RISK ANALYSIS REPORT

Product
Febrile Antigen kit (Salmonella O Reagent (OA, OB, OC, OD), Salmonella H Reagent (HA, HB, HC, HD), Brucella Rose Bangal, Brucella abortus Reagent ,Brucella melitensis Reagent
Proteus OX2 Reagent, Proteus OX19 Reagent and Proteus OXK Reagent.
Context of the file (scope of the analysis): Date: 03.06.2022
Following ISO 14971:2019
RISK ANALYSIS

SN SSN
Estimation of
Estimation
residual risks Impact on Generatio
Risk
Foreseeable sequence of Hazardous situation Effect Proofs of the already n of a effectiveness of
Potential Hazard Control Measures/Preventive Measure for low risk hazards /Ben Acceptability Risk Phase
events (Harm) implementation estimated new verification
S P Score S P Score efit
risks? hazard?

1)improper disposal of the test Biological components become in Hygienic effects due to S3 P4 A Design: NA Proper disposal S3 P5 A No Impact No NA Acceptable NA Post production
remains with sample contact with human. biological materials present Protective measures: NA procedure is clearly phase
1.1 in the used test kit. Information for safety: Precaution in the package insert for user about proper disposal outlined in the Febrile
procedure and to discard Test materials and samples properly in a biohazard container. Antigen package insert

1) Presence of biological Biological component becomes in Infection to the living beings S2 P5 T Design: NA Proper disposal S2 P6 A No Impact No NA Acceptable Not applicaple Production phase
component of animal origin in contact with the environment. Protective measures: NA procedure is clearly
the positive and negative Information for safety: outlined in the Febrile
1.2 control. Precaution in the package insert for user about proper disposal procedure and to discard Test Antigen package insert
1 2) Improper disposal of the materials and samples properly in a biohazard container.
controls during testing.
1) Presence of biological Biological component becomes in Infection to the living beings S2 P3 U Design: Using leak free caps fit to the vial. Inprocess Method S2 P5 A No Impact NO NA Acceptable QC tightness test results. Production and
component of animal origin in contact with the environment. Protective measures: (QC.I02F) for latex kits post production
the positive and negative 1)The QC department tests the tightness of the vials/caps before the secondary packaging. Febrile Package Insert. phases
controls. Information for safety: Warning statment in the package insert for not using leaked vials and specification sheet for
1.3 2) Leakage : vial and cap. making proper disposal of the leaked vials. vials (RDXRPL0xxA00D)

Bio-contamination

1) Presence of biological Biological component becomes in Infection to the living beings S2 P5 A Design: NA Occupational safety and S2 P6 A No Impact Yes, Risk #6. NA Acceptable Training effectivness. Production and
component of animal origin in contact with the environment. Protective measures: NA health warnings and post production
the positive and negative Information for safety: instructions for workers in safety rule about the proper cleaning of guidance (19.06.01) phases
controls. surface and wash the contact area well.
1.4 2) Spillage of the positive and
negative controls during
production process.

1) Presence of biological Biological component in the Infection to the living beings S3 P4 A Design: NA Febrile Package Insert. S3 P5 A No Impact No NA Acceptable NA Production and
component in the sample. sample becomes in contact with Protective measures: NA post production
2) Improper disposal of the the environment. Information for safety: Precaution in the package insert for user about proper disposal phases
sample. procedure and to discard Test materials and samples properly in a biohazard container.
1.5

1) Presence of chemical
component ( phenol 0.5% or
formalin0.5%) in the reagent.
2) the reagent becomes in
2.1
contact with the worker during
filling.
The reagent becomes in contact
with skin, eyes or mucous
membranes.
signs of toxicity may include S3 P4 A Design: NA Occupational safety and S3 P4 A No Impact No NA Acceptable Trainning effectivness Production phase
irritation of skin, eyes and Protective measures: NA health warnings and
mucous membranes and Information for safety: Instructions for workers in safaty rule to wash the area of contact with guidance (19.06.01)
upper respiratory tract water immediately if contact occur.
(Worker). Training for workers about safety rules.

