How do you validate food processing equipment before launch?

1 What is validation?

Validation is a process of collecting and analyzing data to demonstrate that your equipment can perform its intended function and produce the desired outcomes. Validation is not a one-time event, but a continuous activity that covers the entire lifecycle of your equipment, from design to installation, operation, maintenance, and decommissioning. Validation helps you to ensure quality, safety, and compliance in your food manufacturing process, as well as to optimize your performance and efficiency.

2 Why do you need validation?

Validation is essential for food manufacturing because it helps you to meet the regulatory standards and customer expectations for your products. Validation can also help you to reduce the risks of product recalls, rework, waste, and liability. By validating your equipment, you can demonstrate that you have a robust and reliable process that can deliver consistent and high-quality results. Validation can also help you to identify and resolve any potential issues or gaps in your equipment or process before they become costly or harmful.

3 How do you plan validation?

Before you start validating your equipment, you need to have a plan that outlines the scope, objectives, criteria, methods, and documentation of your validation project. This plan should include a description of your equipment and its intended use and function, as well as a list of the relevant regulations, standards, and guidelines that apply. Additionally, you should define the acceptance criteria and performance indicators that will be used to measure and evaluate your equipment. You should also specify the validation activities and tests that will be performed - such as design qualification, installation qualification, operational qualification, and performance qualification - along with the data collection and analysis methods that will be used. Lastly, you should outline the documentation and reporting procedures that will be followed.

4 How do you execute validation?

Once you have a validation plan, you can proceed to execute the validation activities and tests according to your plan. The execution phase of validation involves verifying that your equipment meets the design specifications, installing and configuring it properly, testing and adjusting it under normal and extreme conditions, and confirming that it can produce the expected outcomes. This phase typically consists of four stages: Design qualification (DQ), which verifies that your equipment is designed according to user requirements and regulatory standards; Installation qualification (IQ), which verifies that your equipment is installed and configured correctly and safely; Operational qualification (OQ), which verifies that your equipment can operate and function as intended under normal and extreme conditions; Performance qualification (PQ), which verifies that your equipment can produce the desired results under real conditions. To confirm each stage, documents, drawings, calculations, simulations, models, checklists, inspections, measurements, audits, tests, experiments, trials, samples, analyses or evaluations may be used.

5 How do you document validation?

The final and most important step of validation is to document and report your validation results and findings. Documentation is essential for validation as it provides evidence that your equipment is validated and compliant. It also helps you to track and trace your validation activities, data, and decisions, as well as to support your quality assurance and continuous improvement efforts. Documentation should be clear, accurate, complete, and consistent with the standards of your validation plan. Generally, documentation includes protocols, reports, and records. Protocols are the plans and procedures that describe how to perform the validation activities and tests; they should include the purpose, scope, objectives, criteria, methods, responsibilities, and resources of each validation activity and test. Reports are summaries and analyses of the validation results; they should include the data, observations, calculations, evaluations, conclusions, and recommendations of each validation activity and test. Lastly, records are raw data that support the validation results; they should include data sheets, logs, charts, graphs, certificates or any other documents that show the data collection and analysis methods and outcomes of each validation activity and test.

6 How do you avoid validation pitfalls?

Validation is a complex and challenging process that requires careful planning, execution, and documentation. However, there are some common pitfalls that should be avoided. For instance, skipping or rushing validation steps can compromise the quality, safety, and compliance of your equipment and process, as well as expose you to potential errors or failures. Additionally, using inappropriate or outdated validation methods can result in inaccurate or invalid validation results and findings. Moreover, failing to document or report validation results can undermine the credibility of your validation process. Documentation and reporting provide proof and evidence of your validation activities, data, and decisions. Therefore, it is essential for validation to document and report results in order to verify, audit, or review them.

7 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?