ASQ Section 1216 - Spring Conference April 2, 2009

CAPA:
Systemic & Cost Effective
Christopher Parker – March, 2009

Strategic Quality Systems

Prepared by Christopher Parker, March, 2009

Outline

ƒ Course Objectives
ƒ Why are Analysis skills important?
ƒ The Need for Improvement
ƒ Change the Process to Change the
Results
ƒ Benefits of Process Improvement
ƒ Proactive versus Reactive Improvement
ƒ Analysis Hierarchy
ƒ The importance of CAPA
ƒ 7D Model and Activities
ƒ 7D Model and DMAIC
ƒ 7D Model and PDCA
ƒ Problem Description
ƒ Containment
ƒ Investigate & Define Root Cause
ƒ Tools
ƒ Initial Corrective Action ƒ Exercises
ƒ Permanent Corrective Action ƒ Example
ƒ Verification ƒ Other examples
ƒ Proactive Improvement Excercise
ƒ Summary

Prepared by Christopher Parker, March, 2009

Course Objectives

As a result of attending this course the participant will be able to:

ƒ Identify a problem that requires improvement
ƒ Define a problem in measurable terms
ƒ Contain the problem while developing a long term solution
ƒ Collect and analyze data relevant to the problem of interest
ƒ Analyze the system of causes and determine root cause
ƒ Plan and implement solutions relevant to the root cause of the problem
ƒ Evaluate the effectiveness of the improvement
ƒ Determine opportunities for standardization
ƒ Discuss how to realize the benefits of process improvements

Prepared by Christopher Parker, March, 2009

Why are Analysis skills important?

Prepared by Christopher Parker, March, 2009

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

Prepared by Christopher Parker, March, 2009

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

• Without change in the process we will continue

to achieve the same levels of performance and
encounter the same difficulties and problems we
see today
• We must ask: “What causes problems?”,
identify the Root Cause and change the
process conditions that create our problems to
achieve better results
• Improving the process will by definition improve
the product
• The focus of our improvement efforts will be to
understand the process, to identify critical
changes that need to be made in the process,
and introduce a controlled solution to produce a
better product or service

Prepared by Christopher Parker, March, 2009

Why are Analysis skills important? - Benefits of Process Improvement

ƒ More efficient problem solving process

ƒ Reduction in cycle-times
ƒ Improved materials management
ƒ Improved commit process
ƒ Improved Customer satisfaction
ƒ Reduction in defect levels
ƒ Reduction in WIP and inventories
ƒ Improved process controls
ƒ Improved process efficiencies
ƒ Job enlargement and employee
satisfaction

Prepared by Christopher Parker, March, 2009

Proactive Versus Reactive Improvement

Proactive Improvement Reactive Improvement

ƒ Routine communication with ƒ Poor performance is Impacting the
Customers concerning needs Customer
ƒ Lack of satisfaction with the status ƒ Clearly identified problem
quo ƒ Need to contain the problem
ƒ Monitor performance and ƒ Need to determine root cause and
consider opportunities for correct the problem
Improvement ƒ Examples:
ƒ Take action for improvement prior Customer complaints
to complaints Poor yields
ƒ Examine the workflow to look for Supplier delivery problems
opportunities for Improvement Missing Customer commits
Excessive errors
ƒ Getting people in the process
Audit errors or failures
involved in making improvements Poor CSI Scores
ƒ Examination of financial waste in
all of our activities

Either condition is a good reason to initiate an improvement project

Prepared by Christopher Parker, March, 2009

Why are Analysis skills important? – Analysis Hierarchy

ƒ Continuous Improvement
ƒ Ongoing recognition of opportunities to improve

ƒ Problem Solving
ƒ Solution oriented effort for specific
concerns or issues

ƒ Root Cause Analysis

ƒ Cause identification driven effort necessary
to prevent recurrence

ƒ Failure Analysis
ƒ Technical examination and very focused effort on failed devices to identify
specific details of a very specific concern or issue

Prepared by Christopher Parker, March, 2009

The Importance of CAPA

Prepared by Christopher Parker, March, 2009

The Importance of CAPA – 7D Model and Activities
Detailed Tools Management
Activities & Analysis Involvement
Identify Problem Areas Basic QC Tools
Select a Problem Check Sheet
Define & Contain the Problem Statement and Containment Pareto Diagram Review & Approve
1 Problem Objective, Goal and Benefits Concentration Diagram
problem Perform Resource Analysis (Stakeholder, equip, $) Run Chart
Develop Improvement Plan Flow Chart
Map the Process Cause & Effect Diagram
Define Data Collection Requirements Histogram

