AS9100 - 7.1.5.2 In-House Calibration

[ASDriven]

I'm a bit confused on clause 7.1.5.2. and am curious as to how other Machine Shops (as we are a CNC machine shop) and similar have established their in-house calibration/verification procedure that are AS9100 certified. I've scoured the forums but haven't found an answer, or so I think.

Gage software generates ticket for either calibration or recall verification for all equipment to be in-house inspected.
1) Do we, as a machine shop, have to record the temperature & humidity?
2) - Or state that it was performed under conditions listed in ISO 17025?

Simply put, I'm lost in what needs to be recorded on a In-House Calibration Sheet that's either Calibrated or Recalled/Verified through Master Sets.

 

[Jim Wynne]

I don't know offhand what 17025 says in this regard, but I do know that it's not a good idea to claim compliance with a requirement (or to cite a requirement) without evidence.

 

[ASDriven]

I don't know offhand what 17025 says in this regard, but I do know that it's not a good idea to claim compliance with a requirement (or to cite a requirement) without evidence.

There are so many standards! I just don't know if any of the requirements from ISO 17025 or ANSI Z540-3 or ANSI B89.6.2 need to be recorded and/or stated on our In-House calibration sheets.

Or is it possible to just have a "Master Set SN" line added to the sheet and be ok as this would be traced back to the fully certified and calibrated master set.

 

[Jim Wynne]

The question is about what's reasonable and prudent. If calibrations are likely to be affected by ambient conditions, it's best to control those conditions and cite the controls on the calibration record.

 

[Jen Kirley]

I don't have a copy of the AS standard in front of me, nor ANSI Z540-3 or ANSI B89.6.2 but I am familiar with the environmental controls called out in 17025.

Calibration takes place using traceable standards, performed by qualified individuals in a controlled environment, in accordance with established procedures. As found results are recorded, over the instrument's range depending on the instrument (a scale, for example). If an instrument needs adjustment the as-left result is recorded as well.

These are the data points I have seen on oh-so-many calibration certificates. I do not remember seeing temperature and humidity recordings on any of the calibrations. Many types of temperature and humidity data loggers are available, which chart the readings so a person can trace the conditions on a given day and time. Some can be set up to send an alarm if conditions fall outside of defined parameters. Some are disposable (last about a year), while others have batteries that can be replaced. I have seen the reports they generate when plugged in with USB; they are impressive and can be retained as records.

With these types of records I find individually recording the temperature and humidity on individual certificates to be a complete waste of time.

About master sets: I have too often seen a master set's calibration report with one piece failing. It gets replaced, then what you have is a new piece in the old master set. What did you receive when purchasing the master set? I don't see individual serial numbers on precision pins, but I see them on better quality gauge blocks. These individual numbers should be recorded so you can show the previously failed block was not used for the present day calibration.

I hope this makes sense.

 

[ASDriven]

@Jen Kirley - Never knew temp/humidity loggers existed. We have 2 master block sets that are sent out to an accredited lab for calibration on a rotational schedule with the temperature and humidity recorded on their certifications. I like the individual ID # record suggestion!

For simple in-house calibrations, would having 1) recorded temp & humidity @ the time of in-house calibration & 2) Our unique Master Set ID # on our data sheets be sufficient enough to satisfy measurement traceability? - I understand that a lot will be customer/prime specific.

 

[Kronos147]

The nice thing about the standard is it says calibrate or verify.

In our machine shop, we verify gage pins before use with a calibrated micrometer. If the pin is more than something like .0003 away from the size (.XXX pins), the person notifies management, else, it gets logged that it was verified and then used.

(Deltronic .XXXX pins must be what the the box says.)

We also verify 6" calipers used by production in house. We have a procedure, and a form to capture results that references the procedure.

Everything else is done by a certified metrology company.

 

[BradM]

Hello there!! Welcome.

....
Gage software generates ticket for either calibration or recall verification for all equipment to be in-house inspected.
1) Do we, as a machine shop, have to record the temperature & humidity?
2) - Or state that it was performed under conditions listed in ISO 17025?
....

So the question here (or at least one question) is how to calibrate your in-house instruments. Is that correct?

1. What have you done historically? Did you do them in-house or send them to a qualified lab?
2. Does your organization have a written procedure for verification of these instruments?
3. If we're talking physical/dimensional, do you have calibrated gauge blocks of sufficient accuracy?

Main thing for now.... I would not go past due. You should have a qualified vendor on the supplier list that can easily calibrate/verify these things, if you don't feel you are set up (yet) properly to do them in-place.

If you're going to do them in-house, I would start by purchasing one of the standards Jennifer listed. If your organization is not accredited to ISO17025, I would avoid language as such.

 

[dwperron]

I'm a bit confused on clause 7.1.5.2. and am curious as to how other Machine Shops (as we are a CNC machine shop) and similar have established their in-house calibration/verification procedure that are AS9100 certified. I've scoured the forums but haven't found an answer, or so I think.

Gage software generates ticket for either calibration or recall verification for all equipment to be in-house inspected.
1) Do we, as a machine shop, have to record the temperature & humidity?
2) - Or state that it was performed under conditions listed in ISO 17025?

Simply put, I'm lost in what needs to be recorded on a In-House Calibration Sheet that's either Calibrated or Recalled/Verified through Master Sets.

ISO 17025 does not set out environmental requirements for calibrations.
It requires that the environmental conditions relevant to calibrations, which can include local gravity, atmospheric pressure, etc.,
be recorded. That way if the results need to be duplicated the environmental conditions can be compensated for.

AS9100 7.1.5.2 referring to "suitable environmental conditions" means that you have determined what those "suitable" conditions are, and then that you monitor your conditions to validate that you are meeting those standards. Typically in the dimensional world you will set environmental condition requirements based on your accuracy requirements and the effect of environmental conditions on your measurements.

 

[ASDriven]

@Kronos147 @BradM Thank you both! I definitely believe that I'm dumb and did not understand what the words 'calibrate' and 'verification' actually meant. Including @dwperron , I'm going to avoid any verbiage that insinuates 'declaring' ISO and/or ANSI conformance.

The question, more so, is if I'd be on the correct path to interpreting and initially executing the requirement with minimal adjustments needing to be made. Forgive my lack of knowledge as I'm new to the machining/manufacturing world.

1 & 3) The company decided to do in-house "calibration" last year on shop and personal mics, calipers, indicators, height gages against a master block set.
- The quality control room is currently temperature controlled & I'm looking to a Temp & Humidity Data Logger (as mentioned by @Jen Kirley)
- Quality System would Recall the equipment via the ticket system
- Data being recorded in-house on a data sheet would be the Verification
- On this Data Sheet, should Reference:
- QMS Procedure, Equipment Name & Type with Serial Number
- Is there anything else that should be recorded outside of measure results? (Nominals, -/+ limits, test spec/parameters, Uncertainty)
- Actual Calibration is performed on the Master Sets by an accredited and certified 3rd party lab that are traceable to NIST.
- Which our masters are.

2) We do have a very broad ISO9001 procedure for it but no specifics as it pertains to the equipment type.