Calibration of Processes

Mandy

Involved In Discussions
#1
My experience has taught me that calibration has to do with equipment.

However my company uses the term when discussing a process (here is an example of what they wrote "all the experimental parameters were calibrated, and once optimized a system freeze was done".)

This to me is validation, but before I tackle top management, just want to check with other more experienced QA people out there, that I am correct
Thanks.

PS Our company is developing an IVD.
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#2
My experience has taught me that calibration has to do with equipment.

However my company uses the term when discussing a process (here is an example of what they wrote "all the experimental parameters were calibrated, and once optimized a system freeze was done".)

This to me is validation, but before I tackle top management, just want to check with other more experienced QA people out there, that I am correct
Thanks.

PS Our company is developing an IVD.
If the word calibrate is understood as validate in the process, and the word calibrate is understood as calibrate in measuring equipment, there may be no need to tackle the top management on the use of the word.
The more understanding is necessary at the executing and middle management.
 
#3
My experience has taught me that calibration has to do with equipment.

However my company uses the term when discussing a process (here is an example of what they wrote "all the experimental parameters were calibrated, and once optimized a system freeze was done".)

This to me is validation, but before I tackle top management, just want to check with other more experienced QA people out there, that I am correct
Thanks.

PS Our company is developing an IVD.
Why not use the international vocabulary document and other references, such as ISO 9000 etc and either make a presentation on the (correct) use of terminology, so that everyone is aligned. You are correct and, if the rest of the organization doesn't adopt this (universally) accepted use of terminology, they will get into problems of communication later - especially with external auditors!

Good idea to fix it now!
 
Thread starter Similar threads Forum Replies Date
R Validation of outsourced processes - Calibration - How do we validate that? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
R Identifying Outsourced Processes - Training, Calibration, Consulting - TS-16949 IATF 16949 - Automotive Quality Systems Standard 2
lanley liao Question regarding the calibration of monitoring and measure equipment. Oil and Gas Industry Standards and Regulations 0
N IATF Calibration Lean in Manufacturing and Service Industries 4
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
T Plug Gage Calibration Calibration and Metrology Software and Hardware 1
M Load Cell Calibration using a totalizer on a flow meter General Measurement Device and Calibration Topics 0
E Calibration Records needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D Limited Range Calibration - 5000 lb Industrial floor scale General Measurement Device and Calibration Topics 3
D Calibration of Small Scales General Measurement Device and Calibration Topics 26
C How to Establish the Calibration & Measurement Capability (CMC)? ISO 17025 related Discussions 1
I IQOQ or just initial calibration required? General Measurement Device and Calibration Topics 3
B Calibration in real life ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
A Is calibration of test weight required General Measurement Device and Calibration Topics 4
S Calibration Frequency for Slip Gauge Kit used for CMM Calibration? General Measurement Device and Calibration Topics 0
S Calibration/Verification of customer fixtures IATF 16949 - Automotive Quality Systems Standard 6
Ron Rompen Calibration by manufacturer ISO 17025 related Discussions 4
Q Calibration verification records 7.1.5.2.1 IATF 16949 - Automotive Quality Systems Standard 2
B AS9100D 7.1.5.2 Calibration or Verification Method using outside cal lab AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
W Next Calibration Due Date Calibration Frequency (Interval) 5
S Where do l get calibration standards to run a calibration lab? Other ISO and International Standards and European Regulations 2
A OEM On-Site Calibration issues during Covid19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
D Calibration tolerance question using Pipettes Medical Device and FDA Regulations and Standards News 1
M Calibration Certificate Result issued by an accredited external laboratory General Measurement Device and Calibration Topics 9
G Calibration of "Master Parts" Used as Gauges Calibration Frequency (Interval) 5
R Calibration lab environmental monitoring General Measurement Device and Calibration Topics 4
G Calibration of Rotronic probe but not digital readout? General Measurement Device and Calibration Topics 3
F Standard Calibration Procedures: Recommended Practice ISO 17025 related Discussions 0
T Temperature Requirements For In House Calibration - AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
B Gage calibration frequency, ISO and IATF - What are the requirements Calibration Frequency (Interval) 3
Crimpshrine13 Laboratory Scope - Calibration vs. Test Methods - IATF 16949 IATF 16949 - Automotive Quality Systems Standard 3
Crimpshrine13 Calibration of pH Meter Probe Calibration and Metrology Software and Hardware 3
F ESD workbench "calibration" Manufacturing and Related Processes 2
C Correct Calibration Method for Dial Depth Gage General Measurement Device and Calibration Topics 6
F Nist traceable calibration certificates General Measurement Device and Calibration Topics 1
G Tool tracebility and First calibration requirements for aerospace (AS9100) organisation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
D Calibration of Digital thermometer with surface probe General Measurement Device and Calibration Topics 1
T Calibration or Verification -> Cm and Cmk, etc. Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
G Is repeatability required for equipment calibration? General Measurement Device and Calibration Topics 10
was named killer AS 9100D - Calibration Instructions - Controlled documents? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
B Photovoltaic Tester Calibration General Measurement Device and Calibration Topics 0
B Temperature loop: partial calibration General Measurement Device and Calibration Topics 10
G Glass scale calibration at 74 degrees F? General Measurement Device and Calibration Topics 4
A Digital Timer Calibration Requirements General Measurement Device and Calibration Topics 3
Ron Rompen Barcode Verifier Calibration and Use Calibration and Metrology Software and Hardware 5
S Is Optical Parallel Set required calibration? ISO 17025 related Discussions 1
A Calibration of Power Supplies AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
D Calibration Process Flow Map Example Wanted General Measurement Device and Calibration Topics 3
M Calibration or Verification? What terminology to use ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1

Similar threads

Top Bottom