Equipment Mobility - Transfer of manufacturing lines to a different location

#1
Hi covers,

We are performing transfer of manufacturing lines to a different location and as part of that we need to perform IQ, OQ, and PQ activity.

Right now we are at IQ stage. As a QE, I had a discussion with ME and Cal. team as to what equipment mobility requires. We are not quite clear on this one.

Any experienced Covers can shed some light on this one?

Also, our WI says we need to perform pre and post move calibration if we find the equipment non-mobile.

Thanks in advance for your input
 
Elsmar Forum Sponsor

Marc

Fully vaccinated are you?
Leader
#2
Not medical, but my bet is it's essentially the same if the equipment not mobile (e.g. big surface plates) in that everything has to go through IQ, OQ, and PQ: PPAP Clarification - Tooling Transfers

Not to mention the location of the equipment - Is it used on the line? A small controlled environment lab?

Hopefully an "FDA type" person can correct me if I'm wrong.
 
#3
Not medical, but my bet is it's essentially the same if the equipment not mobile (e.g. big surface plates) in that everything has to go through IQ, OQ, and PQ:
Not to mention the location of the equipment - Is it used on the line? A small controlled environment lab?

Hopefully an "FDA type" person can correct me if I'm wrong.
It is used on a line.

We are having multiple discussions regarding mobility and its link to Calibration.
 

Ronen E

Problem Solver
Moderator
#4
I'm not aware of an FDA guidance for moving facilities. I think you'll have to treat the new facility as a brand new one. This is just my general knowledge - I haven't researched it lately and I don't have direct experience in a similar situation.

Cheers,
Ronen.
 
M

Metron

#5
Has a change control been initiated?
This should have all been captured within this document.
I assume all calibrations were performed pre-move to assure any processes performed at its original location were done with a qualified, calibrated unit.
once moved/ installed an additional post-move calibration would be required along with a full qualification.
this assures all aspects of the unit are operational in its new location.
 
A

albridgeuk

#6
The regulators expect you to validate once you are re-sited. You can mitigate this by using a risk assessment to define exactly what will or will not be affected by the move. However, it is often best practice to revalidate.

Pre-calibration is usually only done to give you confidence that the item is currently serviceable. It does not assist in any other way and is not mandatory.
The only difference between portable and static item calibration is the periodicity between calibrations.

Static items mounted to robust worktops (surface plates, dead weight testers, etc) can actually be extended to 5 years between calibrations. There again fragile test instruments can require pre-use calibration.
It is up to the user to build up the calibration history data, and use that as justification for progressively extending (or reducing) the periodicity of calibration. That is the set up the regulators look for.

Moving qualified equipment means qualifying the new site;
Utility loadings - RFI freedom - EMI freedom - Climatic conditions - access product - access personnel - cross contamination possibilities.
Then all the rest of the equipment functionality tests and inspections.

