DURAMEDICAL SDN BHD ( Reg. No.

481909 U )
Oral DAM MANUFACTURING & QUALITY CONTROL, DESCRIPTION &
PROCESS FLOW CHART
PAGES ANNEXES ISSUE NO DATE
1 0F 4 NIL 1 1st Jan, 07

1. PURPOSE / OBJECTIVES
To provide a detail description of the Manufacturing and Quality Control steps undertaken
for the manufacturing of the Oral Dam in a Flow chart form.

2. SCOPE
Applicable through out the Product Realization process from the In-Coming Raw Material stage to the
Finished Product Shipment stage.

Responsibility Process Flow Description

Approved Approved Approved 1.0) IN - COMING RAW MATERIAL ACCEPTANCE

Purchasing & Vendors Vendors Vendors
Store Function (Latex (Pack Mat 1.1) In - coming Raw materials ( Latex, Chemicals
Supply) (Chemical Supply) & packaging materials) are received and
Supply) quarantined pending incoming QC Inspection.
1.2) In - coming QC inspection carried out based
1.5 on established test methods.
1.1 1.3) In - coming raw materials that passed QC
Top Reviewed By Quarantine inspection are indicated with "Accept" sticker
Management Top Store and transferred to store for issuance to
Management production / packing upon request.
1.2 1.4) In - coming raw material that failed QC
QC Function Fail QC inspection are indicated with "ON HOLD"
Inspection 1.4 sticker pending Top management decision
In-Coming
QC for review and concession.
Inspection 1.5) In-coming raw materials that failed QC
inspection without concession granted are
indicated with "Reject" stickers and returned
Pass QC
1.3 to Vendors for replacement and appropriate
Inspection
Corrective / Preventive Actions requested
Store Store from vendors to prevent similar recurrences.
Function
2.0) LATEX COMPOUNDING AND ACCEPTANCE
2.1
Compounding Latex 2.1) Approved Latex and Chemicals are drawn from
Section Compounding the store for compounding activities.

2.4 2.2 2.2) Compounded Latex batch is QC inspected for

Total Solid Content (TSC), Viscosity, Chloroform
Number and Colour Shade based on established
Compounde
QC Function specifications.
d Latex QC
Inspection
Fail QC 2.3)The passed batch is indicated with a "QC Pass
Inspection Sticker" and approved to be used in the dipping
Pass QC line.
2.3 Inspection
2.4) The failed batch is re directed to the
Approved Latex Batch To be compounding section for appropriate adjustment
used in the Dipping Line
 Approved Latex Batch To be
used in the Dipping Line prior a re QC inspection before acceptance.

DURAMEDICAL SDN BHD ( Reg. No. 481909 U )

Oral DAM MANUFACTURING & QUALITY CONTROL, DESCRIPTION &
PROCESS FLOW CHART
PAGES ANNEXES ISSUE NO DATE
2 0F 4 NIL 1 1st Jan, 07

Responsibility Process Flow Description

Dipping Dipping 3.0) DIPPING PROCESS

Section Process 3.1
3.1) Production of Oral dam starts with
casting latex onto the stainless steel revolving
Drying plate mould ( belt like ) to latex sheet before
Process 3.2 under going drying through a drying oven chamber.
3.6
3.2) The casted sheets are dried over a revolving
Powdering Powdering drier drum.
Section 3.3
Process
3.3) The latex sheets are powdered with talc powder.
Beyond
Specification 3.4
3.4) In process QC inspection carried out on dimension,
QC Section and visual inspection (randomly) are conducted to
3.7 determine the latex sheets' width, thickness and
In process
QC appearance are in accordance with the required
Inspection specifications.

Non 3.5) The products are rolled into roll form and the
Conforming QC inspection status is identified by appropriate
Product QC stickers ( pass / on hold / reject )
Segregated, Within
pending Specification 3.6) The noted deviation are informed to the dipping
Disposition
section for appropriate adjustments and to take
3.5 immediate corrective actions to prevent defective
products during dipping process.
3.7) The Non conforming product are identified
Rolling accordingly and segregated pending Disposition
Process
by the disposition authority.

3.8) The Rolled products are transferred to the store

for in process storage and retrieved from store for
Storage 3.8 the cutting process when required.
4.0) CUTTING PROCESS
Cutting
Section Cutting 4.1 4.1) The latex sheets are cut to the required length.
Process
4.2) In-process quality inspections are conducted on
4.2 the cut latex sheets based on periodic random
Non 4.4 sampling in accordance with in-house Spec.
QC Section Conforming
Product In process QC 4.3)The products within specification are forwarded to
Segregated, Inspection the next process, washing process.
pending
Disposition Beyond
Specification
 Product In process QC
Segregated, Inspection
pending
Disposition Beyond
Specification 4.4) The Non conforming product are identified
Within accordingly and segregated pending Disposition
4.3 Specification by the disposition authority.
DURAMEDICAL SDN BHD ( Reg. No. 481909 U )
Oral DAM MANUFACTURING & QUALITY CONTROL, DESCRIPTION &
PROCESS FLOW CHART
PAGES ANNEXES ISSUE NO DATE
3 0F 4 NIL 1 1st Jan, 07

Responsibility Process Flow Description

5.0) WASHING & DRYING PROCESS

Washing
Washing 5.1
Section 5.1) The cut latex sheets are washed with water to
remove the powder.

