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8 D CORRECTIVE ACTION TRAINING

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TRAINING OBJECTIVES

• Define the steps to an effective closed-loop corrective


action – 8 Disciplines or 8-D
• Demonstrate the completion of a 5-Why Analysis
• Demonstrate the effective use of error-proofing for
irreversible / permanent corrective action
• Provide clear understanding of acceptable vs.
unacceptable corrective action responses

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DEFINITION

CAR (Corrective Action Request) is a


standardized, documented problem resolution
process aimed to contain an issue while
developing permanent resolution, thus
preventing recurrence

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MANY FORMATS

8-D is the most common /


recognized format of CAR 5-phase
An 8-D format can be
slightly different from one
company to another 7-D 7-phase
The type of format is not as 8-D
critical as the elements
covered within the format
6-D other

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CRITICAL STEPS TO EVERY CAR

• Problem Description
• Form Team
• Implement Interim Corrective Action / Containment
• Identify Root Cause
• Implement Permanent Corrective Action
• Verify Corrective Action
• Action to Prevent Recurrence
• Congratulate Team

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Corrective Action Report (CAR) Status: Customer Concern #'s CC #
Date Opened: Next Status Due Date: Open / Closed Divis ion #
Group #
Date Revised: Close Date: Supplier #
(1) TEAM CONTACT (2) PROBLEM DESCRIPTION Com ponent Part No.:
Contact Part No. / Des cription:
Phone Initiator: Location:
Activity Problem Description:
Team Members

(3) CONTAINMENT ACTIONS Responsible TARGET EFFECTIVE VERIFICATION


ACTION(S): Person DATE DATE METHODS RESULTS

(4) ROOT CAUSES CAUSE(S) FOR OCCURRENCE: CAUSE(S) FOR ESCAPE:

(5) CORRECTIVE ACTIONS Responsible TARGET EFFECTIVE (6) VERIFICATION


Interim Actions: Person DATE DATE METHODS RESULTS

Permanent Actions:

(7) PREVENTION Responsible TARGET EFFECTIVE (6) VERIFICATION


Preventative Measures: Person DATE DATE METHODS RESULTS

(8) TEAM MEMBER / REVIEW & APPROVALS

Team Champion: Quality Manager: Plant Manager:


Review & Approval Date: Review and Approval Date: Review and Approval Date:

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PROBLEM DESCRIPTION
Necessary Details

The more complete the following information, the


greater the opportunity for the supplier to expedite
containment activity:
• Part Number
• Lot Number(s) / Date Code if available
• Detailed Description of the issue w/ specification
• Quantity of parts: rejected (how/where parts were
found) vs. available

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PROBLEM DESCRIPTION
Example: poor vs. good

P: Parts do not fit. 10 pcs rejected.


G: Clearance issue of #2 radius. Rejected first 10 pcs out of box
(qty 1000) from lot #001A, dated 05/16/04.

P: Artwork is in wrong position on both ends of carton.


G: Artwork position is out of print on one end by .125” and on
the other end by .125” in the other direction. Lot #125 appears
to be 100% affected.

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FORM TEAM
Reasons for a Cross-Functional Team

• The phrase “Two heads are always better than one!”


• Involving hourly operators / maintenance provides
input from sources that have the most hands-on
experience with the product / process.
• Provides knowledge / experience in cross-functional
disciplines.

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FORM TEAM
Example: poor vs. good

P: Green-Line Team
G: B. Jones - Quality Mgr., T. Hughes – Prod. Supvr., A. Parks –
Operator, M. Lee – Maint.

P: K. Owens – Quality Engr.


G: K. Owens – Quality Engr., R. James – Mfg. Engr., G. Sams –
Maint.

