Corrective and Preventive Action (CAPA)

In order to ensure Portwell offers world-class manufacturing services, the corrective and preventive processes are implemented to manage abnormalities and potential problems.

The QA member in charge of a quality issue involves the supplier to provide corrective actions upon discovering issues. A Supplier Corrective Action form is sent to the supplier to document the root cause, corrective action and Portwell's approval. Once the supplier's corrective actions are returned and approved by the QA team, the document is signed which closes the request in Portwell's quality system.

Portwell reviews open issues monthly to track issues in order to resolve and provide closure. We provide a complete check on all of unresolved issues and establish a time line to close them.

Portwell ensures customer care by identifying and communicating abnormalities. It is for this reason that corrective and preventive action is taken – to find out the root cause and continuously monitor the effectiveness of the quality system after solutions are implemented to ensure issues do not recur.

Abnormality
Discovered
Analyze and
judge which
unit should
be in charged
Submit Analysis
report and
Corrective and
Prevent Action
Procedure
Filing
Conrm the
Eective
Improvement
proposal
Execution
QC Audit
 
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