1) Presence of chemical
component ( phenol 0.5% or
formalin 0.5%) in the reagent.
2) Leakage from uncapped vials
or untight caps.
2.2
The reagent becomes in contact signs of toxicity may include
with skin, eyes or mucous irritation of skin, eyes and
membranes. mucous membranes and
upper respiratory tract
(User and worker)
S3 P4 A Design: Using leak free caps/dropper fit to the vials. 1) Input QC test method S3 P5 A No Impact No NA Acceptable Trainning effectivness. Production phase
Protective measures:The QC department tests the tightness of the vials/caps before the for the glass (QC.R09). Market informa on. /Post production
secondary packaging. 2) Inprocess QC test phase.
Information for safety: Precautions for the user in the package insert to wear Protective method of febrile
clothing. Also washing the area of contact with water immediately if contact occur. antigens (QC.I02F)
Instructions for workers in safaty rule to wash the area of contact with water immediately if 3) Package Insert
contact occur. (PPI2048A01)
Training for workers about safety rules. 4) Occupational safety
and health warnings and
guidance (19.06.01)

1) Presence of chemical The reagent becomes in contact signs of toxicity may include S3 P4 A Design: Using a good quality secondary packaging materials (the vial is individually packed in a 1)Febrile Package Insert S3 P5 A No Impact No NA Acceptable Market information. Post production
component ( phenol 0.5% or with skin, eyes or mucous irritation of skin, eyes and suitable box ). (PPI2048A01). phase
formalin0.5% ) in the reagent. membranes. mucous membranes and Using export carton boxes with foam for shipping process.
2
2) broken vials during testing or upper respiratory tract Protective measures: NA
2.3
shipping. (User and worker) Information for safety: Precaution in package insert for not using damaged vials and making
proper disposal.
Sticking fragile label on the outer box.
Toxicity
 Toxicity
1) Presence of chemical The reagent becomes in contact signs of toxicity may include S3 P4 A Design: NA 1)Discarding procedure S3 P5 A No Impact No NA Acceptable Market information. Production phase
component ( phenol 0.5% or with skin, eyes or mucous irritation of skin, eyes and Protective measures: NA (QPXDI00P) /Post production
formalin 0.5%) in the reagent. membranes. mucous membranes and Information for safety:Instructions for responsible person to ensure that the employee wear a 2)Febrile Antigen phase.
2)Improper disposal of the upper respiratory tract protective protective gloves, mask, lab coat and shoes cover before disposing the materials. Package Insert
2.4
reagent. (User and worker) Precaution in the package insert for user about proper disposal procedure and to discard Test (PPI2048A01).
(user/worker) materials and samples properly in a biohazard container.

1) Presence of chemical
component (phenol 0.5% and
formalin 0.5%) in the reagent.
2) Accidental drinking of the
reagent
2.5
The reagent becomes in contact Digestive system irritation S3 P4 A Design:Design the test to be for profissional use only. Reagent to be labled with the proper 1)Occupational safety S3 P5 A No Impact No NA Acceptable Market information. Production phase
with the digestive system . content (Name of the reagent). and health warnings and /Post production
Protective measures: The reagent and kit to be identified and well labeled during the storage guidance (19.06.01) phase.
and production 2)Febrile Antigen
Information for safety: Package Insert
Warning in the safety rules for workers to deal with all materials as a hazardous material and do (PPI2048A01).
not touch or digest them
Warning in the package insert for users for not drinking or digestion of the reagent.
Warning in the package insert that the test is for well trained proffessionl person .

1) Presence of chemical
component (Phenol 0.5% and
formalin 0.5% ) in the reagent.
2) Spilling the reagent during
2.6 production process.
3) The reagent released in the
sewage system.
the reagent becomes in contact life-threatening or death S5 P5 A Design: The concentration of preservative materials in the reagent to be less than the toxic 1)Discarding procedure S5 P6 A No Impact No NA Acceptable Market information. Production phase
with aquatic organisms in doses for aquatic organisms. level which means that there is a very wide safety margin to these chemical substances used. (QPXDI00P). /Post production
higher than toxic level. Protective measures: NA 2) Febrile antigen MSDS. phase.
Information for safety: instructions for responsible person in discarding procedure about the
proper disposal of the reagent by adding disinfectant, then emptying it into a sink and then flush
the sink with plenty of running water.

1) Presence of infected sample. Direct contact of samples with a Infection to the user S3 P3 T Design: NA Febrile Antigen Package S3 P4 A No Impact No NA Acceptable Market information Post production
2) the user is wounded. wound. Protective measures: NA Insert (PPI2048A01). phase.
3) Performing the test or Information for safety: Precaution for user on proper disposal procedures should be followed.
3 3.1 Cross-infection disposal without wearing
protective clothing.

