SB-Decision_making_guide-zh_CN

EUROPEAN COMMISSIONDG ENTERPRISE AND INDUSTRYDirectorate F-Consumer GoodUnit F3- Cosmetic and Medical DevicesMEDICAL DEVICES: Guidance documentMEDDEV 2.12-1 rev 6December 2009GUIDELINESON A MEDICAL DEVICES VIGILANCE SYSTEMThe present guidelines are part of a set of guidelines relating to questions of application of EC-Directives on MEDICAL DEVICEs. They are legally not binding. The guidelines have been carefully drafted through a process of intensive consultation of the various interested parties (competent authorities, Commission services, industries, other interested parties) during which intermediate drafts were circulated and comments were taken up in the document. Therefore, this document reflects positions taken by representatives of interested parties in the MEDICAL DEVICEs sector.Revision 6 of MEDDEV 2.12-1 incorporates technical modifications to Annex 3 (Report Form - Manufacturer's Incident Report). The April 2007 version of MEDDEV 2.12-1 remains otherwise unchanged. The revised Annex 3 will be applicable as of 20 March 2010.T ABLE OF C ONTENTST ABLE OF C ONTENTS (2)1FOREWORD (4)2INTRODUCTION (4)3SCOPE (5)3.1GENERAL PRINCIPLES (6)3.1.1FOR MANUFACTURERS (6)3.1.2FOR MANUFACTURERS OF IVDS (7)3.1.3FOR NATIONAL COMPETENT AUTHORITIES (7)3.1.4FOR USERS (8)4DEFINITIONS (8)4.1ABNORMAL USE (8)4.2AUTHORISED REPRESENTATIVE (8)4.3CORRECTIVE ACTION (8)4.4DRUG / DEVICE COMBINATION PRODUCT (9)4.5EUDAMED (9)4.6FIELD SAFETY CORRECTIVE ACTION (FSCA) (9)4.7FIELD SAFETY NOTICE (FSN) (10)4.8HARM (10)4.9IMMEDIATELY (10)4.10INCIDENT (10)4.11INDIRECT HARM (10)4.12INTENDED PURPOSE (11)4.13MANUFACTURER (11)4.14MEDICAL DEVICE (11)4.15OPERATOR (11)4.16PERIODIC SUMMARY REPORTING (11)4.17SERIOUS PUBLIC HEALTH THREAT (12)4.18TREND REPORTING (12)4.19UNANTICIPATED (12)4.20USE ERROR (12)4.21USER (12)5MANUFACTURERS´ ROLE (12)5.1INCIDENT REPORTING SYSTEM (13)5.1.1CRITERIA FOR INCIDENTs TO BE REPORTED BY MANUFACTURERS TOCOMPETENT AUTHORITIES (13)5.1.2 CONDITIONS FOR PERIODIC SUMMARY REPORTING UNDER THE MEDICALDEVICE VIGILANCE SYSTEM (15)5.1.2.1INCIDENTS DESCRIBED IN A FIELD SAFETY NOTICE (15)5.1.2.2COMMON AND WELL-DOCUMENTED INCIDENTS (15)5.1.3CONDITIONS WHERE REPORTING UNDER THE MEDICAL DEVICE VIGILANCESYSTEM IS NOT USUALLY REQUIRED (16)5.1.3.1DEFICIENCY OF A DEVICE FOUND BY THE USER PRIOR TO ITS USE (16)5.1.3.2EVENT CAUSED BY PATIENT CONDITIONS (16)5.1.3.3SERVICE LIFE OR SHELF-LIFE OF THE MEDICAL DEVICE EXCEEDED (17)5.1.3.4PROTECTION AGAINST A FAULT FUNCTIONED CORRECTLY (17)5.1.3.5 EXPECTED AND FORESEEABLE SIDE EFFECTS (18)5.1.3.6 NEGLIGIBLE LIKELIHOOD OF OCCURRENCE OF DEATH OR SERIOUSDETERIORATION IN STATE OF HEALTH (19)5.1.4TREND REPORTS (19)5.1.5REPORTING OF USE ERROR AND ABNORMAL USE (20)5.1.5.1REPORTABLE USE ERRORS (20)5.1.5.2USE ERROR WHERE REPORTING UNDER THE MEDICAL DEVICE VIGILANCESYSTEM IS NOT USUALLY REQUIRED (20)5.1.5.3CONSIDERATION FOR HANDLING ABNORMAL USE (20)5.1.6DETAILS TO BE INCLUDED IN MANUFACTURER REPORTS (21)5.1.7TIMESCALE FOR THE INITIAL REPORTING OF AN INCIDENT (21)5.1.8TO WHOM TO REPORT (21)5.2HANDLING OF USER REPORTS SUBMITTED TO THE MANUFACTURER BY ANATIONAL COMPETENT AUTHORITY (22)5.3INVESTIGATIONS (22)5.3.1 PRINCIPLES (22)5.3.2ACCESS TO THE DEVICE SUSPECTED TO BE INVOLVED IN THE INCIDENT (22)5.4 OUTCOME OF AN INVESTIGATION AND FOLLOW-UP (23)5.4.1 PRINCIPLES (23)5.4.2FOLLOW-UP REPORT (23)5.4.3FINAL REPORT (23)5.4.4 FIELD SAFETY CORRECTIVE ACTION (23)5.4.4.1NOTIFICATION TO NATIONAL COMPETENT AUTHORITIES (24)5.4.4.2CONTENT OF THE FIELD SAFETY NOTICE (25)6.RESPONSIBILITIES OF NATIONAL COMPETENT AUTHORITY (26)6.1ACTIONS ON A REPORT FROM USERS OR OTHER SYSTEMS (26)6.2RISK EVALUATION AND SUBSEQUENT ACTIONS (27)6.2.1RISK EVALUATION BY THE NATIONAL COMPETENT AUTHORITY (27)6.2.2MONITORING OF MANUFACTURERS SUBSEQUENT ACTIONS (27)6.2.3NATIONAL COMPETENT AUTHORITY ACTIONS (28)6.3CO-ORDINATION BETWEEN COMPETENT AUTHORITIES (28)6.3.1CIRCUMSTANCES WHERE A COORDINATING NATIONAL COMPETENTAUTHORITY IS NEEDED (28)6.3.2DETERMINATION OF THE COORDINATING NATIONAL COMPETENT AUTHORITY296.3.3THE TASKS OF THE CO-ORDINATING NATIONAL COMPETENT AUTHORITY (29)6.3.4SAFEGUARD CLAUSE (30)6.3.5DISSEMINATION OF INFORMATION BETWEEN National COMPETENTAUTHORITIES (30)6.3.6DISSEMINATION OF INFORMATION OUTSIDE NATIONAL COMPETENTAUTHORITIES BY A NATIONAL COMPETENT AUTHORITY (31)6.4COMPLETION OF THE INVESTIGATION (31)7THE ROLE OF THE NOTIFIED BODIES (32)8THE ROLE OF THE COMMISSION (32)9USERS ROLE WITHIN THE VIGILANCE