CAPA stands for Corrective and Preventive Action. It is a systematic investigation of root causes behind the defects, problems or risks identified in a product or process to prevent their recurrence through Corrective Action(s) or to prevent the occurrence through Preventive Action(s).
Qualityze advanced CAPA management software (QCA) is built to improve the efficiency and effectiveness of your existing CAPA process while enabling your organization to take a holistic approach for:
- Documenting the Root Cause(s)
- Planning the Resolution Activity
- Investigating the Risks
- Performing Root Cause Analysis
- Performing Risk Assessment
- Defining and Implementing the Action Plan
- Performing the Verification and Effectiveness Steps
- Resolving the Quality Issues
The CAPA process plays a very significant role to have an estimated idea of quality issues that might occur through the insights from your subsystems. Therefore; Qualityze corrective action preventive action software is enabled with powerful analytics and reporting capability that notifies you about the quality issues well in advance so that your organization can take corrective measures at right time.
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 and Source Number
- Reported Date
- Reported By
- CAPA Owner and 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
Now that 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
We understand that not every issue reported in CAPA requires action. However, based on the root cause of the problem and the investigation data analysis, it may be necessary to develop an 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 Steps
Verification or validating the effectiveness of the action plans implemented is yet another vital step. In this step, you need to collect and analyze the entire data – be it the issue, its root cause, action plan, or resolution to ensure the overall efficiency and effectiveness of the implementation process.
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.
Industries Qualityze Offers CAPA Implementation for.
Qualityze CAPA Management System works for different industries with the same effectiveness and efficiency. From General Manufacturing to Life Sciences, Pharmaceuticals to Healthcare, Biotech to Metal Manufacturing, Heavy Machinery to Food and Dairy, Automotive to Aviation or Aerospace, Defense to Medical devices, Logistics to Nutraceuticals, our solution makes it easy for you to maintain topmost quality standards with
Configurable Cloud-Based Platform
Based on the cloud-based Salesforce platform, Qualityze CAPA management software solution can be easily configured based on the industry requirements to avoid unnecessary workload. Our solution will not overburden you with maintenance and upgrade costs
Adherence to Compliance Standards
Qualityze corrective action preventive action management software is designed in adherence with industry standards and best practices defined by the regulatory authorities including the Food and Drug Administration (FDA) – 21 CFR Part 820, International Organization for Standardization (ISO) – ISO 9001, ISO 13485, Pharmaceuticals and Medical Devices Agency (PMDA), Therapeutic Goods Administration (TGA), China Food and Drug Administration (CFDA), etc.
Qualityze corrective action preventive action system is a feature-packed and user-friendly software that makes its easy and convenient to use even for the users who have little or no technical expertise.
Why Corrective Action Preventive Action System is Important?
CAPA refers to the process of identifying the root cause of the problems encountered in a quality process, product, or workflow in order to make informed decisions regarding action plans to be implemented. It encourages any organization to:
- Verify and validate the quality issues identified
- Tracking the root-cause of the same
- Take right corrective and preventive action
- Documenting the problems, potential risks, and relevant solutions.
Identifying and Eliminating the Root Cause with Effective CAPA Management Software System
With Qualityze CAPA Management System, you can identify the root-cause of the problems encountered in the quality management system. This further enables you to have a precise risk-assessment, based on which you can determine the right action plan for implementation to avoid the reoccurrence of the issue in the future.
Ours is a feature-packed solution that comes with a user-friendly interface to handle CAPA with complete convenience and efficiency. You can document the quality issues, their potential risks, and decide on the action plan after complete analysis. However, the issue identified must be a valid nonconformance for risk assessment and an action plan to be implemented for the same.
Get Qualityze CAPA management software solution today to treat nonconformance in a streamlined manner to avoid its reoccurrence. The best thing is that you can have a thorough look through the product’s functionality and features by simply requesting a free demo or you can submit your query on our contact page and our team will get back to you at the earliest.