Date

No Issue 8D Ref # Month Lot #/SCR

Received

6D715861TGM
1 CP170902 September 05/09/17
(27449)

Lump

3076260 3076265
2 CP170903 September 05/09/17
3076270

3076260 3076265
3 CP170903 September 05/09/17
3076270
Hole

4 CP171001 October 10/6/2017 28200 / 29011

5 CP170907 September 20/09/2017 28200

Pinholes
 Pinholes

MADG01-02
6 CP170906 September 18/09/2017
(29228)

3076260 3076265
7 CP170903 September 05/09/17
3076270

Dirty

8 CP171008 October 10/23/2017 27995

9 CP171009 October 10/30/2017 28455

Foreign Item

10 CP171102 November 11/9/2017 29951

11 CP171204 December 12/18/2017 28461

12 Tear CP170911 September 12/09/17 27437

13 Tear CP171111 November 7/11/2017 27550

14 Torn CP170904 September 19/09/2017 26945

15 CP171010 October 10/31/2017 30825

Donning tear

16 CP171203 December 12/11/2017 30418

17 Moisture CP170913 September 9/29/2017 30004

18 Size variation CP170915 September 9/6/2017 30599

19 Slippery CP170905 September 18/09/2017 29255

20 Blister Bead CP171101 November 11/4/2017 31092

21 Excess Powder CP171103 November 11/12/2017 30635

22 Sticky CP171107 November 12/11/2017

30004
 23 Less grip CP171109 November 25/11/2017 3045775

### 2018
1 CP180101 JAN 5-Jan-18 3097175

2 CP180206 FEB 5-Feb-18 25352

Different colour
3 CP180302 MAR 6-Mar-18 31231

4 Stiky/Torn CP180102 JAN 9-Jan-18 29524

5 Sticky/Tear CP180104 JAN 10-Jan-18 29065

6 CP180104 JAN 10-Jan-18 29577

7 CP180117 JAN 25-Jan-18 30925

8 CP180206 FEB 5-Feb-18 29986

Sticky
9 CP180208 FEB 28-Feb-18 27818

10 CP180209 FEB 28-Feb-18 27355

11 CP180210 FEB 27-Feb-18 30406

12 CP180225 FEB 12-Feb-18 29108

13 CP180226 FEB 9-Feb-18 29300

14 CP180106 JAN 23-Jan-18 2995165

Lump

15 CP180107 JAN 23-Jan-18 2961975

16

CP180118 JAN 31-Jan-18 27656

Hole

17 CP180222 FEB 23-Feb-18 27656

18 CP180120 JAN 18-Jan-18 28843

Pinholes

20 CP180303 MAR 6-Mar-18 30635

21 CP180113 JAN 16-Jan-18 29371

22 CP180203 FEB 2-Feb-18 30977

Torn

23 CP180221 FEB 23-Feb-18 27656

24 CP180301 MAR 2-Mar-18 3138365/31383

25 Tear CP180205 FEB 5-Feb-18 28625

26 CP180319 MAR 23-Mar-18 31474

Foreign Item

27 CP180207 FEB 2-Feb-18 31030

28 Stain CP180109 JAN 23-Jan-18 2986775

29 Excess Powder CP180202 FEB 2-Feb-18 30354

Customer Brand Mfg Date (mm/yy) Type of glove

MEDLINE NEOLON 2G 04/16 SNKF

Salalah Wallet 07/17 SPKPF

Salalah Wallet 07/17 SPKPF

Sanko Silky fit zero 2016-07 STPZF

SANKO Chemistry
silky fit zero 07-16 STPZF
Industry
McKesson Confiderm LT 01-17 SKF

Salalah Wallet 07/17 SPKPF

Paul Hartmann Peha-Profile Latex 2016-08 STKF

LABOT STERILE LATEX

LABORATORIOS
SURGICAL GLOVES 2016-09 SLPE
AMERICANOS S.A
POWDERED (SLPE [ I ] )

