What is the difference between "Fitness for Purpose" and "Calibration/Verification"?

[placebo_master]

I work at a development firm with ISO9001 and AS9100 accreditations (among others). An AS9100 auditor visited us last fall and issued us an NCR with the following evidence:

No defined process found for retaining documented information on fitness for use [i.e. purpose]. Equipment not calibrated is defined in the system and labeled as "Calibration not Required." [Qty.] 217 items with no documented information on fitness for use.

In response, our management addressed the first sentence of the auditor's comment. Our Calibration Procedure now has a clause that dictates the steps to execute a Fitness for Purpose assessment.

Now, I've been assigned the task of developing a plan to evaluate the 217 uncalibrated assets and list them in our master calibration file. (FYI: I do not have previous calibration system experience--I've only ever been the tool abuser user.) Where I'm struggling with this task is how do I differentiate a "Fitness for Purpose" evaluation from a "Calibration/Verification" evaluation?

At face value, Fitness for Purpose necessitates some kind of measurement using the equipment to confirm it produces a valid measurement--yet how is that different from Calibration/Verification? Is the primary difference that we are doing the work ourselves, as opposed to contracting the work to a calibration service with an ISO 17025 certification?

 

[John C. Abnet]

I work at a development firm with ISO9001 and AS9100 accreditations (among others). An AS9100 auditor visited us last fall and issued us an NCR with the following evidence:

At face value, Fitness for Purpose necessitates some kind of measurement using the equipment to confirm it produces a valid measurement--yet how is that different from Calibration/Verification? Is the primary difference that we are doing the work ourselves, as opposed to contracting the work to a calibration service with an ISO 17025 certification?

Good day @placebo_master ;
Consider this...
If an organization is machining and finish grinding a metal surface to within a tolerance of 0.0001", then a yardstick (tape measure) would not be "fit(ness) ---...for its intended purpose" . This holds true EVEN if the yardstick/tape measure are calibrated .

There are very few prescribed requirements in ISO 9001 so your organization has considerable liberty in how this is determined (unless, of course, you have agreements/requirements with/from the customer).

A typical "minimum" (albeit statistically incomplete) method of ensuring "fitness for purpose" is to have a measuring device with a resolution that is a maximum of 1/10 of the total tolerance. Therefore, if a tolerance is 2", the expected resolution of the measuring device would be 0.2".

There are additional more substantial methods via MSA.

Hope this helps.

Be well.

 

[placebo_master]

This is a helpful start to the discussion. Thank you

We develop many things for many companies operating in several industries... suffice to say we have to be flexible with our processes. And I agree that what you described in ISO 9001 grants us flexibility. For example:

A typical "minimum" (albeit statistically incomplete) method of ensuring "fitness for purpose" is to have a measuring device with a resolution that is a maximum of 1/10 of the total tolerance. Therefore, if a tolerance is 2", the expected resolution of the measuring device would be 0.2".

In this example, I would select a measurement instrument for this specific application, then document why I think an instrument with X resolution is acceptable to measure a widget with Y tolerance. The document would then become an artifact I store in the repository of info we maintain for said widget.

What I've been asked to do (i.e. evaluating all of our uncalibrated equipment) seems to conflict with this example you gave. Maybe an example will better explain where my confusion stems from: how can I execute a fitness for purpose evaluation on a power supply if I don't know what it's end use will be? It could be used in a +/- 1 VDC application or a +/- 100 VDC application. IMO it seems like one shouldn't broadly evaluate the power supplies for its fitness, but should instead evaluate it on a case-by-case basis.

 

[John C. Abnet]

This is a helpful start to the discussion. Thank you

We develop many things for many companies operating in several industries... suffice to say we have to be flexible with our processes. And I agree that what you described in ISO 9001 grants us flexibility. For example:


In this example, I would select a measurement instrument for this specific application, then document why I think an instrument with X resolution is acceptable to measure a widget with Y tolerance. The document would then become an artifact I store in the repository of info we maintain for said widget.

What I've been asked to do (i.e. evaluating all of our uncalibrated equipment) seems to conflict with this example you gave. Maybe an example will better explain where my confusion stems from: how can I execute a fitness for purpose evaluation on a power supply if I don't know what it's end use will be? It could be used in a +/- 1 VDC application or a +/- 100 VDC application. IMO it seems like one shouldn't broadly evaluate the power supplies for its fitness, but should instead evaluate it on a case-by-case basis.

