corrective action - qsg meeting 12 18 09

8/6/2019 Corrective Action - QSG Meeting 12 18 09

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Corrective Action Workshop

CAPA

Based on 8D MethodologyAngelo G. Scangas

President, Quality Support Group Inc.

978-430-7611


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At the conclusion of this module, you should:

Have an understanding of the basic tools and the knowledgeneeded to collect and analyze data to solve problems thataffect the quality of your products and services.

Be better able to implement solutions and containment actions.

Have a full understanding of the key elements of the problemsolving process (Root Cause Analysis).

Develop a verification process to prevent re-occurrence

Share a uniform basis and approach in the methodology of

problem solving.

Objectives Training expectations


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Order of topics in training module.

Trigger points for problem solving activity

Case Study

The Problem Solving Approach

Problem Statement Interim Action / Containment.

Problem Definition and Analysis of Root Cause.

Define Root Cause and Escape Point.

Choose and Verify Corrective action.

Implement and Validate Corrective Action.

Prevent Recurrence.

Congratulate the Team


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The Eight Disciplines

D0 Recognize SymptomsD1 Establish a Team

D2 State and Describe the Problem

D3 Contain the Symptoms

D4 Find and Verify Root Cause

D5 Select and Verify Corrective ActionD6 Implement and Verify PermanentCorrective Action

D7 Prevent Recurrence and Correct SystemFlaws

D8 Recognize the Team


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Problem-

Solving

Process

Become Aware

of Problem

EstablishTeam

Describe Problem

Contain Systems

Select & VerifyCorrective Actions

Implement and

Validate Corrective

Actions

Prevent Recurrence

Recognize Team

Find Root Cause

Identify Potential

Causes

Select Probable

Causes

Is Probable

Cause a

Root

Cause?


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Trigger points for problem solving activity.

What trigger points have you experienced?

Customer Complaints Non-Conformances

Process Control Indicators

Cost Reduction Effort

Continuous Improvement Effort

Suggestion


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Problem StatementProblem Statement

The problem statement is a statement that

clearly and concisely identifies the object

of a problem, and the unsatisfactory

condition for which the cause is not

known.What is the problem?

Why is it a problem?

Based on what evidence?

Whats The Problem?

A problem well-defined is a problem half-solved.

Problem statement


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1. Problem Statement.

2. Interim Action / Containment.

3. Problem Definition and Analysis of Root Cause.

4. Define Root Cause and Escape Point.

5. Choose and Verify Corrective action.

6. Implement and Validate Corrective Action.

7. Prevent Recurrence.



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Containment does not eliminate the root cause of

the problem.

Inform Customer of problem and actions taken to contain it.

Customer Loyalty is an organizations greatest asset!

Remember...


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What is the Problem Definition?

Problem definition and analysis

The Problem Definition is a detailed

description of the relevant facts of the

problem, assembled from information readily

available, as well as additional fact finding

and data collection.

Fact List


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What does the Problem Definition do?

It defines the boundaries of the problem in

terms of what it IS, and what it could be but

ISNOT.

It looks at all the possibilities, and eliminatesthe ones that are not part of the problem.

It clarifies and pins down the facts.


It limits the search by excluding logical

impossibilities.


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Is/Is Not

Is Is Not

What

What object has the problem?

What is the defect?

What similar object could have the problem

but does not?

What defect could the object have but does

not?

Where

Where is the object locatedgeographically when the defect is

noticed?

Where is the defect located on the

object?

Where could the object be located but it isnot?

Where could the defect be located but it is

not?

When

When was the defective object first

noticed? When has it been observedsince?

What is the timing pattern (continuous,

random, or cyclical) and trend?

When could the defective object been noticed,

but was not?

What could the timing pattern and trend be but

is not?

ExtentHow many objects have the defect?

How extensive is the defect?

How many objects could have the defect but

do not?

How extensive could the defect be but is not?


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What is a Root Cause?

A root cause is the reason for a condition or an action

at its origin or source.

In the context of problem solving, a root cause is one

considered to be far enough into the sequence of

causes and effects, that removing it will eliminate the

effect completely and permanently.



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Problem Definition and Analysis process

How to do it.

1. Develop a list of facts to record all relevant

information that is known with certainty.

This list serves as a database for an accurate description

of the problem.

Information must be factual, not inferred.



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Data collection techniques

Check-sheets

Observations

Interviews Statistical Process Control charts

Process Capability Studies

Design of Experiments

Test reports

Scrap reports


Methods used to conduct or facilitate collection of data


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Cause-and-Effect Diagram

Used to structure data collection and analysis to find the

root cause of a problem.

Problem

Methods

EnvironmentMaterials

PeopleMachines

Analysis Tools



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Cause-and-Effect Analysis

Effect

Cause (Machine) Use for grouping ideas. Any grouping that make sensecan be used. The most common are:

Methods, Machines, Materials, People and

Environment

The Problem

1st why?

2nd why?

3rd why? 4th why?

5th why?

Analysis Tools


Cause (Method)


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Analysis techniques

Brainstorming Repeated Whys

Why it happened, why it wasnt detected


.

Other analysis techniques

3W1H

What, Where, When, How big

5W2H

What, Why, When, Where, Who, How, How many

Timeline of changes to people, material, machines, suppliers,

measurements, methods, environment, specifications.

Comparative analysis: IS versus IS NOT

Comparative analysis: Should Vs. Actual

Reproduction of the problem

Review of Failure Mode and Effects Analysis

S


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The output from the Problem Definition andAnalysis process is a list of potential root

causes each of which could explain the

occurrence of the problem.

Output from the Problem Definition and

Analysis process.



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Define root cause and escape point

The root cause is the one identified that satisfies the

requirement of completely explaining the effect. It is the

single verified reason that accounts for the problem. The root cause is supported by the facts without

contradiction.

The root cause is the one whose removal should make the

effect stop permanently.

Which is the Root Cause?

Define root cause and escape point


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Inability to detect the problem at a

control point is NOTa root cause.

(Conversely, the ability to detect the problem

does not remove the root cause.)

Which is (NOT) the Root Cause?

Define root cause and escape point (continued)

Define root cause and escape pointS


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Criteria for a Permanent Corrective Action

What does a good corrective action do?

Fixes the problem at the root causelevel

Generates no additional problems Has been verified to work

Its best if the corrective action can bedesigned so it does not require detection.(Mistake proof)

Choose and verify corrective action


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Corrective Action implementation plan

Implement and validate corrective action

Develop a detailed implementation plan. Be sure to

include What, Where, When, Who, and How

(4W and 1H).

Involve those who will be affected.

Inform those who need advance notification.

Secure approvals when necessary.

Track timing of implementation.

Control any product affected by a change.


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4Ws and 1 H

What( will be done)

Where(will it be done)

When(will it be done)

Who(will do it)

How(will it be done)

Implement and validate corrective action


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The way to prevent recurrence of the problem is

to standardize the corrective action and the

lessons learned into the operating system for the

process.

Prevent Recurrence

Prevent Recurrence


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Thats a wrap!Thank you!

Any further questions?

+s and s

corrective action - qsg meeting 12 18 09

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