Root Cause analysis and Corrective Action.ppt

RCA

1. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
WELCOME!WELCOME!
Americas Aerospace Quality GroupAmericas Aerospace Quality Group
AAQG AAQG
Registration Management CommitteeRegistration Management Committee
RMCRMC
Auditor Training and Workshop SessionAuditor Training and Workshop Session
Minneapolis, MNMinneapolis, MN
July 30-31, 2009 July 30-31, 2009
Value Added Aerospace AuditingValue Added Aerospace Auditing

2. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
Who is R. Darrell Taylor?Who is R. Darrell Taylor?
•Raytheon Corporate AS9100 QMS AuditorRaytheon Corporate AS9100 QMS Auditor
•27 years experience in the quality field (inspector, 27 years experience in the quality field (inspector,
engineer, teacher, director)engineer, teacher, director)
•RABQSA certified Lead QMS auditor, AIEARABQSA certified Lead QMS auditor, AIEA
•ASQ – CQA, CMQ/OE, CQPAASQ – CQA, CMQ/OE, CQPA
•6 6  Master Black Belt, certified Black Belt, Master Black Belt, certified Black Belt,
Raytheon 6 Raytheon 6  Specialist Specialist

3. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
Root Cause & Corrective Action Root Cause & Corrective Action
Analysis Training – Why Needed?Analysis Training – Why Needed?
At a recent IAAR (Independent Association of Accredited At a recent IAAR (Independent Association of Accredited
Registrars) meeting the question was asked, why are OEMs, ABs Registrars) meeting the question was asked, why are OEMs, ABs
and ICOP all focused on correction, root cause analysis and and ICOP all focused on correction, root cause analysis and
corrective action?corrective action?
Simply stated, CBs and suppliers are not delivering to the Simply stated, CBs and suppliers are not delivering to the
Aviation, Space and Defense (aerospace) industries expectations!Aviation, Space and Defense (aerospace) industries expectations!
It is essential all CBs and auditors support industry in its quest to It is essential all CBs and auditors support industry in its quest to
improve these activities within the CB community, its auditor base improve these activities within the CB community, its auditor base
and throughout the supply chain. We can make a difference!and throughout the supply chain. We can make a difference!
Reg Blake – Primary IAAR Rep to AAQG RMC and Americas CB Rep to IAQG OPMTReg Blake – Primary IAAR Rep to AAQG RMC and Americas CB Rep to IAQG OPMT

4. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
Root Cause & Corrective Action Root Cause & Corrective Action
AnalysisAnalysis
The scope of this workshop is to explore how The scope of this workshop is to explore how
we, as auditors, can analyze auditee corrective we, as auditors, can analyze auditee corrective
action and root cause for accuracy, relevancy, action and root cause for accuracy, relevancy,
and completeness for the purpose of and completeness for the purpose of
improving the auditee’s system and have a improving the auditee’s system and have a
positive impact on the aerospace industry.positive impact on the aerospace industry.

5. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
““It is not necessary to change.It is not necessary to change.
Survival is not mandatory.”Survival is not mandatory.”
Quote from : Dr. William Edwards DemingQuote from : Dr. William Edwards Deming

6. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
What is the Auditors Role?What is the Auditors Role?
•Identify RequirementsIdentify Requirements
•Verify Conformance to the Verify Conformance to the
RequirementsRequirements
•Verify the effectiveness of the Verify the effectiveness of the
processprocess

7. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
TopicsTopics
•ProcessProcess
•Corrective Action InitiationCorrective Action Initiation
•Root Cause AnalysisRoot Cause Analysis
•Corrective ActionCorrective Action
•Verification & ValidationVerification & Validation

8. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
Questions to ExploreQuestions to Explore
What constitutes real root cause analysis?What constitutes real root cause analysis?
How is root cause analysis documented?How is root cause analysis documented?
Who should be involved?Who should be involved?
How do we determine if corrective action is How do we determine if corrective action is
effective?effective?
Who should do this?Who should do this?

9. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
AS9100 -8.5.2 Corrective ActionAS9100 -8.5.2 Corrective Action
•The organization shall take action to The organization shall take action to eliminate the causes of nonconformities eliminate the causes of nonconformities
in order to prevent recurrencein order to prevent recurrence. Corrective actions shall be appropriate to the . Corrective actions shall be appropriate to the
effects of the nonconformities encountered. A documented procedure shall be effects of the nonconformities encountered. A documented procedure shall be
established to define requirements forestablished to define requirements for
–a) reviewing nonconformities (including customer complaints),a) reviewing nonconformities (including customer complaints),
–b) b) determining the causes of nonconformities,determining the causes of nonconformities,
–c) c) evaluating the need for action to ensure that nonconformities do not evaluating the need for action to ensure that nonconformities do not
recur,recur,
–d) determining and implementing action needed,d) determining and implementing action needed,
–e) records of the results of action taken (see 4.2.4),e) records of the results of action taken (see 4.2.4),
–f) f) reviewing the effectiveness of the corrective action takenreviewing the effectiveness of the corrective action taken,,
–g) flowing down corrective action requirements to a supplier when it is g) flowing down corrective action requirements to a supplier when it is
determined that the supplier is responsible for the nonconformity,determined that the supplier is responsible for the nonconformity,
–h) h) specific actions where timely and/or effective corrective actions are not specific actions where timely and/or effective corrective actions are not
achieved, andachieved, and
–i) determining if additional nonconforming product exists based on the i) determining if additional nonconforming product exists based on the
causes of the nonconformities andcauses of the nonconformities and
–taking further action when required.taking further action when required.

10. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
ProcessProcess
Conduct
Verification &
Validation
What We Control
What the Auditee Controls
Identify a
Nonconformity
Initiate Corrective
Action
Approve
Corrective
Action
Implement
Corrective
Action
Containment
Root Cause
Corrective Action

11. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
What do you like?What do you like?
What can be done better?What can be done better?

12. Registration Management Committee (RMC)
Auditor Training and Workshop
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July 30-31, 2009
Sample Finding - Observation Sample Finding - Observation
Despite the procedures in place, a certain amount of Despite the procedures in place, a certain amount of
undocumented equipment swapping and borrowing undocumented equipment swapping and borrowing
occurs. Training should be conducted to ensure that occurs. Training should be conducted to ensure that
equipment such swapping/borrowing is approved by equipment such swapping/borrowing is approved by
the assigned owner of the equipment. Otherwise, the assigned owner of the equipment. Otherwise,
there is the danger of equipment not being available there is the danger of equipment not being available
to the owner when needed, since verbal agreements, to the owner when needed, since verbal agreements,
as demonstrated above, are easily forgotten. as demonstrated above, are easily forgotten.
Convincing evidence was given showing that there Convincing evidence was given showing that there
was no chance of an Out of Tolerance item being was no chance of an Out of Tolerance item being
used for testing, which is why this is an Observation used for testing, which is why this is an Observation
and not a finding. Further findings of this sort would and not a finding. Further findings of this sort would
lead to a minor nonconformance.lead to a minor nonconformance.

13. Registration Management Committee (RMC)
Auditor Training and Workshop
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July 30-31, 2009
Corrective Action InitiationCorrective Action Initiation
NOTE: Use AS9101 form or equivalent

14. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
DefinitionsDefinitions
•ASQ (The Quality Audit Handbook)ASQ (The Quality Audit Handbook)
–Finding - A conclusion of importance Finding - A conclusion of importance
based on observation (s).based on observation (s).
•Audit Standards (Willborn)Audit Standards (Willborn)
–Audit Findings – are the significant Audit Findings – are the significant
conclusions and information needed by conclusions and information needed by
the client or audit user for attaining the the client or audit user for attaining the
planned audit objectives. planned audit objectives.

15. Registration Management Committee (RMC)
Auditor Training and Workshop
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July 30-31, 2009
Problem Definition - Simple ApproachProblem Definition - Simple Approach
•Four Elements:Four Elements:
–Source of the RequirementSource of the Requirement
–RequirementRequirement
–Source of the FindingSource of the Finding
–FindingFinding
Fundamentals of Quality Auditing

16. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
ExampleExample
AS9100, paragraph 8.2.2 “Internal Audit” states “The AS9100, paragraph 8.2.2 “Internal Audit” states “The
organization shall conduct audits at planned intervals…” organization shall conduct audits at planned intervals…”
At XYZ company there is no audit plan.At XYZ company there is no audit plan.
Requirement Source
Nonconformance Source
Nonconformance
Requirement

