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

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
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.

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".

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

Are we talking about Validation or Verification?

The seminal threads here on Verification vs. Calibration are:

Calibration vs. Verification - Definition of (http://elsmar.com/Forums/showthread.php?t=3905)

Calibration vs. Verification - A Good List of Definitions (http://elsmar.com/Forums/showthread.php?t=945)

Calibration vs. Verification - ANSI/NCSL/Z540 - Definitions of (http://elsmar.com/Forums/showthread.php?t=938)

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!

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

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.

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

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

I always viewed "calibration" to mean testing the measured parameters, and adjusting if necessary to bring into tolerance, and "certification" to mean obtaining or providing traceability documentation, and "validation" to mean entering it into the system, updating records, and making sure everything is kosher with the applicable operating procedures, and then making it available for it's intended use. For us, we don't really call it "validation" though, we just say it's been QA'ed and ready to go.

Occasionally we get "repair only" work orders where we repair an instrument to get it working, and then we'll calibrate it anyway, taking readings and adjusting if necessary to bring all parameters into tolerance, and we will even provide before and after readings in cases where the repair was to correct out of tolerance readings; but we won't certify it, meaning we won't provide a certificate showing traceability for "repair only" work orders. Then it's up to the customer to calibrate it to their traceable standards.

Just my :2cents: ...

The thread is very interesting and I thank all the participants for their enlightening inputs.

I would like to offer my 2 cents worth of input:

I think calibration refers to checking something against a graduated scale, while verification refers to verifying something against some set standards to find out whether it meets the same or not, and validation means to find out whether something has the capacity to meet the set standards or not.

surendro

Verification is defined as meeting the functional requirements and validation is nothing but meeting the performance requirements.
I think calibration and verification means the same

The biggest difference is that calibration requires traceability.....

Traceability in turn requires (1) unbroken chain of comparison to National or international standards; and (2) stated uncertainties at each step.

Verification is just that - verifying something, so it is not calibration.

Validation is making sure that whatever is verified or calibrated is fit for the intended use.

Note that neither of these three necessarily require any adjustment or similar.....each MAY require it, but that is not a fast rule.

In the actual sense the word "Calibration" is basically belongs to the instrumentation inspection / verification activity. Mean this refer as a proactive approaches however, the “Validation” is concerned with a reactive approaches mean when after the calibration of an instrument, then u will start using you instrument for it's actual purpose mean testing, then you can say at this time that you take your instrument for validation.

Regard's

Rehan Haider