1. Process Risk Assessment and Mitigation
Walt Pozgay, CSSGB
*ISO requires a systematic approach to managing risk, as opposed to risk being only a portion of the QMS.
*Quality is largely about managing risk.
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2. Risk = RISK x LIKELIHOOD CONSEQUENCE Opportunity Likelihood Value Risk
*What is risk? What do we mean when we say that we have a lot at stake?
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*Risk is the product of Consequence and Likelihood
*Risk is increased both with the severity or value of the consequence and with the number of opportunities available for the consequence to occur.
*Coin Flip Analogy: Flipping a penny and flipping a silver dollar have different risks.
*We often have no control over the value of the consequence, so Process risk management mostly works to minimize Likelihood. Mitigation of opportunity or detection of the event before negative outcomes can occur reduces risk.
Mitigation
Risk
Consequence

3. Risk Assessment and Mitigation Process
Understand Ideal
Assess Risks
Implement Mitigation
Outline Process
Develop Mitigation
Understand Ideal
Outline Process
Assess
Risk
Develop Mitigation
*Risk management is a PROCESS unto itself.
<CLICK> Understand
<CLICK> Outline
<CLICK> Assess
<CLICK> Develop
<CLICK> Implement
*Many people jump right to MITIGATION without going through the proper process, resulting in wasted time an resources when the solution doesn’t mitigate the risk.
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Implement Mitigation

4. Understand Ideal Outline Process Assess Risk Develop Mitigation
*The first step in controlling a process is to understand what the end result is. As with any map, a process map is of limited value if the destination is unknown.
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Implement Mitigation

5. Understand the Ideal What is the final product?
Understand Ideal
What is the final product?
What does it look like?
What does it do?
How well does it do it?
What characteristics are important?
What dimensions are significant?
What tolerances are available?
Who decides?
What substitutions are possible?
Is alternate content OK?
Is alternate process sequence OK?
Outline Process
Assess
Risk
Develop Mitigation
*The process does not need to be a manufacturing process. Examples: filling out a form or registering a patient.
<CLICK> Final Product
<CLICK> Characteristics
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To facilitate understanding of this process, we are going to develop a risk mitigation plan for a very complex process……
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Implement Mitigation

6. Understand the Ideal Understand Ideal Outline Process Assess Risk
Develop Mitigation
Implement Mitigation

7. Understand the Ideal What is the final product?
Understand Ideal
Outline Process
Assess
Risk
Develop Mitigation
Implement Mitigation
What is the final product?
What does it look like? Is B OK?
What characteristics are important?
What dimensions are significant? Amount of PB or J?
What tolerances are available?
What substitutions are possible?
Is alternate content OK? Chunky or smooth? Flavor of jelly?
Is alternate process sequence OK? Does PB have to be put on first?

8. Understand the Ideal Peanut butter and jelly sandwich. White bread.
Understand Ideal
Outline Process
Assess
Risk
Develop Mitigation
Implement Mitigation
Peanut butter and jelly sandwich.
White bread.
Choice of smooth or chunky peanut butter.
Choice of strawberry, grape, or orange jelly.
No condiments seeping out of sandwich.
Cut into even halves and plated.
This is how we will define the desired outcome for this discussion. This is the Design Intent PB&J
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9. Understand Ideal Outline Process Assess Risk Develop Mitigation
Implement Mitigation
*Once the ideal is clearly understood, the process can be developed. Several methods of displaying process steps are available. The key is to use a method that clearly sequences the process and that is easily understood by the stakeholders of the process. Consistency is critical, especially when the information has to be shared among diverse groups.
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10. Flow Chart Understand Ideal Outline Process Assess Risk
Develop Mitigation
Implement Mitigation
START
Collect Ingredients 10
Place Slice 1
Terminator
Step
Decision
Delay 20
Spread PB 30
Place Slice 2 40
Spread Jelly 50
Assemble 60
*Flow charts are the most common method of representing a process. Each step should only have one “IN” and one “OUT”, except for decisions. The process should always show a clear path with defined beginning and end.
*The process should be complete enough to be followed by the intended audience. How complex or simple steps are should be considered.
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Cut 70
OK? N 80 Y
Serve 90
STOP

