Author: Parveen K Kohli

The organization shall validate processes when the resulting output cannot be verified by subsequent monitoring or measurement. Consequently, deficiencies become evident after the product has been delivered or is in use. Validation shall demonstrate the ability of these processes to achieve planned results.

To better understand, let’s break this clause into parts:

Part A: Validation of Processes When Subsequent Monitoring or Measurement Cannot Verify Output

  • Organizations must validate processes where the output cannot be verified through monitoring or measurement after the process is completed.
  • Example: In the process of welding a joint:
    • The goal is to achieve a specified strength or mechanical properties for load-bearing purposes.
    • Testing the strength often requires destructive methods (e.g., tensile or bend tests).
    • Such tests are not feasible on the actual joint, as they would destroy the joint.
  • Therefore, validation of the welding process is essential to ensure that the actual weld achieves the desired strength without verifying it through destructive testing.

Part B: Deficiencies Becoming Evident During Product is in Use

  • Process deficiencies may only become apparent after the product is in use or delivered.
  • Example: In a weld joint:
    • Flaws in the process might only be noticed when the product fails to bear the intended load.
    • Such failures can result in the product being unable to perform its intended function.

Part C: Demonstration of Validation to Achieve Planned Results

  • Validation involves verifying and testing the process to ensure it consistently delivers the intended results.
  • Example: In welding:
    • The planned output is to achieve the desired mechanical properties.
    • The welding process is demonstrated on a test coupon following the relevant Welding Procedure Specification (WPS).
    • Mechanical properties are verified by testing the test coupons extracted from the weld joint. If the desired properties are achieved, then the process is considered validated.
    • Detailed records of these tests are maintained in the Procedure Qualification Record (PQR) as evidence of validation.

Concluding Statement

Here, the Welding Procedure Specification (WPS) is a perfect example of process validation. During the WPS approval process, it is validated that if the same essential parameters and variables are used consistently for the production weld joint, it is expected that the joint will have the same mechanical properties that were verified on the test coupon made with the same WPS.

 

Disclaimer: This interpretation is provided solely for guidance and is based exclusively on the author’s learning experience within the API ecosystem. Before forming any judgments, readers are encouraged to rely on their own understanding in light of their organization’s requirements.

Note: API does not endorse this interpretation, either in part or as a whole