CAPA Presentation Spring 2009

8/2/2019 CAPA Presentation Spring 2009

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Prepared by Christopher Parker, March, 2009

Christopher Parker March, 2009

CAPA:

Systemic & Cost Effective

ASQ Section 1216 - Spring Conference April 2, 2009

Strategic Quality Systems


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Outline

Course Objectives

Why are Analysis skills important? The Need for Improvement Change the Process to Change the

Results Benefits of Process Improvement

Proactive versus Reactive Improvement Analysis Hierarchy

The importance of CAPA

7D Model and Activities 7D Model and DMAIC

7D Model and PDCA Problem Description Containment

Investigate & Define Root Cause

Tools Initial Corrective Action Permanent Corrective Action Verification

Exercises Example Other examples Proactive Improvement Excercise

Summary


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Course Objectives

As a result of attending this course the participant will be able to: Identify a problem that requires improvement

Define a problem in measurable terms

Contain the problem while developing a long term solution

Collect and analyze data relevant to the problem of interest

Analyze the system of causes and determine root cause

Plan and implement solutions relevant to the root cause of the problem

Evaluate the effectiveness of the improvement

Determine opportunities for standardization

Discuss how to realize the benefits of process improvements


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Why are Analysis skills important?


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Why are Analysis skills important? - The Need for Improvement

Nature of Business

Very competitive

Need to increase sales and reduce cost simultaneously

Need improvements in all areas over time

Need a common language and tools for problem solving and

process improvement

Ultimately all improvement activities must be viewed in

financial and Customer satisfaction terms


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Why are Analysis skills important? - Change the Process to Change the Results

Without change in the process we will continueto achieve the same levels of performance andencounter the same difficulties and problems wesee today

We must ask: What causes problems?,identify the Root Causeand change theprocessconditions that create our problems toachieve better results

Improving the process will by definition improvethe product

The focus of our improvement efforts will be tounderstand the process, to identify criticalchanges that need to be made in the process,and introduce a controlled solution to produce abetter product or service



Why are Analysis skills important? - Benefits of Process Improvement

More efficient problem solving process Reduction in cycle-times

Improved materials management

Improved commit process Improved Customer satisfaction

Reduction in defect levels

Reduction in WIP and inventories

Improved process controls

Improved process efficiencies

Job enlargement and employee

satisfaction



Proactive Improvement

Routine communication withCustomers concerning needs

Lack of satisfaction with the statusquo

Monitor performance andconsider opportunities forImprovement

Take action for improvement prior

to complaints Examine the workflow to look for

opportunities for Improvement

Getting people in the process

involved in making improvements Examination of financial waste in

all of our activities

Reactive Improvement

Poor performance is Impacting theCustomer

Clearly identified problem

Need to contain the problem

Need to determine root cause andcorrect the problem

Examples:Customer complaints

Poor yieldsSupplier delivery problems

Missing Customer commits

Excessive errors

Audit errors or failures

Poor CSI Scores

Either condition is a good reason to initiate an improvement project

Proactive Versus Reactive Improvement



Why are Analysis skills important? Analysis Hierarchy

Continuous Improvement Ongoing recognition of opportunities to improve

Problem Solving

Solution oriented effort for specificconcerns or issues

Root Cause Analysis

Cause identification driven effort necessaryto prevent recurrence

Failure Analysis

Technical examination and very focused effort on failed devices to identifyspecific details of a very specific concern or issue



The Importance of CAPA



Detailed Tools Management

Activities & Analysis Involvement

Identify Problem Areas Basic QC Tools

Select a Problem Check SheetProblem Statement and Containment Pareto Diagram Review & Approve

Problem Objective, Goal and Benefits Concentration Diagram

Perform Resource Analysis (Stakeholder, equip, $) Run Chart

Develop Improvement Plan Flow Chart

Map the Process Cause & Effect Diagram

Define Data Collection Requirements Histogram

Develop Data Collection Plan Scattergraph Monitor Progress

Collect Data Advanced Tools*

Define Process Baseline Measurement Systems AnalysisEvaluate Data to Determine Relationships Partition of Variation