11. Process Outline Diagram
Understand Ideal
Outline Process
Assess
Risk
Develop Mitigation
Implement Mitigation 50
Assemble 60
Cut 70
Inspect 80
Serve 10
Place Slice 1 30
Place Slice 2 20
Spread PB 40
Spread Jelly
Slice 1
Slice 2
Peanut Butter
Jelly
Plate
Operation
Inspection
Storage
*The Process Outline is useful for simple and complex processes, especially if there are parallel paths and sub-processes.
*Parallel paths are clearly displayed and subassemblies are easily identified and sequenced into the final assembly.
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12. Process Table Make a PBJ Sandwich Understand Ideal Outline Process
Assess
Risk
Develop Mitigation
Implement Mitigation
Step
Move
Wait
Inspect
Store
Make a PBJ Sandwich
10. Gather Ingredients
20. Place Slice 1
30. Spread PB
40. Place Slice 2
50. Spread Jelly
60. Assemble
70. Cut
80. Inspect
90. Serve
*The Process Table is also useful for simple processes. The benefit to this type of process document is that blanks can be printed and the process be mapped on site, with simple notes and tools.
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13. List Understand Ideal Outline Process Assess Risk Develop Mitigation
Implement Mitigation
Step #
Step 10
Collect Ingredients 11
Select bread 12
Select peanut butter 13
Select jelly 20
Place Slice 1 30
Spread Peanut Butter
Step #
Step 40
Place Slice 2 50
Spread Jelly 60
Assemble Sandwich 70
Cut 80
Inspect 90
Serve 91
Plate 92
Deliver to customer
*Once the process is determined, a list of steps is made, making sure to include all sub-steps.
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14. Understand Ideal Outline Process Assess Risk Develop Mitigation
Implement Mitigation
*Once every step and sub-step is identified, the process of understanding what can go wrong begins.
*This process should always include as many stakeholders as possible. One of the common mistakes made by organizations is to make risk analysis the responsibility of a single group (Quality). When all stakeholders provide input, issues are more likely to be identified.
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15. Identify Possible Failures
Understand Ideal
Outline Process
Assess
Risk
Develop Mitigation
Implement Mitigation
Step #
Step
Failure Mode 10
Collect Ingredients 11
Select bread
Wrong type
Wrong brand
Stale
Damaged 12
Select peanut butter
Spoiled 13
Select jelly
Wrong flavor 20
Place Slice 1
Wrong orientation 30
Spread Peanut Butter
Too much
Not enough
Not evenly spread
Torn bread
Step #
Step
Failure Mode 40
Place Slice 2
Wrong orientation 50
Spread Jelly
Too much
Not enough
Not evenly spread
Torn bread 60
Assemble Sandwich
Smashed 70
Cut
Wrong direction
Not centered 80
Inspect
Not inspected
Wrong standard 90
Serve 91
Plate
Improper presentation 92
Deliver to customer
Drop
*For each step and sub-step, everything that CAN go wrong should be listed. At this point there is benefit to listing even “silly” potential faults.
*When the failure modes are identified, their impact must be quantified. As discussed before, Risk is defined in terms of Consequence and Opportunity. Assigning numerical scores to these parameters makes risk analysis much easier.
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16. AIAG Scoring Matrix Understand Ideal Outline Process Assess Risk
Develop Mitigation
Implement Mitigation
SCORE
SEVERITY
PROBABILITY
DETECTION
LIKELYHOOD
FAILURE RATE
Cpk
LIKELIHOOD
CRITERIA 10
Hazardous without Warning
Very High
≥ 1/2
< 0.33
Almost Impossible
< 80% 9
Hazardous with Warning
≥ 1/3
≥ 0.33
Very Remote
80% 8
High
≥ 1/8
≥ 0.51
Remote
82.5% 7
≥ 1/20
≥ 0.67
Very Low
85% 6
Moderate
≥ 1/80
≥ 0.83
Low
87.5% 5
≥ 1/400
≥ 1.00
90% 4
≥ 1/2,000
≥ 1.17
Moderately High
92.5% 3
