Risk Assessment – Process FMEA for Pharmaceutical Tablet Compression

Machine
# Proc Fail Effe S O D RPN Root Curr Rec Own Targ
ess ure cts Caus ent om er et
Step Mod es Cont men RPN
e rols ded
Acti
ons

1 Gra Brid Low 9 5 6 270 High Visu Add Proc 54

nule ging weig moi al agit ess
Fee / ht / stur chec ator, Eng
d inco vari e, ks, inst
nsist abili poor man all
ent ty flow ual level
flow abili tapp /flo
ty, ing, w
hop peri sens
per odic ors,
desi weig imp
gn, ht rove
segr sam gran
egat plin ule
ion g flow
, add
hum
idity
cont
rol

2 Gra Fore Cont 10 2 8 160 Raw Siev Inst QA 40

nule ign ami mat ing, all
Fee part nati erial visu met
d icles on cont al al
in risk ami chec dete
feed nati ks ctor,
on, inlin
scre e
en sifte
brea r,
k, raw
imp mat
 rope erial
r audi
sievi t
ng

3 Die Und Wei 9 5 5 225 Wor Hou Inst Proc 36

Filli er/ ght n rly all ess
ng over OOS feed weig chec Eng
fill er ht kwe
cam, chec ighe
imp ks, r
rope oper feed
r ator back
feed chec loop
er ks ,
spee feed
d, er
gran calib
ule rati
segr on
egat SOP
ion

4 Com Cap Dela 8 6 6 288 High Har Adju QA/ 48

pres ping min spee dnes st Eng
sion / atio d, s com
lami n trap testi pres
nati ped ng, sion
on air, visu prof
low al ile,
prec chec imp
omp ks rove
ress lubr
ion, icati
poor on,
gran add
ule air
lubr rele
icati ase
on

5 Com Stic Surf 7 5 5 175 High Pun Appl Mai 28

pres king ace moi ch y nten
sion / defe stur clea anti- ance
 pick cts e, ning stick
ing stick , coat
y visu ing,
gran al imp
ules, chec rove
pun ks lubr
ch icati
wea on,
r, pun
poor ch
poli heat
shin ing
g cont
rol

6 Tool Pun Wei 6 4 6 144 Lon PM Add Mai 24

ing ch/ ght g sche dim nten
die drift run dule ensi ance
wea / time , on
r defe , visu mea
cts imp al sure
rope insp men
r ecti t,
PM, on torq
abra ue/c
sive urre
gran nt
ule mon
itori
ng

7 Reci Wro Batc 9 2 6 108 Ope Pass RFI Aut 18

pe / ng h rato wor D/ oma
PLC reci OOS r d barc tion
pe erro cont ode
load r, rol, inte
ed simi start rloc
lar -up k,
pro chec reci
duct klist pe
nam lock
es syst
em
8 Clea Cros Pati 10 3 7 210 Imp Clea Vali QA 30
ning s ent rope ning date
cont risk r SOP, d
ami / clea logs clea
nati reca ning ning
on ll , (sw
rush ab/
ed ATP
cha ),
nge colo
over r-
code
d
tooli
ng

9 Sens Dou Dou 7 3 4 84 Sens Dou Add Aut 28

ors ble ble or ble- redu oma
tabl dose misa feed nda tion
et lign sens nt
feed ed, or, sens
dust reje ors,
accu ct imp
mul bin rove
atio mou
n, ntin
wiri g&
ng diag
fault nost
ics

10 Envi High Wei 7 3 6 126 HVA Basi Add Facil 28

ron hum ght C c alar ities
men idity & fluct HVA ms,
t / hard uati C real-
tem ness on, mon time
p drift ope itori mon
n ng itori
door ng,
s cont
rol
limit
s
11 Com Har Diss 8 4 5 160 Une Peri Inst QA/ 32
pres dnes oluti ven odic all Eng
sion s on com hard torq
vari issu pres ness ue/c
atio es sion chec urre
n forc ks nt
e, mon
gran itori
ule ng,
inco SPC
nsist for
ency hard
ness

12 Ejec Tabl Defe 6 4 5 120 Wor Visu Repl Mai 20

tion et ctiv n al ace nten
chip e eject insp eject ance
ping tabl or, ecti or,
/bre ets high on, add
akin spee peri alig
g d, odic nme
misa clea nt
lign ning chec
men ks,
t redu
ce
spee
d