SYSTEM (32)10.1ANNEX 1 EXAMPLES OF INCIDENTs WHICH THE MANUFACTURER SHOULDREPORT (34)10.2ANNEX 2 EXTRACTS FROM DIRECTIVES RELATING TO "MEDICAL DEVICESVIGILANCE" (36)10.3ANNEX 3 REPORT FORM FOR MANUFACTURER’S TO THE NATIONAL COMPETENTAUTHORITY (39)10.4ANNEX 4 EUROPEAN FIELD SAFETY CORRECTIVE ACTION REPORT FORM (44)10.5ANNEX 5 TEMPLATE FOR A FIELD SAFETY NOTICE (48)10.6ANNEX 6 SUGGESTED NATIONAL COMPETENT AUTHORITY REPORT FORMAT (50)10.7ANNEX 7 TITLES OF GLOBAL HARMONISATION TASK FORCE STUDY GROUP 2DOCUMENTS USED IN THE DEVELOPMENT OF THIS MEDDEV AND/OR CITED (53)10.8ANNEX 8 LIST OF THE USED ABBREVIATIONS (54)10.9ANNEX 9 GUIDANCE TO MANUFACTURERS WHEN INVOLVING USERS IN THEVIGILANCE SYSTEM (55)1 FOREWORDThese guidelines on the Medical Device Vigilance System are part of a set of Medical Device Guidelines that promote a common approach by MANUFACTURERs and Notified Bodies involved in the conformity assessment procedures according to the relevant annexes of the directives, and by the National Competent Authorities charged with safeguarding public health.They have been carefully drafted through a process of consultation with various interested parties during which intermediate drafts were circulated and comments were taken up in the documents. Therefore, it reflects positions taken in particular by representatives of National Competent Authorities and Commission Services, Notified Bodies, industry and other interested parties in the MEDICAL DEVICEs sector.The guidelines are regularly updated accordingly with regulatory developments. The latest version of the guidelines should always be used. This revision of these guidelines has: •carefully considered and transposed into the European context the Global Harmonisation Task Force (GHTF)1 international regulatory guidance documents on vigilance and post market surveillance;•addressed the introduction of European medical device database EUDAMED; •amended the document in light of experience with previous clauses.These guidelines are not legally binding. It is recognised that under given circumstances, for example, as a result of scientific developments, an alternative approach may be possible or appropriate to comply with the legal requirements.Nevertheless, due to the participation of the aforementioned interested parties and of experts from National Competent Authorities, it is anticipated that the guidelines will be followed within the Member States and, therefore, work towards uniform application of relevant directive provisions and common practices within Member States.However, only the text of the Directives is authentic in law. On certain issues not addressed in the Directives, national legislation may be different from these guidelines.2 INTRODUCTIONThese guidelines describe the European system for the notification and evaluation of INCIDENTs and FIELD SAFETY CORRECTIVE ACTIONS (FSCA) involving MEDICAL DEVICEs, known as the Medical Device Vigilance System.The principal purpose of the Medical Device Vigilance System is to improve the protection of health and safety of patients, USERs and others by reducing the likelihood of reoccurrence of the INCIDENT elsewhere. This is to be achieved by the evaluation of reported INCIDENTs and, where appropriate, dissemination of information, which could be used to prevent such repetitions, or to alleviate the consequences of such INCIDENTs.These guidelines are intended to facilitate the uniform application and implementation of the Medical Device Vigilance System requirements contained within:1 A list of the used abbreviations is listed in annex 8•the Directive for Active Implantable Medical Devices (AIMD), 90/385/EEC•the Directive for Medical Devices (MDD), 93/42/EEC•the In Vitro Diagnostic Medical Devices Directive (IVDD), 98/79/EC.FIELD SAFETY CORRECTIVE ACTION (FSCA), FIELD SAFETY NOTICE (FSN), USE ERROR and ABNORMAL USE are new concepts introduced in this revision of the guideline to enhance and clarify the European Medical Device Vigilance System while promoting harmonisation with GHTF provisions.The Medical Device Vigilance System is intended to facilitate a direct, early and harmonised implementation of FIELD SAFETY CORRECTIVE ACTION across the Member States where the device is in use, in contrast to action taken on a country by country basis.Corrective action includes, but may not be confined to: a device recall; the issue of a FIELD SAFETY NOTICE; additional surveillance/modification of devices in use; modification to future