Minor
≥ 1/15,000
≥ 1.33
95% 2
Very Minor
≥ 1/150,000
≥ 1.50
97.5% 1
None
≥ 1/1,500,000
≥ 1.67
Almost Certain
99.5%
*Most of us are familiar with the AIAG (Automotive Industry Action Group) FMEA scoring system. For automotive customers, these scores are often required to be used. For many processes, however, they are not applicable. For instance, our sandwich is very unlikely to be “Hazardous with Warning”.
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17. Opportunity (Likelihood) Detection (Likelihood)
Establishing Scoring
Understand Ideal
Outline Process
Assess
Risk
Develop Mitigation
Implement Mitigation
Score
Severity (Impact)
Opportunity (Likelihood)
Detection (Likelihood) 10
Ruined
100%
10% 9
Every customer unhappy
90%
20% 8
Almost every customer unhappy
80%
30% 7
Most customers unhappy
70%
40% 6
Half of customers unhappy
60%
50% 5
Few customers unhappy 4
Almost no customers unhappy 3
No Customer Impact
Severe Cost Impact 2
Moderate Cost Impact 1
Minimal Cost Impact
*One way to make the scoring more meaningful is to assign impacts that are more likely to matter to the product.
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18. Opportunity (Likelihood) Detection (Likelihood)
Establishing Scoring
Understand Ideal
Outline Process
Assess
Risk
Develop Mitigation
Implement Mitigation
Score
Severity (Impact)
Opportunity (Likelihood)
Detection (Likelihood) 5
Every customer unhappy
Always Happens
Never Notices 4
Most customers unhappy
Often Happens
Rarely Notices 3
Few customers unhappy
Sometimes Happens
Sometimes Notices 2
No Customer Impact
Cost Impact
Rarely Happens
Often Notices 1
No Impact
Never Happens
Always Notices
*Even more useful is to simplify them to the extent possible.
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19. Analyze Risks Understand Ideal Outline Process Assess Risk
Develop Mitigation
Implement Mitigation
Step #
Step
Failure Mode
Severity
(S)
Opportunity (O)
Risk
(S x O) 10
Collect Ingredients 11
Select bread
Wrong type 4 3 12
Wrong brand 2
Stale 5 15
Damaged 16
Select peanut butter 6
Spoiled ⁞ 30
Spread Peanut Butter
Too much 8
Not enough
Not evenly spread 9
Torn bread 60
Assemble Sandwich
Wrong orientation
Smashed 80
Inspect
Not inspected
Wrong standard
* Once a scoring scheme is determined, assign scores to each failure mode. Risk has not been assessed and assigned.
* Based on this scoring, the biggest risks are Damaged Bread, Not Enough PB, and Not Inspected.
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20. Understand Ideal Outline Process Assess Risk Develop Mitigation
Implement Mitigation
* With the risk clearly understood, mitigation methods can be determined.
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21. Plan Mitigation Understand Ideal Outline Process Assess Risk
Develop Mitigation
Implement Mitigation
Step #
Step
Failure Mode
Severity
(S)
Opportunity (O)
Risk
(S x O)
Detectability (D)
Risk Priority
(SxPxD) 10
Collect Ingredients 11
Select bread
Wrong type 4 3 12 2 16
Wrong brand
Stale 5 15 30
Damaged 1
Select peanut butter 48 6 36
Spoiled 40 ⁞
Spread Peanut Butter
Too much 8
Not enough 80
Not evenly spread 9 18
Torn bread 60
Assemble Sandwich
Wrong orientation
Smashed 24
Inspect
Not inspected
Wrong standard
* With Risk scored, a direction for improvement can be chosen. However, there is a chance that we can mitigate some of this risk simply by detecting the issue before it causes customer dissatisfaction.
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* When the Detection is included, a different set of priorities are found. Because of Detection, we find that the biggest risk to customer satisfaction becomes “Not Enough PB”. The point is to put the mitigation where it does the most good to reduce Risk.

