1. The Quality Improvement Model
Define Process
The Quality Improvement Model
Select Measures
Collect & Interpret Data
Investigate & Fix Special Causes
Is Process Stable ? No
Investigate & Fix Special Causes
Now going to talk about what to do about an unstable process
This module covers this model step
Purpose:
Assure stability of the measures.
Establish permanency of solutions to recurring special causes.
Improve procedures and training.
Yes
Is Process Capable ? No
Improve Process Capability
Yes
Use SPC to Maintain Current Process

2. Quality Characteristic
Unstable Process
Time
Quality Characteristic
Control Chart
UCL CL
LCL
Circle the special cause
Review what an unstable process is
How do we improve an unstable process?

3. Potential Special Causes
Lack of standardization
Lack of consistent process conditions
Uncontrolled process variables
Unknown process variables
Fluctuating business environment
Equipment malfunctions
Unstable measurement process
Changes in process inputs
Get class to add more
End of month/year - deferred sales (maybe for tax purposes)
Environment
Power failure
Snow storm
New people

4. The Improvement Process
Diagnose
Solve
Study the Symptoms
Theorize Causes
Establish True Causes
Propose Alternative Solutions
Select & Apply Solution
Maintain Improvements
Diagnose = Investigate Find it
Solve = Act Fix it
We must take the time to identify the cause before attempting to solve the problem.

5. Special Cause Action Plan (S.C.A.P.)
A planned sequence of activities for investigating and taking action on a problem which has been detected.
Provides a prioritized listing of potential special causes.
The S.C.A.P. should be updated whenever necessary.
Control charts tell WHEN
Control strategy tells WHAT to do
“Circling special causes never improved anyone’s process”
Andy Anderson story about going to Rochester for a tour and asking an operator what he did when a special cause occurredcled it. Andy tore up the control chart and threw it in the trash saying, “If you aren’t going to do anything about it, why keep the control chart in the first place.”
Actions
1) Investigation
2) Compensation
3) Documentation
4) Correction
5) Prevention
Note: This is the most important part in implementing S.P.C.

6. Investigative Action
Systematic “detective” work to determine the root source of the special cause. The investigative actions should be directed toward determining:
What
When
Why
Where
This is the hard part, FINDING the source of the special cause
Can get frustrating, may not find more than 20-50% of the special causes, even when you look
Have to keep looking, or you’ll find 0%!
Unless the urgency of special cause dictates other action, investigative action should precede any other actions. Regardless of the urgency, investigative action should always be taken at some point.
Note: This is the most important part of the S.C.A.P..

7. Compensating Action
Adjustment made to the process after a nonconformity, defect, or other undesirable process situation in an attempt to restore the process to the desired state, without addressing the underlying cause of the situation. (ISO definition)
May or may not know the cause
“If you do not investigate, you are doomed to compensate.”
Ex. - Start brewing your coffee earlier.
Ex. - Go to dinner and you find a fly in your soup. Management gives you your meal free to make up for it.
Ex. - Car pulls to the right, so you steer a little to the left.
Ex. - Faucet leaks, so you crank the handle tighter.
Eventual domino effect will bite you
Must have already investigated and found the source of the special cause
One time fix
Ex. - Coffee maker takes a long time to brew because of build up. Clean it out, and it works again ... for a while.
Ex. - Car shakes when you drive it. Right front tire is out of balance. Re-balance it and eliminate shakes.. for now. What if the car really needs realignment?
Ex. - Faucet leaks, so replace the washer. Eliminates leak until new washer fails.
Taking action on the process in the form of adjustments to the process. These actions do not remove the cause but are known to adjust the process in a favorable direction. (Adjusting) OR
Taking action on the process to remove the symptom of the special cause. This may not prevent the same problem from recurring in the future. (Fixing)
Adjustments may help one part of the process but could be detrimental to others.

8. Documentation Helps communications
Recording the suspected cause of the problem, what actions were taken and how effective the action was.
Benefits:
Helps communications
Identifies problems which occur most frequently
Accumulates information on the types of actions being taken
Accumulated information guides preventive actions
Feed information back into S.C.A.P. for continual improvement

9. Pareto of Causes
Cause D
Cause G
Cause A
Cause B
Cause N
All others
Frequency of Occurrence
Note: Putting resources to eliminating Cause D will result in most significant
Impact on process improvement.

