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A. Purpose:
To establish, document, implement and maintain a procedure describes the applied system to manage the risks
associated to Titan Industries devices and this process covers all estimated, evaluation, controlling and monitoring the
associated risks of these medical devices in compliance with EN ISO 1497
B. SCOPE
This procedure is applied for all Medical Devices produced by Titan Industries and assessment team for each device is
responsible of implementing this procedure
C. Responsibility
Top Shall ensure that:
management  the provision of adequate resources
 the assignment of competent personnel for risk management.
 define and document a policy for establishing criteria for risk acceptability.
 review the suitability of the risk management process at planned intervals to ensure
continuing effectiveness of the risk management process

D. Abbreviations & Definitions
risk combination of the probability of occurrence of harm and the severity of
that harm
benefit positive impact or desirable outcome of the use of a medical device on
the health of an individual, or a positive impact on patient management
or public health

harm injury or damage to the health of people, or damage to property or the

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environment [
hazard potential source of harm
hazardous situation circumstance in which people, property or the environment is/are exposed to one
or more hazards
life cycle series of all phases in the life of a medical device from the initial
conception to final decommissioning and disposal
post-production part of the life cycle of the medical device after the design has been
completed and the medical device has been manufactured
EXAMPLE Transportation, storage, installation, product use,
maintenance, repair, product changes, decommissioning and disposal.

reasonably use of a product or system in a way not intended by the manufacturer,

foreseeable misuse but which can result from readily predictable human behavior
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risk analysis systematic use of available information to identify hazards and to estimate the risk
residual risk risk remaining after risk control measures have been implemented
risk assessment overall process comprising a risk analysis and a risk evaluation
risk control process in which decisions are made and measures implemented by which risks
are reduced to, or maintained within, specified levels
risk estimation process used to assign values to the probability of occurrence of harm and the
severity of that harm

risk evaluation process of comparing the estimated risk against given risk criteria to determine the
acceptability of the risk
risk management systematic application of management policies, procedures and practices to the
tasks of analyzing, evaluating, controlling and monitoring risk
risk management set of records and other documents that are produced by risk management
file
safety freedom from unacceptable risk
severity measure of the possible consequences of a hazard
E. Forms and Enclosures
-
F. Process/ method:
1. Risk Management Team
Persons performing risk management tasks shall be
 competent on the basis of education, training, skills and experience appropriate to the
tasks assigned to them.
 have knowledge of and experience with the particular medical device (or similar
medical devices) and its use
 identify, analyze and control all Risks raised from incoming material, intermediate
products, finished product and processes

2. Risk management plan

All the activities of risk management should be planned and the risk management plan to be
established for each medical device and this plan will be essential part of risk management
process
This plan shall include
a) the scope of the planned risk management activities, identifying and describing the medical device
and the life cycle phases for which each element of the plan is applicable;
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b) assignment of responsibilities and authorities;

c) requirements for review of risk management activities
d) criteria for risk acceptability, based on the manufacturer’s policy for determining acceptable
risk, including criteria for accepting risks when the probability of occurrence of harm cannot be
estimated;
e) a method to evaluate the overall residual risk, and criteria for acceptability of the overall residual
risk based on the manufacturer’s policy for determining acceptable risk;
f) activities for verification of the implementation and effectiveness of risk control measures; and
g) activities related to collection and review of relevant production and post-production information.
If the plan changes during the life cycle of the medical device, a record of the changes shall be maintained in
the risk management file.
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3. Risk management file

For each medical device Titan Industries will establish and maintain risk management file.
the risk management file shall provide traceability for each identified hazard to:
— the risk analysis;
— the risk evaluation;
— the implementation and verification of the risk control measures; and
— the results of the evaluation of the residual risks.

4. Risk analysis
4.1 Risk analysis process
Titan Industries will perform risk analysis for the particular medical device and the results shall be
recorded in the risk management file.
The documentation of the conduct and results of the risk analysis shall include at least the following:

a) identification and description of the medical device that was analyzed

b) identification of the person(s) and organization who carried out the risk analysis
c) scope and date of the risk analysis.

4.2 Intended use and reasonably foreseeable misuse

Titan Industries has established a document "Instruction for use" for using medical device in a
proper way to avoid the incorrect or improper use of the device.
The instruction leaflet contains the following details:
 Material used in the device.
 Indication / application of product.
 Contraindications
 How to use Dialyzer.
 For single use instruction.
 Warnings.
 Possible consequences resulting from improper use
 Symbols.
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 What is the intended use and how is the device to be used?

 Is the device intended to contact the patient or other persons?
 What materials and/or components are incorporated into the device or are used?
 Is energy delivered to and/or extracted from the patient?
 Are substances delivered to and/or extracted from the patient?
 Are biological materials processed by the device for subsequent re-use?
 Is the device supplied sterile or intended to be sterilized by the user or are other
microbiological controls applicable?
 Is the device intended to modify the patient environment?
 Are measurements made?
 Is the device interpretative?
 Is the device intended to control or to interact with other medical technologies or drugs?
 Are there unwanted outputs of energy or substances?
 Is the device susceptible to environmental influences?
 Are there essential consumables or accessories associated with the device?
 Is routine maintenance and/or calibration necessary?
 Does the device contain software?
 Does the device have a restricted “shelf-life”?
 Possible delayed and/or long-term use effects?
 To what mechanical forces will the device be subjected?
 What determines the lifetime of the device?
 Is the device intended for single use or re-use?
 Is safe decommissioning or disposal of the medical device necessary?
 Does installation or use of the device require special training?
 Will new manufacturing processes need to be established or introduced?
 Is successful application of the medical device critically dependent on human factors such as
the user interface?
 Is f the medical device intended to be mobile or portable?
4.3 Identification of characteristics related to safety
Titan Industries will
 identify and document those qualitative and quantitative characteristics that could affect the safety of the
medical device.
 define limits of those characteristics

4.4 Identification of hazards and hazardous situations

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In these steps, the possible hazards related to the device are identified and an evaluation of the
scope of the risk for each hazard is done as a weighted possibility for hazard to be realized and
the level of severity if occurs.
The hazards possibility and severity and risk level are given as tables below:
The probability and the severity are coded according to the following table.

