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Electronic Quality management

Electronic Quality management

This blog speaks about quality management info like non-conformance, audit management, CAPA,

Why is CAPA Triggered in any Organisation - the ideal Use cases.

What Exactly CAPA Dose

There are many systems in a quality management process, that will enhance the functionality of your process. But the function of a CAPA is to ensure that all these systems work in a proper manner. All the other systems are individual in their purpose, but a CAPA Software is the one which will constantly monitor the functions of all the systems. CAPA always addressees systematic issues such as errors repeated errors in a production cycle.

Where dose it fit into the system

It actually fits into every system of  Quality management, Its function is to Take care of all the errors or discrepancies arise when they are deployed. A CAPA is an integral part of any system, Its good to have CAPA in place to keep things in place.

What triggers a CAPA

A CAPA (Corrective Action Preventive Action) Can be triggered by a Non-conformance, or a Flaw in the system of audit management, or a complaint raised by a vendor, It can be anything.  The Trigger of a CAPA  is the root cause of an issue and  it is designed to develop a successful treatment plan for it.

What are the frequent use cases of CAPA 

  • Non-conformance

  • Audit

  • Complaints

 

Non-conformance

Non- conformance generally occurs in any manufacturing or production industry at the end of the process. These kind of non conformance are normalized with the  non-conformance procedures itself. 

So, when dose a CAPA software or procedure comes into picture ?? It checks the occurrence of the failure which is repeated in the cycle. It is used to find the procedural errors which are causing the repeated failures.

Audit

Internal audits are the systems which are in place to keep your procedure in right path. An internal audit will also keep an eye on the improvement opportunities, Procedures abiding the regulations etc.

Internal Audits are carried out for different procedures and processes across the manufacturing or production process. A CAPA is escalated when a discripency is caused or found. It is expected that you use CAPA to address major, systemic issues including those found during your internal auditing activities. 

Complaints

Complaints are raised when the end product is received by the customer. Customer complaints are escalated to CAPA  after finding the root-cause analysis of the complaint raised.  Also like in non conformance,  a single incident likely will not trigger a CAPA. It is always a systemic issue, so,the repeated occurrence of the  same complaint will lead to a CAPA escalation.

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