Yuhan Kimberly Yuhan Kimberly 2017-4 SKF

PRODENTI CO. LTD MAXITEX PF/SKF 2016-08 SKF

Meditrade GMBH Neopretex OP 11-16 SNKTF

Evercare Latex Surgical PF

BATIST MEDICAL A.S. 2016-04 SKF
Gloves (SKF)
MEDLINE Sensicare PI 01/16 SSAKF

Supra Healthcare Nuzone/SNKTF 2017-9 SNKTF

HPC HEALTHLINE UK 2017-07 STKF

Synthesis/SPKPF

Meditrade GMBH Gentle Premium OP 2017-05 SKF

MEDICA CO., LTD. SENSIFLEX PLUS 2017-07 SKF

Prodenti Co.Ltd Maxitex PF 09-17 SKF

McKesson Confiderm SPCT 2017-10 SNKTF

SANKO SILKY FIT

Sanko 2017-7 STPCF
CORIUM/STPCF_3

Meditrade GMBH 2017-05

Gentle Skin Premium OP SKF

 UNIGLOVES GMBH Expert Plus 2017-06 SKF

2018
ABU LAIL MEDICAL &
SENSIFLEX PLUS Sep-2017 SKF
SPORTS CENTER

Beybi Nuzone Mar-2015 SNKTF

Ulma international
Finessis Corium Oct-2017 STPCF
GmbH/Meditrade

MEDLINE Neolon 2G Feb-2017 SNKF

MEDLINE Neolon 2G Jan-2017 SNKF

MEDLINE Neolon 2G Apr-2017 SNKF

KANNAM LATEX SMKF Aug-2017 SNKF

 Beybi Nuzone Apr-2017 SNKTF

Paul Hartmann Peha Profile Oct-2016 STKF

Paul Hartmann Peha Profile Mar-2016 STKF

Paul Hartmann Peha Profile Jul-2017 STKF

 LABORATOIRES
SKF Nov-2016 SKF
EUROMEDIS

LABORATOIRES
EUROMEDIS Jan-2017 SKF
EUROMEDIS

Yuhan Kimberly YUHAN KIMBERLY/SKF Apr-2017 SKF

Yuhan Kimberly YUHAN KIMBERLY/SKF Mar-2017 SKF

EUROMEDIS SMBKF Oct-2016 SMBKF

EUROMEDIS STPZF Nov-2016 STPZF

SURGICAL SYNTHETIC
PAUL HARTMANN AG Oct-2016 SAKNF
BLEND PF

SANKO CHEMICAL
SANKO SILKY FIT CORIUM Jul-2017 STPCF_3
INDUSTRY
LABORATOIRES
FINESSIS ZERO Nov-16 STPZF
EUROMEDIS

Supra CT Nuzone Oct-2017 SMBKF

EUROMEDIS
STPZF Nov-2016 STPZF
LABORATORIES

Euromedis Finessis Zero Sep-2017 STPZF

Meditrade Neopretex OP Oct-2016 SNKTF

 SENSIFLEX PLUS LATEX
GL INTER-AGO PTE LTD SURGICAL GLOVES Nov-2017 SKF
POWDER FREE

Walki Medical Oy CURITY NITRILE Sep-2017 ENDBF32

Yuhan Kimberly YUHAN KIMBERLY/SKF Apr-2017 SKF

Kannam Latex Neuro Mar-2017 SMBKF

Complaint CIR Action plan

1. Add bumper after latex dipping tank to

remove excess latex picked up from latex
tank.
Effective: August 2017
2. Adjusted the dipping line angle to
upward position after latex dipping tank to
ensure former rotate and allows the latex
to dry evenly.
Effective: August 2017
Chunk / Lump 3. Established stringent in-process control
during production whereby any lump
discovered during inspection, line must be
stopped and latex must be removed and
filtered back in.
Effective: September 2017

1. Increased cleaning frequency of stirrer

from two weeks to once a week.
2. Established stringent in-process control
during production whereby any lump
Lump
discovered during inspection, line must be
stopped and latex must be removed and
filtered back in.

Increase the former cleaning frequency

from three weeks to two weeks to maintain
Hole/ Pinhole
former cleanliness.
Effective: September 2017
Finessis Zero
1) To modify the track and increase the
SIZE : 5.5L
former rotation timing after dipping tank.
Reason : Glove with hole
1. Change the solenoid valve to pneumatic
valve to ensure steam supply stop
completely if temperature achieved.
(Effective Date: 07/09/2017)
2. Installed alarm system for Tumbler 1-3
in case of temperature overshooting.
(Effective Date: 20/03/2017)
SIZE : 7.5
3. Trained new workers for well
Reason : Pin-hole in right thumb
understand on handling the equipment
SIZE 8 :
and report to their superior if found any
Reason : Pin-hole in right thumb
temperature over shoot happen again.
(Effective Date: 31 August 2017)
 1. Increase the former cleaning frequency
from three weeks to two weeks to maintain
former cleanliness.
Effective: September 2017

ONE GLOVE HAD A PINHOLE IN 2. To assign one former operator to each

PALM, ANOTHER HAD A THIN SPOT line and to carry out routine former
IN THE PALM. inspection at the frequency of every shift.
Effective: September 2017

3. Procedure WI-PD-45 is also revised for

this new procedure.
Effective: September 2017
Latex dipping tank has been covered
using plastic strips
4. Conducted to minimize
refresher trainingthe
to all
dirt contamination from surroundings.
former team workers.
Effective:
Effective:August 20172017
September
1. We have disseminate this complaint
to the packing operation team to be more
alert on potential dirt from nozzle of inkjet
printer.
2. Revise AUTOPACK: COMPACT
Black spot NACHINE DAILY PARAMETER
Size: 6.5 CHECKLIST to put in the requirement of
cleaning the machine during start up,
change of material and after any repairing
work (Form: AP-02-03).

