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

1. Corrective and Preventive Action (CAPA) Report
Customer:
CAPA Number:
Address:
CAPA-11-000N
Phone:
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___
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2. Corrective and Preventive Action (CAPA) Report
Quick Fix: Take immediate action. Date of first response:
What immediate action was/should
be taken to prevent recurrence?
Section 3: Root Cause Analysis Reference
Identify the root cause. Events/Source
Ask the five Whys. Identify contributing
Perform Cause and Effect Analysis factors:
_ Lack of training
_ Other
Identify possible
sources or areas
needing correction:
_ Product
_x Process
_ Quality
Identify the corrective/preventive action(s) which will permanently address the
causes identified above. Identify if the action creates new risk. If so, do not
implement action and contact Quality Director. Identify who is responsible party,
due date and completion date. [Attach supporting documents if the space below is
not enough.]
Actions Risk (Y/N) Who Date Documents (test
results, others)
1.
2.
Results of Investigation:
[Results of "cause" investigation. Include the attachment/records/test results as
appropriate in the submitted CAPA form]
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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 Date
Corrective/Preventive Risk Party/Dept(s) Date Section: of Action Verified
Action or Task Items (Y/N) Affected Date Verified by
Completed
1. Corrective Action
[Detail the corrective
actions needed to
eliminate the cause of
nonconformities.]
Steps/Tasks:
[Documentation of steps
needed to deal with
problems requiring
preventive action.]
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4. Corrective and Preventive Action (CAPA) Report
Collect and Compile Data Chart [Include supporting documents] __________
Occurrence: How many times has this issue occurred? ____
Number of Quantities with issues:
Section 5. Reviews
CAPA Effectiveness Review:
[Record of
effectiveness]_______________________________________________
_______________________________________________________________
_____
□ 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 was
determined to be effective] [Preventive action taken and the application of
any controls to ensure that it was effective] [Confirmation that preventive
actions are submitted for management review]
Approval (for Effectiveness Check)
Please review the planned effectiveness check.
Reviewed/CAPA Coordinator: ________________________ Date:________
Attachments: Report
Approvals (one or two department or functional groups):
Discussion/Meeting Minutes/Escalation Memo:
Please review this CAPA report. Review results.
Reviewer: _________________________ Date:________
Section 6: CAPA Closure
VP of Quality Signature: Date:
Or
CAPA Coordinator: ________________________ Date:________
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