1) Exposing the reagent to low Taking medication Suffering from medication S3 P3 T Design: Ensuring that the reagent can endure high or low temperatures. Stability Study for high S3 P4 A No Impact No NA Acceptable Market information Post production
or high temperatures during side effects. Protective measures: 1)Controlling the temperatures of inhouse refrigerators by daily and low temperatures phase.
storage in the company due to verification using digital data loggers. Maintenance Procedure
equipment failure. 2)Preventive maintenance of refrigerators. (QPXMI00P).
2) Exposure of the reagents for Information for safety: NA. GMP procedure
long periods. (QPXGM00P)
4
3)Reagent is not working
properly.
4)Obtaining a wrong result (false
positive result)

1) Exposing the reagent to low Delayed medical action. Serious health condition. S3 P3 T Design: Ensuring that the reagent can endure high or low temperatures. Stability Study for high S3 P4 A No Impact No NA Acceptable Market information Post production
or high temperatures during Protective measures: 1)Controlling the temperatures of inhouse refrigerators by daily and low temperatures phase.
storage in the company due to verification using digital data loggers. Maintenance Procedure
equipment failure. 2)Preventive maintenance of refrigerators. (QPXMI00P).
Storage or operation 2) Exposure of the reagents for Information for safety: NA. GMP procedure
outside prescribed long periods. (QPXGM00P)
environmental 3)Reagent is not working
conditions properly.
4)Obtaining a wrong result (false
negative result)

1) Exposing the reagent to low Taking medication Suffering from medication S3 P3 T Design: Ensuring that the reagent can endure high or low temperatures. Stability Study for high S3 P4 A No Impact No NA Acceptable Market information Post production
or high temperatures during side effects. Protective measures: Using ice bag in the export cartons for shipping to warm regions. and low temperatures phase.
shipping. Information for safety:The storage conditions to be indicated in the inner and outer box. Warehouse procedure
2) Exposure of the reagents for (QPXWA00P).
long periods.
3)Reagent is not working
4
properly.
4)Obtaining a wrong result.
(false positive result)

1) Exposing the reagent to low Delayed medical action. Serious health condition. S3 P3 T Design: Ensuring that the reagent can endure high or low temperatures. Stability Study for high S3 P4 A No Impact No NA Acceptable Market information Post production
or high temperatures during Protective measures: Using ice bag in the export cartons for shipping to warm regions. and low temperatures phase.
shipping. Information for safety:The storage conditions to be indicated in the inner and outer box.
2) Exposure of the reagents for
long periods.
3)Reagent is not working
properly.
4)Obtaining a wrong result.
(false negative result)
 1)Wrong or unclear expiration Taking medication Suffering from medication S3 P3 T Design: NA Inprocess QC test S3 P4 A No Impact No NA Acceptable 1)Market information. Post production
date due to production worker side effects. Protective measures: The quality control department check the expiry date printed on the label method of febrile 2)QC test records. phase.
errors. before the production team proceed their work. antigen (QC.I02F)
2)Using expired kit. Information for safety: Warning in package insert for not using damaged labels. Febrile Antigen Package
5.1
3) Erroneous or faulty results Insert (PPI2048A01).
would be obtained (False
positive result).

1)Wrong or unclear expiration Delayed medical action. Serious health condition. S3 P3 T Design: NA Inprocess QC test S3 P4 A No Impact No NA Acceptable 1)Market information. Post production
date due to production worker Protective measures: The quality control department check the expiry date printed on the label method of febrile 2)QC test records. phase.
errors. before the production team proceed their work. antigen (QC.I02F)
2)Using expired kit. Information for safety: Warning in package insert for not using damaged labels. Febrile Antigen Package
5 5.2 Inadequate labelling
3) Erroneous or faulty results Insert (PPI2048A01).
would be obtained (False
negative result).

1) unlabelled vial Taking medication Suffering from medication S3 P3 T Design: NA Inprocess QC test S3 P4 A No Impact No NA Acceptable 1)Market information. Post production
2) Missing expiry date. side effects. Protective measures: The quality control department check the vial labelling during the method of febrile 2)QC test records. phase.
3) Using expired kit. production. antigen (QC.I02F)
4) Erroneous or faulty results Information for safety: Precaution in package insert for not using vials without labels. Febrile Antigen Package
5.3
would be obtained (False Insert (PPI2048A01).
positive result).

1) unlabelled vial Delayed medical action. Serious health condition. S3 P3 T Design: NA Inprocess QC test S3 P4 A No Impact No NA Acceptable 1)Market information. Post production
2) Missing expiry date. Protective measures: The quality control department check the vial labelling during the method of febrile 2)QC test records. phase.
3) Using expired kit. production. antigen (QC.I02F)
4) Erroneous or faulty results Information for safety: Precaution in package insert for not using vials without labels. Febrile Antigen Package
5.4
would be obtained (False Insert (PPI2048A01).
negative result).