22. Process Controls Remove Substitute Engineer Administer Manage
Understand Ideal
Outline Process
Assess
Risk
Develop Mitigation
Implement Mitigation
Remove
Substitute
Engineer
Risk mitigation can be accomplished via various options, some more likely to be successful than others.
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Remove – remove the risk completely. Example: Keep only white bread on hand. Eliminate blanks in a form.
*Substitute – replace the risky process with a process that has lower risk. Example: Replace jarred peanut butter and jelly with premeasured packets. Replace blanks with check boxes.
*Engineer – develop gaging and poka yokes to make failure less likely. Example: Place bread in a box that only opens when the desired bread is needed. Use computerized form completion.
*Administer – create policies, work instructions, signs, etc. to prevent risk. Example: Placing bread in designated spots. Example forms.
*Manage – strictly oversee operation to prevent risk. Example: Watch each sandwich being made. Have reception personnel complete form.
Talk about the AMS issue where each 2 employees had a supervisor, each 2 supervisors had a manager, each 2 managers had a Toyota QE.
Administer
Manage

23. Spread to within ¼” of crust
Risk Control
Understand Ideal
Outline Process
Assess
Risk
Develop Mitigation
Implement Mitigation
Step #
Step Name
Characteristic
Tool
Standard
Reaction Plan 10
Collect Ingredients 11
Select Bread
Brand
Visual (Label)
Wonder
Notify manager
Type
White
Stale
Touch
No hard surface
Open new loaf
Damaged
Visual
No deformity
Select new slice 12
Select peanut butter
Jiff
Notify Manager
Customer request
Make new sandwich
Spoiled
No separation of oil
Open new jar ⁞ 30
Spread Peanut Butter
Wrong quantity
Measuring spoon
1 tbs ± ¼ tbs
Not evenly spread
Edge Guide
Spread to within ¼” of crust
Torn bread
No damage to slice
Make new slice 60
Assemble Sandwich
Orientation
Align crusts
Adjust
Smashed
Not crushed 80
Inspect
Not inspected
Audit
100%
Wrong standard
Standard PBJ-002 Rev 3
*Taking into mind the severity of the risk and the highest possible mitigation, determine mitigation methods and tools to mitigate each of the failure modes.
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24. Understand Ideal Outline Process Assess Risk Develop Mitigation
Implement Mitigation
Once mitigation has been determined, implementation can occur.
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25. Process Controls Understand Ideal Outline Process Assess Risk
Develop Mitigation
Implement Mitigation
Removal: Only white bread will be stocked.
Replacement: Premeasured packages of Jelly
Engineering: Measuring spoon and edge gauge to ensure proper amount and spreading of PB
Administrative: Work instruction and model.
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26. Summary Understand Ideal Outline Process Assess Risk
Develop Mitigation
*Design drives the process.
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*Process drives the risk analysis.
*RA drives risk mitigation plan.
*Mitigation plan drives tools and procedures.
*Each step should tie backward through the process, with a clear step-by-step chain. For any given tool or procedure, a risk should be mitigated.
*For each mitigation, there should be an identified and quantified risk that was identified in a define process.
*The numbering is important to go through the process.
*Finally, the process should feed back to the design to further mitigate process issues and to prevent them from being repeated in future designs.
Implement Mitigation

27. Questions ?