Action PDCA Road Map Scientific Problem Solving Tools and Techniques of Root Cause Analysis Rita DAngelo AFDO San Diego March 2015 DAngelo Advantage Consulting Learning Outcome ID: 551668
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Slide1
Corrective
ActionPDCA Road Map Scientific Problem Solving
Tools and Techniques of Root Cause Analysis
Rita
D’Angelo
AFDO San Diego, March, 2015
D’Angelo
Advantage
ConsultingSlide2
Learning Outcome
The learner will understand principles, strategies, techniques and best practices for investigating, identifying root cause(s) and designing effective solutions D'Angelo Advantage LLCSlide3
Learn the
quality principles that drive Corrective Action/Preventive Action CA/PADetermine the conditions to initiate formal corrective actionThrough problem solving write clear and actionable problem statementsIdentify best
practices, and potential weaknessesThrough Pan, Do, Check, Act perform root cause analysisDevelop strategies to prevent reoccurrence of the problemIdentify opportunities for improvementLearning Objectives
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Corrective action:
A solution meant to reduce or eliminate an identified problemDefect: A product’s or service’s nonfulfillment of an intended requirement or reasonable expectation for use, including safety considerationsEffectiveness: The state of having produced a decided on or desired effectError proofing:
Use of process or design features to prevent the acceptance or further processing of nonconforming products. Also known as “mistake proofingPreventive action: Action taken to remove or improve a process to prevent potential future occurrences of a problemRoot cause: A factor that caused a nonconformance and should be permanently eliminated through process improvementDefinitions
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ASQ, 2015Slide5
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CAPACorrective and Preventive ActionSlide6
Corrective Action
Preventive ActionBrainstorm to identify and document the root cause of the nonconformityReview the root cause to identify if a system issue existPrevent the reoccurrence
12 Step-Process to CAPA
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To find the
exact root cause of the problemTo prevent its reoccurrenceGoal of Root Cause Analysis
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Good Quality
Customer expectationGood BusinessKeeps us from passing on problems to our internal and external customersISO 9001 RequirementR
oot Cause Analysis
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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?
10.2 Conformity and Corrective ActionSlide10
Take Action
4. Analyze the effect and take action to quarantine effected products or intervene with servicesRecalling the productNotifying the customerScrapping or rework productsD'Angelo Advantage LLCSlide11
Preventive
Action Process5. Establish and implement a fix thorough follow-up to ensure the correction is effective and recurrence has been prevented6. Initiate an improvement to ensure the nonconformance does not reoccurrence
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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
10.3 Continual ImprovementSlide13
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?
Validate Correction Action
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7. Watch the progress or lack of progress
8. Collect post data and determine results9. Communicate to team members10. Document actions taken, rational, changes made and decisions to revise and proceedD'Angelo Advantage LLCCorrective Action ProcessSlide15
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If you can’t measure it You can’t fix itSlide16
Preventive Action
D'Angelo Advantage LLC11. Document lessons learned 12. Use quality tools to build error proofing into the system
Failure mode and effects analysis to identify risksA3 Problem Solving toolsFishboneSwim DiagramsAffinitySlide17
Audit must be performed to determine if the corrective/preventative actions are implemented and reoccurrence is unlikely to reoccur
Post Implementation Follow-up
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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.
Did the Process Work?
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Will the undesired event reoccur?
Is the process in place effective to prevent it?Did the preventative action achieve desirable outcomes?
Effectiveness Checks
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Most difficult step to accomplishSlide20
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Corrective ActionWhy is this necessary?ISO RequirementSlide21
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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 systemRationale: 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 QMSOrganizations must identify the system’s processes and their interactions, and the resources required to operate, control, monitor, measure and continually improve those processes.
The Process Approach What are the problems within the organization and how can we eliminate them?Slide22
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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 objectivesImportance of the process related risks Results of previous audits
Internal Audit Slide23
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Understanding the Logic for Corrective ActionsQuality MethodologiesSlide24
Plan, Do, Check, Act (Deming &
Shewart
)
DMAIC ( Six Sigma)
8 D 8 Disciplines
A3 (Problem Solving tool)
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PLAN, DO, CHECK ACT Slide26
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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 ControlDeming cycle, because W. Edwards Deming introduced the concept in Japan. The Japanese subsequently called it the Deming cycle PDCA
ASQ, 2015Slide27
Core of an Improvement Process
Plan
Check
Act
Do
Never ending
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?
