Key functions of a CAR System - QIT Consulting
Key functions of a CAR System - QIT Consulting Key functions of a CAR System - QIT Consulting
QIT Corrective Action Management System Copyright © 2006 QIT Consulting, Inc. QIT Consulting, Inc. Corrective and Preventive Action System Root Cause Analysis and Case Study June 2006
- Page 2 and 3: Contents �� CAR System Introduc
- Page 4 and 5: CAR System Introduction - Definitio
- Page 6 and 7: CAR System Introduction - Basic Req
- Page 8 and 9: QIT’s QIT s Root Cause Analysis P
- Page 10 and 11: Establish the hypothesis I �� Q
- Page 12 and 13: Establish the hypothesis III ��
- Page 14 and 15: Establish the hypothesis V �� Q
- Page 16 and 17: Test the Hypothesis �� Focus on
- Page 18 and 19: Test the Hypothesis - Failure Mode
- Page 20 and 21: Common Failures �� Fail to conc
- Page 22 and 23: Case Study 1 - Background Informati
- Page 24 and 25: Case Study 2: “Do Do it right in
- Page 26 and 27: Case Study 2 Lesson-learned Lesson
- Page 28 and 29: Perspectives Beyond ISO9000 ��
- Page 30 and 31: Questions or Need Any Help? Maybe w
- Page 32 and 33: QIT Corrective Action Management Sy
- Page 34 and 35: QIT Corrective Action Management Sy
- Page 36 and 37: QIT Production Quality Management S
- Page 38: QIT Supplier Quality Management Sys
<strong>QIT</strong> Corrective Action Management <strong>System</strong><br />
Copyright © 2006 <strong>QIT</strong> <strong>Consulting</strong>, Inc.<br />
<strong>QIT</strong> <strong>Consulting</strong>, Inc.<br />
Corrective and Preventive Action <strong>System</strong><br />
Root Cause Analysis<br />
and<br />
Case Study<br />
June 2006
Contents<br />
�� <strong>CAR</strong> <strong>System</strong> Introduction<br />
�� Ultimate objectives <strong>of</strong> a <strong>CAR</strong> <strong>System</strong><br />
�� Root Cause Analysis<br />
�� Common Failures in a <strong>CAR</strong> <strong>System</strong><br />
�� Case Study and Lesson-learned<br />
Lesson learned<br />
�� Perspectives Beyond ISO9000<br />
�� A <strong>CAR</strong> <strong>System</strong> Check Sheet<br />
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Corrective Action <strong>System</strong> Introduction<br />
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<strong>CAR</strong> <strong>System</strong> Introduction - Definition<br />
�� Corrective Action Request <strong>System</strong><br />
– Also called <strong>CAR</strong> <strong>System</strong><br />
– An element <strong>of</strong> ISO9000/QS9000 standards<br />
�� “The The supplier shall establish and maintain documented<br />
procedures for implementing corrective and preventive action…” action…”<br />
(QS 9000 Element 4.14)<br />
�� “The The organization shall take corrective action to eliminate the<br />
cause <strong>of</strong> nonconformities…”<br />
nonconformities…”<br />
(ISO9000 8.5.2)<br />
– Similar applications/systems:<br />
�� Safety Action Request <strong>System</strong><br />
�� Supplier Corrective Action Request <strong>System</strong><br />
�� Action Management <strong>System</strong> for Service Sector<br />
Primary objective: to eliminate the causes <strong>of</strong> nonconformities<br />
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<strong>CAR</strong> <strong>System</strong> Introduction - Process<br />
Initiating and Preliminary<br />
Analysis Phase<br />
Start<br />
Initiator discovers a<br />
nonconformance<br />
Initiator conducts<br />
preliminary analysis<br />
Initiator issues a<br />
<strong>CAR</strong><br />
Initiator dispatches<br />
the <strong>CAR</strong> to related<br />
dept.<br />
No<br />
Root Cause Analysis and<br />
Implementation Phase<br />
<strong>CAR</strong> Receiver<br />
conducts detailed<br />
root cause analysis<br />
<strong>CAR</strong> Receiver<br />
prepares Corrective<br />
Action Plan<br />
<strong>CAR</strong> Receiver<br />
submits CA Plan to<br />
Initiator<br />
Accept?<br />
<strong>CAR</strong> Receiver<br />
monitors the<br />
progress<br />
Initiator and <strong>CAR</strong><br />
Receiver evaluate<br />
action effectiveness<br />
Problem resolved?<br />
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Yes<br />
Review and Verification Phase<br />
End<br />
Yes<br />
No
<strong>CAR</strong> <strong>System</strong> Introduction – Basic Requirements<br />
�� Initiating and Preliminary Analysis Phase<br />
– <strong>CAR</strong> Number<br />
– Issuer/Originator<br />
– Defect Description<br />
– Issue Date and Deadline<br />
�� Root Cause Analysis and Implementation Phase<br />
– Real Root Cause<br />
– Action Plan, Due Date, and Representative<br />
�� Review and Verification Phase<br />
– Implemented Action<br />
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Root Cause Analysis<br />
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<strong>QIT</strong>’s <strong>QIT</strong> s Root Cause Analysis Process<br />