device design, components or manufacturing process; modification to labelling or instructions for use.3 SCOPEThese guidelines describe the requirements of the Medical Device Vigilance System as it applies to or involves:• MANUFACTURERs2•National Competent Authorities (NCA)•the European Commission•Notified Bodies•USERs and others concerned with the continuing safety of MEDICAL DEVICEsThese guidelines cover the actions to be taken once the MANUFACTURER or National Competent Authority receives information concerning an INCIDENT involving a MEDICAL DEVICE. Information on INCIDENTs which should be reported under the Medical Device Vigilance System may come to the attention of MANUFACTURERs via the systematic procedure to review experience gained from devices in the post-production phase, or by other means (see annexes II, IV, V, VI, VII of MDD and annexes III, IV, VI and VII of IVDD). The term "post-marketing surveillance" as referred to in Annexes 2, 4, 5 in AIMD has the same meaning as the aforementioned "systematic procedure".These guidelines cover Article 8 (AIMD), Article 10 (MDD) and Article 11 (IVDD) outlining the obligations of Member States upon the receipt of INCIDENT reports, from MANUFACTURERs or other sources, concerning any MEDICAL DEVICE. They also include guidance to National Competent Authorities about the issue and receipt of information from National Competent Authorities outside Europe who are involved in the GHTF National Competent Authority Report (NCAR) exchange programme.These guidelines are relevant to INCIDENTs occurring within the Member States of the European Economic Area (EEA) and Switzerland with regard to:•a) devices which carry the CE-mark2 including their Authorised Representatives and persons responsible for placing on the market, see section 4 on definitions.•b) devices that do not carry the CE-mark but fall under the directives scope (e.g. custom made devices)•c) devices that do not carry the CE mark because they were placed on the market before the entry into force of the medical devices directives.•d) devices that do not carry the CE-mark but where such INCIDENTs lead to CORRECTIVE ACTION(s) relevant to the devices mentioned in a), b) and c).These guidelines cover FIELD SAFETY CORRECTIVE ACTION relevant to CE-marked devices which are offered for sale or are in use within the EEA and Switzerland.These guidelines make no recommendations on the structure of the systems by which MANUFACTURERs gather information concerning the use of devices in the post-production phase, of which the Medical Device Vigilance System is an integral part. Such recommendations are outside the scope of this document.3.1 GENERAL PRINCIPLES3.1.1 FOR MANUFACTURERS•The MANUFACTURER or his AUTHORISED REPRESENTATIVE shall notify the relevant National Competent Authority about INCIDENTs and FIELD SAFETY CORRECTIVE ACTIONs when the reporting criteria are met (see section 5.1 and 5.4). •The MANUFACTURER has the responsibility for investigating INCIDENTs and for taking any CORRECTIVE ACTION necessary (see section 5.2 and 5.3).•The MANUFACTURER should ensure that these guidelines are made known to their AUTHORISED REPRESENTATIVEs within the EEA and Switzerland, persons responsible for placing devices on the market and any other agents authorised to act on their behalf for purposes related to medical devices vigilance, so that the MANUFACTURERs' responsibilities may be fulfilled.•The MANUFACTURER should ensure that their AUTHORISED REPRESENTATIVE within the EEA and Switzerland, persons responsible for placing devices on the market and any other agents authorised to act on their behalf for purposes relating to medical devices vigilance, are kept informed of INCIDENT reports as appropriate.•Where an INCIDENT occurs as a consequence of the combined use of two or more separate devices (and/or accessories) made by different MANUFACTURERs, each MANUFACTURER should submit a report to the relevant National Competent Authority (see section 5.1)•MANUFACTURERs must keep the Notified Body advised of issues occurring in the post production phase affecting the certification (see the relevant annexes of the relevant directives and section 7 of this document). This would include relevant changes derived from the vigilance system.The act of reporting an INCIDENT to a National Competent Authority is not to be construed as an admission of liability for the INCIDENT and its consequences. Written reports may carry a disclaimer to this