Product and Process Control Systems

1. Product and ProcessControl Systems

2. Purpose • Assure that your company’s products are meeting the needs of customers with regard to quality and that company suppliers are meeting internal company requirements. • Validate and/or map the current processes for the selected products. • Evaluate whether the current product and process controls that are in place are able to meet these needs. • Identify optimized or new “Critical to Quality – Critical to Customer” requirements for the “vital few” needs and assure that an effective “process control system control plan” is in place for the selected products and sub-components to assure customer and company needs are satisfied. • Understand the relationship of CCRs (Critical Customer Requirements) to KPCs (Key Product/Process Characteristics) and the process to identify KCCs (Key Control Characteristics). • Create small process control teams that will optimize existing or create Product and Process Control Systems for the selected products. • Schedule time over the next few weeks to begin the process of improving the process controls and metrics defined in the control systems. Product-Process Control 2 .PPT

3. The purpose of an organization is to meet the needs of its customers at the lowest optimum cost. It creates products. Products can be goods, services, or information. Products are produced by processes. A process is a sequence of events or tasks that create an output: a product. A process includes everything involved at each step: people, techniques, equipment, materials, energy, facilities, etc. A customer is one who receives the output of a process or any step in a process. External customers are a “cast of characters” located beyond your organization. Agree on Common Definitions Product-Process Control 3 .PPT

4. Agree on Common Definitions • An internal customer is one who is located within your organization. • Meeting the needs of internal customers is a prerequisite for meeting the needs of external customers AS LONG AS IT DOES NOT SUB-OPTIMIZE the external customers • Management must meet both sets of needs. • Quality is measured by the extent to which the specific needs of • specific customers are met. • Process outputs embody both product features and deficiencies. • Process variation is any change to the process that negatively impacts our ability to meet the needs of our customers. Product-Process Control 4 .PPT

5. How Do CCRs Relate to KPCs All… Are… Not all… Are… KPC CCR CCR KPC Product-Process Control 5 .PPT

6. What Is a Key Characteristic? • A KEYcharacteristic is a product characteristic for which reasonably anticipated variationcould significantly affecta product’s safety, compliance to government regulations, performance, or fit. Added Care Needed What you would like LSL Std. USL LSL KPC USL Loss Taguchi Loss Function Product-Process Control 6 .PPT

7. Two kinds of characteristics Product Key Product Characteristic (KPC) Safety / Compliance Fit / Function Process Key Control Characteristic (KCC) Control of a process characteristic will ensure that variation of a product characteristic is reduced Key Characteristic Concepts Product-Process Control 7 .PPT

8. Fit/Function Key Product Characteristics Fit / Function Standard Product Characteristics Fit / Function Symbol Product Characteristic Pyramid • A product characteristic for which reasonably anticipated variation could significantly affect: • Customer outcomes other than safety/compliance such as: • Fit • Function • Performance • Durability • Mounting or appearance • Ability to process or build the product Product-Process Control 8 .PPT

9. Safety/Compliance Characteristics Fit / Function Standard Product Characteristics Safety/ComplianceSymbol Product Characteristic Pyramid • A product characteristic for which reasonably anticipated variation could significantly affect: • Product Safety • Compliance with Governmental Standards and Regulations • Emissions • Environmental Product-Process Control 9 .PPT

10. Selecting KPCs and KCCs • Key Product Characteristics (KPCs) are outputs froma process that are measurable on, within, or about the product itself. They are the outputs perceived by the customer. • Examples of Key Product Characteristics (KPCs): • KPCs "On" The Product - Width, Thickness, Coating Adherence, Surface Cleanliness, Etc. • KPCs "Within" The Product - Hardness, Density, Tensile Strength, Mass, Etc. • KPCs "About" The Product - Performance, Weight, Etc. • Key Control Characteristics (KCCs) are inputs that affect the outputs (KPCs). They are unseen by the customer and are measurable only when they occur. Product-Process Control 10 .PPT

11. Translate KPCs to Effective KCCs KCC KCC KPC KCC KCC • Identify the exact step where each KPC is created • Determine what process characteristic(s) impact the KPC and how they affect KPCs • May require studies (Design of Experiment, PFMEA) • These are your Key Control Characteristics (KCC) • Determine how to measure those KCCs • Determine how repeatable and reproducible those measurements are (measurement system capability) • Determine your process capability • Develop your process control system • Implement your process control system Product-Process Control 11 .PPT

12. Tools to Identify KCCs • List of KPCs • FMEA (Failure Mode and Effects Analysis) • Process Capability Studies • Process Flow Diagrams • DOE (Design of Experiments) • Process Control Plans • Cause-Effect Diagrams • Pareto Analysis Product-Process Control 12 .PPT

13. KPCs May Be… • Dimensions • Attributes • Properties • Engineering Specifications/Tests • Usage • Function/System Function • Orientation • Fit and Finish • Feature for a Part • A Sub-assembly • A System Product-Process Control 13 .PPT

14. KCC Test • The following will determine if a process parameter is or is not a key control characteristic. • A Key Control Characteristic (KCC) is: • A process parameter for which variation must be controlled around some target value to ensure that variation in a KPC is maintained around its target values during manufacturing and assembly. • A process parameter for which reduction in variation will reduce the variation of a KPC. • Directly traceable to a KPC. • Particularly significant in ensuring a KPC achieves target value. • Not specified on product drawing or product documentation. Product-Process Control 14 .PPT

