How To Manage Expectations for Unplanned Quality Events

By ETQ on August 26, 2022

Avoiding unplanned events with a quality events app

When a quality event occurs, an organization’s response marks a crucial tipping point. With a dedicated process in place, a business can streamline triage, investigation, and problem-solving, thus effectively future-proofing itself against further issues. A quality events app creates a standardized process to ensure every investigation is performed consistently, promptly, and with the correct steps taken in the right order.

Without this process, businesses lack visibility of quality events, meaning critical issues go undetected. From there, issues snowball unnecessarily until bottlenecks form in the productivity timeline, which can cripple the manufacturing process. ETQ’s Quality Events app provides a standard process for investigating an event to ensure each investigation is consistently conducted. In this blog, you’ll learn what a quality event is, common types to look out for, what problems can be solved thanks to ETQ’s Quality Events app, and – crucially – why this app is so valuable. 

What is a Quality Event?

A quality event is any quality-related issue that requires assessment to discover whether it should be escalated further – and, if so, in what ways and how far. The issue goes through a triage process while quality management software captures each aspect of the event so that nothing is lost. This also means everything can be tracked to inform future decisions and encourage proactivity, meaning quality events can be avoided.

At the beginning of the investigation process, basic information about what happened and actions taken are collected within the app to initiate an event. At this point, the event is reviewed to determine the risk level. If the risk is minimal, the event may only need to be tracked and traced; if the risk is high, a deeper investigation is necessary.

The next step is plan development and approval if the quality event is deemed serious enough to warrant further investigation. The investigation dives deep into various factors, including root cause analysis and trending information, to determine whether the issue is likely to be systemic. The next step might lead to a CAPA, but not necessarily. 

Types of quality events include:

  • Auditing – An audit can discover errors, which would constitute a quality event.
  • Complaints – Complaints are treated as a quality event, and processing them properly enables businesses to avoid similar complaints in the future.
  • Deviation – A deviation within a process is flagged as a quality event and tracked to ensure it doesn’t cause harm.
  • Non-conformance – Non-conformance generally constitutes a serious quality event, as it can have legal consequences.
  • Out of spec – For example, if the test results of a sample don’t meet the required criteria.
  • Out of trend – A result that doesn’t trend with previous results also constitutes a quality event.

Five Problems a Quality Events Application Solves

A dedicated quality events application solves many problems that otherwise have serious ramifications for a business, including:

  • Lack of management when tracking event investigations
  • Lack of identification of risk to determine what kind of action is required
  • Lack of visibility of the impact of a product’s quality due to an event
  • Lack of visibility of severe impact on other products in the field
  • Overall quality of product risk and branding reputation

The ability to fully track every element of a quality event through a quality events app unlocks the visibility required to avoid further plans and future-proof your organization.

Putting the App’s Values Into Focus

So, why is ETQ’s Quality Events app so valuable? 

Standardization

The app standardizes the process of investigating an event to provide consistency across every investigation. Without standardization, deviations are likely to appear in the quality events process, which defeats the purpose of having these processes in the first place.

Streamlining

Operations are streamlined, saving data-entry time, supporting audits, and improving root cause analysis by identifying systemic issues. This streamlining allows you to future-proof your business against further problems and gains back the time you would otherwise spend on manual data entry.

Track and trace

Tracking trending product data to identify risks and reduce quality deficiencies ultimately improves the quality of those products. This has a knock-on effect on your organization’s productivity and reputation.

Good practice

A quality events app is an essential part of good manufacturing practice. As many manufacturing processes inevitably become more sophisticated, streamlining quality is necessary. 

Using ETQ’s Quality Events app is the most effective way to manage event investigations in a timely and compliant manner. No matter how big or small the event, tracking every tiny detail unlocks the power of continuous improvement while protecting your business against future threats. 

To learn more about unexpected events, watch the webinar: Managing Unexpected or Unplanned Events or request a demo.