effect.When placing on the market of a particular model of MEDICAL DEVICE ceases, the MANUFACTURER’s vigilance reporting obligations under the Medical Device Directives remain. However, a MANUFACTURERs legal trading arrangements change with mergers and acquisitions etc. Where the vigilance and other post market surveillance obligations are being transferred to another legal entity it is important that post market surveillance activitiescontinue and that Competent Authorities are appraised of the implications and provided with new contact details as soon as possible, so that any detrimental effects on the functioning of the vigilance system are minimised.For a complete description of the MANUFACTURER’s role in the Medical Device Vigilance System, see section 5 of these guidelines.3.1.2 FOR MANUFACTURERS OF IVDSVigilance reporting for IVDs may be more difficult since IVDs do not generally come into contact with patients. Therefore, it can be difficult to demonstrate direct HARM to patients, unless the device itself causes deterioration in state of health. HARM to patients is more likely to be indirect - a result of action taken or not taken on the basis of an incorrect result obtained with an IVD. Whether as a result of direct or INDIRECT HARM, INCIDENTs should be reported.It may be difficult to determine if a serious deterioration in the state of a patient’s health was or could be the consequence of an erroneous result obtained with an IVD, or if the HARM was the consequence of an error by the USER or third party. There should be a predisposition to report under such circumstances (see section 5.1).In the case of potential errors by USERs or third parties, labelling and instructions for use should be carefully reviewed for any possible inadequacy. This is particularly true for devices used for self-testing where a medical decision may be made by the patient. Inadequacies in the information supplied by the MANUFACTURER that led or could have led to HARM to USERs, patients or third parties should be reported.In particular, it can be extremely difficult to judge events in which no HARM was caused, but where HARM could result if the event was to occur again elsewhere.3.1.3 FOR NATIONAL COMPETENT AUTHORITIESFor the purposes of Medical Devices Vigilance System, Member States are represented by appointed National Competent Authorities, their vigilance contact points being listed on the European Commission web site:http://ec.europa.eu/enterprise/medical_devices/contact_links_en.htm•The National Competent Authority monitors the investigation of the INCIDENT carried out by the MANUFACTURER.•The National Competent Authority should take any further action that may be necessary to supplement the actions of the MANUFACTURER.•Depending on the outcome to the investigation, any information necessary for the prevention of further INCIDENTs (or the limitation of their consequences) should be disseminated by the National Competent Authority.•Member States should ensure that organisations and individuals involved in purchasing MEDICAL DEVICEs and in the provision of health-care are aware that their co-operation is vital in providing the first link in the vigilance chain. In order to enhance the efficiency of the Medical Device Vigilance System, National Competent Authorities should encourage the reporting of INCIDENTs by the USER and other professionals involved in the distribution, the delivery or putting in to service of the device. This includes organisations and individuals responsible for providing calibration and maintenance for MEDICAL DEVICEs. Such reports may be made directly to the MANUFACTURER or to the National Competent Authority as well depending on national practice.Information held by National Competent Authorities in connection with the Medical Device Vigilance System is to be held in confidence, as defined by the relevant articles of the directives3. However, any INCIDENT report should be available on request, and in confidence, to the other European Competent Authorities and to other National Competent Authorities participating in the GHTF exchange programme.For a complete description of the National Competent Authority’s role in the Medical Device Vigilance System, see section 6 of this guideline.USERS3.1.4 FOR•USERs should report INCIDENTs with MEDICAL DEVICEs to the MANUFACTURER or to the National Competent Authority depending on national practice.