3. To tighten the AQL for minor debris in

QA inspection data sheet for
1. Additional units
thermoforming of insect
machine killerQA-34)
(From: has been
purchased
from AQL 2.5 to increase the effectiveness of
to AQL 1.5.
insect control. One unit of insect killer will
be installed at the latex dipping exit area.
2. In order to prevent worker from forget to
switch off the light at dipping area, we will
install light sensor at latex dipping room &
after latex dipping area to automatically
switch off the light when no one is working
at this area. This is to prevent light from
Found an insect (mosquito inside a
attracting the insect to the latex dipping
glove)
area.
3. The entire production has been alerted
on this issue to reinforce the must to only
open one door at a time at the double
door entrance.

1. The team did a Gemba walk at the

relevant production line #3 that
manufactured this glove. We did not find
Mosquito embedded in the gloves. any mosquito flying around and there is no
breeding ground for the mosquito.

2. We do realized that there is positive

pressure from outside that could push air
flow through the mosquito net at left side
of the dipping line #1.

3. As a preventive measure, we will

replace all the mosquito net with the solid
transparent sheet to shield all the net to
prevent any potential of tiny mosquito or
flies get push through the net by strong air
pressure or when part of the net torn after
aging.

Insect embedded in the gloves.
Gloves tear at finger and at cuff.
Affected quantity: 13 boxes
Sample received: Size 6.5, 7.0, 7.5
The cuff area of gloves has been torn.
This was found before donning.
The following actions have been taken
to prevent the reoccurrence of this
incident:
1. Installed plastic curtain at latex
dipping area.
2. Installed additional insect killer at
latex dipping area.
3. Reinforce the insect control by
installing an additional unit of insect
killer at the entrance of double door
exit.
1. Increase the former cleaning frequency
from three weeks to two weeks to maintain
former cleanliness.
Effective: September 2017
2. To assign one former operator to each
line and carry out routine former
inspection at the frequency of every shift.
Effective Date: 25/09/2017
3. Revise work instruction, WI-PD-45 to
change the inspection frequency from
once a day to once a shift.
Effective Date: 15/10/2017
4. To conduct re-fresher training to all the
former team workers on the work flow and
former checking.
Effective Date: 25/09/2017
We takes this feedback as valuable
input for us to continuously improve
our manufacturing process.
We have disseminated the
occurrence of such defect to our
operation team during daily production
meeting to alert them to ensure the
amount of anti-oxidant added into the
latex compound in not at lower end of
the spectrum and to takes all the
precaution action to prevent any
potential sedimentation that may affect
the performance of the anti-oxidant in
the latex film.
 1. Increase the former cleaning frequency
from three weeks to two weeks to maintain
former cleanliness.
Effective: September 2017

2. To assign one former operator to each

line and to carry out routine former
Short Complaint Description: inspection at the frequency of every shift.
Gloves – tearing Effective: September 2017

Detailed Complaint Description: 3. Procedure WI-PD-45 is also revised for

It was noticed the glove was holed at this new procedure.
level of left thumb. Effective: September 2017

4. Conducted refresher training to all

former team workers.
Effective: September 2017

Optimizing the polymer wash tu,bling

From customer’s finding, this issue is
originated from donning difficulty. User
need to manipulate the finger in order
to fit well. This has led to the palm
tearing.
process by increasing tumbling time ( Nov
17)
2. Put in the control to check on the
donning property for each lot during QA
inspection ( Nov 17)

We have disseminate this complaint on glove

tearing during donning to our production team
during daily production meeting to alert the
team to monitor closely the manufacturing
Glove has been torn when donning. process.

1. Will continue to monitor in-process

inspection of gloves before washig
SIZE : 7.0
process per WI-QA-01 procedure.
Quantity: 144 boxes
2. QA inspectors had been informed on
1. The left and right glove are different
this complaint and they are reminded to
in coating
follow strictly th polymer coating checking
2. Glove not dry enough
as per WI-QA-26 procedure. (October
2017)

1. Production & QA team has been

Size 6.5 for Sensiflex is bigger than
previous supply
appraised on customer concern of
potential high variation in glove dimension
from batch to batch.
2. To revise in-house specification for palm
width tolerance from ± 5mm to ± 3mm

Effective: October 2017

1. The DC solution used in the polymer

coating process has been removed to
prevent the surface from too slippery.
2. The tumbling cycle time of the coating
process has been increased from 15 mins
Gloves slippery to 20 mins in order to achieve a more
homogenous mixing and thus a more
consistent grip within the same lot
processed.
3. To alter SKF formula to prevent grip
from becoming too slippery again.

