Model essay on security risk analysis report?

The extensive and in-depth application of information technology makes the problem of information security more complicated. How to effectively anal

Model essay on security risk analysis report?

The extensive and in-depth application of information technology makes the problem of information security more complicated. How to effectively analyze the information security risks, analyze the security vulnerabilities existing in the organization and fix them in time, so as to minimize the security risks of the organization, has become an important content in the field of information security research. This paper is a model report of security risk analysis compiled by me for your reference only.

Article 1:

Product name: * * Name on the registration standard * * *

Risk assessor and background: * * Project leader, doctor from medical perspective, designer from technical perspective, application perspective and market perspective, and provide personnel qualification certificates, such as training qualification and professional title level * * *

Compile: date:

Date of approval:

1. Compilation basis

1. 1 related standards

1* * yy0316-2003 Application of medical device risk management in medical devices

2 * * * GB 9706.1-1995 Medical electrical devices Part I: General safety requirements;

3 * * * IEC 60601-1-4:1996 Medical Electrical Equipment-Part I: General Safety Requirements-4: Parallel Standard: Medical Programmable Electrical System.

4*** Product standards and others

1.2 product related information

1* * instruction manual

2*** Hospital usage, maintenance records, customer complaints, accident records, etc.

3*** Articles and other information in professional literature

2. Purpose and scope of application

This is a report on XXXX risk management, in which all possible hazards and the reasons for each hazard are judged. The severity and probability of possible damage caused by each hazard are estimated. When a certain risk level is unacceptable, take control measures to reduce the risk, and evaluate the residual risk after taking risk measures. Finally, make the level of all remaining risks acceptable.

This report is applicable to ... products in the design and development stage * * * or small batch production stage * * *.

3. Product description

The objectives of this risk management are ... * * * preferably with photos or pictures * * *, product overview, mechanism and indications:

Taboo:

The device consists of the following parts: * * * text description or schematic diagram * * *

4. Determine the intended use and safety-related characteristics of the product.

* * * Answer the questions in Appendix A to determine the characteristics of medical devices that may affect safety * * *

4. 1 What is the intended use and purpose of the product? How to use it?

Factors to be considered: prospective users and their spirit, physical quality, skill level, cultural background and training, etc.

Ergonomic issues, the use environment of medical devices and who installed them.

Can patients control and influence the use of medical devices?

Are medical devices used to sustain life or to sustain life?

Do you need special intervention in case of medical device failure?

Are there any special problems in the interface design that will lead to careless use errors * * * See 4.27***

Devices for diagnosis, prevention, treatment, relief or trauma compensation, anatomical correction and pregnancy control.

Which function?

4.2 Are medical devices expected to come into contact with patients or other people? How to contact? How long is the contact?

Factors to be considered: nature of expected contact: surface contact, invasive contact and * * * or * * * implantation.

The duration of each contact.

Frequency of each contact

4.3 What materials and * * * or * * * components are contained in, used with or in contact with medical devices?

Factors to consider: Are the safety-related characteristics known?

4.4 Is the energy for or from the patient?

Factors to be considered: the form of transmitted energy and its control, quality, quantity and duration.

4.5 Are there substances provided to or extracted from patients?

Factors to be considered: whether the substance is supplied or extracted.

Single substance or several substances?

Maximum and minimum transmission rates and their control

4.6 Are biomaterials reused after being treated by medical devices?

Factors to be considered: treatment methods and types of substances to be treated * * * such as automatic blood transfusion and dialysis * * *

4.7 Are medical devices provided in sterile form or sterilized by users, or sterilized by other microbial control methods?

Factors to be considered: Is the medical device intended to be used once or repeatedly?

Packaging and storage life of medical devices

Limit on the number of reuse cycles

Limitations of sterilization treatment methods used

4.8 Are medical devices expected to be routinely cleaned and disinfected by users?

Factors to consider: the type of cleaning agent or disinfectant used.

Limit of disinfection cycles

The design of medical devices may affect the effect of daily cleaning and disinfection.

4.9 Are medical devices expected to improve patients' environment?

Factors to be considered: temperature, humidity, atmospheric composition, pressure and light.

4. 10 is the medical device measured?

Factors to be considered: measurement variables

Accuracy and precision of measurement results * * * CMC mark with measurement function * * *

4. 1 1 Are the medical devices analyzed?

Factors to be considered: Does the medical equipment show the conclusions drawn from the input or obtained data * * * Mainly software * * *

Calculation method and confidence limit adopted

4. 12 are medical devices expected to be used in combination with drugs or other medical technologies?

