Download - PAT A FRAMEWORK FOR EXCELLENCE
PAT
A FRAMEWORK FOR EXCELLENCE
ByTimothy Leistikow
ASQ FD&C DIVISION22. October 2004
PAT Goals
Risk Management
CurrentTechnology
Manufacturing Innovation
Characterization of “Future State” of manufacturing
• Quality ensured through effective & efficient processes
• Recognizing the capability of process control strategies to mitigate risk of poor quality
• Product & process specifications based on formulation and process factors
• Continuous real time quality assurance
Characterization of “Future State” of manufacturing
• Quality ensured through effective & efficient processes
• Recognizing the capability of process control strategies to mitigate risk of poor quality
• Product & process specifications based on formulation and process factors
• Continuous real time quality assurance
Process Efficiency and Effectivity
Basic Process Functions?Process Failures?
Failure Effect on Process and Product?Process controls?
Control Effectivity?
Assessing Process Effectivity and Efficiency
• Functional Block Diagram• Failure Modes and Effects Analysis• Characteristics Matrix• Design of Experiments • Dynamic Control Planning
Characterization of “Future State” of manufacturing
• Quality ensured through effective & efficient processes
• Recognizing the capability of process control strategies to mitigate risk of poor quality
• Product & process specifications based on formulation and process factors
• Continuous real time quality assurance
Process Control Strategies
FMEA PFMEA
EMEA
Product Process
Human Error
Process FMEA & EMEA
• Indicates risks to process output quality
• Documents process control rationale
• Shows effects of process variation on product quality
• Prioritizes Continuous Improvement effort
• Indicates risk areas due to human error
• Provides direction for Poka – yoke applications
• Reveals Management induced errors
• Continuous Improvement format for operators
Equipment Error Modes Analysis
People Processes Gap AnalysisPeople Processes Matrix
SYSTEMMaintenance Operations Materials
Formal SOP 325SOP 156
SOP 958SOP 639
SOP 187
Informal SkillsManualsEnvironment
SkillsEquipment KnowledgeEnvironment
SkillsIT SystemKnowledge
EMEA paradigm shift
• Errors aren’t caused by “bad” personnel• It’s “good” people having bad results
EMEA Process
The greatest discovery of my generation is that human beings can alter their lives by altering their attitudes of mind.
William James
Characterization of “Future State” of manufacturing
• Quality ensured through effective & efficient processes
• Recognizing the capability of process control strategies to mitigate risk of poor quality
• Product & process specifications based on formulation and process factors
• Continuous real time quality assurance
Characteristics MatrixAutomotive Application
• C = Characteristic is used for clamping• L = Characteristic used for locating• X = Characteristic changed at operation
DimNo
Description
Tolerance
Operations05 10 20 30
1 ID +/- .01 X C X2 Face +/- .001 X C C4 OD +/- .005 X
Characteristics Matrix Paradigm Shift Example
• X = characteristic affected by operation – see process flow diagram
• S = Characteristic must be stable• NC = Characteristic not controlled
Charact.Descript
Tol. Operation number / Capability10 Cpk 20 Cpk 30 Cpk
H20 PH PH 6-8
X 1.56 S 1.44 S 1.0
H20 Temp
+/- 1 deg
NC 0.9 NC 0.9 X 2.0
Measurement Capability Studies
• Use of DOE to assess measurement capability
• Measure capability as a ratio of variation to process/product tolerance (% tolerance)
• Typical requirement – 6 sigma can be no more than 30% of tolerance
Characterization of “Future State” of manufacturing
• Quality ensured through effective & efficient processes
• Recognizing the capability of process control strategies to mitigate risk of poor quality
• Product & process specifications based on formulation and process factors
• Continuous real time quality assurance
Continuous Real Time
• Measuring the characteristic• Creating the signal• Interpreting the signal• The response
Line of sight
Clean Room4
6
Continuous Real Time Feedback
Line of sight
Clean Room
Continuous Real Time Feedback
Operator instructions
Operator Feedback
The real problem is not whether machines think but whether men do. – -- B. F. Skinner
Manufacturing Innovation
Innovation in manufacturingCustomer Satisfaction
New
Materials
New
Processes
New
Skills
Customer
Satisfaction
Manufacturing Innovation Benchmarking
Automotive Quality Planning
Advanced Product Planning and Control Plan Process (APQP)
Advanced Product Quality Planning and Control Plan (APQP)
• PLAN – DO – STUDY – ACT (Cycle of continuous improvement)
• Organizes reviews of elements that affect quality
• Identifies risks to product quality • Reveals critical paths and efficiency
problems
Goal of Product Planning Cycle
The APQP cycle
Upfront planningDocuments the experience from one program
Applies acquired knowledge to the next program
Learning from the past
• Experience is the name every one gives his mistakes. – -- Elbert Hubbard
Common ToolsLoss of knowledge
•Computers -DOS operating systems
• Maybe 20% of current windows users know how to operate.
