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CAPA Process Training
Polaris Supply Chain Training
Revised: December 2, 2015
Revision Number: 1Polaris CONFIDENTIAL
2
CAPA Process Agenda
CAPA: Polaris Internal Training ModulePolaris CONFIDENTIAL
Learning Objectives
Why is CAPA Training Important?
CAPA Process Overview & Process Flow
Navigating Reliance CAPA
Iniating a CA or a PA
Severity, Containment & Countermeasures
Root Cause Method - Using the 5-Why
Corrective Action
Escapement: Non-Detection
Examples: 5-Why and Corrective Action
Verification of Implementation
Escalation: Recurrences & Delinquent
Validation:
Effectivity Metrics
Learning Objective Recap
Competency Quiz
3
Learning Objectives
Focus on these objectives throughout the training
At the end of this training, participants will be able to:
• Understand the Overall CAPA Process
• Understand When & Why the CAPA Process is
implemented.
• Understand Your role & responsibilities surrounding the
CAPA Process.
• Recognize and Teach sound CAPA Process
fundamentals to others.
Polaris CONFIDENTIAL
4
CAPA Methodology
Sound CAPA Methodology Prevents Recurrences Polaris CONFIDENTIAL
Why is CAPA training Important?
• Correct CAPA Methodology is one of the most
misunderstood disciplines in quality.
• It’s the most important discipline for the elimination of
known problems.
• The time spent on faulty CAPA submissions is significant
and very costly to Polaris and Suppliers.
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
5
CAPA Methodology
Methodology starts with clear Roles and ResponsibilitiesPolaris CONFIDENTIAL
Roles & Responsibilities
Suppliers:
• Respond to CAPA events using sound CAPA methodology in
expected time frame.
Polaris SQE / SDE and Plant Quality:
• Initiate CAPA’s and follow through to closure.
Purchasing:
• Initiate
• Overall understanding of system.
• Basic navigation, visibility to open and closed CAPA’s.
• Support the SQE and SDE by ensuring supplier compliance.
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
6
CAPA Methodology
Methodology starts with clear Roles and ResponsibilitiesPolaris CONFIDENTIAL
CAPA Terms
Initiator:
• Initiates a CAPA in the Reliance system.
• May be asked to jointly approves RC/CA (Root Cause Corrective
Action) in some cases.
Owner:
• Performs the Root Cause / Corrective Action.
• ….or delegates to the supplier (supplier quality problems).
Responsible:
• Implements the corrective action plans.
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
7
Roles &
Responsibilities
CAPA Methodology
Methodology starts with clear Roles and ResponsibilitiesPolaris CONFIDENTIAL
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
8
CAPA Methodology
Leveraging our SME’sPolaris CONFIDENTIAL
IMPORTANT – Role Clarification
The Owner is not selected on the basis of who is to
be blamed for a problem.
They are selected because they have the necessary
knowledge or expertise to conduct the Root Cause
investigation.
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
9
CAPA Flow
Understand the Top Level View FirstPolaris CONFIDENTIAL
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
General Overview (Full Size Flow Chart is
available).
CA Warranted
Owner declines, explanation via Reliance
Initiator generates CA
Owner Accepts CA
Initiator Accepts?
End Escalates to Mgr.
Responsible takes Immediate Containment Action
Responsible takes Immediate steps to recitfy problem short
term.
Responsible provides RC/CA
Owner reviews RC/CA
Owner Accepts?
Responsible provides Implementation response
Owner Verification Implementation Task(s)
Owner Accepts?
Yes
No
Yes
No
Yes
No
NoYes
Validation Period 180 days.
Owner Accepts?
Owner
Responsible Party
Initiator
Yes
No
Owner adds Initiator as 2nd Approver
CA Process Flow
Close with Approval
24 Hours
24 Hours
Immediate
Immediate
7 days
24 Hours
14 days from 1st notification
24 Hours
24 Hours
Case by Case Basis
24 Hours
24 Hours
Expected Cycle Time
Manager Cancels?
YesClose without approval
No
Initiator / Owner Consensus Effort
Begins
Correct Owner
No
Yes
CA sent to appropriate
owner.
Immediate
24 Hours
24 Hours
24 HoursInitiator Accepts?
Yes
No
Responsible Confirms all Verification is complete
Case by Case Basis
Close without approval.
Recurrence?Owner flags as “Recurrence” and determines whether CA warrants Resp. Party on-site.