Factors to consider: determine the drugs or other medical technologies that may be used, and whether patients with potential problems related to interaction comply with treatment.

4. 13 is there any unexpected energy or material output?

Energy-related factors to be considered: noise and vibration, heat.

Radiation * * * includes ionizing, non-ionizing and ultraviolet, visible and infrared * * * contact temperatures.

Leakage current and electric field and * * * or * * magnetic field.

Material-related factors to be considered: emissions of chemicals, wastes and body fluids.

4. 14 are medical devices sensitive to the environment?

Factors to be considered: the operation, transportation and storage environment * * * includes light, temperature, vibration, leakage, sensitivity to changes in energy and refrigeration forms and electromagnetic interference * * *

4. 15 do medical devices affect the environment?

Factors to be considered: the impact on energy and refrigeration, the emission of toxic substances and the generation of electromagnetic interference.

4. 16 Do medical devices have basic consumables or are they from Fujian?

Factors to be considered: the specifications of consumables or accessories and the restrictions on users' choice of them.

4. Does17 need maintenance and calibration?

Factors to be considered: whether the maintenance and * * * or * * * calibration are realized by operators or users or professionals, and whether special substances or equipment are needed for proper maintenance and * * * or * * * calibration.

4. 18 is there any software for medical devices?

Factors to be considered: Is the software expected to be installed, verified, modified or replaced by users and * * * or * * * operators?

4. 19 is there a storage period for medical devices?

Factors to be considered: signs or descriptions and disposal of such medical devices.

4.20 Is there any delayed and * * * or * * long-term use effect?

Factors to be considered: ergonomics and cumulative effects

4.2 1 What kind of mechanical force does the medical device bear?

Factors to be considered: Is the force borne by medical devices under the control of users or through interaction with other personnel?

4.22 What determines the life of medical devices?

Factors to consider: aging and battery exhaustion

4.23 Is the medical device expected to be used once?

4.24 Do medical devices need to be safely withdrawn for execution or disposal?

Factors to be considered: waste products generated when medical devices are disposed of by themselves. * * * For example, do medical devices contain toxic or harmful substances, or can these substances be recycled * * *

4.25 Does the installation or use of medical devices require special training?

Factors to be considered: including commissioning and delivery to end users.

Is it possible to be installed by someone who does not have the necessary skills?

4.26 Is it necessary to establish or introduce a new production process?

The introduction of new production processes in production facilities must be regarded as a potential source of new dangers, such as new technologies and new production scales.

4.27 Does the successful use of medical devices depend decisively on human factors, such as user interface? Factors to consider: User interface design features that may lead to misuse are not easy to be misused.

4.27. 1 Do medical devices have connecting parts or accessories?

Factors to be considered: possibility of connection error, difference, similarity with other products, connection strength, feedback of connection integrity, too tight and too loose connection.

4.27.2 Does the medical instrument have a control interface?

Factors to be considered: interval, coding, grouping, graphic display, feedback mode, error, slip, control difference, visibility, starting or changing direction, whether control is continuous or intermittent, and reversibility of binding or action.

4.27.3 Does the medical device display information?

Factors to be considered: visibility, directionality, holistic and transparent views in different environments, clarity of displayed information, unit, color coding, and accessibility of decisive information.

4.27.4 Are medical devices controlled by menus?

Factors to be considered: complexity and number of layers, understanding of state, setting path, guiding method, number of steps of each action, clarity of sequence, storage problems, and importance of control functions related to accessibility.

4.28 Is the medical device expected to be mobile or mobile?

Factors to be considered: necessary clamping, handle, wheel, brake, mechanical stability and durability.

5. Hazard determination

* * * According to Appendix D, the answers include at least five aspects, such as energy, biology, environment, use and maintenance, focusing on the analysis of hazards and their causes. They can also be listed according to the characteristics of the product itself, but they are required to be compared with 3. Product expectation.

Judge safety-related characteristics to classify dangerous uses and problems; First, find the potential causes intuitively with professional knowledge, and further cause analysis can be applied to FMEA*** failure mode and effect analysis * * *, FTA*** fault tree analysis * *. ***

6. Risk assessment

6. 1 Evaluation criteria * * * Same as in the risk management plan * * *

6. 1.3 risk acceptance criteria

Risk = severity × probability level

6.2 Risk Assessment Form

7. Risk control

Through the above evaluation, we can see the acceptable degree of product risk. There is no need to take control measures for risks within a wide acceptable range. Further measures must be taken to control the risks in reasonable and feasible areas and unacceptable areas.

