"Peb ua tiav cov ntu - Puas yog Peb Yuav Tsum Sau Txhua kauj ruam?"
"Peb tau luam tawm cov khoom, ntxuav lawv, polished ... peb puas yuav tsum tau sau ntawv rau txhua tus ncej- cov kauj ruam ua haujlwm?"
Yog tias koj ua haujlwm nrog Hlau 3D Printing lossis siv SLM 3D Printing Prototyping, cov lus nug no tshwm sim txhua lub sijhawm - tshwj xeeb tshaj yog thaum pab pawg tab tom sim txav nrawm.
Los ntawm kev pom kev lag luam, tag nrho traceability tuaj yeem xav zoo li:
Cov ntaub ntawv ntxiv
Tus nqi ntxiv
Ntxiv sijhawm
Tab sis ntawm no yog qhov tseeb - thiab nws tseem ceeb:
Hauv kev tsim kho mob, kev tshaj tawm - kev ua haujlwm yam tsis muaj kev tshawb nrhiav tsis raug suav tias yog tswj hwm - thiab cov txheej txheem tsis tswj tau ua tsis tau raws li.
Cia peb taug kev los ntawm qhov no kom meej meej thiab siv tau, yog li koj nkag siab qhov twg traceability tseem ceeb - thiab qhov twg nws tuaj yeem ua lossis tawg koj qhov project.
Qhov "Full Traceability" txhais tau li cas?
Hauv cov ntsiab lus yooj yim:
Traceability txhais tau tias koj tuaj yeem taug qab txhua kauj ruam ntawm ib feem ntawm lub neej voj voog - los ntawm cov khoom siv raw mus rau cov khoom kawg.
Raws li kev lag luam txhais, traceability suav nrog cov ntaub ntawv:
Cov khoom siv
Kev tsim cov kauj ruam
Tshaj tawm - cov ntsiab lus ua tiav
Kev kuaj thiab tshuaj ntsuam xyuas
Kev faib tawm thiab siv cov ntaub ntawv
Hauv kev tsim khoom siv kho mob, traceability yog siv rau:
Ua kom cov khoom muaj kev ruaj ntseg
Tswj kev tswj kom zoo
Ua raws li cov cai tswj hwm
Txheeb xyuas thiab kho cov teeb meem sai sai
Txoj kev yooj yim kom nkag siab nws:
Yog tias muaj qee yam tsis raug, traceability teb:
"Qhov twg, los ntawm cov batch, ua li cas, thiab nws mus qhov twg?"
Puas yog tag nrho Traceability xav tau rau Post-Kev ua tiav?
Lus Teb luv luv: Yog - rau feem ntau daim ntawv thov kev kho mob
Tab sis cia peb rhuav tshem nws kom ncaj ncees.
1. Kev Pom Zoo: Cov txheej txheem tseem ceeb npaum li cov khoom
Cov neeg tswj xyuas zoo li US Food and Drug Administration tsis tsuas yog ntsuas cov cuab yeej kawg nkaus xwb - lawv ntsuas tag nrho cov txheej txheem tsim khoom, suav nrog kev tshaj tawm - ua.
Qhov ntawd suav nrog:
Ntxuav
Kev kho cua sov
Nto xov
Sterilization
Vim li cas traceability yuav tsum:
Vim tias cov kauj ruam no cuam tshuam ncaj qha rau:
Kev nyab xeeb
kev ua tau zoo
sib xws
Yog tias koj tsis tuaj yeem ua pov thawj tias ib feem tau ua tiav li cas, cov neeg tswj xyuas yuav xav txog cov txheej txheem tsis tswj xyuas.
2. Txheej txheem validation yuav tsum tau traceability
FDA qhia tau hais tias cov neeg tsim khoom yuav tsum:
Ua pov thawj tias lawv cov txheej txheem tsis tu ncua tsim cov khoom hauv cov lus qhia tshwj xeeb.
Tab sis ntawm no yog lub ntsiab lus tseem ceeb:
Koj tsis tuaj yeem lees paub cov txheej txheem uas koj tsis tuaj yeem taug qab.
Qhov ntawd txhais tau tias:
Rau txhua tus ncej- cov kauj ruam ua tiav, koj xav tau cov ntaub ntawv xws li:
Parameters siv
Cov cuab yeej koom nrog
Operator los yog system cav
Batch kev txheeb xyuas
Yog tsis muaj traceability, validation poob sib nrug.
