1. Scientific Problem Solving
Corrective Action
PDCA Road Map
Scientific Problem Solving
Tools and Techniques of Root Cause Analysis
Rita D’Angelo
AFDO San Diego, March, 2015
D’Angelo Advantage Consulting

2. Learning Outcome
The learner will understand principles, strategies, techniques and best practices for investigating, identifying root cause(s) and designing effective solutions
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3. Learning Objectives
Learn the quality principles that drive Corrective Action/Preventive Action CA/PA
Determine the conditions to initiate formal corrective action
Through problem solving write clear and actionable problem statements
Identify best practices, and potential weaknesses
Through Pan, Do, Check, Act perform root cause analysis
Develop strategies to prevent reoccurrence of the problem
Identify opportunities for improvement
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4. Definitions
Corrective action: A solution meant to reduce or eliminate an identified problem
Defect: A product’s or service’s nonfulfillment of an intended requirement or reasonable expectation for use, including safety considerations
Effectiveness: The state of having produced a decided on or desired effect
Error proofing: Use of process or design features to prevent the acceptance or further processing of nonconforming products. Also known as “mistake proofing
Preventive action: Action taken to remove or improve a process to prevent potential future occurrences of a problem
Root cause: A factor that caused a nonconformance and should be permanently eliminated through process improvement
ASQ, 2015
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5. CAPA Corrective and Preventive Action
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6. 12 Step-Process to CAPA Corrective Action Preventive Action
Brainstorm to identify and document the root cause of the nonconformity
Review the root cause to identify if a system issue exist
Prevent the reoccurrence
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7. Goal of Root Cause Analysis
To find the exact root cause of the problem
To prevent its reoccurrence
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8. Root Cause Analysis Good Quality Customer expectation Good Business
Keeps us from passing on problems to our internal and external customers
ISO 9001 Requirement
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9. 10.2 Conformity and Corrective Action
When a conformity occurs the organization shall react to the non-conformity:
Take action, control and correct it
Deal with the consequences
Evaluate the need for action and eliminate the non-conformance so it does not occur again
Review the NC
Determine the cause
Determine if similar NC exists
Implement any action needed
Review the effectiveness of any corrective action
Make changes to the QMS
Corrective actions shall be appropriate to the effects of the NC
How is the continuous improvement program implemented?
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10. Take Action
4. Analyze the effect and take action to quarantine effected products or intervene with services
Recalling the product
Notifying the customer
Scrapping or rework products
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11. Preventive Action Process
5. Establish and implement a fix thorough follow-up to ensure the correction is effective and recurrence has been prevented 6. Initiate an improvement to ensure the nonconformance does not reoccurrence
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12. 10.3 Continual Improvement
The organization shall continually improve the suitability, adequacy and effectiveness of the QMS:
Results of data collection
Changes in the context of the organization
Changes in identified risk
New opportunities
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13. Validate Correction Action
Did the corrective action(s) eliminate or control the direct cause ?
Are the results desirable?
Will the action immediately contain the problem and immediately prevent it from recurring?
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14. Corrective Action Process
7. Watch the progress or lack of progress
8. Collect post data and determine results
9. Communicate to team members
10. Document actions taken, rational, changes made and decisions to revise and proceed
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15. If you can’t measure it
You can’t fix it
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16. Preventive Action 11. Document lessons learned
12. Use quality tools to build error proofing into the system
Failure mode and effects analysis to identify risks
A3 Problem Solving tools
Fishbone
Swim Diagrams
Affinity
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17. Post Implementation Follow-up
Audit must be performed to determine if the corrective/preventative actions are implemented and reoccurrence is unlikely to reoccur
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18. Did the Process Work?
Did the implemented corrective action require a change?
If an alternate corrective action is necessary document the changes
Periodic checks are necessary to ensure the corrective actions are still in place and continue to be effective.
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19. Effectiveness Checks Most difficult step to accomplish
