风险管理(英文版)

合集下载

风险管理程序英文版

风险管理程序英文版

The purpose of this procedure is to provide for a system and in structi ons, and to assig n resp on sibilities for identifying and evaluating risks.2.0 ScopeThis procedure applies to risks related to the QMS.3.0 Procedure3.1The need for risk identification is determined on the basis of information and trendsregard ing the performa nee and effective ness of the QMS. I n particular:Regulatory requireme ntsProduct safety requireme nts and con siderati onsProduct and service noncon formitiesProcess problems and noncon formitiesSupplier quality performa nee recordsReject and scrap ratesField service recordsOn time delivery performa neeProducti on equipme nt maintenance recordsCustomer feedback and compla intsQuality man ageme nt system audit recordsData loss/corrupti on in cide nts, n etwork outages, etc.3.2Risks are identified and evaluated when quality performance data indicates that there are trends of decreas ing quality capability an d/or effective ness of the quality man ageme nt system. For example:in creas ing in cide nce of product noncon formity; excessive equipme nt problems; or in creas ing n umber of audit findings against the same quality system process or department.3.3Initiating risk management projects3.3.1Risks are ide ntified, evaluated and addressed in DaMei Risk Man ageme nt module; with in a framework of a Risk Man ageme nt Project.3.3.2Risk man ageme nt projects may be proposed by any orga ni zati onal un it and any employee in the compa ny. Requests for in itiati ng a risk man ageme nt project are submitted to Man ageme nt represe ntative or Gen eral man ager, as appropriate. Only Man ageme nt represe ntative and Gen eral man ager have the authority to initiate, or approve the initiation of risk management projects. This is to prioritize and direct resources where risk con trol is most urge nt.4.0 Risk man ageme nt project4.1Risk management projects are initiated in DaMei Risk Management module using electronic form EF-380-1 Risk Project.4.2When initiating a new project, select in form EF-380-1 the risk assessment method that will be used for the project:1)Hazard Evaluation: This is a method for evaluating hazards and related harms, rather than estimating the actual risks. The method is based on evaluating hazardous situations and associated harms (risk cases), and existing controls that reduce the likelihood of the hazardous situation occurring and/or reduce the severity of the harm. The evaluation results in a decision whether additional controls need to be implemented to further reduce risk. Although no a full fledged risk analysis, it is an excellent method for dem on strati ng 'risk based thinking' without going into formal and complex risk an alysis studies. This method should not be used when evaluating risks related to the safety of medical devices.2)Risk Matrix Analysis: This is a structured, formal method for assessing risks using a risk matrix. The risk matrix for the project is defined usinga template provided in formEF-380-01 (click the Risk Matrix tab in the form). This method is often referred to in technical literature as a Prelim inary Hazard An alysis (PHA). It is a top-dow n approach, using a list of known hazards as in put for the risk analysis. The risk matrix method is the most flexible and versatile, as it can be applied to any product, process or system, and does not require detailed kno wledge about the system to be an alyzed. Where appropriate, the risk matrix Analysis method should be used when evaluating risks related to the safety of medical devices.Other Method: Select this item when some other risk assessment method will be used, for example: Failure Mode Effects An alysis (FMEA), Failure Mode, Effects and Criticality An alysis (FMECA), Fault Tree Analysis (FTA), Hazard Analysis and Critical Control Points (HACCP), etc.4.3Risk man ageme nt projects are periodically reviewed to en sure that they remai n releva nt and up to date. Review dates are scheduled, and the review are docume nted in form EF-380-1 in the 'Reviews' block.5.0 Hazards5.1Hazards are con diti ons, circumsta nces, practices or other 'thi ngs' that can be a source of harm or loss. Hazards do not cause harms; they just make harms possible. Hazards are usually con sta nt, i.e., they are always there, unl ess the hazard is completely removed.5.2For each risk man ageme nt project ide ntify all releva nt hazards and en ter them into DaMei Risk Man ageme nt module (select the project and en ter hazards into the 'Hazards' grid).。

项目风险管理简介(英文版)

项目风险管理简介(英文版)

Develop An Effective Mitigating Strategy
More often than not, a risk will require multiple actions to be effectively mitigated.
Analysis often reveals that the same mitigating action is assigned to a variety of risks; another indication that the true risk has not yet been properly identified.
Risk logs quickly become unmanageable because of their size.
Identify Risks
This problem will not only cause schedule delays, budget overruns, poor quality, etc., but also lead the project team to lose confidence in their ability to effectively mitigate risk.
Avoid the risk. Do something to remove it. Use another supplier for example.
Transfer the risk. Make someone else responsible. Mitigate the risk. Take actions to lessen the impact
Now
Introduction

