Kev lees paub zoo hauv Kev Tsim Kho Cov Khoom Siv Kho Mob: Ib Daim Ntawv Qhia Ua Ntej

Hauv kev lag luam khoom siv kho mob, kev ruaj ntseg zoo (QA) tsis yog kev cai tswj hwm nkaus xwb; nws yog qhov kev cog lus tseem ceeb rau cov neeg mob kev nyab xeeb thiab kev ntseeg tau ntawm cov khoom. Raws li cov chaw tsim khoom, peb muab qhov tseem ceeb tshaj plaws hauv txhua qhov ntawm peb cov haujlwm, los ntawm kev tsim mus rau ntau lawm. Cov lus qhia dav dav no yuav tshawb nrhiav cov kev coj ua zoo tshaj plaws rau kev lees paub zoo hauv kev tsim khoom siv kho mob, muab kev nkag siab zoo rau cov kws tshaj lij kev lag luam.

 

Nkag siab txog Kev Pov Hwm Zoo hauv Kev Tsim Kho Cov Khoom Siv Kho Mob

Kev ruaj ntseg zoo hauv kev tsim khoom siv kho mob suav nrog cov txheej txheem txheej txheem thiab cov txheej txheem tsim los xyuas kom meej tias cov khoom ua tau raws li cov cai thiab cov qauv kev cai. Qhov no suav nrog kev npaj ua haujlwm thoob plaws hauv cov txheej txheem tsim khoom, los ntawm kev tsim thawj zaug mus rau kev soj ntsuam tom qab kev lag luam.

1. Kev Ua Raws Cai

Kev ua raws li cov qauv kev tswj hwm yog lub hauv paus ntawm kev ruaj ntseg zoo hauv kev tsim khoom siv kho mob. Hauv ntau thaj chaw, cov khoom siv kho mob yuav tsum ua raws li cov lus qhia nruj raws li cov cai tswj hwm xws li US Food and Drug Administration (FDA) thiab European Medicines Agency (EMA).

Cov neeg tsim khoom yuav tsum paub lawv tus kheej nrog cov kev cai no thiab xyuas kom lawv cov kev tswj xyuas zoo (QMS) ua raws li lawv. Qhov no suav nrog kev tswj xyuas cov ntaub ntawv kom meej, ua cov kev tshuaj xyuas tsis tu ncua, thiab siv cov kev kho kom raug thaum tsim nyog. Los ntawm kev ua li ntawd, cov tuam ntxhab tsis tsuas yog ua raws li cov cai tab sis kuj tsim kev ntseeg siab nrog lawv cov neeg siv khoom.

2. Kev Tswj Xyuas Kev Nyab Xeeb

Kev tswj hwm kev pheej hmoo zoo yog qhov tseem ceeb hauv kev lag luam khoom siv kho mob. Ib txoj hauv kev zoo los txheeb xyuas, ntsuas, thiab txo cov kev pheej hmoo cuam tshuam nrog cov khoom yog qhov tseem ceeb. Qhov no suav nrog kev soj ntsuam kev pheej hmoo thaum lub sijhawm tsim qauv thiab thoob plaws hauv lub neej ntawm cov khoom.

Siv cov cuab yeej xws li Failure Mode and Effects Analysis (FMEA) pab txheeb xyuas cov ntsiab lus tsis ua haujlwm thiab lawv qhov cuam tshuam rau kev nyab xeeb ntawm tus neeg mob. Los ntawm kev hais txog cov kev pheej hmoo no thaum ntxov hauv txoj kev txhim kho, cov tuam txhab tsim khoom tuaj yeem txhim kho tag nrho cov khoom zoo thiab kev ntseeg siab ntawm lawv cov khoom siv.

3. Tsim Tswj

Kev tswj kev tsim qauv yog ib qho tseem ceeb ntawm kev ruaj ntseg zoo hauv kev tsim khoom siv kho mob. Nws koom nrog txoj hauv kev rau kev tsim cov khoom tsim, kom ntseeg tau tias txhua qhov kev qhia tshwj xeeb thiab cov kev xav tau raug ua tiav.

