Risikoanalyse Greenspring Nasal 2021.3.9

SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)
Document No. LSY-PP -2021-0202 Version. No. 1.0
RISK MANAGEMENT REPORT

1. Scope and Introduction
This document is Risk Management Report of SARS-CoV-2 Antigen Rapid Test Kit
(Colloidal Gold). This analysis was planned at the beginning stage of device design, and
report was prepared at the stage of initial lot production. In line with the change of risk
and technology on the device this analysis will be performed together. Main methods and
procedures we selected herewith are focused on ISO 14971:2019.
2. Definition
○ Harm: Injury or damage to the health of people, or damage to property or the
environment
○ Hazard: Potential source of harm
○ Risk: Combination of the probability of occurrence of harm and the severity of that
harm
○ Risk Analysis: Systematic use of available information to identify hazards (3.4) and to
estimate
the risk
○ Safety: Freedom from unacceptable risk
3. Reference Standards and Documents
No. Standard Name Reference No.

Medical device-Application of risk management to medical
1 ISO 14971:2019
devices
2 Medical devices — Guidance on the application of ISO 14971 ISO/TR 24971:2013
4. Management Responsibility and Qualification of Personnel

Name Title Qualification
The deputy head of the project, is
Management
Yongqing Jiang responsible for the implementation of the
Representative
risk analysis process
To estimate the faults and incidents
production
Bin Huang resulted from the errors of the operator
supervisor
from the application point of view
Jinchao Zhang R&D Supervisor To estimate the probability of the failures
1

from the technical point of view
To estimate the probability risk from the
Xiaojuan Zhang Quality supervisor
product quality point of view
5. Risk Management policy and Risk management process
Risk Management policy
If possible, the risks will be reduced as possible as we can, even if the risks are
acceptable before reduced.
5.1 Risk management process

Flow of Risk management:
2
6. Criteria for Acceptability
6.1 The severity of a hazard
3

Common
Level Possible description
terms
S1 Negligible Inconvenience or temporary discomfort
S2 Minor Result in temporary injury or impairment not requiring
professional medical intervention.
Serious Result in injury or impairment requiring professional
S3
medical intervention.
S4 Critical Results in permanent impairment or life-threatening injury
S5 Catastrophi Result in patient death.
c
6.2 The probability of a hazard
The probability of a hazard will be different for the deferent cause. The probability is
classified in a number of classes using 5 classes.
Level Common terms Possible description
P1 Frequent ≥10-3
P2 Probable ＜10-3 and ≥10-4
P3 Occasional ＜10-4 and ≥－10-5
P4 Remote ＜10-5 and ≥－10-6
P5 Improbable ＜10-6
6.3 The risk level

Severity
Probability S1 Negligible S2 Minor S3 S4 Critical S5
Serious Catastrophic
P5 Frequent R U U U U
P4 Probable R R R U U
P3 R R R U
A
Occasional
P2 Remote A A R R R
P1 A A A A
A
Improbable
Risk level: Risk = Severity × Probability
A-Acceptable; R-Risk as low as reasonably practicable; U-Unacceptab
4

7. R
isk analysis
7.1 Intended use

The SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) is used for the qualitative
detection of the SARS-CoV-2 antigen in human nasal swab specimens and is designed
for self-testing.
7.2 Reasonably foreseeable misuse
A. possible errors of operators:
-- improper reagents or samples were used ;
-- the test is not carried out according to the instruction, and the operation procedure is
changed or simplified at will;
-- Storage under inappropriate conditions.
-- Children need help.
7.3 Identification of characteristics related to safety
According to ISO 14971:2019 & ISO/TR 24971, the risk manager identify and document
those qualitative and quantitative characteristics that could affect the safety of the
medical device, as shown in "Annex 1-Questions related to Identification of hazards".
7.4 Identification of hazards and hazardous situations
Identify and document known and foreseeable hazards associated with the medical
device based on the intended use, reasonably foreseeable misuse and the characteristics
related to safety in both normal and fault conditions. As shown in "Annex 2-Relationship
between hazards, foreseeable sequences of events, hazardous situations and the harm
that can occur".
7.5 Risk estimation
Because the kit is not in contact with the patient, the risk associated with the patient is
only shown if the test results are incorrect. The test results of this product are for
diagnostic aid only and cannot be used as the sole basis for confirming or excluding
diagnosis. To achieve diagnostic purposes, the results should always be assessed in
combination with clinical examination, medical history, and other laboratory data, will not
directly lead to adverse medical measures. But if clinical doctors ignored the kit's
intended use and kits are directly related to the test results as the only diagnosis,
incorrect results can lead to improper medical measures so as to cause damage to
patients, this kind of situation, need to consider the damage severity and occurrence
probability, according to the criteria for acceptability to estimate risk of risk for the
patient.
5
8. Risk evaluation and risk control