17. Registration Management Committee (RMC)
Auditor Training and Workshop
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July 30-31, 2009
Problem DefinitionProblem Definition
•4W:4W:
–WhatWhat was affected was affected
–Where Where did the problem take placedid the problem take place
–WhenWhen was the problem discovered was the problem discovered
–WhoWho Discovered the problem Discovered the problem
•2H:2H:
–HowHow much was affected much was affected
–HowHow often has the problem occurred often has the problem occurred
•1C: 1C:
–WhatWhat is the consequence is the consequence
Correct, Prevent, Improve

18. Registration Management Committee (RMC)
Auditor Training and Workshop
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July 30-31, 2009
Complete Problem DefinitionComplete Problem Definition
•What What is the problem?is the problem?
•WhenWhen did it happen? did it happen?
•WhereWhere did it happen? did it happen?
•What is the What is the significance significance of the problem?of the problem?
Apollo Root Cause Analysis

19. Registration Management Committee (RMC)
Auditor Training and Workshop
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July 30-31, 2009
Corrective Action Initiation RequirementsCorrective Action Initiation Requirements
•Write complete sentencesWrite complete sentences
–The problem description needs to be written clearlyThe problem description needs to be written clearly
–Stick to the facts. Don’t make it a story. Stick to the facts. Don’t make it a story.
–Be precise in defining the requirement and deficiencyBe precise in defining the requirement and deficiency
–Avoid abbreviations, acronyms…Avoid abbreviations, acronyms…
•Noncompliance issues (Major, Minor) need to Noncompliance issues (Major, Minor) need to
“violate” some requirement or they may “violate” some requirement or they may
document the absence of a processdocument the absence of a process
–Program plan, procedure, standard (AS9100), etc.Program plan, procedure, standard (AS9100), etc.
–Always include the violated requirement in the problem Always include the violated requirement in the problem
descriptiondescription

20. Registration Management Committee (RMC)
Auditor Training and Workshop
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Problem Description Requirements Problem Description Requirements
(cont.)(cont.)
•Problem Description SufficiencyProblem Description Sufficiency
–Identify What, Where, When, as appropriateIdentify What, Where, When, as appropriate
–Reference the EvidenceReference the Evidence
–The responsible assignee needs to have enough information The responsible assignee needs to have enough information
from the problem statement to conduct root cause analysis from the problem statement to conduct root cause analysis
and identify corrective actionand identify corrective action
•Self-check the problem descriptionSelf-check the problem description
–Is the statement complete and self-sufficient?Is the statement complete and self-sufficient?
–Ask yourself … So What?Ask yourself … So What?
–Where does it say that I have to?Where does it say that I have to?

21. Registration Management Committee (RMC)
Auditor Training and Workshop
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July 30-31, 2009
““A problem well defined is a problem A problem well defined is a problem
half solved” half solved”
(anonymous)(anonymous)

22. Registration Management Committee (RMC)
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July 30-31, 2009
CASE STUDY 1CASE STUDY 1
WRITING A PROBLEM DESCRIPTION

23. Registration Management Committee (RMC)
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Levels of NonconformitiesLevels of Nonconformities

24. Registration Management Committee (RMC)
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July 30-31, 2009
AS9101 - DRAFTAS9101 - DRAFT
MajorMajor
Minor Minor
NOTE: An observation is not a nonconformity

25. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
AS9101 - DRAFTAS9101 - DRAFT
•3.23.2 Major NonconformityMajor Nonconformity
•A non-fulfillment of a requirement which, is likely to result in the A non-fulfillment of a requirement which, is likely to result in the
failure of the quality management system or reduce its ability to failure of the quality management system or reduce its ability to
assure controlled processes or products; it can be one or more of assure controlled processes or products; it can be one or more of
the following:the following:
–a nonconformity where the effect is judged to be detrimental to the integrity a nonconformity where the effect is judged to be detrimental to the integrity
of the product, or service;of the product, or service;
–the absence of, or total breakdown of a system to meet a 9100-series the absence of, or total breakdown of a system to meet a 9100-series
standard requirement, an organization procedure, or customer quality standard requirement, an organization procedure, or customer quality
management system requirement;management system requirement;
–any nonconformity that would result in the probable shipment of any nonconformity that would result in the probable shipment of
nonconforming product; andnonconforming product; and
–a condition that could result in the failure or reduce the usability of the a condition that could result in the failure or reduce the usability of the
product or service and its intended purpose.product or service and its intended purpose.

26. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
AS9101 - DRAFTAS9101 - DRAFT
•3.33.3Minor NonconformityMinor Nonconformity
•A non-fulfillment of a requirement which is not likely to A non-fulfillment of a requirement which is not likely to
result in the failure of the quality management system or result in the failure of the quality management system or
reduce its ability to assure controlled processes or reduce its ability to assure controlled processes or
products; it can be one of the following:products; it can be one of the following:
–a single system failure or lapse in conformance with a a single system failure or lapse in conformance with a
9100-series standard or customer quality management 9100-series standard or customer quality management
system requirement; orsystem requirement; or
–a single system failure or lapse in conformance with a a single system failure or lapse in conformance with a
procedure associated to the organization's quality procedure associated to the organization's quality
management system.management system.
•NOTE: A number of minor nonconformities against one NOTE: A number of minor nonconformities against one
requirement, e.g. on different sites, can represent a total requirement, e.g. on different sites, can represent a total
breakdown of the system, and thus be considered a major breakdown of the system, and thus be considered a major
nonconformity.nonconformity.

27. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
What do you like?What do you like?
What can be done better?What can be done better?

28. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
EXAMPLEEXAMPLE
•Nonconformance Description:Nonconformance Description:
–Some departments are not included in the distribution list of Some departments are not included in the distribution list of
relevant quality procedures such as Engineering was not relevant quality procedures such as Engineering was not
included on the distribution list for Procedure XYZ, Control of included on the distribution list for Procedure XYZ, Control of
Nonconforming Material, although Engineering is involved in Nonconforming Material, although Engineering is involved in
the disposition decisions.the disposition decisions.
•Root Cause:Root Cause:
–Inadequate review of procedure needs.Inadequate review of procedure needs.
•Corrective Action:Corrective Action:
–Company A will issue Procedure XYZ to Engineering by Company A will issue Procedure XYZ to Engineering by
12/31/200X.12/31/200X.
–Company A will then post Quality Procedures on its intranet Company A will then post Quality Procedures on its intranet
with access available to all departments.with access available to all departments.

29. Registration Management Committee (RMC)
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Containment ActionContainment Action
•Containment addresses the immediate issue. Containment addresses the immediate issue.
–For example, you have a car that will not start. For example, you have a car that will not start.
Containment gets it started. Containment gets it started.
–If we have a controlled process to keep measuring If we have a controlled process to keep measuring
equipment calibrated and someone finds un-calibrated equipment calibrated and someone finds un-calibrated
or delinquent calibration dates, the or delinquent calibration dates, the containmentcontainment would would
be to get the equipment calibrated.be to get the equipment calibrated.
•During development of Containment, the auditee During development of Containment, the auditee
will determine how big is this issue.will determine how big is this issue.
Stop the bleeding!!!

30. Registration Management Committee (RMC)
Auditor Training and Workshop
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July 30-31, 2009
Root Cause AnalysisRoot Cause Analysis

31. Registration Management Committee (RMC)
Auditor Training and Workshop
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July 30-31, 2009
Root CauseRoot Cause
•DEFINITIONS:DEFINITIONS:
•Root Cause (s): The original event (s), action (s), and/or condition (s) Root Cause (s): The original event (s), action (s), and/or condition (s)
generating (directly or in cascade) an actual or potential undesirable generating (directly or in cascade) an actual or potential undesirable
condition, situation, nonconformity or failure.*condition, situation, nonconformity or failure.*
•Note : There are often several root causes for one problem*Note : There are often several root causes for one problem*
•Contributing Causes: Contributing causes are causes that taken alone would Contributing Causes: Contributing causes are causes that taken alone would
not cause the problem but can increase the risk of the issue to happen. not cause the problem but can increase the risk of the issue to happen.
Analysis for these causes generally require taking small steps (or a finer Analysis for these causes generally require taking small steps (or a finer
look) to be identified and fixed.*look) to be identified and fixed.*
•Root Cause Analysis: The process of identifying all the causes (root causes Root Cause Analysis: The process of identifying all the causes (root causes
and contributing causes) that have or may have generated an undesirable and contributing causes) that have or may have generated an undesirable
condition, situation, nonconformity or failure.*condition, situation, nonconformity or failure.*
•Examples of traditional root causes tend to focus on lack of, or currency of a Examples of traditional root causes tend to focus on lack of, or currency of a
procedure, training of stakeholders in applicable policy/procedures, lack of procedure, training of stakeholders in applicable policy/procedures, lack of
an effective tool to perform a task, etc. an effective tool to perform a task, etc.
*IAQG - SCMH

32. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
ExampleExample
•AS9100, paragraph 8.2.2 “Internal AS9100, paragraph 8.2.2 “Internal
Audit” states “The organization shall Audit” states “The organization shall
conduct audits at planned conduct audits at planned
intervals…” intervals…”
•At XYZ company there is no audit At XYZ company there is no audit
plan.plan.
Requirement Source
Nonconformance Source
Nonconformance
Requirement

33. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
Root Cause AnalysisRoot Cause Analysis
5 Why’s
Apollo
Fishbone
DMAIC
Process Maps
Process FMEA
DOE
5 Why’s
Design FMEA
Control Charts
Pie Charts
Histograms
Control Plans
Pareto Charts
Force Field Analysis
Affinity Diagrams
Interrelationship Digraph
Scatter Diagram
Brainstorming
Flowcharts
Run Charts
Barrier Analysis
Change Analysis
Tree Diagrams
Process Capability
Events & Causal Analysis
Risk Tree Analysis

34. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
ResponseResponse
•Containment – N/AContainment – N/A
•Root Cause Analysis – Did not understand the Root Cause Analysis – Did not understand the
requirementrequirement
•Corrective Action – Write planCorrective Action – Write plan
COMMENTS?

35. Registration Management Committee (RMC)
Auditor Training and Workshop
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July 30-31, 2009
Why do we have poor root cause Why do we have poor root cause
analysis?analysis?

36. Registration Management Committee (RMC)
Auditor Training and Workshop
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July 30-31, 2009
ReasonsReasons
– – We have not set criteria about what makes an acceptableWe have not set criteria about what makes an acceptable
corrective action plan (we are satisfied when we don’tcorrective action plan (we are satisfied when we don’t
receive any more defective parts and stop here)receive any more defective parts and stop here)
– – We continue to accept bad answers (even if say we willWe continue to accept bad answers (even if say we will
not, reality of life makes us accepting )not, reality of life makes us accepting )
– – People (internal and external) have not the Root CausePeople (internal and external) have not the Root Cause
Analysis culture, don’t know any process or are notAnalysis culture, don’t know any process or are not
effectively trainedeffectively trained
*IAQG - SCMH

37. Registration Management Committee (RMC)
Auditor Training and Workshop
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July 30-31, 2009
Investigation ChecklistInvestigation Checklist
•Describe the fast fix that was taken, Is it working?Describe the fast fix that was taken, Is it working?
•Identify owner and those involved.Identify owner and those involved.
•Gather information:Gather information:
–DataData
–Employee InputEmployee Input
–Flowcharts of the processFlowcharts of the process
–ProceduresProcedures
–Records – (quantitative data)Records – (quantitative data)
•Has the problem occurred in the past?Has the problem occurred in the past?
•Identify Root Cause.Identify Root Cause.
Book: Correct! Prevent! Improve!

38. Registration Management Committee (RMC)
Auditor Training and Workshop
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Rules of InvestigationRules of Investigation
•Use proven root cause analysis toolsUse proven root cause analysis tools
•Think “out – of – the – box”Think “out – of – the – box”
•Take the time neededTake the time needed
•Put a plan togetherPut a plan together
Book: Correct! Prevent! Improve!

39. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
Actions and ConditionsActions and Conditions
Oxygen
Oily Rags
Match
Match
Strike
TIME
Apollo: Root Cause Analysis

40. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
ApolloApollo•There is no such thing as a single root cause!!There is no such thing as a single root cause!!
Action
Condition
Condition
Action
Condition
Condition
Action
Condition
Condition
Action
Condition
Condition
STOP
Beyond
your area
of control

41. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
N
O
T

R
E
Q
U
I
R
E
D
FREQUENCY
I
M
P
A
C
T
O
P
T
I
O
N
A
L
R
E
C
O
M
M
E
N
D
E
D
M
A
N
D
A
T
O
R
Y
Modified from IAQG - SCMH
OBSERVATION MINOR MAJOR
5 WHY’s APOLLO
Understand Understand
the severity the severity
of the of the
problemproblem
Root Cause Requirement?

