Validation is a helpful tool for companies. It is a way to ensure the equipment and process/product are consistently going to produce quality product that meets the needs of the customer and the requirements of the product. Validation is useful when full verification is not cost effective or not possible. In the cases of regulated industries, validation is necessary when verification is not used during normal production.
There are many different kinds of validation that help to support making an efficient and quality driven product consistently during manufacturing of a product. The following types of validation are described and many may apply to the products and production processes used in your company.
Equipment Validation (Installation Qualification)
Installation Qualification is used in order to ensure that equipment is installed properly. This testing also ensures that the Is establishing by objective evidence that all key aspects of the process equipment and ancillary system installation adhere to the manufacturer’s approved specification and that the recommendations of the supplier of the equipment are suitably considered. Consider things like if there is an electrical element, pneumatic, or mechanical element to challenge as examples.
Operational Qualification is a validation that proves that all operating ranges within a process produce a result or product meeting its predetermined specifications. The extremes of the process allowed during normal production are challenged. An example of an Operational Qualification would be challenging the mixing speed and mixing time for a mixing process. The extremes of the lowest time and lowest speed would be a run to challenge that the material is mixed to a homogenous solution. Another run would be the highest time and highest speed to show that the material is mixed, but doesn’t cause damage to the material.
A Process Qualification is a validation that proves that a sub-process consistently produces a result or product meeting its predetermined specifications. The challenge is a nominal operation conditions to ensure that the process will reliably produce good product or parts. An example of a Process Qualification is challenging the nominal process of metal stamping out a blade for a hand saw. There are steps on production before and after metal stamping, but there are requirements, specifications, and outputs that can be evaluated for this process alone.
A Process Validation is a validation that proves that the entire manufacturing process consistently produces a result or product meeting its predetermined specifications. The challenge is a nominal operation conditions to ensure that the process will reliably produce good product or parts. An example of a Product Validation is challenging the nominal process of making a hand saw (product). The validation would include different process steps that are all a part of making this product such as the metal stamping of the blade, the attachment of the handle, and the sharpening of the blade.
A Software Validation is needed to challenge that software is meeting all requirements. Software validations may be needed on the following:
- Software on a product
- Software within the Quality System
- Software driving manufacturing equipment
- Software used in the manufacturing of a product (examples include calculations)
The software needs to be challenged that it is meeting the requirements identified for that application such as being able to save and user rights. The software should also be challenged to ensure that things don’t happen that shouldn’t like the ability to change a formula or altering a record after the fact without an audit trail (person’s identification and date/time stamp).
A Cleaning Validation is qualification that the cleaning process used is capable of getting rid of any contaminants and remnants of a previous product prior to starting a new product. This is a necessary step to ensure the process will not have cross contamination between products.
A Spreadsheet Validation is qualification of a spreadsheet used within production or the company’s quality system. The spreadsheets can be used as logs for data in a quality system or could be used to calculate material or results within a manufacturing process.
A Room Validation is the qualification of a room for it’s intended purposes and requirements. An example of when a room validation would be needed is for a clean room that has been built prior to using the room in production.
Test Method Validation
A Test Method Validation is the qualification of a test. Within production testing can occur during the receipt of a raw material or component, in-process of manufacturing, and once the product is built prior to sending the product to customers. The tests are used to determine good from bad product or parts. There are steps that must be conducted to make sure the test is capable of telling good from bad parts or product. An example of a challenge within a Test Method Validation is making bad parts and ensuring the test is capable of rejecting the parts when mixed randomly with good parts in a blind test.