For each identified hazardous situation, we using the criteria for risk acceptability to
evaluate the estimated risks and determine if the risk is acceptable or not. If the risk is
“Risk as low as reasonably practicable” or “not acceptable”, We will perform risk control
activities. At the same time, re-evaluate the risk after taking measures to confirm
whether the risk level is acceptable.See “Annex 3- Risk assessment, risk control and
remaining risk records.
9. Residual risk evaluation

According to the information in Annex 3, after taking measures to reduce risks, the
residual risk of SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) is reduced to an
acceptable level.
10. Roduction and post-production activities

Company had established and maintained a systematic procedure---Corrective Action
Procedure to review information obtained from the medical device or similar devices in
the post-production phase. The information shall be evaluated for possible relevance to
safety, especially the following:
a) if previously unrecognized hazards are present;
b) if the estimated risk(s) arising from a hazard is no longer acceptable;
c) if the original assessment is otherwise invalidated.
If any of the above conditions is met, the results of the evaluation shall be fed back as an
input to the risk management process.
According to this information relevant to safety, a review of the appropriate steps of risk
management process for the medical device will be considered. If there is a potential that
the residual risk(s) or its acceptability has changed, the impact on previously
implemented risk control measures willll be evaluated. The results of this evaluation shall
be recorded in the risk management file according to procedure Risk Management. And
this file is a living file.
By far, our products fail to market in EU, and there is no adverse incidents obtained from
the markets where our products had been sold.
11. Conclusion
6
Aft Document No. LSY-PP -2021-0202 Version. No. 1.0
er risk analysis, evaluation and effective control measures are taken on SARS-CoV-2
Antigen Rapid Test Kit (Colloidal Gold), the residual risk of the product is acceptable, which
indicates that the risk management implemented on the product is effective and can
guarantee the safety and effectiveness of the product.
7
Annex 1-Questions related to Identification of hazards

Questions Answer
A.2.1 What is the intended use SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)
and how is the medical device is used for the qualitative detection of the
to be SARS-CoV-2 antigen in human nasal swab
used? specimens and is designed for self-testing.
A.2.2 Is the medical device
No
intended to be implanted?
intended to be in contact with The kit is used by operator himself.
the patient or other persons?
A.2.4 What materials or
components are utilized in the The kit contains biochemical reagents,
medical device or are used animal-derived and human-derived biomaterials,
with, or are in contact with, and the test samples are nasal swab.
the medical device?
A.2.5 Is energy delivered to or
No
extracted from the patient?
A.2.6 Are substances The product itself does not provide substances to
delivered to or extracted from the patient, but nasal swab specimens/samples
the patient? collected from patient
A.2.7 Are biological materials
processed by the medical
device for subsequent re-use, No
transfusion or
transplantation?
supplied sterile or intended to
be sterilized by the user, or No
are other microbiological
controls applicable?
intended to be routinely
No
cleaned and disinfected by the
user?
A.2.10 Is the medical device No
8

