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