NO.

REF PROCESS Potential failure mode

1 Formulation API CoA- PSD, Density

2 Formulation Excipient compatibility studies
3 Formulation surface area of MgSt
Disintegration/dissolution profile of match existing product
4 Formulation
superdisintergrant level
5 Formulation Stability using Opadry II PEG, PVA based coating
6 Formulation Can we used Propylene Glycol to thin ink ?
7 Formulation Low melting point of stearic acid
8 Formulation Acetaminophen degragation of UV + Hydrolysis , Dimer
9 Formulation micro testing on Compap skip lot testing
10 Formulation 4 new supplier to the company, MgSt, Wax, Butyl Alcohol
11 Dispensing fiber drum material of construction from coviden
12 Dispensing variance of 100kg from Coviden
13 Dispensing damaged container
14 Dispensing sandwich MgSt 50% impact on blend uniformity
15 Dispensing addition of MgSt rinse with Avicel
16 Dispensing Pre-Weigh Process/Risk for manual dispensing
 CONSEQUENCE LIKELIHOOD RISK INDEX VALUE
Potential effects of failure
Score 1 to 5 Score 1 to 5 (C * L) 1 to 25
physical prop, dissolution 1 2 2
stability failure 3 2 6
compressibility, dissolution 1 2 2

development/supply timeline impact 4 2 8

stability failure 3 2 6
print quality 1 2 2
impact compression unit op, stability issue 3 2 6
release or stability failure (new analytical method) 3 2 6
reject lots, potential supply chain impact 3 2 6
failure on incoming testing, vendor audit 3 1 3
flow of material into Tote 2 3 6
inventory, logistics impact 1 4 4
reject lots, potential supply chain impact 1 4 4
overlubrication, underlubrication 1 3 3
underlubrication 1 4 4
EHS impact 3 4 12
 PRIORITY
RISK OWNER MITIGATION / CONTINGENCY ACTION

2 Trend data from Coviden

6
2

6
2
6
6
6
3
6
4 determine variance on drum weight
4
3 split compap weighing in 2 parts
4
12
MITIGATED RISK INDEX VALUE RISK INDEX VALUE REDUCTION NUMBER STATUS/HISTORY/COMMENTS