Questions Answer
intended to modify the patient
environment?
A.2.11 Are measurements
No
taken?
No
interpretative?
intended for use in
conjunction with other No
medical devices, medicines or
other medical technologies?
A.2.14 Are there unwanted Yes.The waste and waste liquid generated during
outputs of energy or or after the use of the kit shall be properly treated
substances? before being discharged or discarded.
The kit should store at room temperature (2 -30℃
A.2.15 Is the medical device or 35.6-86℉) in a dry shady place. Avoid direct
susceptible to environmental sunlight. Please refer to the instruction for the
influences? requirements of temperature in the process of
transportation and use.
A.2.16 Does the medical
device influence the No
environment?
A.2.17 Are there essential
consumables or accessories
No
associated with the medical
device?
A.2.18 Is maintenance or
No
calibration necessary?
No
device contain software?
Yes. Please refer to the instruction for use
device have a restricted
condition, storage condition and expiry date
shelf-life?
A.2.21 Are there any delayed or
No
long-term use effects?
A.2.22 To what mechanical No,there is no mechanical forces will the device be
9

Questions Answer
forces will the medical device subjected.
be subjected?
A.2.23 What determines the Stability of bioactive components in kit, and
lifetime of the medical device? storage condition and transportation condition of
the kit.
Yes
intended for single use?
A.2.25 Is safe Yes.Products don’t contain infectious and toxic
decommissioning or disposal ingredients, but the nasal swab from users may be
of the medical device dangerous, after use should be treated as medical
necessary? waste.
A.2.26 Does installation or use
of the medical device require
Yes. The operator can read the manual well.
special training or special
skills?
A.2.27 How will information for
provided in the instruction manual.
safe use be provided?
A.2.28 Will new manufacturing
processes need to be No
established or introduced?
A.2.29 Is successful
application of the medical
device critically dependent on No
human factors such as the
user interface?
A.2.29.1 Can the user interface
design features contribute to No
use error?
A.2.29.2 Is the medical device
used in an environment where
No
distractions can cause use
error?
A.2.29.3 Does the medical
device have connecting parts No
or accessories?
A.2.29.4 Does the medical No
10

Questions Answer
device have a control
interface?
A.2.29.5 Does the medical
No
device display information?
A.2.29.6 Is the medical device
No
controlled by a menu?
A.2.29.7 Will the medical
device be used by persons No
with special needs?
A.2.29.8 Can the user
interface be used to initiate No
user actions?
No
device use an alarm system?
Storage environment does not meet the
A.2.31 In what way(s) might the
requirements; The waiting time is not correct after
medical device be deliberately
the sample is added.The waiting time is not
misused?
correct after the sample is added.
device hold data critical to No
patient care?
intended to be mobile or Yes
portable?
A.2.34 Does the use of the
Yes. It depends on the test accuracy and stability
medical device depend on
of the kit.
essential performance?
11
Annex 2-Relationship between hazards, foreseeable sequences of events, hazardous situations and the harm that can occur
hazard Foreseeable sequence of events Hazardous situation Harm
Biological and Kits may be contaminated with Incorrect
microbial resulted in an incorrect
chemical microorganisms during storage, examination
contamination inspection result.
hazards transportation, and use. results
Incorrect
Incorrect sample adding error or sample resulted in an incorrect
examination
measurements spilling. inspection result.
results
Delayed
Loss or deterioration Use improperly stored or expired The test result is not
examination
of function kits. credible.
results
Incorrect
Using samples that do not meet resulted in an incorrect
examination
the requirements. inspection result.
Operational results
hazard Incorrect
resulted in an incorrect
Incorrect use Use of unsuitable instruments. examination
inspection result.
results
Incorrect
Mix different batch number kits. Deviation of test results. examination
results
The operator confused the sample Delayed
The test result is not
Lack of attention position, or the reaction time examination
credible.
control was wrong. results
12

Delayed
The experiment was not carried The test result is not
Break the rules examination
out the instructions. credible.
results
Delayed
The operator lacks the necessary The test result is not
Lack of knowledge examination
expertise. credible.
results
Delayed
Violation of The test result is not
Use uncertified instruments. examination
conventional credible.
results
The wrong label on the component Incorrect
Label error causes the operator to use the examination
inspection result.
wrong component. results
The collection, treatment and Improper use of sample may Incorrect
preservation conditions of result in incorrect inspection examination
samples were not clear. results. results
Information
It is impossible to determine Delayed
hazard The content about quality control
whether the test results of examination
Incomplete instruction is incomplete.
the kit are valid. results
The expiry date of the kit was not
Delayed
specified in the operation manual, It is impossible to judge the
examination
which resulted in the kit being validity of the test results.
results
used beyond the expiry date.
13

