Certainty can be a rare commodity in manufacturing from the manufacturer’s perspective. Volatility can affect the supply chain practically without warning, competitors can introduce game-changing products and consumer tastes can change seemingly on a whim. But when it comes to the quality and effectiveness of the processes manufacturers use in their facilities and what they produce, certainty is crucial. This is what makes process verification and process validation essential components of success in the manufacturing sector.
Even though they sound like two terms for the same thing, process verification and process validation are subtly different but equally important. Without both elements in place, manufacturers risk overlooking defects until corrective action is no longer feasible. Understanding what makes each procedure unique and critical ensures smooth manufacturing operations.
What is process verification?
In short, continuous process verification is the means through which a manufacturer determines specifications are being met by a specific process within its operations by focusing on documentation, inspections, testing and audits. For example, if a part must be produced with a width of 50 millimeters, the manufacturer checks machine calibration records to verify that the equipment is configured and calibrated to produce parts of that specific width. This applies to meeting regulatory requirements as well as product specs.
What is process validation?
Whereas process verification determines whether a process can produce a single product that meets specifications and requirements, process validation testing is concerned with ensuring that the process can accomplish this more than once. The purpose of process validation is to make sure the results of the process design are repeatable and consistent, as well as to determine how to preserve that consistency in the event one or more specs change. This involves studying statistical data, long-term performance analysis and conducting trial runs. An example would be checking a new welding process to make sure it is capable of meeting strength requirements across multiple production runs.
Key differences in process verification vs. validation
There are four key categories in which continued process verification and process validation differ from each other:
- Timing: Verification typically happens during setup and implementation of a process, while validation is done after implementation to check its reliability.
- Scope: The key question asked in verification is, “Are we doing this right?” On the other hand, the main question answered by validation is, “Does this process work consistently over the long term?”.
- Focus: The simplest way to express it is that verification focuses on checking compliance with specs, while validation assesses the effectiveness of the process in real-world use.
- Documentation: Both verification testing and validation depend on detailed reporting, but validation typically involves the use of more-robust statistical evidence.
Examples of verification and validation in manufacturing
Both techniques are used frequently throughout manufacturing operations, although it may not be obvious in many cases. An example of process verification in a manufacturing setting might be inspecting a CNC program to make sure the tool paths are correct before machining work begins. On the other hand, the running of multiple production batches to confirm finished parts meet specifications consistently would be an example of process validation in action.
Different industries may apply these strategies for different purposes. For instance, the aerospace sector uses them to ensure what it produces will be safe for long-term use, while the food production industry focuses on meeting consumer expectations for product quality and consistency.
Why both verification and validation matter
Each of these procedures is vital for ensuring the success of manufacturing processes. However, attempting to rely on one or the other may be a recipe for failure. Manufacturers who focus all their attention on verification without validation may miss crucial information about long-term variability in their processes. In contrast, concentrating all efforts on validation activity means there’s a significant risk of manufacturing processes being flawed from the start and the manufacturer not realizing it until it’s too late.
Having both verification and validation working in concert ensures compliance, reliability and the quality of the finished product. This means manufacturers gain greater certainty in their processes, which in turn leads to fewer recalls and increased consumer trust.
Best practices for verification and validation
Implementing process verification and validation successfully isn’t as difficult as it may seem at first, as long as manufacturers follow a few basic guidelines:
- Establish clear protocols for documentation to ensure accurate reporting.
- Use statistical process control and real-time monitoring.
- Leverage digital tools such as CMMS, IIoT sensors and quality management systems to automate as much of the procedures as possible.
- Involve cross-functional teams that include representatives from engineering, quality assurance and operations.
- Update processes regularly to reflect any new standards or regulations that may develop.
Finding support for verification and validation
Verification ensures specs are met, while validation is concerned with making sure processes deliver consistent results in the real world. Both are essential for compliance, safety and efficiency, and they require the right level of experience and expertise to implement them successfully.
Manufacturers should consider working with an outsourced maintenance partner to ensure they have technical expertise and skilled technicians. This partner can manage their equipment, so it provides the reliability that is critical for their operations. As a leading provider of manufacturing and industrial maintenance expertise, ATS offers support for manufacturing companies looking to enhance their capabilities in this regard. Our experts can help customers audit their processes and strengthen areas of opportunity. To learn more about what we can do, reach out and speak with one of our representatives today.
