What is EQMS?
EQMS (enterprise quality management software) is a system that enables businesses to organize procedures, processes, and responsibilities related to best practices for achieving product goals and policies. Compared to standard quality management software, EQMS software specifically helps larger businesses with ensuring quality and compliance throughout their supply chain.
Enterprises need comprehensive tools to analyze risks, set quality objectives, implement workflows, and use audits for optimal performance. Heavyweight EQMS solutions focus on providing the concept of “hard” quality management, which accounts for:
- Just-in-time principles, quality data and reporting, design quality management, statistical process control (SPC), benchmarking, and zero-defect mentality
- Continuous improvement and innovation of quality standards, information and performance measurement, process management, planning, process control, and product and service design.
- Diagram types: cause and effect, scatter, affinity, relations, force-field analysis, run charts, control charts, quality function deployment, failure mode, and effect analysis.
EQMS software typically focuses on controlling both design and production processes in order to achieve specific goals of standardization. Because of this, EQMS options tend to be installed across an entire network and have very lengthy implementation times (weeks to months), along with long training sessions.
Differences Between QMS and EQMS
In the early days of quality management, QMS was more of a traditional paper-based system that relied on records and documents stored safely for regulatory requirements. The advent of business software brought about the term electronic quality management systems, which was routinely shortened to eQMS. However, QMS software today refers to any electronic method of managing quality, while EQMS (not the changed capitalization) refers to the enterprise variety.
If you’re already familiar with traditional quality management software, you might be wondering how adding “enterprise” can make such a difference. The main distinction between a standard quality management system and an enterprise quality management software lies within the key benefits:
- Collaborate with teams and departments: Larger organizations can reduce the gap between diverse teams and departments that hold different roles and responsibilities
- Improved data management: Enterprises tend to deal with large volumes of data, including change controls, history of corrective actions, nonconformances, and customer complaints for regulatory and compliance standards.
- Improved traceability: EQMS allows for the ability to trace historical records with improved data integrity, improving overall organizational effectiveness.
- CAPA management: The closed-loop nature of enterprise quality management software makes corrective actions easy to perform tasks–leading to an easier path of compliance and regulatory standards.
EQMS Features
Enterprise quality management software has introduced a wave of automated, standardized, and centralized processes for cross-functional collaboration. Certain functionalities are given in standard quality management processes, including quality planning, parts non-conformance, approval management, and complaint management.
Corrective and Preventive Action (CAPA)
Corrective and Preventive Action software, or CAPA software, is a continuous improvement tool that collects and analyzes key metrics to identify and eliminate product quality issues, process inefficiencies, and equipment issues. This means CAPA processes are used to correct nonconformances which may occur during production.
CAPA features within enterprise quality management software will alert you to these potential issues through risk assessments and root cause analysis, which identify the underlying problem with a product or process. By finding out the root cause, you’ll be able to more easily resolve the issue, and actions can be taken to prevent the nonconformance from occurring again.
Audit Management
The right EQMS software can schedule, track, and execute audits and inspections–ensuring your documentation is always up to date, complete, and accurate. Audit management modules aim to implement best-practice audit planning, improve audit efficiency, drive continuous improvement, and enhance the visibility of results.
Audit management lets best practices be put into practice, such as creating audit programs and managing schedules and resources. These programs can be reused during future planning cycles–reducing time and labor costs. Audit efficiency can also be improved through integration with popular apps such as Outlook and Google Calendars–allowing your staff quick access to email notifications, dashboards, and shared calendars.
Risk Management
Risk management is used by manufacturers to identify hazards associated with their own production processes. Additionally, there are many compliance regulations they must deal with that specify how to estimate, evaluate, and control these risks, as well as monitor controls for effectiveness across the product lifecycle. Risk management modules within EQMS software allow you to create what-if scenarios to reliably analyze potential costs related to quality exceptions.
Risk differs from product to product, so you won’t want to limit your risk management processes to one method. EQMS solutions offer document management tools. By documenting your overall process, you can increase control of your project from concept through post-production–all while collecting details on your product line, machines, and overall project status.
Failure Mode and Effects Analysis (FMEA)
Failure modes and effects analysis refer to studying the consequences of the ways (or modes) in which something might fail. Failures include any errors or defects–usually ones that can/will affect the customer. FMEA features within EQMS software aim to decrease manufacturing costs by providing opportunities for preventive maintenance instead of reactive maintenance.
The following indicates a small sample of some of the benefits FMEA provides manufacturers:
- Define corrective actions
- Identify causes and effects
- Improve economic production
- Avoid defects
- Prevent failure
- Reduce product development time and costs
- Define and minimize risks
- Improve quality and reliability
Statistical Process Control (SPC)
Statistical process control (SPC) tools collect quality and performance data in real-time to identify product quality issues and process variations in order to take corrective action before extensive issues occur. These features can help reduce waste and downtime by measuring and controlling the underutilized resources in your organization–allowing for better decision-making with equipment issues.
SPC modules within enterprise quality management software monitor product quality control data and the performance of machines and other manufacturing tools. This data is displayed to shop floor personnel whenever product quality or machine performance falls outside predefined acceptable ranges. This data is typically presented via control charts, Pareto charts, or histograms.
Who Uses EQMS?
Any organization with a desire for a more advanced internal quality process, external quality process, and improved compliance and risk can benefit from implementing an EQMS software. The industries that most commonly use these systems include engineering, manufacturing, supply chain, service-based businesses, and suppliers.
Manufacturing as a whole is by and large the biggest benefactor and user of quality management systems in order to consistently deliver high-quality products. Specific examples of complex manufacturing industries which benefit greatly from EQMS include:
- Aerospace and defense
- Medical device
- Automotive
- Circuit board and computing
Healthcare is anticipated to emerge as an industry needing regulatory updates and innovation in medical devices. With an increase in the use of the Internet of Things (IoT), their demand for QMS solutions should increase over the coming years. Manufacturers of medical devices will benefit from using EQMS to maintain ISO 13485 compliance.
In short, any manufacturer dealing with complex supply chain management can benefit from quality management options. Additional business processes that can be accomplished include inspections, dispositions, supplier ratings, shop floor execution, and traceability.
Benefits of EQMS
The benefits of enterprise quality management software are the same benefits of quality management software, which assist manufacturers in meeting some of their most critical business challenges:
- Ensuring Regulatory Compliance: Includes ISO 9001, Title 21 CFR Part 11, NERC, SSOP, HAACP, and more.
- Analyzing and Reducing Risk: Prevents errors, defects, unexpected service work, lawsuits, and recalls.
- Increasing Customer Satisfaction: Ensure customers evaluate your products for reliability, ease of use, and performance.
- Eliminating Inefficiency and Paper Waste: Electronic quality management systems help eliminate manual paper-based processes.
Limitations of EQMS
While enterprise quality management software has a number of advantages (especially over basic QMS software options), it does have certain disadvantages, primarily in terms of cost. The implementation process is also increasingly complex, which can take time. However, as described above, these costs can be balanced out by the long-term benefits offered by comprehensive EQMS.
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