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) 1 Of 17 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?) 2 Of 17 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 3 Of 17 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 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 Batch Issue Description Issue # Batch Build Date 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 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 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 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?