Should You Change Your Process Before You Update Your Tooling?

Many companies are actively improving or developing a plan to improve their quality management system (QMS) procedures. This is a good thing on the surface; however, these businesses often don’t rewrite procedures to account for the objectives of other departments, and they don’t bother to upgrade their tooling to make this work easier because the current system seems to work well enough. 

Organizations undergoing digital transformation are missing an opportunity to decrease their time to market and improve quality by optimizing their procedures, people, and tools together. 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. Of course, the main purpose of quality management is to maintain quality, but it also serves to improve quality and/or efficiency wherever possible. 

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. However, they tackled this project without consulting other departments like engineering or reviewing the tools used by their teams. They believed the process was primarily a compliance issue and assumed that updating the procedures alone would solve any issues.

As a result, the quality team made changes, such as tightening the documentation process for change requests, assuming this would improve traceability and compliance. However, they didn’t account for the manual work required to fulfill these new steps or how their outdated tools would hinder developers from easily implementing the changes.

This siloed approach led to a few key issues:

1. Increased workload for developers: Developers found themselves spending significantly more time documenting changes manually because the tools they used weren’t integrated with the broader project management system. Instead of focusing on coding and testing, they were bogged down by administrative tasks, which led to frustration and slower development cycles.
2. Misalignment across teams: The quality team’s new procedures didn’t take into account how the engineering team worked on a day-to-day basis. This created friction between the teams, as engineers now had to navigate procedures that didn’t match their workflows. For example, the new process required multiple approvals for even minor changes, which caused unnecessary delays in product development.
3. Decreased morale and efficiency: The extra manual work, combined with a lack of coordination between departments, started to affect the overall efficiency and morale of employees. Developers were frustrated with having to adapt to new procedures that seemed disconnected from their actual work, and quality managers were disappointed when their new processes weren’t followed correctly or were seen as burdensome.

Ultimately, Acme Corp didn’t achieve the improvements they’d hoped for. 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. These elements all interact with each other in a complex process that unfolds over months, even years, to bring a product to market.

Companies undergoing digital transformation often want to focus solely on updating their procedures to "catch up" to the current environment of people and tools (e.g., evolving organizational structures and new tools available to the industry). But they will only be able to achieve marginal improvements compared to competitors who decide to take a more holistic approach. 

For example, if a company continues to rely on legacy tools like spreadsheets or document-centric systems, it will constrain its ability to write procedures that are well-integrated with other processes and systems. This is because outmoded tools are not connected or synced and, therefore, require a great deal of manual copying and pasting. And, if quality teams update procedures with just their own quality and compliance objectives in mind, they will lack alignment with engineering, operations, and other key functions that may have other priorities, such as increasing speed and time to market.  

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. For example, are there manual steps that could be automated or are people following processes that no longer fit with their current workflows? 
2. Consult cross-functional teams: Engage stakeholders across engineering, quality, regulatory, and operations to discuss how current processes impact their work. Encourage open dialogue to identify where misalignment exists between departments. This collaborative approach ensures that everyone’s challenges and priorities are understood, which will help create procedures that work for all teams and not just a single department.
3. Modernize your tooling: Outdated tools that require manual updates or lack integration between systems can slow down your team and create compliance risks. After mapping out inefficiencies and setting agreed-upon goals, explore modern, connected tools that automate routine tasks like documentation and traceability. Integrated tools should align with your procedures, enabling teams to focus on high-value work rather than administrative burdens. 
4. Gather feedback for continuous improvement: After deploying new procedures and tools, establish a continuous improvement cycle. Regularly gather feedback from teams on how well the new processes are working. This allows you to make iterative improvements and quickly address any issues that arise. 

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. They can also launch small iterations quickly, putting out dozens of small releases per year rather than one major release requiring long periods of development. 
• Lower safety risk: When the release cycle and verification and validation (V&V) activities are properly in sync, teams can take comfort in knowing that there is comprehensive test coverage to ensure the safety and efficacy of all critical functionalities and features. 
• Lower regulatory risk: Regimented processes with audit trails allow teams to quickly identify the root cause of a failure and fix problems when they occur. A real-time requirements traceability matrix allows the company to stay audit-ready and prove that everyone took the proper steps in the appropriate order. 
• Improved efficiency: Automation that guarantees everyone follows the proper SOPs reduces the need for manual intervention, allowing teams to focus on higher-value tasks. The increased productivity and shorter development cycles also mean that resources are used more efficiently, resulting in cost savings.

Ultimately, an integrated approach to quality management will help a business achieve operational excellence — a state of operating with greater speed and agility while making fewer errors and delivering products that have a demonstrable positive impact on people. 

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. This informs how you prioritize speed and quality across the product lifecycle. Of course, you want your product to be of the highest quality possible, but there is a difference between developing a class III medical device like a pacemaker (which has extremely stringent quality processes and must be perfect upon initial release) vs. a mobile app used to count calories (which can prioritize agility and speed because minor imperfections can be quickly fixed after release). 

In addition to risk classification, you must also have a firm understanding of your organization’s high-level objectives around which your procedures, people, and tooling should be tailored. For example, let’s say a company developing an app that analyzes biomarkers to help people optimize their sleep wants to reduce its release cycles from 12 weeks to four weeks. To achieve this objective while accounting for risk, they should first identify the potential negative consequences their app could have if not developed properly (e.g., recommendations that worsen sleep quality, misdiagnosis of sleep disorders, customer data breaches, etc.). 

From there, the quality team writes procedures that prevent these negative consequences while allowing everything else to move in an agile manner. Ideally, this would include collaborating with developers to identify and streamline tasks with the highest cycle times. For instance, they might rationalize who has to perform certain reviews — instead of involving stakeholders from marketing, engineering, product, quality, etc., they could pare it down to just engineering and quality. Modern tooling can help teams optimize these processes with far less manual work. 

Beacon Biosignals used Ketryx to reduce documentation cycle time by 75% and shorten release cycles from four weeks to two weeks while significantly enhancing documentation quality. Read more here.

Finally, the company practices continuous improvement to reach the desired release schedule. They observe where the process breaks down or has inefficiencies (e.g., integration issues with custom-built solutions for traceability) and then use that feedback to further optimize the processes, people, and tools involved.  

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. Highly skilled (and highly paid) professionals spend a lot of time copying and pasting information from one system to another, when their efforts should be going toward much more valuable, complex problem-solving. 
2. They manually verify that teams have followed procedures correctly. 

Ketryx solves these challenges by connecting your existing QMS and dev tools, eliminating error-prone copying and pasting from previously siloed systems. It also embeds engineering controls that automatically enforce your procedures and ensure the right steps are taken in the right order. This is crucial, as global companies with large development teams working concurrently on many different features across many different product versions are often massively slowed down by manual enforcement of QMS procedures (which also introduces unnecessary risk).  

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. 

Ketryx dramatically simplifies the lives of QA/RA professionals and developers, assuring organizations that things are happening as they’re supposed to, in a verifiable way, and providing evidence that demonstrates compliance. Want to learn more?

‍Watch Empowering the SDLC Process with Tools to Bridge R&D and Quality to learn how QA/RA professionals and software developers can foster a collaborative environment through improved understanding, processes, and tools.