SBS - The Best Value in QMS software

Relocation of Equipment - Equipment Validation template wanted

D

dbazinet

#1
We are an AS9100, ISO 9001, ISO 13485 registered electronics contract manufacturer of circuit board assemblies. I am looking for an equipment validation template that can be used to validate a piece of equipment after picking up that piece of equipment and moving it to a new location. Does anyone have a template that I can download? Thanks.
 
Last edited by a moderator:
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#3
Was the system in a validated state before? If so, can the original validation protocols be used - at least as a basis to start (you may be able to make risk-justified decisions to do a subset of the effort).

Do you have anything like a validation master plan? That would possibly drive what all you need to do.
 
#4
This may help - IQ required if moving Equipment or if the Equipment is new, Sounds logical since the only thing that you need to verify is the installation at a new location.
 

dsanabria

Quite Involved in Discussions
#5
We are an AS9100, ISO 9001, ISO 13485 registered electronics contract manufacturer of circuit board assemblies. I am looking for an equipment validation template that can be used to validate a piece of equipment after picking up that piece of equipment and moving it to a new location. Does anyone have a template that I can download? Thanks.
First start with AS9102 - First Article Inspection Report - once you move an equipment from location, you are required to perform one per AS9102 - if it is flown down to you.

Next - find out what else your customer requires when relocation an equipment.

Third check out the standard on software - AS9115 - not sure if it applies (deliverable software.

Finally: http://www.sae.org/servlets/registr...HGeneral&PAGE=getSCMHBOOK&vgenNum=184&scmhs=2

Chapter 7.1

Start with those and then come back to the cove.
 

somashekar

Staff member
Super Moderator
#6
We are an AS9100, ISO 9001, ISO 13485 registered electronics contract manufacturer of circuit board assemblies. I am looking for an equipment validation template that can be used to validate a piece of equipment after picking up that piece of equipment and moving it to a new location. Does anyone have a template that I can download? Thanks.
Please use the same templates that you used during the first location of the equipment ...
 
Thread starter Similar threads Forum Replies Date
jkuil Calibration before and after relocation of GMP manufacturing equipment Calibration Frequency (Interval) 7
M Office and manufacturing site relocation effect on Device Technical File CE Marking (Conformité Européene) / CB Scheme 2
W Allowing our IATF to Expire Due to Relocation. Any Backlash? IATF 16949 - Automotive Quality Systems Standard 3
R Manufacturing plants relocation - Medical Device Medical Device and FDA Regulations and Standards News 7
B Manufacturing site relocation of pre amendment Class II medical device Manufacturing and Related Processes 4
A Machine Relocation within Facility - Is re-validation required? ISO 13485:2016 - Medical Device Quality Management Systems 8
K GUDID / UDI and Company Relocation Other US Medical Device Regulations 3
G Plant Relocation - Is it necessary to perform FAI? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
M SAE AMS 2750E Relocation Hot or Cold Recording Sensor Manufacturing and Related Processes 1
A Is MSA useful to prove a Measurement System after Relocation? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
K Do we need to perform Analytical Method Validation upon Relocation? General Measurement Device and Calibration Topics 5
T Is recertification needed for our plant relocation ? IATF 16949 - Automotive Quality Systems Standard 10
N Question on facility relocation and Product Labeling CE Marking (Conformité Européene) / CB Scheme 2
E Quality Plan for Relocation of our Production Document Control Systems, Procedures, Forms and Templates 8
T Office Relocation Installation Inspection Sheet Document Control Systems, Procedures, Forms and Templates 5
P Seeking sample Resignation Letter - Health and Relocation reasons Career and Occupation Discussions 3
M Is PQ really needed after relocation of a Visual CMM General Measurement Device and Calibration Topics 2
S Telecommuting as an alternative to relocation Career and Occupation Discussions 3
D Would relocation to a bigger plant affect our TS 16949 certification? IATF 16949 - Automotive Quality Systems Standard 9
B PFMEA Risk Assessment - Transfer of Production to a New Building (Relocation) FMEA and Control Plans 9
P Relocation Advice - UK to Florida Career and Occupation Discussions 20
A How to write a letter informing a customer of a process relocation? Misc. Quality Assurance and Business Systems Related Topics 5
M Calibration of equipment IATF 16949 - Automotive Quality Systems Standard 2
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
A Canadian Safety Labels for medical electrical equipment Canada Medical Device Regulations 2
lanley liao Question regarding the calibration of monitoring and measure equipment. Oil and Gas Industry Standards and Regulations 3
P Equipment URS, pFMEA and dFMEA ISO 14971 - Medical Device Risk Management 3
D Question on equipment - when to use reference only or research only stickers ISO 13485:2016 - Medical Device Quality Management Systems 5
L Gage RandR on automated equipment. IATF 16949 - Automotive Quality Systems Standard 7
W How long do you keep information about equipment no longer used? Document Control Systems, Procedures, Forms and Templates 2
B 4DINSPEC Inspection Equipment General Measurement Device and Calibration Topics 0
D Equipment Register and PM question ISO 13485:2016 - Medical Device Quality Management Systems 2
R Classification of USB DC operated medical equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
H IEC 60601-1 ME equipment or ME system IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D Definition of equipment for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
J Confusing on Harmonic Emissions/Voltage Fluctuations/Flicker test for CISPR 11 Class A Equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
C 8.5.1.1 Control of Equipment, Tools, and Software Programs - Questions about the extent of control of NC programs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
D Equipment Register related question ISO 13485:2016 - Medical Device Quality Management Systems 1

Similar threads

Top Bottom