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Verification and validation

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Guest user Created:   Nov 02, 2020 Last commented:   Nov 13, 2020

Verification and validation

Dear Tracey,
Hope you are doing well,
Actually, I need your help to find the accurate and the most clear difference between validation and verification on the laboratory.
I really appreciate your answer.
Thank you for your time.

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ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Tracey Evans Nov 03, 2020

The ISO 17025:2017 standard has included the definitions in the revision to clarify the difference. Verification involves providing objective evidence that a given item meets specified requirements. For equipment, for example a balance is verified daily using a range of suitable calibrated weights that have been calibrated and have a reported measurement uncertainty. If the results of the calibrated weights fall within the acceptable limits of variation (e.g the 5.000 g falls between 4.999 and 5.001 g), the balance said to be verified to meet specified requirements.

Validation (of a method) is in fact also a simply a verification activity, where the specified requirements are shown to be adequate for an intended use. This means parameters are verified to meet specified requirements and are suitable (adequate) for the purpose of the test. This means as an example, that the method performs suitably (using calibrated and verified equipment) in terms of, for example accuracy and precision for the purpose of the test. 

Typically it is said that laboratories verify standard published methods.  This means that they can meet the published performance for the specific use. If any customisation is made to the method or applied to different matrices, the method must be validated. This basically involves testing more parameters than verification. 

The ISO 17025 toolkit includes the procedure for validation and verification of methods, named Test and Calibration Method Procedure, along with two supporting documents Test Method Development, Verification and Validation Register and Test Method Development, Verification and Validation Record. The procedure is also available separately at https://advisera.com/17025academy/documentation/test-and-calibration-method-procedure/

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Guest user Nov 09, 2020

1. Dear Tracey, Really appreciate your time snd need to sdk you also if i done have traceability or stander to calibrate any device can i used ane method created by my lab employee???

2. I need ti ask you about calibration based on iso 17025 if should be done by third party on we can do as internal party then records 

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Expert
Tracey Evans Nov 13, 2020

You asked

if i done have traceability or stander to calibrate any device can i used ane method created by my lab employee???

Unless the client  or regulations require you to use a standard method, the laboratory is free to use any suitable method. “Suitable” means that the method measures what it is supposed to, in the matrix of interest; accurately, and reliably and meets the parameters required by the client; for example for limit of detection and precision. An inhouse method, however, requires a more extensive validation experiments than a standard method.

You also asked 

I need ti ask you about calibration based on iso 17025 if should be done by third party on we can do as internal party then records"

Certain calibrations can be performed inhouse, justified based on the assurance risk and the type of measuring equipment. You need to use an external accredited calibration laboratory if you need to meet legal requirements, those of your accrediation program, or do not have the expertise or suitable equipment /  calibrators that can provide results with unbroken metrological traceability to international measurement units.  Have look at the answer provided for a similar question. “Calibration of laboratory equipment” at https://community.advisera.com/topic/calibration-of-laboratory-equipment/
 

For further information see the following:
The article What does ISO 17025:2017 require for laboratory measurement equipment and related procedures? at https://advisera.com/17025academy/blog/2019/07/25/iso-17025-measurement-requirements-of-the-standard/
The ISO 17025 document template: Equipment and Calibration Procedure at https://advisera.com/17025academy/documentation/equipment-and-calibration-procedure//

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Nov 02, 2020

Nov 13, 2020

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