Does every piece of equipment used in a laboratory need to have an IQ protocol written and executed?

duff999

Quite Involved in Discussions
#1
Does every piece of equipment used in the lab need to have an IQ (installation qualification) protocol written and executed? Would this include hand tools such as micrometers, calipers, etc. Can recent calibration services performed cover the IQ portion. Also, if no IQ was every performed on any of the equipment do you suggest performing the IQ.

thanks
 
Last edited by a moderator:
Elsmar Forum Sponsor

yodon

Leader
Super Moderator
#2
All equipment should be appropriately qualified. It's your responsibility to define (and defend) what's appropriate.

Calibration is not qualification. Calibration is about accuracy; qualification is about appropriateness. Part of qualification may be calibration but not all.
 

duff999

Quite Involved in Discussions
#3
All equipment should be appropriately qualified. It's your responsibility to define (and defend) what's appropriate.

Calibration is not qualification. Calibration is about accuracy; qualification is about appropriateness. Part of qualification may be calibration but not all.
Thanks of always being a wealth of knowledge in answering my questions. I am circling back with calibration and qualification, for pipettes specifically. I understand that calibration can be part of the qualification process, do you have any experience with what other than calibration can satisfy IQ, OQ of a pipette. During calibration they measure accuracy, and perform operational tests. Would I need any more than that to defend that things are installed and operational. Thanks
 

Tidge

Trusted Information Resource
#5
I am circling back with calibration and qualification, for pipettes specifically. I understand that calibration can be part of the qualification process, do you have any experience with what other than calibration can satisfy IQ, OQ of a pipette. During calibration they measure accuracy, and perform operational tests. Would I need any more than that to defend that things are installed and operational. Thanks
Consumable lab tools like pipettes shouldn't need much more in an "IQ" other than identification of the specific type pipette used, and storage conditions established.

I would totally pass on an individualized OQ, assuming that you implement a standard method of reading the measurements of specific pipettes you use. ASTM may have such a standard, or there may be another recognized technical society.

As far as "PQ", I can foresee two possible approaches:
  1. A typical "run through the standard process with standard variation from raw materials, operators." using your manufacturing/test procedures
  2. Some sort of round-robin testing of pipette usage against the (ASTM?) standard
My first PQ suggestion is IMO more valuable, as you can leverage/inform control charts for your standard process. The second is only recommended if there is some variability (attributed specifically to the use of the pipettes) that you want to analyze, or are otherwise required to monitor/control.
 
#6
If you have an IQ OQ PQ based process already then the IQ on these hand tools could simply be a check for suitability. E.g. Range, calibration status, damage and included in the lab asset register with recal dates. If you don’t have a prescriptive process you can do the same and call it a “hand tool introduction process” and include some of the PQ suggestions above
 

Mhalik

Starting to get Involved
#7
Hello, in the last company I worked in, I defined a differently approach depending if it was an equipment or measuring device.
For what we called equipment, we automatically performed IQ and OQ of the equipment, and then if it was a special process we would add OQ and PQ of the process.
In another hand, for the measuring devices we only performed verification/calibration and metrology follow up (life sheet, identification, planning) .
Note that complex test benches were part of "equipment" : we had the IQ/OQ of the equipment + PQ (Gage R&R)

Our notified body was OK with this approach for ISO 13485 and CE mark, but it was never submitted for FDA audit

I never had pipette in our production area but I think I would have treated them following our "measuring device" approach
 