1) The label doesn’t match with Taking medication Suffering from medication S3 P3 T Design: NA 1) Production Worker S3 P4 A No Impact No NA Acceptable 1)Market information. Post production
the reagent. side effects. Protective measures: 1) The Production Manager/Supervisiour department to receive the Tasks SOP (SOP-PR3) 2)QC test records.
2)Obtaining a wrong result. printed labels and then assign them to workers. 2) Line Clearance Sheet
5.5 (False positive result) 2) The QC department to check that there is no presence of any different kind of materials that (QRXPR45F).
are not related to the btach record. 3) Reconciliation Form
3) Label reconciliation control. (QRXPR302F)
Information for safety: NA

1) The label doesn’t match with
the reagent.
2)Obtaining a wrong result.
(False negative result)
5.6
Delayed medical action. Serious health condition. S3
P3 T Design: NA 1) Production Worker S3 P4 A No Impact No NA Acceptable 1)Market information. Post production
Protective measures: 1) The Production Manager/Supervisiour department to receive the Tasks SOP (SOP-PR3) 2)QC test records.
printed labels and then assign them to workers. 2) Line Clearance Sheet
2) The QC department to check that there is no presence of any different kind of materials that (QRXPR45F).
are not related to the btach record. 3) Reconciliation Form
3) Label reconciliation control. (QRXPR302F)
Information for safety: NA

1) The labels dosnt stick well on Taking medication Suffering from medication S3 P3 T Design: NA Inprocess QC test S3 P4 A No Impact No NA Acceptable 1)Market information. Post production
the vial. side effects. Protective measures: The QC department to check that labeling process of vials and boxes. method of febrile 2)QC test records.
2) use the unlabeled vial to The Q.C department check the quality of label before enter them to warehouse. antigen (QC.I02F)
perform the test. Information for safety: Precaution in the product package insert stated that don’t use the Febrile Antigen Package
5.7 3) Erroneous or faulty results reagent if the label is not available or damaged. Insert (PPI2048A01).
would be obtained (False Input label inspection
positive result). (QCR.13)

1) The labels dosnt stick well on Delayed medical action. Serious health condition. S3 P3 T Design: NA Inprocess QC test S3 P4 A No Impact No NA Acceptable 1)Market information. Post production
the vial. Protective measures: The QC department to check that labeling process of vials and boxes. method of febrile 2)QC test records.
2) use the unlabeled vial to The Q.C department check the quality of label before enter them to warehouse. antigen (QC.I02F)
perform the test. Information for safety: Precaution in the product package insert stated that don’t use the Febrile Antigen Package
5.8 3) Erroneous or faulty results reagent if the label is not available or damaged. Insert (PPI2048A01).
would be obtained (False Input label inspection
negative result). (QCR.13)

1)Wrong content of the package Taking medication Suffering from medication S3 P4 A Design: NA Package insert (SOP- S3 P5 A No Impact No NA Acceptable 1)Market information. Post production
insert due to package insert side effects. Protective measures: PR2). 2)QC test records. phase.
officer errors. 1. Control of package insert under documentation control and during design phase. Inprocess QC test
2)perform the test by following 2. Record the package insert code, revision number and revision date on the dispense order. method :(QC.I02F)
Incorrect package insert. 3. The package insert to be signed by Q.C deprtament before transferring it to production.
6.1 3) Erroneous or faulty results Information for safety: NA
would be obtained (False
positive result).
 1)Wrong content of the package Delayed medical action. Serious health condition. S3 P4 A Design: NA Package insert (SOP- S3 P5 A No Impact No NA Acceptable 1)Market information. Post production
insert due to package insert Protective measures: PR2). 2)QC test records. phase.
officer errors. 1. Control of package insert under documentation control and during design phase. Inprocess QC test
2)perform the test by following 2. Record the package insert code, revision number and revision date on the dispense order. method :(QC.I02F)
Incorrect package insert. 3. The package insert to be signed by Q.C deprtament before transferring it to production.
6
3) Erroneous or faulty results Information for safety: NA
would be obtained (False
negative result).

Inadequate operating
instructions
1)Missing package insert due to Taking medication Suffering from medication S3 P4 A Design: NA Final QC test method S3 P5 A No Impact No NA Acceptable 1)Market information. Post production
worker errors. side effects. Protective measures: 1) The QC department to check the content of the kit. QC.F02L 2)QC test records. phase.
2)Perform the test without 2) Package insert reconciliation control. Reconciliation Form
following the package insert. Information for safety: 1)Precautions on box for read the package insert. (QRXPR302F).
3) Erroneous or faulty results Box design.
6.3
would be obtained (False
positive result).