10. Corrective Action Eliminate the source once and for all
Actions taken to eliminate the causes of existing nonconformity, defect, or other undesirable situation in order to prevent recurrence (ISO definition).
Permanent removal of the root source of recurring special causes that have been identified.
Eliminate the source once and for all
May be expensive
Ex. - Use filtered water in your coffee maker to eliminate hard water build up
Ex. - Stop running over curbs in your Honda and messing up your alignment
Ex. - Restaurant initiates a pest-control program
Ex. - Washerless faucet
Focus is on preventing major recurring special causes.
Implementation results in variability reduction.

11. Preventive Action
Action taken to eliminate the causes of a potential nonconformity, defect, or other undesirable situation in order to prevent occurrence.(ISO definition)
Permanent removal of the root source of a potential special cause that could affect the process.
May involve using learning's from one process on another process where the special cause might also occur.

12. Control To A Standard A standard way to perform a task.
A standard range that a key process variable should be within.
Standards should be audited.
Note: S.O.P.'s NOT being followed can be a major reason for instabilities on control charts!

13. Why S.C.A.P.'s? Control "Charts" will NOT improve the process!
S.C.A.P's IMPROVE the process
Provide a procedure for operations to follow in identifying and removing the special cause symptom.
Promote a standardized approach to investigating and compensating for special causes.
Provide a vehicle for documenting causes found and actions taken to aid in future problem solving.

14. Remember The C&E Matrix
Note: C&E is a good place to start building control strategies. This information will be used to develop a Failure Modes Effect Analysis (FMEA) …

15. FMEA Definition A structured approach to: Assist in developing SCAP's
identifying the ways in which a product or process can fail
estimating the risk associated with specific causes
prioritizing the actions that should be taken to reduce the risk
evaluating the design validation plan (product) or the current control plan (process)
Primary Directive: Identify ways the product or process can fail and eliminate or reduce the risk of failure

16. Role of FMEA
Key tool of process team to improve the process in a preemptive manner (before failures occur)
Used to prioritize resources to insure process improvement efforts are beneficial to customer
Used to document completion of projects
Should be a dynamic document, continually reviewed, amended, updated

17. Purposes of FMEA Analyzes new processes
Identifies deficiencies in the process control plan
Establishes the priority of actions
Evaluates the risk of process changes
Identifies potential variables to consider in Exploratory Data Analyses (EDA) and Design of Experiments (DOE) studies
Guides the development of new processes
Helps set the stage for breakthrough

18. FMEA Inputs and Outputs
Process map
C&E matrix
Process history
Process technical procedures
Outputs
List of actions to prevent causes or to detect failure modes
History of actions taken

19. FMEA Team Team approach is necessary Recommended representatives:
Design
Practitioners / Operators / Supervisors
Quality
Reliability
Maintenance
Materials
Testing
Supplier

20. FMEA Terms Next, Going to define each of these terms… Failure Mode
Effect
Cause
Current Controls
Severity, Occurrence, Detection
Risk Priority Number (RPN)
Next, Going to define each of these terms…

21. Failure Mode - Definition
Failure Mode - the way in which a specific process input fails - if not detected and either corrected or removed, will cause the effect to occur
Can be associated with a defect (in discrete manufacturing) or a process input variable that goes outside of specification
Anything that an operator can see that’s wrong is considered a failure mode
Examples
Incorrect PO number
Sample Size too small
Dropped call (customer service)
Temperature too high
Surface contamination
Paint too thin

22. Effect - Definition Effect - impact on customer requirements Examples
Generally external customer focus, but can also include downstream processes
Examples
Incorrect PO number: Accounts receivable traceability errors
Dropped call: Customer dissatisfaction
Temperature too high: Paint cracks
Surface contamination: Poor adhesion
Paint too thin: Poor coverage

23. Cause - Definition Cause Examples
Sources of process variation that causes the failure mode to occur
Identification of causes should start with failure modes associated with the highest severity ratings
Examples
Incorrect PO number: Typographical error
Dropped call: Insufficient number of CS representatives
Temperature too high: Thermocouple out of calibration
Surface contamination: Overhead hoist systems
Paint too thin: High solvent content

24. Current Controls - Definition
Systematized methods/devices in place to prevent or detect failure modes or causes (before causing effects)
Prevention consists of mistake proofing, automated control and set-up verifications
Controls consist of audits, checklists, inspection, laboratory testing, training, SOP’s, preventive maintenance, etc.