All sizes were found having
bubble/blister on the bead.
Excess powder is found.
Customer found this lot for right side
glove is sticky.
1. To replace beading roller which are
worn off.
2.Machine operator to monitor the beading
roller from time to time to ensure beading
no issue.
1. Process improvement changes has
been made by tighten the control range of
the polymer total solid control and
reducing the amount of dosage to a lower
limit use for coating (effective date: 15th
Nov 2017)
2. Residual powder content test conducted
on gloves produced after the changes
showed reduction in residual powder
content. Thus, we believe this would
reduce the potential of having whitish
mark inside the glove at finger area.
3. There is a quality control plan in place
whereby residual powder content test is
performed on every lot after chlorination
process to ensure the powder content is
below the powder free glove requirement
limit which is 2mg/glove.
1. As part of our continuous
improvement effort, our production team
has started to monitor the latex film
dryness prior to coating dipping line by
line.
2. Production team has also been
alerted to target the polymer coating % at
optimal level. This was done during daily
production meeting.
 1.In order to improve the consistency of
the gloves performance in terms of grip,
donning, tensile properties and glove
color, we have set the rule of thumb that
all freshly dipped gloves for powder free
process must follow the requirement of
keeping in store for 24 hours before go for
powder free washing process. June
Looks yellowish than what they have
2017
been buying.
2.As part of the quality control,
It is less grippy than what they have
we are having our QA inspector and
been buying.
production supervisor to routinely check
on the tag card of each washing load to
ensure the time lap between dip date and
washing date is more than 24 hours. June
2017
3.Work instruction for powder free process
flow WI-PF-34 will be updated to reinforce
this requirement. Jan 2018

1. Left and right hand different colour to

our packing operation team.
Left and right different colour 2.
One QA supervisor will do rountine
random daily check

a) No action required.

b) We have changed the drying load

size from by gloves volume in standard bin
size to by weight. This will ensure each bin
is having the same gloves weight to
a) Gloves had bad smell.
enhance the drying efficiency.
b) Gloves sticky each other and
also to packaging.
c) Additional rinsing cycle has been
c) Gloves give allergic reaction to
added into the powder-free washing
user.
process to increase the robustness of the
d) Discoloration/Gloves colour
process to take eliminate any variation in
transferred to packaging.
glove dipping leaching process.

d) Color limit samples has been

established to ensure consistency of color
from one manufacturing batch to another
batch. The grade of wrapper has also
been changed.

Different green color tone on the same different production dates.
lot produced
1) Sticky
2) Torn
2) Lot # 701900074275
Notification Description
- inner package torn upon opening
- tearing after about 20 minutes
Short Text For Defect Type Code
- sticking together
- Tearing too easily
1) Lot # 704004236865
Notification Description
Glove finger tips won’t open
Short Text For Defect Type Code
- sticking together
Glove sticky at fingers
1Packing operation team has been
instructed not to pack gloves from different
production dates into same purchase
order and also not to pair gloves from
2.Colour variation = QA
will set a colour requirement
The following changes have been made to
improve the donning property to higher
end of the donning spec range:
1. Optimizing the polymer wash tumbling
process by increasing the tumbling time
2. Put in the control to check on the
donning property for each lot during QA
inspection
• Corrective Action: Reduced the output
bin quantity for each row from 40 wallets
to 35 wallets. •
Corrective Action: To improve the donning
property to higher end of the donning spec
range.1. increasing the tumbling time 2. 2.
Put in the control to check on the donning
property
Shift the average Polymer % to middle of
the acceptable range.
1. Drying oven temperature prior to
polymer dipping has been optimized to get
optimum condition for online polymer
coating. The dryness of the latex film is
monitored closely with routine check by
our SME operator. 2. Polymer (% TSC)
concentration increased by 0.5% to have
sufficient coating to eliminate sticky issue.

