As you know by now, CAPA stands for Corrective and Preventive action. 

The organized step-by-step procedure used to manage a CAPA would be called a CAPA Management System. It may also be termed the disciplined way of handling the CAPA process. 

CAPA is an essential tool that one must use in any Quality Management System, and it would follow the three simple steps:

  • Identifying the problem
  • Correcting the problem 
  • Preventing the problem from recurring 

All companies have an essential activity in their operation. This activity would be around troubleshooting in case of nonconformities. Not conforming to the standards impacts the company financially by losing time in rework, downgrading the products, and ultimately losing time or having dissatisfied customers. 

The ability of a company to make quick decisions to correct a problem and put controls in place makes a company’s QMS efficient. The goal is to make sure that issues of the exact nature do not occur in the future.

All too often, most companies take corrective and preventive actions when a quality issue is detected. However, in many such cases, proper documentation is missed out on.

How does the absence of proper documentation affect the CAPA Management System?

Correctly documented actions, provide historical insight into:

  • What had happened?
  • What was the cause? 
  • How was it corrected?
  • What measures were taken so that the nonconformance would not happen again? 

All the above documentation would help put the whole system on the Plan-Do-Check-Act cycle and help make continuous improvement.

The documentation would also provide evidence that the organization did CAPA. One can have a CAPA Management System on a paper-based manual system or a software-based automated system. The software-based paperless automated system would be more efficient and economical in the long run. 

QISS module on CAPA is just the right software for handling CAPA. The QISS CAPA module will automate the step-by-step process by identifying the issue, finding the root cause, finding probable solutions, picking up the best solution, implementing it, and reviewing the action taken. It would also help you do the trending analysis automatically to see the effects visually.

A CAPA Management System may have cross-functional involvement in the supply chain, training, calibration, Risk Assessment, etc. 

QISS CAPA module successfully automates all the interacting components. 

Choose suitable software for your business from QISS essential software list. We are always ready to provide you ISO-based QMS services through QISS QMS software.