When and how do you perform a validation?

When and how do you perform validation?

If you search for the meaning of validation, you may end up in a web of information. Validation is not the same for every situation or every company. A new or modified element (process, product, machine, building) can always be validated.

The purpose of validation is to ensure that you are aware of all the risks in advance and have assessed them. To achieve this goal, the following questions are important: when is validation necessary? And how can you carry it out in practice?

What is validation?

In a nutshell, validation is declaring “something” to be valid. It is a process for achieving an accepted level of quality for a given item. For an HACCP system, this boils down to obtaining proof that “something”, if implemented correctly, is capable of controlling the hazard to a specified result.

When to validate?

Validation applies to all changes or innovations within a company. There are situations that clearly require validation. Examples include a new HACCP system, new production premises, process, product (group), etc.

In addition, GFSI-recognised standards such as BRCGS, IFS and FSSC 22000 specify mandatory situations that must be validated. Examples include the validation of CCPs, cleaning, shelf life, claims, rework, etc.

However, there are also less clear situations where you can go in any direction. A good start is to ask yourself whether the change or innovation fits into the existing system. For example, a new machine fits into an existing system if an older version has been in use for years. The process step is the same, but the technology and possibly also the working method have been improved.

A new product that is simply a smaller and lighter version of an existing product also fits into the current HACCP system. Discussing new ideas for improvements to the process, machinery and recipes in a meeting is a good starting point. As a quality manager, don't hesitate to join in the coffee corner chats when colleagues are discussing future innovations.

Often, the “corridor stories” are a good indicator of new projects. Then ensure that there is a platform where multiple disciplines can discuss developments within their area of responsibility. Good and timely communication about developments and investments is important for the validation process. During this consultation, a decision can be made on how to carry out and plan the validation.

How do you carry out a validation?

Validation checklist

If a change fits within the existing system, it may be sufficient to go through a validation checklist, for example.

This checklist can include mandatory and desired (customer) requirements, which the validation team can use to easily assess each requirement. If the change leads to substantive changes to the HACCP system or business operations, it is necessary to meet with the validation team and write a validation report.

New machine

Is a new or different machine being put into use? Use a machine checklist to check all requirements. These include calibration, data on product contact materials, chemical agents such as cleaning and disinfecting agents and lubricants, etc. This can often be completed by the purchaser of the machine (technical service). Assessment is carried out by the HACCP team.

If the new machine is for a new process step, a checklist will not suffice. The hazard identification and risk analysis must be examined in detail. It is essential to draw up a validation report. For example, will a CCP/OPRP be added?

New product

A new product that fits within an existing product or product range can also be validated using a checklist or product development procedure. It is important that the raw material has the same parameters, such as allergens, pH and best-before date, as the current products. In the case of a new supplier, the company's existing purchasing agreements apply. If these are met, the product fits within the existing system.

If the production of the new product requires a new raw material, process step, working method or machine, it does not fit into the existing system. Multiple disciplines must be involved in the validation team and a validation report must be written in which all aspects of the quality system (including HACCP) are discussed. This does not only involve the development of the new recipe, but also the validation of new machines, process steps, substantiation of shelf life, claims, allergens, etc.

During the validation meeting, discuss all changes in business operations resulting from the new product. During the validation process, the planning and actions to be carried out, such as test productions, sensory, microbiological and/or chemical research, can be managed. Write a validation report using the input from the meetings, all the information obtained and the results. Use this to substantiate that the new product is satisfactory and meets customer requirements and legal requirements.

Read more about validations and product development

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New space or new premises

If a production area in the existing premises is to be used for a different purpose, a validation checklist can be used if the area was previously suitable for existing production. If the new purpose requires different resources (climate control, pest control plan, etc.), this is linked to the basic requirements programme and some documents, such as the floor plan and the Food Defence analysis, may need to be amended. Report these changes in a validation report.

Is a new production location being built? Then validate in four phases.

Phase 1: design

The key question in this phase is: what are the minimum requirements (basic conditions programme) that the food company must meet in order to produce food safely in a suitable factory, and which service providers do we need to achieve this? This phase starts with drawing up the floor plans and considering the quality (materials) during construction. This phase is carried out before any equipment is installed.

Phase 2: installation

In this phase, the focus is on assessing the requirements for the delivery and installation of the premises and machinery. Adjustments can still be made at this stage to better meet previously set requirements.

Phase 3: operational

Requirements and agreements from previous phases are assessed to determine whether they have actually resulted in a food-safe production environment. Is everything working according to the design and is additional control required?

Phase 4: verification

The entire project is evaluated in the fourth phase and serves as approval of the overall validation.

Start the validation process in good time

Validation can be seen as a complex project. If future ideas are discussed at an early stage, the seed can be planted. This seed will then grow into a successful and strong tree through all possible communication channels and reports! Ask for support with validation issues in good time.

Our Quality Assurance specialists are happy to help you validate and substantiate new products, processes, machines or spaces. Please contact us.