Stratify Data to Understand Root Cause Regression

Develop a Cause & Effect Diagram Capability Analysis Monitor Progress

Determine the 5 Whys Control Charts

Benchmark on Best In Class Processes

List and Prioritize Root Causes Fault Tree Analysis, FMEA

Brainstorm Potential Solutions

Evaluate Cost, Complexity, Impact, Benefit and Risk (see criteria) Brainstorming

Prioritize Solutions into Long Term and Short Term Effort Impact Analysis Review & ApproveCommunicate Implementation Plan Prioritization Matrix

Implement Solution

Collect Representative Sample of Data Basic QC Tools

Compare Performance to Baseline Annotated Run Chart

Reach the Improvement Goal? If no go back to 4 Advanced Tools* Review Effectiveness

Evaluate Improvements in Series Control Charts

Statistical Tests

Identify Opportunities and Owner for Standardization

Determine the Stability of the Solution Review & ApproveDetermine the controls needed to sustain the gains Advanced Tools* Recommendations for

Implement Needed Controls Control Charts Standardization

Implement Standardized Solutions

Realize Benefits of Improvement

Reflect on the Improvement Process

Determine Any Lessons Learned

Document and Communicate Improvements Close Team

Close the Project or Team

Select Next Project or Process for Improvement* Get assistance from your Building or Site Quality Engineer

Define & Contain theproblem

Measure the problem

Perform Root CauseAnalysis

Plan & ImplementImprovement

Assess Effectiveness

Standardize & Control

Realize & Reflect

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5

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The Importance of CAPA 7D Model and Activities



7 Step Improvement Model PDCA

Data IIProblem SpecificData, Map theProcess, StratifyData and ExamineRelationships to

Isolate the Problem

4. Plan &

ImplementImprovement

IdentifyProblem

Areas

6. Standardizeand Control

2.Measure

theProblem

Select aProblem

Data IBaseline ProcessPerformance,ExamineDashboards

Data IIIRepresentativeSample in TimeSeries to See theEffects ofImprovements

3. PerformRootCauseAnalysis 5. Assess

Effectiveness ofImprovement

1. Define &Contain TheProblem

7. Realize

Benefits andReflecton theImprovementProcess

PLAN

ACT

CHECKD

O



The Importance of CAPA 7D and DMAIC

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Problem Description

Problem Definitionis the most important part of the process a poorly defined problem will never be solved.

Listen to the problem from the source

Assume nothing

Understand the focus and intent of the source Identify tone and elements of emphasis in the message

Identify as many details of the problem as possible

Stick with facts and known details

Focus on what, when, and where Remain systemic, do not tell stories

Do not ask who it leads to blame

Do not ask why it fosters assumptions

What is the significance of the problem Impact on relationship, processes, metrics

Be concise

Confirm the definition with the source


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Containment

Containmentis more than just segregating material or processes. Assures the internal\external customer they will no longer be impacted

Provides evidence for the analysis

Every effort and priority must be made to identify and detain anyimpacted material or processes.

Have all inventory locations of the risk material been identified?(incoming, returns, stock, kits, WIP, finished goods, shipped product)

Be specific as to how much material, B\L, location, and where it is now.

Assure that the material is prevented from accidental use.

Has the process been stopped pending review and evaluation?

If elements are performed in stages or pieces, edit the CAPA record with each detail as it isavailable, such as: 04-AUG (CWP) Moved B\L 23647 to HOLD


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Containment

Containmentmay include actions to be defined as Initial CorrectiveAction details.

All material has been quarantined

Area employees have been made aware of the concern and these

immediate changes have been made Etceteras

Remember to remain factual and concise. Do not tell stories orprovide information beyond what is needed to support the ProblemDescription.

Open additional CAPAs if the containmentprocess identifies additional concerns beyondthe scope or definition.


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We all know what the rootcause is .. correct?

No procedures

The supplier

The Productionteam

You are

No training

Customer is toodemanding

I was onvacation

Poorcommunication


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Investigation and Defining Root Cause(s) is most often impaired bypresumptions and paradigms.

We do that well, we just had a bad day

This was an exception, not the standard

_____ just doesnt understand This is just like every other problem

Remain objective and find the evidence that ledto the behavior, mistake, or problem identifiedin the Problem Description.