Yes
No
180 Days
3 Paths
• CAPA Declined
Path
• Primary Path
• Failed Results
Path
10
CAPA Initiation Considerations
Robust CA’s Eliminate Risk of RecurrencePolaris CONFIDENTIAL
CA’s versus PA’s: There are two documents within the CAPA module;
Corrective (CA) or a Preventive Action (PA).
A CA is generated after a non-conformance of product,
process, or procedure occurs which warrants a
documented discovery of root cause and corrective
action.
CA Goal: Ensure the non-conformance is corrected
and will never recur.
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
11
CAPA Initiation Considerations
Focus on Prevention not ReactionPolaris CONFIDENTIAL
CA’s versus PA’s:
A PA is generated after a risk has been identified, but
before a non-conformance has occurred.
The PA is generated in an attempt to prevent the
problem from generating a non-conformance.
The benefits of identifying risk beforehand (PA)
versus after a non-conformance (CA) cannot be
overstated.
PA’s Far Outweigh CA’s in organizational value.
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
12
CAPA Initiation Considerations
Initiated only if Warranted Polaris CONFIDENTIAL
Initiating a CAPA: A CAPA can be initiated by anyone.
A request for a CAPA shall be submitted to the
Appropriate Owner (expertise).
The request will be reviewed by the Owner to
determine if:
A. They are the appropriate Owner.
B. A CAPA is warranted.
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
13
CAPA Initiation Considerations
Initiated only if Warranted Polaris CONFIDENTIAL
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
The CAPA will be
processed unless:
• Criteria not met.
• CAPA already
opened.
• Normal Channels
not attempted
(Minor)
CAPA Warranted
Initiator generates CAPA
Owner Accepts CAPA
Yes
No
24 Hours
24 HoursCorrect Owner
No
Yes
CAPA sent to appropriate
owner.
Immediate
14
CAPA Initiation Considerations
Initiated only if Warranted Polaris CONFIDENTIAL
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
If CAPA is declined…..:
• Explanation provided
within CAPA.
• Escalation path
available.
• Consensus is the goal.
Owner declines, explanation via Reliance
Initiator Accepts?
End Escalates to Mgr.
NoYes
24 Hours
Manager Cancels?
YesClose without approval
No
Initiator / Owner Consensus Effort
Begins
24 Hours
15
CAPA Initiation Considerations
Initiated only if Warranted Polaris CONFIDENTIAL
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
The CAPA will be reviewed for
Owner selection.
The Owner is not selected on
the basis of who is to be
blamed for a problem.
They are selected because
they have the necessary
knowledge or expertise to
conduct the Root Cause
investigation.
CAPA Warranted
Initiator generates CAPA
Owner Accepts CAPA
Yes
No
24 Hours
Correct Owner
No
Yes
CAPA sent to appropriate
owner.
16
CAPA For Critical or Major NC’s…
CAPA Initiation Considerations
Mandatory CAPA’sPolaris CONFIDENTIAL
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
Category CAPA Inputs Critical Major Moderate Minor
Performance Impact
MajorX
Performance Impact
ModerateX
Performance Impact
MinorX
Potential Product /
Consumer Safety or
Compliance Impact
X
Customer Satisfaction
Risk Moderate X
Process
ImpactInternal Audit /
ProceduralX X
Line Impact > 2 hours X
Excess of 100 pieces
Non-ConformanceX
Line Impact < 2 hours X
Recurring Low Impact
Non-Conformance X
Recurrence of
Previously closed
CAPA
X
Prod
uct I
mpa
ctO
pera
tions
Impa
ct
CAPA
Shall
be
Initiated
17
CAPA
For
Moderate
or
Minor
NC’s…
CAPA Initiation Considerations
Mandatory CAPA’sPolaris CONFIDENTIAL
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
Category CAPA Inputs Critical Major Moderate Minor
Performance Impact
MajorX
Performance Impact
ModerateX
Performance Impact
MinorX
Potential Product /
Consumer Safety or
Compliance Impact
X
Customer Satisfaction
Risk Moderate X
Process
ImpactInternal Audit /
ProceduralX X
Line Impact > 2 hours X
Excess of 100 pieces
Non-ConformanceX
Line Impact < 2 hours X
Recurring Low Impact
Non-Conformance X
Recurrence of
Previously closed
CAPA
X
Prod
uct I
mpa
ctO
pera
tions
Impa
ct
CAPA
May
18
CAPA Severity - Line Impact
Line
Severity
Escalation
CAPA Initiation Considerations
Mandatory CAPA’sPolaris CONFIDENTIAL
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
19
CAPA Initiation Considerations
Maintaining CAPA IntegrityPolaris CONFIDENTIAL
Challenging - Problem Description
If a Supplier feels the Problem Description is
inaccurate they should contact their SQE/SDE and
request a change.