25. Risk Priority Number (RPN)
The output of an FMEA is the Risk Priority Number
The RPN is a calculated number based on information you provide regarding
the potential failure modes,
the effects, and
the current ability of the process to detect the failures before reaching the customer
It is calculated as the product of three quantitative ratings, each one related to the effects, causes, and controls:
Effects
Causes
Controls
RPN = Severity X Occurrence X Detection

26. Definition of RPN Terms
Severity (of Effect)- importance of effect on customer requirements - could also be concerned with safety and other risks if failure occurs (1=Not Severe, 10=Very Severe)
Occurrence (of Cause)- frequency with which a given cause occurs and creates a failure mode. Can sometimes refer to the frequency of a failure mode (1=Not Likely, 10=Very Likely)
Detection (capability of Current Controls) - ability of current control scheme to detect or prevent:
the causes before creating failure mode
the failure modes before causing effect
1=Likely to Detect, 10=Not Likely at all to Detect

27. "Example" Rating Scale
Detection is typically assumed to imply action can be taken

28. FMEA Form - Initial Assessment

29. FMEA Form - Long Term History

30. FMEA Methodology Two major approaches:
Starting with Cause & Effect Matrix
Starting with FMEA directly from the Process Map
We will explain the approach using the C&E matrix, though both approaches are very similar
Spreadsheet tools have been prepared to assist you in the preparation of the FMEA

31. FMEA Methodology - Starting with C&E Matrix
Advantage: The Cause & Effect Matrix assists the team in defining the important issues that the FMEA should address by helping to prioritize important customer requirements
Process inputs that could potentially impact these requirements
Prioritizing the Key Process Inputs according to their impact on the Output variables (We want to focus on Inputs that highly impact a large number of Outputs first
The C&E Matrix also provides quantitative output that can be used in the determination of the specific severity ratings for the next stage of the FMEA process

32. FMEA - Step by Step Remember the internal customers!
1. For each process input, determine the ways in which the input can go wrong (failure modes)
2. For each failure mode associated with the inputs, determine effects of the failures on the customer
Remember the internal customers!
3. Identify potential causes of each failure mode
4. List the Current Controls for each cause or failure mode
5. Create Severity, Occurrence, and Detection rating scales
6. Assign Severity, Occurrence and Detection ratings to each cause
7. Calculate RPN’s for each cause
8. Determine recommended actions to reduce high RPN’s
9. Take appropriate actions and recalculate RPN’s

33. Process Mapping Examples
Manufacturing
Outputs
TV of Mix -Quality Check around extrusion
TV of Mix - Quality Check around extrusion
Surface Area
Pore Volume
Appearance pH
Temp
Specific Gravity
Clarity
Appearance (Color, Wetness)
Appearance (Color)
Physical Chemical Properties
Cycle Time (plugging)
Zone 3 Temp
Mixing
Water and Metals Preparation
Extrusion
Extrude through die
Dryer Calciner
Material
drying, surface
area issues
NADM
Solution Preparation
Impregnation
Metals addition
Fluid Bed Dryer
Final preparation / appearance issues
Total Rate C
Mixer Speed C
Al2O3 Qual U
Rec Comp U
Ext Rate C
Die Wear U
Ext RPMs C
Die Change U
Temperature C
Rot speed C
Draft C
Feed Rate C
Drying air U
Inputs Types
Inputs Types
Nitric Acid C
H2O2 C
Water C
ADM C
Hold Time U
Agitation C
Phos Acid C
Nozzle Type C
Spray Time C
Moly C
Nickel C
Base C
Rate C
Air Flow C
Res Time C

34. FMEA Step 1
1. For Each Process Input, Determine the Ways in Which the Input Can Go Wrong (Failure Modes)
We will first deal with the Moly Flow Rate input variable.

35. FMEA Step 2
2. For Each Failure Mode Associated with the Inputs, Determine Effects
These effects are internal requirements for the next process and/or to the final customer

36. FMEA Step 3 3. Identify Potential Causes of Each Failure Mode
In most cases, there will be more than one Cause for a Failure Mode but we’ll keep it simple for this exercise
May elect to list both effects on a single line since they relate to a single cause, and reduce a line in the table.

