CAPA (Corrective and Preventive Action) Management

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

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. Our solution supports various methodologies like 8D, 5W-2H, and world class manufacturing (WCM) with smart recommendations at every step to guide your team to CAPA closure.

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With CQ CAPA Management Solution, you can identify and initiate a corrective and/or preventive action process, then conduct an investigation and/or link it to existing investigations or root causes for a complete record. CQ’s AI capabilities also allow you to detect trends early on and define the appropriate action plan. CQ’s advanced RCA tools help you ensure success along with effectiveness checks, 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) with smart recommendations at every step to guide your team to CAPA closure.

- There are eight key processes in a robust quality management system. These include NonConformance, Customer Complaints, CAPA, Equipment, Product and Process Inspections, Workforce Digitization, Audit/Risk and Compliance, and Supplier Management. The key to addressing any quality issue at a system level is to have a 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 leaders to collaboratively implement action plans and verify the effectiveness of a CAPA. There are eight key processes in a robust quality management system. These include Nonconformance, Customer Complaints, CAPA, Equipment, Product and Process Inspections, Workforce Digitization, Audit/Risk and Compliance, and Supplier Management. The key to addressing any quality issue at a system level is to have a 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 leaders to collaboratively implement action plans and verify the effectiveness of a CAPA.
- The Eight disciplines (8D) model of problem-solving is extremely popular among quality professionals in the automotive, manufacturing, and healthcare sectors. If you are a fan or if your organization relies on the methodology to identify, correct, and eliminate recurring problems, ComplianceQuest has a built-in 8D CAPA workflow. Other models like world class manufacturing (WCM) and 5W-2H are also offered. The CQ CAPA solution is made up of foundation blocks along with a built-in workflow indicator operating system that companies can use as is or configure to suit their needs.
- 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 them to design appropriate action plans and close CAPAs in sync with the stated risk management goals.
- In today’s rapidly changing world, you need to take advantage of the latest Artificial Intelligence (AI) and data technology to make life easier for your team. With CQ, your teams can leverage analytics, pattern recognitions, trends, and data visualization to spot key issues that need immediate corrective action in a fraction of time. CQ’s platform automatically serves recurrent nonconformances and similar CAPA records to help you identify trends before they become major quality events. Also, during investigations and RCA, it helps to derive insights from quality analytics to drive a more efficient investigation, and ultimately a better CAPA workflow.
- Collaboration and teamwork are at the core of a CAPA process. For example, while 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. 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.
- 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

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

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

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

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

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

Gain visibility, improve collaboration and minimize lag times for supplier corrective actions.

What They Say About Us

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 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
We went live with CQ just a few weeks ago and it works great! We received excellent training and after some playing around and getting used to it we found that it is really easy to use. So far we have implemented Document and Training Management as well as CAPA and both have everything we need right out of the box. After years of cumbersome spreadsheets and databases CQ is a blessing. It makes document management quick and easy… and it’s a pleasure to use.

Helen Cary, Document Control Specialist

Lin Engineering

Key Features of CQ CAPA Management Solution

Effectiveness Verification & Closure

Track the effectiveness of CAPA actions with as many verification plans and effectiveness reviews as needed.
Link to other EQMS Processes

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

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

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

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 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.
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

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 & 5 WHY 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. 5 WHY Root Cause Analysis provides functionality to document numerous root causes, attach evidence and capture
decisions as needed for the investigation.
Define Action Plans

Capture clearly defined action plans along with due dates, for various CAPAs and link them to related root causes.
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

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