Do NAVAIR and T.O. Procedures require validation?

J

jfgunn

#1
For some calibration methods, we use NAVAIR and T.O. procedures that we obtain from GIDEP.

I belive these procedures are valid and would not reuire additional validation much like an ASME standard. I have heard others who disagree.

I would like to know other people's thoughts on the topic. If you have a though from the view point of A2LA, L-A-B, IAS, NVLAP or ACLASS, that would be great.
 
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J

joshua_sx1

#2
Yes they do… since some of their requirements are differ from the conventional calibration procedures used in manufacturing and/or even in aviation…

…I have thought of it from aviation point-of-view…
 
J

joshua_sx1

#3
:notme: I have to add… and the only way to find whether you are complying with the regulatory requirements is to validate your procedures…
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#4
On this subject, I can't speak for most of the ABs you mention, but for IAS I can.....

The NA 17-20 and NA 17-25, and the USAF T.O.33K series procedures are considered validated and may be used exactly as obtained from GIDEP. A modification of the procedures (e.g., different setup) will require validation of the difference. The validation must include the uncertainty.

Hope this helps.

Hershal
 

Jerry Eldred

Forum Moderator
Super Moderator
#5
They are well developed good procedures. However, they are not perfect (no procedure is). They often follow the OEM requirements, but not always. I can't think of the model HP network analyzer; but there is a unit that comes to mind which HP (Agilent) required a particular impedance matching transformer to test one function. The T.O. (or Navair - which ever it was) did not even check that function. I believe it was a 600 Ohm impedance input which required a special (impossible to find) little matching transformer to enable testing with 50 Ohm instruments.

The OEM tested it; GIDEP did not. This constitutes a LIMITED CALIBRATION (checking less than the full specs of the instruments). This is acceptable to some; not acceptable to others.

There are other cases where on a complex instrument, the T.O. procedure whittles down an OEM procedure of between 200 and 300 pages down to 80 pages. I don't know the precise implications, but that may well be the issue - that we don't know the implications.

Often GIDEP may test the full range of the instrument, but make minor changes. Other times some areas are not tested. So my bottom line would be you need to be sure the GIDEP procedure meets your needs.
 

ScottBP

Involved In Discussions
#6
It has always been my lab's policy that if an OEM calibration procedure is available, use that over a T.O. (or NAVAIR or Army T.B.) procedure for the same unit, because quite often the military writes the T.O.s to fit their needs, takes fewer readings, or more, depending on the unit. Take a Fluke 5500A calibrator for example, where the T.O. overkills some parts compared to the manufacturer's procedure, yet loosens tolerances and skips over some sections. Example: The mfg. procedure calls for readings of square wave AC in decades of 3V at certain frequencies (e.g. 300 mV, 3 V, 30 V @ 10 Hz, 1 kHz, 20 kHz, 100 kHz), whereas T.O. 33K8-4-1093-1 calls for the readings to be in decades of 6V at more frequencies in different ranges (e.g. 600 mV, 6 V, 60V @ 9.5 Hz, 40 Hz, 0.9 kHz, 19 kHz, and 100 kHz). And the T.O. also tests the triangle and truncated sine function of the 5500A, whereas nothing is mentioned in the mfg. procedure. To top it off, the manufacturer's procedure's test point limits are at 90 day spec, whereas the T.O. specs are at 1 year spec.

The T.O. also takes into consideration what should be in the inventory of most PMEL labs (e.g. just about all PMELs have a set of ESI SR-1010 standard decade resistors on hand, whereas very few have Fluke 742A standard resistors, as called for in the mfg. procedure.) Our lab doesn't have 742As, but does have the SR-1010s, so we refer to that part of the T.O. for setup instructions, but use the mfg. procedure for the test points.

Having said that, would we actually have to write an in-house procedure that combines the two in order to satisfy the auditors?
 

Jerry Eldred

Forum Moderator
Super Moderator
#7
Those are some well made points. If I interpret your question correctly, if you are calibrating using a T.O. which differs in part from the OEM procedure, I think I understand you wonder if you would need to write what I'll call an "Addendum Procedure" for the T.O. to cover the differences; so that with T.O. combined with the "Addendum Procedure" you would fully cover the requirements of the OEM procedure?

I am not an ISO17025 auditor, so this is just my shot at it...

I believe it is debatable whether you would HAVE to. So I'll "talk out of both sides of my mouth" (so to speak):

WHY YOU WOULD HAVE TO: An instrument is spec'd by the OEM, and (implicitly) the procedure developed by the OEM THEORETICALLY covers all those specs to the degree necessary to assure it meets those specs. Therefore, anything LESS than the procedure developed by the OEM may be construed NOT to fully test those specs. This applies only to instruments which have a proper OEM calibration procedure.

WHY YOU WOULD NOT HAVE TO: Deviations from an OEM procedure do not necessarily mean that the instrument is not adequately checked to its full specs. For (fictitious) example, a DMM has 3, 30, 300, 1000 Volt DC ranges. OEM procedure checks at 3.000, 30.00, 300.0, 1000 Volts DC; a GIDEP procedure tests at 2.900, 29.00, 290.0, 900 Volts DC. In both cases tolerances are correctly calculated. For the sake of discussion, I would debate that testing at slightly below full range has some advantages and does not reduce the adequacy of the calibration. In OEM procedure there is possibility of false ranging (unit autoranges up to next range), and at full 1000 Volts DC, possibility of damage (I've always been nervous when testing 1000 VDC on DMMs).

MY BOTTOM LINE (Opinion) ON THIS: If you calibrate instruments in a compliant environment which requires appropriate adequacy of your calibration methods (i.e.: fully test OEM specs versus GIDEP (T.O.)), there needs to be good engineering judgment that the GIDEP procedure is adequate. I believe (not know; believe) if you review a GIDEP procedure that differs from OEM procedure, you must decide whether those differences still adequately verify full performance of the instrument. You need to be intellectually honest about it. If the GIDEP procedure is fully adequate with differences, document it. If you review a GIDEP that has no differences (maybe looks different but in fact tests all the same specs), document that. If it does not test all specs, don't use the procedure.

I believe if you have reviewed differences and properly documented and approved them, it should hold up in an audit. The answer to an auditor who observes differences would then be that those differences have been reviewed, determined not to impact the adequacy of the calibration method, and the procedure approved.

The followup question I guess would be how do you know it is still valid with those differences. I would suggest also that in the approval, there be some justification of with the answer to that question.

This I think is analogous to requirements for when you develop an inhouse procedure. There needs to be a peer review process or other such method to validate adequacy of the procedure.

I'd definitely like to hear from some of the ISO17025 auditors what they think of my points.
 
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