SBS - The best value in QMS software

Need suggestion on Software or App for Tracking Quality Plan Status

P

pog451

#1
Hi all,

I wonder if anyone has come across something that will help me here. Ill need to provide some background, the actual question is at the bottom.

My company essentially builds big steel boxes (up to anywhere around 10m x 10m x 5m), although they can be smaller (2m x 2m x 3m or so)

We build on a project for project basis and currently generate a paper Quality Plan for each unit that tracks through production with the part and is signed off as QC gates are passed.

With the big units, an order is generally only 2 or 3 pcs so its not an issue, but the smaller units can run to 10 to 20pcs per project. The issue we have is that if an order has 20 units, that's 20 sets of documentation that need to be generated and distributed (not to mention maintained) and that's work that keeps us from doing more productive things.

During a brainstorming session recently, while we were fantasising about all our suppliers having ERP system that could have barcodes on a manufacturing plan we would just need to scan (not going to happen, we use a lot of often fairly primitive LCC manufacturers) we thought about storing the progress data centrally on OUR sharepoint system and giving the (globally located) supplier a (cheap) tablet with an app that would be able to wirelessly call up the project details (possibly using a bar- or QR-code on the unit) and allow them to both determine the current status and register whatever had just been completed. ideally this would register not just quality gates but production progress too.

Has anyone come across an app or even a complete system that does something like this (and please, no "SAP can do this" or similar, I need something small, cheap, lean and standalone)?

Thanks for all input!

Andy
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
D Low risk IVD study in the UK, do I need MHRA approval? UK Medical Device Regulations 1
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J Records Control - Does each individual record need to be numbered? Records and Data - Quality, Legal and Other Evidence 2
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
J Do Software Subcontractors need to be ISO13485 compliant in the EU? EU Medical Device Regulations 3
K Do I need a "State of the art" plan? CE Marking (Conformité Européene) / CB Scheme 1
S Need advice for schooling Quality Manager and Management Related Issues 6
R What information do i need to get from the device manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
S Need guidance on project ISO 13485:2016 - Medical Device Quality Management Systems 2
H Need MSA 4th ed. compliant attribute MSA template General Measurement Device and Calibration Topics 4
J Need Change Control Yes/No Decision Tree Template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
C Does an accessory need an IFU if it use is discussed in the Parent device IFU? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
B Countries with no need for FSC (Free sales certificate) Other Medical Device Regulations World-Wide 0
R The term "Benefit Risk Ratio" in EU MDR, do I need to present benefit risk analysis as a RATIO Risk Management Principles and Generic Guidelines 4
A Brexit When does the UK responsible person need to be in place? UK Medical Device Regulations 10
R Do we need issue ECN (Engineering Change Notice) towards updated Material Specification? Design and Development of Products and Processes 2
N IPC-A-630 - Is this free or do i really need to pay for it? Manufacturing and Related Processes 4
C ISO/ IEC 17021 Resource requirement (need help) Document Control Systems, Procedures, Forms and Templates 5
P Need a programmer for QVI's VMS software for optical inspection machine Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
silentmonkey How to decide what characteristics need to be verified during incoming inspection? ISO 13485:2016 - Medical Device Quality Management Systems 5
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
T Do I need a qualified compiler for class B software? IEC 62304 - Medical Device Software Life Cycle Processes 3
E 13485:2016, Sections 4.1.6, 7.5.6 and 7.6 - Validation of Software - Need some Advice please ISO 13485:2016 - Medical Device Quality Management Systems 3
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
L Proof of Concept Studies - Do we need to comply with SAE reporting? Medical Device and FDA Regulations and Standards News 3
gunnyshore Adding a new facility - do I need to submit an amendment to the MDL or MDEL, or both? Canada Medical Device Regulations 3
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 1
SocalSurfer AS9100 new certificate, but need QMS software, help Quality Assurance and Compliance Software Tools and Solutions 2
A Demonstration of Equivalence - Need for comparing biological characteristics for an SamD EU Medical Device Regulations 1
G Need to change KPI we called NC parts (maximum 3%.) to FTQ (first time quality) IATF 16949 - Automotive Quality Systems Standard 4
W Need for current design or process control FMEA and Control Plans 2
L Turkish Requirements - Does the Software need to be translated? CE Marking (Conformité Européene) / CB Scheme 2
J Need for a cleanroom in the manufacture of a medical device for a clinical trial EU Medical Device Regulations 4
S Need help with analysing a survey on minitab Using Minitab Software 1
M IATF 16949 8.5.1.3 Verification of job set-ups - Do we need secondary check? IATF 16949 - Automotive Quality Systems Standard 7
P Electrosurgical Device User Need: Cord Flexibility -> Requirement Other Medical Device and Orthopedic Related Topics 4
P Do I need to get registered or have German entity to sell IVD products in Germany? CE Marking (Conformité Européene) / CB Scheme 2
J Documentation structure - Do I need Work Instructions? Document Control Systems, Procedures, Forms and Templates 23
G Need resources / tutorials about OPS (Operation) for ISO IT (Information Technology) Service Management 8
D Do non-IATF customers need to be included in audit scope? IATF 16949 - Automotive Quality Systems Standard 23
M Do you need an Applicable general safety and performance requirements Checklist? EU Medical Device Regulations 2
Y Does Solidworks (2D/3D drafting modules) need validation? Other Medical Device and Orthopedic Related Topics 5
M Do we need to create a new CER or can we just update the existing CER EU Medical Device Regulations 3
K A proposal for the model Quality Management - I need help for the project ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B Record Management - Does the QMS need to control templates of records? Records and Data - Quality, Legal and Other Evidence 17
Q Need clarification on requirements.... Class i, gmp & 510(k) exempt Medical Device and FDA Regulations and Standards News 12
U Do we need clinical trial data for Class IIa medical device under MDR EU Medical Device Regulations 7
G Do we need to QA cert? We only plan to supply reagents Medical Device and FDA Regulations and Standards News 3
I MSA requirement for 5 Micrometers + CP changes need customer approval? IATF 16949 - Automotive Quality Systems Standard 2
R Evaluating the need for preventive action Preventive Action and Continuous Improvement 3

Similar threads

Top Bottom