Customizing SAFe®: Addressing Real Customer Needs with Applied SAFe

Why customizing SAFe® isn’t a violation of the framework—it is a necessity for a compliant Lean QMS.

For Quality Managers and Process Engineers in regulated sectors like MedTech, Automotive, or Defense, the Scaled Agile Framework (SAFe®) often presents a dilemma. On one side, the framework offers a coherent system for business agility. On the other hand, the rigorous demands of standards like ISO 26262, ASPICE, or FDA regulations require specific, auditable processes that “out-of-the-box” SAFe does not explicitly define.

“An effective Framework provides a coherentsystem of elements that work together to achieve a specific set of outcomes.

Implementing these elements in a particular context is the secret to unlocking value.”
– Andrew Sales, Chief Methodologist at Scaled Agile.

In high-assurance environments, that context is also compliance. To achieve agility without compromising quality, organizations must build a bridge between their theoretical framework and operational reality. Here is how to navigate the customization of SAFe® to establish a robust Lean Quality Management System (QMS).

For more detailed information, we recommend viewing the 50-minute webinar by Andrew Sales and Peter Pedross, Founder of PEDCO and creator of Applied SAFe.

Customizing SAFe Video - Recording

Duration: 60 Minutes (40 presentations & 15 questions)

Customizing SAFe goes beyond configuring teams and adjusting PI cadences; it means fundamentally adding new elements to the Framework or modifying existing ones where context demands it. In this 60-minute interactive session, Andrew Sales, SAFe Chief Methodologist, and Peter Pedross, CEO PEDCO, explore when and how to adapt, improve, remove, and extend elements of the SAFe Framework to unlock value in your context.

Andrew will showcase the brand new Customizing SAFe guidance and provide insights on how to apply the ‘four customizing SAFe guardrails’ and how to facilitate a customizing SAFe workshop. Peter will share PEDCO’s Applied SAFe, which they developed specifically as an enterprise solution to customize the Framework. In particular, he will share case studies of global organizations that have used Applied SAFe to create a Lean QMS with traceable changes, role and workflow extensions, and implementation patterns used in regulated industries.

Learning Objectives:

Recognize the difference between configuring SAFe and customizing SAFe, and when customization is needed.
Apply the four guardrails to propose safe, outcome-oriented changes and implement a lightweight process for customization
Recognize the critical role that Applied SAFe plays in supporting organizational-wide customization of SAFe to unlock business results

Introduction: The “One-Size-Fits-All” Myth

For professionals in regulated industries like automotive, defense, or finance, implementing the standard Scaled Agile Framework (SAFe) can feel like forcing a square peg into a round hole. The friction is palpable—conflicting terminology clashes with established corporate language, valuable existing practices seem to have no place, and the critical need to prove compliance to auditors creates constant pressure. This pressure often leads organizations to mistakenly consider abandoning the framework, viewing it as the source of the friction.

However, the solution isn’t to discard a powerful tool but to embrace a disciplined approach to customization. The secret to unlocking the true value of SAFe, especially where quality and compliance are non-negotiable, lies in intelligently tailoring the framework to fit your organization’s unique context. This transforms the framework from a generic blueprint into a high-performance engine calibrated for your specific context.

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1. The Real Secret: Customization Unlocks Value

It is essential to understand that SAFe is a framework, not a rigid, prescriptive process. Its purpose is to provide a coherent system of elements that guide an organization toward specific outcomes. The ultimate goal is always to achieve business outcomes, and this requires thoughtfully selecting and tailoring the framework’s elements to a specific organizational context.

“An effective Framework provides a coherent system of elements that work together to achieve a specific set of outcomes. Implementing these elements in a particular context is the secret to unlocking value.” Andrew Sales – Scaled Agile Inc.