8. Residual risk assessment

After taking risk reduction measures, dangerous risks, for example, whether new risks have been introduced after taking risk reduction measures, and if so, must be re-evaluated and controlled * * *

If there are large risks that cannot be reduced, it is necessary to collect and review information and literature about the expected use and expected medical benefits to determine whether the benefits exceed the risk level after taking control measures for all the remaining risks in Table 3.

9. Post production information

As this product has not been fully produced, once it is officially produced,

10. Conclusion

Through the analysis and evaluation of hazards, the risk caused by hazards is acceptable, so the product is safe.

Article 2:

Safety risk analysis report of serum alkaline phosphatase detection kit ***ALP***

1. General

Serum alkaline phosphatase assay kit * * * hereinafter referred to as ALP assay kit * * * is an enzyme reagent for clinical detection of in vitro diagnostic chemical reagents. Because the examination is not carried out in the human body or on the human body surface, it will not cause direct risk to the patient or the person being examined. However, in some cases, the risks associated with in vitro diagnostic reagents may lead to or contribute to wrong decisions, which may constitute indirect risks. In addition, the hazards related to use and related risks should also be considered. This safety risk analysis report is mainly based on YY/T03 16-2000 "Medical Devices-Risk Management-Application of Risk Analysis", Appendix A "Determining the Characteristics of the Possible Impact of Medical Devices on Safety" and Appendix B "Risk Analysis Guide for in vitro Diagnosis of Medical Devices" and GB7826-87 "Failure Mode and Effect Analysis of System Reliability Analysis Technology * * * FMEA * *

2. Qualitative and quantitative determination of medical devices

2. 1 intended use and purpose

ALP detection box is an in vitro diagnostic reagent, which is based on the principle of biological enzyme reaction and photochemical reaction, and realizes the determination of ALP in samples by measuring the change of absorbance in unit time. ALP test kit is expected to be used in the diagnosis of hepatobiliary and skeletal diseases.

2.2 Is the product in contact with patients or other personnel?

ALP test box is an in vitro diagnostic reagent, which has no contact with patients and generally does not touch the operator's panel.

2.3 Product manufacturing material safety

The ALP detection box adopts AR grade chemical analytical purity, and the chemicals used in this kit are all clinical routine biochemical reagents. NaN3 has certain toxicity, but the content is very small, and the rest substances are non-toxic. Therefore, when using the kit, you should avoid touching the panel as much as possible. Waste bottles and waste liquid treatment should meet the requirements of environmental protection.

2.4 Is there energy applied to or obtained from the patient?

No energy is applied to the patient, and no energy is obtained from the patient.

2.5 Are there substances provided to or obtained from patients?

The ALP test kit does not contact with the patient, but the medical staff indirectly draws blood from the patient.

2.6 Whether the kit has been processed by instruments before use.

The reagents extracted from ALP detection box by pipette are all disposable, and there is no reuse after treatment.

2.7 Is the product provided in sterile form or can be used by users after sterilization?

The product is analytically pure medical chemical reagent, which is prepared, tested and packaged in a 654.38+ million-class clean room without user sterilization.

2.8 Whether the patient's environment has been improved?

not applicable

2.9 Does it have measuring function?

ALP detection box is used to measure the ALP content in human serum by means of instruments, and the reagent itself has no measurement function.

2. Is10 processed and analyzed?

not applicable

2. Is11combined with medicine or other medical technologies?

It must be used on biochemical analyzer with certain absorbance accuracy.

2. Does12 have unsatisfactory energy and material output?

not applicable

2. Is13 sensitive to the environment?

ALP test chamber should be protected from light, low temperature and dry during transportation and storage, and there are no special requirements for operation.

2. 14 Consumables for supporting use

ALP test boxes generally do not need consumables, but they need to be calibrated or diluted with distilled water if necessary.

2. 15 Maintenance and calibration

not applicable

2. Does16 equipment have software?

not applicable

2. 17 storage life

ALP test chamber requires the storage environment to meet the requirements of technical standards, and the storage period is six months. The production date and storage period are listed in the special package of the kit.

2. 18 delay/long-term use effect

When using ALP test kit, the use of the kit cannot be postponed because of the unstable chemical substances.

2. 19 mechanical force

not applicable

2.20 factors that determine product life

Standardized and correct use, transportation and storage conditions are the basic conditions to ensure the design life of products.

2.2 1 scheduled usage mode

The detection of ALP extracted by pipette is disposable.

2.22 Dangers affecting the environment

The product was created in the workshop of 654.38 million+. After preparation, mixing, testing and packaging, no volatile gases were removed. After use, the product was destroyed as medical waste together with blood samples.