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IMPLEMENT INTERIM CORRECTIVE
ACTION / CONTAINMENT
Process Steps
Upon being notified of an issue or finding an issue, the steps of thorough containment
are as follows:
1. Stop current production of respective product
2. Contain suspect product to protect customer as well as supplier
– Obtain facts (P/N, Qty, Lot #, description of defect, etc.) on suspect product
– Contain product at customer location, supplier location, and in transit
– Make arrangements with customer, if necessary, to substitute suspect product with
certified stock
3. Sort / certify suspect product
– Sort per containment procedure (customer presides over supplier)
– Make arrangement with customer to either send company representative or contract a
third-party to sort / certify stock on-site at customer.
– 100% sort / certify product until permanent corrective action is implemented
– Note identification method of certification (i.e. paint dot (color?) on part or label,
sticker (color?) on part or label, etc.)

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IMPLEMENT INTERIM
CORRECTIVE ACTION /
CONTAINMENT
• Although the standard is toofrespond
Goals to Interim Corrective
the Supplier
Action / Containment in less than 24 hours, most all
customers, in most all cases, are looking for an immediate
response, as in, a matter of a few hours.
• Make the situation as painless as possible for the customer.
– In some cases it may not be a supplier issue; however, unfortunately,
no matter how much we would like this to even out, the old adage still
seems to apply in most cases: “guilty until proven innocent”

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IMPLEMENT INTERIM CORRECTIVE
ACTION / CONTAINMENT
Example: poor vs. good

P: Sorted inventory at Maytag and at mfg. site


G: Sorted 10 totes of 200 pcs. each at Maytag for lot #013A1 / date code
06/09/04, finding 34 pcs. with bent tab. Sorted 5 totes of 200 pcs. each at
mfg. site for lot #013A1 / date code 06/09/04, finding 13 pcs.

P: Quarantined suspect product at Maytag and notified mfg. site.


G: Quarantined lot #B078 at Maytag and mfg. site. Issued quality alert #02-
05 for missing stud. Sorted all inventory at mfg. site for lot #B078 – out of
860, found 4 parts with missing stud. Sourced 3rd party to sort the 1540
pcs. of lot #B078 at Maytag.

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IDENTIFY ROOT CAUSE
Analysis Tools

• Brainstorming - used in every root-cause analysis


• Cause & Effect / Fishbone
• 5-Why Analysis - formalized process utilizing brainstorming
• Process Mapping
• Pareto
• FMEA’s
• DOE
• Checklists
• Multi-Vari
• SPC
• Gage R&R
• Simulation
• Advanced Six Sigma Statistics

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IDENTIFY ROOT CAUSE
5-Why Analysis

Operator Error is not an acceptable cause, but rather why did the operator
error occur?
1st Why 2nd Why 3rd Why

Contributing Contributing Root


Event / Direct
Cause Cause Cause
Problem Cause

As root cause confirmation, work the chain backwards to


assure it makes sense
3 – Why Chains
Contributing Contributing Root
• Why did problem occur? Cause Cause Cause
• Why did it reach customer?
NOTE: A direct cause can break off into multiple contributing
• Why did system fail? causes, and thus have more than one root cause.

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IDENTIFY ROOT CAUSE
Definition of Causes

Direct Cause: The cause that directly resulted in the


event or the first cause in the chain

Contributing Cause: A cause that contributed to the


event or all causes after the direct cause

Root Cause: A contributing cause at the end of a branch


or chain, selected by the team for its significance; the
last cause

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IDENTIFY ROOT CAUSE
Example of 5-Why Analysis

Event / Direct Cause Root Cause Corrective


Problem Action

Lens alignment is Lens welded while Product or fixture


Lens assembled
out of being assembled detail to properly
out of alignment
specification out of alignment align lens

Fixture sensor for


Welder functions
out of alignment
even though lens
which will auto-
out of alignment
shut off welder

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IDENTIFY ROOT CAUSE
Class Exercise - Flashlight Case Study
Problem / Issue: Flashlight does not light

