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Corrective Action and Preventive Action, also called CAPA, is a systematic investigation of the root causes of identified defects/problems or identified risks to prevent their recurrence (corrective action) or to prevent the occurrence (preventive action).
The advanced capability of Qualityze CAPA management software (QCA) complements your established CAPA process and enables your organization to take a holistic approach to,

  • Document
  • Plan
  • Investigate
  • Perform root cause analysis
  • Perform risk assessment
  • Implement
  • Perform verification and effectiveness steps
  • Resolution of quality issues

The essential part of the CAPA process is to get an early signal of quality issues from your subsystems. Qualityze’s CAPA management software has inbuilt powerful analytics and reporting capability to provide you an early indication of quality issues so that your organization can take simple corrections.

Document

Quality issues potentially arise from several subsystems that are put in place to support the Quality Management System within the organization. Issues such as improper design; inadequate product specification; failure of purchased materials; inadequate manufacturing instructions, processes, tools or equipment; inadequate training or lack of training; inadequate resources, that needs to be documented and tracked with a unique number.
With Qualityze’s CAPA management system module, this can be achieved by completing the Initiation steps. Within the Initiation step, you can capture key information such as:

  • Title
  • Problem Statement
  • CAPA Source and Source Number
  • Reported Date
  • Reported By
  • Criticality
  • CAPA Owner and others

Besides these information, you have an option to create additional custom fields to capture information that your business needs. Once the record is saved, a unique number will be assigned by the system for you to keep track of the CAPA record.

Plan

Once the quality issue is documented and tracked with a unique number, you as a CAPA owner needs to plan the resolution activity.
With Qualityze’s CAPA management software module, this can be achieved by completing the Resolution steps. In this step, you have an option to perform an initial risk assessment to help further plan the course and level of investigation.
We understand that not every CAPA goes needs the same level of investigation. The extent of the investigation depends on the several criteria such as criticality, the risk to a patient, risk to the company, extent of the defect etc.
The Qualityze CAPA management system module allows you to choose the CAPA workflow or close out the CAPA with no further action. Additionally, if the CAPA workflow is selected, you have the flexibility to select/deselect the task, define the task owner and the task due date that is necessary for each CAPA record.

Investigate, identify root cause and risk assessment.

The root cause investigation of a CAPA is an important part of the quality management system. The extent of investigation depends on the several criteria such as criticality, risk to patient or end user, risk to the company, extent of the defect etc.In Qualityze, you use the Investigation task to document the investigation result or outcome. Investigation task is where you document the root cause(s) and perform the risk assessment. The flexibility of the system allows you to document multiple root causes. Additionally, you can also document the results of investigation.

In Qualityze, you use the Investigation task to document the investigation result or outcome. Investigation task is where you document the root cause(s) and perform the risk assessment. The flexibility of the system allows you to document multiple root causes. Additionally, you can also document the results of investigation.

Implement action plan

We understand that not every CAPA requires action. However, based on the root cause of the problem and analyzing the investigation data, it may be necessary to develop an action plan. In Qualityze, you use the Implementation task to create action plans that are needed to help eliminate or minimize the cause of the quality issue. You can categorize action plans as Correction, Corrective, Preventive or Risk Based. The flexibility of the system allows you to document multiple actions plans to address the root cause that was identified during the investigation task. Additionally, you have an option to document the verification plan in this task to help monitor the effectiveness of the implemented action plan.

In Qualityze, you use the Implementation task to create action plans that are needed to help eliminate or minimize the cause of the quality issue. You can categorize action plans as Correction, Corrective, Preventive or Risk Based. The flexibility of the system allows you to document multiple actions plans to address the root cause that was identified during the investigation task. Additionally, you have an option to document the verification plan in this task to help monitor the effectiveness of the implemented action plan.

Verification and Effectiveness steps

Verification or validating the effectiveness of the action plans implemented is a vital step. In this step, data needs to be collected and analyzed to ensure the effectiveness of the action plans that were implemented.

In Qualityze, you use the Effectiveness Review task to document the verification plan and objective evidence to validate the success of the action plans implemented. Additionally, in the Closure Review, you as a CAPA owner can make the determination whether or not the CAPA was effective in eliminating or minimizing the cause of the quality issue based on the analysis of the objective evidence collected in the Effectiveness Review task.

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