Preventive Actions

(CAPA) Corrective Action & Preventive Action Browse Table

 

Access the Preventive Action log from the Main Menu > Browse Logs > 1) CAPA Log

 

PreventiveAction1

In the CAPA browse table image above ...

A.Preventive Actions are combined into the Corrective Actions log or CAPA log.

B.Use the Add button to open the CAPA form and add a Preventive Action or Corrective Action.

(CAPA) Corrective Action & Preventive Action Form, Tab 1) Incident or Non-Conformity and Cause

CAPAformTab1forPA

In the CAPA form Tab 1) image above ...

A.For a Preventive Action, record the Statement of Concern into the field for Statement of Concerns.

B.Typically Preventive Actions do not require a Statement of Cause.

C.If you wish to print a Preventive Action record using a specific form for Preventive Actions then you can select or designate a form listed in the Control of Documents module and index.

(CAPA) Corrective Action & Preventive Action Form, Tab 3) Preventive Action and Review

CAPAformTab3forPA

In the CAPA form Tab 3) image above ...

 

A.For a Preventive Action, record the Statement of Concern into the field for Statement of Concerns on the CAPA form, Tab 1).

B.On CAPA form, Tab 3) record the Solution for Preventive Action into the Solution for Preventive Action field. In addition, record the (PA) Preventive Action Classification field, which is linked to a user-defined look-up table.

C.For a Preventive Action, check the Intended as a Preventive Action Record check-box field.

D.Identify the person that completed the Preventive Action, date completed and essential attachments.

E.For a Preventive Action, record the appropriate proof of effectiveness, including the Action Verified check-box and Action Effective check-box.

F.Record the Management Review comments for the Preventive Action.

G.If you wish to print a Preventive Action record using a specific form for Preventive Actions then you can select or designate a form listed in the Control of Documents module and index.

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