Root cause analysis is a process to establish and<br />
test the hypothesis<br />
�� Utilize the best knowledge available<br />
– Forming a cross-functional cross functional team<br />
– Data from a Knowledge Base<br />
�� Establish the theory and hypothesis<br />
– Qualitative approach<br />
– Quantitative approach<br />
�� Test the hypothesis<br />
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Forming a Cross-functional Cross functional Team<br />
�� Involving as many people from the business value<br />
stream as possible<br />
– Sales and Marketing<br />
– Engineering<br />
– Operation<br />
– Quality<br />
– Service<br />
– …<br />
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Establish the hypothesis I<br />
�� Qualitative approach<br />
– Proper probing to collect information<br />
�� Where did the problem occur?<br />
�� When did the problem occur?<br />
�� Who is involved?<br />
�� Why did the problem occur?<br />
�� How did the problem occur?<br />
– <strong>QIT</strong> Corrective Action Management <strong>System</strong> users can<br />
also retrieve historical data from the Knowledge Base<br />
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Establish the hypothesis II<br />
�� Category the contributing factors to 5 categories – Man,<br />
Machine, Material, Method, and Environmental Factor<br />
Environmental<br />
Factor<br />
Material Method<br />
Motivation<br />
Quality<br />
Training<br />
Man Machine<br />
Quantity<br />
Identification<br />
Fixture<br />
Tooling<br />
Root Cause<br />
Theory<br />
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Jig<br />
Procedure<br />
Design
Establish the hypothesis III<br />
�� Define all potential contributing factors <strong>of</strong> the failure, and<br />
then use Risk and Cost to weight each contributing<br />
factors<br />
– A cross reference <strong>of</strong> Risk and Cost<br />
�� Risk<br />
– Severity<br />
– Occurrence<br />
– Currant Control<br />
�� Cost<br />
– Direct Cost<br />
– Approval Cost<br />
– Other Cost<br />
High Risk and Low Cost<br />
Low Risk and Low Cost<br />
Risk<br />
High Risk and High Cost<br />
Low Risk but High Cost<br />
Cost<br />
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Establish the hypothesis IV<br />
�� Focus on the top 3 (high risk and high cost) contributing<br />
factors and form a theory for the failure<br />
�� For instance, in one <strong>of</strong> our customer complaint analysis<br />
– Man – lacking <strong>of</strong> training (Risk =50, Cost=$5k)<br />
– Machine – poor workmanship (Risk =50, Cost=$5k)<br />
– Material – N/A<br />
– Method – improper design <strong>of</strong> the latch (Risk =150, Cost=$50k),<br />
inappropriate assembly procedure (Risk =350, Cost=$5k), and no<br />
inspection for the latch assembly (Risk =250, Cost=$15k)<br />
�� We can then describe the theory as - The problem was<br />
caused by improper design <strong>of</strong> the latch, inappropriate<br />
assembly procedure and inspection procedure<br />
�� The next thing we need to do is to test this hypothesis<br />
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Establish the hypothesis V<br />
�� Quantitative Approach<br />
– Design <strong>of</strong> Experiment (DOE)<br />
– Liner Regression<br />
– Correlation<br />
�� These statistical methods can also be used to<br />
establish a mathematical model to decipher the<br />
theory<br />
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Test the Hypothesis<br />
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Test the Hypothesis<br />
�� Focus on the top three factors and implement<br />
corrective actions<br />
�� Review and verify the results. If the outcome is in<br />
a positive trend, the hypothesis is true, otherwise,<br />
it is false.<br />
– Yield <strong>of</strong> the production<br />
– Number <strong>of</strong> customer returns/complaints<br />
– Number <strong>of</strong> <strong>CAR</strong> issued<br />
– Repeated Failure Mode<br />
�� Establish a new theory based on the new data<br />
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Test the Hypothesis - Example<br />
Use the data from CAPA <strong>System</strong> or Production <strong>System</strong> to verify the<br />
action results.<br />
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Test the Hypothesis – Failure Mode Analysis<br />
Sort the failure mode by different factors to<br />
see the trending<br />
Snapshot <strong>of</strong> <strong>QIT</strong> Corrective Action <strong>System</strong> Web Edition<br />
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Common Failures in a <strong>CAR</strong> <strong>System</strong><br />
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Common Failures<br />
�� Fail to concentrate on evaluating the CA plan, instead<br />
focus excessively on running <strong>CAR</strong> dispatching processes<br />
