Traceability for Mercury Argon Calibration Source to Calibrate a Spectrometer?

R

RCW

Quite Involved in Discussions
#1
#1
I am using an Ocean Optics HG-1 Mercury Argon Calibration Source to calibrate a spectrometer. My dilema is justifying within my quality systems that there is no calibration traceability for the Calibration Source. Ocean Optics has confirmed there is no calibration / verfication to be done with the Calibration Source. The unit is using the natural, physical characteristics of mercury and argon for wavelength generation.

A number of options come to mind. I can label the Calibration Source as "No Calibration Requred" and wait for some outside auditing source (3rd party or customer) to jump on that. Maybe still log it in my calibration system? I'm looking for suggestions on the proper way to handle this situation. This is all very new to me as my monitoring and measurement equipment is usually traceable to NIST standards.
 
Elsmar Forum Sponsor
Hershal

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#2
#2
This may not have gotten much response yet since the weekend is almost here. I and I am sure others also will look around and see if we can help.
 
T

True Position

#3
#3
RCW said:
I am using an Ocean Optics HG-1 Mercury Argon Calibration Source to calibrate a spectrometer. My dilema is justifying within my quality systems that there is no calibration traceability for the Calibration Source. Ocean Optics has confirmed there is no calibration / verfication to be done with the Calibration Source. The unit is using the natural, physical characteristics of mercury and argon for wavelength generation.

A number of options come to mind. I can label the Calibration Source as "No Calibration Requred" and wait for some outside auditing source (3rd party or customer) to jump on that. Maybe still log it in my calibration system? I'm looking for suggestions on the proper way to handle this situation. This is all very new to me as my monitoring and measurement equipment is usually traceable to NIST standards.
Click to expand...
Can you validate the purity of your reference materials?
 
R

RCW

Quite Involved in Discussions
#4
#4
True Position said:
Can you validate the purity of your reference materials?
Click to expand...
I don't know. I was given this unit by somebody else here at work. They told me there weren't any certification documents with it. I would have to contact the manufacturer of the unit to see if some kind of purity documentation is available.

Personally, I do not have a way to verify the purity at my workplace.
 
J

JaxQC

#5
#5
I would suggest going with both 1) validate the purity of your reference materials as mentioned previously as well as 2) the use of a "master". Some material that will not change over time (expire) and use a small sample periodically to verify that you get the same result. If you start to run out, do a comparison to the new batch of sample material and note the bias or shift.
 
W

WalkingSeed

Involved In Discussions
#6
#6
With intrinsic standards you need to have it verified by a recognized body or participate in an inter-laboratory comparison program. This is mandatory only if you are pursuing ISO-17025 but the practice is valid and does verify the proper operation of your source.