1)Missing package insert due to Delayed medical action. Serious health condition. S3 P4 A Design: NA Final QC test method S3 P5 A No Impact No NA Acceptable 1)Market information. Post production
worker errors. Protective measures: 1) The QC department to check the content of the kit. QC.F02L 2)QC test records. phase.
2)Perform the test without 2) Package insert reconciliation control. Reconciliation Form
following the package insert. Information for safety: 1)Precautions on box for read the package insert. (QRXPR302F).
3) Erroneous or faulty results Box designs.
6.4
would be obtained (False
negative result).

1)The design team have not all user facing safety hazards Depends on the resulted S3 P5 A Design: NA Risk analysis procedure S3 P6 A No Impact No NA Acceptable Post market review. Post production
possible attempts to design the hazard as covered in this Protective measures: (CRXRI00P). phase
hazard-related feature out of risk analysis; risk # (1,2, 3) 1. Conduct proper risk analysis. Post Marketing/ Product
the device. 2. Review the hazards and the related warning that may result from post market review or Review Procedure
Insufficient warning and
2)Perform the testing by changes in the product. (CEXPM00P).
7 7.1 precautions in the label
following package insert or label Information for safety: NA
and package insert
that contains insufficient
warning which lead to user error.

1)The kit used by unskilled Taking medication Suffering from medication S3 P5 A Design: NA Package Inserts S3 P6 A No Impact No NA Acceptable Market information. Post production
personnel. side effects. Protective measures: NA Supply agreement
2)Obtaining a wrong result Information for safety: 1)Warning in the package insert and label that the test should be
8.1 (False positive result) performed only by well trained and skilled people.
2) Distribution to authorised dealers only, whose responsibility to sell to professional users.
Use by unskilled
8
/untrained personnel 1)The kit used by unskilled Delayed medical action. Serious health condition. S3 P5 A Design: NA Package Inserts S3 P6 A No Impact No NA Acceptable Market information. Post production
personnel. Protective measures: NA Supply agreement
2)Obtaining a wrong result Information for safety: 1)Warning in the package insert and label that the test should be
8.2 (False negative result) performed only by well trained and skilled people.
2) Distribution to authorised dealers only, whose responsibility to sell to professional users.

1)The user does not abide by the Taking medication Suffering from medication S3 P6 A Design: NA Box designs. S3 P6 A No Impact No NA Acceptable NA Post production
user's instructions. side effects. Protective measures: NA phase.
2)Perform the test without Information for safety: Precautions on box for read the package insert.
abiding the instruction.
9.1 3)Obtaining a wrong result.
(False Positive Result)

Reasonably foreseeable
9
misuse 1)The user does not abide by the Delayed medical action. Serious health condition. S3 P6 A Design: NA Box designs. S3 P6 A No Impact No NA Acceptable NA Post production
user's instructions. Protective measures: NA phase.
2)Perform the test without Information for safety: Precautions on box for read the package insert.
abiding the instruction.
9.2 3)Obtaining a wrong result.
(False Negative Result)

1) Performing test without Taking medication Suffering from medication S3 P4 A Design: NA Box designs S3 P5 A No Impact No NA Acceptable Market information. Post production
reading the package insert. side effects. Protective measures: NA phase.
2) Erroneous or faulty results Information for safety: Symbol on box for reading the package insert
10.1
would be obtained (False
Violation or positive result).
abbreviation of
10
instructions, procedures, 1) Performing test without Delayed medical action. Serious health condition. S3 P4 A Design: NA Box designs S3 P5 A No Impact No NA Acceptable Market information. Post production
etc. reading the package insert. Protective measures: NA phase.
2) Erroneous or faulty results Information for safety: Symbol on box for reading the package insert
10.2
would be obtained (False
Negative result).
 Incompatibility with 1)The user perform the test on a Delayed medical action. Serious health condition. S3 P5 A Design: NA Package insert S3 P6 A No Impact No NA Acceptable Market information. Post production
accessories. black glass slide. Protective measures: NA phase
2)Results are not clear. Information for safety: 1)Warning in the package insert for not using black glass slide during
3)User will redo the test. testing.
11 11.1
2)Information in the materials provided for using black slides.

Glass vial can be broken during broken glass becomes in contact Injury. S4 P4 A Design: NA Occupational safety and S4 P6 A No Impact No NA Acceptable Market information. Production phase
production. with worker. Protective measures: NA health warnings and
Information for safety: Warning In safty rules for not handling the broken glass with hands and guidance (19.06.01)
12.1 using a brush and dustpan to clean up broken glass and Placing the broken glass in the
designated sharp edges container.