– Root Cause: primary interests were stretched thin by the<br />
comprehensive distribution processes<br />
�� Fail to use existing data to establish root cause theory and<br />
prove the theory<br />
�� Fail to use existing data to establish predict and prevent<br />
future failures and carry over best practices<br />
– Root Cause 1: It is hard to use a single index (risk, cost, or<br />
defective quantity) to predict future product/process behavior<br />
– Root Cause 2:It is an arduous and time-consuming time consuming task to<br />
summarize data<br />
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Case Study 1: A million-dollar million dollar Switch<br />
Failure<br />
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Case Study 1 – Background Information<br />
�� A US major household product company was forced to<br />
scrap millions dollars <strong>of</strong> products due to a potential fire<br />
hazard caused by a defect in a switch<br />
�� Internal investigations uncovered<br />
– Same problem was discovered 4 years ago<br />
– A <strong>CAR</strong> was issued, and the corrective action was reported<br />
completed<br />
– Similar failure mode still could be found in new production, but it did<br />
not catch attention because it was buried in the <strong>CAR</strong> system by<br />
other high occurrence failure modes<br />
– Further investigation indicated that this high risk problem had been<br />
encountered in similar switch designs, but it was overlooked<br />
because <strong>of</strong> the defect’s defect s low occurrence<br />
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Case Study 1 – Lesson-learned<br />
Lesson learned<br />
This million-dollar million dollar problem could have been prevented<br />
1. If results <strong>of</strong> the <strong>CAR</strong> could be monitored constantly, and<br />
information could be sent back to production promptly.<br />
2. If the failure mode could be ranked by the failure risk<br />
category rather than the quantity <strong>of</strong> similar <strong>CAR</strong>s issued<br />
3. If the design engineer could learn from or be informed <strong>of</strong> the<br />
history and the problems <strong>of</strong> the original designs<br />
<strong>Key</strong> <strong>functions</strong> <strong>of</strong> a <strong>CAR</strong> <strong>System</strong>:<br />
To monitor, prioritize, and reconciliation<br />
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Case Study 2: “Do Do it right in the first time”<br />
time<br />
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Case Study 2 – Background Information<br />
�� A division <strong>of</strong> a Fortune-500 Fortune 500 company launched a<br />
project called “do do it right in the first time” time<br />
– Goal was to improve customer satisfaction and reduce<br />
cost<br />
�� The project failed because people were reluctant<br />
to respond to the project concept<br />
– “we we are human being, we are not perfect, and we are<br />
bound to make mistake from time to time …”<br />
Is it possible to always do things right the first time?<br />
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Case Study 2 Lesson-learned<br />
Lesson learned<br />
�� Can we always do things right the first time?<br />
– No, we can’t. can t. We are human being, and we tend to<br />
make mistakes<br />
– Wait a minute… minute Yes, we can, if we can learn from our<br />
pervious mistakes!<br />
�� This project could have been a huge success if<br />
employees were asked to always refer to the<br />
pervious failures as well as the best practice from<br />
the product/process history every time they took on<br />
a new project<br />
<strong>CAR</strong> <strong>System</strong> could play a key rule in leading<br />
Continuous Improvement projects<br />
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Perspectives Beyond ISO9000<br />
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Perspectives Beyond ISO9000<br />
�� An effective <strong>CAR</strong> <strong>System</strong> should<br />
– Achieve the objectives identified in ISO9000<br />
�� To eliminate the causes <strong>of</strong> nonconformities<br />
– and go beyond:<br />
�� Streamline the <strong>CAR</strong> dispatching processes<br />
�� Monitor the action results constantly<br />
�� Utilize various indexes to prioritize corrective actions<br />
– Risk, cost, defective quantity, and etc.<br />
�� Provide product/process history and previous failures to<br />
prevent problems in new product lines<br />
Does your current <strong>CAR</strong> <strong>System</strong> achieve these objectives?<br />
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<strong>CAR</strong> <strong>System</strong> Check Sheet<br />
Items Yes No<br />
Initiating and Preliminary Study Phase<br />
Can the <strong>CAR</strong> <strong>System</strong> record Preliminary Root Case?<br />
