Association of CAPA and Nonconformance with an Audit
Associating audit with CAPA and Nonconformance helps to investigate and take preventive and corrective actions to meet the specifications and quality of the product. There are two types of associations manual and automated. It is possible to associate the audit with the existing Quality Management System objects, CAPA, and Nonconformance , using a workflow, known as auto-generation.
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Association of CAPA and Nonconformance is possible when the audit is in the Manage Response state.
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Association of an audit with CAPA and Nonconformance request can be achieved manually using Change Association business rules. The
Change Association Rules table is available under the site and organization contexts. If the
Change Process rule is enabled in the
Change Association Rules table, then the new CAPA or Nonconformance requests appear in
Associated Process Objects of an audit. If the
Change Reference rule is enabled in the
Change Association Rules table, then the created CAPA or Nonconformance records appear in
Associated Process Objects of an audit. If both the
Change Process and
Change Reference rules are enabled,
Change Reference rule takes precedence and the new CAPA or Nonconformance requests appear in
Associated Reference Objects of an audit. For more information, see
Change Association Rule Administration.
The association of an audit with the new CAPA or Nonconformance requests is available in the following windows:
• Actions menu on Audit Information page
• Right-click menu on Audit Table page
• Actions menu on Nonconformance Request Information page
• Actions menu on CAPA Request Information page
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For a finding, a Nonconformance request is associated with the audit by default. However, if you do not have the Nonconformance installed, the CAPA is automatically enabled and associated with the audit. For two or more audit findings, the Nonconformance or CAPA requests that are equal to the number of findings are associated with each finding. However, if both the Nonconformance and CAPA are available, the Nonconformance always gets priority over CAPA.
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