15. Product and Process Control Systems  SENSOR (Device and/or person measuring the control subject) CONTROL SUBJECT (Specific attribute or variable to be controlled) STANDARD (Specification, target value)     ACTUATOR (Adjusts the process) NOT OK  UMPIRE (Does control subject meet the standard?) OK End of One Cycle • Purpose • To maintain a specific output of a process at it’s standard; • To assume consistent production; • To assure stability; • To prevent/correct departure from a specific standard Product-Process Control 15 .PPT

16. Choose Control Subjects Choose Control Subjects Establish Measurement Establish Standards of Performance Measure Actual Performance OK? Compare to the Standards Not OK? Take Action on the Difference • Identify major work process • Identify objective of the process • Describe the work process • Identify customers of the process • Discover customer needs (Critical Customer Requirements) • Select control subjects (KPCs and KCCs) Product-Process Control 16 .PPT

17. Process Map Go to supermarket Yes Pick up Long list of No basket items? Yes Get shopping cart Shop Go to More than No express ten items? lane Yes Go to any check-out Put groceries on conveyor Pay for Receipt groceries Leave store Product-Process Control 17 .PPT

18. Concept of Dominance • The number of control subjects can be overwhelming. • Operating processes are influenced by many variables: • Input materials • Physical facilities • Human skills • Environmental conditions • Often one variable is more important than all the rest combined. Such a variable is said to be the “dominant variable.” Product-Process Control 18 .PPT

19. Dominant Variables Product-Process Control 19 .PPT

20. Dominant Variables Dominant Process Variables • Set-up dominant: Some processes are highly stable, and their results can be reproduced over many cycles of operation. The design for control should provide the operating forces with the means for precise set-up and the means to validate it before operations begin. A common example is an operation or a printing process. • Time-dominant: Here the process is known to change progressively with time, e.g., depletion of consumable supplies, heating up, length of an operation, wear of tools. The design for control should provide means for periodic evaluation of the effect of any progressive change, and for convenient readjustment. • Component-dominant: Here the main variable is the quality of the input materials, sub-assemblies, and components. An example is the assembly of complex electronic or mechanical equipment, such as a computer. For the short run, it may be necessary to resort to inspection of materials from a supplier. For the long run, the design for control should be directed at supplier relations, including joint planning with suppliers to upgrade their inputs. Cont’d. Product-Process Control 20 .PPT

21. Dominant Variables • Worker-dominant: In these processes, quality depends mainly on the skill and knack possessed by the workers. The skill trades and specialists are well-known examples. The design for control should emphasize aptitude testing of workers; training and certification; quality rating of workers; error-proofing to reduce worker errors. • Information-dominant: Here the processes are of a “job-shop” nature, so that there is frequent change in what product is to be produced. As a result, the job information changes frequently, as in the case of a service department. The design for control should concentrate on providing an information system that can deliver accurate, up-to-date information on just how this job differs from its predecessors. Cont’d. Product-Process Control 21 .PPT

22. Establish Measurement Choose Control Subjects Establish Measurement Establish Standards of Performance Measure Actual Performance OK? Compare to the Standards Not OK? Take Action on the Difference • Develop unit of measure • Develop sensor Product-Process Control 22 .PPT

23. Measurement 98.6 98.6 • Unit of Measure • A defined amount through which one can evaluate a quality feature in numbers • Sensor • A method or instrument that can make the measurement Product-Process Control 23 .PPT

24. Ideal Unit of Measure • Is understandable • Provides an agreed-upon basis for decision-making • Is customer focused • Applies broadly Product-Process Control 24 .PPT

25. Types of Sensors Technical Human Product-Process Control 25 .PPT

26. Establish Standards of Performance Choose Control Subjects Establish Measurement Establish Standards of Performance Measure Actual Performance OK? Compare to the Standards Not OK? Take Action on the Difference • Set targets • Develop control methods • Set checking criteria Product-Process Control 26 .PPT

27. Criteria for Targets • Customer focused • Aggressive and realistic • Help control the process Product-Process Control 27 .PPT

28. Develop Checking Methods What will be checked How the checking will be done When it will be checked Who is responsible Product-Process Control 28 .PPT

29. Example: Baking a Cake Product-Process Control 29 .PPT

30. Measure Actual Performance Choose Control Subjects Establish Measurement Establish Standards of Performance Measure Actual Performance OK? Compare to the Standards Not OK? Take Action on the Difference • Charter indicators • Develop detailed work • Instructions Product-Process Control 30 .PPT

31. Compare to the Standards Choose Control Subjects Establish Measurement Establish Standards of Performance Measure Actual Performance OK? Compare to the Standards Not OK? Take Action on the Difference • Quality Goals • Quality Manual Product-Process Control 31 .PPT

32. Take Action on the Difference Choose Control Subjects Establish Measurement Establish Standards of Performance Measure Actual Performance OK? Compare to the Standards Not OK? Take Action on the Difference • Analyze process • Make contingency plans • Troubleshoot Product-Process Control 32 .PPT

33. Three Types of Actions Troubleshooting Quality Improvement Quality Planning Product-Process Control 33 .PPT

34. Next Steps • Work in assigned teams to: • Map assigned processes • Analyze processes for accuracy • Review the key processes to define CCRs, KPCs, and KCCs • Utilize a Process Control System Six Sigma Template to document Product and Process Control Systems for the assigned processes • Identify a plan to close the gaps if company and customer requirements are not met Product-Process Control 34 .PPT

35. Process Control System (Business Process Framework) Process Owner: Direct Process Customer: Date: Process Description: CCR: Flowchart Measuring and Monitoring Measures (Tools) Where & Frequency Specs &/or Targets Key Measurements Responsibility (Who) Contingency (Quick Fix) Remarks Product-Process Control 35 .PPT