Will the undesired event reoccur?
Is the process in place effective to prevent it?
Did the preventative action achieve desirable outcomes?
Most difficult step to accomplish
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20. Corrective Action Why is this necessary? ISO Requirement
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21. The Process Approach
Statement: Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system
Rationale: The QMS is composed of interrelated processes. Understanding how results are produced by this system, including all its processes, resources, controls and interactions, allows the organization to optimize its performance.
As did ISO 9001:2000 and 2008, the DIS continues to require organizations to do some specific things related to the processes of their QMS
Organizations must identify the system’s processes and their interactions, and the resources required to operate, control, monitor, measure and continually improve those processes.
What are the problems within the organization and how can we eliminate them?
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22. Internal Audit
Clause 9.2 says an organization must "plan, establish, implement and maintain an audit program," and establish the "frequency, methods, responsibilities, planning requirements and reporting."
The audit program must consider the follows:
Quality objectives
Importance of the process related risks
Results of previous audits
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23. Understanding the Logic for Corrective Actions Quality Methodologies
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24. Plan, Do, Check, Act (Deming & Shewart) DMAIC ( Six Sigma)
8 D 8 Disciplines
A3 (Problem Solving tool)
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25. PLAN, DO, CHECK ACT
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26. PDCA
A four-step process for quality improvement that is referred to as the Shewhart cycle:
Walter Shewhart discussed the concept in his book Statistical Method From the Viewpoint of Quality Control
Deming cycle, because W. Edwards Deming introduced the concept in Japan. The Japanese subsequently called it the Deming cycle
ASQ, 2015
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27. Core of an Improvement Process
Shewhart or Deming cycle
What is the problem?
What changes are desirable?
What is most important to this team?
What data is available?
Study results
What did we learn?
What can we predict?
Plan
Act Do
Never ending
Repeat: PDCA
Carryout the change Decided by the team
On a small scale (Pilot)
Observe the
effects of the pilot
Check
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28. DMAIC
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29. Six Sigma
Six Sigma- Measure of quality that strives for near perfection
Six Sigma is a disciplined, data-driven approach and methodology for eliminating defects (driving toward six standard deviations between the mean and the nearest specification limit) in any process
Defect: Anything outside of customer requirements
A process must not product more that 3.4 defects per million ..
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30. DMAIC Define the problem
Measure key performance of current problem - Collect
baseline data
Analyze the data and understand cause and effect
relationships
Improve the process
Determine root cause
Use quality tools such as error proofing, standard work,
VSM (run pilot)
Control the process to ensure all defects are eliminated and
build quality into the process and monitor
Goal: According to the Six Sigma Academy, Black Belts save companies approximately $$$$$$230,000 per project and can complete
four to 6 projects per year
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31. 8D Methodology A standard “MIL-STD 1520 Corrective Action and
Disposition System for Nonconforming Material”
created by the U.S. Department of Defense (DOD) in
1974 and later adopted by Ford Motor Company
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32. 8 Disciplines D0: Plan: Plan for solving the problem
D1: Use a Team: Establish a team
D2: Define and describe the Problem: Specify the problem by identifying in quantifiable terms the who, what, where, when, why, how
D3: Develop Interim Containment Plan; Define and implement containment actions to isolate the problem from any customer.
D4: Determine, Identify, and Verify Root Causes
D5: Choose and Verify Permanent Corrections (PCs) for Problem/Non Conformity:
D6: Implement and Validate Corrective Actions: Define and Implement the best corrective actions.
D7: Take Preventive Measures
D8: Congratulate Your Team
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33. A3 Writing Problem-Solving, like telling a story
TOYOTA 11x 17 communicated by fax
Team based problem solving using
Based on (Plan-Do-Check-Act) cycles
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34. A3 Writing Identify the problem Define the hypothesis
Perform problem solving with PDCA cycles
Understand the current condition
Understand the data to be collected
Target condition
Action items
Implementation Plan
Monitor and prevent reoccurrence
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35. DMAIC Define Measure Analyze Improve Control
What is the fundamental difference between these 3 methodologies?
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36. D'Angelo Advantage LLC