Details:
• Batteries are tested 100% by customer
• Spring height that contacts battery found to be short / undersized ranging from .4355 - .4370
vs. specification of .4375 +/- .0005
• No incoming inspection done on springs by customer
• Spring supplier does no on-going capability analysis for this spring P/N or any other parts
• Supplier’s 1st piece verification data shows spring height at low end of specification, but in
tolerance
• Flashlights that did not light did have springs measure out of tolerance for height
• Height was not called out as a key characteristic on drawing

Assumptions:
• Current part – new problem
• 10 – 20% rejects uniform throughout production lot
• 1st piece verification consisted of 1 piece approval
• Spring supplier performing no additional inspection after 1 st piece verification
• All other flashlight components are within print specifications

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IDENTIFY ROOT CAUSE
Class Exercise - Why did problem occur?

Contributing
Event / Cause
Problem

Root Cause

Direct Cause Contributing Contributing


Cause Cause

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IDENTIFY ROOT CAUSE
Class Exercise - Why did it reach the customer?

Contributing
Event / Cause
Problem

Root Cause

Direct Cause Contributing Contributing


Cause Cause

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IDENTIFY ROOT CAUSE
Class Exercise - Why did system fail?

Contributing
Event / Cause
Problem

Root Cause

Direct Cause Contributing Contributing


Cause Cause

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IDENTIFY ROOT CAUSE
5-Why Analysis Worksheet
Action(s) to Target Actual
Problem: be taken Responsibility Completion Completion

Why did the issue / problem occur?

(1st why)

(2nd why)

(3rd why)

(4th why)

(Root Cause)

Why did the issue / problem reach the customer?

(1st why)

(2nd why)

(3rd why)

(4th why)

(Root Cause)

Why did the system fail?

(1st why)

(2nd why)

(3rd why)

(4th why)

(Root Cause)

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IMPLEMENT PERMANENT
CORRECTIVE ACTION
The ‘Complete’ Response

Proposed solutions do not become preventive corrective actions until they are
implemented. To implement, you have to know:

WHAT is the corrective action?


WHO is responsible for getting it done?
WHEN is it going to be done?

Every corrective action listed on a CAR should have the WHAT, WHO,
WHEN, to be complete.

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IMPLEMENT PERMANENT
CORRECTIVE ACTION
Unacceptable vs. Acceptable Responses

U: Retrain the operator


A: Retrain the operator with evidence of training record / updated matrix

U: Fixed the machine


A: Preventative maintenance program to prevent machine from future failure

U: Supplier issue; supplier response is “can’t do anything about it.”


A: Supplier issue; “not a simple solution”, request extension, but provide
timeline of actions to completion

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IMPLEMENT PERMANENT
CORRECTIVE ACTION
Documents to be Reviewed

Process Flow
Incorrect flow
Correct of documents
flow of taken by
documents, most, usually
addressing PFMEA only
all that addressing
apply Control Plan

Control Plan

Work Instructions – set-up & operating

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IMPLEMENT PERMANENT
CORRECTIVE ACTION
Error-Proofing

Also called Mistake Proofing or Poka-Yoke

Error-Proofing should be the goal of every permanent


corrective action!

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IMPLEMENT PERMANENT
CORRECTIVE ACTION
Error-Proofing - Format & Function

• Format of:
– Design modifications IDEAL
– Equipment / fixture updates IDEAL
– Additional / change in operation sequence

• Function of:
– Eliminating error at the source IDEAL
– Detecting an error in the process of it occurring
– Detecting a defect after it has been made

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IMPLEMENT PERMANENT
CORRECTIVE ACTION
Error-Proofing - Example #1
• The situation: At the freezer liner subassembly line, the operator is
required to place six screw anchors on the outside of the liner. If a
screw anchor is missing, the cabinet must be scrapped at a cost of
about $200.

• The solution: Screw anchors are provided in lots of six on paper


backing. If the operator has screw anchors left over after the
operation, he has made a mistake.

• The principle: This is an example of a Error-Proofing device that


detects an error in the process of it occurring. Feedback is
immediate and so is corrective action; and, therefore mistake will not
be passed on to the next station.

