D1 D2 Supplier Corrective Action D2 - Define the Problem

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Supplier Corrective Action
D1 - Establish the Team: (If information is not applicable, please indicate by writing N/A or crossing out.)
CPS
D1
Location
Contact
Phone
Email
Cell
Buyer
Supplier
Name
Part Number
Description
Phone
Cell
Email
CHAMPION
Team leader
SCA#
Issue Date
RMA#
NCR#
STATUS DATA
Team Members :
D2 - Define the Problem
Describe the issue in terms of who, what, when, where, why, how and how many of the problem.
Repeat Issue:
Yes
No
Problem Description Pictures
Picture 1
Picture 2
D2
Picture Description
Picture Description
Picture 3
Picture 4
Picture Description
Picture Description
D3 - Take Short Term Action (Containment) (24- 48 hrs)
3.1 Verified By :
Define and implement actions to isolate the problem and contain suspect inventory until permanent corrective action is available.
Describe the Containment method, identification and cutoff shipment
TASKS/INDICATORS
D3
A)
B)
C)
RESPONSIBILITY
RESULT
DATE
Containment of Parts at Cooper
In Stock
In All WIP Locations
In Finished Goods
Containment of Parts at Supplier
In Stock
In all WIP Locations
Containment of Parts in Transit
D)
E)
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D4 - Determine Root Cause- (Occurrence)
(Detection)
Identify the problem statement's root cause and validate the problem can be turned on/off through experimentation. Also identify the root cause of the detection
and quality systems failures.
1)
5Why Occurrence
5 Why Detection
2)
D4
3)
4)
5)
Highlight method used to determine Root Cause: Brainstorming Fishbone 5 Whys? Pareto Charting Paynter Charting
4.1 Escape Point
Place in the process where the effect of the root cause should have been detected and contained.
D5 - Develop and Verify Solution
5.1 Verified By:
Identify solutions to eliminate the root cause and stated problem. Mistake proofing methodologies should be incorporated where possible.
Action Description
TARGET DATE
EFFECTIVE DATE
RESPONSIBILITY
RESULT
A)
B)
C)
D)
Corrective Action Pictures
Picture 1
Picture 2
D5
Picture Description
Picture Description
Picture 3
Picture 4
Picture Description
Mistake proofing
Picture Description
Yes
No (Why Not?)
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D6 - Implement and Validate Corrective Action
6.1 Verified By :
Monitor effectiveness of problem and root causes elimination. Identify method of effectiveness verification, quantified verification results, and effective date.
Verification Method
D6
TARGET DATE
EFFECTIVE DATE
RESULT
RESPONSIBILITY
A)
B)
C)
SIMILAR PROCESSES/PRODUCTS AFFECTED (At Risk)?
Yes
No ( Provide details)
D7 - Prevent Problem Recurrence
Modify the management systems, operating systems, practices, and procedures to prevent recurrence. Implement corrective actions on similar product or
processes at risk of this problem.
Check if Updated:
D7
FMEA
Control Plan
Operator Instructions
Inspection Instructions
Internal Freq.
Maintenance Schedule
Other (indicate below)
A copy of inspection data will be provided with each shipment until 3 production lots have been completed.
D8 - Recognize the Team
Notify team of successful resolution of problem.
D8
NAME / TITLE
NAME / TITLE
NAME / TITLE
NAME / TITLE
Submitted For Closure By:( Supplier)
NAME / TITLE
NAME / TITLE
NAME / TITLE / DATE
NAME / TITLE
NAME / TITLE
Final Approval By: (Cooper)
NAME / TITLE
Ken Nelson
NAME / TITLE
NAME / TITLE / DATE
NOTE: All evidence must be attached to the original CAR either electronically or hard copy.
copies sent
Director
to: of Quality
Quality Leader
Senior Corporate Buyer
Director of Supply Chain
Corporate Supplier Development Engineer
Quality Manager
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Insert files , links or pictures in this tab to support the corrective action steps as required.
For instance if you need more room for pictures you can add them on this tab, just label them for the section they
support
You can also place updated Control documentation, training records, work instructions in this area.
COSTS:
SORTING/ REWORK:
Location:
Sorting to be done by
supplier, XXXX only to sort Customer
if no other options available Location:
0
0
hrs
+ Sorting
company
charges
hrs
=
$0
=
$0
PO # for sorting
Company
SHUT DOWN/
STOCKOUT/
0
hrs
X
SCRAP
0
pcs
X
Employees
X
0
Part Cost
$125
= $
-
= $
-
= $
-
TRANSPORTATION:
EXPEDITING COSTS
Other
ADMINISTRATIVE COSTS for SCAR
TOTAL COSTS
=
$250.00
$250.00
Work Instructions for Corrective Action Report Completion
If information is not applicable, please indicate by writing N/A or crossing out.