12 Sharp edges or point. Glass vial can be broken during broken glass becomes in contact Injury. S3 P4 A Design: 1)Using a good quality secondary packaging materials (the vial is individually packed in a Finished product S3 P6 A No Impact No NA Acceptable Market information. Post production
shipping, transportation and with worker/ User suitable box and the is packed in a cartoon box with sponge). specifications (PDX) phase
testing. 2)Using export carton boxes with foam for shipping process. Package Inserts
Protective measures:
12.2 Information for safety: 1)Warnning in package insert for not using damaged vials and making
proper disposal.
2)Sticking fragile label on the outer box.

1) Deteriorated or defected
test kit.
2) Erroneous or faulty results
would be obtained (False
13.1
positive result).
Taking medication Suffering from medication S3 P4 A Design: NA Inprocess Q.C test S3 P5 A No Impact No NA Acceptable 1)Market information. Post production
side effects. Protective measures: The quality control department ensures that each lot must be tested method of febrile 2)QC test records. phase.
before the releasing of the batch. Antigen (QC.I02F).
Information for safety:NA Finished Q.C test
method of febrile
Antigen (QC.F02F).

1) Deteriorated or defected Delayed medical action. Serious health condition. S3 P4 A Design: NA Inprocess Q.C test S3 P5 A No Impact No NA Acceptable 1)Market information. Post production
test kit. Protective measures: The quality control department ensures that each lot must be tested method of febrile 2)QC test records. phase.
2) Erroneous or faulty results before the releasing of the batch. Antigen (QC.I02F).
would be obtained (False Information for safety:NA
13.2
negative result).

Misrepresentation of
13
results. 1)Performing the test without Taking medication Suffering from medication S3 P4 A Design: NA Label design S3 P5 A No Impact No NA Acceptable 1)Market information. Post production
reading the package insert. side effects. Protective measures: NA 2)QC test records.
2) Erroneous or faulty results Information for safety: The test labels instruct the user to read the package inserts before
would be obtained (False performing the tests.
13.3
positive result).

1)Performing the test without Delayed medical action. Serious health condition. S3 P4 A Design: NA Label design S3 P5 A No Impact No NA Acceptable 1)Market information. Post production
reading the package insert. Protective measures: NA 2)QC test records.
2) Erroneous or faulty results Information for safety: The test labels instruct the user to read the package inserts before
would be obtained (False performing the tests.
13.4
positive result).

1Wrong expiry date printed on Taking medication Suffering from medication S3 P4 A Design: NA Inprocess Q.C test S3 P5 A No Impact No NA Acceptable 1)Market information. Post production
the test kit. side effects. Protective measures: The quality control department check the expiry date printed on the kit method of febrile 2)QC test records. phase.
2) User used the kit after the before the production team proceed their work. Antigen (QC.I02F).
expiry date. Information for safety: NA.
3)Erroneous or faulty results
14.1 would be obtained (False
positive result).

Lack of determination of
14 end of the life of the
1Wrong expiry date printed on Delayed medical action. Serious health condition. S3 P4 A Design: NA Inprocess Q.C test S3 P5 A No Impact No NA Acceptable 1)Market information. Post production
medical device life
the test kit. Protective measures: The quality control department check the expiry date printed on the kit method of febrile 2)QC test records. phase.
2) User used the kit after the before the production team proceed their work. Antigen (QC.I02F).
expiry date. Information for safety: NA.
3)Erroneous or faulty results
14.2 would be obtained (False
negative result).
 1) Bad secondary packaging Taking medication Suffering from medication S3 P4 A Design: Using a good quality secondary packaging materials packed in a suitable box. Using Warehouse procedure S3 P5 A No Impact No NA Acceptable Market information. Post production
materials. side effects. export carton boxes with foam for shipping process. (QPXWA00P). phase.
2) deteriorated test. Protective measures: NA
3)Erroneous or faulty results Information for safety: NA
15.1
would be obtained (False
positive result).

1) Bad secondary packaging Delayed medical action. Serious health condition. S3 P4 A Design: Using a good quality secondary packaging materials packed in a suitable box. Using Warehouse procedure S3 P5 A No Impact No NA Acceptable Market information. Post production
materials. export carton boxes with foam for shipping process. (QPXWA00P). phase.
2) deteriorated test. Protective measures: NA
15.2 3)Erroneous or faulty results Information for safety: NA
would be obtained (False
negative result).
Inadequate packaging
(contamination and/or 1) Deterioration of the devices The reagent or the glass becomes Possible hazards (Bio- S3 P5 A Design: 1) Using a good quality secondary packaging materials (the vial is individually packed in Product specification S3 P6 A No Impact No NA Acceptable Training effectiveness Production phase
15
deterioration of the during in- house handling and in contact with the persons or contamination, Toxicity, a suitable box and the latex kit is packed in a cartoon box with sponge). sheet
device) storage. environment. Cross-infection, sharp 2) Using export carton boxes with foam for shipping process.
2) Broken vials and release of edges) lead to death or
15.3 the reagent. injury. Protective measures: NA
(see risk # 1, 2, 3 and 12)
Information for safety: NA

