Corrective Action Response Form With Instructions

Corrective Action Request Form

CORRECTIVE ACTION RESPONSE Assignee: Personnel or Supplier Name of person responsible for corrective action.

Number: Initiation Date:

Date

Phone: Associated Phone # FROM: Person Requesting response

Fax: Standard/Spec/Dwg: List Requirement

Associated Fax # Reply Due Date: 10 days

Part Name: List Part Name

Part Number: List Part Number(s)

Criticality: Major System or Minor Non system Internal Rejection Tag: #

Customer Report Number(s):

List Customer Rejection #’s

Problem Identification: List the Nonconformance exactly as written on rejection and/or finding

Immediate Correction:

Responsible for Action: QA verify plan:

Assignee

QA designee

QA closure of actions:

QA designee

Date Date Date

Corrective Action Request Form 

How has the non-conforming condition been corrected? • Was the non-conforming unit scrapped or reworked?

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Was it scrapped at your facility or at customer? Was it reworked at your facility or at customer?

• If a non-compliance issue, describe the changes that were made. Describe how the extent of the non-conforming condition been determined and contained?

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Did you look for the same discrepancy in stores, WIP or suppliers?

• Did you deliver other discrepant units to your customer or sub-tier suppliers? • If you found other discrepant units, did you contain and correct them?  What actions were taken to ensure that all parties involved in the non-conforming condition have been or will be informed of the problem? • Did you inform the customer if there were any additional delivered units? • Did you tell all the individuals in your company that need to know? E.g. manufacturing, planning, engineering, design, procurement, document control, quality, facilities, operators. • If a sub tier supplier delivered the part, have they been informed? Or, • If the part passes through (Process Issue) the facility of a sub tier supplier, have they been informed?  What is the direct cause of the non-conformance? (Direct cause is a main contributor to the root cause) • What event or action “directly” caused the non-conforming condition? • Did the operator make an error during manufacturing?  It is acceptable to have operator error as a direct cause! • Was special process training needed? • Was the correct tooling used? • Was the engineering drawing at the correct revision level? • Was the planning at the correct level, accurate and effective?  What is the corrective action plan for the direct cause of the non-conformance? • How do you plan to prevent the discrepancy from happening again in the short term? • Include where, how, and by whom.

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Will an extra inspection step need to be added to the manufacturing process?

• Who will ensure this is carried out? What is the schedule for completion of the direct cause corrective action? • When will the direct cause corrective action take effect? • Immediately? Over the next two weeks? Before the next line unit is delivered (e.g. line 1031)? Does the response include the “effectivity” of the next shipment when the same part or product will be shipped to customer without the noted defect? What date will you complete the reworked part or the replacement part?

• If appropriate, what line number? What is the plan to verify the success of the direct cause solution? • Will you check “X” number of orders/pieces for the known non-conforming issue? • Will you perform an audit? When?

Root Cause:

Responsible for Action: QA verify plan:

Assignee

QA designee

QA closure of actions:

QA designee

Date Date Date

Corrective Action Request Form 

Is the root cause response a statement of fact and not a narrative discourse that attempts to explain the situation away or rationalize the condition? • Root cause is derived from asking, “Why did the direct cause happen?” • This should be a brief statement about the Root Cause. For example, “Procedure controlling this process was vague and did not provide the necessary detail.” • Note: Operator Error is NOT acceptable as a root cause. It is always reasonable to ask, "Why did the operator make an error?" The root cause should address systemic issues, like planning and its development, training, procedures, work instructions, and policy issues.

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Does the root cause statement address a fundamental issue without any obvious “why” questions imbedded in it? • Extensive analysis is called for in root cause identification. You can ask questions like, "Were there procedures? Were the procedures clearly written? Was there training? Was there an implementation plan?” • Change should be systemic but still at a level where the writer has control over the process.

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Does the root cause statement focus on a single issue? • If more then one issue is discovered, prioritize them.

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Does the root cause statement refrain from repeating the finding? • Watch out for this!

Root Cause Correction: 

Does the root cause corrective action plan address the root cause statement? • Again, something to watch for! • Does the root cause corrective action plan fix the identified root cause?

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Does the root cause response include the ship/line number or date (“Effectivity”) when the root cause corrective action will be complete?

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Does the root cause corrective action plan establish an implementation plan with dates? • What is the actual or projected date the Root Cause will be fixed. • Changes to procedures? Training requirements? • When changes to procedures are made, a plan to train and then cut over to the new procedure is required.

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Does the root cause corrective action plan assign responsibility and a schedule for the completion of the action plans? • If the correction is to be complex and implemented over time, be sure to include a schedule (Gantt Chart) that includes key milestones during the project. • If the identified root cause is not completed at the time the response is submitted, a schedule is required.

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Does the root cause corrective action plan provide evidence of revisions to policies, procedures, or work instructions? • Provide objective evidence of all completed activities. This could be copies of revised documents, photos of shop changes, or training records.

ECD: Corrective Action Verification Plan: 

Has the supplier determined when the plan will be implemented? • For example; Procedures updated, Training completed, Notices sent to sub-tiers (If required) • Complex projects will require a plan as to how changes to the suppliers system will be managed. This plan should describe how change will be controlled and verified to be efficient and effective.

Follow Up: The Follow-Up Audit 

Has it been determined when and what will be audited to determine if the corrective action has been effective?

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Will this be added to the annual audit questionnaire?

ECD:

Responsible for Action: QA verify plan:

Assignee

QA designee

QA closure of actions:

QA designee

Date Date Date