1.0 Team Contact/General Information
CPS
Enter in the Cooper Plant Location that the product is used in
Enter in the name of the CPS main Contact person for your company
Enter in the Contacts Phone number
Enter in the Contacts E-Mail Address
Enter in the Date Code from the Product
Enter in the Field Contact name
Supplier
Enter in Supplier Contact Name
Enter Part Number (Obtained from the Customer Drawing)
Enter Part Description
Enter Suppliers Phone Number
Enter Suppliers Fax Number
Enter Suppliers E- Mail Address
Define your team
Champion (Area Manager)
Team Leader (Assigned by Area Manager)
Enter CAR #
Enter CAR Issue Date.
RMA#, NCR#: Indicate document numbers associated with this CAR
Status Date:
This date is to be updated each time the CAR is revised. This will be done by whoever makes the
changes.
2.0 Problem Description
Describe the internal / external problem by identifying " what is wrong with what" and detail the
problem in quantifiable terms. Check box to indicate if this is a repeat issue.
Provide as detailed as possible pictures of the problem.
Save this file to the correct "type" folder using the CAR# as the first part of the file name.
3.0 Interim Containment Activities
The Interim Response Due Date is 2 working days (48 hours) from issue date.
Response Actions. There may be multiple activities (i.e. Sort, Quality Watch, etc.); list them
and who performed the activity and the results.
Document interim containment. Ensure containment of the non-conforming product has occurred
(in-house, in-transit, at warehouses and customer locations) and ensure the customer has
sufficient defect free product.
Update CAR log with actual date of containment.
3.1 Verification
Verification should be done by a person other than who was responsible for the activities.
Initial and date.
Notify the customer when all CAR containment activities are verified.
Establish the Team:
(See Section 8 CAR TEAM MEMBERS.)
Champion and Team Leader establish a small group of people with the process and/or product knowledge,
authority, and skills in the required technical disciplines to solve the problem and implement
corrective action.
Note: Participation of Team Members must be approved by their Area Manager.
ecps-supplier-corrective-action.xls
9/17/07
4.0 Root Cause(s):
Isolate and verify the root cause by testing root cause theories against the problem description.
Methods: BRAINSTORMING FISHBONE 5WHYS? PARETO CHART PAYNTER CHART
4.1 Escape Point
Place in the process where the effect of the root cause should have been detected and contained.
5.0 Corrective Action(s)
Select the best Corrective Action to remove the root cause. Also select the
best corrective action to contain the effect of the root cause. Verify that both decisions
will be successful when implemented without causing undesirable effects.
If Mistake proofing is not used as a corrective action, state reason.
5.1 Verification
Verification should be done by a person other than who was responsible for the activities.
Initial and date.
Team to determine a feasible date as to when permanent corrective action will be implemented and
verified. Document date on Report.
Provide as detailed as possible pictures of the corrective action or an updated picture to the problem
is not present.
6.0 Implement Permanente Corrective Action
Implement Permanent Corrective Actions and Remove Interim containment actions.
VALIDATION TASK
Identify processes used to validate (prove) the permanent Corrective Action effectiveness.
6.1 Verification
Verification should be done by a person other than who was responsible for the activities.
Initial and date.
7.0 Prevent Action - Verifications
Check when Sections 3.1, 5.1 , and 6.1. are all verified.
Initial and date.
Modify the necessary systems including policies, practices and procedures to prevent recurrence
of this problem and similar ones. Make recommendations for systemic improvements , as
necessary , and document technical lessons learned.
8.0 Team
All Corrective Action team members names to be listed.
Closure:
The Team Leader will submit all Evidence and Completed CAR template to the Initiator.
The Initiator will review and submit for Final Approval.
Note: It is preferred that all evidence is embedded electronically although this is not required. If it cannot be
embedded, hard copy must be submitted.
FINAL APPROVAL
The initiator will submit completed CAR and evidence for final approval to:
Quality Manager: Customer
Plant Manager: Internal
Supplier Development Engineering Supervisor : Vendor
The final approver will review and close the CAR. The completed CAR will be turned
into the Document Coordinator for complete closure in the system.
ecps-supplier-corrective-action.xls
9/17/07
CORRECTIVE ACTIONS & ROOT CAUSE
Corrective Actions
REMEMBER:
1) Corrective Actions must aim at permanent solutions.
2) CARs must employ mistake proofing (if feasible).
3) CAR forms must be updated when progress is made.
