There are a lot of different kinds of validation. There is a common confusion on when a validation is necessary and which type of validation should be done. This question spans across different industries and different types of product (examples include physical product and virtual product). Below is a breakdown of when validation should be performed.
Verification Versus Validation
When determining whether to perform validation or verification, a first step is to determine if full verification is even possible in normal production. An example where full verification is not possible is in the case of destructive testing. If the full verification is possible within production, the next decision is to determine if it is cost prohibitive to perform full verification in normal production. If full verification is possible and feasible, then the company has the option of performing full verification in normal production (each manufacturing lot) or performing validation. If full verification is not possible or is not feasible, then validation is necessary.
Equipment Validation (Installation Qualification)
Installation Qualification is needed to show that the equipment is set-up properly and per the manufacturer’s recommendations/requirements. Examples of those requirements could be ensuring the equipment is level, ensuring the correct range of electricity is hooked up to the equipment, or that connections are complete and will not leak. Additionally, any required safety aspects that need to be in place for the operators would be challenged. An example would be ensuring that guarding is in place to protect an operator from having their hands in a place that has a pinch hazard.
Operational Qualification is necessary when an operation has multiple settings or a window that will be allowed during normal production. Examples include mixing speed ranges, injection molding temperature ranges, and torque ranges for screwing on a component.
A Process Qualification is needed when a subprocess has individual requirements that need to be challenged. Or is a process being very operator dependent, it would need to be challenged without additional variables carried over from earlier processes to understand if the process alone is capable of making good product. If a Process Qualification is conducted, the Product Validation should be conducted as well. If only a subprocess is validated, there could be an interaction with the process steps around that process that could cause failures if not understood and tested.
A Process Validation is needed to show the beginning to end of the manufacturing process for a product is capable of consistently making good product that meets all requirements and outputs. A Product Validation is necessary when full verification is not possible or is not feasible.
A Software Validation is needed when the software is driving production, used in the company’s quality management system, or is in the product to be sold/is the product to be sold. Software validation is believed to be very different than hardware validation out of a lack of understanding, but in actuality, validation at its core is the same no matter what it is validating. Software Validation is used to show that the software as written is capable of meeting the product’s outputs, specifications, and requirements.
A Cleaning Validation is necessary if the equipment is not dedicated to the production of a specific product and there is a potential of cross-contamination. An example is if a piece of filling equipment is used to fill multiple products, there is the potential that the first few bottles of the fill could contain a small amount of the product that was filled the last run. A Cleaning Validation would show that the cleaning procedure when followed will not allow cross-contamination.
A Spreadsheet Validation is necessary if there is data and/or calculations to be used within production. An example would be if the amount of material to be added is dependent on an earlier test result. The formula for the calculation is saved within a spreadsheet so the operator only has to type in the input to get the resulting output as a decision in production. Additionally, a Spreadsheet Validation is necessary if there is information used within the Quality System of the company. An example of this would be a log used to track non-conformances. The validation would challenge that each non-conformance is uniquely identifiable, the data cannot be erased accidentally, and other requirements as determined by the regulatory requirements and individual quality system requirements of the company.
A Room Validation is needed if there are aspects to a room that need to be challenged and are necessary for the production of good parts/product, the safety of the operators, and/or other requirements for regulatory bodies, government agencies (OSHA as an example), or the company itself. An example would be if the room needs to have specific ventilation and temperature/humidity controls.
Test Method Validation
A Test Method Validation is needed when there is a decision in production or the acceptability of the product out of a test. It is used to determine if the test is able to determine good from bad parts. It is also used to determine that the same results will occur no matter who is running the test and no matter when they are running the test. A Test Method Validation is used to show that the test is valid. An example would be an assay of a chemical reaction to show the functionality of a product at the end of production.