Affect the
Repeatability does not No effective control of The measurement results
outcome
meet the requirements repeatability before delivery. varied greatly.
judgment
Reagent The non-specificity of the kit was Incorrect
non-specificity(e.g. not effectively controlled before examination
inspection result.
interfering factors) delivery. results
The instruments used for Incorrect
Measurement This results in the deviation
Hazards from ex-factory inspection have not examination
imprecision of test results.
fault conditions been calibrated. results
Unstable materials
Delayed
(e.g. during Not in the prescribed conditions The test result is not
examination
transportation, storage for storage, transport, use. credible.
results
or use)
The results of samples near the Delayed
Samples near the The test result cannot be
critical value are examination
critical value judged.
not easy to judge. results
A serious deviation from the
Improper storage temperature will Incorrect
Not stored and transported under
environmental cause the reagent to fail to examination
prescribed conditions.
Environmental conditions remain stable until the results
hazard specified expiry date.
Waste samples, waste liquid, Toxic and harmful Cause human
waste containers, internal and external substances pollute the injury or
packaging are not treated as environment. environmental
14

medical waste. damage
Incorrect
The package is damaged and the resulted in an incorrect
Improper packing examination
kit is damp inspection result.
results
15
Annex 3: Risk assessment, risk control and remaining risk records

P: Probability; S: Severity; RL: Risk level; RS: Residual risk level;. Before Action: Before the Risk control measures taken.
After Action: After the Risk control measures taken
Before Actions After Actions New risk
Description of Risks Risk control measures action
S P RL S P RS arises ?
1. The production and transportation
conditions of the components
containing active ingredients in the kit
require drying to inhibit the growth of
microorganisms;
2. The preparation containers and
microbial repackers of semi-finished products
3 3 R 3 1 A No
contamination are treated with high pressure
sterilization before being used;
Biological and 3. Produce products in clean workshops
chemical hazards with humidity less than 10% to reduce
the risk of environmental pollution;
4. Specify the storage conditions of the
product in the manual.
Kit components
1. Gloves, overalls or other protective
and samples to be
3 3 R measures shall be worn during 3 2 R No
tested are
operation.
infectious
Toxicity and 2 3 R 1. Gloves, overalls or other protective 2 2 A No
16

sensitization of measures shall be worn during
kit components operation.
2. Strictly standardize laboratory
safety
management.
1. The instructions provides detailed
procedures for adding samples and
Incorrect
3 3 R emphasizes matters needing attention. 3 1 A No
measurements
2. Operators were trained to use the
kit.
1. The storage conditions and expiry
date of the kit are clearly marked on
the package and the instructions;
Loss or
Operational 2. The storage conditions and expiry
deterioration of 3 3 R 3 2 R No
hazard date of the kit are clearly marked on
function
the package and the instructions;
3. Emphasize to customers that
out-of-date kits should not be used.
1. The instructions provides complete
sample requirements, applicable
Incorrect use 3 2 R instrument requirements; 3 1 A No
2. To emphasize to customers that kit
of different batches should not be
17

mixed;
3. Provide technical support to
customers.
1. Inform the operator the possible risk
of inattention;
Lack of attention 3 1 A 2. Operators should check before 3 1 A No
adding samples and operate
cautiously.
Each kit comes with a instructions that
Break the rules 3 1 A covers complete information and 3 1 A No
precautions.
Lack of
3 1 A Strengthen training for operators. 3 1 A No
knowledge
1. Inform the kit to be used by
professionals and train new users;
Violation of
3 2 R 2. Complete information and 3 1 A No
conventional
precautions are provided in the
instructions.
1. Strictly manage the printing,
acceptance and use of labels to ensure
Information
Label error 3 4 R correct contents; 3 2 R No
hazard
2. Strictly manage the packaging and
cleaning of products;
18

