Modern Enterprise-Wide Quality management System beyond PLM

Nov 09, 2022
Why Do Businesses Need to Consider Plm Investment?
A holistic quality approach links the supply chain to existing aspects of quality management. Innovation isn’t slowing down, and the majority of industries are streamlining supply chains to increase speed to market, keep costs under control and manage the production of complex devices, that’s why the ability to implement a robust enterprise quality solution is needed to define, identify, analyze and correct quality issues/events, to implement safe and effective quality solutions
Swetha Makineni
Swetha Makineni

Senior Solution Architect


However, ensuring consistently high levels of quality across the entire product cycle requires systems and solutions that address quality issues across the board. The capacity to identify, verify and revise nascent quality issues must be quick, and extend to all corners of the enterprise. Putting this into practice would require a closed-loop, cloud-based, enterprise quality management solution that is not only limited to product development but can also work to address quality issues arising across the entire supply chain and downstream applications.
Looking Beyond Product Development
It is all too common for manufacturers to approach quality control with a narrow vision, one that often only looks at the product development process. At first glance, this might not seem problematic, but when examined in light of the rule of ten (which states that the cost of a problem becomes exponentially higher as it is discovered at a later stage in the manufacturing process ), it assumes much higher importance.
However, if manufacturers were to temporarily look beyond this and seek to implement a quality system that would facilitate the identification of quality issues (Customer Complaints/Non-Conformances) at an early phase, implement corrective and preventive actions, perform Audits and further integrate the right quality information between systems, then various technical and economic benefits can be achieved at an earlier phase, which in turn will compound profits across the entire product value chain.
Quality is no longer synonymous with product integrity alone: instead, it is a company’s on-going commitment to excellence across all the departments, individuals and processes involved in developing the product (including sustainability, regulatory requirements, quality enforcement, cost reduction and efficiency, prevention of failures, standard reporting, lessons learned and know-how transfer, etc.). Traditionally, companies have managed quality internally, relying on in-house teams that mostly use static quality documents or isolated applications for quality management tracking. However, businesses have begun to feel the need for something more robust to manage their ever-expanding and increasingly complex business requirements. This shift has given way to smarter modes of managing quality, in the form of EQM.
Assessing Enterprise Quality Management Systems and beyond.
Any chain is only as strong as its weakest link. This analogy applies equally well to the modern supply chain, and there is no better way to take stock of existing quality control management systems than to take a long, hard look at the potential areas of failure. Any organization in the manufacturing business must constantly be on the lookout for two things: risk and quality. How do the existing quality processes mitigate risk? How effective are existing systems when it comes to responding to a quality-related crisis? These are some of the first questions that organizations need to ask themselves.
Beyond initial impressions, it would do well to look at the collaborative aspects of the existing system. Understanding the extent of visibility into all aspects of quality, evaluating approaches for continuous improvement, and knowing how quality integrates with the overarching business process would reveal the strengths and weaknesses of the existing manufacturing setup.
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Oracle's Quality Management Cloud provides a unified platform for enabling quality visibility, collaboration, and execution.
The key focus of Oracle Quality Management is to provide quality teams with enterprise level quality control, guide users with quality issue resolutions, implement corrective and Preventive actions, facilitate inspections at critical points throughout Supply chain execution and a closed-loop quality management system.
Closed-loop Quality Management
To understand closed-loop quality management, it is necessary to first look at the existing quality management frameworks that are currently employed within an organization. From start to finish, a product launch will go through the following phases: design and R&D, procurement, manufacturing operations, and service/customer complaints. For a product to be truly successful, each stage must go without a hitch, and problems, if any, should be corrected almost instantly.
A closed loop management system seeks to remedy this by reducing conversation silos, connecting product results from the field to upstream functions, and stitching together the PLM, the SCM, CRM, and field service management platforms. It puts a wrap on all of this by bringing quality and regulatory requirements and processes such as non-conformances, corrective and preventative actions (CAPAs), SCARs, and electronic instructions for use (eIFUs).
Implementing a Closed-loop Integrated Enterprise Quality Management System
A New way of thinking has emerged as companies embed quality processes across the product value chain and QMS interoperability to improve overall successful new product introductions, and release products in compliance . Manufacturers who already have a PLM framework in place should be given some credit as it indicates their commitment to product quality. However, ‘closing the loop’ in the quality management system requires a few other steps to be implemented:
  • Prioritize closed-loop quality management: Product quality can improve only when it is an enterprise-wide initiative. Everyone, from the CEO to the assembly line worker must pedestalize product quality and orient their actions accordingly.
  • Inculcate proper business capabilities: To ensure that strategy and technology investments work as intended, the company must have the right systems in place. Investing in automated data collection systems, real-time monitoring of adverse events, analytical tools, and role-based visibility is required for a closed-loop quality management system.
  • Invest in PLM and Quality management interoperability: PLM and QMS interoperability is a technology strategy that demonstrates a high correlation with world-beating performance. Implementing such a strategy catapults quality management from a mere business function to an enterprise-level business process.
  • Synergies between strategy and technology investment: High-performing organizations prioritize aligning their strategy with technology investments. In the context of a closed loop management system, this would translate to improving transparency and quality control across product innovation, manufacturing, and supply chain operations.
The Future of Enterprise Quality
Collectively, organizations are at a unique point in history where they not only need to change their outlook toward quality but also have the tools to revamp their processes in a matter of months. For several companies, the first step in this journey would be to start moving more of their processes into the cloud and stitch all processes together to ensure a cohesive quality management system. This would not only lead to companies realizing better quality within the company but would inevitably translate to lower operational costs, increased goodwill, and greater profits.
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