Classification severity hazard

Risk levels:
Risk is the combination of the severity of harm and the probability of occurrence of that harm
Risk Level = severity x possibility
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Classification of risks associated to each hazard:

Risk Level Class

R1 (0 – 4) Acceptable (ACC)
R2 ( As Far As Possible (AFAP)
R3 ( Unacceptable
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4.5 Risk estimation

Risk estimation incorporates an analysis of the probability of occurrence of harm and the severity
of the harm
Information or data for estimating risks can be obtained, for example, from:
 published standards;
 scientific or technical investigations;
 field data from similar medical devices already in use, including publicly available reports of incidents;
 usability tests employing typical users;
 clinical evidence;
 results of relevant investigations or simulations;
 expert opinion; or
 external quality assessment schemes for in vitro diagnostic medical devices.

5. Risk evaluation
For each identified hazardous situation, Titan Industries shall evaluate the estimated
risks and determine if the risk is acceptable or not, using the criteria for risk
acceptability defined in the risk management plan.
If the risk is acceptable, it is not required to apply Risk control and the estimated risk shall be
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treated as residual risk.

If the risk is not acceptable, then Titan Industries shall perform risk control activities
6. Risk control
Titan Industries shall determine risk control measures that are appropriate for reducing the
risks to an acceptable level by using one or more of the following risk control options in the
priority order listed:
 inherently safe design and manufacture;
 protective measures in the medical device itself or in the manufacturing process;
 information for safety and, where appropriate, training to users.
- Risk control measures can reduce the severity of the harm or reduce the probability of occurrence
of the harm, or both.
- Implementation of each risk control measure shall be verified. This verification shall be recorded
in the risk management file.
- After the risk control measures are implemented, Titan Industries shall evaluate the residual risk
using the criteria for risk acceptability defined in the risk management plan. The results of this
evaluation shall be recorded in the risk management file.
- If a residual risk is not judged acceptable using these criteria, further risk control measures shall
be considered
- If a residual risk is not judged acceptable using the criteria established in the risk management
plan and further risk control is not practicable, Titan Industries may gather and review data and
literature to determine if the benefits of the intended use outweigh this residual risk.
- Titan Industries shall review the effects of the risk control measures with regard to whether:
 new hazards or hazardous situations are introduced; or
 the estimated risks for previously identified hazardous situations are affected by the
introduction of the risk control measures.
- Titan Industries shall review the risk control activities to ensure that the risks from all identified
hazardous situations have been considered and all risk control activities are completed.
- The results of this review shall be recorded in the risk management file.
- Compliance is checked by inspection of the risk management file.
7. Evaluation of overall residual risk
After all risk control measures have been implemented and verified, Titan Industries shall
decide if the overall residual risk posed by the medical device is acceptable using the criteria
defined in the risk management plan.
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- If the overall residual risk is not judged acceptable using the criteria established in the risk
management plan the manufacturer may gather and review data and literature to
determine if the medical benefits of the intended use outweigh the overall residual risk.
- If this evidence supports the conclusion that the medical benefits outweigh the overall
residual risk, then the overall residual risk can be judged acceptable. Otherwise, the
overall residual risk remains unacceptable.
- For an overall residual risk that is judged acceptable, the manufacturer shall decide which
information is necessary to include the accompanying documents in order to disclose the
overall residual risk.
- The result of the overall residual risk evaluation shall be recorded in the risk
management file.
- Compliance is checked by inspection of the risk management file and the accompanying
documents.

8. Risk management review

Prior to release for commercial description if the medical device, Titan Industries shall carry
out a review of the risk management process.
the review shall at least ensure that:
 the risk management plan has been appropriately implemented
 the overall residual risk is acceptable
 appropriate methods are in place to obtain relevant production and post production
information
- The result of this review shall be recorded management report included in the risk
management file
- The responsibility for review should be assigned in the risk management plan to persons
appropriate authority
- Compliance is checked by inspection of the risk management file
9. Production and post-production activities
Titan Industries has established, documented and maintained a system to collect and review
information through customer complaint and customer feedback.
- Quality department receive the documented complaint and customer feedback from sales
and marketing department, then Q.C analyze the complaint and take the appropriate
action which guarantee the prevention of complaint re-occurrence.
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- When doing any modifications in Medical Device (production process and / or design),
when new standards are published applicable to Medical Device or applicable to
technology used for its production which may affect the risk of Medical Device, the risk
management would be reviewed to determine whether new risks may be identified.

A. References.
EN ISO 14971-2019
ISO/TR 24971
B. Change History.
Issue/modification date Issue/modification No. Description of modification
DD/MM/YY (1/0) First issue

C. Approvals
Name Position Signature / date
Prepared by
Reviewed by
Approved by