Alex
 
Thread starter Similar threads Forum Replies Date
H DIN 12880:2007-05 Clause 7.2 Test Equipment Description CE Marking (Conformité Européene) / CB Scheme 0
B Painted surface of a protective Class I equipment. CE Marking (Conformité Européene) / CB Scheme 1
K What are the differences between the certificates required for home and medical medical equipment? US Food and Drug Administration (FDA) 1
B ISO 13485 Qualification of R&D Equipment Qualification and Validation (including 21 CFR Part 11) 1
R EU 2017-745 - Dental Equipment CE Marking (Conformité Européene) / CB Scheme 4
T Need advice on what inspection equipment to buy. General Measurement Device and Calibration Topics 2
Q What is considered "Multimedia equipment" (60601-1-2 section 7.1.3) IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
V Is it required to recalibrate reference- standard instruments after equipment qualification General Measurement Device and Calibration Topics 0
armani Monitoring and measuring equipment for occupational health and safety purposes Occupational Health & Safety Management Standards 10
P Type of MSA study according to measurement equipment Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
Rene Minassian Control of (TMME) Testing and Measurement Equipment Oil and Gas Industry Standards and Regulations 2
M Cameras and Visual Inspection Equipment General Measurement Device and Calibration Topics 3
JoeRandom11 Question about Customer Supplied Equipment AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
C Equipment IQ and OQ ISO 13485:2016 - Medical Device Quality Management Systems 9
D PPE (Personal Protective Equipment) in the UK CE Marking (Conformité Européene) / CB Scheme 1
D Recommendations for equipment used to validate cold storage units General Measurement Device and Calibration Topics 3
T PFMEA vs MFMEA or DFMEA on equipment/machinery FMEA and Control Plans 19
E Brass in medical equipment Other Medical Device and Orthopedic Related Topics 5
G QSB+ : capability of measurement equipment IATF 16949 - Automotive Quality Systems Standard 15
M Gage R&R automated test equipment Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
G Developing our custom test methods and test equipment US Medical Device Regulations 5
E Compressed air quality in ME equipment (used in OR) IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M ISO 17025:2017 Clause 6.4 - Measuring Equipment Validity ISO 17025 related Discussions 2
W Strategy for determining which components from a system should be "ME EQUIPMENT" -- home healthcare environment IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
M Do i need to have equipment validation if 100% testing is completed? Qualification and Validation (including 21 CFR Part 11) 6
K Brazil (INMETRO) for Medical Electrical and IVD Equipment? Other Medical Device Regulations World-Wide 0
Y Creating Equipment qualification protocol Qualification and Validation (including 21 CFR Part 11) 2
R Suggest modern equipment/instrument for plastic bottle inspection? Quality Tools, Improvement and Analysis 1
S Certification of equipment after move General Measurement Device and Calibration Topics 14
B Building my own measurement equipment General Measurement Device and Calibration Topics 3
J Process Capability - Determining the process capability of certain equipment Lean in Manufacturing and Service Industries 6
W Classes and Applied Part IEC60601 Electromedical Equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A PPAP Alternate Equipment IATF 16949 - Automotive Quality Systems Standard 10
Q Measurement Equipment Revocation - Looking for a Disposal Form with Risk Assessment IATF 16949 - Automotive Quality Systems Standard 10
E Comparison of Personal Protective Equipment Standards EN 14605 vs GB24539 and ISO 13982 vs GB 24539 Occupational Health & Safety Management Standards 0
E Comparison of Respiratory Protective Equipment Standards (China Standard Compare with EU standard of EN149 Occupational Health & Safety Management Standards 2
M Calibration of equipment IATF 16949 - Automotive Quality Systems Standard 4
P 7.5.10 Customer property - applies to leased/rented equipment? ISO 13485:2016 - Medical Device Quality Management Systems 10
S Class I Equipment with mobile power inverter IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
U Calculate acceptance of equipment reading after calibration General Measurement Device and Calibration Topics 2
K Ground Bond Test for Class I Medical Electrical Equipment - calibration problems IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
W Equipment Bracketing Approach US Food and Drug Administration (FDA) 0
H Still having trouble as to what equipment falls under 8.5.1.1 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S Medical device equipment calibration Qualification and Validation (including 21 CFR Part 11) 1
J Register of the monitoring and measuring equipment AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
B Do CTQs need to be equipment specific? FMEA and Control Plans 8
M IATF 16949 SI # 10: Integrated self-calibration of measurement equipment- Needs for explanation IATF 16949 - Automotive Quality Systems Standard 2
B Risk analysis for defective measuring or measuring equipment out of calibration General Measurement Device and Calibration Topics 2
C Revalidation of Process Equipment for Equipment Transfered to New Facility. ISO 13485:2016 - Medical Device Quality Management Systems 5
V Clause 7.1.3.1 Plant, facility, and equipment planning Lean in Manufacturing and Service Industries 0

Similar threads

Top Bottom