ISOTECH TTI-10 found out of calibration - Calibration house was wrong?

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#1
We recently received out ISOTECH TTI-10 back from the cal house and it was "received OOC' we opened a CAPA. This device is a temperature measuring device. We ran some internal tests. We set it against an oven we have that was calibrated last month. It should be noted that my companies sole product is a temperature measuring patch that is verified and validated.

For the test we put the over to 30'C and placed the TTI-10 and 20 of our own devices in the oven. The result was that all of our patches agreed with the oven but the TTI-10 was 0.400'C over the set point.

I havean ISO 13485 audit next week. We have sent the TTI-10 to ISOTECH with our complaint for them to review this issue.

How should I defend this to the auditor that I believe the calibration house was wrong?

TLDR: We sent a device out for cal and the cal house said it was received OOC. We sell validated devices that also do the same thing the tool does and it disagrees.
 
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dwperron

Trusted Information Resource
#2
Ed,

Forgive the stupid question, but I need to follow my script.

You sent the TTI-10 out for calibration. Did you include a probe, and were they calibrated as a system?
The reason why I ask is that you do not mention anything about the probe you used with the meter, and that could be the problem.
 

dwperron

Trusted Information Resource
#4
Did they calibrate it with the probe, or did they just do a resistance substitution with the meter?

Also, tell about the oven.
How was it calibrated? To what accuracy? What point in the oven is being monitored?
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#5
It was calibrated with the probe.

The oven report is as follows:

Customer:
Address: Calibration Location:
Contact:
Manufacturer: Date Received:
Description: Date Calibrated:
Model Number: Calibration Due Date:
Serial Number: Calibration Procedure:
Asset Number: Performed By:
Ambient Temperature: 20.8° C Relative Humidity: 36.4%rh Barometric Pressure: 0
Measurement Uncertainty: See Calibration data sheet
Reviewed: Date:
Page 1 of 2
Quality Manager
10/16/18
Ambient Calibration Conditions
Vaisala Temp/Humidity Probe HMP77B P2520230 06/21/18 06/21/21
Vaisala Temp/Humidity Indicator MI70 P2310011 06/21/18 06/21/21
01/30/17 01/30/20
01/30/17
10/16/18
10/16/18
10/15/20
Calibration Date: Due Date:
01/30/20
Calibration Equipment Used
Cincinnati Sub-zero
Temperature/Humidity chamber
MCH-3-50-50-H/AC
MC1129026
57.3
CP0001
Omega Type T Probe 52 CL032250
Name/Description: Model: Serial:
Fluke Process Calibrator 744 8776014
Certificate Number: 68152-01
Certificate of Calibration

Equipment Calibrated

The Uncertainty is estimated using a coverage factor (k) of 2, providing a confidence level of approximately 95%.
This calibration is traceable to the international system of units (SI) through standards calibrated by accredited
laboratories, or through standards calibrated at NIST. This laboratory meets the requirements of ISO/IEC 17025-
2005 and ANSI/NCSL Z540-1-1994. This certificate shall not be reproduced, except in full, without prior written
approval by Auto Technology Company.
Calibration interval and tolerance can only be determined by the customer. When determining the calibration
interval and tolerance, the customer should use the governing quality policies, test procedures, and calibration data
to determine interval and tolerance of above calibrated item(s).
CALIBRATION
CERT# 2563.01
MFG/MODEL: Cert #:
Location: Serial / ID #:
Work Order No.: Date Calibrated:
All calculations and data transfers have been reviewed for accuracy and completeness
Condition
Process
Variable
Lower
Limit
As Found As Left
Upper
Limit
Uncertainty
TEMPERATURE
Cabinet -70.0° C -72.0° C -70.3° C -68.0° C 1.2° C
50.0° C 48.0° C 50.1° C 52.0° C 1.2° C
150.0° C 148.0° C 148.9° C 152.0° C 1.2° C
HUMIDITY
Cabinet 20.0 %RH 15.0 %RH 22.2 %RH 25.0 %RH 1.9 %RH
50.0 %RH 45.0 %RH 52.3 %RH 55.0 %RH 1.9 %RH
95.0 %RH 90.0 %RH 96.1 %RH 100.0 %RH 2.6 %RH
Performed By: Unless otherwise noted
As Found = As Left
Date Performed:
*N/F = Found not functioning,
Cal. Environment: the customer was alerted.
This item was not calibrated.
Notes: Customer has requested Every other Year calibration interval.
If as found is highlighted
Page 2 of 2 above, it was out of tolerance

10/16/18
20.8°C 36 %RH
n/a Tuesday, October 16, 2018

Cincinnati Sub-zero Model #
MCH-3-50-50-H/AC 68152-01
 
Last edited:

dwperron

Trusted Information Resource
#6
You have a problem if you are trusting your calibrated oven's accuracy.

You are concerned that there was a 0.4°C difference between the oven and your TTI-10 meter.
Although the formatting of the calibration data you provided got scrambled, it appears that the tolerance for the oven is ± 2.0°C, with a measurement uncertainty listed of 1.2°C for the calibration. With those numbers there is no way you can declare the oven to be accurate to 0.4°C.

The meter your calibration lab used for calibrating the oven has a basic accuracy of 0.3 to 0.6°C (depending on the temperature being measured) and the Type T probe they used adds 0.5 to 1.0°C (depending on if it is special limits of error material).

They also don't declare where they are monitoring the chamber temperature during the calibration. Was it up at the top with the controller probe, or was it in the center of the chamber, or somewhere else. How does this compare to where you are monitoring the temperature? They did not do a multi-point calibration in the oven, and they do not reference the oven's temperature uniformity tolerance, so just the placement in the oven can cause considerable temperature deviations which are undocumented.


Your TTI-10 has a basic accuracy of ± 0.012°C for the meter and 0.15 to 0.3°C for the probe (depending on the class of the probe).

Unless the TTI-10 calibration was botched I'd trust your meter long before the oven.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#7
I should also mention Our Main product is a device that measures temperature validated to ASTM E1112 (2011) and it has a tolerance of +/- 0.10 'C at 37'C and it disagrees with the TTI and says it is off by 0.4 'C. at 37'C
 

dwperron

Trusted Information Resource
#8
Since you are having the calibration reviewed by your provider you will have to wait for their response.

When you get it back you can perform a basic sanity check by making an ice bath "slushy" and checking the accuracy of your meter/probe.
A well made ice bath will give you much better accuracy than 0.4°C, so you will see if their calibration is your problem.
 
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