-- Quality System Management Document--
CE technical documents
Document Name:
Document No.:
Risk Analysis
SYQ/CE -03
Document Version No.:
Controlled State
A/0
Confidential Document
Prepared by: Zhao Suofang Date:-
Checked by:
Yu Gang
Date:-
Approved by:
Jin Hui
Date:-
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
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Prepared
Zhao Suofang
Checked
Yu Gang
Date
-
Approved
Jin Hui
Date
-
Effective Date
-
Table of contents
1. Foreword
2. Purpose
3. Application
4. Document reference
4.1 Standard
4.2 Product specification
5. Object of risk control
5.1 Intended use
5.2 Application environments
6. Members of the risk control group
7. Risk Management Plan
8. Risk management process
9. Implementation of risk control process
9.1Stepl Determination of possible hazards
9.2 Step2 Risk estimation
9.3Step3 Risk evaluation
9.4Step4 Take risk control measures
9.5Step5 Evaluation of residual risk
9.6Step6 Risk/benefit analysis
9.7Step7 Result of risk control
9.8 Step8 Production and post-production information
10. Conclusion on risk control
11. Appendix
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1.
Foreword
This report is to describe the risk control carried on the Disposable infusion set manufactured by
our company. All potential hazards and potential cause of each hazard have been determined in this
report. Evaluations have been made on possible serious level may led by each hazard and occurring
rate of each hazard. For unacceptable risks, necessary measures must be taken, and also evaluate the
residual risk level after taking relevant measures.
By taking proper measures to reduce the risks which may lead to various kinds of potential
hazards to the acceptable level, and also to reduce the total amount of every kind of hazards to the
acceptable level.
2. Purpose
Aim of this risk control is to carry out determination on all risks that may be led by the Disposable
infusion set that have been put into production in our company, also to stipulate the necessary relative
measures, in order to keep the risk level within an acceptable level. By taking risk control the
company may take relative measures of continuously improving quality of the products, to meet
customer stipulated or potential requirements constantly.
3.
Application
This risk analysis is applied to tracheal tube produced by the company.
4.
Documents reference
4.1 Standards
1. MDD93/42/EEC Amended by 2007/47/EC
2. ENISO14971:2009
3. ISO 8536-4
2010
4. GB- Production specification
Please refer to production specification instruction.
5.
Object of risk control
5.1 Intended use of the product
As
a class product, Disposable infusion set is used to administer fluids from a container to a
patient’s vascular system through a Infusiom or catheter inserted into the vein.
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5.2 Application environments
Only for single use;
Do not use if packing is damaged;
Use immediately after the packing is opened;
Destroy after use
6.
Members of the risk control group
Name
Title
Jin Hui
Technical manager
Lu Fei
Production manager
Chang Yu
Quality manager
Xi Xiaoqing
Sales Director
Yu Gang
Product specialist
Responsibility
Authority
Risk management for approve
the
risk
R&D phase
management plan and
risk management report.
Risk management for Review and implement
product
realization the risk management
phase
plan
Risk management for Review and implement
product
realization the risk management
phase
plan
Risk management for Review and implement
post-marketing
the risk management
surveillance phase
plan
Risk management for
/
clinical use phase and
prepare the risk
analysis report
7. Risk Management Plan
Define the risk management methodology to be used
The risk management process is scalable to ensure that the level, type, and visibility of risk
management are commensurate with both the risk and the importance of the project.
A. Risk Identification - Risks will be identified by using the Risk Assessment Questionnaire
Template, augmented to include other project specific risks, as appropriate.
B. Categorize Risks - The Risk Assessment Questionnaire Template groups the risks into
categories. The project will create additional categories, as required.
C. Risk impact Assessment - For each risk identified, assess the risk event in terms of
likelihood of occurrence and its effect on project objectives if the risk event occurs. This
information will be used to prioritize the risk using established threshold criteria.
