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Acestar Audit by WD & JCY 18th July 2013

Acestar : Mr. Peter, Shamila


WD: Mr. Tham, Mr. Gray Tan, Mr. VP Chong
JCY : Mr.Shager, Mr. Endraan, Mr. Suren, Nabilah
Remark: The line audited is B3 (Interleaf) and B4 (Bag)
Stretch film is recommended to be totally removed

S/N Findings Action PIC ECD Status Remark


Raw Material
Have to check on one other type of raw material : HF0961 (Not used
1 Sampling for MESA Test Shamila (ACEStar) 23 July, 2013 DONE No Mesa Detected
for WD)
2 Swab on the raw material mixer Sampling for MESA Test Shamila (ACEStar) 23 July, 2013 DONE No Mesa Detected
3 Test cotton string on the raw material packaging Sampling for MESA Test Shamila (ACEStar) 24 July, 2013 DONE No Mesa Detected
4 Need to test for MESA on additive (A) Sampling for MESA Test Shamila (ACEStar) 23 July, 2013 DONE No Mesa Detected
5 Need to test the raw material packaging bag Sampling for MESA Test Shamila (ACEStar) 24 July, 2013 DONE No Mesa Detected
Extrusion Machine
6 Swab the screw at extrusion machine No screw were found Shamila (ACEStar) 22 July, 2013 DONE No Mesa Detected
7 Swab at ALL PU rollers Sampling for MESA Test Shamila (ACEStar) 31 July, 2013 DONE No Mesa Detected
1) Before 2) After

8 Rubber hose for cold air flow need to be changed to collar lock Will change to collar lock Shamila (ACEStar) 22 July, 2013 DONE

Changing Room

9 Add instruction for cosmetic and spectical check Will provide WI Shamila (ACEStar) 22 July, 2013 DONE D:\ACE Star
Production\ISO\ISO

Cleanroom
10 Swab on the heat seal rubber Sampling for MESA Test Shamila (ACEStar) 31 July, 2013 DONE No Mesa Detected
11 Swab on the cut knife Sampling for MESA Test Shamila (ACEStar) 1 August, 2013 DONE No Mesa Detected
Sharpening of knife is done every 6-
How is the sharpening of cut knife was done? 9 months. Is a dry sharpening
12 Shamila (ACEStar) 22 July, 2013 DONE No Mesa Detected
-any lubricant added? process that do not use any
chemicals.
Others
13 AceStar's wiper need to test for MESA Sampling for MESA Test Shamila (ACEStar) 1 August, 2013 DONE No Mesa Detected
WD Audit Process Mapping Sampling
Date: 19-Jul
Objective: To Identify incoming source of MESA

INTERLEAF PRODUCTION LINE 3

Process Location Sample Description ECD Mesa Result

Raw Material Mixer Machine HDPE resin HF0961 (not used for WD) 23-Jul No MESA
Additive resin (A) 23-Jul No MESA
Swab - raw material mixer's blade 23-Jul No MESA
Cotton string used on the raw material packaging 24-Jul No MESA
Raw material packaging bag 24-Jul No MESA

Extrusion Blow Film Machine BF 3

Mould PE exit area 24-Jul No MESA

Swab - Black PU rollers 25-Jul No MESA

Winding Winding Unit C3


Swab - Yellow PU rollers 1 26-Jul No MESA

Swab - Yellow PU rollers 2 26-Jul No MESA

Swab - Yellow PU rollers 3 26-Jul No MESA

Cut & Seal Cutter Machine C3

Swab - Orange PU rollers 1 27-Jul No MESA

Swab - Orange PU rollers 2 29-Jul No MESA

Swab - Black PU rollers 3 29-Jul No MESA

Swab - Black PU rollers 4 29-Jul No MESA

30-Jul No MESA
Swab - Cutter

FG

Others AceStar wiper 1-Aug No MESA


WD Audit Process Mapping Sampling
Date: 19-Jul
Objective: To Identify incoming source of MESA

BAG PRODUCTION LINE 4

Process Location Sample Description ECD Mesa Result

Raw Material Mixer Machine


(Same Mixer used for Line 3 and 4)

Extrusion Blow Film Machine BF 4

Mould PE exit area 25-Jul No MESA

Swab - Black PU rollers 25-Jul No MESA

Winding Winding Unit C4


Swab - Red PU rollers 1 27-Jul No MESA

Swab - Yellow PU rollers 2 27-Jul No MESA

Cut & Seal Cutter Machine C4

Swab - Black PU rollers 1 30-Jul No MESA

Swab - Black PU rollers 2 30-Jul No MESA

Swab - Black PU rollers 3 31-Jul No MESA

Swab - Black PU rollers 4 31-Jul No MESA

Swab - Heat Seal Tap 31-Jul No MESA

Swab - Cutter 1-Aug No MESA

FG

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