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IMPLEMENT PERMANENT
CORRECTIVE ACTION
Error-Proofing - Example #2
Misalignment of
these two rails • The situation: At the cabinet foaming
could cause the stations, there was a potential failure
cabinet to be mode to damage a cabinet when it was
damaged
being loaded into the foaming stations
from a cart. If the cabinet was damaged,
it had to be scrapped at a cost of $90.

• The solution: Y-brackets were built to


enable the operator to align and quickly
roll the cart into the proper position.
This Error-Proofing device not only
eliminated the damage to the cabinet, but
it also greatly reduced time spent trying
to align the carts, thus improving
productivity as well. This cost for this
poka-yoke device was about $20 each.

• The principle: This is an example of an Error-Proofing device that eliminated the error at the
source. By preventing the misalignment in the carts, the device is preventing the defect from
being made.

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VERIFY CORRECTIVE ACTION

• Attempt to reproduce the failure


• Verify zero defects in next xxx (to be a set standard,
whether it be customer or supplier driven)
shipments

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PREVENT RECURRENCE
Actions of Prevention

• Standardize corrective action on like part designs /


processes
• Update lessons learned database with corrective
action activity
• Expand training as necessary
• Periodic follow-up with customer to assure issue is
closed

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SCAR RESPONSES
Example #1 - What do you think?

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SCAR RESPONSES
Example #1 (continued) - What do you think?

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SCAR RESPONSES
Example #2 - What do you think?

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SCAR RESPONSES
Example #2 (continued) - What do you think?

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SCAR RESPONSES
Example #3 - What do you think?

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SCAR RESPONSES
Example #3 (continued) - What do you think?

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SCAR RESPONSES
Example #3 (continued) - What do you think?

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SCAR RESPONSES
Example #4 - What do you think?

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SCAR RESPONSES
Example #4 (continued) - What do you think?

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SCAR RESPONSES
Example #5 - What do you think?

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SCAR RESPONSES
Example #5 (continued) - What do you think?

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SCAR RESPONSES
Example #6 - What do you think?

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SCAR RESPONSES
Example #6 (continued) - What do you think?

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SCAR RESPONSES
Example #7 - What do you think?

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SCAR RESPONSES
Example #7 (continued) - What do you think?

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SCAR RESPONSES
Example #8 - What do you think?

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SCAR RESPONSES
Example #8 (continued) - What do you think?

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FINAL REVIEW
Summary Exam

• Corrective Action Training - Summary Exam.doc

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Measurements Materials Personnel

Problem

Environment
Machines
Methods

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The Cause and Effect Diagram Exam ple

Adm in/Service Exam ple First produced in 1950 by Professor


Measurements Materials M en Kaoru Ishikawa - Also called the:
- Ishikawa Diagram
- Fish Bone Diagram

Developed to represent the


relationship between som e “effect and
Failure Mode all possible “causes” influencing it.
(Defect)
Create using M initab:
- Stat>Quality Tools>Cause and Effect
Failure - Enter in causes for each of the
Effect “6M” branches
Environm ent Methods M achines
- After “Cause and Effect” have been
selected, click the Help button for
instructions

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The Cause and Effect Diagram Example Continued

Measurements Materials Personnel

Specimen not suffici Plastic bags Patient not in room

Analyzer out of cal Ice Can’t procure specimen

Lab Results Delays


Courtesy visits
Room too hot
Info desk delays Analyzers not avail
Time of bag spec
Info link
Order slip delays
Room too cold
Multiple Results
Centrifuge not avail
Poor identification

Envi ronment Methods Machi nes

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Organize Brainstorming Ideas
Copy Process Fishbone

Measurements Materials Personnel

Out of cal Wrong size paper Select wrong orientation

Copy Misaligned

Humidity Doc moved when


Align marking not clear
lid closed

Environment Methods Machines

What other causes should we add?

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