I do not know if Ocean Optics is accredited by an ILAC or APLAC signatory but if they are, a C of C or some other statement of the quality / accuracy of the device from them should suffice. It is left up to you to determine the appropriate inter-laboratory comparison or recertification interval.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
S IATF 16949 - Partial traceability of Aftermarket products IATF 16949 - Automotive Quality Systems Standard 5
R DHR question: Traceability of components ISO 13485:2016 - Medical Device Quality Management Systems 2
A Does AS9100 require traceability to operators performing the work? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
J Traceability of component parts - Bolts, screws and washers ISO 13485:2016 - Medical Device Quality Management Systems 3
R Traceability on Unmarked Parts - AS9100 requirements AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 7
T Non conformance product identification and traceability 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
B Traceability of Thermoelement Batches ISO 17025 related Discussions 7
G ISO 17025:2017 Uninterrupted chain of traceability for test laboratories ISO 17025 related Discussions 6
J What is the minimum standard for automotive component traceability? Manufacturing and Related Processes 2
A Validation of Calibration Methods and Traceability - ISO 17025 ISO 17025 related Discussions 3
shimonv Design input/output traceability for mechanical parts ISO 13485:2016 - Medical Device Quality Management Systems 13
K Identification and Traceability with an ERP system - Barcode Labels? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B PED 2014/68/EU - Is this Traceability audit finding correct? Other ISO and International Standards and European Regulations 4
N FDA Traceability Requirements - Component lots ISO 13485:2016 - Medical Device Quality Management Systems 2
Stefan Mundt ISO 9001:2015 - 8.5.2 Identification and Traceability Manufacturing and Related Processes 14
S How to maintain a design traceability matrix ISO 13485:2016 - Medical Device Quality Management Systems 2
N Requirements for the identification and traceability of demo product for sales force US Food and Drug Administration (FDA) 1
MrTetris Traceability in Medical Sofware Development Process IEC 62304 - Medical Device Software Life Cycle Processes 3
M Medical Device Traceability ISO 13485:2016 - Medical Device Quality Management Systems 9
G Where to list chain of traceability? ISO 17025 related Discussions 6
A AS5553B Counterfeit Prevention - Traceability requirements AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 10
T In house Calibration? Measurement equipment traceability requirements - ISO9001 General Measurement Device and Calibration Topics 12
R ISO 9001:2015 Clause 7.1.5.2 - Is Measurement traceability applicable? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M Medical Device Traceability Matrix - Examples EU Medical Device Regulations 6
DeeDeeM IATF16949, clause 8.5.2.1 Identification and traceability-supplemental IATF 16949 - Automotive Quality Systems Standard 1
DeeDeeM IATF 16949 - Clause 8.5.2 Identification and Traceability IATF 16949 - Automotive Quality Systems Standard 7
D IATF 16949 - 8.5.2.1 Traceability Plan - Does anyone have an example? IATF 16949 - Automotive Quality Systems Standard 4
A UDI - Traceability of Products Other US Medical Device Regulations 1
B AS9100 Rev D - Traceability of Consumables AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
J Customer Identification and Traceability in Manufacturing Plans Manufacturing and Related Processes 5
S Traceability and the initiation of GMP Activities 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
N Calibration Traceability - Fluke 753 dpc with thermocouple Calibrated by Fluke ISO 17025 related Discussions 4
T Policy or Good Guidance for a Traceability Decision Tree (Serial and Batch Numbers) Misc. Quality Assurance and Business Systems Related Topics 4
J How to understand IATF 16949 Clause 8.5.2.1 - Traceability IATF 16949 - Automotive Quality Systems Standard 5
A Aluminum Die Casting Product Traceability Manufacturing and Related Processes 10
G Traceability - Checklist from NIST General Measurement Device and Calibration Topics 4
Raffy ISO 13485 NIST Traceability requirements for calibration of test equipment ISO 13485:2016 - Medical Device Quality Management Systems 3
G Traceability of laser based x-y measuring machine General Measurement Device and Calibration Topics 5
A Power Traceability certificate for values for voltage, current and phase General Measurement Device and Calibration Topics 1
Q Allowed no manuals, technical instructions traceability in products ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Is NIST traceability required if a Refractometer calibration is done in-house? Calibration Frequency (Interval) 6
M Component Lot Number Traceability - Class I reusable and "resposable" Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 10
B What is the FDA guidance regarding selling replacement parts and traceability? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J Individual part traceability - ink/paint sprayer? IATF 16949 - Automotive Quality Systems Standard 4
A Active Implantable Medical Devices - Legal Traceability Requirements ISO 13485:2016 - Medical Device Quality Management Systems 7
M Establishing traceability from calibrated glassware to non calibrated ones General Measurement Device and Calibration Topics 5
M Traceability of Tissue Samples US Food and Drug Administration (FDA) 1
R Drilling Service Identification and Traceability Requirements Quality Manager and Management Related Issues 4
G Required Chains Identification for Traceability Calibration and Metrology Software and Hardware 3
A Ensuring Tooling Use Tracking and Traceability AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
Similar threads
Top Bottom