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CAPA: Preventive Action - the ISO 9001 Standard Requirements


Preventive action is performed to eliminate potential event that can create nonconformity. While talking about preventive action, we must remember that the nonconformity has not taken place yet and it is a preventive action of identifying and eliminating the cause of nonconformity.

For effective implementation of preventive action, documentation of the process and steps is a must. Only a proper documentation will help you track the effectiveness and sufficiency of the preventive action process.

Objective of Preventive Action

Based upon the prerequisite of your organization, objective of the preventive action may be a numerical, quantitative or a quality requirement. Objectives defined by ISO 9001 are not recommendations; in fact the objectives are the requirements of ISO 9001. As per the requirements stated in ISO 9001, a company needs to observe functionality of an implemented preventive action and also needs to verify its objectives in order to improve the functionality of the CAPA.

Preventive Action Closing Date

To measure and monitor the effectiveness of preventive actions, a closing time should be assigned. As per the ISO 9001 requirements, a defined time frame should be mentioned which will examine the effectiveness of the preventive action.

Documentation and Preventive Action

To keep a track on the status of the preventive action, documentation is a must. Starting from the launch of the program, procedure, day-to-day follow ups and results, everything has to be kept in an understandable order so that it becomes easier to track and understand the flow of the action. In short, documentation is needed for monitoring whether the nonconformity has indeed been prevented. Only after seeing positive result, preventive action can be closed. In case of failure of one preventive action, a second one can be introduced. Although, ISO 9001 does not approve launch of a second preventive action, still to cut the existence of a potential nonconformity, considering a second preventive action is suggested.

However, below are the processes which h you must remember to document:

  • Possible Nonconformity
  • Finding out the cause
  • Action taken to combat the nonconformity
  • The closing
  • The results

ComplianceOnline with its effort to bring the knowledge related to Preventive action to the door step of your company has collaborated with many industry experts who have vast experience in implementing CAPA processes and have more than 20-30 years in the same. So, join hands with ComplianceOnline today, attend webinars related to CAPA and help your team to build bulletproof CAPA system.

Also, take advantage of these webinars available in the format of recordings or CDs and train your entire team with below CAPA based webinars.

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ComplianceOnline Trainings

COURSE TITLE  
'Preventive Action' - the often ignored side of CAPA: Use FMEA to build preventive action into your CAPA program
This Quality management training will show you how to use methods you probably already have in place to create effective preventive action. Linking these on-going tools to your CAPA program will increase the benefit.
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Bullet-Proof CAPA
How can companies allocate scarce resources to those activities that have the greatest impact to product quality / safety, minimize resources on minor issues, and still satisfy the regulatory agencies?
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CAPA Management and Compliance with Regulatory Requirements
This regulatory training will provide benefits to companies' required to have a process for collecting, assessing and documenting deviation and complaints and ensuring that corrective and preventive actions are compliant with GXP requirements.
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Effective CAPA Management: How to Implement a Risk-based Approach to Improve Your Quality System
In this course, we will introduce you to a new method of managing your CAPA system, The Gateway: A Risk-based Filter.
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Maintaining an Effective CAPA Program and Using Risk Assessment Tools: Current Trends
Learn how to use and how far to go with an effective and efficient approach for your CAPA investigation.
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