1) Deterioration of the devices
during shipping.
2) Leakage or broken vials.
15.4
The reagent or the glass becomes Possible hazards (Bio- S3 P5 A Design: 1) Using a good quality secondary packaging materials (the vial is individually packed in Product specification S3 P6 A No Impact No NA Acceptable Market information. post production
in contact with the persons or contamination, Toxicity, a suitable box and the latex kit is packed in a cartoon box with sponge). sheet phase
environment. Cross-infection, sharp 2) Using export carton boxes with foam for shipping process.
edges) lead to death or Protective measures: NA
injury. Information for safety: Sticking fragile label on the outer box.
(see risk # 1, 2, 3 and 12)

1) Wrong sample type . Taking medication Suffering from medication S3 P4 A Design: NA Box Designs S3 P4 A No impact No NA Acceptable Market information. Post production
2) User performed the test side effects. Protective measures: NA phase.
without reading the package Information for safety: Precautions on box for reading the package insert
16.1 insert.
3) Erroneous or faulty results
would be obtained (False
positive result).
specimen identification
16
errors. 1) Wrong sample type . Delayed medical action. Serious health condition. S3 P4 A Design: NA Box Designs S3 P4 A No impact No NA Acceptable Market information. Post production
2) User performed the test Protective measures: NA phase.
without reading the package Information for safety: Precautions on box for reading the package insert
16.2 insert.
3) Erroneous or faulty results
would be obtained (False
negative result).

1)Not-following storage Taking medication Suffering from medication S3 P5 A Design: NA Package Insert S3 P6 A No Impact No NA Acceptable Market information. post production
conditions for preserving the side effects. Protective measures: NA phase
opened devices. Information for safety: warning in the package insert to close the vial after each test.
2)Leaving the device opened for
prolonged period of time.
17.1 3)Reagent is not working
properly.
4)Erroneous or faulty results
would be obtained (False
positive result).
Deterioration of
17 performance for the
1)Not-following storage Delayed medical action. Serious health condition. S3 P5 A Design: NA Package Insert S3 P6 A No Impact No NA Acceptable Market information. post production
open devices
conditions for preserving the Protective measures: NA phase
opened devices. Information for safety: warning in the package insert to close the vial after each test.
2)Leaving the device opened for
prolonged period of time.
17.2 3)Reagent is not working
properly.
4)Erroneous or faulty results
would be obtained (False
negative result).
 1)Improper storage of kit Taking medication Suffering from medication S3 P4 A Design: 1) Using a good quality secondary packaging materials (the Test devices are packed in a GMP procedure S3 P5 A No impact No NA Acceptable Market information. Post production
(in house, shipping and in use). side effects. suitable box. (QPXGM00P) phase.
2)Deterioration of the test. 2) Using export carton boxes with foam for shipping process. Supply agreement
3) User performing the test Protective measures: Controlling the temperatures of in-house storage by daily verification Package inserts
using a deteriorated test. using digital data loggers.
18.1 4) Erroneous or faulty results Information for safety: 1)The storage condition to be indicated in the package insert, label and
would be obtained (False packaging.
positive result). 2)Precaution on storing and transporting the reagent according to the manufacturer’s
stability problems (in specifications to be mentioned in the distributor supply agreement.
storage, in shipping, in
18
use, after first opening 1)Improper storage of kit Delayed medical action. Serious health condition. S3 P4 A Design: 1) Using a good quality secondary packaging materials (the Test devices are packed in a GMP procedure S3 P5 A No impact No NA Acceptable Market information. Post production
of the container). (in house, shipping and in use). suitable box. (QPXGM00P) phase.
2)Deterioration of the test. 2) Using export carton boxes with foam for shipping process. Supply agreement
3) User performing the test Protective measures: Controlling the temperatures of in-house storage by daily verification Package inserts
using a deteriorated test. using thermometers and weekly verification using digital data loggers.
18.2 4) Erroneous or faulty results Information for safety: 1)The storage condition to be indicated in the package insert, label and
would be obtained (False packaging.
negative result). 2)Precaution on storing and transporting the reagent according to the manufacturer’s
specifications to be mentioned in the distributor supply agreement.