This represents a crucial mindset shift. It moves teams from “doing SAFe” to “using SAFe.” “Doing SAFe” often manifests as cargo-cult behavior—focusing on ceremonies, adhering dogmatically to every role and artifact, and measuring success by compliance to the framework itself. In contrast, “using SAFe” is outcome-driven. It means pragmatically applying the framework’s elements to solve specific business problems and measuring success by the tangible value delivered to the organization and its customers.

Configuration vs. Customization: Know the Difference

Before making changes, it is critical to distinguish between configuring and customizing.

Configuration (Tailoring): This involves selecting options already built into the framework. Which roles do we need? Which ART topology fits our value stream? In Applied SAFe®, this is handled natively with over 520 built-in tailoring options, allowing you to switch elements on or off without breaking the system.
Customization: This describes situations where new elements are added, or default definitions are modified to fit a specific context.
In regulated environments, customization is often unavoidable. You might need to Adapt terminology for government work, Extend the framework to include hardware engineering lifecycles, or Improve processes by integrating specific risk management practices.

2. Your QMS, Reimagined: SAFe as a Lean Quality Management System

For any organization operating under regulatory scrutiny, the primary concern is maintaining a robust Quality Management System (QMS). A traditional QMS often follows a rigid, waterfall model with quality and compliance checked at distinct, after-the-fact phase gates: Requirements complete, Design complete, Critical design complete. This turns quality assurance into a series of costly, late-stage inspections.

With the right approach, SAFe becomes the foundation of a modern, Lean QMS. This reimagined system focuses on building quality and compliance in incrementally, verifying and validating continuously, and ultimately releasing validated solutions on demand. The bridge to this reality is PEDCO’s Applied SAFe, a standard implementation of SAFe specifically designed to function as a customizable Lean Quality Management System. It provides the structure to operate with agility while meeting the stringent demands of regulated work.

“SAFe as a LEAN QMS on how to achieve business agility in a regulatory compliant way -> Applied SAFe”

3. More Than Just Tweaking: The Three Pillars of Meaningful Customization

Effective customization is a structured activity that goes far beyond simply changing terminology. It follows disciplined patterns that allow an organization to adapt the framework to its context, integrate new ideas, and apply its principles to new areas of the business. There are three primary methods for meaningful customization:

Adapt: This involves tailoring SAFe to a specific context, an essential first step to overcome initial adoption barriers and make the framework intuitive within the corporate culture. A prime example is SAFe in Government, where terminology is adapted for the public sector. Concepts like “Mission Owners,” “Mission Innovation,” and “Mission Value” are introduced to align the framework with the unique vocabulary and goals of government agencies.
Improve: This is the practice of integrating other proven, best-in-class practices from the wider industry, ensuring your SAFe implementation doesn’t become an echo chamber. The Sao Paulo Treasury provides a compelling case study. By incorporating quarterly Objectives and Key Results (OKRs) synchronized with their Program Increment (PI) cadences, they created a powerful synergy between strategic goals and execution, leading to a remarkable 296% increase in the number of features delivered or in progress.
Extend: This pillar is the path to true business agility: applying Lean-Agile principles to business operations, breaking down silos between technology and functions like finance, marketing, and HR. Oracle Applications Lab successfully extended SAFe to its core financial and accounting teams. This resulted in the elimination of 54% of manual accounting tasks and enabled them to close the books and report earnings in less than 10 days—21 days faster than the average Fortune 500 company.

Customizing Safely: The Guardrails

When you need to customize—for example, to add a specific “Safety Manager” role or a “Safety Assessment” milestone—it is vital to follow strict Guardrails to ensure you don’t break the agile flow..

We recommend validating every change against four key tests:

Does it enhance agility rather than compromise the essence of SAFe?
Is it the right solution, or just the easiest fix?
Does it amplify outcomes rather than maintaining the status quo?
Does it optimize systemically rather than solving a local problem?

4. Proof in Practice: How Skyguide Flies with a Customized SAFe

To see the power of customization in a highly regulated, safety-critical environment, look no further than Skyguide, the Swiss air navigation service provider. Tasked with establishing SAFe in a context where errors are not an option, they needed a way to blend agile principles with stringent compliance requirements.