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D. Phohtize Risks - Risks that meet the threshold criteria will be recorded in the Risk
Response Plan.
E. Risk Response Planning:
-
For each risk in the Risk Response Plan, determine the options and actions to reduce the
likelihood or consequences of impact to the project's objectives.
-
Determine the response based on a cost/benefit analysis (cost vs. expected
effectiveness).
-
Describe the actions to be taken to mitigate the risk
-
Describe the actions to be taken when the risk event occurs (contingency plan)
-
Assign responsibilities for each agreed upon response
-
Assigned a "due date" where risk responses are time sensitive
-
Incorporated this information into the Risk Response Plan
F. Risk Response Tracking:
-
Document the dates and the actions taken to mitigate the risk
-
Document the actions taken when the risk event occurred (contingency plan)
-
Document any subsequent actions taken
-
Incorporate this information into the Risk Response Plan
G. Monitor Risk:
-
Establish systematic reviews and schedule them in the project schedule. -These reviews
are to ensure:
-All of the requirements of the Risk Management Plan are being implemented
-
Assess currently defined risks
-
Evaluate effectiveness of actions taken
-
Status of actions to be taken
-
Validate previous risk assessment (likelihood and impact)
-
Validate previous assumptions
-
State new assumptions
-
Identify new risk
-
Risk Response Tracking
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Communications
H. Control Risk:
-
Validate mitigation strategies and alternatives
-
Take corrective action when actual events occur
-
Assess impact on the project of actions taken ($$, time, resources)
-
Identify new risks resulting from risk mitigation actions
-
Ensure the Project Plan (including the Risk Management Plan) is maintained
-
Ensure change control addresses risks associated with the proposed change
- Revise the Risk Assessment Questionnaire and other risk management documents to
capture results of mitigation actions.
-
Revise Risk Response Plan
-
Communications
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8. Risk management process
Overview of the steps in the risk management process see the following flowchart:
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9
Implementation of risk control process
9.1 Stepl: Determination on known and foreseeable hazards
The hazard will be marked with "H "in risk control form, (see the risk analysis report)
Information resources: the following information can be regarded as potential hazard list
Available risk analysis report on homologous product
Investigations on developer of the product
Determinations made by medical experts
Analysis medical devices report from foreign authorities
Site documents, complains and accident records gained from homologous products which
have been put into use.
9.1.1 Estimation on serious level of each hazard
Serious level of each hazard must be estimated and semi-quantitative judged (in the form of
serious level) by the medical expert.
Item
Serious level
9.1.2
1
Neglectable
2
Slight
3
Dangerous
4
Catastrophic
Description
Have almost no or no potential possibility of harm
Results in temporary or can generally be cured injury or
impairment
Results in permanent impairment or life-threatening
injury
Results in patient death
Judgment of potential causes of each hazard
Members of the group shall at first find the potential causes directly base on their professional
knowledge.
The founded hazard causes must be recorded in "Cause" column of risk control report, and
mark with "C...". (see the risk analysis report)
9.1.3
Estimation on occur rate of each cause
Occur rate of each potential cause must be estimated. In addition, the relative information
resources are:
Using experience of equivalent products (e.g. service statistic data)
Customer complain
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Investigation on service life of self product
Expert judgment
Such estimation carried out by relative personnel can be divided into following 6 categories:
No
Category
Description
1
Almost impossible
Never occurred
2
Much less
The typical condition is: package of 1 in 10000 cannot be tear open
3
4
5
Seldom
Unmeant
Likely
The typical condition is: package of 1 in 1000 cannot be tear open
The typical condition is: 1 was found in 100 products
The typical condition is: often found during use of the product
6
Frequent
The typical condition is: occurred in each use
Estimation on occur possibility of the hazard
If possible, the occur possibility of the hazard can be divided into following 6 levels:
Level
Probability of occurrence
6 Frequent
≥-
5 Much possible
4 Seldom
3 Much less
2 Extremely less