101条风险管理准则中英文

101条风险管理准则中英文

vah hcihw serusae m tne meganam ksir lla gnitpoda morf tifeneb nac tegdub detimilnu na htiw ytitne nA「
」 �準标策决為会机之活 存以而準标策决非性效有之本成时此�险保用利常通�险风移转能可大最儘�险风之準水围范一此於高� �合组本成切适之策对险保非与险保取求�险风之準水围范一此於低� �围范险风之 同不个两的开分所下围范或準水之力能失损大最之受承能业企 �生发之失损次一重著应理管险风「 �文译 .si lavivrus ;enoz siht ni noiretirc a
」 �案方理管险风的大最额差值现本成期预与值现益收期预 择选应体个济经�时案方理管险风之突衝相互取选在体个济经�时由理之际实或算限之限有了為当「 �文译 o stifeneb fo ssecxe tsetaerg eht ti sreffo taht erusae m eht esoohc dluohs ytitne eht ,serusae m tne mega nam ksir evisulcxe yllautu m neewteb esoohc tsum ytitne na ,snosaer lacitcarp ro yrategdub rof ,neh W「 �文英 ��� 」.seulav tneserp detcepxe sa desserpxe era stsoc dna stifeneb htob neh W .stsoc rev
」 �益获可 即案方之值现本成期预於大值现益收期预取採案方理管险风之有所对要只体个济经之制限算预少较「 �文译 stsoc fo eulav tneserp detcepxe eht naht retaerg eulav tneserp detcepxe na htiw ytitne eht ot stifeneb e �文英 ��� 」.ytitne taht ot serusae m esoht fo

风险管理策略【英文】

风险管理策略【英文】

• Companies had managers but not necessarily strategic leaders • Could not react to changes in technology, demography, customer preferences, and nontraditional competitors.
"Concentration — that is, the courage to impose on time and events his own decision as to what really matters and comes first — is the executive's only hope of becoming the master of time and events." — Peter Drucker, The Effective Executive
Strategic goals and objectives
• Identify the goals first; make a list. • Set specific targets for each strategic imperative. "Improving customer satisfaction," "reengineering key processes," or "changing the culture" is in everyone’s list. Set concrete measurable goals – e.g. actual number of dissatisfied customers; product defects). • Don’t hide behind percentages.

医疗器械风险管理报告英文版模板

医疗器械风险管理报告英文版模板
4
3.5Instruction of product
4
4.Risk analysis
4
4.1Risk analysis procedure
4
4.2Intended use/intended purpose and identification of characteristics related to the safety
2. Scope
This report is applicable to the product ofXXXwhich including the following parts:
1.PCB
2.Ceramic heater
3.Alkaline battery
4.Plastic enclosure
er operation manual
8. Annex
TABLE: Intended use and identification of characteristics related to the safety of the
medical device from IEC 60601-1
19
20
20
20
20
21-24
1.
This risk analysis was made in accordance with EN ISO 14971:2012 – Application of risk management to medical devices.
RiskManagementreport
ProductName
XXX
Type/Model
XXX-XXX
Issue date
5/11/2019

信用风险管理英文版

信用风险管理英文版
*
Company A $295,396,000 $261,201,000 124*
Peer Average
51.3 D Cash
51.3 $261,201,000 $122,002,230
+$173,393,770
Equals 295.4M/261.2M x 90(or number of days in sales period)
Credit Risk Management
Enhancing Your Bottom Line
Credit Background
Thorough identification and accurate measurement of credit risk, supported by strong risk management can help improve the bottom line …..An uncertain and volatile economic environment significantly impacts this ability …..The desire to grow and turn in outstanding results has a tendency to put pressure on the checks and balances within businesses
Reporting
The business strategies and objectives drive the establishment of credit policies and procedures. Measurement and reporting as well as the use of current technologies enhance credit decision-making and improve risk management. The entire process is continually re-evaluated and improved.

风险管理英文课件 (12)

风险管理英文课件 (12)
l What is the 99% VaR and expected shortfall of each project?
l What is the 99% VaR and expected shortfall for the portfolio?
Spectral Risk Measures
1. A spectral risk measure assigns weights to quantiles of the loss distribution
2. VaR assigns all weight to the Xth percentile of the loss distribution
3. Expected shortfall assigns equal weight to all percentiles greater than the Xth percentile
l The 1% point of the distribution of gains is 2 − 2.33 × 10 or −$21.3 million.
l The VaR for the portfolio with a six-month time horizon and a 99% confidence level is $21.3 million.
VaR vs. Expected Shortfall
l VaR satisfies the first three conditions but not the fourth one.
l ES satisfies all four conditions.
Example 12.5 and 12.7
l Regulators have indicated that they plan to move from using VaR to using ES for determining market risk capital

