Wednesday, November 25, 2009

Sharing Session - Part 2

Dah dapat la sikit idea on how to do this assignment... since i was working in a plastic injection molding company... and we are now targeting to run a consumable product dimana it is mostly come from the medical business....

"Software validation is a requirement of the Quality System regulation, which was published in the Federal Register on October 7, 1996 and took effect on June 1, 1997. Validation requirements apply to software used as components in medical devices, to software that is itself a medical devices, and to software used in production of the device or in implementation of the device manufacturer’s quality system"

No wonder la beria-ia nk study benda ni.... nk tak nk.. kena la buat.. kang assesment naik gaji tak ada markah pulak... :(......

1st..... choose equipment.. satu cukup la.....
2nd.... kena guna benda yg accurate... and need to prove that.. that thing is accurate.... apa ekk.. ?
3rd.... how to prove benda yg accurate tu... guna equipment yg dipilih... to validate the software yg digunakan oleh equipment tu... kalau setakat validation approval dari supplier... memang dah ada....
4th.... method apa yg akan digunakan untuk prove that the software used is validated....
5th... function apa dalam software tu yg nk divalidatekan... takkan semua function... setahun tak siap...

Lagi... lagi...... ????

6th... haaa... validation range..... fit for use la.. kan...

Ni baru nk kasik draft pada si director tu... eii... walaupun rupamu tidak kukenang....

chayok... chayok.... berusahalah.....

Tuesday, November 10, 2009

Sharing Session among the Quality Engineers - Part 1

Pening2... ingat kan masa study je dapat assignment... dah keje pun dapat assignment jugak... susah jgk dpt 2 bos ni....

Currently, I need to report to Company Operation Director ... and Group Quality Director.... yg leceh dan sgt2 la cerewet ni... of course la QD (quality director)... byk songeh.. perfectionist konon... geram jek... boleh pulak bebudak ni cakap...
"ehh... farah... bila ko communicate face 2 face dgn dia kan.. mcm bpk dgn anak... muka sama"... hishhh.. simpang malaikat dpt bapak mcm tu... it is not easy to become a H.O.D .... tapi pujuk jgk hati ni....

TAKE IT AS A CHALLENGE.. THEN YOU WILL SUCCEED.. 

setiap org dapat 1 tajuk.... antaranyer.... SPC, 7 QC TOOLS... bla .. bla.. bla... itu memang la senang.. common item.... tapi ada 2 topic yg susah.... kena kat batang hidung sendiri..... SOFTWARE VALIDATION, & CORRELATION TECHNOLOGY....
i was assigned to complete the software validation since my department byk menggunakan measuring equipment to perform inspection and testing....

AArrrggghhhhhhh...... kusut..... malasnyer nk research... study... measure.. and implement...... 

And my sharing session is on March 2010... Lega.... Nasib baik dapat tepis correlation technology bg pada org lain.. atas alasan... sekarang ni... byk new mold transfer... soooo bz....

And now... how to start.... ??

Purpose.. ? Objective... ? Scope.. ?

Lagiii... ?

okla... nk search internet... nk carik bahan... eii.. rasa mcm zaman belajar pulak..