The Tier 1 Validation Advantage
A validation strategy is required to create the logic and evidence that the manufactured product conforms to the declared properties. By creating a structured approach to validation, Tier 1 aims to create a simplified, repeatable, and cost-effective Additive Manufacturing validation strategy, which helps our partners spend more time creating innovative product designs.
A robust validation strategy is as important as an optimized design or process. It should align with the requirements of regulatory bodies and standards organizations, and when designed well, will accelerate time to market and facilitate future product launches. A good validation strategy will also assist in the day-to-day management of processes by defining the testing and revalidation requirements for process changes. Conversely, a weak validation strategy presents serious risks to your product quality, your business and your ability to sell product into your target markets. This risk is particularly acute with new technologies such as Additive Manufacturing, where processes and technologies are continually evolving and experience of implementing at scale is rare. Given that additive technologies create both the material and geometry of the product, the consequences of producing out of specification can be severe.
At Tier 1, our validations start with our documentation framework, which defines the documents that constitute the validation, their relationship to each other, and the intended audience for each document. Our approach to validation is the result of 20 years of experience in launching and maintaining additive products into serial production for global regulated markets.
Read on to see how your additive process aligns with ours and contact us if you’d like to discuss more.
Creating a Structured Validation
Our philosophy at Tier 1 is to create a framework for all the documents required in a validation and defines which user communities shall access them. The framework provides an overview of the validation logic and is easily accessible by the different groups that interact with it. It also defines which users may be expected to access the different documents and provides guidance on the style and controls required. Tier 1’s approach is to create a framework in 3 levels, which reflect the different uses for the documents as shown in the figure below. The content specifics may vary by industry.
The Level 1 documentation is the definitive set of reports and studies that describe the released process, the manufactured material properties, and how they relate to the product. These documents reflect the process and its outputs in their validated production state and remain unchanged unless a change occurs in the end-to-end process that initiates revalidation.
The unique nature of additively manufactured material and how it relates to product performance is also captured here. This includes addressing factors such as anisotropic material properties, variations in raw material properties, the impact of variations of build platform design, and the relationship between manufactured products and Quality Control strategy. This approach can also be implemented on highly novel materials that may be created using Additive Manufacturing which may not be covered by existing standards.
Importantly, level 1 documents may be made available to outside organizations, which may include regulatory bodies, and as such the language and content needs to be carefully considered. For example, the language and scope of the documents should be different depending on if they are used for a one-off product or an entire product family. This is where Tier 1’s experience and skill can help our partners create efficient and leverageable validations. There are clear time and cost benefits if the effort involved in creating a product and process validation can then be leveraged by subsequent products, or if the scope of the validation includes potential updates to the manufacturing process.
The Level 2 documentation describes the process control strategy and its validation. At Tier 1, we have developed a methodology where we map the end-to-end process, identify all potential critical process variables, and capture the impact of these variables on the final product or material. This process analysis is combined with process risk documentation to understand the validation or verification requirements during the manufacturing process.
Level 2 documents are often live documents that are used to manage and maintain the day-to-day process and need to be structured to be accessible to a broad range of disciplines.
The Level 3 documentation describes the R&D efforts that support the derived process operating windows. These documents are typically for internal use only and are the platform for process improvement and updates. They may also be used for product disposition should the process experience an unexpected event, for example, how to disposition product in the event of an out-of-specification heat treatment cycle.
We hope this article has provided insight into Tier 1’s approach to process validation has been informative and thought-provoking. We are passionate about advancing the use of additive manufacturing and don’t hesitate to contact us if we can further support your additive validation questions.