The QMSCAPA v1 window form is divided into tabs:

 

1)Incident / Non-Conformity and Containment;

2)Cause and Corrective Action

3)Preventive Action and Review (includes verification)

4)View Attachments (related to the CAPA)

5)Task List (related to the CAPA)

 

1) Incident / Non-Conformity and Containment tab;

 

1.Use the default CAPA form name/number, the Version and Effective Date are populated by the Form Id.

2.Enter the appropriate CAPA Due Date.

3.The Created and Saved dates are automatically generated.

4.The Author Name is the person who originates the CAPA request.

5.The Process or Department that is most directly involved with the Statement of Concern or problem.

6.The Type of CAPA is related to the Action Request or Preventive Action and, or non-conformances.

7.The Client information is optional.

8.Assigned to is the person who will be taking or leading the Corrective Action or Preventive Action.

9.The CWG (Current Work Group) is a code that is related to the person or a group the person belongs as a member. The CWG is used to filter CAPAs that are for a specific person or group.

10.The Statement of Concerns is required.

11.The Containment Action or Initial Action field was added in v1.35

12.The Statement of Cause, also known as "root cause."

 

2) Cause and Corrective Action tab

 

capaformtab2b

 

A.Use the Statement of Cause field to record the cause of the problem, also commonly referred to as the root cause.

B.Use the Corrective Action field to record the appropriate corrective action used.

C.Use the Form for Printing field to select the appropriate form for printing.

The "CA completed by" is the person that completes the Corrective or Preventive Action request, which may be the same as the "Assigned to" person.

The CA attachment is optional.

The "CA completed date" is related to the Correction Action completion.

The "CAPA Status" is related to whether or not the CA or PA has been acted upon and, or completed.

If the CAPA Status is set to "New CAPA" then the "new CAPA Id number" should be entered into the "CAPA Reference" field.

 

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3) Preventive Action Request and Review Tab:

 

capaform2

 

1.The "PA Classification" is used to group Preventive Actions into specific classes or types and groups.

2.The "Solution for Preventive Action" is optional, if not appropriate.

3.The 'PA Completed by" is the person that completed the PA.

4.The "PA Attachment" is optional.

5.The "PA Completed date" is the date the PA solution is adopted or implemented.

6.The "ISO Clause" and Non-conformance type (Major, Minor, OFI [Opportunity for Improvement] are optional.

7.The "Verified by" is the person that inspects the CAPA and determines if the solution was effective.

8.The "Verified date" is required.

9.The "Proof Effectiveness" is a comment that reports the proof used to verify the effectiveness of the CAPA.

10.The "Reviewed by Mgr" is the Management Representative or the appropriate Top Management person who reviews the CAPA.

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