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With the evolution of quality management, there has been a shift away from manual and paper-based solutions. Organizations are now leveraging the power of automation and integration across the value chain to improve the quality of products and processes. This progression has materialized directly in the quality management software space.
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One of the most widely used processes for improving the quality of products and processes is nonconformance reporting and corrective and preventive actions (CAPA). Because the CAPA process is a critical component of quality management, it has naturally become a central piece to many different types of companies delivering enterprise quality management software (EQMS), including enterprise resource planning (ERP), product life-cycle management (PLM), manufacturing operations management (MOM), and EQMS pure-play software providers.
Using benchmark data from the 2012–2013 LNS Research Quality Management Survey, I’ll discuss the importance of automating CAPA procedures and provide some context into how it’s being used.
Automating corrective and preventive actions
CAPA processes are not only necessary for process-driven organizations but also required in many industries. Companies have traditionally managed the CAPA process with spreadsheets and homegrown or point solutions. Although this has worked for smaller organizations, it’s proved ineffective for larger ones with distributed facilities and business units.
By providing a platform for cross-functional communication and collaboration, the automation capabilities found within EQMS have improved CAPA’s effectiveness. EQMS streamlines the CAPA processes, significantly strengthening a company’s ability to investigate, resolve, and avoid nonconformances.
Automation and the portfolio of quality management functionalities
Without a doubt, effective quality management requires the use of an arsenal of tools and resources. This mix varies depending on the type of company and industry, but there is a general set that is employed across the board. The LNS survey asked nearly 400 executives which EQMS functionalities their organizations currently had automated (see figure 1).
Click here for larger image.
As illustrated in figure 1, a majority of executives noted that their companies were automating CAPA as a part of EQMS. With a 53-percent use rate, aside from document control, automated CAPA was considerably ahead of every other option. Because of the role that it plays in continuous improvement, and that it was one of the original capabilities delivered by early entrants to the market, this is not terribly surprising.
What may be surprising to some readers is that the adoption rate is not higher, and that adoption rates of other quality management functionalities fall off so quickly after CAPA and document control. In future articles we will examine the full range of processes that should be automated beyond CAPA as a part of EQMS, and which of these functions are most associated with driving benefits in key performance indicators (KPIs).
Effect of automated CAPA management on the products-in-compliance metric
It’s always interesting to cross-reference an EQMS functionality with performance in a particular metric. In the LNS survey, we asked executives about their 2012 performance in products in compliance, where LNS defines products in compliance as a percentage of total products produced while in compliance with both external regulations and internal process specifications.
The chart in figure 2 depicts how the adoption of automated CAPA has affected performance of products in compliance.
Figure 2:
The box plot in figure 2 shows the distribution of performance in products in compliance for companies with automated CAPA management, as compared to those companies that are currently planning to implement this technology or have no plans to implement it. Clearly, there are major differences between the groups, and what stands out most is:
• The top 50 percent of companies with automated CAPA have 100 percent to 99 percent of products in compliance.
• The bottom 50 percent of companies without automated CAPA have 97 percent to 85 percent of products in compliance.
Based on this research it is clear that automating nonconformance monitoring and CAPA can drive considerable performance improvements for products in compliance. Companies that struggle in this area should consider how best an automated CAPA solution can fit within their existing IT infrastructures. Unfortunately, our additional analysis has shown that nonconformance monitoring and CAPA do not drive significant performance benefits in other, more operational, metrics such as first pass yield or overall equipment effectiveness.
In future articles we will examine where else CAPA can make a difference, such as with new-product introduction and cost of quality. We’ll also look at which areas of EQMS can deliver these performance benefits and how adopting a broader platform of quality functionality can help drive both operational and compliance benefits.
Originally published Feb. 28, 2013, on the LNS Research blog.
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