How do you validate your testing equipment?

1 Why validate your testing equipment?

Validation is not only a good practice, but also a regulatory requirement for food manufacturers. Validation helps you to demonstrate that your testing equipment is fit for purpose, and that it can produce accurate and reproducible results. Validation also helps you to identify and correct any potential errors, defects, or deviations in your equipment performance. By validating your testing equipment, you can enhance your product quality, reduce your risks, and comply with the standards and regulations of your industry and market.

2 What are the steps of validation?

Validation is not a one-time event, but an ongoing process that involves planning, execution, and documentation. The steps of validation may vary depending on the type, complexity, and purpose of your testing equipment, but generally include qualification, verification, performance evaluation, and revalidation. Qualification is the initial step of validation where you verify that your testing equipment is properly installed, calibrated, and operational. Verification is the step where you confirm that your testing equipment can perform the specific tests and measurements it is designed for. Performance evaluation assesses how well your testing equipment performs under real-world conditions. Revalidation repeats the validation process periodically or whenever there are any changes or modifications to your testing equipment. Revalidation helps ensure that your testing equipment remains valid and reliable over time.

3 How do you plan your validation?

Planning is an essential element of validation, as it assists in defining the scope, objectives, criteria, and methods of the validation process. It also helps to allocate the resources, time, and personnel needed for the validation activities. To plan the validation, you should identify your testing equipment and its intended use by clearly describing its components, functions, specifications, and limitations. Additionally, review the relevant standards and regulations that apply to your testing equipment, product, and market. Furthermore, develop a written validation protocol that outlines the steps, methods, procedures, and criteria of your validation process. This protocol should include the roles and responsibilities of your validation team along with the equipment and materials needed for data collection and analysis. Additionally, it should include reports that you will generate and maintain.

4 How do you execute your validation?

Execution is the core part of validation, where you perform tests and measurements with your testing equipment, and collect and record data and results. To execute your validation, you must follow your validation protocol and comply with standards and regulations that apply to your industry and product. Additionally, you should use the equipment and materials specified in the protocol, as well as appropriate standards, reference materials, or samples for verification tests. Furthermore, you should document any deviations, anomalies, or problems that arise during the process, and how they are resolved. Lastly, ensure that all data and results obtained from testing equipment are accurate, complete, and consistent.

5 How do you document your validation?

Documentation is the final part of validation, where you summarize, analyze, and report the data and results that you have collected and recorded during the process. This helps to demonstrate and communicate the validity and reliability of your testing equipment. Your analysis and evaluation should be documented in a written report, which should include the details of your validation protocol, your testing equipment, your data and results, and any deviations or anomalies. Additionally, it is important to maintain your validation records, such as your validation protocol, your validation report, your data and results, and any other evidence. These records should be organized, accessible, and secure.

6 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?