Cov ntsiab lus tseem ceeb ntawm kev tsim qauv tsim muaj xws li:

Tsim Kev Npaj:Tsim kom muaj ib txoj kev npaj meej uas qhia txog cov txheej txheem tsim, nrog rau cov sijhawm thiab lub luag haujlwm.

Design Input:Sib sau ua ke thiab sau cov neeg siv cov kev xav tau thiab cov kev cai tswj hwm.

Design Verification thiab Validation:Xyuas kom meej tias cov khoom ua tau raws li cov qauv tsim thiab ua tau raws li qhov xav tau los ntawm kev sim nruj.

Los ntawm kev siv cov txheej txheem tswj kev tsim qauv zoo, cov tuam txhab tsim khoom tuaj yeem txo qhov kev pheej hmoo ntawm kev tsim cov teeb meem uas tuaj yeem cuam tshuam cov khoom zoo.

4. Supplier Quality Management

Qhov zoo ntawm cov khoom siv raw thiab cov khoom tseem ceeb cuam tshuam rau cov khoom kawg. Yog li ntawd, tsim kom muaj kev sib raug zoo nrog cov neeg muag khoom thiab ua raws li kev tswj hwm tus neeg muag khoom zoo yog qhov tseem ceeb.

Cov neeg tsim khoom yuav tsum ua cov kev ntsuam xyuas zoo ntawm cov neeg xa khoom muaj peev xwm, suav nrog kev tshuaj xyuas thiab kev ntsuam xyuas ntawm lawv cov txheej txheem zoo. Kev saib xyuas tsis tu ncua thiab kev ntsuas kev ua tau zoo pab xyuas kom cov neeg muab khoom ua tau raws li cov qauv zoo.

5. Kev txhim kho tsis tu ncua

Kev ruaj ntseg zoo tsis yog kev siv zog ib zaug; nws yuav tsum tau cog lus rau kev txhim kho tas mus li. Kev txhawb nqa kev coj noj coj ua zoo hauv lub koom haum txhawb kom cov neeg ua haujlwm txheeb xyuas thaj chaw txhim kho thiab qhia cov kev coj ua zoo tshaj plaws.

Kev siv cov txheej txheem xws li Lean thiab Six Sigma pab txhim kho cov txheej txheem, txo cov khoom pov tseg, thiab txhim kho cov khoom zoo. Kev cob qhia thiab kev txhim kho tsis tu ncua rau cov neeg ua haujlwm pab txhawb rau cov neeg ua haujlwm paub ntau dua rau kev lees paub zoo.

 

Xaus

Kev ruaj ntseg zoo hauv kev tsim khoom siv kho mob yog txheej txheem ntau yam uas yuav tsum tau ua kom tiav. Los ntawm kev ua raws li cov qauv kev tswj hwm, siv cov tswv yim tswj kev pheej hmoo zoo, tswj xyuas kev tsim qauv zoo, tswj cov khoom lag luam zoo, thiab txhawb cov kab lis kev cai ntawm kev txhim kho tas li, cov tuam txhab tuaj yeem ua kom muaj kev nyab xeeb thiab ua tau zoo ntawm lawv cov khoom.

Kev paub txog cov kev coj ua zoo tshaj plaws hauv kev lees paub zoo yog qhov tseem ceeb rau kev tswj hwm kev sib tw. Los ntawm qhov tseem ceeb ntawm qhov zoo, cov tuam txhab lag luam tsis tsuas yog tiv thaiv cov neeg mob tab sis kuj txhim kho lawv lub koob npe nrov thiab kev vam meej hauv kev lag luam.

Kev ua raws li cov kev coj ua zoo tshaj plaws rau kev lees paub zoo hauv kev tsim khoom siv kho mob tuaj yeem ua rau cov neeg mob tau txais txiaj ntsig zoo dua qub thiab muaj kev vam meej rau yav tom ntej rau kev lag luam. Ua ke, peb tuaj yeem tsim kom muaj kev nyab xeeb thiab txhim khu kev noj qab haus huv ib puag ncig.


Post lub sij hawm: Oct-16-2024