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 Scope
This procedure applies to risks related to the QMS.
3.0 Procedure
3.1The need for risk identification is determined on the basis of information and trends
regard ing the performa nee and effective ness of the QMS. I n particular:
Regulatory requireme nts
Product safety requireme nts and con siderati ons
Product and service noncon formities
Process problems and noncon formities
Supplier quality performa nee records
Reject and scrap rates
Field service records
On time delivery performa nee
Producti on equipme nt maintenance records
Customer feedback and compla ints
Quality man ageme nt system audit records
Data 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 projects
3.3.1Risks 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 project
4.1Risk 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 using
a template provided in form
EF-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 Hazards
5.1Hazards 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).。