Formalize the investigation

Document all findings, supportive of the issueas well as dead ends

Remain systemically focused and do notbe content with individual observations


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Check Sheet

Process Flowchart Cause & Effect Diagram

Run Chart

Pareto Diagram

Histograms

5 Whys

Simple Tools

Brainstorming

Scatter Diagrams

and others


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Robust Tools

FMEA & Control Plans

Hypothesis Testing

=

x

x

x

x uLSLuUSLZCpk 3

,3

min

Capability

Control Charts100 75 50 25 25 50 75 100

On timedelivery

Defectfree

Correctquantity

NPIprocess Change

control

Inventorymanagement

RMA frequency

CustomerRequirementPerformance

X

X

X

X

X

X

XX

X

Radar (Spider) Chart

Failure Analysis


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Initial Corrective Action

The Initial Corrective Actionshould provide: Confidence that recurrence is minimized or eliminated

Containment of any adulterated material or rogue processes

Commitment to defect free material and compliant processes

Continuation of controlledactivity

Initial Corrective Actionis not: The end of the CAPA process

Do not allow activity and progress to stall

An explanation or sales pitch

support and document all decisions and actionstaken or not taken

If elements are performed in stages or pieces, edit the CAPA record with each

detail as it is available, such as: 04-AUG (CWP)


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Permanent Corrective Action

Permanent Corrective Actionmust contain three elementsthat specifically provide a solution for the identified issue(s):

1. A systemic definition

2. That is sustainable3. And be preventive in nature

Failing to provide these elements suggest the corrective action is

incomplete and may not be addressing the root cause.

For example: Training is never a permanent corrective action.

Defining a new required and standardized training

course as an elementof the corrective action issystemic and sustainable. Expecting the courseis completed annually and prior to working inthe process is preventive.

f


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Verification

Only through Verificationwill the process be complete.

The verification process should be done after the initial

and permanent corrective actions have had anopportunity to provide evidence of success.

Sometimes this may best be done by the Internal Auditingfunction in order to remain independent and within theQuality System processes.

T i 7D CAPA b k t DMAIC S


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Define & Contain theproblem

Measure the problem

Perform Root CauseAnalysis

Plan & ImplementImprovement

Assess Effectiveness

Standardize & Control

Realize & Reflect

1

2

3

4

5

6

7

Tying 7D CAPA back to DMAIC - Summary

Wh A l i kill i t t?


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Why are Analysis skills important?

E l I i I ti


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Example Incoming Inspection

Problem Description:

Required Certificate of Compliance (CoC) documents from suppliers arenot included in as much as 35% of all required receipts. Leading tonon-value-add activity to attain the CoC, inspection delays, and in

some cases, negatively impacting production.Two CAPA paths:

CAPA Address reasoning for lack of inclusion in shipments asrequired.

CAPA+ - Address whyCoC is required and eliminate the need wherethere is no value-added in the system.

Addressing the greater scope and

analyzing the need for CoC suggestingclose to $50,000 in annual savings.- Plus minimizing\eliminating correctivecosts associated with CoC recovery.

Oth l


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Other examples

In Class Exercise: 10 Min

Other problem description examples:

1. Customer return for soldering issues.

2. On-Time-Delivery rates


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Proactive Improvement Excercise

In Class Exercise: 15 Min

Exercise Description:1. Begin exploring improvement opportunities by listing yourcore

products or services outputs. (departmental or individual)

2. Relate the products or services to the processes by listing theprocesses that generate them.

3. On a 1 to 10 scale, in the eyes of your customer, rank the criticality ofyour products or services. (10 is most critical)

4. On a 1 to 10 scale estimate your current process performance.(10 is the best)

Summary


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Summary

You should now be able to

Define a problem in measurable terms

Contain the problem while developing a long term solution

Collect and analyze data relevant to the problem of interest

Analyze the system of causes and determine root cause

Plan and implement solutions relevant to the root cause of the problem

Evaluate the effectiveness of the improvement

Determine opportunities for standardization

Discuss how to realize the benefits of process improvements

Examine the improvement process for lessons learned and newproblems to solve


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CAPA Presentation Spring 2009

Documents

Transcript of CAPA Presentation Spring 2009