•Once corrective (or other) action is identified, hospital administrators, medical practitioners and other health-care professionals, and USER representatives responsible for the maintenance and the safety of MEDICAL DEVICEs, can take the necessary steps.Such steps should, where practicable, be taken in co-operation with the MANUFACTURER.For a complete description of the USER’s role in the Medical Device Vigilance System, see section 9 of this guideline.4 DEFINITIONS4.1 ABNORMAL USEAct or omission of an act by the OPERATOR or USER of a MEDICAL DEVICE as a result of conduct which is beyond any means of risk control by the MANUFACTURER.Reference: EN IEC 60601-1-64.2 AUTHORISED REPRESENTATIVEAny natural or legal person established in the Community who, explicitly designated by the MANUFACTURER, acts and may be addressed by authorities and bodies in the Community instead of the MANUFACTURER with regard to the latter’s obligations under the directive.4.3 CORRECTIVE ACTIONAction to eliminate the cause of a potential nonconformity or other undesirable situation. NOTE1: There can be more than one cause for non-conformity.NOTE 2: Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence.Reference: EN ISO 9000:2000, 3.6.53 AIMD 15, MDD 20 and IVDD 204.4 DRUG / DEVICE COMBINATION PRODUCTA MEDICAL DEVICE incorporating a medicinal product or substance where the action of the medicinal product or substance is ancillary to that of the device. In this case, the lead directive are the Medical Devices Directives (AIMD, MDD).4.5 EUDAMEDThe European database for MEDICAL DEVICEs EUDAMED is to centralise:•data relating to registration of MANUFACTURERS and MEDICAL DEVICES placed on the Community market,•data relating to certificates issued, modified, supplemented, suspended,,withdrawn or refused,•data obtained in accordance with the vigilance procedure.Reference: Article 14a of MDD and article 10 of IVDD.4.6 FIELD SAFETY CORRECTIVE ACTION (FSCA)A FIELD SAFETY CORRECTIVE ACTION is an action taken by a MANUFACTURER to reduce a risk of death or serious deterioration in the state of health associated with the use of a MEDICAL DEVICE that is already placed on the market. Such actions should be notified via a FIELD SAFETY NOTICE.NOTE 1:The FSCA may include- the return of a MEDICAL DEVICE to the supplier;- device modification;- device exchange;- device destruction;- retrofit by purchaser of MANUFACTURER's modification or design change;- advice given by MANUFACTURER regarding the use of the device (e.g. where the device is no longer on the market or has been withdrawn but could still possibly be in usee.g. implants or change in analytical sensitivity or specificity for diagnostic devices)A device modification can include:- permanent or temporary changes to the labelling or instructions for use;- software upgrades including those carried out by remote access;- modification to the clinical management of patients to address a risk of death or serious deterioration in state of health related specifically to the characteristics of the device. For example:- For implantable devices it is often clinically unjustifiable to explant the device.Corrective action taking the form of special patient follow-up, irrespective ofwhether any affected un-implanted devices remain available for return, constitutesFSCA.- For any diagnostic device (e.g. IVD, imaging equipment or devices) the recall of patients for retesting or the retest or review of previous results constitutes FSCA.- advice relating to a change in the way the device is used e.g. IVD MANUFACTURER advises revised quality control procedure -use of third party controls or more frequent calibration or modification of control values for IVDs.NOTE 2: This guideline uses the definition of FSCA as synonym for recall mentioned in article 10(1), paragraph 1b) of the MDD and Article 11 IVD Directive since there is no harmonised definition of recall.4.7 FIELD SAFETY NOTICE (FSN)A communication to customers and/or USERs sent out by a MANUFACTURER or its representative in relation to a Field Safety Corrective Action.4.8 HARMPhysical injury or damage to the health of people, or damage to property or the environment. Reference: ISO/IEC Guide 51:19994.9 IMMEDIATELYFor purposes of this guideline, IMMEDIATELY means without any delay that could not be justified.4.10 INCIDENT“Any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient, or USER or of other persons or to a serious deterioration in their state of health.”Reference: Article 10 of the MDDNote 1: There is a similar definition in Article 8 of the AIMD and Article 11 IVD Directive with minor wording differences.Note 2: A description of “serious deterioration in the state of health” is given in section 5.1.1.