The QMSCAPA Corrective Action & Preventive Action (CAPA) Form is organized into five Tabs or sections. The collection of fields and related Tables are designed to provide tools for the user to record information about an incident or nonconformity, plus information about the cause and corrective actions.
The numeric references in the CAPA form image above are described below:
1)Incident or Nonconformity and Cause
The CAPA Incident or Nonconformity and Cause tab is designed to be used for recording information about the incident or nonconformity, including:
a)Process / Department
c)Part # or Product/Service identifier
d)Group # (reference #, batch #, lot # etc.)
e)CAPA Dates (created, saved, issued, due, etc.)
f)Type of CAPA
h)Customer Feed-back (complaint)
The CAPA Corrective Action tab is designed to be used for recording Corrective Actions, including:
a)Person (primary) assigned, date completed and primary record attachment.
3)Preventive Action and Review
The CAPA Preventive Action and Review tab is designed to be used for recording Preventive Actions and Management Review information, including:
a)Verification, proof of effectiveness and the date verified
b)Management review comments and review date
The CAPA Form View Attachments tab is designed to assist with the organization and retrieval of attached (or stored) electronic documents that are related to a CAPA.
CAPA Form Task List are designed to organize the investigation and assign others to task that are relevant to the investigation or corrective actions necessary to prevent the incident or nonconformity from being repeated.
6)Tab 1: Statement of Concern or Problem and the Immediate Action Taken
The Statement of Concern field is designed to be used for recording the initial facts of an incident or nonconformity and the immediate actions taken.
7)Tab 1: Statement of Cause
The Statement of Cause field, often referred to as the 'root cause', is a large text field for recording the results or determination of an investigation into the cause of an incident or nonconformity.
8)Tab 1: New CAPA Reference #
The field labeled Enter New CAPA Reference # provides a mean to link an existing CAPA # to a new CAPA# if the CAPA is re-opened for any reason in the future.
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