How to verify and validate prototypes and products 

When we say testing, we often mean both verification and validation, as it may appear to be a subtle difference between the two terms. In fact, there is a crucial difference. Validation answers the question “Are you building the right thing?” and verification “Are you building it right?”. 

In this blog post, I sort out the terms and each process involved–and how PTC Codebeamer adds value and simplifies for all stakeholders involved.  

You can also join us on the 14th of June for our webinar where we will have a closer look at requirements management and the connection to PLM. Together, we will have a closer look at the requirements management tool, Codebeamer, and discuss how it can help in the daily business. Register for the webinar here – Requirements Engineering in the Mechanical World

The six steps of requirement management 

The process of verification and validation is an integrated part of the overall requirements management. It can be boiled down to six steps: 

1. 1. Identify stakeholders. 
   2. Collect, analyze, and document initial requirements from stakeholders. 
   3. Agree on and approve requirements. 
   4. Continuously communicate with stakeholders. 
   5. Revise requirements, assess the impact, and document changes. 
   6. Verify and validate requirements. 

 I will focus on the last step of the list, verification and validation (V&V), and how Codebeamer is a powerful tool in keeping track of, organizing, and documenting the V&V. But I want to stress that it is not the last step in a linear process. This is a continuously ongoing process, where all steps intertwine. 

A definition of validation of verification 

The Project Management Body of Knowledge Guide (PMBOK guide), a standard adopted by the Project Management Institute (PMI), defines validation and verification as follows in its 4th edition: 

• “Validation. The assurance that a product, service, or system meets the needs of the customer and other identified stakeholders. It often involves acceptance and suitability with external customers. Contrast with verification.” 
• “Verification. The evaluation of whether or not a product, service, or system complies with a regulation, requirement, specification, or imposed condition. It is often an internal process. Contrast with validation.” 

(Source: Wikipedia) 

Here’s a breakdown of each process: 

Verification 

• Design Verification: Here you confirm the product design meets the specified requirements. Include checks and reviews to ensure that the design documents, specifications, and plans are accurate and complete. 
• Component Verification: Before assembly, you need to verify that individual components or parts meet quality standards and specifications. You may do this by measuring, testing, and inspecting the components. 
• Process Verification: Verification also extends to manufacturing processes themselves. Here, you ensure the processes can consistently produce products that meet quality requirements. When verifying the process, you may test equipment, calibrate tools, and monitor process parameters. 
• Documentation Verification: To ensure accuracy and completeness, you must verify all documentation related to the product, including drawings, specifications, and procedures. 

With test coverage reports, Codebeamer shows the traceability, from the requirements (stakeholder requirements, quality standards and specifications) to the test cases, and shows the corresponding results, reflecting one or more test runs.  

Validation 

• Product Validation: Here you confirm that the final product meets the user’s needs and intended use. You can do this by testing prototypes or samples under real-world conditions to ensure they perform as expected. 
• Process Validation: Validation also applies to manufacturing processes. In this step, you ensure you can consistently produce products that meet quality requirements. You may conduct trials, analyze data, and adjust the process. 
• Regulatory Compliance Validation: In industries with regulatory requirements (such as medical devices or automotive), you ensure products meet regulatory standards and requirements set by relevant authorities. 
• User Validation: In some cases, you may let users or stakeholders validate your products to ensure that they meet usability and functionality expectations.

The seamless integration with Codebeamer and PLM Windchill allows to define which products/prototypes you will validate from the test cases. In general, Codebeamer can help you handle different verification and validation processes. It enables traceability through the entire process and documents the results. 

Documentation and reporting 

• Maintain detailed documentation throughout the verification and validation processes. This includes records of tests conducted, results obtained, deviations encountered, and any corrective actions taken. 
• Generate reports that summarize the outcomes of both verification and validation. These reports are important for demonstrating compliance with quality standards, regulatory requirements, and customer specifications. 

 With different reports, like test coverage reports, Codebeamer tracks the status of the verification and validation process. If it discovers an issue during the verification and validation phase, defects can be created to document what went wrong and plan additional actions. 

Continuous improvement 

• Once again: Verification and validation are not one-time activities but are ongoing throughout the product lifecycle. Identify how you can improve both the product and the manufacturing processes by getting feedback from verification and validation activities. 
• Continuous improvement efforts aim to enhance product quality, increase efficiency, and reduce costs. 

 You can execute a test run several times in Codebeamer, to continuously track the development and changes of the product. 

Overall, verification and validation are critical in ensuring that your products meet quality standards, regulatory requirements, and customer expectations. These processes help mitigate risks, improve product reliability, and enhance customer satisfaction. 

Agile Development with Codebeamer – MedTech – Case study

An interesting case study that was made with the Neuromodulation department at Medtronic, a global leader in medical technology, describes how they adopted Codebeamer to address challenges that their previous software ecosystem couldn’t efficiently handle. This transition allowed them to move from legacy systems to state-of-the-art solutions and processes.

You can read the entire Case Study here – Medtronic Case Study

If you want to learn more about the benefits of ALM you can read my other blog – How you can benefit from ALM

Johan Adelgaard,

Head of Sales & Marketing PDSVISION Nordics