1)Not-following of storage Taking medication Suffering from medication S3 P5 A Design: Ensuring that the reagent can endure high or low temperatures. Stability Study for high S3 P6 A No Impact No NA Acceptable Market information. post production
conditions or inadequate side effects. Protective measures: Controlling the temperatures of refrigerators by daily verification using and low temperatures phase
specification for storage. digital data loggers. (SS.13.6).
2)Deterioration of the reagent. Information for safety: 1)The storage condition to be indicated in the package insert, label and GMP procedure
4)Erroneous or faulty results packaging. (QPXGM00P)
18.3 would be obtained (False 2)Precaution on storing and transporting the reagent according to the manufacturer’s Package Insert
positive result). specifications to be mintioned in the supply agreement Supply agreement.

1)Not-following of storage Delayed medical action. Serious health condition. S3 P5 A Design: Ensuring that the reagent can endure high or low temperatures. Stability Study for high S3 P6 A No Impact No NA Acceptable Market information. post production
conditions or inadequate Protective measures: Controlling the temperatures of refrigerators by daily verification using and low temperatures phase
specification for storage. digital data loggers. (SS.13.6).
2)Deterioration of the reagent. Information for safety: 1)The storage condition to be indicated in the package insert, label and GMP procedure
4)Erroneous or faulty results packaging. (QPXGM00P)
18.4 would be obtained (False 2)Precaution on storing and transporting the reagent according to the manufacturer’s Package Insert
positive result). specifications to be mintioned in the supply agreement Supply agreement.

1) Wrong sample type . Taking medication Suffering from medication S3 P4 A Design: NA Box Design S3 P5 A No impact No NA Acceptable Post market review. Post production
2) User performed the test side effects. Protective measures: NA
without reading the package Information for safety: Precautions on box for reading the package insert
insert.
3) Erroneous or faulty results
19.1 would be obtained (False
positive result).

specimen identification
19
errors. 1) Wrong sample type . Delayed medical action. Serious health condition. S3 P4 A Design: NA Box Design S3 P5 A No impact No NA Acceptable Post market review. Post production
2) User performed the test Protective measures: NA
without reading the package Information for safety: Precautions on box for reading the package insert
insert.
3) Erroneous or faulty results
19.2 would be obtained (False
negative result).

1) Performing the test without Taking medication Suffering from medication S3 P4 A Design: NA Box Design S3 P4 A No impact No NA Acceptable Post market review. Post production
reading the package insert. side effects. Protective measures: NA
2)Wrong sample preparation. Information for safety: Precautions on box for reading the package insert
2)Obtaining a wrong result.
20.1 (false positive result)

problems related to
20 taking, preparation and
1) Performing the test without Delayed medical action. Serious health condition. S3 P4 A Design: NA Box Design S3 P4 A No impact No NA Acceptable Post market review. Post production
stability of specimens.
reading the package insert. Protective measures: NA
2)Wrong sample preparation. Information for safety: Precautions on box for reading the package insert
2)Obtaining a wrong result.
20.2 (false negative result)
 1Wrong expiry date printed on Taking medication Suffering from medication S3 P4 A Design: NA Shelf life and S3 P5 A No Impact No NA Acceptable 1)Market information. Post production
the test kit. side effects. Protective measures: we have a shelf life determination expiry date SOP to determine the determination of shelf 2)QC test records.
2) User used the kit after the expiry date . life SOP-SL
Determination of Expiry expiry date. Information for safety: NA.
21 21.1 date without a verifiable 3)Erroneous or faulty results
reference would be obtained (False
positive result).
►Conclusion: According to our criteria for risk acceptability:

Residual Risk Number of Residual Risk

Acceptable 56
Tolerable 0
Unacceptable 0

►Risk/Benefit analysis for Individual Residual Risk:

No need for risk benefit analysis for individual residual risk

►Global Residual Risk:

Acceptable
Unacceptable

►Are they any combinations of acceptable risks that can lead to unacceptable global residual risk?
No

Risk Analysis team

Name Position Role Date

1 Suzan Shebli Product Specialist/ General Manager Expert/ Approver 03.06.2022

2 Siti Mira Aina Badly Sham QA Manager Expert/ Reviewer 03.06.2022
3 Noradila Syawani A.Molok QA Officer Advisor 03.06.2022
4 Mizwaruddin Sidek QA Officer Advisor 03.06.2022
5 Nurliyana Ab. Azit QC Manager Advisor 03.06.2022
6 Nur Hikmah Asri Warehouse Officer Advisor 03.06.2022
7 Muhamad Hakeem Iman Mahzan Planning Officer Advisor 03.06.2022