Get Ultimate Control with Quality Events Software

June 10, 2024

At its heart, quality management is about control – control of the disparate activities that go into producing products and services that are consistently effective, safe and compliant with standards and regulations. Unfortunately, unexpected circumstances sometimes throw a wrench into our well-laid plans, making it necessary for us to stop and reevaluate the path forward. In manufacturing, these are considered Quality Events and should be managed with the same measure of control as the rest of our quality program.

Quality events software addresses that mandate by simplifying the process of assessing a quality event, determining its priority and moving it along the proper path forward. This article gives an overview of quality events software and how it can help your business control quality events in the most efficient, cost-effective way possible.

What is quality events software?

In manufacturing, a quality event is any departure from an expected behavior that could have an impact on the quality of a product or service. Quality events can be materials defects, process failures, nonconformities, out-of-specification events, or any other issue that impacts the quality or production of goods and services.

Quality events software provides a centralized system for managing all aspects of quality events, from initial reporting to risk assessment to final resolution. By leveraging automation, real-time analytics and quality management system (eQMS) integrations, quality event software helps organizations maintain high standards of quality and compliance while reducing the administrative burden on quality control teams.

Quality events software enables manufacturers and quality professionals to systematically detect, analyze and correct unplanned events that impact quality and safety. With quality events software, you can easily prioritize and manage investigations, track and trend data, and integrate with related processes, such as corrective and preventive actions (CAPAs), deviations and supplier management.

Identifying a quality event

Being able to effectively identify quality events is the first step to ensuring that potential problems are promptly addressed for the least impact on product quality and regulatory compliance. Common methods for identifying a quality event include:

Routine inspections and audits – Many quality events are identified when auditors review processes, procedures and products against established standards. Any deviations or nonconformances discovered during this time are logged as quality events.

Customer feedback – Issues reported by customers often highlight problems that may not have been detected internally. Capturing and analyzing feedback with quality events software helps identify recurring problems and areas that need improvement.

Supplier reporting – Supplier issues can also be a source of a quality event, especially if the supplier provides critical product components or raw materials. Establishing strong communication channels with suppliers and regularly reviewing their performance can help in early detection of quality issues originating from external sources.

Regular monitoring – Continuous monitoring of production processes and product performance is essential for real-time identification of quality events. This includes automated monitoring systems that can detect deviations to parameters such as temperature, pressure or other critical process variables. With quality events software, any deviations detected are automatically flagged as quality events for further investigation.

Quality control - Routine quality control testing of products at various stages of production can uncover defects or deviations from specifications. Failures or anomalies identified during these tests can be recorded as quality events.

Using quality events software

Once a quality event is identified, quality events software helps you determine the path forward. The software acts as a central hub for quality events activities, where tasks are evaluated, assigned and monitored. Using templated or configurable workflows, your quality events can be systematically addressed for more effective and efficient outcomes.

While every company should tailor its quality events process to meet the unique needs of its product, a general quality event software workflow may look as follows:

Identification
Recording
Evaluation
Risk level determination
Investigation
Resolution plan
Implementation
Validation
Closure

Each step in the process can be managed by quality events software. Quality events can be captured and triaged according to type, impact or risk level. With QT9 QMS’s quality events application, this can be defined by users.

Events with higher risk are identified and moved along the most appropriate path to resolution. More serious quality events requiring deeper investigation may trigger root cause analysis or corrective actions, which can be initiated via the software and assigned to the appropriate stakeholders. Similarly, quality events identified as having low risk of adverse impact are assigned lower priority and may follow a less intense path to resolution.

Quality events software records details and documents the events process from beginning to end, supporting the audit process by capturing all necessary reviews and approvals, and providing built-in tracking and traceability. Robust data capture and reporting also enhance trend analysis and enable you to make more effective decisions.

Benefits of quality events software

The benefits of quality events software go beyond task management. Automating the QE process enhances collaboration and accuracy by providing a central hub and streamlined methods for managing quality events. Benefits of implementing quality events software include:

Better risk management

Quality event software helps in identifying, assessing and mitigating risks associated with quality events. By providing a systematic approach to risk management, the software ensures that potential risks are addressed promptly, reducing the likelihood of significant quality or compliance issues.

Integration and collaboration

Quality events software has built-in integrations with processes, such as CAPA management, supplier management and customer feedback, giving you an end-to-end platform for identifying, addressing and recording quality events. Information, updates and reports are easily shared, ensuring that all stakeholders are informed and aligned throughout the process.

Automated workflows

Automated workflows inherent in quality event software guide users through predefined steps for capturing, reporting, analyzing, resolving and closing events. The software allows you to assign tasks, set deadlines and track progress. Automating these tasks reduces the risk of human error, ensures consistency and accelerates the resolution process. What’s more, features such as email alerts and electronic signature approvals help to keep the process moving.

Simplified regulatory compliance

Although quality events are not specified in regulatory standards per se, quality events software helps to appropriately address related regulatory requirements, such as deviations, corrective actions and nonconformities. All quality events are documented, tracked and resolved.

Centralized data management

Quality event software centralizes all data related to quality events, providing a single platform for recording, tracking and managing incidents. This centralization ensures that all relevant information is easily accessible, eliminating the need to search through various systems or paper records.

Cost savings

By improving efficiency, reducing the likelihood of non-compliance fines, minimizing product recalls, and preventing the recurrence of quality issues, quality event software can lead to significant cost savings.

Features to look for in quality events software

When selecting quality events software, it’s important to consider features that will best support your organization’s quality management needs. Some things to look for:

Integrations

Being able to connect your quality events with other quality applications, including CAPAs, customer feedback and supplier management, is a key feature of quality event software. With quality events management as part of your eQMS, tasks such as corrective actions and root cause analysis can be initiated and resolved, with all data linked to a central hub, providing visibility into status and trends.

Configurable

Because quality event priorities will be different for every organization, it’s important to be able to configure workflows to your needs. For example, with QT9’s quality events software, users are able to label priority levels in a way that best meets their needs. For instance, instead of low and high priority, you might want to assign numbers from a continuum.

User-friendly interface

Dashboards and other organizational features will give you a comprehensive overview of quality event status and next steps. Quality events software should offer a framework for all tasks encompassing your quality events, while at the same time offer enough customization to best address your needs.

Cloud-based

A cloud-based system allows users access from anywhere, including satellite offices or in the field. This helps to ensure that all stakeholders are working with the most current information and are kept apprised of any changes or updates.