CAPA Management: A Holistic Approach to Resolve Quality Issues
Highly regulated industries require a standardized, repeatable CAPA management process to eliminate the systemic issues, such as deviations, defects, nonconformances, and more by identifying and addressing their root cause(s) through efficient investigation, so that it does not reoccur. It’s high time that such industries upgrade their traditional CAPA processes with the next-generation CAPA Management software solutions to overcome challenges like visibility, inefficiency, and disparate systems.
Qualityze CAPA Management enables organizations to develop a risk-based, compliance-driven process for addressing systemic issues to prevent a recurrence. It guides the user with a comprehensive approach to mitigate quality issues while meeting compliance and fostering a culture of continuous improvements.
With Qualityze CAPA Management Software, you can standardize the process to:
- Initiate a CAPA with Critical Information
- Plan the Most Appropriate Resolution
- Investigate to Determine Actual Root Cause
- Perform Risk Assessment
- Define and Implement the Action Plan
- Perform the Verification and Effectiveness Steps
- Resolve the Quality Issues
CAPA Management Overview
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
- Perform root cause analysis
- Perform risk assessment
- Implement Action Plans
- Perform Effectiveness Review
- Resolution of quality issues
- Digital Signature
- Audit Trail
- Notification & Alerts
Documenting the Root Cause(s)
Quality issues potentially arise from several subsystems that are put in place to support the Quality Management System within the organization. Every issue including improper design; inadequate product specification; failure of purchased materials; inadequate manufacturing instructions, processes, tools or equipment; inadequate training or lack of training; inadequate resources, needs to be reported and tracked in a systematic manner.
And Qualityze CAPA management system offers you the same functionality in a series of steps starting from the Initiation Step where you can capture all the requisite information like:
- Problem Statement
- CAPA Source & Source Number
- Reported Date
- Reported By
- CAPA Owner & others
Like Qualityze Nonconformance Management Software, CAPA software is also configurable. You can easily create new fields as per your business information needs. On saving each record, you will get a unique number to keep the track of the CAPA process for the issues reported.
Planning the Resolution Activity
Once the documentation step is done and you have got your unique reference number to track the process. The next step for you, as a CAPA owner, is to proceed with the planning of the resolution activity.
The Qualityze CAPA Management Software helps you with the planning through its resolution step, wherein you get an initial risk assessment for planning the course and level of investigation.
We completely understand that not every CAPA issues needs to undergo same level of investigation. The extent of the investigation depends on the several factors such as criticality, the risk to a patient, risk to the company, extent of the defect etc.
The Qualityze CAPA Management System offers you two options either to go ahead with the CAPA workflow or to opt-out the CAPA depending upon the criticality of the issue. if you choose to proceed with the CAPA workflow, you can further select/deselect the task, define the task owner, and the task due date, which is necessary for each CAPA record.
Investigate, Identify Root cause and Risk Assessment
Investigating the root cause is the most significant part of a CAPA practice in quality management system. Through Qualityze, you can easily document the investigation result or outcome in the Investigation task.
Investigation task is the step where you document the root cause(s) and perform the risk assessment accordingly. You can list multiple root causes for an issue along with the resolution required and the result.
Qualityze Corrective Action Preventive Action Management Software also allow you to record the entire investigation and analysis report for future reference.
Define and Implement Action Plan
Qualityze CAPA software is designed with an Implementation task to help creating action plans that can eliminate or minimize the cause of the quality issue. You can further categorize the action plans as Correction, Corrective, Preventive or Risk Based. Easy-to-use, this interactive solution allows you to document multiple actions plans in order to address the root cause, which was identified during the investigation task. Additionally, you have an option to document the verification plan in this task through which you can monitor the effectiveness of the implemented action plan.
Verification and Effectiveness Review
The Effectiveness Review task of the Qualityze CAPA Software allows 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 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.
Why CAPA Management Is Important
CAPA refers to identifying the root cause of the problems encountered in a quality process, product, or workflow to make informed decisions regarding action plans to be implemented for effective resolution. It encourages any organization to:
- Verify and validate the quality issues identified
- Tracking the root-cause of the same
- Take a right corrective and preventive action
- Documenting the problems, potential risks, and relevant solutions.
How does Qualityze CAPA Management Help Businesses?
