SBS - The best value in QMS software

Manufacturing build requests - process and form

indubioush

Quite Involved in Discussions
#1
I was hoping to get some input from all of you about your build request processes. How do you handle build deviations, R&D builds for feasibility, special design verification builds, etc.? What information do you capture on your build request form? What are the pitfalls to watch out for? I appreciate the help. I work for a medical device company and we have to figure out the best way to capture these types of manufacturing build requests.
 
Elsmar Forum Sponsor

Ninja

Looking for Reality
Staff member
Super Moderator
#3
Howdy,

It depends quite a great deal on what you are building...what kind of part are you building?
A device? A machine? An injection molded part?
 

Ninja

Looking for Reality
Staff member
Super Moderator
#5
This thing you are building for medical device manufacturing...

A device? A machine? An injection molded part?
 
Thread starter Similar threads Forum Replies Date
D Cable Manufacturing Build Audit Checklist Manufacturing and Related Processes 6
Marc The US Manufacturing Exodus Continues - Chinese to build Cessna business jets World News 1
S CE and Manufacturing license Manufacturing and Related Processes 1
S Manufacturing Process FDA FOIA Medical Device and FDA Regulations and Standards News 3
S Manufacturing Process FDA FOIA US Food and Drug Administration (FDA) 4
S Critical characteristic on manufacturing operations test procedure Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
P ISO 8 classified medical manufacturing room Qualification and Validation (including 21 CFR Part 11) 1
P How to measure DPPM in Chemical batch manufacturing Quality Tools, Improvement and Analysis 1
M MSA Study Type 1 not capable. We are at the limit. And manufacturing wants to continue producing. Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
M Office and manufacturing site relocation effect on Device Technical File CE Marking (Conformité Européene) / CB Scheme 2
lanley liao How to keep the manufacturing capability under the API monogram Oil and Gas Industry Standards and Regulations 6
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
Ed Panek What are the limits on manufacturing changes and substantial changes? EU Medical Device Regulations 6
Z Rapid audit template for plastic parts manufacturing process Manufacturing and Related Processes 12
P IQ, OQ, PQ protocol, and report templates for Distributed Control Systems in Pharmaceutical Manufacturing Systems. Qualification and Validation (including 21 CFR Part 11) 0
K One CE Mark holder - multiple manufacturing sites EU Medical Device Regulations 3
M Indian Medical Device Rules - Manufacturing and Wholesale Lic. Required? Other Medical Device Regulations World-Wide 12
R Manufacturing plants relocation - Medical Device Medical Device and FDA Regulations and Standards News 7
R Medical Device - Change manufacturing plant Design and Development of Products and Processes 6
P New Global HQ Suggestions for Virtual manufacturing/own brand labelling of medical devices? EU Medical Device Regulations 4
S Manufacturing Execution Systems Software Costs Manufacturing and Related Processes 0
P Managing How PPAP Requirements are Communicated in the Manufacturing Process and to Suppliers APQP and PPAP 5
J Control Plan use on the manufacturing floor FMEA and Control Plans 4
S PSW - Requirements for "off-the shelf" component that has multiply manufacturing locations Off the Shelf Item Manufacturing and Related Processes 1
DuncanGibbons Additive Manufacturing Processes Thread Manufacturing and Related Processes 5
S Can assembly manufacturing sub-supplier be certified IATF 16949? IATF 16949 - Automotive Quality Systems Standard 6
A ISO 14971 PFMEA Manufacturing Risk ISO 14971 - Medical Device Risk Management 2
L Manufacturing Process Audit Help IATF 16949 - Automotive Quality Systems Standard 6
H Line Balancing in Backpack Manufacturing Manufacturing and Related Processes 2
DuncanGibbons Resources for aiding in procedure, work instruction and manufacturing plan development and management AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
L SAE AS9145 vs. SAE AS6500 (Manufacturing Management Program) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Watchcat Best Regulatory Oversight for Off-Shore Device Manufacturing? Other Medical Device Regulations World-Wide 1
DuncanGibbons Manufacturing Plan vs Material Specification vs Control Plan Manufacturing and Related Processes 5
qualprod Automation in manufacturing - Print Shop ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
N Address of Legal Manufacturing Site in ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 1
M Description of the requirements of clause 9.2.2.3 manufacturing process audit- needs your feedback IATF 16949 - Automotive Quality Systems Standard 0
M Operational (free) simulation games for manufacturing and quality Lean in Manufacturing and Service Industries 5
V Manufacturing requirements for respiratory ventilators - clean room required? Medical Device and FDA Regulations and Standards News 6
J Guidance on manufacturing non-surgical face masks US Food and Drug Administration (FDA) 3
P Manufacturing equipment (e.g.: Dental Welder): medical device or not? US Food and Drug Administration (FDA) 5
S Contagious Diseases in Medical Device Manufacturing ISO 13485:2016 - Medical Device Quality Management Systems 5
C Manufacturing overages & nonconforming material documentation ISO 13485:2016 - Medical Device Quality Management Systems 3
Z US Manufacturing Site Closing, device manufactured elsewhere Medical Device and FDA Regulations and Standards News 1
L Manufacturing site expansion - When to notify your NB EU Medical Device Regulations 3
Q Legal Manufacturing Address Change – multiple registrations at same address 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N China - Start manufacturing before change approval? China Medical Device Regulations 3
J Manufacturing procedure / work instruction depth ISO 13485:2016 - Medical Device Quality Management Systems 12
F AS9100D, raw material standards are a requirement for manufacturing? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
C Looking for China Good manufacturing practice China Medical Device Regulations 1

Similar threads

Top Bottom