This 5-page form is used to document corrective and preventive actions (CAPAs) for issues like non-conformances, audit findings, and quality problems. It includes sections to describe the problem, perform a root cause analysis, identify and implement corrective/preventive actions, verify the actions fixed the problem, and get final approval to close the CAPA. The example form describes a customer complaint issue and outlines replacing a failing hardware part, instituting a new raw material inspection procedure, and plans to check the actions fixed the problem by reviewing field reports and testing.

1. Corrective Action and Preventive Action Form FRM-820.100
Rev 0
This form is to be completed for all CAPAs (non-conformance, audit findings,
inadequate quality systems, etc.). Please forward the completed and signed form to
the CAPA coordinator or Quality Director at __. [Note: Delete all purple texts after
you completed this form. The blue texts are examples that should be replaced by
actual data.]
Section 1: Description of Problem (To be completed by CAPA Owner)
Name/Dept [Assigned Issued Date: Non-conformance/ Category
to/CAPA Owner]: hazard rating: Audit observation/
Major Mgt Review
Moderate Modification in
Minor Procedure(s)
CAPA Num: Preventive Safety
Customer Complaint
Quality Element: Maintenance
Status:_____(Open, Closed) CAR Num: ________________ (Equipment)
[Process/Product/ Other: _______
Quality System]
Description of problem (if the problem is described in the CAR report, you may enter a summary and
attach the CAR report to this form and make reference to it here):
[Describe in detail the customer complaints, product nonconformities, quality problem]
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2. Corrective Action and Preventive Action Form FRM-820.100
Rev 0
Take immediate action. Date of first
response:
Replacements of parts, ordered new part on ____ , shipped on ___
and installed on ________
What immediate action was/should be taken to prevent
recurrence?
Section 2: Root Cause Analysis Reference
Identify the root cause. A cause and effect or Fish Bone Diagram Events/Source
might be useful coupled with brainstorming with a team of Identify contributing
experts and for each probable causes, ask the five Whys. factors:
_ Lack of training
_ Poor raw material
inspection
_ supplier quality
audit and selection
_ Other
Identify possible
sources or areas
needing correction:
_ Software
_ Firmware
_ Hardware
_ Process (mfg)
_ Quality System
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3. Corrective Action and Preventive Action Form FRM-820.100
Rev 0
Identify the Corrective/Preventive Action(s) [To be deleted… 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.]
1. Replace hardware part that is failing all the time..who.date.what is the deliverable..
2. Refer to Section 3 for details.
Results of Investigation:
[Results of "cause" investigation. Include the attachment/records/test results as
appropriate in the submitted CAPA form]
See attached form. Testing result for HW..or firmware..after putting the new hw,
integration test..results …reliability tests….
1. Raw material selection..Instituted new procedure for thorough inspection. New
procedure is attached.
Reviewer: _________________________ Date:________
[Memo from reviewer for additional team if applicable.]
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4. Corrective Action and Preventive Action Form FRM-820.100
Rev 0
Section 3: Implement and Verify Action Plan
No. New Responsible Date Effectiveness of Date
Corrective/Preventive Risk Party/Department(s) Completed Action Verified Verified
Action or Task Items (Y/N) Affected by
[Verification
[Detail the actions to section]
prevent occurrence or
recurrence of the
problem]
Collect and Compile Data Chart [Include supporting documents]
Section 4. Reviews
Planned CAPA Effectiveness Review:
[Record of effectiveness]_______________________________________________
[_Planned action 6 months later: inspected field reports and absence of similar
problem__]
[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.
Mgt Reviewer/CAPA Coordinator: _________________________ Date:________
Attachments: Report
Approvals (one or two department or functional groups):
Discussion/Meeting Minutes/Escalation Memo:
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5. Corrective Action and Preventive Action Form FRM-820.100
Rev 0
Approval (for closure)
Please review this CAPA report. Review results.
Reviewer: _________________________ Date:________
CAPA Coordinator: ________________________ Date:________
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