Dig deeper into quality issues to obliterate the root cause(s) and prevent their recurrence using Qualityze intuitive and configurable workflows, fields, dashboards, and reports. With Qualityze CAPA Management, you can
- Record CAPA-Related Information to Assess Risks
- Minimize the CAPA Cycle Time
- Ensure CAPA Effectiveness
- Integrate the Nonconformance and CAPA Processes
- Integrate with Existing Business Systems
- Drive Continuous Improvement
- Controlled CAPA Records and Data
Record CAPA-Related Information to Assess Risks
Qualityze enables you to capture all the CAPA-related information through its user-friendly forms. It typically includes Title, Description, Problem Statement, CAPA Source, and Auto-generated Number, Reported Date, Reported By, Criticality, CAPA Owner, and much more. Having the standardized forms and workflows to capture information helps maintain accuracy in reporting, analysis, and root cause investigation.
Whether the CAPA is triggered due to Supplier, Audit, Customer Complaints, or Nonconformance, Qualityze CAPA Management allows you to adjust the workflow based on the criticality assigned to the issue. It enables you to make a risk-based approach in resolving quality problems.
Minimize the CAPA Cycle Time
With built-in alerts and notification capability, automated email approvals, and configurable workflows, Qualityze CAPA Management can mitigate quality problems more effectively and efficiently. It facilitates real-time collaboration with involved parties regarding investigations, approvals, reviews, action plans, and their implementation schedules to manage issues quickly.
You can schedule the CAPA approvals and effectiveness reviews to ensure that they are implemented on time, reducing the overall CAPA cycle time. Qualityze CAPA Management also enables you to communicate with involved parties, including suppliers, customers, and employees regarding the impact of CAPA on regular operations. The searchability of CAPA records and relevant information is significantly improved so you can easily track the documented records, irrespective of their age.
Ensure CAPA Effectiveness
Qualityze CAPA Management allows you to perform effectiveness reviews that ensure corrective actions or preventive actions implemented are working well. You can specify the verification plans to check the effectiveness of CAPAs.
The configurable workflow allows you to add multiple verification plans to perform an effectiveness check. You can re-initiate for the CAPA that failed to mitigate quality problems it is intended for, providing details as closure comments.
You can further map the CAPAs to their root cause as a proactive approach to similar quality problems that may arise in the future, putting you in better control to manage risks.
Integrate the Nonconformance and CAPA Processes
It’s easy to access all the nonconformances records with references using Qualityze CAPA management. We have a set of smarter quality solutions to help you succeed in quality management, creating a closed-loop system.
You can initiate a CAPA directly for a Nonconformance that requires detailed investigation.
Qualityze CAPA Management can collect all the information relevant to the nonconformance, deviation, and defects stored in the centralized database. It accelerates the investigation and CAPA implementation, reducing the process cycle time.
Integrate with Existing Business Systems
Integrating CAPA with existing systems allows you to take a holistic and compliant approach to quality management, ensuring effective resolutions.
Drive Continuous Improvement
With Qualityze CAPA Management, you can leverage standardized reports to provide real-time visibility through your systems to identify the compliance risks, improvement opportunities, and make better decisions.
The system’s in-built reporting and trend analysis tools provide critical information to drive continuous improvement, enabling you to achieve operational excellence.
Be more proactive in managing risks and create a culture of continuous improvements with Qualityze!
Controlled CAPA Records and Data
Qualityze CAPA management standardizes and streamlines the CAPA processes, ensuring that all your quality data and records are safe. You can leverage role-based security controls, password authentication, and audit trail to trace the events and actions performed on quality data.
It also supports digital documentation and electronic signature to maintain compliance with regulatory standards, such as FDA 21 CFR Part 11.
Qualityze CAPA Management – Giving Industries More Control Over CAPAs
Qualityze CAPA Management works for all industries, including – Manufacturing, Life Sciences, Pharmaceuticals, Medical Devices, Nutraceuticals, Biologics, Food and Beverages, Automotive, Aerospace, and Defense Logistics, to assess risks and eliminate problems while maintaining compliance with applicable regulatory standards.
Qualityze CAPA Management Solution comes with
- Centralized CAPA Database
- Audit Trail
- Risk Matrix
- Personalized Dashboards
- Task Scheduler
- E-Signature Validation
- Chatter, and more.