If the Owner feels the Problem Description is
inaccurate they shall send it back to the Initiator or
locate a CAPA Manager with the access rights
required to correct it.
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
20
CAPA Initiation Considerations
Internal Recurrences TrackedPolaris CONFIDENTIAL
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
Severity – Recurrence
Definition:
• A previous CA…..
• Same Non-conformance
• Over any period of time
• Not limited to part quality
Owner Accepts CAPA
Recurrence?
Owner flags as “Recurrence” and determines whether CAPA
warrants supplier top management on site.
Yes
21
CAPA Initiation Considerations
External Recurrences TrackedPolaris CONFIDENTIAL
Severity – Recurrence – Part Quality
Weighed more heavily against the Supplier.
Supplier may incur additional consequences, as
described in the Supplier Business Practices Manual
(SBPM).
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
22
CAPA Initiation Considerations
External Recurrences TrackedPolaris CONFIDENTIAL
Severity – Recurrence – Part Quality
A Recurrence may require the supplier to send a
member of Senior Management to present the CA to
Polaris Purchasing and Supply Chain Management.
Driven by SQE/SDE, or Plant Quality, at the discretion
of Supply Chain Management.
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
23
CAPA Initiation Considerations
Internal Recurrences TrackedPolaris CONFIDENTIAL
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
Responsible takes Immediate Containment Action
Responsible takes Immediate steps to recitfy problem short
term.
Responsible provides RC/CA
Containment & Countermeasures:
Immediate Action to….• Quarantine…
• Support Polaris Production…
• Ensure that all non-conformances are…
• Sorted
• Reworked
or
• Removed….
…to mitigate any disruption to the
Polaris production processes.
24
Immediate Impact Reduction
Ensure Mutual Understanding of Non-Conformance ImpactPolaris CONFIDENTIAL
Containment & Countermeasures – (cont.)
When the non-conformance is…..
• Critical to Safety
• Performance
or
• Line Impact > 2 hours
The Supplier shall be present at the Polaris
manufacturing plant to obtain first-hand knowledge of
problem……..…..
…..at the discretion of Supply Chain Management.
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
25
CAPA Methodology
Severity Dictates EscalationPolaris CONFIDENTIAL
Non-Conformance – Critical – Supplier Quality
• Polaris SQE/SDE or 3rd Party must be On-Site at the
supplier to audit implementation.
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
26
Immediate Impact Reduction
Root Cause can be ElusivePolaris CONFIDENTIAL
Root Cause - Methodology
Historically the evaluation of CAPAs has exposed
flaws in the Root Cause Analysis….
….leading to the wrong Corrective Action.
The most common error?
Failure to dig deep enough into the problem to identify
the true Root Cause.
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
27
Immediate Impact Reduction
Standardized Root Cause Methods RequiredPolaris CONFIDENTIAL
Root Cause
Investigations often stop at a level removed from the
Root Cause.
This leads to taking the wrong Corrective Action…
….or one that is less effective….
……..resulting in recurrences.
To aid in the Root Cause discovery process Polaris
requires the use of the 5-Why method.
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
28
CAPA Methodology
Sound Methods Means More Effective CAPA’s Polaris CONFIDENTIAL
Methodology: 5-Why
The simplest method of following the discovery path to the Root Cause.
Caution:
• Avoid tangents (branching out in another direction).
• Avoid Circular Thinking & Repetition.
(Example to follow)
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
29
CAPA Methodology
Sound Methods Means More Effective CAPA’s Polaris CONFIDENTIAL
Methodology: 5-Why
Root Cause - Break-Out
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
Wh
at is
the
Sys
tem
ic r
oo
t cau
se?
Problem Description:
Explain the Systemic Root Cause:
Why:
Why:
Why:
Why:
Wh
y p
rob
lem
was
no
t det
ecte
d?
Problem Description:
Explain why the problem was Not Detected :
Why:
Why:
Why:
Why:
Ho
w p
rob
lem
was
cre
ated
Problem Description:
Explain why the Problem Occurred:
Why:
Why:
Why:
Why:
• Escapement
• Systemic
• Problem
30
Immediate Impact Reduction
Reproduce the nonconformance when possiblePolaris CONFIDENTIAL
Responsible provides RC/CA
Owner reviews RC/CA
Owner Accepts?
Yes
No
Root Cause – Prove - Out
Reproducing the Non-
conformance by turning the Root
Cause on and off.