As stated, there is no requirement within ISO 9001 as to HOW sufficiency is determined. ISO 9001 heavily (rightly so) focuses on RBT (risk based thinking), therefore, your organization can simply analyze (don't overthink that....since it sounds from your original post that the current method(s) have been in place and apparently ?? working well for some time. [By the way...this begs the question as to why the CB only NOW decided the current approach warranted an NC ??] ) the risk and then apply the measurement device that your organization deems within an acceptable level of risk.

Hope this helps.
Be well.

 

[qualprod]

I work at a development firm with ISO9001 and AS9100 accreditations (among others). An AS9100 auditor visited us last fall and issued us an NCR with the following evidence:

No defined process found for retaining documented information on fitness for use [i.e. purpose]. Equipment not calibrated is defined in the system and labeled as "Calibration not Required." [Qty.] 217 items with no documented information on fitness for use.

In response, our management addressed the first sentence of the auditor's comment. Our Calibration Procedure now has a clause that dictates the steps to execute a Fitness for Purpose assessment.

Now, I've been assigned the task of developing a plan to evaluate the 217 uncalibrated assets and list them in our master calibration file. (FYI: I do not have previous calibration system experience--I've only ever been the tool abuser user.) Where I'm struggling with this task is how do I differentiate a "Fitness for Purpose" evaluation from a "Calibration/Verification" evaluation?

At face value, Fitness for Purpose necessitates some kind of measurement using the equipment to confirm it produces a valid measurement--yet how is that different from Calibration/Verification? Is the primary difference that we are doing the work ourselves, as opposed to contracting the work to a calibration service with an ISO 17025 certification?

The first question it means, that what is used is appropriated for that, example, to measure a piece you have to use a caliper or micrometer, can’t be used a flexible tape or a multimeter , the second one, calibration , to ensure your equipment is validated against international standards, and verification to ensure your equipment is able to measure , comparing it against a ( 1 meter, 1 feet, 1 pound) , without the need to calibrate it.

 

[dwperron]

Now, I've been assigned the task of developing a plan to evaluate the 217 uncalibrated assets and list them in our master calibration file. (FYI: I do not have previous calibration system experience--I've only ever been the tool abuser user.) Where I'm struggling with this task is how do I differentiate a "Fitness for Purpose" evaluation from a "Calibration/Verification" evaluation?

"Fitness for their purpose" is different from "suitable for the specific type of monitoring and measurement activities being undertaken ". Calibrations show that the tool is "fit" for the purpose of using it to make a measurement, those calibration records are the "documented information" which is required.

What your auditor seems to be questioning is the use of "Equipment not calibrated". That is certainly allowed, but many times an organization fails to differentiate between when calibrated tools are required or not. Your organization is required to:
When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing
confidence in the validity of measurement results, measuring equipment shall be:
a. calibrated

Once the tool is deemed to require calibration it is placed in the "register of the monitoring and measuring equipment".

If your auditor is stating that the 217 tools that you have deemed to not require calibration somehow require that you document their "fitness" then he is wrong. 7.1.5.2 clearly states that not all equipment requires calibration. The two classes of tools need to be treated separately. Your auditor may be questioning your decisions as to which tools require calibration.

 

[placebo_master]

(don't overthink that....since it sounds from your original post that the current method(s) have been in place and apparently ?? working well for some time. [By the way...this begs the question as to why the CB only NOW decided the current approach warranted an NC ??] )

I didn't mean to give the impression that we have a process that has been working: this conversation is motivated by the fact that, previously, we had no process for evaluating fitness for purpose. We only just recently implemented the process (as a result of the NC the auditor gave us), and since its implementation it hasn't been used by our engineering staff. That's a whole other issue

If your auditor is stating that the 217 tools that you have deemed to not require calibration somehow require that you document their "fitness" then he is wrong. 7.1.5.2 clearly states that not all equipment requires calibration. The two classes of tools need to be treated separately. Your auditor may be questioning your decisions as to which tools require calibration.

This is the root of my confusion, so I'm glad you mentioned this. I'm not sure if the auditor is wrong, or if the auditor's message was misconstrued in the CAPA we initiated. I wasn't in the room when it happened, so I don't have first-hand knowledge of what the auditor said. Obviously you won't have the answer either, but this discussion is nonetheless valuable to me because it'll help me better frame the problem with my manager.