CAPA Overview and Methodology V - Training PowerPoint

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


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


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


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


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



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



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



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…


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…



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



Intro to CAPA

Initiating CAPAs

Severity, Contain.

Countermeasure

CAPA Lifecycle

Effectivity Metrics

CAPA Improvement

Feedback Loop

19


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


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


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


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


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.


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


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


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?


Explain why the problem was Not Detected :

Why:

Why:

Why:

Why:

Ho

w p

rob

lem

was

cre

ated


Explain why the Problem Occurred:

Why:

Why:

Why:

Why:

• Escapement

• Systemic

• Problem

30


Reproduce the nonconformance when possiblePolaris CONFIDENTIAL


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?


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.….


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


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


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

Thank you!

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Date post:	04-Jan-2017
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CAPA Overview and Methodology V - Training PowerPoint

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