Can the <strong>CAR</strong> <strong>System</strong> record Quality Cost?<br />
Can the <strong>CAR</strong> <strong>System</strong> record Failure Mode?<br />
Can the <strong>CAR</strong> <strong>System</strong> record Failure Risk Category?<br />
Root Cause Analysis and Implementation Phase<br />
Can the <strong>CAR</strong> <strong>System</strong> record Real Root Cause and action plans?<br />
Can the <strong>CAR</strong> <strong>System</strong> record user’s user s comments and implemented actions?<br />
Can the <strong>CAR</strong> <strong>System</strong> record user verifications for action results? results?<br />
Monitoring and Verification Phase<br />
Can the <strong>CAR</strong> <strong>System</strong> prioritize <strong>CAR</strong>s, utilizing Risk Category, Quality Cost, and Defective quantity?<br />
Can the <strong>CAR</strong> <strong>System</strong> summarize top 10 failure modes and rank them them<br />
by Risk Category, Quality Cost, and Defective<br />
quantity?<br />
Can the <strong>CAR</strong> <strong>System</strong> report the effectiveness by using the trending trending<br />
<strong>of</strong> Risk Category, Quality Cost, and Defective quantity?<br />
Can the <strong>CAR</strong> <strong>System</strong> provide a Product/Process Knowledge Base for for<br />
users to look up failure and action history?<br />
If you answered Yes to all these questions, then congratulations! You have a robust <strong>CAR</strong><br />
system in place already!<br />
If you got one or two No’s, your system may need some improvements<br />
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Questions or Need Any Help?<br />
Maybe we can help at <strong>QIT</strong> <strong>Consulting</strong>!<br />
<strong>Consulting</strong><br />
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<strong>QIT</strong> <strong>Consulting</strong>, Inc.<br />
�� A Quality Assurance and Six Sigma <strong>Consulting</strong><br />
and S<strong>of</strong>tware Design Company<br />
– Quality S<strong>of</strong>tware Design<br />
– Quality Assurance, Six Sigma and Lean Manufacturing<br />
<strong>Consulting</strong><br />
– Supplier Management and Outsourcing<br />
– Training<br />
Email: service@qitconsulting.com<br />
Website: Http://www.<strong>QIT</strong><strong>Consulting</strong>.com<br />
Phone: (207) 651-4835 651 4835<br />
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<strong>QIT</strong> Corrective Action Management <strong>System</strong><br />
�� <strong>Key</strong> Functions and Benefits<br />
– Easy to use and deploy<br />
– Reduce quality cost and quality system administrative<br />
cost<br />
– Issue and dispatch internal <strong>CAR</strong>, Supplier <strong>CAR</strong>, and<br />
ISO9000 Internal Audit <strong>CAR</strong><br />
– Monitor corrective actions progress<br />
– Monitor department and supplier performance<br />
– Establish a Product Knowledge Base to prevent<br />
problems from happening again<br />
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<strong>QIT</strong> Corrective Action Management <strong>System</strong> Web Edition<br />
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<strong>QIT</strong> Corrective Action Management <strong>System</strong><br />
Trending <strong>of</strong> Cost and Risk to<br />
monitor quality performance<br />
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<strong>QIT</strong> Production Quality Management <strong>System</strong><br />
�� <strong>Key</strong> Functions and Benefits<br />
– Easy to use and deploy. No specific 6-Sigma 6 Sigma knowledge<br />
is needed<br />
– Instantly establish 6-Sigma 6 Sigma production control<br />
– Reduce quality cost and 6-Sigma 6 Sigma implementation cost<br />
– Use Long-term Long term Sigma, Short-term Short term Sigma, Yield,<br />
Throughput Yield, Cycle Time to report and monitor<br />
production performance<br />
– Report performance in <strong>System</strong>, Product, Process, and<br />
Work Order levels<br />
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<strong>QIT</strong> Production Quality Management <strong>System</strong><br />
The trending <strong>of</strong> Cost, Risk and Six<br />
Sigma Measurements to monitor<br />
quality performance<br />
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<strong>QIT</strong> Supplier Quality Management <strong>System</strong><br />
�� <strong>Key</strong> Functions and Benefits<br />
– Easy to deploy and use<br />
– Reduce quality cost and improve supplier quality<br />
– Capture incoming inspection data<br />
– Report supplier Quality and Delivery Performance<br />
– Report supplier rolling 12-month 12 month performance<br />
– Supplier Report Card<br />
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<strong>QIT</strong> Supplier Quality Management <strong>System</strong><br />
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