2.23 Do users need special training?

Users don't need special training, but they must meet the qualifications of biochemical inspectors in hospitals and be able to operate under the guidance of professionals or after reading the instruction manual in detail.

2.24 Inconsistency and Inconsistency of Batch

The inhomogeneity and inconsistency of batches directly affect the test results, resulting in the risk of misjudgment of diseases. It is necessary to control the intra-batch precision, inter-batch precision and accuracy and other related indicators.

2.25 *** Same interference factors

In addition to the strong electromagnetic interference around the biochemical analyzer, R 1 and R2, during the use of ALP test box, the sample volume ratio, temperature and reaction time have a direct impact on the success or failure of the test results.

2.26 Identification error

Improper identification directly affects the authenticity of transportation, storage and test results of products. Marks include single packaging bottle marks, packaging box marks and transportation and storage marks. For example, the double reagents R 1 and R2 are wrongly identified, which leads to the failure of detection, unclear identification of expiration date, distorted detection results due to misuse of expired products, and unclear deterioration of products due to the identification stored in dark and low temperature.

2.27 inappropriate instructions for use

Improper instructions can't guide the operation, such as the ratio of R 1 to R2, sample size, temperature, time * * * incubation time, reaction time, validity period of measurement time * * * after the first bottle opening, and it is forbidden to touch the panel during operation. , should comply with the relevant regulations, otherwise it will cause detection errors or harm to the environment.

2.28 Energy hazards

not applicable

2.29 Biological hazards

not applicable

3. Risk assessment and prevention

3. 1 Expected use and purpose risk

Alkaline phosphatase detection box is used to determine the content of alkaline phosphatase in serum. Clinical diagnosis of hepatobiliary and skeletal diseases. Each batch of products is strictly controlled with intra-batch precision, inter-batch precision, accuracy and stability. The products were compared with imported and domestic similar reagents in the laboratories of the Second Xiangya Hospital of Central South University and Hunan Cancer Hospital, which met the requirements of testing and registered products. Therefore, the risk of accuracy and reliability in use has been reduced to an acceptable limit.

3.2 Risk of contact with patients or others

Testers should operate according to the relevant operating procedures of the laboratory, and the reagent will not contact the operator's panel and mucosa, which has been clearly stated in the precautions in the product instruction manual. If you come into contact with the panel and mucous membrane, please wash it with tap water immediately, which will not cause injury risk to the operator.

3.3 Material safety risks

The chemicals used in the reagents are all routine clinical biochemical reagents in China at present. Although NaN3 is toxic, its content is very small and it has no corrosive effect on the panel. In the product manual, used waste liquid and bottles are required to be treated as medical waste to prevent harm. We believe that the safety risk of materials has been reduced to an acceptable limit.

3.4 Risks of applying or obtaining energy to patients

not applicable

3.5 Obtaining substantial risks from patients

For the blood test of patients, professionals use disposable sterile syringes to take blood samples and then send them for inspection, so there is no risk of obtaining substances from patients during the repeated use of ALP test boxes.

3.6 Risk of reuse of instruments after treatment

The single bottle of the product is a reusable liquid packaging bottle, and the reagent extracted by each pipette is used once, so there is no risk of reuse after being treated and sterilized by the instrument.

3.7 Risk of aseptic use

ALP kit is a clinical chemical reagent, and there is no risk in aseptic use.

3.8 Improve patients' environmental risks

3.9 Determination of risks

not applicable

3. 10 risk analysis and treatment

not applicable

3. 1 1 Risk of combined use with drugs or other medical devices

The absorption accuracy and constant temperature accuracy of biochemical analyzer have influence on the detection results. As long as the instrument is maintained according to the routine of the laboratory, the accuracy and function of the instrument are guaranteed, and the testing personnel are qualified professional laboratory medical personnel, then the risk can be minimized.

3. 12 Energy and material export risks

not applicable

3. 13 Environmental sensitivity risk

The product is required to be stored at a low temperature of 2℃ ~ 8℃ away from light to prevent deterioration, and used and stored according to the requirements of the product instruction manual, so as to minimize the risk of environmental sensitivity.

3. 14 consumption risk of supporting use

Not applicable, a small amount of distilled water should be used if necessary. The quality of distilled water should meet the requirements of distilled water used in biochemical laboratories, and there is no water quality risk.

3. 15 Maintenance and calibration risks

not applicable

3. 16 Software risk

not applicable

3. 17 storage life risk

In the product standards, product packaging labels and product instructions, the shelf life is specified as six months. Within one month after the expiration of the sampling period of the stability test, the efficiency of the product meets the requirements of various indicators in the standards, so the risk of shelf life has been minimized.