Carryout the change Decided by the
team
On a
small scale (Pilot)
Observe the
effects of the pilot
Repeat: PDCA
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DMAICSlide29
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http://www.isixsigma.com/new-to-six-sigma/getting-started/what-six-sigma/Six Sigma Six
Sigma- Measure of quality that strives for near perfectionSix 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 processDefect: Anything outside of customer requirements A process must not product more that 3.4 defects per million..Slide30
DMAIC
Define
the problemMeasure key performance of current problem - Collect baseline dataAnalyze the data and understand cause and effect relationshipsImprove 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
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Goal:
According
to the Six Sigma Academy, Black
Belts
save companies approximately
$$$$$$
230,000 per project and can complete
four
to 6 projects per yearSlide31
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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 http://en.wikipedia.org/wiki/Eight_Disciplines_Problem_SolvingSlide32
D0:
Plan: Plan for solving the problemD1: Use a Team: Establish a teamD2: Define and describe the Problem: Specify the problem by identifying in quantifiable terms the who, what, where, when, why, howD3: 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 MeasuresD8: Congratulate Your Team8 Disciplines
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A3 WritingProblem-Solving, like telling a story TOYOTA 11x 17 communicated by fax Team based problem solving using
Based on (Plan-Do-Check-Act) cyclesSlide34
A3 Writing
Identify the problem
Define the hypothesisPerform problem solving with PDCA cyclesUnderstand the current condition Understand the data to be collectedTarget conditionAction items
Implementation Plan
Monitor and prevent reoccurrence
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Define
Measure
Analyze
Improve
Control
What is the fundamental difference between these 3 methodologies?Slide36
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Educated guess on how to resolve problem
Hypothesis
How do we do this?
1.
Communicate with the customer and team to create
a favorable process together
2. Define
a process Slide38
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
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?Slide39
Ask “why” 5 times
Problem AnalysisIdentify the root causes Prevent from reoccurring-Countermeasure
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?
W
e’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
n
o defined process?
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Target Condition
How do we do it?
Brainstorm and agree
on
an PERFECT achievable process
1. Have
we meet the customer
’
s requirement?
2. Is
this reasonable? Slide41
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?
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Current condition
Target
condition
Ideal state
Don
’
t
wait until you have a perfect solution
Next obstacle waiting
Working towards the Target Condition
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Implementation Plan
Specific Task
Who
By When
Date Completed
Education
Sue Brown Team leader
March 31, 2015
1 week
Roll out the
new
a
ction
p
lan
Assign responsibility to carryout
the plan
Consider
Who & when to implement new plan?
Educate all members involved in the process
Example
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Collect
post data- Same data points as beforeRepeat PDCA if target is not met
Results & Metrics Is the plan effective? Did we achieve the agreed target?
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CDC 2015Slide45
New plan becomes a part of the daily work
Revise standardized work as needed/ on goingTrain & educate new employees Assign responsibility to sustain & monitor results
Monitors-New processStandardization
Standardize the newly acquired process
Sustain results for long time
How do we do it?
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Quality Tools
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Fish BoneSlide48
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Affinity Diagramhttp://www.six-sigma-material.com/images/AffinityDiagram.GIFSlide49
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BrainstormSlide50
Defect
identified
Appoint a group leader Write your detailed A3 Present your A3 story 5 min per group
In your group
Breakout- A3 Writing
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Hypothesis
What is the educated guess to correct this? Problem Background
State the problem Narrow down to specificsCurrent ConditionWhat 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
Target Condition
What is the outcome needed to achieve?
What is possible from first round of PDCA?
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
Action Plan
What NEW steps are required to achieve the target condition?
Is root cause considered to prevent reoccurring?
Metrics
Assign responsibility for monitoring & sustaining the new implemented plan
A3 Report
Plan
Do-Check-Act
Way things happen now – Current State
The better way of work – Ideal State
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
Standardization
Standardize the new process
Post standard work as a
“
Job Aide
”
where daily work is performed
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Commonalities
of Quality Methodologies
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Root cause analysis to determine nonconformance's Quality methodology (Plan, Do, Check, Act)Develop strategies to prevent reoccurrence of the problem
Opportunities for improvementSlide54
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 servicesUse proven quality methods and approaches for ensuring problems are adequately contained, and then preventedTake Home Lessons
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