10-30 years ago
How tools have changed
There is no reason for any individual to have a computer in his home.
– -- Kenneth H. Olson, President of DEC, Convention of the World Future Society, 1977
“Success is meeting customer needs in a timely manner at a cost that represents
value”
• Timing of elements for Quality Planning• Simultaneous engineering
Quality Planning Sequences Planning
Product Design andDevelopment
Process Design and Development
Validation Activities
Production
Launch
Feedback Assessment & Corrective Action
Planning Program
• Things gone wrong reports• Things gone right reports• Capability indicators• Problem resolution reports• Customer returns/rejections
• Product Goals• Reliability and Quality
Goals• Preliminary Process Flow
Chart• Preliminary listing of
Product and Process Characteristics
• Product Assurance Plan
Inputs Outputs
Quality Planning Sequences Planning
Product Design andDevelopment
Process Design and Development
Validation Activities
Production
Launch
Feedback Assessment & Corrective Action
Product Design & Development
• Design for manufacturability
• Design reviews• Product Specifications• Material
Specifications
• New tooling and facilities requirements
• Gages/Testing requirements
• Prototype Control Plan• Special Product and
Process Control Characteristics
Design Outputs Advanced Quality Planning
Product Design & Development
• Identifying special Product and Process Characteristics
• Identification of testing and gauging requirements
• New equipment requirements
Design Review Process APQP Team
Concurrent Engineering
Design of ExperimentsVariation of Product
Design FMEA’sDesign for manufacturability
Design FMEA
• Aids in identifying controls needed to reduce variation of product
• Indicates where risk elements to Product Quality may exist
• Provides an open format for listing continuous improvement tasks
• Provides a knowledge base for identifying root causes.
Quality Planning Sequences Planning
Product Design andDevelopment
Process Design and Development
Validation Activities
Production
Launch
Feedback Assessement & Corrective Action
Process Design and Development
• Packaging Standards• Process Flow Charts• Measurement Systems Analysis Plan• Process FMEA’s• Process Instructions• Characteristics Matrix
OUTPUTS
FMEA & EMEA Supporting Analyses
• Functional Block Diagrams• Characteristics Matrix• Process Flow Charts• Design of Experiments• Cause and Effect Diagrams• Capability Studies (Process)• Capability Studies (Measurement Process)
Quality Planning Sequences Planning
Product Design andDevelopment
Process Design and Development
Validation Activities
Production
Launch
Feedback Assessment & Corrective Action
Feedback Assessment & Corrective Action
• Documentation of Variation sources affecting Product Quality (Risks)
• Identification of critical path items affecting Delivery and Product Quality (Risks)
• Continuous Improvement– Lessons learned during APQAP Project– Elements requiring further optimization– Elements requiring reduction in variation
Successful Risk Managementis based on
• Recognizing what can go wrong• Determining the probability of occurrence• Determining the severity of occurrence
• What we anticipate seldom occurs: but what we least expect generally happens. – -- Benjamin Disraeli
Final thoughts