3. 18 Risk of long-term or long-term use impact

Product standards and instructions stipulate that expired products are strictly prohibited, so there is no risk of delayed use.

3. 19 mechanical force risk

3.20 Risk determining product life

Chemical reagents are required to prevent strong sunlight, and product deterioration will affect service life. Avoid high-temperature or low-temperature storage and prevent freezing from damaging the molecular structure of reagents, which are clearly stipulated in product standards, instructions for use and packaging labels. Therefore, the factors that determine the product life are minimized.

3.2 1 expected usage pattern risk

The single packaging bottle of the product is packed with liquid multi-purpose consumables, and the reagent extracted by the pipette is disposable. After use, the mixed blood samples must be processed and destroyed, so the risk of predetermined use mode is basically impossible.

3.22 Impact of environmental risks

In the whole process of production, transportation, storage and use, the product will not cause harm to the environment. After use, it will be disinfected according to the relevant regulations of hospital laboratories and medical wastes, so the environmental risk has been reduced to an acceptable minimum.

3.23 Personnel Professional Training Risks

Personnel engaged in hospital biochemical tests are professionals with certain knowledge and skills, and the risk of professional training for personnel by products has been minimized.

3.24 Risk of batch unevenness and inconsistency

In the product standard, the PH value, CV*** within the batch, CV*** between batches, accuracy, etc. They are strictly controlled and must be inspected before leaving the factory, so the risk of irregular and inconsistent batches has been minimized.

3.25 *** Interference Risk

The biochemical laboratory of the hospital itself is built in a place with small external interference sources, which ensures the anti-interference ability of the instrument and the control accuracy of temperature and time. As long as the operators operate according to the requirements of the manual and the national clinical laboratory operating procedures formulated by the Ministry of Health, the interference risk of the instrument has been minimized.

3.26 Identifying the Risk of Errors

In the product standard, product identification includes single packaging bottle identification and transportation and storage identification of * * * identification box in the packaging box. Single packaging bottle identification and packaging box identification are mandatory items before leaving the factory. The contents of each label setting have been reviewed by experts from the Provincial Medical Device Standardization Technical Committee, and have been revised and improved, thus minimizing the risk of label errors.

3.27 Improper use indicates risks.

Product specifications are specified in product standards, and products are evaluated as mandatory items when they leave the factory. The format, content and safety precautions of the product instruction manual have been reviewed, revised and improved by experts, so the risk of unknown product instruction manual is minimized.

3.28 Energy Risk

not applicable

3.29 Biological risk

not applicable

Through the above-mentioned hazard judgment, risk estimation, prevention and resolution in the whole process of raw material production, configuration, detection, labeling, packaging, transportation, storage, use method and safety precautions, storage and post-use treatment, as well as the whole process control and risk prevention measures for product quality in registered product standards, instructions for use and enterprise rules and regulations, it can be seen that the safety risk coefficient of kit products produced by our company has been reduced to a minimum, which can meet the aquatic products acceptable to users.

Article 3:

Safety production risk analysis report

/kloc-general situation of safety production risk management and control in 0/xx year.

Requirements:

* * *1* * introduce the annual risk control measures and task completion of the company and unit, and explain the reasons for the failure.

* * * 2 * * Summarize and refine the achievements and shortcomings of the five categories of risk management and control of safety production in our unit, especially the management and control mode formed in the risk management and control of power grid, devices and individuals * * * *.

Work situation and effect of risk management and control of production safety in 2 xx years

2. 1 Strengthen power grid risk management and control to ensure system security and stability.

2.2 Implement equipment risk control to ensure the safe and reliable implementation of important equipment.

2.3 Strengthen personal risk control and actively prevent the risk of personal death accidents.

2.4 Implement social impact risk pre-control measures to maintain the good image of the company.

2.5 Implement environmental and occupational health control measures to ensure the physical and mental health of employees.

2.6 Strengthen emergency management and improve the ability of disaster prevention and power conservation.

Risk analysis of production safety in 3 xx years

3. 1 power grid security risk

3.2 Equipment safety risks

3.3 Personal safety risks

3.4 Social Impact Risk

3.5 Environmental and Occupational Health Risks

4 xx years safety production risk control measures.

Related requirements:

* * *1* * Risk pre-control measures should be as operable as possible, list specific implementation projects, and specify the responsible units and departments, supervision and inspection units and departments, and completion time.

***2*** Develop risk pre-control measures one by one according to the assessed risks.

4. 1 power grid safety risk control measures

4.2 Device safety risk control measures

4.3 Personal safety risk control measures

4.4 Social Impact Risk Control Measures

4.5 Environmental and occupational health risk control measures