3. Additive Manufacturing ua Traceability tseem ceeb dua
Piv nrog rau kev tsim khoom qub,SLM 3D luam ntawvmuaj:
Ntau txheej txheem variable
Ntau rhiab heev rau kev hloov pauv
Kev pheej hmoo siab ntawm kev hloov pauv
FDA kev tshawb fawb tseem ceeb tias kev tsim khoom ntxiv qhia txog kev hloov pauv ntau dua vim muaj ntau yam txheej txheem
Qhov kev hloov pauv ntawd yuav tsum tau tswj hwm - thiab traceability yog qhov koj ua pov thawj tswj.
Dab tsi yuav tsum tau taug qab hauv Post-Kev Ua Haujlwm?
Yog tias koj ua haujlwm nrog lub tuam txhab hlau 3D luam ntawv, ntawm no yog qhov "tag nrho traceability" feem ntau suav nrog:
1. Cov ntaub ntawv tu txheej txheem
Txoj kev siv (ultrasonic, tshuaj, thiab lwm yam)
Duration thiab parameters
Cov tshuaj ntxuav tu
2. Cov ntaub ntawv kho cua sov
Kub
Sijhawm
Cov khoom siv ID
3. Nto Finishing Parameters
Txoj kev polishing
Roughness phiaj
Cov cuab yeej lossis cov tshuab siv
4. Kev soj ntsuam xyuas
Kev ntsuas qhov ntev
Nto zoo
Kev kuaj xyuas ua haujlwm
5. Batch & Part Identification
Cov naj npawb
Khoom siv batch
Ntau ntau
Qhov no tsim muaj keeb kwm tiav rau txhua ntu.
Traceability nyob rau hauv Prototyping vs Production
Nov yog qhov uas ntau tus neeg yuav khoom tsis meej pem.
HauvSLM 3D Printing Prototyping:
Traceability tej zaum yuav raug txwv
Kev tsom xam yog nyob rau hauv kev ceev thiab tsim validation
Cov ntaub ntawv tsawg kawg nkaus
Hauv kev tsim kho mob:
Yuav tsum muaj traceability tag nrho
Txhua kauj ruam yuav tsum tau sau tseg
Cov ntaub ntawv yuav tsum tau ua
Qhov no yog vim li cas ntau qhov haujlwm tsis ua haujlwm thaum tsiv los ntawm cov qauv mus rau kev tsim khoom.
Cov Ntaub Ntawv Tiag: Thaum Tsis Muaj Kev Tshawb Fawb tau dhau los ua teeb meem
Ib tus neeg siv khoom tuaj rau Sunhingstones tom qab qhov teeb meem ua raws.
Dab tsi tshwm sim:
Cov khoom dhau qhov kev sim thawj zaug
Zoo saib tau
Qhov teeb meem:
Tsis muaj traceability rau post- cov kauj ruam ua
Kev kho cua sov tsis tau sau tseg
Cov txheej txheem ntxuav tsis sib haum
Qhov tshwm sim:
Tsis tuaj yeem ua pov thawj tswj cov txheej txheem
Kev cai xa ntawv qeeb
Peb ua dab tsi:
Ua ib tug tag nrho traceability system
Txuas txhua feem rau nws cov ntaub ntawv ua haujlwm
Cov ntaub ntawv tsim nyog
Qhov kawg tshwm sim:
Dhau kev tshuaj xyuas
Txhim kho qhov sib xws
Txo kev pheej hmoo nyob rau yav tom ntej batch
Sunhingstones kuj tau hais nyob rau hauv ESTA- hais txog kev lag luam kev sib tham rau kev tswj xyuas cov txheej txheem muaj zog thiab traceability nyob rau hauv hlau 3D luam ntawv tej yaam num.
Yuav ua li cas yog tias koj tsis muaj Traceability?
Cia peb ua tau zoo heev.
Kev Ua Raws Cai Risk
Kev cai tsis kam lees
Kev kuaj tsis tau
Kev pheej hmoo zoo
Unknown txheej txheem variation
Kev ua haujlwm tsis sib xws
Rov nco txog qhov pheej hmoo
Tsis muaj traceability:
Koj tsis tuaj yeem cais qhov cuam tshuam
Tej zaum koj yuav tsum nco qab tag nrho cov khoom siv
Nrog traceability:
Koj tuaj yeem txheeb xyuas qhov chaw twg raug cuam tshuam
Koj txo tus nqi thiab kev pheej hmoo
Vim li cas Traceability yog qhov ua tau zoo ua lag luam
Ntau tus neeg yuav khoom pom traceability raws li lub nra.