a) Gloves had bad smell.
b) Gloves sticky each other and
also to packaging.
c) Gloves give allergic reaction to
user.
d) Discoloration/Gloves colour
transferred to packaging.
Sticking at finger and pouch
Cuff stick to fingers
Cuff stick to fingers and folding area
stick to pouch
a) No action required.
b) We have changed the drying load
size from by gloves volume in standard bin
size to by weight. This will ensure each bin
is having the same gloves weight to
enhance the drying efficiency.
c) Additional rinsing cycle has been
added into the powder-free washing
process to increase the robustness of the
process to take eliminate any variation in
glove dipping leaching process.
d) Color limit samples has been
established to ensure consistency of color
from one manufacturing batch to another
batch. The grade of wrapper has also
been changed.
In order to enhance further the drying
process, we have changed the load size
measurement for each drying process
from quantity by bin to by weight of fixed
22 Kg per bin. This will help to ensure
consistency of gloves loading for each
cycle of drying process and eliminate the
potential of insufficient drying from load
size variation.
In order to enhance further the drying
process, we have changed the load size
measurement for each drying process
from quantity by bin to by weight of fixed
22 Kg per bin. This will help to ensure
consistency of gloves loading for each
cycle of drying process and eliminate the
potential of insufficient drying from load
size variation.
In order to enhance further the drying
process, we have changed the load size
measurement for each drying process
from quantity by bin to by weight of fixed
22 Kg per bin. This will help to ensure
consistency of gloves loading for each
cycle of drying process and eliminate the
potential of insufficient drying from load
size variation.

- Gloves found sticky resulting to
difficulty in donning
- Glove found sticky,stuck together on monitor the latex film dryness prior to
finger resulting difficulty in donning coating dipping line by line.
Rubber lump
Rubber lump
Glove have holes at folding area
- Glove have holes at cuff holding
area
Bubbles found on Fingertips
Pinhole found on little finger tip
1. Our production team has started to
monitor the latex film dryness prior to
coating dipping line by line.
2. Production team
has also been alerted to target the
polymer coating % at optimal level
1. Our production team has started to
2. Production team
has also been alerted to target the
polymer coating % at optimal level
Established stringent in-process control
and two additional workers to remove any
escapa glove from stripping process
Established stringent in-process control
and two additional workers to remove any
escapa glove from stripping process
Provide training to post drying handler.
Record temperature of process of each
batch and verify bt production officer
For corrective action, the former
management team will revise the Work
Instruction WI-PD-19-B and Wi-PD-18-B
(Former Inspection and Former Cleaning)
to ensure all the formers on the line are in
good conditions at all time. Revise
inspection and cleaning method as well as
frequency.
Provide training to former management
team on how to inspect and clean the
former.
To solve pinholes problem, to minimize the
chance of air bubble being generated by
preventing the carryover of unstripped
gloves using alarm system.
1. Adjust the position of the former to a
correct position during dipping and to
increase former rotation.
2. Ensure the control specification able to
pick up sufficient amount of compound

Gloves is torn on the finger tips before
donning. Only affected some pairs.
Gloves break while putting it on.
- Torn gloves
Gloves found with major break before condition and conduct daiily checking to
donning
Gloves tear very easy
Provide training to strippers to ensure
proper stripping of the gloves. Established
One Point Instruction on how to strip the
glove.Perform 100% inspection on all the
gloves.
Provide thorough training to sorting worker
with the proper segregation to avoid
defective glove to be mixed with good
glove
1. Optimizing the polymer wash tumbling
process by increasing the tumbling time
2. Put in the control to check on the
donning property for each lot during QA
inspection
Provide training to strippers to ensure
proper stripping of the gloves. Established
One Point Instruction on how to strip the
glove. Please refer attachment.
Perform 100% inspection on all the
gloves.
Provide thorough training to sorting worker
with the proper segregation to avoid
defective glove to be mixed with good
glove. Separate defective gloves into red
bag and good glove into white bag.
Provide thorough training to packing
worker to remove those defective gloves
during loading the glove into wrapper.
Introduce ONE POINT INSTRUCTION on
proper storage for glove and storage
ensure remain closed
1. Increase the former cleaning
frequency from three weeks to two weeks
to maintain former cleanliness.
2. To assign one former operator to
each line and carry out routine former
inspection at the frequency of every shift.
3. Revise work instruction, WI-PD-
45 to change the inspection frequency
from once a day to once a shift.
4. To conduct re-fresher training to
all the former team workers on the work
flow and former checking.

Foreign body was found on the inner removed and filtered back in.
side of sterile glove which had caused 2. Two additional workers were
pressure, friction and discomfort to the dedicated to each production line to
hand.
A lot of torn gloves inside boxes.
Found a bottle cap inside the box.
Nasty sew on gloves inside box
Stain
Too much powder outside glove
1. Established stringent in-process
control during production whereby any
lump discovered during inspection, line
must be stopped, and latex must be
remove any escape glove from the
stripping process.
One additional worker to remove torn
glove caused by former out of alignment.
Ban worker from bringing mineral water to
production place and to put minimal
lubricant on track above auto stack
machine and remove excess lubricant.
Bins cleaned for every cycle of usage.
Implementation CGMP system, monitoring
and training for workers and conduct
refresh training on emphasizr GMP
cleaning.
1. Process improvement changes has
been made by tighten the control range of
the polymer total solid control and
reducing the amount of dosage to a lower
limit use for coating (effective date: 15th
Nov 2017)
2. Residual powder content test
conducted on gloves produced after the
changes showed reduction in residual
powder content. Thus, we believe this
would reduce the potential of having
whitish mark inside the glove at finger
area.
3. There is a quality control plan in place
whereby residual powder content test is
performed on every lot after chlorination
process to ensure the powder content is
below the powder free glove requirement
limit which is 2mg/glove
Implementation date

