I often have discussions with peers and co-workers about whether we should validate or verify some process or activity.
I find there is significant confusion as to what these terms actually mean and what an Customer and/or Third Party should be doing.
Since I recently had one of these discussion, I thought I would share my thoughts.
The Wikipedia Definition states….. Verification and Validation are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. These are critical components of a quality management system such as ISO 9000.
Common definition can be expressed as:
- Verification is intended to check that a product, service, or system meets the design specifications. This can also be the Customer’s specified requirements.
- Validation is intended to ensure a product, service, or system meets the operational needs of the user.
Here’s a simple way to look at it. Verification comes before (and after) Validation because you can’t successfully Validate a process or product until you have Verified that it meets the established design criteria or requirements….and then you can Verify that it has been Validated….and then you can Validate it was Verified.
Another common way to determine the difference would be that Validation answers “Are you building the right thing?” and Verification answers “Are you building it right?”
Where “Building the right thing” refers back to the user’s needs, while “building it right” checks that the requirements are met.
So with that in mind, here are a few examples on how “I” would use these terms……..
When it comes to specially engineered equipment, I will
- Review the process of how the manufacturer Validates the design
- Utilize the services of a Third Party Quality Assurance Inspector to Verify that the manufacturing control features are being performed
I also often use the services of a Third Party Quality Assurance Inspector to Verify that a contracted Service Provider is following an approved Service Plan (as in API Q2).
I have also used the services of a Third Party Quality Assurance Inspector to Validate that an Equipment or Service Provider has met the requirements of their Quality Management System.
I may also Validate that the Equipment or Service Provider has a process of Verification in place that ensures compliance to agreed terms.
I will Validate that an Equipment provider has a plan for maintaining traceability – I will then Verify that traceability was maintained during the Manufacturing Operation.
Note: This blog was contributed by Jim Hood and posted on DeepMar Consulting Website.