Their implementation approach treated Applied SAFe as a “toolbox.” They committed to using as much of the standard SAFe content as possible but strategically adapted and extended the framework where necessary to meet their unique operational needs.

Their customizations included:

Adapting standard SAFe processes to support the special needs of an Air Navigation Service Provider.
Adding company-specific roles, practices, and work products. Crucially, these enhancements were made explicit; any company-specific content was clearly marked with the Skyguide logo, creating an unambiguous visual language for all users.
Creating team-type-specific processes to effectively manage suppliers with different delivery models, accommodating both agile and traditional waterfall approaches within the same framework.

By taking this tailored approach, Skyguide achieved a wealth of powerful outcomes. They implemented consistent, auditable, and compliant processes in just two months and passed the audit in a total time of 4 months. The new model allows departments to collaborate on a common set of deliverables regardless of their chosen lifecycle. Furthermore, the training overhead was remarkably low: just three days of training enabled the process engineering team, and only 1.5 hours of self-learning were sufficient for Agile Release Train members to become productive with their customized SAFe Implementation. -> Read the full report here.

5. The Auditor’s Friend: Design compliance in, do not replicate a standard

A common and dangerous pitfall in regulated environments is attempting to create a process model that is a direct, one-to-one replica of a reference standard like ISO 26262 or Automotive SPICE. This often results in “process theater”—a complex, bureaucratic system that no one actually follows, creating significant risk during an audit.

A far more effective and resilient strategy is to design a company-specific process model that reflects how your teams actually work—”The way we like it.” and how these elements of the QMS support a compliant way of working. This way, the standard requirements become your friend to improve your implementation of SAFe in your own context, and compliance becomes an integral part of your daily work.

This approach is the auditor’s friend because it produces a living, breathing process that people understand and use daily. When auditors arrive, they don’t just see a compliant document; they see a compliant culture and consistent execution, which is far more convincing and resilient to scrutiny. A platform like Applied SAFe is designed to support this exact approach, allowing a single internal process model to be mapped to multiple regulatory standards.

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Conclusion: From Framework to Finishing Touch

Customizing SAFe is not about breaking the rules or dismantling the framework. It is about intelligently applying the framework’s principles and practices to achieve specific goals within a specific context. It is the crucial finishing touch that aligns a powerful blueprint with the real-world needs of your organization.

For enterprises in regulated fields, a disciplined and structured approach to customization is the key. Using tools like Applied SAFe, organizations can transform the framework from a generic guide into a powerful, fine-tuned engine for delivering exceptional value while upholding the highest standards of quality, safety, and compliance.

About the PEDCO Suite

This is why we are excited that PEDCO has broadened offerings to a suite of tools, which can be leveraged to support and propel agile practices for Government applications:

PEDCO AI Companion is a tool which uses artificial intelligence to increase the efficiency and effectiveness of QMS processes.
PEDCO AuditPro is a tool which utilizes artificial intelligence to aid and enhance the auditing process.
PEDCO Applied SAFe® is a customizable Lean-Agile Quality Management System (QMS) software platform. It provides the processes, roles descriptions, work product models, practices for building in compliance, and guidance to propel adoption of the Scaled Agile Framework.

Together, these tools enable a faster ramp up time when pivoting an organization, support a common understanding on the way of working, and foster regulations and safety.

Government agencies face unique challenges such as traditionally waterfall-centric governance and long acquisition lifecycles. The PEDCO Suite can help address these obstacles and enable transition to faster approaches. The Applied SAFe software platform provides a structured approach, framework and guidance to implement Lean-Agile practices at scale. The tool suite helps build a solid Lean-Agile foundation, which is crucial for evolution from traditional project-oriented approaches to a continuous flow of value. In addition, the PEDCO Suite promotes the creation of high-performing teams of teams, which is essential for managing large and complex technology programs involving government employee/contractor collaboration. Furthermore, the PEDCO Suite includes practices and AI capabilities for building in quality and compliance, which are critical in the highly regulated government environment.