2 Measure the problem Develop Data Collection Plan

Collect Data
Scattergraph
Advanced Tools*
Monitor Progress

Define Process Baseline Measurement Systems Analysis

Evaluate Data to Determine Relationships Partition of Variation
Stratify Data to Understand Root Cause Regression
Perform Root Cause
3
Develop a Cause & Effect Diagram Capability Analysis Monitor Progress
Determine the 5 Whys Control Charts
Analysis Benchmark on Best In Class Processes
List and Prioritize Root Causes Fault Tree Analysis, FMEA
Brainstorm Potential Solutions

4 Plan & Implement

Evaluate Cost, Complexity, Impact, Benefit and Risk (see criteria) Brainstorming
Prioritize Solutions into Long Term and Short Term Effort Impact Analysis Review & Approve

Improvement Communicate Implementation Plan

Implement Solution
Prioritization Matrix

Collect Representative Sample of Data Basic QC Tools

Compare Performance to Baseline Annotated Run Chart
5 Assess Effectiveness 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 & Approve
6 Standardize & Control Determine 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

7 Realize & Reflect

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

Prepared by Christopher Parker, March, 2009

7 Step Improvement Model – PDCA

7. Realize
and
Benefits
6. Standardize
Reflect on the
Improvement and Control
Process

1. Define & 3. Perform

Identify Contain The Root
CH Problem Problem Cause
EC Areas Analysis 5. Assess
Effectiveness of
DO

K
2. Improvement
Measure 4. Plan &
Select a the Implement
AC

N Problem
Problem
T

A Improvement
PL

Data I Data II Data III

Baseline Process Problem Specific Representative
Performance, Data, Map the Sample in Time
Examine Process, Stratify Series to See the
Dashboards Data and Examine Effects of
Relationships to Improvements
Isolate the Problem

Prepared by Christopher Parker, March, 2009

The Importance of CAPA – 7D and DMAIC
1

4
5

6
7

Prepared by Christopher Parker, March, 2009

Problem Description

ƒ Problem Definition is the most important part of the process

– a poorly defined problem will never be solved.
ƒ Listen to the problem from the source
ƒ Assume nothing
ƒ Understand the focus and intent of the source
ƒ Identify tone and elements of emphasis in the message
ƒ Identify as many details of the problem as possible
ƒ Stick with facts and known details
ƒ Focus on what, when, and where
ƒ Remain systemic, do not tell stories
ƒ Do not ask who – it leads to blame
ƒ Do not ask why – it fosters assumptions
ƒ What is the significance of the problem
ƒ Impact on relationship, processes, metrics
ƒ Be concise
ƒ Confirm the definition with the source

Prepared by Christopher Parker, March, 2009

Containment

ƒ Containment is more than just segregating material or processes.

ƒ Assures the internal\external customer they will no longer be impacted
ƒ Provides evidence for the analysis

ƒ Every effort and priority must be made to identify and detain any
impacted material or processes.
ƒ Have all inventory locations of the risk material been identified?
(incoming, returns, stock, kits, WIP, finished goods, shipped product…)
ƒ Be specific as to how much material, B\L, location, and where it is now.
ƒ Assure that the material is prevented from accidental use.
ƒ Has the process been stopped pending review and evaluation?
ƒ If elements are performed in stages or pieces, edit the CAPA record with each detail as it is
available, such as: 04-AUG (CWP) Moved B\L 23647 to HOLD

Prepared by Christopher Parker, March, 2009

Containment

ƒ Containment may include actions to be defined as Initial Corrective

Action details.
ƒ “All material has been quarantined”
ƒ “Area employees have been made aware of the concern and these
immediate changes have been made …”
ƒ Etceteras

ƒ Remember to remain factual and concise. Do not tell stories or

provide information beyond what is needed to support the Problem
Description.
ƒ Open additional CAPAs if the containment
process identifies additional concerns beyond
the scope or definition.

Prepared by Christopher Parker, March, 2009

Investigate & Define Root Cause

We all know what the root

cause is ….. correct?