(C) of this document.4.11 INDIRECT HARMSome diagnostic devices and all IVDs do not act directly on the individual. HARM may occur as a consequence of the medical decision, action taken/not taken on the basis of information or result(s) provided by the device.Examples include• misdiagnosis,•delayed diagnosis,• delayed treatment,• inappropriate treatment,•transfusion of inappropriate materials.For self-testing devices, a medical decision may be made by the USER of the device who is also the patient.4.12 INTENDED PURPOSEThe use for which the device is intended according to the data supplied by the MANUFACTURER on the labelling, in the instructions and/or in promotional materials. Reference: Article 1.2 (h) of the IVDD and Article 1.2 (g) of the MDD4.13 MANUFACTURERThe natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.Reference: Article 1.2 (f) of the IVDD and Article 1.2 (f) of the MDD4.14 MEDICAL DEVICEFor the purpose of the Medical Devices Directives 90/385/EEC, 93/42/EEC and 98/79/EEC, any instrument, apparatus, appliance, material or other Article, whether used alone or in combination, including the software necessary for its proper application intended by the MANUFACTURER to be used for human beings for the purpose of:- diagnosis, prevention, monitoring, treatment or alleviation of disease,- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,- investigation, replacement or modification of the anatomy or of aprocess,physiological-control of conception,and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.4.15 OPERATORPerson handling equipment.4.16 PERIODIC SUMMARY REPORTINGPERIODIC SUMMARY REPORTING is an alternative reporting regime that is agreed between the MANUFACTURER and the National Competent Authority for reporting similarINCIDENTs with the same device or device type in a consolidated way where the root cause is known or an FSCA has been implemented.4.17 SERIOUS PUBLIC HEALTH THREATAny event type which results in imminent risk of death, serious deterioration in state of health, or serious illness that requires prompt remedial action.This would include:•events that are of significant and unexpected nature such that they become alarming as a potential public health hazard, e.g. human immunodeficiency virus (HIV) or Creutzfeldt-Jacob Disease (CJD). These concerns may be identified by either the National Competent Authority or the MANUFACTURER.•the possibility of multiple deaths occurring at short intervals.Reference: GHTF SG2 N33R114.18 TREND REPORTINGA reporting type used by the MANUFACTURER when a significant increase in events not normally considered to be INCIDENTs according to section 5.1.3. occurred and for which pre-defined trigger levels are used to determine the threshold for reporting.NOTE: GHTF SG2 document N36 'MANUFACTURER's TREND REPORTING of Adverse INCIDENTs' provides useful guidance (see annex 7).'4.19 UNANTICIPATEDA deterioration in state of health is considered UNANTICIPATED if the condition leading tothe event was not considered in a risk analysis.NOTE: Documented evidence in the design file is needed that such analysis was used to reduce the risk to an acceptable level, or that this risk is well known by the intended USER. 4.20 USE ERRORAct or omission of an act, that has a different result to that intended by the MANUFACTURER or expected by the OPERATOR of the MEDICAL DEVICE.4.21 USERThe health care institution, professional, carer or patient using or maintaining MEDICAL DEVICES.5 MANUFACTURERS´ ROLE5.1 INCIDENT REPORTING SYSTEMThe MANUFACTURER or their AUTHORISED REPRESENTATIVE must submit an initial INCIDENT report to the National Competent Authority for recording and evaluation. Each initial report must lead to a final report unless the initial and the final report are combined into one report. But not every INCIDENT report will lead to a corrective action.As a general principle, there should be a pre-disposition to report rather than not to report in case of doubt on the reportability of an INCIDENT.Reference to the following considerations may be made in the report, or should be kept on file by the MANUFACTURER in the case of a decision not to report.INCIDENTs which occurred outside the EEA and Switzerland and do not lead to a FIELD SAFETY CORRECTIVE ACTION relevant to these geographic