Requirements Traceability Matrix for Manufacturing

Ever asked yourself, what is a requirement traceability matrix? Let’s take a look at requirement traceability matrix meaning in more detail. As we note in our intro, a requirement traceability matrix is a document that shows the relationship between requirements and other artifacts throughout the lifecycle of a product’s development.

In addition, following ISO 9001:2015 standards for accurate traceability through product identification and record-keeping is a necessity for businesses aiming to maintain credibility and demonstrate compliance to both their customers and regulators.

Let’s explore an in-depth view of RTM for the following subsectors:

Automotive Industry Traceability

In the automotive industry, traceability systems are essential for meeting customer requirements and ensuring products meet industry regulations and requirements. Traceability systems help manufacturers ensure and demonstrate compliance with safety regulations, such as ISO 26262 which helps ensure functional safety.

Aerospace Industry Traceability

Traceability in the aerospace industry is also imperative as the smallest flaws in a product can be a huge threat to life. The AS 9100 standard demands traceability from the beginning to the end of the supply chain.

As such, it's a necessity for manufacturers to trace all parts and raw materials and document their processes in depth. This traceability is also important for the maintenance and repair of a spacecraft as it gives engineers and technicians the full history of each component, helping to make repairs and maintenance checks faster and more efficient.

Pharma Industry Traceability

Traceability is important for managing and ensuring that quality and safety standards are met for critical products like medical devices and pharmaceuticals, allowing companies to trace the journey of drugs and devices throughout the entirety of the supply chain. Traceability systems can help ensure patient safety and ensure manufacturers meet standards like ISO 13485.

An RTM is essential for making sure manufacturers connect design specifications and customer requirements with the development and verification of a final product. Traceability in manufacturing and logistics is key for making sure all parts and raw materials are traceable and helps ensure teams meet regulatory requirements and quality standards. This can help businesses avoid potentially expensive product recalls and support them to pass ISO audits.

What are some of the main advantages of the requirement traceability matrix? An RTM provides full visibility across manufacturing processes; connecting design specifications, customer requirements, raw materials, testing, quality and regulatory requirements with the final product.

This gives manufacturing teams deep insights into every aspect of a product’s development and highlights how each component impacts the others. This is important for illuminating any potential issues or bottlenecks quickly and efficiently and helps teams ensure compliance and hit quality control standards.

Beyond these benefits, manufacturing teams use RTMs to help improve efficiency throughout the product development process and ensure accountability.

Let’s review the requirement traceability matrix meaning in more detail.

An RTM is a document that charts the relationship between requirements and other artifacts throughout the lifecycle of a product’s development, giving manufacturing teams a clear roadmap to follow that ensures a product moves through all the necessary stages of product development safely and efficiently.

Who is responsible for an RTM? Often, quality assurance or quality control managers are responsible for putting together an RTM. They frequently request support from design and manufacturing engineers, compliance officers, and supply chain managers.

Here are the main elements of a RTM:

General Information

This section covers the foundational details for each requirement, allowing you to easily identify them and understand their context. It typically includes the Requirement ID, which is the unique identifier given to each requirement. This section provides a description of the requirements. It covers its source, function, and purpose. It also often includes its relationship to and relative importance to other requirements.

Requirement Status

This section shows where a requirement is in the lifecycle, such as proposed, approved, implemented, or verified. This section typically also includes a desired timeline for the requirement to move through each stage.

Requirement Owner

This section outlines who is responsible for which requirement, whether that's one person or multiple. It covers contact details for each owner as well as details on their role. This makes it clear who is responsible for what and how other members of the team can contact owners if they need to.

Acceptance Criteria

This section specifies which criteria need to be hit for the requirement to be considered complete and acceptable. Each criteria is clearly defined, measurable, and easy to test. Each criteria often follows a "given, when, then," format; requiring each requirement to move through the necessary stages and through to completion. This section is important for reducing ambiguity and providing clarity for requirements that reach the acceptance phase, reducing conflicting opinions and misunderstandings between stakeholders.

Potential Risks

This section outlines the potential risks tied into each requirement, such as technical complications or a lack of resources. By outlining prospective risks ahead of time, teams can address any potential issues and put plans in place to help either prevent risks or resolve them quickly and mitigate damage as much as possible.

Test Cases

This section is essential for completing the validation process as it connects requirements to their tests. These tests are essential for helping you verify products and the processes used to create them meet quality standards and regulations. They're also important for demonstrating compliance during an audit. In the manufacturing space, test cases may involve a combination of performance and durability tests and tests on assembly procedures.

Now you understand what a requirement traceability matrix looks like, let’s take a look at how to create one.

Identify your objectives

The first step is to pinpoint your objectives. What do you want your RTM to help you achieve? From helping you to ensure quality standards and meet regulatory requirements to helping to improve the efficiency of your manufacturing processes. Identifying your objectives up front provides clarity to stakeholders and helps make sure your RTM meets your goals.

Decide on components

After setting your objectives, you need to choose your RTM’s components, meaning the types of artifacts you’ll include and how you’ll determine their relationships. Examples include customer needs, design specifications, quality control guidelines, recall information, bills of materials, regulatory guidelines, and test cases.

Define your metrics

It’s important to clearly define your metrics to make sure RTM effectively moves projects forward. For example, some solid metrics include: how many requirements you’ve successfully traced or how many issues you found during the testing phase.

Gather relevant data

For the RTM to successfully guide your team, what data will you need on your requirements and other project artifacts? For example, you may need to collect regulatory documents, test plans, and data from consumer or customer surveys and interviews.

Fill in your traceability matrix

Once you’ve gathered your data, you’ll need to fill in your traceability matrix. To do this, involves creating a table with columns for each one of the above components. Then lay out rows for each requirement, complete with the requirement IDs, and add in all the information you gathered in the above stages. Once this is complete, add in details on the relationships between each requirement and all relevant artifacts.

An RTM is an essential document for helping guide teams throughout the entirety of the manufacturing process. It is essential for helping to ensure quality standards are met, regulatory compliance is adhered to, and for helping teams trace raw materials.