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S S

IX
FOR

CUSTOMER &Six SigmaNTELLIGENCE COMPETITIVE I

IGMA
OF STATISTICS
OFFICE: +1-208-885-4410

SYSTEMS INNOVATION & DESIGN

DEPARTMENT
REDGEMAN@UIDAHO.EDU

Client, Enterprise & Competitive Intelligence for Product, Process & Systems Innovation DR. RICK EDGEMAN, PROFESSOR & University ofIX SIGMA BLACK BELT CHAIR S Idaho Dr. Rick L. Edgeman,

S S
IX
DEPARTMENT

Six Sigma

IGMA
OF STATISTICS

DMAIC: The Measure Phase

Client, Enterprise & Competitive Intelligence for Product, Process & Systems Innovation Dr. Rick L. Edgeman, University of Idaho

S S
IX
DEPARTMENT

Six Sigma

IGMA

a highly structured strategy for acquiring, assessing, and applying customer, competitor, and enterprise intelligence for the purposes of product, system or enterprise innovation and design.

OF STATISTICS

Client, Enterprise & Competitive Intelligence for Product, Process & Systems Innovation Dr. Rick L. Edgeman, University of Idaho

Six Sigma
Define the problem and customer

Define

requirements.

Measure
Measure

Control

defect rates and document the process in its current incarnation.


Analyze process data and determine
the capability of the process.

Improve the process and remove


defect causes.

Improve

Analyze

Control process performance and


ensure that defects do not recur.

Client, Enterprise Competitive Intelligence for Product, Process & Six Sigma&Innovation & the DMAICSystems Innovation Algorithm Dr. Rick L. Edgeman, University of Idaho

Six Sigma
Measure:
What Measurements are Important and What Tools Should be Used?
1. Select Customer Critical to Quality (CTQ) Characteristics;
2. Define Performance Standards (Numbers & Units); 3. Establish the Data Collection Plan, 4. Validate the Measurement System, 5. and Collect the Necessary Data.

Client, Enterprise & Competitive Intelligence for Product, Process & Systems Innovation Dr. Rick L. Edgeman, University of Idaho

Six Sigma
Measure: 1. Select Customer Critical to Quality (CTQ) Characteristics.
Among useful quality tools in the MEASURE phase are:
Quality Function Deployment (QFD) which relates CTQs to measurable
internal sub-processes or product characteristics.

Process Maps create a shared view of the process, reveals redundant or


Unnecessary steps, and compares the actual process to the ideal one.

Fishbone Diagrams provide a structure for revealing causes of the effect. Pareto Analysis provides a useful quantitative means of separating the vital
few causes of the effect from the trivial many, but require valid historical data.

Failure Modes and Effects Analysis (FMEA) identifies ways that a subprocess or product can fail and develops plans to prevent those failures. FMEA is especially useful with high-risk projects.
Client, Enterprise & Competitive Intelligence for Product, Process & Systems Innovation Dr. Rick L. Edgeman, University of Idaho

Six Sigma
Measure: 1. Select Customer Critical to Quality (CTQ) Characteristics.
FAILURE MODES AND EFFECTS ANALYSIS (FMEA)
Failure Modes and Effects Analysis (FMEA) Process is a structured approach that has the goal of linking the FAILURE MODES to an EFFECT over time for the purpose of prevention. The structure of FMEA is as follows:

Preparation FMEA Process Improvement


a. b. c. d. e.
Select the team Develop the process map and steps List key process outputs to satisfy internal and external customer requirements Define the relationships between outputs and process variables Rank inputs according to importance.
Client, Enterprise & Competitive Intelligence for Product, Process & Systems Innovation Dr. Rick L. Edgeman, University of Idaho

Six Sigma
Measure: 1. Select Customer Critical to Quality (CTQ) Characteristics.
FAILURE MODES AND EFFECTS ANALYSIS (FMEA)
Preparation FMEA

Process Improvement

a. Identify the ways in which process inputs can vary (causes) and identify associated FAILURE MODES. These are ways that critical customer requirements might not be met. b. Assign severity, occurrence and detection ratings to each cause and calculate the RISK PRIORITY NUMBERS (RPNs). c. Determine recommended actions to reduce RPNs. d. Estimate time frames for corrective actions. e. Take actions and put controls in place. f. Recalculate all RPNs. FAILURE MODE: How a part or process can fail to meet specifications. CAUSE: A deficiency that results in a failure mode sources of variation EFFECT: Impact on customer if the failure mode is not prevented or corrected. Client, Enterprise & Competitive Intelligence for Product, Process & Systems Innovation Dr. Rick L. Edgeman, University of Idaho

FMEA Standardized Rating System


1 < RPN = (Degree of Severity)*(Likelihood of Occurrence)*(Ability to Detect) < 1000
RATING 1 2 DEGREE OF SEVERITY Customer will not notice the adverse effect or it is insignificant. Customer will probably experience slight annoyance. LIKELIHOOD OF OCCURRENCE ABILITY TO DETECT Sure that the potential failure will be found or prevented before reaching the next customer. Almost certain that the potential failure will be found or prevented before reaching the next customer. Low likelihood that the potential failure will reach the next customer undetected. Controls may not detect or prevent the potential failure from reaching the next customer. Moderate likelihood that the potential failure will reach the next customer. Controls are unlikely to detect or prevent the potential failure from reaching the next customer. Poor likelihood that the potential failure will be detected or prevented before reaching the next customer. Likelihood of occurrence is remote. Low failure rate with supporting documentation. Low failure rate without supporting documentation. Occasional failures. Relatively moderate failure rate with supporting documentation. Moderate failure rate without supporting documentation. Relatively high failure rate with supporting documentation.