2/6/2017
Oct-17

Nov-17
Nov/Dec2017

1st Dec 2017

12-Dec

Oct-17
Nov-17

1st Dec 2017

14th Dec 2017

 Jan-17

1. N/A

2. Dec 2017

3. Oct 2017

4. Sep 2017 & June 2017

 1. 12th Mar 2018

2. Schedule to be on Apr 2018

Nov-17

Nov-17

Jan-18

Jan-18
 1. N/A

2. Dec 2017

3. Oct 2017

4. Sep 2017 & June 2017

Dec-17

Dec-17

Dec-17
 Dec-17

Dec-17

Sep-17

Sep-17

Feb-18

Schedule to implement on
21/3/2018

Dec-16

Jan-18
 Mar-17

Nov-17

Mar-18

Mar-18

1/9/2017

25/09/2017

15/10/2017

25/09/2017
Sep-17

Feb-18

May-17

Nov-17
 Date
No Remark 8D Ref # Month Lot #/SCR
Received

1 Misplace CP170901 September 04/09/17 3066270

6K721521TGN
2 CP170908 September 25/09/17
(28513)

7 CP170914 September 9/27/2017 28890

8 CP171001 October 10/6/2017 28200 / 29011

Foreign Item
9 Foreign Item CP171002 October 10/16/2017 29844

10 CP171003 October 10/16/2017 30058

11 CP171004 October 29725

15 CP171007 October 10/23/2017 29648

17 CP171106 November 21/11/2017 2940460

20 CP171110 November 27/11/2017 28152

21 CP171201 December 12/8/2017 2961870

4 CP170910 September 12/09/17 27437

Wrong Lot No
 Wrong Lot No

22 CP171202 December 12/19/2017 31353

5 Label CP170912 September 9/26/2017 30453

11 Printing Error CP171005 October 10/19/2017 27656

18 Empty Pouch CP171108 November 27/11/2017 29803

Date
No Remark 8D Ref # Month Lot #/SCR
Received
4 Mix size
CP180111 JAN 16-Jan-18 29108

6 CP180201 FEB 1-Feb-18 30549

Printing Problem

14 CP180315 MAR 22-Mar-18 30688

13 CP180310 MAR 12-Mar-18 28200

Label

15 CP180316 MAR 22-Mar-18 30208

16 Ink CP180318 MAR 23-Mar-18 30537

8 Foreign Item CP180207 FEB 2-Feb-18 31030

 Customer Brand Mfg Date (mm/yy) Type of glove

Salalah Wallet 07/17 SKF

MEDLINE NEOLON 2G 09-16 SNKF

KEVENOLL DO
BRASIL
PRODUTOS
Maxitex Compact 2016-11 SLP
MEDICOS
HOSPITALARES
LTDA

Sanko Silky fit zero 2016-07, 2016-11 STPZF

 Medline Neolon 2G 2017-04 SNKF

Medline Neolon 2G SNKF

Chemil Srl Sensiflex Plus 2017-03 STKF

Yuhan Kimberly Yuhan Kimberly 2017-02 SKF

Ulma Medical LLC Neuro (SMBKF) 2017-01 SMBKF

Kalir Engineering Pluto 2016-07 SKF

Yuhan Kimberly Yuhan Kimberly 2017-02 SKF

Meditrade GMBH Neopretex OP 11-16 SNKTF

 Medline Japan NEOLON 2G 2017-11 SNKF

BBRAUN VASCO SURGICAL 2017-07 SKF

McKesson Finessis Zero 2016-06 STPZF

Abook SP Z.O.O Sensiflex Plus 2017-03 SKF

2018
Customer Brand Mfg Date (mm/yy) Type of glove

Euromedis EUROMEDIS Nov-2016 SKF

Medline Neolon 2G Jul-2017 SNKF

B.BRAUN VASCO SURGICAL

Jul-2017 SNKTF
MELSUNGEN AG CHLOROPRENE
SANKO CHEMICAL
STPZF Jul-2016 STPZF
INDUSTRY

MCKESSON
GLOBAL
CONFIDERM SPT May-2017 SAKNF
SOURCING UK
LIMITED

SENSIFLEX PLUS
GL INTER-AGO LATEX SURGICAL
Jun-2017 SKF
PTE LTD GLOVES POWDER
FREE

Walki Medical Oy CURITY NITRILE Sep-2017 ENDBF32

 Complaint

Carton size 7.0 but inside have size

6.5 gloves. 13 cartons involved.

