across the life cycle

21. Product Life Cycle (PLC) • Two Perspectives • Marketing: Focuses on the features to sell the product • Product Design/Engineering: Focuses on the features to make the product Both have a common element…. Define the features to ensure the product meets the requirements

22. Product Life Cycle (PLC) • Defining requirements • Potentially different requirements at different phases of the life cycle • Examples • Products at Introduction may command higher costs or have fast speed to market, different customers want different options such as packaging design or sizes or formulations • Products at maturity phase (commodities) have competition and would be driven by lower costs • Some requirements may be the same through all phases • Need for product availability • Product customization • Quality!!

23. Product Life Cycle (PLC) • Defining requirements • How do we define product requirements? • Marketing Perspective • Market Surveys, Customer Interviews. Product Gap Analysis • Design/Engineering Perspective • Subject matter experts (SMEs) know specific problems that exist • Scientist or Engineer explores ideas in research, Prototyping • Do they always align? • Not always. • Why would they not align? • Different interests by the groups, not understanding the customer needs, technical issues, others….

24. Quality Function Deployment • Developed by Yoji Akao in 1966 • Formal method to develop design quality aimed at satisfying the consumer and the translating into design targets and quality assurance points used in the production phase • Voice of the Customer: “what do they want or probably need” • Prioritize spoken and unspoken wants and needs • Translate needs into technical characteristics and specifications • Build and deliver a quality product or service by focusing everybody toward customer satisfaction • Voice of the Product Engineer; how will we design the product • Translate the customer needs into product specifications • Voice of the Engineer; how will we make the product • Translate the product specifications into process specifications • Voice of Manufacturing: how will produce it consistently • Ensure process specifications are met with controlling the correct parameters

25. Quality Function Deployment • QFD has four phases • Product Planning: Convert Customer Requirements into Product Features • Product Design: Convert Product Features into Product Design Elements • Process Planning: Convert Product Design Elements into Manufacturing Processes • Process Control: Convert Manufacturing process into performance indicators/process control parameters

26. Concurrent Engineering • Parallel Alignment of Product Design and Process Design • Interaction of Product Features and Process Design Opportunities/Constraints • Eliminate “over the wall” engineering • Influence on the product design • What raw materials that are less hazardous/less impact to environment • Manufacturing Science: What process technologies are best practice in the industry and guide development studies to understand critical process parameters • Understand scale-up issues early in the product development • Understand the impact on a large scale earlier in the development phase

27. Concurrent Engineering • Example: Pharmaceutical Example • Building a typical pharmaceutical plant for a single product $50 – 500 million US • Timeframe from conceptual design to startup: 3 years + • Product being considered is in clinical trials but could be approved in one year • What should you do? • Option 1: Linear path and wait for approval prior to process design and construction • Option2: Concurrent Engineering between researchers, pilot plant engineers and process engineers • Answer: Concurrent Engineering • Involve process engineering, facility selection and design groups to review potential process with pilot plant • Early purchase of equipment and long term items • Invest small amount of design effort to reduce time to approved production facility

28. Concurrent Engineering • Cost of Change

29. References • Akao, Quality Function Deployment • Gryna, Frank, Quality Planning and Analysis • Miller Landon, Concurrent Engineering Design • ASQ website, www.asq.org

30. Homework Assignment No. 3 • Pick a particular product in one of the industries • Develop 5-6 Customer Requirements (Needs) • Apply QFD Model to generate • Product Requirements • Process Design Requirements • Process Parameter Requirements • Hint: Select 3-4 in each category, exercise is meant to show alignment between the categories, not to be exhaustive in any one category.

31. Homework No. 4 • Case Study: Implementation of QFD in a Dairy Company • Follow critical analysis guidance in syllabus

32. Next Week • Module 3 • GxPs • Quality Systems • Quality Control • Quality Culture, Governance and Mgt Techniques • Quality Organizational Structures