42. Registration Management Committee (RMC)
Auditor Training and Workshop
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July 30-31, 2009
What Makes a Good Root Cause?What Makes a Good Root Cause?
•Document the primary cause (s) of the Document the primary cause (s) of the
nonconformancenonconformance
–Understand the problem statementUnderstand the problem statement
–Don’t assume that people know or understand the problem well Don’t assume that people know or understand the problem well
enough to determine root causeenough to determine root cause
–Data collection and analysisData collection and analysis
•Involve people who have an understanding of the Involve people who have an understanding of the
problemproblem
•Use the cause and effect principleUse the cause and effect principle
•Facilitate the Root Cause AnalysisFacilitate the Root Cause Analysis
–Provide the knowledge of RCA toolsProvide the knowledge of RCA tools
•When solved, the problem will not recurWhen solved, the problem will not recur

43. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
Analyzing a Root Cause Analyzing a Root Cause
•How does an auditor evaluate a root cause?How does an auditor evaluate a root cause?
–CONNECT THE DOTS!!CONNECT THE DOTS!!
•Does the root cause fit the problem statement?Does the root cause fit the problem statement?
•Does the root cause fit the containment?Does the root cause fit the containment?
•Is there any indication of the use of “tools”?Is there any indication of the use of “tools”?
–Is this a repetitive root cause?Is this a repetitive root cause?
–Is this a point analysis, or a system Is this a point analysis, or a system
analysis?analysis?

44. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
What do you like?What do you like?
What can be done better?What can be done better?

45. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
Example Example
•Corrective Action SubjectCorrective Action Subject
–Residue on contact causing intermittent Residue on contact causing intermittent
electrical connection.electrical connection.
•Problem Description:Problem Description:
–Found 2 units of XYZ which has intermittent electrical Found 2 units of XYZ which has intermittent electrical
connection. Contact pieces are found with glue residue. connection. Contact pieces are found with glue residue.
This is non- conforming to note 3 of assembly drawing This is non- conforming to note 3 of assembly drawing
XYZ rev G.XYZ rev G.

46. Registration Management Committee (RMC)
Auditor Training and Workshop
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July 30-31, 2009
•Root Cause AnalysisRoot Cause Analysis
–After investigation it was discovered that the adhesive After investigation it was discovered that the adhesive
permabond did not have a regulating component to permabond did not have a regulating component to
restrict the amount of flow that was being applied. This restrict the amount of flow that was being applied. This
caused an overflow of glue into the area and the timing caused an overflow of glue into the area and the timing
of the subsequent assembly did not allow for the of the subsequent assembly did not allow for the
detection of the contamination. None of the detection of the contamination. None of the
documentation identified the need for this regulation documentation identified the need for this regulation
device. This was indicated during the initial build device. This was indicated during the initial build
however the documentation did not reflect what was however the documentation did not reflect what was
considered a common practice.considered a common practice.

47. Registration Management Committee (RMC)
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July 30-31, 2009
•Corrective Action Short Term Corrective Action Short Term
(immediate action for existing material)(immediate action for existing material)
–Amend work instructions to emphasize that board and Amend work instructions to emphasize that board and
domes must be thoroughly cleaned and domes are not to be domes must be thoroughly cleaned and domes are not to be
installed for eight hours after board installation.installed for eight hours after board installation.
•Corrective Action Long TermCorrective Action Long Term
(long term preventive action)(long term preventive action)
–The bottle that contains the adhesive was modified with a The bottle that contains the adhesive was modified with a
regulator to control the flow of the glue and to limit the regulator to control the flow of the glue and to limit the
expansion of the glue once pressure is added. Also the expansion of the glue once pressure is added. Also the
Immediate Corrective Action will be a secondary action Immediate Corrective Action will be a secondary action
applied to further safe guard applied to further safe guard

48. Registration Management Committee (RMC)
Auditor Training and Workshop
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July 30-31, 2009
Evaluating Corrective ActionsEvaluating Corrective Actions
Definition – Action taken to Definition – Action taken to
eliminate the causes of an existing eliminate the causes of an existing
nonconformity, defect, or other nonconformity, defect, or other
undesirable situation in order to undesirable situation in order to
prevent recurrence – prevent recurrence – ASQ Audit HandbookASQ Audit Handbook

49. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
Corrective ActionCorrective Action
•This is the specific action (s) you take to address the root This is the specific action (s) you take to address the root
cause of a problem. cause of a problem.
•They will only be effective if you have identified the true They will only be effective if you have identified the true
root cause of the problem. root cause of the problem.
–For example, cleaning battery terminals or replacing a battery For example, cleaning battery terminals or replacing a battery
in your car will not resolve the problem of a car that will not in your car will not resolve the problem of a car that will not
start if the root cause of the problem is a bad alternator. start if the root cause of the problem is a bad alternator.
•Corrective action includes the changes in policy, procedure Corrective action includes the changes in policy, procedure
and training to affected stakeholders with assignments to and training to affected stakeholders with assignments to
specific individuals and scheduled dates for task specific individuals and scheduled dates for task
completion. completion.

50. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
Elements of a Corrective ActionElements of a Corrective Action
•Containment – Stop the BleedingContainment – Stop the Bleeding
•Root Cause AnalysisRoot Cause Analysis
•Design, Implement Corrective Action PlanDesign, Implement Corrective Action Plan
•Verify Corrective Action Plan is ImplementedVerify Corrective Action Plan is Implemented
•Validate the effectiveness of the Corrective Action Validate the effectiveness of the Corrective Action
PlanPlan

51. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
Traditional vs. ApolloTraditional vs. Apollo
Match
Strike
Operator
Unaware of
the
Requirements
Train
Operator
Oxygen
Oily Rags
Match
Put in locked fireproof container on
the North side of the building
Put in fireproof container on the
South side of the building, empty
daily
Nothing – too costly
ROOT CAUSE
CONDITIONS

52. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
Point Solution
System Solution
ROBUST!!!!
Individual
Management
CULTURE SHIFTCULTURE SHIFT
Now Future

53. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
PitfallsPitfalls
•Binary ThinkingBinary Thinking – Understand there are grades of solutions – Understand there are grades of solutions
•Incomplete or Faulty InformationIncomplete or Faulty Information – Accepting facts to be true when – Accepting facts to be true when
they are notthey are not
•Desire to BelieveDesire to Believe – Self prophesies – Self prophesies
•Failure to Develop alternative HypothesisFailure to Develop alternative Hypothesis – Options – Options
•Making the pieces fit the puzzleMaking the pieces fit the puzzle – focus on preferred solution – focus on preferred solution
Root Cause Analysis

54. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
PitfallsPitfalls
•Correlation vs. CausationCorrelation vs. Causation – look at different paths – look at different paths
•Technical TerminologyTechnical Terminology – cloudy solution – cloudy solution
•Words vs. MeaningWords vs. Meaning – buzz words, acronyms… – buzz words, acronyms…
•Not checking thinking and opinionsNot checking thinking and opinions – accepting the first – accepting the first
solutionsolution
Root Cause Analysis

55. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
Analyzing a Corrective Action Analyzing a Corrective Action
•How does an auditor evaluate a corrective action?How does an auditor evaluate a corrective action?
–CONNECT THE DOTS!!CONNECT THE DOTS!!
•Does the corrective action fit the:Does the corrective action fit the:
– problem statement?problem statement?
– the containment?the containment?
–the root cause?the root cause?
–Does the Problem Statement connect to the Does the Problem Statement connect to the
Containment to the Root Cause to the Corrective Containment to the Root Cause to the Corrective
Action Plan?Action Plan?

56. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
Analyzing a Corrective Action Analyzing a Corrective Action (cont.)(cont.)
–Is this a repetitive corrective action plan?Is this a repetitive corrective action plan?
–Is this a point solution, or a system solution?Is this a point solution, or a system solution?
–Is the corrective action plan realistic?Is the corrective action plan realistic?

57. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
CASE STUDY 2CASE STUDY 2
Analyzing a Root Cause and Corrective Action

58. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
Verification & ValidationVerification & Validation

59. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
DefinitionsDefinitions
•Verification – Confirmation by examination and Verification – Confirmation by examination and
provision of objective evidence that specified provision of objective evidence that specified
requirements have been fulfilledrequirements have been fulfilled
•Validation - Confirmation by examination and Validation - Confirmation by examination and
provision of objective evidence that the particular provision of objective evidence that the particular
requirements for a specified intended use are requirements for a specified intended use are
fulfilledfulfilled

60. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
VerificationVerification
•Verify that the actions have been completed and Verify that the actions have been completed and
are effectiveare effective
•What does this mean?What does this mean?
–We must see evidence that the containment actions and We must see evidence that the containment actions and
corrective actions are completedcorrective actions are completed
–Example - documentation released, training completed Example - documentation released, training completed
with attendance sheetswith attendance sheets

61. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
ValidationValidation
–EffectivenessEffectiveness
•We are getting the desired results from our processWe are getting the desired results from our process
•Implementation of the actions noted on a corrective Implementation of the actions noted on a corrective
actionaction
•Look at the process to ensure that the problem Look at the process to ensure that the problem
documented on the corrective action has been eliminateddocumented on the corrective action has been eliminated
–Good to have a couple of examples of the new process Good to have a couple of examples of the new process
being implementedbeing implemented

62. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
What do you like?What do you like?
What can be done better?What can be done better?

63. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
ExampleExample
•Problem Description:Problem Description:
–Found that pump assembly p/n 12345 cannot function properly. Upon Found that pump assembly p/n 12345 cannot function properly. Upon
investigation, we found rubber flashing within the pump tubes is investigation, we found rubber flashing within the pump tubes is
prohibiting air flow. Tubes p/n 2323, 2424, 2525 and 2626 are all prohibiting air flow. Tubes p/n 2323, 2424, 2525 and 2626 are all
affected. Units from lotcode XYZ are affectedaffected. Units from lotcode XYZ are affected..
•Immediate Corrective Action:Immediate Corrective Action:
–Determined Scope of problem by reviewing WIP and Finished Goods Determined Scope of problem by reviewing WIP and Finished Goods
for the described defect.for the described defect.
–Found defect in parts and developed repair method to eliminate Found defect in parts and developed repair method to eliminate
–Eliminated defect from in house WIP and Finished Goods PartsEliminated defect from in house WIP and Finished Goods Parts

64. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
•Root Cause TypeRoot Cause Type
–Vendor Supplied Part was incorrectVendor Supplied Part was incorrect
–Operator Failed to perform process as designedOperator Failed to perform process as designed
•
•Root Cause Corrective ActionRoot Cause Corrective Action
–Issued Corrective Action to Vendor for Flashing left in the unit.Issued Corrective Action to Vendor for Flashing left in the unit.
–Verified process in place to check for flashing .Verified process in place to check for flashing .
–Reviewed Process with all assigned personnel to ensure Reviewed Process with all assigned personnel to ensure
correct process would be performedcorrect process would be performed
–Added requirement for QA Inspector to randomly check for Added requirement for QA Inspector to randomly check for
Flashing in the material and record results on Roving Flashing in the material and record results on Roving
Inspection Sheet.Inspection Sheet.
–Added requirement for the Lead to perform the same random Added requirement for the Lead to perform the same random
check and record results on the Roving Inspection Sheet.check and record results on the Roving Inspection Sheet.

65. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
Questions???Questions???

66. Registration Management Committee (RMC)
Auditor Training and Workshop
Minneapolis, MN
July 30-31, 2009
BibliographyBibliography
•Correct, Prevent, ImproveCorrect, Prevent, Improve – Jeanne Ketola & Kathy – Jeanne Ketola & Kathy
Roberts, ASQ 2009Roberts, ASQ 2009
•Apollo Root Cause AnalysisApollo Root Cause Analysis, Dean L. Gano, Apollian , Dean L. Gano, Apollian
Publications 2003Publications 2003
•Fundamentals of Quality AuditingFundamentals of Quality Auditing, B. Scott Parsowith, ASQ , B. Scott Parsowith, ASQ
19951995
•Root Cause Analysis: A Tool for Total QualityRoot Cause Analysis: A Tool for Total Quality Management, Management,
Anderson, Gaylord F.; Dell, Larry D.; Wilson, Paul F.; 1993Anderson, Gaylord F.; Dell, Larry D.; Wilson, Paul F.; 1993
•The ASQ Auditing HandbookThe ASQ Auditing Handbook, Third Edition - J.P. Russell, , Third Edition - J.P. Russell,
editing director; 2006editing director; 2006
•Websites:Websites:
–IAQG Supply Chain Management Handbook; IAQG Supply Chain Management Handbook;
www.sae.org/scmh www.sae.org/scmh