‘Quality Touches Everything’ Series: Infuse Quality into Your Product Lifecycle

In a recent engagement with a medical device company known for its innovative robotic surgery products, the CQ team resonated with a line that was repeated time and again:

Quality Touches Everything.

The firm experienced a product recall with one of its robotic surgery products - which was much higher than usual. This incident led to a valuable realization: the approach to quality in the design phase had been somewhat informal and not fully integrated. While this scenario presented challenges, it importantly highlighted the company's commitment to world-class quality and patient safety, setting the stage for a transformative journey towards integrating quality more deeply into its product development process, right from the design phase.

This anecdote underscores a crucial lesson: quality cannot be an afterthought. In today's fast-paced and regulatory-compliant environment, especially in sectors like manufacturing, life sciences, and medical devices, integrating quality management into every phase of the product lifecycle is not just beneficial—it's essential.

At CQ, we recently published a whitepaper titled ‘Optimizing Change Management Throughout the Product Development Lifecycle’. In this paper, we highlight the following aspects related to how one of the key issues in the product lifecycle related to managing change:

• Often, a change is planned but it gets “missed out” because it was not put into the process. A quality issue that has been spotted requires a “change” to happen - but the only way to ensure this gets done effectively is by integrating quality management and PLM processes/workflows.
• “Do it right and do it quick” is the best way to approach change management. Sometimes, even though the proposed change is something that was required and asked for by the internal teams, not having a good “change request process” can hinder the process. Implement one to ensure the correct process is followed promptly.
• Fear of the unknown: A known devil is better than an unknown angel is a common saying that fits the change implementation process like a glove. Often, the fear of what could go wrong holds people back from carrying out the changes or seeing it through to its logical end. A change review board can help provide transparency into the change implementation process. It helps to understand the impact and the activities that need to be conducted.

The reason we bring this up here is to emphasize the importance of QMS and PLM processes to operate in a unified fashion. Be it change management, risk management, RCA, and CAPA processes - a "quality touches everything mindset" can be a game changer.

The Challenge of Siloed Processes

Traditional product development processes, often siloed and managed through disparate systems, pose significant risks. They slow down development, introduce errors, and inflate costs. In contrast, a product lifecycle management (PLM) system that integrates quality ensures that products meet the highest standards from inception to retirement.

ComplianceQuest's PLM solution is designed for this very purpose. It offers a cloud-based, collaborative platform that brings together all stakeholders in the product development process.

It is purpose-built to ensure the following:

• Centralization and Data Visibility: A single source of truth for product data and documents, improving visibility and reducing errors.
• Collaboration: Streamlined communication across departments and with external partners, accelerating development cycles. It plays a key role in making sure all stakeholders in the product journey are on the same page.
• Compliance: Built-in compliance with industry regulations, ensuring that products meet all necessary standards before they reach the market.
• Quality Integration: Quality is not just a checkpoint but a foundational aspect of the development process, reducing the risk of costly recalls or failures.

4 Key Pillars of the ‘Quality Touches Everything’ Mindset

Design Quality

At the heart of every successful product is superior design quality. This initial phase sets the foundation for how the product will perform and meet user expectations. An integrated PLM system ensures that quality is embedded in the design process, facilitating early identification of potential issues and enabling design improvements before they become costly or hazardous.

Quality Management for Better Change Management

Change is inevitable in product development. An integrated quality management system (QMS) within PLM ensures that changes are made in a controlled, transparent manner, minimizing disruptions and maintaining compliance. This approach ensures that all modifications enhance the product without compromising its integrity or regulatory compliance.

Proactive Product Risk Management

Identifying and mitigating risks early in the product lifecycle is critical. An integrated QMS enables proactive risk management by systematically analyzing potential issues and implementing preventive measures. This not only ensures the safety and reliability of the product but also protects the brand from the reputational damage associated with product failures.

Supplier and Manufacturing Quality

The quality of a product is also a direct reflection of the quality of its components and the manufacturing process. Integrating supplier and manufacturing quality management within the PLM process ensures that every element of the product, from raw materials to finished goods, meets stringent quality standards. This integration fosters a collaborative environment with suppliers, ensuring that quality is a shared priority and directly contributing to the overall quality of the final product.

These core aspects underscore the importance of an integrated approach to quality management throughout the product lifecycle. By focusing on design quality, change management, risk management, and supplier/manufacturing quality, companies can significantly enhance product quality, safety, and compliance, ensuring success in the competitive market landscape.

To know more, visit: https://www.compliancequest.com/product-lifecycle-management-plm/

Why CQ PLM is the Ideal Solution

Choosing ComplianceQuest's PLM solution means investing in a future where quality touches everything. With its emphasis on integration, collaboration, and compliance, CQ PLM ensures that quality is not a final step but a continuous thread throughout the product lifecycle. This approach not only mitigates risks but also fosters innovation, accelerates time-to-market, and ultimately, delivers products that are safe, reliable, and successful in the market.

To know more, request a demo of CQ’s PLM solution: www.compliancequest.com/online-demo