Removes all doubt that the root
cause has been found.
Impractical in some instances
(Cost, safety, other
considerations).
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
31
CAPA Examples
Move from the General to the SpecificPolaris CONFIDENTIAL
Example 1: 5-Why
Problem Description: The toaster always burns my
second batch of toast.
Why: The same setting for the second batch yields a
different result than the first batch.
Why: The second batch of toast “browns” faster.
Why: The toaster is “warmed up” on the second batch.
Why: The toaster requires one cycle to reach normal
operating temperature.
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
32
CAPA Examples
5-Why Leads to CAPolaris CONFIDENTIAL
Example 1: 5-Why (cont.)
The last Why = Root Cause
Root Cause: The toaster requires one cycle to reach
normal operating temperature.
Understanding the Root Cause leads to the Corrective
Action.
Corrective Action: Set the toaster at the “second batch
setting” and cycle toaster one time before inserting the
bread.
(did you notice it only took 4 Whys?)
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
33
CAPA Examples
5-Why will Reveal Systemic if ApplicablePolaris CONFIDENTIAL
Example 1: 5-Why - Specific & Systemic
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
Specific:
Burnt Toast
Problem
Solved
Systemic
Corrective
Action:
Improves other
products in the
same process.
34
CAPA Examples
Escapement Root Cause Reduces Recurrence RiskPolaris CONFIDENTIAL
Example 1: 5-Why - Escapement
In the toaster example the Burnt Toast was detected immediately in the process.
There was no delivery of Non-conformance to the customer.
When Non-conforming products are delivered to the customer this is called Escapement.
Escapement also requires a 5-Why Root Cause Analysis.
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
35
CAPA Examples
5-Why will Reveal Systemic if ApplicablePolaris CONFIDENTIAL
Example 2: 5-Why
Problem Description: There are scratches in the painted tanks along the top middle of the fuel tank.
Why: The tanks often brush against the neighboring rack hooks when being removed from the hanging hook.
Why: There is insufficient room between the racks to safely remove the tanks.
Why: The Set-Up sheet does not take removal clearance into consideration, only part size.
Why: The Set-Up sheet is created to ensure cost objectives are met and not quality.
Why: The organization does not include the paint line leadership in PFMEA’s (Quality Engineering operates in a vacuum).
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
36
CAPA Examples
Systemic Leads to Break-Through Quality GainsPolaris CONFIDENTIAL
Example 2: 5-Why (cont.)The last Why = Root Cause of Problem & Systemic
Problem Root Cause: Rack Clearance Insufficient.
Systemic Root Cause: The organization does not include the paint line leadership in PFMEA’s.
Understanding the Root Cause leads to the Corrective Action.
Corrective Action:
Problem: Factor the operator clearance area requirements when creating the Set-Up sheet.
Systemic: Include the paint line leadership in PFMEA’s.
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
37
CAPA Examples
Tangible Results Require Specific ActionsPolaris CONFIDENTIAL
Example 2: Corrective Action
Ensure there is a direct and specific action for each task required to address the Root Cause.
Suppliers sometimes make broad statements without a clear action.
• “We will ensure that the paint line hooks always leave room for removal”
Really?..........How?
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
38
CAPA Examples
Tangible Results Require Specific Actions
Example 2: Corrective Action (cont.)
Look for a one to one alignment between the Root Cause(s) and each Corrective Action task(s).
Look for specific details explaining how the Corrective Action will be Carried out.
• A minimum of 3 feet will exist between the part surface and the next rack to allow for un-racking.
Really?..........How?
Polaris CONFIDENTIAL
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
39
CAPA Examples
Objective Evidence to Demonstrate Systemic Corrections
Example 2: Corrective Action
The Paint Line Engineering Master template will be amended to include a minimum spacing for manual un-racking.….
Polaris CONFIDENTIAL
Customer
Part Number
Color
Oven Temp
Line Speed (Ft p/min)
Rack Type
Parts per Rack
Rack Spacing ft: 3' + part width
Rev
Date
Engineer Jim H.
5
H-Pattern, 3 foot
4
4
2
3/23/2016
Dynamic Coating Inc.
Paint Line Set Up Sheet
Polaris
1021999
Cardinal Black
425
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
Adding the additional
spacing requirement to the
shop process template.
…..addressed a Systemic
Root Cause…..
…… with a Systemic
Corrective Action
40
CAPA Methodology
Detection as a Planned & Documented ActivityPolaris CONFIDENTIAL
Review: Escapement
Identify whether or not specific controls are in place to
monitor the characteristic at….