Thread starter Similar threads Forum Replies Date
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
E Does every metallic part have to be protectively earthed (class I ME)? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
L Does every document on a project require a document number? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C Does every procedure need to be included within a policy? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J Does Every Staff need to read the ISO9001 Quality Manual from Cover to Cover? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
Q Does 21 CFR 820 really revise every year? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Q Does every Process Control listed in FMEA have to be listed in the Control Plan FMEA and Control Plans 4
L 8.2.4.2 First Article Inspection - Does every new part that is run require a FAIR AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
C Does every PMA part have to have an 8130 form? Or compliance with part 21.303? Federal Aviation Administration (FAA) Standards and Requirements 4
C Does all gauges mean every gage? Manufacturing Engineering (Paragraph 7.6.2) IATF 16949 - Automotive Quality Systems Standard 10
G Does ISO 9001 require a procedure for every part of the business? Document Control Systems, Procedures, Forms and Templates 8
G Does ISO9001 require every nonconformance to have a root cause analysis? Problem Solving, Root Cause Fault and Failure Analysis 21
S TS 16949 Compliant Control Plans - Does every item need a record? FMEA and Control Plans 5
D Certified shipment does it mean every part has to be checked 100%? Nonconformance and Corrective Action 12
K Does every Nonconformance Require a Corrective Action? Nonconformance and Corrective Action 8
D Does every company or employee owned gage have to be calibrated? General Measurement Device and Calibration Topics 2
D Following AS9102 for FAI Requirements - Does EVERY Component Need Its Own FAI? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 40
A Issuing Countermeasure Report - Does every nonconformance identified require an NCR? Nonconformance and Corrective Action 2
W Does every nonconformance require a corrective action? Nonconformance and Corrective Action 6
H Does ISO state in anyway that we MUST keep physical first piece parts? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
XRAY_3121 Class II heating pad - does the power supply have to have IEC 60601-1 testing?? US Medical Device Regulations 5
F Change in address for critical supplier - does NB need to be informed? CE Marking (Conformité Européene) / CB Scheme 16
S Brexit ISO 13485:2016 + Corrigendum - What does a UKCA DoC require? EU Medical Device Regulations 2
G Does anyone know about tobacco-free nicotine pouches? US Food and Drug Administration (FDA) 0
cgaro62 Does FDA apply to a non-medical 13485 certified custom manufacturing company? ISO 13485:2016 - Medical Device Quality Management Systems 11
R Does anyone use iQMS for their ISO based document control? Manufacturing and Related Processes 1
V How many hrs does it take to create a Technical File (TD)? EU Medical Device Regulations 4
M How does FDA determine OAI and VAI after inspection? ISO 13485:2016 - Medical Device Quality Management Systems 0
G Does TPI agencies comes under outsourced process as per Q1 Oil and Gas Industry Standards and Regulations 11
N FPY requested for an industry that does not have rework IATF 16949 - Automotive Quality Systems Standard 4
William55401 21 CFR 11 Password Aging - What does "periodically" revised mean in your org? Qualification and Validation (including 21 CFR Part 11) 3
I CQI-15 Welding System Assessment 2nd edition - Does not require Ultrasonic Welding anymore? Customer and Company Specific Requirements 0
Ajit Basrur Does "Refurbishment" fall under "Service"? ISO 13485:2016 - Medical Device Quality Management Systems 13
T Does marketing company require CE mark if manufacturer has CE mark on product? EU Medical Device Regulations 5
Watchcat REGULATORY WATCHCAT De Novo Post-Mortem 6 – How Does This Even Happen? Other US Medical Device Regulations 0
T What does VW mean by annual requalification? Customer and Company Specific Requirements 3
I Does BSI require suppliers to be ISO 9001 Certified? EU Medical Device Regulations 12
Watchcat Does Regulatory Affairs put the "no" in innovation? Other US Medical Device Regulations 14
Q Does anyone know what this call out means? Manufacturing and Related Processes 3
K COPLANARITY: Composite profile tolerance on multiple surfaces- what does" lower dimensional reference frame tolerance" control? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
P Does FDA require certification for quality system internal audit for auditor? Qualification and Validation (including 21 CFR Part 11) 1
H Does anyone has feedback on a notified body for small companies? EU Medical Device Regulations 3
M Does 4.5 - Alternative RISK CONTROL apply to the Particular Standards? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
E Does IVD need to integrate with hospital IT infrastructure? Medical Information Technology, Medical Software and Health Informatics 2
D What does a level 1 (PSW) PPAP actually promise? APQP and PPAP 19
R GS1 DataMatrix code does not meet GS1 Specification EU Medical Device Regulations 0
M Does the scope of ISO 9001:2015 applies to tenders, pricing and sales department of a medical devices distributor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
K Why does load cell supplier requires force verification General Measurement Device and Calibration Topics 3
M Does C=0 strictly mean 1 bad, all bad, all the time? ISO 13485:2016 - Medical Device Quality Management Systems 6

Similar threads

Top Bottom