Verification vs. Validation vs. Calibration - What is the difference?

S

Sean Manning

Hi Guys

We were in the process of reviewing our methods and one interesting debate opened up on the use of words "calibration" and "validation". Can anyone provide a clear explanation on the difference between these 2 terms.

All the best

Sean
 

Jim Wynne

Leader
Admin
Context is everything. "Calibration" is comparison of a measurement device against a standard and adjustment if necessary, but the definition of "validation" is controlled by context.
 

Mike S.

Happy to be Alive
Trusted Information Resource
Validation is defined in ISO 9000 section 3.8.5 as "confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled".
 

Hershal

Metrologist-Auditor
Trusted Information Resource
JSW05 has a good definition of verification.

Calibration is basically a comparison of an item to a standard that is closer to SI, also known as a higher level standard. Such comparison requires traceability of the calibration. Traceability is defined as an unbroken chain of comparisons to National or international standards (e.g. standards maintained by NIST), AND stated uncertainties at each step. The traceability of course needs to ultimately go to SI, where possible.

Sometimes the comparison will result in unacceptable readings (e.g. out of tolerance) and then adjustment may be required. Technically, the adjustments may - or may not - be calibration. Typically, a small adjustment that is "incidental" to calibration (e.g. zero the reading on calipers) is part of calibration, but involved things (e.g. open up an oscilloscope for internal adjustments) is different.

Hope this helps.

Hershal
 

Mike S.

Happy to be Alive
Trusted Information Resource
In summary, FWIW, from Marc's second link:

verification - conformation by examination and provision of objective evidence that specified requirements have been fulfilled. (ISO Standard 8402)

validation - confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use are fulfilled. (ISO Standard 8402)

calibration - a set of operations that establish, under specified conditions, the relationship between values of quantities indicated by a measuring instrument or measuring system or values represented by a material measure or a reference material, and the corresponding values realized by the standard.

NOTES

1 The result of a calibration permits either the assignment of values or measurands to the indications or the determination of corrections with respect to indications.

2 A calibration may also determine other metrological properties such as the effect of influence quantities.

3 The result of a calibration may be recorded in a document sometimes called a calibration certificate or a calibration report. (International Vocabulary of Basic and General Terms in Metrology)

:bonk: Sounds like some of the terms sometimes overlap.

I hope there is not a test on this tomorrow!
 

Marc

Fully vaccinated are you?
Leader
ISO 8402:1994 Status: Withdrawn 2000-12-08

NOTE:

Withdrawn Standards

ISO 8402:1994 Quality management and quality assurance -- Vocabulary

Technical committee: ISO/TC 176/SC 1

Withdrawal date: 2000-12-08

Replaced by:
ISO 9000:2000 Quality management systems -- Fundamentals and vocabulary
 
S

Sean Manning

Validation v's Calibration

Hi All,

Thanks for the responses. My original question concerned Validation v's Calibration, which was lost to a degree during feedback.
Please see something I've put togther, which may help to bring Validation more into the discussion.

In terms of the equipment life cycle for example Validation will determine that the equipment is functionally and operationally capable and meets the intended purpose before use.
Calibration and Maintenance determine that equipment is within specification after use.

As well as for equipment, Laboratory Validation proves that test methods and personnel perform within documented parameters.
 
J

JerryStem

To me (simplest terms):

Calibration: Checked against a known standard and adjusted if necessary

Validation: Checked against a known standard

(We use calibration and certification here, same thing. We calibrate the instrument and certify the standard, which is not adjustable.)

Jerry
 
S

salarium

Just my 2 cents.

I thought verification was conformance by objective evidence to a published specification.

Validation would have more to do with usability or users needs. Simulated use testing in the hands of the customer. How well does the design meet the intended use from the customer perspective?

Calibration assumes a measurement capability with tolerances. Establishing accuracy and repeatability etc.

Salarium
 
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