Loose foreign particulate inside of

pouch

Insect Contamination

1. Poor seal on the pouch (Caught in

seal)
2. Hair Mixed
3. Same hand
 Size 7.0, Loose Foreign matter

Size 5.5 & 7.0, Loose Foreign matter

Customer found one piece of metal in

the pouch

Customer found one piece of metal in

the pouch

Mosquito on glove.

Customer found mosquito packed in

pouch

andy wrapper packed together with the glove inside the wrapper

Lot No wrongly indicate in box.

At pouch: Lot No: 274370616. At box:
Lot No: 2743765.
Correct No should be 274370616
(SCR+Manufacturing date)
 Incorrect lot number (TGN7110001J)
on the pouch. ‘1’ is missing after TGN

Carton label is with spelling mistake.

Power

Ink rub off on pouch.

Few empty pouch received in a box

018
Complaint
Size: 6.5 . 2 left hands gloves packed
in pouch

We found that indistinct barcode label

on the outer carton. So we could not
read the barcode by handy barcode
reader. 16 cartons affected.

Printing not clear

Expiry date on Pouch is different from
the box label.

Pouch have different expirry date with

dispenser and outer box

Black print on glove dropped of and

transffered to sleeve when glove
removed.

A lot of torn gloves inside boxes.

Found a bottle cap inside the box.
Nasty sew on gloves inside box
 CIR Action plan

1. ‘Sticker Request’ form (AP-33) has been revised to include

information on the reason of additional sticker request in order to have a
proper control if re-print the sticker due to damage or missing (Effective:
16/08/2017).

2. To train all packing and sticker printing workers to understand on

the revised ‘Sticker Request’ form.
(Effective: 16/08/2017).

3. QA to verify the re-printed sticker to ensure the re-printed sticker is

correct.
(Effective: 16/08/2017

1. Revise AUTOPACK: COMPACT NACHINE DAILY PARAMETER

CHECKLIST to put in the requirement of cleaning the machine during
start up, change of material and after any repairing work (Form: AP-02-
03).
(Effective date: 0ctober 2017)

2. To tighten the AQL for minor debris in QA inspection data sheet for
thermoforming machine (From: QA-34) from AQL 2.5 to AQL 1.5.
(Effective date: 0ctober 2017)

1. Repaired all the small opened channel at the packing and auto
packing area (Effective: 05/2017).
2. Installed additional units of insect killer at packing area (Effective:
05/2017).
3. Add signage to the packing entrance to remind the door shall be
closed at all the time (Effective: 01/2017).

1. Adjusted the width of ‘guilder’ for feeder at packing machine, to

ensure the wrapper is fit and aligned properly on the conveyor and
prevent misalignment from happening.
2. Fixed ‘stopper fixtures’ at packing machine before wrapper entering
the sealing section, to ensure the top & bottom end of wrapper is folded
properly.

1. Staffs are strictly not allowed to comb hair at changing room. Signage
has been placed at the changing room to remind the operators.
2. Installation of air tunnel blower to remove loose hair from the workers
cloths or hair net, if there is any.
3. Use IPA to clean the ‘output bin’ before packing. This is to avoid dust,
hair or foreign particles.
4. To use ‘net type space cap’ covering head to neck except eyes which
is more efficient and does not have the adhesive feature.

1. Increase the height of middle partition of the wallet machine to

prevent left/right glove mix up.
2. Additional picture of left & right glove will be displayed at packing
machine to show the correct position of the gloves after cuffing & side
recognition.
1. Revise AUTOPACK: COMPACT NACHINE DAILY PARAMETER
CHECKLIST to put in the requirement of cleaning the machine during
start up, change of material and after any repairing work (Form: AP-02-
03).
2. To tighten the AQL for minor debris in QA inspection data sheet for
thermoforming machine (From: QA-34) from AQL 2.5 to AQL 1.5.

1. Revise AUTOPACK: COMPACT NACHINE DAILY PARAMETER

CHECKLIST to put in the requirement of cleaning the machine during
start up, change of material and after any repairing work (Form: AP-02-
03).
2. To tighten the AQL for minor debris in QA inspection data sheet for
thermoforming machine (From: QA-34) from AQL 2.5 to AQL 1.5.

