B08_J.8_SoW_Exhibit 4 PM SPE Corrective Action Request Response Instructions.docx

CORRECTIVE ACTION REPORT FORM

INSTRUCTION PAGE 1

Problem Description Section 1 Problem Description – The following shall be documented:

1. A detailed, specific description of the problem

1. How many items were initially found that contain the problem

1. When was the problem discovered

1. Where was the problem discovered

How was the problem discovered Note: This section will be completed by the CAR Issuing Activity.

Problem Solution Team Section 2 A list of Team Members that includes the following information shall be documented:

1. Member name

1. Member title

1. Member phone number

1. Approval authority

1. Member e-mail address

Containment Actions / Short Term Corrections Section 3 The quantity of suspect product at the Contractor’s facility (this include Subcontractors and material suppliers). This is to include the method of Quarantine, Quarantine Identification, method of Certification against the problem and Certification Identification. (Example: If product is screened and bad product is removed, good product is re-packaged and the package has a green “Certified” label adhered to it).

The quantity of suspect product in transit. This is to include the method of notification to the recipient. A proposed method of Certification against the problem (Return Authorization, Contractor to go on-site and rework or screen product, etc.). A method of Certification Identification.

The quantity of suspect product in the Government’s possession. This is to include Return Authorization and details of Quarantine and Certification upon receipt back into the Contractor’s facility, or details of arrangements made for Quarantine and Certification at the Government’s facility.

Root Cause Analysis Section 4 Root Cause Analysis – The following shall be documented:

1. An explanation of why the failure happened.

1. An explanation of why the failure was not detected.

NOTE: Root Cause Verification – Explain in detail what actions were taken to assure the TRUE Root Cause was found

Corrective Action Plan Section 5 Document the specific plan for changes to meet the contract and product requirements for the items that were out of control. This plan shall include the responsible individual for each action plan item along with the expected date of completion.

Validation Section 6

1. Identify each nonconformance individually and include the corrective action implemented.

Applicable to the occurrence of the problem:

1. List each Action individually and include the date of implementation and the name of the Team Member responsible.

1. Provide detail for each Action of how it was proven that the action taken eliminated the problem. Include the date and the name of the Team Member responsible.

Applicable to the non-detection of the problem:

1. List each Action individually and include the date of implementation and the name of the Team Member responsible.

1. Provide detail for each Action of how it was proven that the action taken eliminated the problem. Include the date and the name of the Team Member responsible.

The following shall be documented:

1. Describe the methods used (i.e. – number of trials with corrections in place, measurements, inspections, etc; this includes data on the number of items inspected vs. number of subject defects found, etc.) to verify the actions taken are effective and will remain effective. Include hard data as applicable.

Prevention Error Proofing Section 7

1. Consider other processes where these Corrective Actions could be of benefit.

1. Identify Poke-Yoke’s or error proofing processes implemented for each problem.

Standardization and Control Section 7B The following shall be documented:

1. Provide details regarding updates of documents such as – Process Failure Modes and Effects Analysis (FMEA), Process Control Plan, Process Flow Diagrams, Visual Aids, Work Instructions, Operating Procedures, Training Methods / Records, Preventive Maintenance Plans, Etc.

Examples of each, as applicable, should be included with the Corrective Action Report.

1. List the Team Members by name, input the date and allow each Team Member the opportunity to comment on the project.

1. Secure DCMA signature on CAR response

CAR Timeline:

NOTE: Contractor shall not exceed 15 working days for final CAR response without written request for an extension from DCMA.

CAR response Section 4-6 completed CAR response Section 2-3 completed Final CAR response updated: Section 7-8, completed

Supplier:

Address:

Status:

Recurrent Failure:

1. Problem Description

Description of the problem:

How many parts have the problem?

When were the parts found?

Where were the parts found?

How were the parts found?

2. Problem Solution Team

3. Containment Action

Your action taken to capture all non-conforming product in your inventory, finished goods, WIP, & in transit, prior to receipt

Action:

At Government Facility

Action:

Verification (Date and result):

Material at Government Facility Disposition

No. RMA:

Material in Transit

Action:

Verification (Date and result):

At Supplier’s Facility

Action:

Total Number of parts sorted:

Percentage defective:

Total Number of defective parts:

What is the identification mark to signify?

4. Root Cause Analysis

Use the “5 Why’s Analysis” technique to determine the most basic cause that resulted in a nonconformity that can be reasonably identified, fixed, or eliminated through process improvement.

Why did the failure occur?

1. Why?

2. Why?

3. Why?

4. Why?

5. Why?

Why was the failure not detected?

0. Why?

2. Why?

3. Why?

4. Why?

5. Why?

Verification of Effectiveness Explain in detail what actions were taken to verify that the root cause was found and effective.

5. Identify Solutions

Solutions that address and correct the root cause. Solutions determined to be the best of all alternatives. Document and verify the permanent Corrective Action in the Action Item Table

Applicable to occurrence of failure

Click here to enter a date.

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How did you validate that the action/improvement measure eliminated the non conformance?

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Applicable to non-detection of failure

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6. Validation

Implement and validate to ensure that corrective action does “what it is suppose to do.” Detect undesirable side effect. Document this on the action Item Table. Return to root cause analysis, if necessary

Evidence:

7. Prevention (Design/Information System Review)

Determine what improvements in the systems and processes would prevent problem from recurring. Ensure that corrective action remains in place and are successful.

Were Pokes-Yokes (Error Proofing) Implemented because of this failure?

7B. Standardization and Control:

Control Plan

FMEA

Flow Process Diagram

Visual Aid

Operation Standards

Manufacturing Set-up Sheet

Manufacturing Check Sheet

Process Work Instructions

QA Inspection Forms

Preventive Maintenance Plan

Job Certifications/ Recertification requirement

Other

8B. Attach any additional information to end of this report.

Submitted By:

Signature/Title: X______________________________

Government Status:

Government Signature/Title:

X____________________________ Date: Click here to enter a date..

8B. Defense Contract Management Agency.

Reviewed By:

Signature/Title: X______________________________

DCMA Status:

DCMA Signature/Title:

X____________________________ Date: Click here to enter a date.

Action Item Table