.svg) # Should You Change Your Process Before You Update Your Tooling? Jake Stowe October 16, 2024 ## Table of Contents 1. [Catalysts for procedure improvement](/content/blog/process-and-tooling#catalysts-for-procedure-improvement/index.html) 2. [The problem with updating procedures in a silo](/content/blog/process-and-tooling#the-problem-with-updating-procedures-in-a-silo/index.html) 3. [Understanding the connection among procedures, people, and tools](/content/blog/process-and-tooling#understanding-the-connection-among-procedures-people-and-tools/index.html) 4. [How to work toward an integrated approach to quality management](/content/blog/process-and-tooling#how-to-work-toward-an-integrated-approach-to-quality-management/index.html) 5. [The benefits of an integrated approach to quality management](/content/blog/process-and-tooling#the-benefits-of-an-integrated-approach-to-quality-management/index.html) 6. [Laying a foundation for continuous improvement and operational excellence](/content/blog/process-and-tooling#laying-a-foundation-for-continuous-improvement-and-operational-excellence/index.html) 7. [How Ketryx facilitates operational excellence](/content/blog/process-and-tooling#how-ketryx-facilitates-operational-excellence/index.html) 8. [It’s time to transform your quality approach](/content/blog/process-and-tooling#its-time-to-transform-your-quality-approach/index.html) Many companies are actively improving or developing a plan to improve their quality management system (QMS) procedures... Let’s explore why an integrated approach to quality management is superior to working on procedures in a silo. ## Catalysts for procedure improvement There are two main reasons why an FDA-regulated company might be actively revising (or thinking about revising) its quality procedures: 1. **Continuous improvement**: As the company’s products evolve, opportunities emerge to make the software manufacturing process better (e.g., faster or higher quality). 2. **Inadequate procedures**: An internal or external review may determine that the organization’s procedures are insufficient. The worst-case scenario is if this comes to light when a company fails an FDA audit or is subject to an FDA medical device recall. To avoid scenarios like reason number two, organizations should focus on number one — continuous improvement... ## The problem with updating procedures in a silo Let’s consider a fictional example of a medical device software company, Acme Corp, that recently decided to update its QMS procedures. The organization had been using the same QMS procedures for years and after a recent internal audit, leadership tasked the quality team with rewriting these procedures as soon as possible... Had they taken a holistic approach, involving all stakeholders and upgrading their tools alongside the updated procedures, they could have created a much better environment for continuous improvement. ## Understanding the connection among procedures, people, and tools As you can see, quality procedures don’t exist in a silo. To build a high-performance software manufacturing process, you must consider the interplay among three critical elements: the procedures that control product development, the people who must follow those procedures, and the tools that help them do their jobs... This is because outmoded tools are not connected or synced and, therefore, require a great deal of manual copying and pasting. ## How to work toward an integrated approach to quality management To create an effective quality management system that connects procedures, people, and tools, companies must adopt a structured approach. Here are four steps to guide you through examining and improving your end-to-end process: 1. **Assess current procedures, people, and tools together**: Identify bottlenecks, inefficiencies, or areas of friction in how people execute procedures and how well the tools support their work. 2. **Consult cross-functional teams**: Engage stakeholders across engineering, quality, regulatory, and operations to discuss how current processes impact their work. 3. **Modernize your tooling**: Outdated tools that require manual updates or lack integration between systems can slow down your team and create compliance risks. 4. **Gather feedback for continuous improvement**: After deploying new procedures and tools, establish a continuous improvement cycle. ## The benefits of an integrated approach to quality management While establishing and maintaining an integrated approach to quality management certainly takes some work, the rewards are worth it. Well-aligned procedures, people, and tools yield benefits such as: - **Faster time to market**: Teams can develop, test, and deploy software more rapidly. - **Lower safety risk**: When the release cycle and verification and validation (V&V) activities are properly in sync... - **Improved efficiency**: Automation that guarantees everyone follows the proper SOPs reduces the need for manual intervention, allowing teams to focus on higher-value tasks. Ultimately, an integrated approach to quality management will help a business achieve operational excellence... ## Laying a foundation for continuous improvement and operational excellence If your company struggles to update its QMS procedures or feels restricted by current procedures, there are certain factors you should keep top of mind when building a foundation for continuous improvement and operational excellence. One major factor is a product’s risk classification... For instance, they might rationalize who has to perform certain reviews... Finally, the company practices continuous improvement to reach the desired release schedule... ## How Ketryx facilitates operational excellence It’s difficult to overstate the importance of modern tools in speeding up development while ensuring a high level of quality. Most MedTech companies are using antiquated tools that cause them to leak cycle time in two main places: 1. They must manually maintain alignment between systems. 2. They manually verify that teams have followed procedures correctly. ## It’s time to transform your quality approach Revising procedures in isolation from the people who execute them and the tools that support them only delivers a fraction of the value compared to an integrated approach. A connected lifecycle management platform offers a streamlined, holistic path toward integrated quality management that ensures quality and development teams are always on the same page and working toward the same strategic goals.