Corrective and preventive action plan CAPA report form

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Corrective and preventive action plan CAPA report form for medical device for FDA compliance with 21 cfr part 820.100

Corrective and preventive action plan CAPA report form for medical device for FDA compliance with 21 cfr part 820.100

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  • 1. Corrective and Preventive Action (CAPA) ReportCustomer: CAPA Number:Address: CAPA-11-000NPhone:Item Description: Number PO # Order #:Supplier Part Description: () CAPA Owner: Issued Date: Risk rating: Category: (Supplier)___________ _/__/2011 Major___ Audit observation Supplier Salesforce Moderate___ Procedure___ CAR/CAPA #: __ Case #:NNNN Minor__x__ Preventive Status: Opportunity for Action/Safety___ CAPA Owner: □ Open improvement___ Mgt Review____ Complaint Action Report Email from QA (CAR Num): CAR-0000N □ Close Customer_x__ Maintenance Other: phone call Description of problem Alleged injury description and associated information: None Reasons: None Section 2: Immediate Action Medical Device/Vigilance Reportable? Yes X No Document notification date and place report in file. Date Reported: __NA__________ Performed Date: NA By: NA Have you collected all the information to allow you to do an investigation as required? Yes ____ No___ Doc Num: N Page 1 of 4 CONFIDENTIAL
  • 2. Corrective and Preventive Action (CAPA) ReportQuick Fix: Take immediate action. Date of first response:What immediate action was/shouldbe taken to prevent recurrence?Section 3: Root Cause Analysis ReferenceIdentify the root cause. Events/SourceAsk the five Whys. Identify contributingPerform Cause and Effect Analysis factors: _ Lack of training _ Other Identify possible sources or areas needing correction: _ Product _x Process _ QualityIdentify the corrective/preventive action(s) which will permanently address thecauses identified above. Identify if the action creates new risk. If so, do notimplement action and contact Quality Director. Identify who is responsible party,due date and completion date. [Attach supporting documents if the space below isnot enough.]Actions Risk (Y/N) Who Date Documents (testresults, others)1.2.Results of Investigation:[Results of "cause" investigation. Include the attachment/records/test results asappropriate in the submitted CAPA form]Doc Num: N Page 2 of 4 CONFIDENTIAL
  • 3. Corrective and Preventive Action (CAPA) Report Testing Results: Please review the deviation information. Assign a team to investigate the root cause and suggest action plans. Reviewer: _________________________ Date:________ Approver:__________________________ Date:________ CAPA Coordinator (Supplier/): ________________________ Date:________ Section 4: Implementation and Verification of Propose Action Plan Summary Notifications (email and phone call) sent to (Supplier) by _____________________________(Title/ Med PM) on _________ (date).Number of New Responsible Due Verification Effectiveness DateCorrective/Preventive Risk Party/Dept(s) Date Section: of Action VerifiedAction or Task Items (Y/N) Affected Date Verified by Completed1. Corrective Action[Detail the correctiveactions needed toeliminate the cause ofnonconformities.]Steps/Tasks:[Documentation of stepsneeded to deal withproblems requiringpreventive action.] Doc Num: N Page 3 of 4 CONFIDENTIAL
  • 4. Corrective and Preventive Action (CAPA) ReportCollect and Compile Data Chart [Include supporting documents] __________Occurrence: How many times has this issue occurred? ____Number of Quantities with issues:Section 5. ReviewsCAPA Effectiveness Review:[Record ofeffectiveness]___________________________________________________________________________________________________________________□ New or Revised Documents Completed□ Verification/Validation Completed□ Training Completed□ Additional Follow-up needed or audit□ Other (Internal Audit, Monitor, Comparison of Before and After)______[Measures taken to ensure that corrective action was taken and that it wasdetermined to be effective] [Preventive action taken and the application ofany controls to ensure that it was effective] [Confirmation that preventiveactions are submitted for management review]Approval (for Effectiveness Check)Please review the planned effectiveness check.Reviewed/CAPA Coordinator: ________________________ Date:________Attachments: ReportApprovals (one or two department or functional groups):Discussion/Meeting Minutes/Escalation Memo:Please review this CAPA report. Review results.Reviewer: _________________________ Date:________Section 6: CAPA ClosureVP of Quality Signature: Date:OrCAPA Coordinator: ________________________ Date:________Doc Num: N Page 4 of 4 CONFIDENTIAL