gov 2015 slide 1 corrective action pdca road map scientific problem solving corrective action pdca...

GOV 2015Slide 1

Corrective ActionPDCA Road Map

Scientific Problem Solving

Tools and Techniques of Root Cause AnalysisRita D’AngeloAFDO San Diego, March, 2015D’Angelo Advantage Consulting

GOV 2015Slide 2

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 LLC

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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

Learning Objectives

© 2015 D’Angelo Advantage Consulting

GOV 2015Slide 4

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

Definitions


ASQ, 2015

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CAPACorrective and Preventive

Action

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Corrective Action Preventive Action

1. Brainstorm to identify and document the root cause of the nonconformity

2. Review the root cause to identify if a system issue exist

3. Prevent the reoccurrence

12 Step-Process to CAPA


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To find the exact root cause of the problem

To prevent its reoccurrence

Goal of Root Cause Analysis


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Good Quality Customer expectation Good Business Keeps us from passing on problems to our

internal and external customers ISO 9001 Requirement

Root 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 Action

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Take Action

4. Analyze the effect and take action to quarantine effected products or intervene with services

1. Recalling the product2. Notifying the customer3. Scrapping or rework products


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Preventive Action Process

5. 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 Improvement

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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 progress8. Collect post data and determine results9. Communicate to team members10. Document actions taken, rational, changes made and decisions to revise and proceed


Corrective Action Process

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If you can’t measure it You can’t fix it

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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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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


Most difficult step to accomplish

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Corrective ActionWhy is this necessary?

ISO Requirement

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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 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.

The Process Approach

What are the problems within the organization and how can we eliminate them?

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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 objectives Importance of the process related risks Results of previous audits

Internal Audit

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Understanding the Logic for

Corrective ActionsQuality

Methodologies

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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

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A four-step process for quality improvement that is referred to as the Shewhart cycle:

1.Walter Shewhart discussed the concept in his book Statistical Method From the Viewpoint of Quality Control

2.Deming cycle, because W. Edwards Deming introduced the concept in Japan. The Japanese subsequently called it the Deming cycle

PDCA

ASQ, 2015

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Core of an Improvement Process

Plan

Check

Act DoNever 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

© 2014 D’AngeloAdvantage Consulting © 2015 D’Angelo Advantage Consulting

GOV 2015Slide 28


DMAIC

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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

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..

http://www.isixsigma.com/new-to-six-sigma/statistical-six-sigma-definition/

http://www.isixsigma.com/new-to-six-sigma/statistical-six-sigma-definition/

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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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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_Solving

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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 Team

8 Disciplines


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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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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

© 2014 D’AngeloAdvantage Consulting © 2015 D’Angelo Advantage Consulting

GOV 2015Slide 35 © 2015 D’Angelo Advantage

Consulting

DMAIC

Define

Measure Analyze

Improve Control

What is the fundamental difference between these 3 methodologies?

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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

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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?

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Ask “why” 5 times

Problem Analysis Identify 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? 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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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?

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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 WhenDate

Completed

EducationSue Brown

Team leader March 31, 20151 week

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


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Collect post data- Same data points as before

Repeat PDCA if target is not met

Results & Metrics

Is the plan effective? Did we achieve the agreed target?


CDC 2015

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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

Standardization

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 Bone

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Affinity Diagram

http://www.six-sigma-material.com/images/AffinityDiagram.GIF

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Brainstorm

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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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HypothesisWhat is the educated guess to correct this?

Problem Background

State the problem Narrow down to specifics

Current 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 AnalysisWhat is the root cause of this problem?Choose simplest problem-analysis toolAsk “why” 5 times

Target ConditionWhat is the outcome needed to achieve? What is possible from first round of PDCA?

Results Test the effectiveness of new planRecollect 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 ReportPlan Do-Check-Act

Way things happen now – Current State The better way of work – Ideal State

Implementation PlanRoll out the New Plan- “Action Plan” as a pilotAssign responsibility to implement the plan.who ? When ? Where? Get consensus &train all involved

StandardizationStandardize the new process Post standard work as a “Job Aide” where daily work is performed


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Commonalities of Quality Methodologies


GOV 2015Slide 53


1. Root cause analysis to determine nonconformance's

2. Quality methodology (Plan, Do, Check, Act)

3. Develop strategies to prevent reoccurrence of the problem

4. Opportunities for improvement

GOV 2015Slide 54

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

Take Home Lessons


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QUESTIONS??

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D'Angelo Advantage Consulting LLC

mailto:[email protected]

gov 2015 slide 1 corrective action pdca road map scientific problem solving corrective action pdca...

Documents

corrective action slide

preventive action slide

formal corrective action

problem root cause

exact root cause

root causes

qms corrective actions

actionable problem statements