3. Inform the user to pay attention to
the label when using the product.
Incomplete
instruction(The
collection,
1. The instructions makes clear
treatment and
2 3 R provisions on the sample requirements; 2 1 A No
preservation
2. Train operators.
conditions of
samples were not
clear).
Incomplete
instruction(The
expiry date of the
kit was not
specified in the The instructions specifies the period of
3 2 R 3 1 A No
operation manual, validity.
which resulted in
the kit being used
beyond the expiry
date).
Incomplete
instruction(The 1. The effectiveness of the experiment
2 3 R 2 1 A No
content about should be evaluated in advance.
quality control is
19

incomplete).
1. The formula of the kit is fixed, and
the source of raw materials is stable;
Repeatability 2. Standardize the production process,
does not meet the 2 3 R strict quality control procedures; 2 1 A No
requirements 3. Repeatability be controlled within
the allowable range before leaving the
factory.
1. Raw materials were screened, and
antigens with better specificity were
Reagent
adopted;
Hazards from non-specificity(e.
3 2 R 2. In the manual, the substances that 3 1 A No
fault conditions g. interfering
may cause interference and the
factors)
corresponding concentration are
explained.
Measurement
3 1 A Periodic calibration of instrument. 3 1 A No
imprecision
Unstable
1. The manual informs the storage
materials (e.g.
conditions and validity of the kit;
during 3 2 R 3 1 A No
2. The expired reagent shall not be
transportation,
used.
storage or use)
Hazards Influence of 3 5 U The instructions "precautions" tell you 3 2 R No
20

from normal use interfering not to use samples with severe
substances in the hemolysis.
sample
Samples near the Users are advised to repeat the
2 4 R 2 2 A No
critical value experiment.
Improper
The packaging and instructions inform
environmental 2 3 R 2 1 A No
the storage conditions of the kit.
conditions
In strict accordance with the laboratory
management code and biosafety code,
waste 3 2 R all samples, washing liquid and various 3 1 A No
Environmental waste liquid should be treated as
hazard medical waste liquid.
1. In the final assembly, strictly follow
SOP and arrange desiccants and kits in
parallel;
Improper packing 3 2 R 3 1 A No
2. The user is required to carefully
check whether the packaging is leaking
air.
NOTE: The control measures can be omitted for the risks that fall in Acceptable Area, but to enhance the reliability of the device,
the control measures be still take.
21

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SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)

Document No. LSY-PP -2021-0202 Version. No. 1.0

RISK MANAGEMENT REPORT

No. Standard Name Reference No.

4. Management Responsibility and Qualification of Personnel

Document No. LSY-PP -2021-0202 Version. No. 1.0

Risk Management policy

5.1 Risk management process

Document No. LSY-PP -2021-0202 Version. No. 1.0

6. Criteria for Acceptability

6.1 The severity of a hazard

Document No. LSY-PP -2021-0202 Version. No. 1.0

6.2 The probability of a hazard

6.3 The risk level

Document No. LSY-PP -2021-0202 Version. No. 1.0

7.1 Intended use

Document No. LSY-PP -2021-0202 Version. No. 1.0

8. Risk evaluation and risk control

9. Residual risk evaluation

10. Roduction and post-production activities

Aft Document No. LSY-PP -2021-0202 Version. No. 1.0

Document No. LSY-PP -2021-0202 Version. No. 1.0

Annex 1-Questions related to Identification of hazards

Document No. LSY-PP -2021-0202 Version. No. 1.0

Document No. LSY-PP -2021-0202 Version. No. 1.0

Document No. LSY-PP -2021-0202 Version. No. 1.0

Document No. LSY-PP -2021-0202 Version. No. 1.0

Document No. LSY-PP -2021-0202 Version. No. 1.0

Document No. LSY-PP -2021-0202 Version. No. 1.0

Document No. LSY-PP -2021-0202 Version. No. 1.0

Document No. LSY-PP -2021-0202 Version. No. 1.0

Annex 3: Risk assessment, risk control and remaining risk records

Document No. LSY-PP -2021-0202 Version. No. 1.0

Document No. LSY-PP -2021-0202 Version. No. 1.0

Document No. LSY-PP -2021-0202 Version. No. 1.0

Document No. LSY-PP -2021-0202 Version. No. 1.0

Document No. LSY-PP -2021-0202 Version. No. 1.0

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