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CQ CAPA (Corrective And Preventive Action) Management Software

CQ CAPA (Corrective And Preventive Action) Management Software


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Automate your Corrective and Preventive Action (CAPA) Process – with Integrated Risk Management

Drive continuous improvement (CI) of operations with a comprehensive yet easy-to-use system designed to effectively manage your corrective and preventive action (CAPA) processes

Enable your workforce to detect and address systemic issues and mitigate risks
with a world-class CAPA Management Solution

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With CQ CAPA Management Software, you can identify and initiate a corrective and/or preventive action process, detect trends, conduct or link to an existing investigation and root cause analysis (RCA), define action plans to change or improve, and ensure effectiveness checks with a structured verification and closure.

For any enterprise, a robust CAPA process is crucial to address systemic issues and drive continuous improvement of your business processes. CQ CAPA management solution uses predictive analytics and intelligence to identify the right issues to solve. Our key focus is on helping you implement effective preventive action plans to mitigate risks. Our solution supports various methodologies like 8D, 5W-2H, and World Class Manufacturing (WCM).

Address Systemic Issues

There are eight key processes in a robust quality management system. These include Nonconformance, Customer Complaints, CAPA, Equipment, Product and Process Inspections, Workforce Digitalization, Audit/Risk and Compliance, and Supplier Management. The key to address any quality issue at a system level is to have an unified QMS that is connected end-to-end. CQ CAPA Management Solution integrates with the rest of the quality processes making it easier for the quality leader to collaboratively implement action plans and verify the effectiveness of a CAPA.

Address Systemic Issues
Support for various CAPA methodologies like 8D and 5W-1H

Support for various CAPA methodologies like 8D and 5W-2H

The eight disciplines (8D) model of problem-solving is extremely popular among quality professionals in the automotive, manufacturing, and healthcare sectors. The methodology focuses on product and process improvement by identifying, correcting, and eliminating recurring problems. Other models like World Class Manufacturing (WCM) and 5W-2H also offer proven approaches to taking corrective and/or preventive actions. The CQ CAPA solution is made up of foundation blocks along with a built-in workflow indicator. Companies can use the workflow as is or may configure to suit their needs.

Integrated Risk Management

The CQ CAPA Management Solution is designed to offer integrated risk management, along with the CAPA process. This offers quality leaders far more insight into risk detection and corresponding prioritization, allowing to design appropriate action plans and the closure of CAPAs in sync with the stated risk management goals.

Integrated Risk Management
Use AI and Data to spot key issues and drive investigations

Use AI and Data to spot key issues and drive investigations

In today’s rapidly changing world, business and quality professionals are looking for a next-generation EQMS. They are looking to taking advantage of the latest Artificial Intelligence (AI) and data technology to make their lives easier. Using analytics, pattern recognitions, trends, and data visualization, quality teams can spot key issues that need immediate corrective action in a fraction of time. Also, during investigations and RCA, it helps to derive insights from quality analytics. Overall, the data and AI framework of Einstein Analytics enables a more efficient CAPA workflow.

Ease of Collaboration

Collaboration and teamwork are at the core of a CAPA process. For example, using the 8D methodology, the first step is to select a team with both product and process knowledge. CQ CAPA Management Solution is designed for ease of collaboration. Since it is also part of CQ EQMS, it also integrates with ERP and CRM systems to include Customer, business and Supplier data to drive decision making that is inclusive of the various stakeholders.

Ease of Collaboration
Reduce Cost of Quality (CoQ)

Reduce Cost of Quality (CoQ)

Cost of poor quality (COPQ) includes all costs associated with poor quality products or services. Broadly, this is put into three buckets – appraisal costs or the costs of evaluating if a product meets quality standards; internal failure costs or quality-related costs incurred before the product reaches customers; and external failure costs, or quality-related costs incurred after the product reaches customers. Implementing CQ CAPA Management Solution will certainly help reduce the Cost of Quality (CoQ) within your organization by helping you implement a continuously improving quality management system.