• The stage where it is created.
• Later stages of the process.
• Performed by Production and QA personnel
• Always in Final Audit.
• Ensure measurement method is robust.
• Request a gage R&R when a variable dimension.
• Request gage calibration cert.
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
41
CAPA Methodology
Verification Requires DocumentationPolaris CONFIDENTIAL
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
Responsible provides Implementation response
Owner Verification Implementation Task(s)
Owner Accepts?
YesNo
Verification
Such as….
• Inspection records.
• Work Orders listing new
process parameters.
• Pictures of modified
tooling, gages, fail-safes.
Definition: Obtaining
objective evidence that the
Corrective Action has been
implemented.
42
CAPA Methodology
Verification for Conditional ApprovalPolaris CONFIDENTIAL
Verification – Objective Evidence
Builds confidence which strengthens the Polaris /
Supplier partnership.
Helps ensure the CAPA gains are sustainable.
(Content varies on a case by case basis).
Conditional Approval:
CAPA’s which pass Verification shall be conditionally
closed pending Validation.
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
43
CAPA’s of Higher Complexity
Advocate for the SupplierPolaris CONFIDENTIAL
Escalation – Preventing Delinquency
Sometimes the Responsible has a legitimate reason
for needing additional time to complete a CA at one of
the stages.
They don’t always ask for an extension.
If they are late find out why, and if warranted extend
the due date based on the merit of their explanation.
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
44
CAPA’s of Higher Complexity
Due Date Exceptions Based on CircumstancesPolaris CONFIDENTIAL
Escalation – Preventing Delinquency
CAPAs may require additional time to complete when
Root Cause is elusive or the implementation is delayed
due to:
• Intermittent failure
• Latent failure
• Subject matter expertise required
• Production scheduling delays
• Other unforeseen circumstances
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
45
CAPA Management
Advocate for the SupplierPolaris CONFIDENTIAL
Escalation – Preventing Delinquency
An extension of the due date shall be granted on a
Case by Case basis.
Supplier must demonstrate justification for requiring
additional time.
The duration of the extension shall be based on the
time required to overcome the Root Cause
investigation or implementation constraints.
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
46
CAPA Neglect
Escalate When WarrantedPolaris CONFIDENTIAL
Escalation – Delinquency - Suppliers
CAPAs which are overdue shall be escalated through
the Performance Escalation Process (PEP).
May result in the loss of business, business hold, or
no new business.
Will lead to charges and part/materials will be put on
Quality Alert.
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
47
CAPA Examples
Validation Period will Prove or Disprove MethodologyPolaris CONFIDENTIAL
Validation: Requirements
The absence of RMO’s for a 180 day period,
or a consecutive series of shipments (at the
discretion of the Owner) without a
non-conformance.
180 days after Conditional Approval the Owner receives an e-mail reminder from Reliance telling them to close the CAPA.
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
48
Effectivity Measures
Sound Methodology + Due Diligence = Reduced RecurrencesPolaris CONFIDENTIAL
Effectivity
Measured and monitored to identify how effectively CAPAs have been implemented without a Recurrence.
A One-Month snapshot of all CAPA’s closed for the month, 6 months prior.
Jan. Feb. March April May June July Aug. Sept. Oct. Nov. Dec.
July Aug. Sept. Oct. Nov. Dec. Jan. Feb. March April May June
Measured Month
Closed Month (6 Months Prior)
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
49
Effectivity Measures
Effectivity Supports Corporate Quality GoalsPolaris CONFIDENTIAL
Effectivity
Conditional Approval becomes Formal Approval after 180 days with no Recurrence.
The expectation is that there are No Recurrences.
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
50
In Review
Sound Methodology + Due Diligence = Reduced RecurrencesPolaris CONFIDENTIAL
In Review
Intro to CAPA
Initiating CAPAs
Severity, Contain.
Countermeasure
CAPA Lifecycle
Effectivity Metrics
CAPA Improvement
Feedback Loop
Learning Objectives
Why is CAPA Training Important?
CAPA Process Overview & Process Flow
Navigating Reliance CAPA
Iniating a CA or a PA
Severity, Containment & Countermeasures
Root Cause Method - Using the 5-Why
Corrective Action
Escapement: Non-Detection
Examples: 5-Why and Corrective Action
Verification of Implementation
Escalation: Recurrences & Delinquent
Validation:
Effectivity Metrics
Learning Objective Recap
Competency Quiz
51
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END of Document
Polaris CONFIDENTIAL
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