5.2) The washed rubber sheets are tumbled dried

Drying & 5.2 in a drying tumbler to remove any residue
Adding of
Flavor moisture and the desired flavor / fragrance added
if required.

5.3) In-process quality inspections are carried out on

5.3 the dried Oral dam based on periodic
random sampling in accordance with in-house
Non 5.5
QC Section specifications.
Conforming
Inprocess
Product
QC 5.4)The products within specification are forwarded to
Segregated,
Inspection
pending the next process, Die - Cut process.
Disposition
Beyond
Specification Within 5.5) The Non conforming product are identified
Specification accordingly and segregated pending Disposition
by the disposition authority.
5.4
6.0) DIE-CUT PROCESS

6.1) The cut rubber sheets are stacked for the Die-
Stacking 6.1 cutting process.

Die-Cut 6.2) The stacked rubber sheets are die-cut to the

Section Die-Cut 6.2 required sizes and peeled into individual sheets.

6.3) In-process quality inspections are carried out on

6.3 the die-cut Oral dam based on periodic
random sampling in accordance with in-house
QC Section Non 6.5 specifications.
Conforming
Inprocess
Product
QC 6.4)The products within specification are forwarded to
Segregated,
Inspection the next process, Packing process.
pending
Disposition Beyond
Specification Within 6.5) The Non conforming product are identified
Specification accordingly and segregated pending Disposition
by the disposition authority.
6.4
7.0) PACKING PROCESS
Packing Packing
Process 7.1
 Packing
Section Process 7.1 7.1) The Oral dams are packed into sealed
bags / boxes and shipping cartons with Lot
number and expiry date in accordance with
specified packing requirements.
DURAMEDICAL SDN BHD ( Reg. No. 481909 U )
Oral DAM MANUFACTURING & QUALITY CONTROL, DESCRIPTION &
PROCESS FLOW CHART
PAGES ANNEXES ISSUE NO DATE
4 0F 4 NIL 1 1st Jan, 07

Responsibility Process Flow Description

7.2) Post packing quality inspections are carried out
7.2 on the packed Oral dam based on
sampling plan in accordance with the in-house
QC Section Non 7.4 specifications.
Conforming
Post Packing
Product
QC Inspection 7.3)The products within specification are arranged to
Segregated,
pending be forwarded to the Finished goods store.
Disposition
Beyond Within 7.4) The Non conforming product are identified
Specification Specification accordingly and segregated pending Disposition
by the disposition authority.
7.3
Temporary Finished 7.5) The packed goods are transferred to the
Goods Store 7.5 Temporary Finished Goods Store pending
Pre-Shipment QA Inspection.
The failed
lot is 8.0) PRE-SHIPMENT QA INSPECTION
screened on 8.1
QA Dept a batch by 8.3 8.1)Pre-Shipment QA Inspection carried out on packed
batch basis Pre-Shipment Oral Dam. Sampling based on Lot size
and QA Inspection
in accordance with sampling plan ISO 2859-1.
replaced Pre-shipment inspection carried out according to
with New Beyond Within the product specifications specified in the Quality
batches and Specification Specification
(Failed) Plan.
subject to re (Passed)
QA Inspection includes - Dimensional Checks,
inspection Physical properties, Visual Inspection and
8.2 Packaging and Labeling requirements.

8.2)The lots within specification are considered as

pass and are transferred to Finished Goods
8.4 store and is ready for shipment.
Pre-Shipment
8.5 Test Report
(COR) 8.3)The failed lot, is screened on a batch by batch
Store basis and failed batches are replaced with new
Reject Store
Function batches and the new reconfigured lot is subject
to undergo pre-shipment inspection and testing.

Store Finished Goods 8.4) The failed batches are segregated out and
Function Store transferred to Reject Store as scraps.

8.5) For the Lots accepted at the Pre-shipment testing

stage, a Pre-shipment Test Report ( Certificate of
Release ) is issued by the QA Dept for shipment.
verifying the approval for shipment.
 Shipment of 9.0) SHIPMENT
Mkt Dept & Finished Product
Store Function 9.1 9.1)The Oral dams are shipped based on
specified delivery dates.
END