1. As part of the preventive measure, it been have revised AUTOPACK:

COMPACT MACHINE DAILY PARAMETER CHECKLIST to put in the
requirement of cleaning the machine during start up, change of material
and after any repairing work (Form: AP-02-03).
2. The implement the relevant corrective action will be done once the
defective sample is received and confirmed the source of such foreign
material “metal”.
(Effective date: Oct 2017)

1. As part of the preventive measure, we have revised AUTOPACK:

Compact Machine Daily Parameter Checklist to put in the requirement
of cleaning the machine during start up, change of material and after
any repairing work (Form: AP-0203).
2. We will implement the relevent corrective action once we received the
defective sample and confirmed the source of such foreign material
'metal''. (Oct 2017)
As a preventive measure, we will replace all the mosquito net with the
solid transparent sheet to shield all the net to prevent any potential of
tiny mosquito or flies get push through the net by strong air pressure or
when part of the net torn after aging.
We have disseminated the occurrence of this incidence with our
packaging operation and maintenance team during daily production
meeting to reinforce the discipline of pest control, machine houses
keeping and line clearance. 28/11/2017

1) Strictly impose HR rules in restrictions on bringing in food such as

candy. Workers have to go through spot check upon entering the
security point.

2) Constant (once a month) spot checks will be carry out at packing

area (picture as attached).

3) Disciplinary actions will be initiated against employee who does not

comply the rules and regulation of the company.

1. ‘Sticker Request’ form (AP-33) has been revised to include

information on the reason of additional sticker request in order to have a
proper control if re-print the sticker due to damage or missing (Effective:
16/08/2017).
2. To train all packing and sticker printing workers to understand on the
revised ‘Sticker Request’ form (Effective: 16/08/2017).
3. QA to verify the re-printed sticker to ensure the re-printed sticker is
correct. (Effective: 16/08/2017).
We have disseminated this complaint to the technician in charge to warn him
not to make the same mistake again. This was done during daily briefing
meeting.
QA inspector will take sample from both rolls of pouch cavity, verify, sign and
keep one printed pouch sample from each roll as master copy.
1. To have QA inspector to crosscheck printed master label artwork with
master label artwork in the system and verify against the printed label
and update the work instruction, WI-QA-30-01.
Effective: 27 September 2017

2. To revise Packing Label for Approval form (PK-58) to have additional

personal to counter check include Packing Officer/Packing Manager’s
verification column before submit to QA for the verification.
Effective: 02 October 2017

1.We have disseminated this complaint to our packing operation,

packing maintenance and QA team to monitor closely on the present of
such ink rubbed off defect. Oct 2017
2.A verbal complaint has also been log in with supplier of the pre-printed
pouch film. Oct 2017

a) The packing operators who perform the wrapper feeding at front

end of machine have been retrained on the correct ‘feeding’ procedure
per OPI-ATP-02. 17 Jul 2017
b) CCTV have been installed to monitor the pouch quality including
empty pouch. Once observed empty pouch, the operator will press the
button and the blower installed at the packing machine will blow away
the empty pouch and thereby preventing it from being collected and
packed into the box. June 2017

CIR Action plan

Increase height of middle partition on wallet machine to prevent glove
mixed. Picture of left and right glove Iis displayed at packing machine to
show correct position.

Network connection has been changed from Wi-Fi to direct network

cable for label printing.

We have disseminated this complaint to our packing operation, packing

maintenance and QA team to monitor closely after the changing
parameter settings to avoid mis looked problem from happening.
1. Incoming QA do verification check on all pre-printed stickers before
release to packing operation. 2. Line
clearance checklist has been updated to include the need for QA
inspector to cross check
information on box sticker, pouch & carton to match with Order
information. 3. Replacement boxes
with correct expiry dates will be arranged and send to customer once
affected quantity is confirmed.

The WI ''Autopack platen machine daily parameter checklist (AP-02-02)''

has been revised in January 2018 by including an additional checking
on the pouches quality for: -
i) Dye test
ii)Peel ability test
iii) Visual check on: -
a) Lot number
b) Size
c)Manufacturing/expired date
d)Data matrix code
e) Printing
All the above checking must be carry out by packing technician during
machine
We have start up and change
disseminated of brand,tosize
this complaint our packing operation, packing
maintenance and QA team to monitor closely on the present of such ink
rubbed off defect.

A verbal complaint has also been logged in with supplier of the pre-
printed pouch film. The supplier also is currently investigating on the
quality of the link and work on improvements
One additional worker to remove torn glove caused by former out of
alignment. Ban worker from bringing mineral water to production place
and to put minimal lubricant on track above auto stack machine and
remove excess lubricant.
Implementation date CIR Status

Done
 Done

Oct-17

Jun-17 Closed

Dec-17 Closed

8/16/2017 Done
 21-Dec Closed

9/26/2017 Done

Done

Closed

Implementation date CIR Status

Feb-17 Closed

Mar-17 Closed

Closed/Waiting for
Apr-18
review
Mar-18 Closed

Closed/Waiting for
Jan-18
review

Oct 2017
closed
Oct 2017

Feb-18 Closed