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CAPA Training corrective-action

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Presenter: Tim Beadle
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Agenda
Investigation Weakness
Actions
•
•
Corrective
Preventative
Evidence
•
•
Objective Evidence
Measures of Effectiveness
Key Points
Summary
Questions
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DIVE PROCESS
Define
problem
Investigate
process
Verify
solution
Ensure
improvement
UTC Interactive RRCA Tool
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RRCA CAPA
The true success of any
Root Cause investigation is
dependent on the actions
taken and their
effectiveness.
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Governing Procedures
AS9100 - Quality Management Systems Requirements for Aviation, Space and Defense
Organizations is the basis for these actions.
AS13000 - Problem Solving Requirements for
Suppliers
Supported by:
–
–
–
WP 8.1 Internal Audit
PW 1.1.2. Corrective Actions
PW 1.1.3. Processes for Addressing Enterprise Risks and
Opportunities
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RRCA CAPA
• Corrective Action (CA) - Definition
Action taken to eliminate the cause of a detected nonconformity or
other undesirable situation to prevent recurrence (adapted for ISO
9000:2005).
Examples:
• Replacing failed hardware
• Repairing a Milling Machine
SAE Definition: Corrective Action
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RRCA CAPA
• Preven[ta]tive* Action (PA) - Definition
Action to eliminate the cause of a potential nonconformity or other
undesirable potential situation (see ISO 9000).
Examples:
• Updating Design Procedures
• Changing Software Code
SAE Definition: Preventative Action
*SAE uses Preventive, Pratt uses Preventive
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Key Points - Actions
When developing actions…
– What specific action is being done?
– What conditions will it be done under?
– Why is the action being taken?
– How will the action be taken?
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Key Points - Actions
Words Matter…
Active verbs - describes things
that can be demonstrated instead
of explained - work rather than a
state of being
x Adequate
x Support
x Consider
x Review
x Investigate
Measureable nouns - signifies
things that are tangible and
concrete
x Confidence
x Motivation
x Communication
x Opportunity
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CAPA Examples
PN/ Description
Specific Actin for correction.
Actionee
Corrective / Preventative
Action
Due Date
What prevents future seal misassembles?
Issue Description
Is there a design practice change needed?
5321000-01, ENGINE ASSY-TURBOFAN
90C30G3578 / CASE HALFHPC,UPPER CASTING
FDC #1 bearing carbon seal mis assembly
B/P Violation
“Assist” is weak.
What specifically will be done?
How will completion be shown?
Class I EC to add markings on the
seal plate denoting orientation of
face.
Martin, Julia
10/31/2018
Assisted defect recognition on x-ray
DDA technology
1/31/2019 Day, Jane
LLEM 265: Parts meet all b/p requirements, but do not meet design
“Robust” is vague. Inspection only
intent for durability and life. Root cause contained to plant 5
discovers the problem and
5322121 / Compressor Fan Blade
Develop more robust PAA inspection
replacement
corrects
it.
12/15/2018
Smith,
Joseph
produced hardware only, per engineering test results. Flight safety
Assembly
method
What prevents design shortfall?
recommends field action to remove and replace.
.064-.098 CR has surface variation.
30G5908 / COMPRESSOR ROTOR AXIAL, HIGH PRESSURE, 8th STAGE
“Adequate” is weak.
How does the process need to change?
How will implementation be shown?
Implement into process plan EC to
allow for adequate transition
method.
11/15/2018 Doe, John
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Corrective vs. Preventive
• Corrective vs. Preventive can depend on your view point.
– Preventive action is taken to prevent occurrence whereas corrective action is taken to
prevent recurrence. [9136]
Released Hardware
Corrective
Preventative
Replacing effected
Replacing effected
Replace Hardware due to Field Event Hardware before a Field
Event
Changing Hardware Design Changing Hardware Design
Design
to address a Field Event
before a Field Event
Changing Hardware Design
Approach
Approach is always
Preventative
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RRCA CAPA
• Objective Evidence- Definition
Unbiased, factual data supporting the existence or verity of
something. Objective evidence may be obtained through observation,
measurement, test, or other means. [9162]
Examples:
• Signed training agendas
• Test Logs/Reports
• Published Procedures/Instructions
Trust me
SAE Definition: Objective Evidence
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RRCA CAPA
• Measure of Effectiveness (MOE) - Definition
Predefined Method to assess the impact of implemented actions on
an issue.
•
MOE can be specific to a particular issue
•
•
•
•
Control Charts
Inspection results
Trend Charts
Elephant Charts
Turnbacks
Examples:
TARGETED TURNBACK TREND ANALYSIS
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Key Points - Evidence
When creating actions…
–
–
–
–
–
Is the action is implementable?
How will the action be proven to have worked?
What is the timeframe for the action to take effect?
Can the impact of the action be measured?
Is the action changing behavior?
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Summary
Actions
• Define specific, active, implementable actions
• Identify both corrective and preventative actions
Evidence
• Collect objective evidence to prove action implementation and
effectiveness
• Define a measure of effectiveness that suits the action
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Questions
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