Support Your Entire Organization

Management

Management

Get visibility across issues in real-time to quickly identify systemic issues, reduce cost, and prevent recurrences
Quality

Quality

Improve process control to reduce quality gaps, lead time, increase production yield and prevent nonconforming products and the associated custmer satisfaction from reaching the marketplace
Manufacturing

Manufacturing

Enable teams to quickly capture, triage, find the root cause, and take any remedial steps to effectively prevent waste, rework, and delays
Engineering

Engineering

Quickly access necessary nonconformance data to perform investigation and risk assessment to eliminate the root cause(s)
Operations

Operations

Easy retrieval of information to reduce review cycle time and for data-driven decisions to authorize disposition of nonconforming material
Suppliers

Suppliers

Gain visibility, improve collaboration and minimize lag times for supplier corrective actions
“ComplianceQuest is amazingly robust and easy to use. We first started using CQ for Document Control but today we use it for Training, CAPA, Complaints, Change Control, Supplier Management, and Audit Management. Our experience has been very positive throughout selection to implementation. The CQ solution is extremely powerful and has a variety of applications and modules. Configurable reporting and dashboarding features allow for ease of communication and transparency of data within the company.
All processes are electronically linked, adding both ease and traceability to interrelated QMS processes (I can launch a CAPA from my Complaint form!) (I can launch an Engineering Change Order from my CAPA form!). Configuration can be as simple or as complex as you make it.”

–Manager, Quality Assurance, Global Life Sciences Company

Key CQ CAPA Management Features

Key CQ CAPA Management Features

1

Identify and Initiate 

Identify and Initiate

Analyze all possible issues that need a CAPA, irrespective of whether the source of the issue is a product, process, or even a continuous improvement (CI) initiative. Document different types of CAPA events using user-friendly web forms.

Assess Risk 

Assess Risk

Each documented event may be systematically evaluated for risk to determine the type and priority of CAPA. Risk assessment can be performed using established risk standards and can be followed both locally and globally.

Investigation & Root Cause Analysis 

Investigation & Root Cause Analysis

Enables collaboration and teamwork for investigation and RCA. Depending on the nature of the issue, the CQ solution enables ease of collaboration with suppliers and external subject matter experts.

Define Action Plans 

Define Action Plans

Capture clearly defined action plans along with due dates, for various CAPAs.

Reviews & Approvals 

Reviews & Approvals

Route the CAPA record for reviews to relevant people and solicit feedback and necessary approvals. Approvers can either be predefined based on the type of CAPA or can be defined dynamically.

Implementation 

Implementation

Enables plan assignees to implement the approved corrective and preventive action plans. Additional plans can be recorded as deemed necessary to effectively address the root cause.

Effectiveness Verification & Closure 

Effectiveness Verification & Closure

Track the effectiveness of CAPA actions. After the preventive actions have been successful and the issue hasn’t recurred, close the CAPA.

Link to other EQMS Processes 

Link to other EQMS Processes

Ease of integration with Audit Management, Change, Complaints, Nonconformance, and other key EQMS Processes.

Communication/Collaboration 

Communication/Collaboration

Collaborate with team members, suppliers, and other stakeholders to ensure the CAPA steps have been implemented as needed.

ERP/CRM Integration 

ERP/CRM Integration

CQ EQMS integrates with ERP and CRM, to ensure quality data is tracked across the product lifecycle, end-to-end.

Mobile Access 

Mobile Access

Access your EQMS solution on the go — anywhere, anytime, and on any device. Complete access to the solution including reports, approvals, record views, reviews, alerts, etc.

Reporting and Analytics 

Reporting and Analytics

Utilize pre-developed best practices-based reports. Create any number of additional reports and dashboards to suit your requirement. Information is easily retrievable, helping you make quick decisions.

Social Like & Follow 

Social Like and Follow

Like and follow relevant records in the system. Choose to be notified via email, dashboard, and/or mobile to stay abreast of developments.

CAPA Datasheet

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