I was on
vacation

No procedures
Customer is too
demanding

The supplier

No training

The Production
team

You are …
Poor
communication

Prepared by Christopher Parker, March, 2009

Investigate & Define Root Cause

ƒ Investigation and Defining Root Cause(s) is most often impaired by

presumptions and paradigms.
ƒ “We do that well, we just had a bad day …”
ƒ “This was an exception, not the standard”
ƒ “_____ just doesn’t understand”
ƒ “This is just like every other problem …”

ƒ Remain objective and find the evidence that led

to the behavior, mistake, or problem identified
in the Problem Description.
ƒ Formalize the investigation
ƒ Document all findings, supportive of the issue
as well as “dead ends”
ƒ Remain systemically focused and do not
be content with individual observations

Prepared by Christopher Parker, March, 2009

Simple Tools

Check Sheet Pareto Diagram

Brainstorming
5 Whys

Process Flowchart Cause & Effect Diagram

Histograms

•
•
•
• •
• … and others
•
• • • •
•
•

Run Chart Scatter Diagrams

Prepared by Christopher Parker, March, 2009

Robust Tools

NPI
Correct process Change
quantity control

Defect X X
free
100 X 75 50 25 25 50X 75 100
FMEA & Control Plans Control Charts
Customer
Requirement X
Performance X
X
On time X Inventory
delivery management
⎡USL − u x LSL − u x ⎤
RMA frequency
Cpk = Z min ⎢ , ⎥
⎣⎢ 3σ x 3σ x ⎦⎥ Radar (Spider) Chart

Capability

Hypothesis Testing

Failure Analysis

Prepared by Christopher Parker, March, 2009

Initial Corrective Action

ƒ The Initial Corrective Action should provide:

ƒ Confidence that recurrence is minimized or eliminated
ƒ Containment of any adulterated material or rogue processes
ƒ Commitment to defect free material and compliant processes
ƒ Continuation of controlled activity

ƒ Initial Corrective Action is not:

ƒ The end of the CAPA process
ƒ Do not allow activity and progress to stall
ƒ An explanation or sales pitch
ƒ support and document all decisions and actions
taken 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)

Prepared by Christopher Parker, March, 2009

Permanent Corrective Action

ƒ Permanent Corrective Action must contain three elements

that specifically provide a solution for the identified issue(s):

1. A systemic definition
2. That is sustainable
3. 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 element of the corrective action is
systemic and sustainable. Expecting the course
is completed annually and prior to working in
the process is preventive.

Prepared by Christopher Parker, March, 2009

Verification

ƒ Only through Verification will the process be complete.

ƒ The verification process should be done after the initial

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

ƒ Sometimes this may best be done by the Internal Auditing

function in order to remain independent and within the
Quality System processes.

Prepared by Christopher Parker, March, 2009

Tying 7D CAPA back to DMAIC - Summary

Define & Contain the

1
problem

2 Measure the problem

Perform Root Cause

3
Analysis

4 Plan & Implement

Improvement

5 Assess Effectiveness

6 Standardize & Control

7 Realize & Reflect

Prepared by Christopher Parker, March, 2009

Why are Analysis skills important?

Prepared by Christopher Parker, March, 2009

Example – Incoming Inspection

Problem Description:
Required Certificate of Compliance (CoC) documents from suppliers are
not included in as much as 35% of all required receipts. Leading to
non-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 as
required.
CAPA+ - Address why CoC is required and eliminate the need where
there is no value-added in the system.

Addressing the greater scope and

analyzing the need for CoC suggesting
close to $50,000 in annual savings.
- Plus minimizing\eliminating corrective
costs associated with CoC recovery.

Prepared by Christopher Parker, March, 2009

Other examples

Other problem description examples:

1. Customer return for soldering issues.

2. On-Time-Delivery rates <80%.

3. Not following procedure _________.

In Class Exercise: 10 Min

Prepared by Christopher Parker, March, 2009

Proactive Improvement Excercise

Exercise Description:
1. Begin exploring improvement opportunities by listing your core
products or services – outputs. (departmental or individual)
2. Relate the products or services to the processes by listing the
processes that generate them.
3. On a 1 to 10 scale, in the eyes of your customer, rank the criticality of
your products or services. (10 is most critical)
4. On a 1 to 10 scale estimate your current process performance.
(10 is the best)

In Class Exercise: 15 Min

Prepared by Christopher Parker, March, 2009

Summary

You should now be able to …

ƒ Define a problem in measurable terms

ƒ Contain the problem while developing a long term solution
ƒ Collect and analyze data relevant to the problem of interest
ƒ Analyze the system of causes and determine root cause
ƒ Plan and implement solutions relevant to the root cause of the problem
ƒ Evaluate the effectiveness of the improvement
ƒ Determine opportunities for standardization
ƒ Discuss how to realize the benefits of process improvements
ƒ Examine the improvement process for lessons learned and new
problems to solve

Prepared by Christopher Parker, March, 2009

Prepared by Christopher Parker, March, 2009