4) The comments section of the CAR log must be updated, especially if a due date has to be extended.
5) Actions must be effectively implemented ASAP.
6) Evidence of action effectiveness must be submitted to close the CAR.
7) Teams must initiate and document Preventive Actions if possible.
Root Cause
Root causes are weaknesses (ineffective processes or controls) in our QMS that cause or allow (fail to prevent) errors and nonconformances.
Effective corrective action will PREVENT recurrence or REDUCE THE FREQUENCY of occurrence.
Immediate causes are NOT root causes. Typical immediate causes you may see on Corrective Action reports are:
Operator error
Failure to follow procedures/work instructions
Work instructions not updated
Inspection not recorded by the operator
Gage not turned in for calibration
Operator not trained
Inadvertent omission
Corrective Action that addresses only the immediate cause will NOT prevent recurrence.
Nonconformance:
Immediate cause:
Corrective Action:
Functional gage past due for calibration
Quality Assurance did not calibrate the gage before the due date
Calibrate the functional gage (fixes the immediate problem only)
It's possible that this was a random occurrence and won't happen again, but without further analysis, the problem may pop up again.
Root Cause analysis attempts to get at the heart of the problem so that it can be fixed and prevent recurrence.
Always keep evidence of how you determined the Root Cause in case the 1st solution doesn't work. You can then refer back to your notes
to select another possible root cause without having to go through the whole process (brainstorming, 5Whys?, Fishbone, etc.) again.
See the 5 WHYS tab for one method of Root Cause analysis applied to this gage calibration problem.
Any of the methods used to determine Root Cause can also be employed to generate possible solutions.
BRAINSTORMING
The Team may meet to Brainstorm possible Root Causes or generate solutions.
One person records the ideas (meet where there's a large write-on board) as fast as they can.
Team members state ideas randomly. Some will come up with more than others.
When the flow starts to dry up, go around the table calling on each individual to state another idea or "Pass".
Continue these rounds until all members say "Pass" on one round.
Rules:
1) Every person and every idea has equal worth.
2) Criticism of an idea is not allowed.
3) Encourage wild and exaggerated ideas.
4) Build on the ideas put forward by others.
5) Quantity counts at this stage, not quality.
When finished, have members vote for three ideas ranked in order of importance.
Save all results in case the "best" Root Cause/solution doesn't prove effective.
Cause-and-Effect Diagrams (Fishbone or Ishikawa Diagrams)
Use to make sure you’re not overlooking any possible causes (measures)
Couple with the “5 Whys?” tool
List categories of problem sources
Use Brainstorming to generate problems and possible causes
Puts focus on “prime suspects”
Forces team to look beyond “pet theories”
Allows team to document which theories it has
considered, targeted and verified
Construct a chart that looks like the bones on a fish
6 main categories (bones)
Extend smaller bones from the main bones to list problems and possible causes
PEOPLE
ENVIRONMENT
METHODS
Causes
Effect (problem)
MATERIALS
MEASURES
MACHINES
5 WHYS? ANALYSIS
5 WHYs? analysis consists of team members identifying a possible root cause by asking "Why?" until the root cause is uncovered.
It may take more or less than five Whys? to get to the Root Cause; Five is typical in most cases.
Consider the gage calibration nonconformance illustrated on the CA and Root Cause tab:
Nonconformance:
Functional gage past due for calibration
WHY?
Gage Tech did not calibrate the gage before the due date.
WHY?
Gage didn't show up on the gage recall list.
WHY?
Calibration interval was not entered on the gage master record.
WHY?
a) Gage Tech didn't know the interval when the gage was entered in the master list.
b) Gage Tech didn't follow up to enter the interval later.
WHY?
GageTrak does not force entry of the interval when entering gages in the master list.
Now that a possible Root Cause has been identified, generate a solution, implement it and check for proof that it's effective.
Go back to CAR Form
5 Why Analysis - Occurrence
Corrective Action Number
Therefor
Problem Description:
ROOT CAUSE OF PROBLEM - (D#4 in 8D Process):
WHY #1:
Therefor Therefore Therefor Therefore
Response to
Why #1
WHY #2:
Response to
Why #2
WHY #3:
Response to
Why #3
WHY #4:
Response to
Why #4
WHY #5:
Response to
Why #5
Root Cause:
Corrective Action - (D#5 in 8D Process):
Resp:
1
Resp:
2
Resp:
3
Resp:
4
Resp:
5
Documents to be Revised:
Type
Work Inst/Proc
Design Doc
Control Plan
DFMEA
PFMEA
Process Flow
Rev Req?