Six Sigma

3 4 5

Customer will experience annoyance due to slight degradation of performance. Customer dissatisfaction due to reduced performance. Customer is made uncomfortable or their productivity is reduced by the continued degradation of the effect. Warranty repair or significant manufacturing or assembly complaint. High degree of customer dissatisfaction due to component failure without complete loss of function. Productivity impacted by high scrap or rework levels. Very high degree of dissatisfaction due to the loss of function without a negative impact on safety or governmental regulations. Customer endangered due to the adverse effect on safe system performance with warning before failure or violation of governmental regulations. Customer endangered due to the adverse effect on safe system performance without warning before failure or violation of governmental regulations.

High failure rate without supporting documentation.

Very poor likelihood that the potential failure will be detected or prevented before reaching the next customer.

Failure is almost certain based on warranty data or significant DV testing. Assured of failure based on warranty data or significant DV testing

Current controls probably will not even detect the potential failure.

10

Absolute certainty that the current controls will not detect the potential failure.

Client, Enterprise & Competitive Intelligence for Product, Process & Systems Innovation Dr. Rick L. Edgeman, University of Idaho

Failure Modes and Effects Analysis (FMEA)

Six Sigma
Prepared by: Page ____ of ____ FMEA Date (Orig) ______________ (Rev) _____________

Process or Product Name: Responsible:

How severe is the effect on the

How often does the Cause or

How well can you detect the

customer?

Client, Enterprise & Competitive Intelligence for Product, Process & Systems Innovation Dr. Rick L. Edgeman, University of Idaho

Calculated

Potential Failure Mode In what ways can the process step go wrong?

Potential Failure Effects What is the impact of the Failure Mode on the customer?

Potential Causes What are the causes of the Failure Mode?

Current Controls What are the existing controls and procedures that prevent the Cause or Failure Mode?

Cause or Failure Mode?

Failure Mode occur?

Process Step/Part Number What are the process steps?

S E V

O C C

D E T

R P N

Actions Recommended What are the actions for reducing the occurrence, decreasing severity or improving detection?

Resp. Who is responsible for the recommended action?

Six Sigma
Measure:
1. Select Customer Critical to Quality (CTQ) Characteristics.
FAILURE MODES AND EFFECTS ANALYSIS (FMEA)
Preparation FMEA Process Improvement

Develop and implement plans to reduce RPNs.


Client, Enterprise & Competitive Intelligence for Product, Process & Systems Innovation Dr. Rick L. Edgeman, University of Idaho

Six Sigma
Measure: 2. Define Performance Standards: Numbers & Units
At this stage customer needs are translated into clearly defined measurable traits. OPERATIONAL DEFINITION: This is a precise description that removes any ambiguity about a process and provides a clear way to measure that process. An operational definition is a key step towards getting a value for the CTQ that is being measured. TARGET PERFORMANCE: Where a process or product characteristic is aimed If there were no variation in the product / process then this is the value that would always occur. SPECIFICATION LIMIT: The amount of variation that the customer is willing to tolerate in a process or product. This is usually shown by the upper and lower boundary which, if exceeded, will cause the customer to reject the process or product. DEFECT DEFINITION: Any process or product characteristic that deviates outside of specification limits.
Client, Enterprise & Competitive Intelligence for Product, Process & Systems Innovation Dr. Rick L. Edgeman, University of Idaho

Six Sigma
Measure:
3. Establish Data Collection Plan, Validate the Measurement System, and
Collect Data.
A Good Data Collection Plan: a. Provides clearly documented strategy for collecting reliable data; b. Gives all team members a common reference; c. Helps to ensure that resources are used effectively to collect only critical data. The cost of obtaining new data should be weighed vs. its benefit. There may be viable historical data available. We refer to actual process variation and measure actual output: a. what is the measurement process used? b. describe that procedure c. what is the precision of the system? d. how was precision determined e. what does the gage supplier state about: f. Do we have results of either a: * Accuracy * Precision * Resolution * Test-Retest Study? * Gage R&R Study?
Client, Enterprise & Competitive Intelligence for Product, Process & Systems Innovation Dr. Rick L. Edgeman, University of Idaho

Six Sigma
Measure: 3. Establish Data Collection Plan, Validate the Measurement
System, and Collect Data. Note that our measurement process may also have variation. a. Gage Variability: Precision: Accuracy: Both:

b. Operator Variability: Differences between operators related to measurement. c. Other Variability: Many possible sources. Repeatability: Assess effects within ONE unit of your measurement system, e.g.,

the variation in the measurements of ONE device. Reproducibility: Assesses the effects across the measurement process, e.g., the variation between different operators. Resolution: The incremental aspect of the measurement device.
Client, Enterprise & Competitive Intelligence for Product, Process & Systems Innovation Dr. Rick L. Edgeman, University of Idaho

Six Sigma
Measure: 3. Establish Data Collection Plan, Validate the Measurement
System, & Collect Data. GAGE R&R (Repeatability & Reproducibility) STUDY: a. Operators at least 3 recommended; b. Part the product or process being measured. It is recommended that at least 10 representative (reflects the range of parts possible) parts per study, with each operator measuring the same parts. c. Trial each time the item is measured. There should be at least 3 trials per part, per customer. Source of Variation % Contribution
Total Gage Repeatability & Reproducibility Repeatability Reproducibility Part-to-Part Total Variation R1 + R2 R1 R2 100% - (R1 + R2) 100%

Client, Enterprise & Competitive Intelligence for Product, Process & Systems Innovation Dr. Rick L. Edgeman, University of Idaho

S S
IX
DEPARTMENT

Six Sigma

IGMA
OF STATISTICS

End of Session

Client, Enterprise & Competitive Intelligence for Product, Process & Systems Innovation Dr. Rick L. Edgeman, University of Idaho

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