- Overview
- What is Electronic Quality Management System (eQMS)?
- Difference between QMS and eQMS
- Develop a Culture of Quality
- Functions of eQMS
- Benefits of eQMS
- Final Thoughts
Historically, paper-based and spreadsheet-centric quality systems were used to monitor and analyze quality-related data. Manual data entries and disconnected files made it difficult to track and manage quality-related information. Regarding challenges, while addressing top-quality management objectives for life sciences industry, respondent results were:
All thanks to the evolution of integrated IT-based systems like eQMS that made it easier to record and report quality variables across various access points. This blog discusses the definition, functions, benefits, and future of eQMS software with respect to total quality management.
What is Electronic Quality Management System (eQMS)?
Electronic Quality Management System or eQMS is a software solution that records, manages, and documents quality-centric processes electronically so that goods are produced within tolerance, meet all necessary requirements, and are free of any defects. An eQMS software offers techniques, processes, structures & resources required for meeting total quality management in an efficient & cost-effective manner. Application of this IT infrastructure ensures process efficiency and reduces human error.
eQMS system is often used to identify potential quality concerns even before they occur. It provides enhanced visibility into the QA and QC processes of the manufacturing organization. An eQMS includes compliance management, change management, investigation of adverse events, initiating corrective and preventive action, managing risks, and integrating complaint management into the quality process. An eQMS system helps organizations bring together a closed-loop system of quality that is based on accountability at every level.
Like any business management software, eQMS software can be implemented on-premise, on cloud, and in a hybrid model. Depending upon the data access needs of the organization, decision makers can choose any of these modes of deployment. Vendors understand that sizeable organizations need other software for business management as well and therefore, they enable eQMS to integrate with different programs like ERP, CRM, PLM, and MES.
Difference between QMS and eQMS
Some organizations use a collection of spreadsheets or paper-based reports as QMS to execute their quality management operations. Whereas, eQMS is an integrated software that assimilates all functions of quality management onto a single system. In a QMS, interdependent functions are operated independently, which might lead to the creation of different versions of the same information. On the contrary, eQMS offers a single version of truth by storing the entire data pool on a single location.
Working on a paper-based QMS can restrict access of updated documents, along with having no records of previous changes available. Unsigned/unauthorized documents are flagged in an eQMS software, a functionality absent in traditional QMS. Further, regulatory compliance can prove to be a pain with a traditional QMS, whereas eQMS handles compliance documentation with convenience and ease. Therefore, it is advisable for quality-oriented manufacturers to implement an eQMS.
Develop a Culture of Quality…
“55% of respondents who don’t own enterprise quality management software (eQMS) say their quality metrics aren’t properly measured.”- LNS Report
However, if utilized properly, eQMS can help manufacturers inculcate a culture of quality in the organization. Everyone in the organization should speak the language of quality and resources should be calibrated to deliver the highest quality products. eQMS software is optimized for maintaining factory equipment, inspecting raw materials/finished goods, and responding to quality audits. The successful implementation of eQMS can result in enhanced product quality, fewer product recalls, reduced wastage, and lesser warranty claims.
eQMS system offers data integration capabilities that consolidate all the quality-related data onto a unified database and drive improvement across the entire product life cycle. On top of it, eQMS is also conveniently scalable to match the growth of the manufacturing organization. The implementation of eQMS results in the elimination of departmental silos and helps in setting up auto-generated alerts for drawing immediate attention towards quality issues, thus ensuring accountability.
Talking about the culture of quality, ISO 9001:2015 is the primary regulatory guideline that ensures that a specified standard of quality is upheld across the organization. The eQMS software follows the rules specified by the ISO 9001:2015 document so that the process, person, organization, system, resource, and finally, the product meets the required standards. It specifies the primary characteristics for a company’s culture, in order to maintain the quality in business processes, workforce efforts and the final product.
Functions & Features of eQMS
Specific facets of total quality management require specific features to be included in the eQMS system. Below listed are the most important functions of eQMS:
- Non-Conformance – It is important to identify product issues by testing for quality and eQMS helps the organization identify events of non-conformance in following the SOPs. Valid issues are considered for further actions, while invalid issues are terminated on the spot. eQMS also records all the actions taken to correct the non-conformity.
- CAPA – When a non-conformance issue is identified and found to be valid, eQMS initiates the process of improvement. It specifies the corrective actions that need to be taken in terms of change in process and the preventive action required to rework/scrap the product, so that the final product quality is maintained up to the standards.
- Complaint Management – The eQMS software helps manufacturing organizations establish a complaint handling process. The entire complaint management life cycle from documenting the problem, performing root cause analysis, providing timely response to the customer, and triggering internal CAPA is integrated into the eQMS system.
- Change Management – When a process change is required or a CAPA issue is raised, the eQMS system manages and documents the entire change control process. It helps businesses automate the entire change management process starting from initiating change requests, impact evaluation, actual implementation, and culminating with verification and closure.
- Training Management – eQMS helps organizations keep their employees updated with the latest certifications on all controlled documents in the organization. It helps manager identify training needs and keeps track of employee performance throughout the process. The eQMS software can also issue certificates on completion of the training modules.
- Document Management – eQMS manages all the critical documents of the organization from creation to approval & publishing to archival. Along with updating to the latest version of the documents, eQMS also facilitates the removal of obsolete files. It can also create a master list and document map to track document changes.
- Compliance Management – eQMS can help manufacturers by maintaining a clear list of compliance requirements. It automates the tracking and control of compliance-related activities like documentation, planning, reporting, audit, etc. eQMS also simplifies the reporting of non-compliance events to save the company from legislative action.
- Risk Management – eQMS takes a very structured approach to identify, assess, control, communicate and review all the quality risks in the organization. With eQMS, organizations can take actions to ensure that any anticipated problems don’t occur and if they do, have a control mechanism to rectify them.
- Audit Management – eQMS helps organizations conduct internal and external audits to enhance product quality. It can schedule, structure, perform and assess periodic and ad-hoc audits within the specified time frame. The audit management functionality also helps organizations meet industry-specific compliance requirements.
Benefits of eQMS
An eQMS can transform the manufacturing organization in terms of men, machines, materials and methods. Below are the major benefits of an eQMS:
- Improves effectiveness by defining and meeting the organization’s quality goals
- Inculcates quality culture by permeating a quality-based value system in the organization
- Improves data management by creating a central database for a single source of truth
- Improves accessibility by enabling log-in from various access points, like laptops, phones & tablets
- Improves audit by defining tolerance parameters and enabling audit trails
- Increases customer satisfaction by adhering to quality policies and executing processes
- Improves compliance by keeping updated compliance records and automating alerts
- Improves documentation and defines critical processes and objectives
Final thoughts
eQMS focuses on the consistency of the process. It ensures that every time a production cycle is performed, the same information, material, methods, skills & controls are applied in a constant manner. Along with heightened productivity, an eQMS helps prevent costly mistakes, enhance product management, improve risk forecasting and establish quality metrics. Therefore, it is important for organizations to implement an eQMS and BatchMaster’s BM QualityMaster can prove to be a perfect choice.
Get BM QualityMaster today and enjoy the benefits of end-to-end quality management. Feel free to write to us at contact@bmqualitymaster.com, or visit our website to know more about it as well as our other products.
