Sunday, 23 March 2014


When it comes to quality management, there is a set of tools often used for managing common business processes, regardless of industry. Chances are you're already familiar with how processes such as document control, audits, and corrective action work. The issue facing many companies is not how to manage these processes but how to streamline them to make them more efficient and effective in solving quality challenges.

This article is the first in a six-part series that will discuss typical business challenges and the corresponding quality management solutions that can help alleviate them. Here we will focus on one of these solutions, corrective action, and the best way to use it to manage adverse events.

The challenge: Ineffective filtering of adverse events

In many businesses, adverse events immediately trigger a corrective action, regardless of the event’s criticality. The challenge with this approach is that if every event is treated as needing a corrective action, a company will eventually lose visibility into highly critical events. This happens because there is no qualification process to separate critical events from non-critical ones. Corrective action becomes an inefficient measure for any adverse event within the organization. Over time, these corrective actions will build up and cause a bottleneck. At that point the sheer amount of data coming into the corrective action system will overwhelm it.

The result: Loss of visibility and build-up of critical events

Say you've gotten to the point where so much data have built up that the process is now at a standstill. Your process efficiency has diminished, which is costing you time and money, and you have been left with a large amount of open corrective actions that must be addressed.

While these events continue to add up, you also may be collecting a heap of high-risk, critical events you are unaware of because the minor events are obscuring the critical ones. Most companies use completion dates to track the handling of corrective actions, but there again critical events will be overlooked, simply because they are not yet due for completion. It’s like a needle in a haystack: You have all these events, but there is no clear way to discern the critical from the non-critical.

With visibility into these critical events compromised, you risk overlooking something that could have severe operational consequences. Your organization will be left with an overload of open corrective actions, all with varying levels of criticality and severity—which could result in non-compliance, recall, and ultimately, loss of brand equity.

Many organizations try to address their corrective actions manually. When you work without any level of automation, such as software, for workflow and data retention, you must rely on tools that hinder visibility and traceability. A paper workflow is the worst kind of manual workflow, but even spreadsheets and email can be troublesome. We trade so many emails in a day that even important things like corrective action plans can easily get lost in the barrage. This limits accountability (“I didn't get that email”) and visibility (“I don’t remember what you said in that email”). Tackling workflow manually will simply result in more time needed to complete the process.

The answer: A streamlined, automated approach

For any process to be truly efficient and address issues of visibility and accountability, you need an automated method of filtering adverse events. Automation alone will reduce the chance of human error, which increases the overall quality of the process. The ability to identify high-risk events immediately is also crucial. If you can put a method in place that uses quantitative risk tools to manage adverse events, you will be able to reduce the number of corrective actions as well as the time it takes to address them. Automation speeds up the decision-making process, which leads to greater efficiency.

Once you establish a process to filter critical events from the non-critical, you will be able to better address adverse events. Filtering brings to light the critical events that require a formal corrective action vs. those that can be easily and immediately corrected. These latter typically do not pose a systemic issue for your organization, meaning that they are usually single, isolated problems.

Essentially, the concept of risk filtering forces a company to look at events not just in terms of a complaint or problem that needs to be addressed, but as potential risks to the organization. Automating this process means that instead of simply recording all adverse events for corrective action and assigning them completion dates, a risk-matrix calculation will be done first to determine how much weight to assign the event. Low-risk events can be corrected immediately and informally; high-risk events will be addressed through the corrective action process and evaluated by the team more quickly. That way, the quality group focuses on the high-risk events first.

Automating the management of adverse events using risk as a filtering agent will make the corrective action process easier and more intuitive for your organization. Visibility into all critical events will allow you to greatly reduce your risk of non-compliance, save time, and free up valuable resources to accomplish other tasks. Essentially, risk management becomes the new metric of how you address events, as opposed to completion dates or other means.

Automation and workflow keep correction actions in one place, and track them through predefined roles, phases, and deliverables. However, this doesn't solve the problem of “what do we tackle first?” It’s important to ensure that the “right” metrics are used to address adverse events. Completion dates are not the right metric because you may have critical events that have a major effect on processes and are waiting to be handled simply because they are not due. Risk is a more reliable and compliance-centric way of measuring how you address events because it considers an event’s overall business effect above anything else. By building the risk component directly into the handling adverse events, you are creating a process that will prioritize automatically how you handle them.

A real example

Within the life-science industry, where compliance is a very critical part of the business, a typical organization receives thousands of complaints monthly. Out of these complaints, hundreds are sent to the quality department to be investigated, each with a different level of severity. This is where the challenge will arise for the organization. The typical defining metric for addressing them is how long each has been open, not their level of criticality. Those that are open the longest will be addressed first.

At this point the organization will recognize the need for a more effective method of filtering the hundreds of corrective actions to find those most critical to the business.

Using level of risk as a filter for each event, the organization can focus on high-risk events first and streamline the corrective action process. The result will be a reduction in the number of corrective actions as well as the amount of time needed to complete them. There also will be better handling and greater visibility into events that might occur in other areas with similar conditions.

Going from hundreds or even thousands of corrective actions to only 20 or 30 per month on average means the company is executing a more efficient process. It will be able to respond more quickly to events, and reduce time to complete corrective actions on average. The company will improve the process by reducing the number corrective actions, leading to as much as an 80-percent increase in process efficiency.


The takeaway is this: If an adverse event is immediately correctable, don't open a corrective action. Correct it… immediately. Treating these minor corrections as one-time events will reduce the backlog in the corrective action process and lead to greater visibility into those systemic issues that actually require a corrective action. This also ensures that there will be no critical events waiting to surprise you. Automating the way you manage and filter adverse events using an objective and systematic method such as risk will drastically reduce the amount of corrective actions within your system, increase productivity, cut costs, and make the process a whole lot easier on you.

Sources: Tim Lozier, EtQ Inc.

1 comment:

Ana Rojo said...

It is a very interesting post. All companies need to implement methods to facilitate and streamline its management, because if you have a quality management system with which only complicate the solutions are nor applying this system well and loses its effectiveness.
I look forward to the second part.