To further highlight, let’s explore a success story for one of PEDCO’s aerospace customers who has benefited significantly from their application of PEDCO’s Applied SAFe platform.

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Applied SAFe®: Lean-Agile QMS Reimagined

Bring lean-agile organizations to life

Applied SAFe® is the world’s only implementation of the Scaled Agile Framework (SAFe®) as a comprehensive Lean Quality Management System.

Streamlines SAFe adoption for rapid, efficient implementation
Provides a fully-fledged agile QMS with defined roles, activities, and metrics
Seamlessly integrates portfolio management, value stream mapping, and compliance
Approved by Scaled Agile Inc., ensuring a trusted, scalable framework

Applied SAFe

Cut Down Discussions

2/3

Reduce Cost of Delay

> 2 years

Aerospace Case Study - Skyguide

Skyguide, a leading service organization in civil and military air navigation, embarked on a transformative journey to leverage SAFe (Scaled Agile Framework) for its product development processes. Challenges arose in integrating existing processes, ensuring regulatory compliance, and optimizing efficiency. As such, Skyguide worked with PEDCO, adopting Applied SAFe as a Lean Quality Management System (QMS). They integrated SAFe with their existing process assets while ensuring compliance with Swiss federal laws and European regulations. The realized benefits are inspiring:

Compliance and Efficiency: Achieved 100% compliance with federal laws and European regulations by integrating SAFe processes with their existing process asset library, which includes system engineering practices, tools, work products, and roles .
Process Optimization: Led to cross-department process understanding and significantly simplified workflows.
Customizability and Flexibility: SAFe processes became individually customizable for different teams, ensuring the required flexibility and facilitating better cooperation between business units.
Reduced Reaction Time: Implementing Applied SAFe reduced the reaction time for changes in Agile processes.
Rapid Integration: Integrated existing process assets into SAFe and adopted SAFe processes to support special needs in architecture, deployment and release, safety assessment, and compliance management within just four months .
Self-Sufficiency: Quality management team was trained to lead the further integration Applied SAFe, allowing the organization to execute lean-agile process engineering by itself after just five days of training

It is exciting to see government industries evolve to employ agile practices, and to help cultivate this with the PEDCO Suite which can enable and empower positive transformations. The PEDCO Suite provides frameworks, training, AI navigation and auditing aids to help government agencies optimally progress to Lean-Agile practices.

Skyguide - Applied SAFe in Aerospace

Sykyguide, a service organization for civil and military air navigation services has been using SAFe successfully and it was the wish of the company to leverage SAFe as the primary established product development process. Read in this case study how Applied SAFe was used as a solution to implement compliant SAFe processes, the benefits of the solution, and achieved results.

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The Future of Quality Management

As we look to the future, the combination of agile methodologies and AI-powered tools is set to redefine quality management. The PEDCO Suite is at the forefront of this transformation, offering solutions that not only meet current needs but also anticipate future challenges.

Key Benefits of the PEDCO Suite:

Faster adaptation to changing market conditions
Works with any kind of QMS
For any kind of standard (ASQMS, ASPICE, ISO 26262, IEC 62304, ISO 13485, company specific standards, etc.)
Improved compliance with regulatory standards
Enhanced innovation capabilities
Reduced time and resources needed for quality management processes
Increased accuracy and consistency in auditing and reporting

By embracing these AI-driven tools, companies can position themselves at the cutting edge of quality management, ensuring they remain competitive and compliant in an increasingly complex business environment.

In conclusion, as agile methodologies mature and AI continues to advance, the integration of these technologies in quality management is no longer optional—it's imperative.

The PEDCO Suite offers a comprehensive solution to catapult companies into this new age of AI-driven quality management, enabling them to thrive in the face of rapid change and innovation.