37. FMEA Step 4 4. List the Current Controls for Each Cause
For each failure mode/cause we list how we are either preventing the cause or detecting the failure mode
We will list the procedure number where we have a SOP
We need to be considerate of “holes” in the current controls column…..in this example, there are controls on the operation

38. FMEA Step 5
5. Create Severity, Occurrence, and Detection Rating Scales
Example Rating Scale

39. FMEA Step 6
6. Assign Severity, Occurrence and Detection Ratings to Each Cause
We are now ready to transfer the worksheet input to the FMEA form
Copy and paste the worksheet columns into the appropriate FMEA form columns
The team then starts scoring each row to compute the RPN values
Notes:
You will only use one Severity value
Determine which effect has the highest associated Severity and use that SEV value for ALL causes for the related failure mode (Worst Case)
When combining effects that have the same cause … Next Slide

40. RPN Review
Once you calculate the RPN for each failure mode / cause / controls combination, review the results and look for insights
Do the gut check - does the Pareto of items make sense?
If not, maybe the ratings given are varying
Determine potential next steps:
Data collection
Experiments
Process improvements
Process control implementations

41. Approaches to FMEA Approach One (C&E Matrix Focus)
Start with key inputs with the highest scores from the C&E Matrix analysis
Fill out the FMEA worksheet for those Inputs
Calculate RPN’s and develop recommended actions for the highest RPN’s
Complete the Process FMEA for other Inputs over time
Approach Two (Customer Focused)
Fill out the failure mode and effects columns of the worksheet. Copy to FMEA form and rate Severity.
For High Severity Ratings, List causes and rate Occurrence for each Cause
For the highest Severity * Occurrence Ratings, evaluate current controls
For Highest RPN’s develop recommended actions

42. Approaches to FMEA Continued…
Approach Three (Comprehensive)
Good approach for small processes
Fill out the FMEA worksheet beginning with the first process step and ending with the last
Score SEV, OCC and DET for all causes
Develop recommended actions for highest RPN’s
Approach Four (Super Focused)
Pick the top Pareto defect item (Damaged Components) or Failure Mode (Variability in Temperature)
Focus the FMEA process on only that defect or failure mode
Purpose: To “kill” that failure mode

43. S.C.A.P. Considerations 1) Sporadic Problems 2) Chronic Problems
1) A single joint is above UCL or below LCL
2) A run of 8 above or below CL
Target
Time
2) Chronic Problems
Bad
Better
1) Sporadic Problems
Note: S.C.A.P. may need to be specific to the type of instability

44. Measurement System Investigation
Special Cause Detected
By Production Control
Chart
Does
Control Strategy
Direct Investigating for
Special Cause in
Laboratory?
Retest Sample
Test
Results
Confirmed? Is Range
Between Test Results
Less Than
3.7sM?
Measurement
Process Stable?
(Accuracy
Monitoring)
Report Initial Test
Result To Production
Check for Special Cause
in Production Process No
Yes
Was Data
Recorded
Correctly?
Notify Production
of Lab Problem
Find and Correct
Measurement Process
(Precision Monitoring)
(Accuracy Monitoring)
Correct Error
Discard Original
Test Results
Report Corrected
Results to Production
Measurement System Investigation

45. Knowledge/Systems Requirements for a S.C.A.P.
Compensating Action
Criteria for judging if compensating action is appropriate.
What process variable is to be adjusted?
Required effect of process variable adjustment.
Amount of adjustment to obtain the required effect.
Criteria for judging if stability has been restored.
Investigative Action
Standard (Required) Process Operating Conditions.
Equipment failures signals.
Raw material analysis techniques.
Well-defined procedures.
Corrective Action
Well-defined procedures for correcting any deviation detected in the Investigative Action.
“Last Resort” adjustment procedures.
Documentation
Procedures/Systems for documenting actions, results and additional observations.
Procedures, Lists, charts for accumulating actions, results and additional observations.

46. S.C.A.P.
Control Charts provide information, I.e., when to take action and when not to take action.
People must know what action to take. Actions need to be standardized for all people.
People control the process, not the control charts.
Investigation of Assignable Causes and the correction/ prevention of problems should never end.
Control Charts and the S.C.A.P. need to be reviewed periodically and updated as needed.
Process Control is the responsibility of Operations. Control Charts need to be in the hands of the people who control the process.

47. Statistical Process Control
Use SPC to Maintain Current Process
Collect & Interpret Data
Select Measures
Define Process
Is Process Capable ?
Improve Process Capability
Is Process Stable ?
Investigate & Fix Special Causes No
Yes
Statistical Process Control (SPC)
is a collection of activities:
Selection of appropriate process measures
Collection of process data
Graphical analysis of data
Analysis of process stability
Use of data to investigate and fix special causes in a continuous improvement cycle
Circle the steps on the model that are classically thought of as SPC
SPC is not just control charts
SPC is very data driven
SPC is a never ending loop