37. Hypothesis
Educated guess on how to resolve problem
How do we do this?
1. Communicate with the customer and team to create a favorable process together
2. Define a process

38. Current Condition What is the baseline? Where are we?
Collect data- what does the data show?
Analyze & prioritize the starting point
How do we do this?
1. Use simple data to document current situation (check mark on clip board as it happens)
2. Use maps to demonstrate pathways, flow of information
3. All affected/involved must collect data

39. Problem Analysis Identify the root causes
Prevent from reoccurring-Countermeasure
Ask “why” 5 times
How did we do it?
Why wasn’t the shipment transported on time?
No one knew it had to be
Why didn’t anyone know the requirement?
1. Requirement was changed but not communicated
Why wasn’t it communicated or identified?
We’ve always done it this way- Sally didn’t inform us
Why is it this way?
1. No process in place to identify new requirement
2. Why is there no defined process?
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40. Target Condition Brainstorm and agree on an PERFECT achievable process
How do we do it?
1. Have we meet the customer’s requirement?
2. Is this reasonable?
Target condition is the improved way or the better way but may not be the perfect or ideal way. Think how to address the root cause from happening, how to redesign the process. How do we measure this improvement? Who might be affected by this up stream, down stream.
Eg. What needs to be done to get proper plates? How should it be labeled?
Nurse managers contacted, Posters created for education and training , nurse managers to educate new staff, constant communication with clinics post training. 40 40

41. Action Plan Develop steps for the new plan Team consensus
Consider
Does the plan make sense?
Areas affected by (Up & downstream effects)
Is the root cause considered?
The plan for eg. Develop standard of proper labeling derm plates, Create visuals, Educate and Train staff. Plan-Do-Study-Act cycles for mistake-proof. Is it a good fix for the root cause identified. To implement, customer-supplier meetings for clinic staff and Nursing staff , decide who will supervise, train new employees, etc,
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42. Don’t wait until you have a perfect solution
Working towards the Target Condition
Ideal state
Next obstacle waiting
Target condition
Don’t wait until you have a perfect solution
Current condition
So far this what we have done. With incremental improvements from current to target condition , and eventually to ideal. May require multiple improvements. Multiple PDCA cycles.
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43. Implementation Plan Roll out the new action plan
Assign responsibility to carryout the plan
Consider
Who & when to implement new plan?
Educate all members involved in the process
Example
Specific Task
Who
By When
Date Completed
Education
Sue Brown Team leader
March 31, 2015
1 week
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44. Results & Metrics Is the plan effective?
Did we achieve the agreed target?
Collect post data- Same data points as before
Repeat PDCA if target is not met
CDC 2015
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45. Standardization Standardize the newly acquired process
Sustain results for long time
New plan becomes a part of the daily work
Revise standardized work as needed/ on going
Train & educate new employees
Assign responsibility to sustain & monitor results
Monitors-New process
How do we do it?
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46. Quality Tools
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47. Fish Bone
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48. Affinity Diagram
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49. Brainstorm
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50. Breakout- A3 Writing In your group Defect identified
Appoint a group leader
Write your detailed A3
Present your A3 story
5 min per group
In your group
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51. A3 Report Plan Do-Check-Act Problem Background State the problem
Narrow down to specifics
Implementation Plan
Roll out the New Plan- “Action Plan” as a pilot
Assign responsibility to implement the plan.
who ? When ? Where? Get consensus &
train all involved
Hypothesis
What is the educated guess to correct this?
Results
Test the effectiveness of new plan
Recollect same data points and compare with “Current Condition”
Did we reach the outcome set in the “Target Condition”?
If not, repeat PDCA cycle
Current Condition
What is the current situation or baseline? Collect simple data. What does the data tell us? Analyze collected data to show the current situation
Problem Analysis
What is the root cause of this problem?
Choose simplest problem-analysis tool
Ask “why” 5 times
Metrics
Assign responsibility for monitoring & sustaining the new implemented plan
Target Condition
What is the outcome needed to achieve?
What is possible from first round of PDCA?
Standardization
Standardize the new process
Post standard work as a “Job Aide” where daily work is performed
Action Plan
What NEW steps are required to achieve the target condition?
Is root cause considered to prevent reoccurring?
Way things happen now – Current State
The better way of work – Ideal State
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52. Quality Methodologies
Commonalities of
Quality Methodologies
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53. Root cause analysis to determine nonconformance's
Quality methodology (Plan, Do, Check, Act)
Develop strategies to prevent reoccurrence of the problem
Opportunities for improvement
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54. Take Home Lessons
Define the problem, assess conditions for root causes, define proper actions to contain and prevent the problem, and then develop a plan to deploy those actions
Conduct corrective & preventive action (CA/PA) in response to non-conforming product or services
Use proven quality methods and approaches for ensuring problems are adequately contained, and then prevented
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55. QUESTIONS?? dangeloadvantage@gmail.com Dangeloadvantage.com
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