(风险管理)风险分析及方法简述

(风险管理)风险分析及方法简述

风险分析及方法简述(中英文)1 Basic Risk Management Facilitation Methods 基本的风险管理的便利方法Some of the simple techniques that are commonly used to structure risk management by organizing data and facilitating decision-making are:下面是一些简单的通常使用的方法,进行风险管理和制定决策:Flowcharts/流程图Check Sheets/检查清单Process Mapping/过程图Cause and Effect Diagrams (also called an Ishikawa diagram or fish bone diagram)/因果图(或者叫鱼骨图)2 Failure Mode Effects Analysis (FMEA) 失效模式与效果分析2.1 Describe/描述FMEA (see IEC 60812) provides for an evaluation of potential failure modes for processes and their likely effect on outcomes and/or product performance. Once failure modes are established, risk reduction can be used to eliminate, contain, reduce or control the potential failures. FMEA relies on product and process understanding. FMEA methodically breaks down the analysis of complex processes into manageable steps. It is a powerful tool for summarizing the important modes of failure, factors causing these failures and the likely effects of these failures.FMEA提供了工艺潜在失效模式的评估和对产品性能或结果的潜在影响。

  1. 1、下载文档前请自行甄别文档内容的完整性,平台不提供额外的编辑、内容补充、找答案等附加服务。
  2. 2、"仅部分预览"的文档,不可在线预览部分如存在完整性等问题,可反馈申请退款(可完整预览的文档不适用该条件!)。
  3. 3、如文档侵犯您的权益,请联系客服反馈,我们会尽快为您处理(人工客服工作时间:9:00-18:30)。

3rd Review
4th Review Date: Name: Signed:
C Hazard
(potential for harm) Example:
Working at height
1Trapped Hand
2Operation of machine
3Visual imparement
4Noise
B
Assessment ref. no. …
Date of assessment: …31/03/04
Assessor(s)/team: …P.REEK
…G.STICKA
S.SARGEANT

Q
Periodic reviews – maximum
intervals for activities with:
occur often
Frequent Regular or continuous occurrence
1
2
3
4
5
Multiple fatalities
Extensive damage
Significant harm*
International impact
5
Single fatality
Major injury
1 to 25
9 medium
1
2
3
6
Examining results on display screens
Continuous use of DSE
Gradual deteration of eyesight
3
DSE legislation, not a continuous process
2
6
C
Hazard: The hazard is the thing with the potential for harm, such as a flammable substance,
rotating machine or deep water. Record all of the significant hazards associated with the
Incredible Extremely unlikely to ever occur
Probability
Improbable Unlikely but may occur exceptionally
Occasional Likely to
occur some time
Probable Likely to
Activity (or area) being assessed: …Dytel/Moore Vernon Gauges
People affected:
Rolls-Royce: 8 Frequency/duration: 8hs 3shfts Others: 0 Frequency/duration: N/A
Name
Signature
Date
J. Bloggs
Joe Bloggs
26/12/2000
2
3
4 Noise reduction plan in progress
0
5
0
2
6 Better Hand tooling
1
1
1
Consequence
People
Assets Environment Reputation
Although the risk assessment matrix covers risks to people, assets, environment and reputation, each of these risk areas should be considered separately, e.g. consider environmental hazards independently.
Risk Assessment Part 1: Assessment with existing control measures
A Business: …TURBINE SYSTEMS Department: …DIMENSIONAL Dept. no.: …2225 Location: …PCF
relates. Where the risk assessment is generic it should be clearly stated.
Indicate the people who could be affected (including contractors and the public) and the frequency and duration of exposure – precise details are not required.
foreseeable causes of exposure to the hazards.
E.g. how the substance is released, how a person becomes trapped in a dangerous machine, how a person comes into contact with deep water.
B
A unique reference number should be allocated to the assessment, and the date of the initial
assessment and the main parties involved should be recorded.
Major damage
Moderate, long-term
harm*
National impact
4
Localised damage
Moderate, short-term
harm*
Considerable impact
3
Lost time injury
Minor damage
Low impact, little harm*
General factory noise
Finish area extraction & machine noise
Gradual hearing impairment
Area is ppe controlled &
3 hearing protection must
2
6
be worn
Dropping of tooling fixtures unsafe working practices
2
Annual monitoring @ OHD
2
6
Page 1
Re-assess risks to show how proposed actions will be effective in reducing the risk.
Also consider whether any new hazards will be introduced .
Limited Impact
2
First aid injury
No damage
No impact*
No Impact
1
Medium Low
High
R
Lead Assessor
Signed
Name (print)
Position
Date
Accountable Manager
* Refer to “Environmental Aspects and Impacts Assessment methodology and EnvAID user’s guide” for explanation of environmental probability and consequence categories. Page 2
5Physical injury
6Hand held tooling vibration
D Hazardous event (what happens) Fall from ladder
Fixture closing on components
RSI
E Foreseeable cause
(cause of hazardous event) Loss of balance
D
Hazardous Event: Give a very brief description of the hazard scenario or event – i.e. what
happens that could lead to harm.
E
Foreseeable cause: Record the plausible causes of each hazard being released or the
Unsafe working practices
Continuous loading & unloading of components
F Consequence (outcome)
Details of harm
Value 1 to 5
Bken fingers
1
G Existing control measures used
Consequence 3
Probability 2
Risk
6 med
1
M
N
P
Planned action completion date
Actual completion
date
1/1/2001
25/12/2000
相关文档
最新文档