Non-conforming events are detrimental to the delivery of healthcare and healthcare services. In addition to causing potential patient harm, they often also cause financial losses, unsatisfied customers, and reputational damage.

Defining quality and its importance

The aim of quality management is to achieve organizational quality policies and objectives.² Non-conforming event management is a fundamental aspect of a Quality Management System (QMS) that deals with identifying, tracking, and remediating identified non-conformances. This allows an organization to reduce defects in a continuous process of improvement.

Healthcare facilities can use non-conforming event management combined with cost of poor quality tracking to identify and reduce the costs of poor quality.  When the root causes of non-conforming events are identified, actions to improve quality can be put into place. This will ultimately improve patient safety and satisfaction, and in turn, improve business outcomes such as financial bottomline, as well as mitigate risk. 

Furthermore, tracking quality allows organizations to understand the return on investment for their quality program or initiatives and justify current or additional investment in quality.

Non-conforming event management improves patient safety and satisfaction

Calculating the cost of quality 

The American Society for Quality defines the cost of quality as “a methodology that allows an organization to determine the extent to which its resources are used for activities that prevent poor quality, that appraise the quality of the organization’s products or services, and that result from internal and external failures”.³ The cost of quality is comprised of the cost of good quality (CoGQ) and the cost of poor quality (CoPQ). CoGQ (cost of conformance) is comprised of prevention costs and appraisal costs. CoPQ (cost of non-conformance) is comprised of internal failure costs and external failure costs.

Hard versus soft failure costs

Failure costs (internal and external) can be further broken down into hard costs and soft costs:

• Hard costs: Obvious costs which are often easy to calculate, such as additional hourly wages spent on correcting a non-conforming event that occurred or reagents and supplies which were wasted
• Soft costs: Costs which are usually less obvious and harder to quantify but still negatively impact the financials of an organization, such as low employee morale or reputational damage

Although difficult to assess, it is important to conservatively estimate soft failure costs. This will help to more closely quantitate the actual CoPQ for your organization, and provide awareness to the potential repercussions these events can have on the financials of the business. 

Some soft costs relating to poor quality are more difficult to assess than others, but usually a creative calculation is possible to conservatively estimate soft costs. When customers, government agencies, patients, and employees see an organization experiencing a serious patient safety issue or see an organization producing persistent poor quality, it can be very damaging for the business. For instance, a clinical laboratory can track the customers who stop using their services, but it is more difficult to track the number of potential customers that never purchased services because they heard about the poor quality issues. 

In addition, the stress and low morale that an error may cause for employees could lead to an increase in burnout, poor focus leading to more errors, work-related illnesses, or higher turnover rate. It is possible to estimate the business lost by working with the sales team to come up with a conservative figure and the financial impact of low morale can be represented by estimated hours of productivity lost. These are just examples of how CoPQ soft cost calculation can be achieved. The more data that can be collected on these considerations the better the CoPQ estimate will be.

Reducing CoPQ leads to cost savings and cost avoidance

When a failure or non-confirming event occurs, an investigation and root-cause analysis will allow you to determine an appropriate corrective action in order to eliminate the root cause of the event. Calculating CoPQ allows for an understanding of the cost savings and/or avoidance that will be realized in implementing the corrective action.

Eliminating the root cause of non-conforming events saves money

Capturing the CoPQ associated with each non-conforming event or near miss allows your organization to quantitate the financial benefit of your corrective actions and other quality improvement activities. Poor quality and rework create unnecessary financial losses and assigning a monetary value to that waste provides the motivation to eliminate it.