2020 represented the sharpest economic slowdown in modern history.
Nonetheless, with manufacturing orders reaching a three-year high in February 2021, according to the Institute of Supply Management (ISM), manufacturing is poised for a huge comeback in 2021.
Of course, that doesn’t mean manufacturers can just sit back and reap the benefits. Accompanying challenges have resulted, including supply chain shortages, personnel constraints, and the shift to remote work.
With that in mind, let’s look at five important quality management trends to watch in 2021 and how companies can leverage automation to take advantage of the opportunities they present.
Supplier Quality Management Becomes Mission-Critical
Today, supply chains are being squeezed like never before, with ISM data showing lead times and delivery problems increasing amid widespread materials and staff shortages.
As a result, manufacturers must look to secondary and often tertiary suppliers to fulfill orders. Further compounding this challenge, some of these suppliers may have had quality issues in the past.
Capitalizing on the current boom requires additional controls to avoid complaints and recalls. Automating supplier quality management provides extra safeguards and enables real-time visibility into the state of quality and vendor performance. Companies can use the EQMS to ensure products are up to standard by:
- Creating supplier scorecards that give an instant snapshot of a vendor’s compliance history
- Adjusting incoming inspection rules according to risk and past quality issues
- Linking supplier quality management to related processes like corrective action, complaint handling, and nonconformance tracking
- Centralizing communication with suppliers to avoid mistakes and lost information
Accelerating Adoption of Cloud Software
Gartner Group reports that COVID-19 is accelerating cloud adoption, forecasting that public cloud services will make up 14.2% of global IT spending by 2024. The new normal of remote work is driving the trend, as is the need to ensure efficiency, agility, and business continuity.
While the Gartner survey focuses on the public cloud, there are also robust options for privately hosted EQMS. It’s worth considering whether to work with a company that stores data with Amazon Web Services (AWS) or one that manages EQMS data and servers itself. Security is a growing concern for companies transitioning to a cloud-based EQMS, especially given the sensitive nature of the information stored there.
AWS, Microsoft Azure, and other public clouds emphasize the security of their platforms. However, an EQMS software provider that manages a private cloud can maintain the same levels of security or higher.
Remote Audit Readiness
Another pandemic-driven impact in quality management trends is that regulatory agencies worldwide have amended their requirements to allow remote audits. For instance, remote audits are now an option for some companies undergoing ISO certification or surveillance audits. They’re also allowed in certain circumstances for companies needing to certify to the new EU Medical Device Regulation (MDR) or Medical Device Single Audit Program (MDSAP).
While the process may be unfamiliar, benefits can include reduced audit time and more efficient audits. Key steps to take in preparing for a remote audit include:
- Doing a test run to ensure your technology and participating team members are ready
- Determining the route you’ll take through the plant and how you’ll share critical information
- Testing applications, devices, and connectivity throughout the audit route
- Submitting documentation ahead of time so auditors can review it before the audit
Companies should look to leverage the EQMS wherever possible to streamline these audits. For instance, document control can help prepare documents, while reporting solutions contain performance data and evidence of monitoring activities. Corrective actions and complaint management tools are also critical, showing that you’ve taken proper action on issues (and identifying outstanding problems to address before the audit).
Related Reading: Remote Audits in the Age of COVID-19
Tighter Integration of Quality Processes
Integration of quality processes is likely to remain one of several key quality management trends for quality leaders this year. The most effective quality processes connect with each other as well as other business areas, creating an interconnected, controlled system. Linking activities, data, and deadlines keep things moving and prevent issues from falling through the cracks.
Let’s say, for example, a medical device manufacturer receives a report of an adverse event. In this situation, several things need to happen. The company must:
- Record the complaint.
- Determine if the event needs to be reported to regulatory authorities and submit required documentation such as the manufacturer incident report (MIR) required for EU medical devices.
- Launch an investigation and root cause analysis.
- Determine the scope and extent of the impact on existing products.
- Identify whether a recall is necessary.
- Correct the problem and take steps to prevent a recurrence.
Each of these steps impacts other quality processes including documentation, training, change management, and more. Using integrated, configurable software provides a significant advantage over using different customized or point solutions for various processes.
Embracing EQMS Across the Organization
Just as quality is more than just a department, the quality management solution impacts more than just the quality department. Embracing EQMS across the organization is key to ensuring quality throughout all processes within a unified system, which leads to continuous improvement.
- The EQMS is connected to other vital systems such as Manufacturing Execution System (MES), Manufacturing Operations Management (MOM), and enterprise resource planning (ERP).
- Data can be pushed and pulled from the EQMS, such as pulling information from human resources (HR) records to build competency profiles.
- Data is used to make decisions, with a focus on strategically using metrics to drive continuous improvement.
As the world enters the new normal, quality management trends have shifted. Supply chain quality management has taken a front seat in the competitive landscape. Remote work is here to stay, and cloud adoption is accelerating. The ability to capitalize on this year’s opportunities will hinge on whether companies can leverage the technology available today. That’s where the EQMS will make the most significant difference in 2021—by improving efficiency and guiding the path towards digital transformation.
Learn how one medical device manufacturer replaced paper processes with an automated EQMS – read the case study