Document Number
Date
Comp:
Date
Comp:
Date
Comp:
Date
Comp:
Date
Comp:
Date Revised
Verification of Effectiveness - (D#6 in 8D Process):
Resp:
1
Resp:
2
Resp:
3
Resp:
4
Resp:
5
Date
Comp:
Date
Comp:
Date
Comp:
Date
Comp:
Date
Comp:
5 Why Analysis - Detection
Corrective Action Number
Therefor
Problem Description:
ROOT CAUSE OF PROBLEM - (D#4 in 8D Process):
WHY #1:
Therefor Therefore Therefore Therefore
Response to
Why #1
WHY #2:
Response to
Why #2
WHY #3:
Response to
Why #3
WHY #4:
Response to
Why #4
WHY #5:
Response to
Why #5
Root Cause:
Corrective Action - (D#5 in 8D Process):
Resp:
1
Resp:
2
Resp:
3
Resp:
4
Resp:
5
Documents to be Revised:
Type
Work Inst/Proc
Design Doc
Control Plan
DFMEA
PFMEA
Process Flow
Rev Reqd?
Document Number
Date
Comp:
Date
Comp:
Date
Comp:
Date
Comp:
Date
Comp:
Date Revised
Verification of Effectiveness - (D#6 in 8D Process):
Resp:
1
Resp:
2
Resp:
3
Resp:
4
Resp:
5
Date
Comp:
Date
Comp:
Date
Comp:
Date
Comp:
Date
Comp:
Frequency
PARETO CHARTS
80% of the effects are due to 20% of the causes (the 80:20 rule is approximate; actual % may vary)
A. Data is easy to gather
B. Charts are easy to construct and interpret
C. Allows the Team to focus on the parts of the problem with the greatest impact
D. The vertical axis needs to be as tall as the total count number
E. The categories of data are arranged in descending frequency
Cause
Paynter Charts
A. Combines the concepts of a run chart with a Pareto chart.
B. The run chart is typically used at the top and a list of defects/deficiencies are listed below the x axis to indicate what items make up the count for each reporting period.
C. Used for effectiveness of Containment/Corrective action.
D. Helps with Root cause identification
Paynter Chart Template (For example look below)
# Defective
Defect Paynter Chart
0
1
2
3
4
5
6
7
8
9
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13
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28
29
30
Batch
Issue Description
Issue #
Batch
Build Date
1
2
3
4
5
6
7
8
9
10
11
12
13
14
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23
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25
26
27
28
29
30
1
2
3
4
5
6
7
8
9
10
TOTALS
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Paynter Chart Example
# Defective
Defect Paynter Chart
50
45
40
35
30
25
20
15
10
5
0
1
2
3
4
5
6
7
8
9
10
11
12
13
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16
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Batch
Issue Description
Wrong components
Broken Part
Out of Roundness
Flash
Issue #
1
2
3
4
5
6
7
8
9
10
Batch
Build Date
1
1-Jul
6
2
5
1
2
3-Jul
9
3
6
1
3
5-Jul
16
1
4
3
4
7-Jul
13
1
3
3
5
9-Jul
13
0
4
0
6
11-Jul
10
3
1
0
7
13-Jul
2
4
0
0
8
15-Jul
0
1
0
0
9
17-Jul
0
2
0
0
10
19-Jul
0
3
0
0
11
21-Jul
0
7
0
0
12
23-Jul
0
2
0
0
1
2
3
7
2
13
14
15
Example
TOTALS
14
19
24
20
17
14
6
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Verification
Verification should be done by a person other than who was responsible for the activities.
Initial and date.
Check when Sections 3.1, 5.1 , and 6.1. are all verified.
Initial and date.
Modify the necessary systems including policies, practices and procedures to prevent recurrence
of this problem and similar ones. Make recommendations for systemic improvements , as
necessary , and document technical lessons learned.
Verification is complete when you have turned the problem on or off, or have error-proofed the process.
At minimum you must go through and update the control documentation to ensure that the incident and
any subsequent actions have been properly recorded.
In addition this is the time to review lessons learned from this exposure and see if any of them can be applied to
similar product lines or components
within a like product family. This makes the corrective action more robust in nature.
Checklist for verification:
Have you updated your Flow Chart?
Have you updated your Control Plan?
Have you updated your Process FMEA?
Was a drawing update required?
Have you updated your work instructions if necessary?
Was training refresher or new training required?
Did you verify training was effective and how?
Did you update the training records?
Have you modified any charting or checklists used at the assembly or work station?
Have you provided supporting objective evidence of verification on the Objective Evidence Tab
Was the verifier knowledgeable on the topic but independent from the team?
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