Tab sis qhov tseeb, nws pab koj:
Txo kev pheej hmoo
Txhim kho qhov sib xws
Ceev kom pom zoo
Tsim kev ntseeg siab nrog cov neeg siv khoom
Nws tsis yog kev cai tswj hwm nkaus xwb - nws yog kev sib tw kom zoo dua.
Yuav ua li cas xaiv tus neeg muab khoom siv nrog Kev Ua Tau Zoo
Yog tias koj tab tom nrhiavHlau 3D Printing, nug cov lus nug no:
1. Koj puas muab cov ntaub ntawv ua tiav?
Lawv yuav tsum qhia:
Kauj ruam -los ntawm - cov ntaub ntawv kauj ruam
Batch taug qab
2. Koj puas tuaj yeem taug qab txhua ntu ntawm tus kheej?
Tsis yog los ntawm pawg - los ntawm ib feem
3. Puas yog koj qhov system ua raws li ISO 13485?
Qhov no yog tus qauv thoob ntiaj teb rau cov cuab yeej kho mob zoo
4. Dab tsi yog sau thaum xa ntawv - ua tiav?
Nrhiav kom paub meej - tsis yog cov lus teb dav dav
5. Koj puas tau xeem dhau kev kuaj ua ntej?
Kev paub tseem ceeb
Kev tsis nkag siab ntau
Cia peb tshem cov no:
"Traceability tsuas yog rau cov ntaub ntawv"
Nws suav nrog tag nrho cov txheej txheem
"Peb tuaj yeem ntxiv traceability tom qab"
Nws yuav tsum tau ua nyob rau hauv lub workflow
"Prototypes tsis xav tau nws"
Muaj tseeb - tab sis kev tsim khoom ib txwm ua
"Nws tsuas yog cov ntaub ntawv"
Nws yog pov thawj ntawm kev tswj
FAQ
Puas yog yuav tsum muaj kev taug qab rau cov cuab yeej kho mob tom qab- ua tiav?
Yog - tshwj xeeb tshaj yog rau cov khoom kho mob tswj hwm.
Tag nrho traceability suav nrog dab tsi?
Cov khoom siv, kev ua cov kauj ruam, kev sim, thiab cov ntaub ntawv xa tawm.
Puas yog SLM 3D Printing xav tau ntau dua?
Yog - vim muaj kev hloov pauv ntau dua.
Kuv puas tuaj yeem hla traceability rau prototypes?
Yog - tab sis tsis yog rau kev tsim khoom.
Yuav ua li cas yog tias traceability ploj lawm?
Tej zaum koj yuav ua tsis tau cov kev soj ntsuam los yog kev pom zoo tswj.
Kuv yuav ua li cas thiaj ua tau raws li qhov tseeb?
Ua haujlwm nrog cov tuam txhab paub txog thiab txheeb xyuas cov txheej txheem ntxov.
Kev xav zaum kawg - Yog tias koj tsis tuaj yeem taug qab nws, koj tsis tuaj yeem ua pov thawj nws
Yog tias muaj ib qho khoom siv, nws yog qhov no:
Hauv kev kho mob Hlau 3D Printing, traceability tsis yog cov ntaub ntawv - nws yog pov thawj tias koj cov txheej txheem tswj hwm.
Tsis muaj nws:
Koj tsis tuaj yeem lees paub koj cov txheej txheem
Koj tsis tuaj yeem ua pov thawj tsis sib xws
Koj tsis tuaj yeem hla kev tshuaj xyuas
Tsim Traceability rau hauv koj qhov project txij hnub Ib
Yog tias koj tab tom npaj ib txoj haujlwm kho mob, tsis txhob kho traceability raws li kev xav tom qab.
Xa koj cov duab kos rau peb thiab xav tau.
Peb yuav pab koj:
Txhais kev ua haujlwm traceable
Teem prototyping nrog ntau lawm
Tsim ib txoj kev npaj tsim khoom raws
Tsis muaj kwv yees. Tsis muaj cov ntaub ntawv ploj lawm. Tsuas yog tag nrho tswj los ntawm pib mus rau tag.
Cov ntaub ntawv
FDA - Cov txheej txheem ntawm 3D Printed Medical Devices
FDA - Kev txiav txim siab rau cov khoom siv kho mob Additive Manufactured
FDA – Additive Manufacturing Research Program
SEACOMP - Qhov tseem ceeb ntawm Traceability nyob rau hauv Medical Device Manufacturing
PTC – Nkag siab txog cov cuab yeej kho mob Traceability
Kev lag luam tshaj tawm txog kev tsim khoom zoo tshaj plaws