The growth of utilization of technology in QMS provides many advantages but also raises critical concerns. This growth is occurring as a result of technological advancements and changes in the global manufacturing marketplace. While these developments have the potential for increasing customer satisfaction and continuous improvement of business processes they also present added complexity to decision making and cybersecurity.
Industry 4.0, a term used to describe modern manufacturing, has introduced enhanced advancements in automation, Artificial Intelligence (AI), and the Internet of Things (IoT). These technologies enable real-time data analysis, predictive maintenance, and smarter production processes. Robotics have also become an essential part of today’s manufacturing floor. Robotic process automation can be used in dangerous or monotonous production processes to improve safety, efficiency and product quality.
Data Based Decision-Making
An abundance of data allows for nearly instant decision-making when using advanced analytics and AI. This can lead to identifying issues in processes before they become issues, reducing defects and nonconformities. IoT devices allow for increased interconnectedness and monitoring allowing for rapid responses. These advantages can extend beyond the manufacturing floor to insights into supply chain optimization to reduce supply chain disruptions while maintaining quality of raw materials.
Potential Quality Issues
The implementation of technology in QMS processes can change the scope of the overall program. If this change in scope is not effectively documented and relevant revisions made to process procedures the QMS can be out of step. This can create a disconnect at management levels where resourcing decisions are critical. Additionally, a large amount of data, while useful for tactical decision making can obscure the strategic vision that is critical for an organization’s long term success.
Cybersecurity Concerns
Internet of Things and cloud based technology in QMS create risk profiles that should be carefully evaluated before implementation. The number of devices required can create an overwhelming task for already overburdened IT staff. Cyber attacks on IoT devices is on the rise. One in three data breaches occur on an IoT device and 60% of those breaches occur due to outdated software.
Manufacturing companies are increasingly targeted by cyber attacks, particularly ransomware, due to their reliance on interconnected systems and valuable data. These attacks can lead to significant financial losses, operational disruptions, and theft of intellectual property.
Upper Management Commitment
As with any management system, upper management commitment is the key to success. The modern C-Suite must measure and weigh a number of risk factors. Over focus on QMS processes can open the door to cyber vulnerabilities. To much emphasis on cybersecurity protocols can result in a loss of availability of data critical to business processes. All major decisions must be weighed and considered with the long view in mind.
CVG Strategy Consultants
Quality Management
CVG Strategy quality consultancy team can help your organization implement an integrated business management system effectively and painlessly. Our consulting services will guide you through all phases of QMS, from assessment and development to the certification process.
CVG Strategy also provides the inclusion of statutory requirements for export compliance into your program. Ask our experts how we can provide this feature into your quality management system. Additionally, CVG Strategy can provide you with Quality Management training courses that will empower your team to achieve in a QMS environment.
CVG Strategy has experience in a large number of quality management systems standards. In addition to ISO 13485:2016 our Global Exemplar Lead Auditors can assist you designing and implementing a QMS to the following standards:
- AS9100
- ISO 27001
- BS EN 13485:2016
- FDA Title 21 Part 820
- EN ISO 14971:2019
CVG Strategy can provide a QMS that incorporates multiple quality standards. This includes incorporating management strategies for ensuring compliance to industry regulations such as EU Directive 98/79EC for medical devices.
CVG Strategy Export Compliance Solutions
While many export compliance providers offer programs geared toward compliance with a single set of regulations, CVG Strategy offers a harmonized program that will ensure that your company is compliant to ITAR, EAR and international regulations. Furthermore we consolidate this program in a collection of documents that can be integrated into a quality management system.
Cyber Security Consulting
CVG consultants have over a decade of experience with ISMS, Quality Management Systems (QMS) and Export Compliance. We understand that each business has a unique set of requirements that demand tailored solutions.