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.  

Customization with Applied SAFe®

It‘s common that in larger companies a lot of practices and standard operating procedures already exist. It‘s also common that different life cycle models are concurrently executed in the same company. Because of this, Applied SAFe® already comes with strategies, concepts, and guidelines on how such integrations and extensions can be done.

  • Use the included and comprehensive ‘Applied SAFe® Process Modeling Guideline’ to extend and adapt Applied SAFe® with your company specific processes; save months to define such a modeling guideline.
  • Work with SAFe® add on processes in order to professionally manage your process development, assessment, deployment, and governance.
  • You get all the content of SAFe (texts and images) with the right to use and change them, even if you need to translate to different languages

Applied SAFe® is also capable of making use of various life cycle models. As proposed by SAFe®, teams can run with Scrum as an agile method; additionally, it‘s possible to coexist with other life cycles by synchronizing via the Agile Release Train. Teams can choose their life cycle depending on their needs and their agile readiness. This solution has the advantage to let some teams smoothly adopt Agile, while other teams could choose other life cycles to work with; such as for example the V-Model, Disciplined Agile Delivery (DAD), iterative or waterfall.

Interested in Compliance? We created mappings from Applied SAFe to various reference models like CMMI, Automotive SPICE 3.0, IEC 62304, CTR-180 (FDA) and more. It’s our concept to enable you to do this mapping by yourself. However, if you don’t want to do this customization by yourself, we will help you to adapt the standard process implementation to your needs.

ACTUAL, CONCRETE EXAMPLES

The sections below contain screen shots of the actual implementation of Applied SAFe®, they serve as testimonials of what the product looks and feels like.

PEDCO AG is a proud collaboration partner of Scaled Agile Inc.

SAFe® and Scaled Agile Framework® are registered trademarks of Scaled Agile, Inc.

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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:

  1. Recognize the difference between configuring SAFe and customizing SAFe, and when customization is needed.
  2. Apply the four guardrails to propose safe, outcome-oriented changes and implement a lightweight process for customization
  3.  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:
  1. Does it enhance agility rather than compromise the essence of SAFe?
  2. Is it the right solution, or just the easiest fix?
  3. Does it amplify outcomes rather than maintaining the status quo?
  4. Does it optimize systemically rather than solving a local problem?

4. 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.

Customizing Applied SAFe - Examples from the real world

The following details explain customization with Applied SAFe®.

Process Engineering

Integrate, adjust and extend Applied SAFe based on concepts like workspace hierarchies, effective use of process types for a number of deployment strategies, inheritance mechanisms for process elements, process model extensions with your existing and new process assets, and more.

With Applied SAFe you are able to:

  • Change all elements of Applied SAFe (logo’s, pictures, colors, models, etc.)
  • Extend Applied SAFe® and integrate existing company processes
  • Engineer new processes with the building blocks as defined in Applied SAFe®
  • Enhance the model in the spirit and architecture of Applied SAFe® including using, altering the Applied SAFe® Modeling Guideline
  • Understand the process types to integrate core processes, branch and merge process versions
  • Adapt tailoring, adoption of processes and tailoring questions/answers
  • Integrate new and existing reference models such as ASPICE, CMMI, ISO 26262, and more
  • Ensure compliance of processes
  • Understand the use of different alternatives for process quality checks
  • Version and release processes including state management

This is normally done by Process Engineers, Quality Managers, and/or the Lean Agile Center of Excellance (LACE) team. They would also be providing the possible tailorings and/or extending Applied SAFe with their own processes. If this is something you would be interested in then you would need to take the Applied SAFe Quality Manager and the Applied SAFe Process Engineer trainings.

Applied SAFe Meta Model_5.0

Editing Process Models and its contents

The process and its model shall be edited and modeled in conjunction with domain and process architecture. You can either add and enhance the model with additional content or you can change the existing content of Applied SAFe.  The Applied SAFe modeling guideline is a comprehensive part of Applied SAFe for this purpose.

Process Engineers

  • All modeling activities are executed by the nominated process engineer.
  • Creation and/or deletion of any element in relation to a process area whether in terms of  processes, activities, process steps, work products, guidelines, checklists and templates must be consulted with the process manager(s) or the Quality Manager.
  • No process engineer shall invent a new or delete a process area content by himself.

Process Managers

In larger organizations, it is common that for every process area, a specific process manager role is established. This role leads a small group of process engineers changing the process in the large.

  • An exception exists for the description of activities, where the process manager himself is directly responsible for editing the content.
  • A process manager is limited to alter the inputs/outputs and role responsibilities of activities by using existing work products/roles.
  • Creation of new work products or all other changes to the process model shall only be executed by the process engineer after consulting domain, process, architecture and process owner.

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.

Compliance Mapping

Have the ability to map your processes against one or more reference models such as:

  • Maturity models developed as a quality gage by industry and standardization committees
  • Industry Standards
  • In-house standards within an organization

Widely used maturity models for evaluating process quality include the following: ISO 26262, IEC 61508, IEC 62 304, Automotive SPICE, CMMI (Capability Maturity Model Integration).

As previously mentioned, it’s our concept to enable you to do this mapping by yourself. However, if you don’t want to do this customization by yourself, we will help you to adapt the standard process implementation to your needs.

Learn more about compliance here

Ready to unlock the key to your Digital Transformation?

Get more information on PEDCO Applied SAFe features, scaled agility, and compliance.
REQUEST A FREE DEMO