areas do not need to be reported. Incidents which occurred outside the EEA and Switzerland and led to a FIELD SAFETY CORRECTIVE ACTION relevant to the above-mentioned geographical areas must be reported as a FIELD SAFETY CORRECTIVE ACTION.Where appropriate, MANUFACTURERs should notify their AUTHORISED REPRESENTATIVE, persons responsible for placing devices on the market and any other agents (e.g. distributors) authorised to act on their behalf of INCIDENTs and FSCA reported under the Medical Device Vigilance System.If the MANUFACTURER is located outside the EEA and Switzerland, a suitable contact point within should be provided. This may be the MANUFACTURER's AUTHORISED REPRESENTATIVE, persons responsible for placing devices on the market or any other agent authorised to act on their behalf for purposes relating to Medical Devices Vigilance.Any report should not be unduly delayed because of incomplete information.5.1.1 CRITERIA FOR INCIDENTs TO BE REPORTED BY MANUFACTURERS TOCOMPETENT AUTHORITIESAny event which meets all three basic reporting criteria A – C listed below is considered as an INCIDENT and must be reported to the relevant National Competent Authority. The criteria are that:A: An event has occurredThis also includes situations where testing performed on the device, examination of the information supplied with the device or any scientific information indicates some factor that could lead or has led to an event.Typical events include, but are not limited to:a) A malfunction or deterioration in the characteristics or performance.A malfunction or deterioration should be understood as a failure of a device to perform in accordance with its INTENDED PURPOSE when used in accordance with the MANUFACTURER’s instructions.。

In todays rapidly changing world,the ability to think independently is more crucial than ever.This essay aims to discuss the significance of independent thinking and its impact on personal growth,decisionmaking,and societal progress.IntroductionThe world is filled with information,and the ability to sift through this information and form ones own opinions is a vital skill.Independent thinking allows individuals to analyze,evaluate,and synthesize information to make informed decisions.It is the cornerstone of innovation,creativity,and problemsolving.Personal Growth1.SelfReliance:Independent thinking fosters selfreliance.It enables individuals to trust their own judgment and abilities,which is essential for personal development and selfconfidence.2.Critical Analysis:It encourages critical analysis of information,preventing blind acceptance of ideas or beliefs without questioning their validity.3.Adaptability:Independent thinkers are more adaptable to change because they are not solely reliant on external guidance.They can assess new situations and devise solutions based on their understanding.DecisionMaking1.Rational Choices:Independent thinking leads to more rational decisionmaking.It helps individuals weigh the pros and cons of various options and choose the most suitable course of action.2.Avoiding Groupthink:It guards against the pitfalls of groupthink,where conformity can lead to poor decisions that might not have been made if individuals had been encouraged to think independently.3.Ethical Considerations:Independent thinkers are more likely to consider the ethical implications of their decisions,leading to more morally sound choices.Societal Progress1.Innovation:Societies that value independent thinking are more likely to fosterinnovation.Independent thinkers challenge the status quo and push the boundaries of what is known and possible.2.Diversity of Thought:A diversity of thought is essential for a healthy society. Independent thinkers contribute to this diversity,offering unique perspectives and solutions to societal challenges.3.Civic Engagement:Independent thinkers are more likely to be civically engaged, participating in the democratic process and contributing to the betterment of their communities.Challenges to Independent ThinkingDespite its importance,independent thinking faces several challenges:rmation Overload:The sheer volume of information available can overwhelm individuals,making it difficult to process and analyze data effectively.2.Social Pressure:There is often social pressure to conform,which can discourage independent thought.cational Systems:Traditional educational systems may not always encourage independent thinking,focusing instead on memorization and standardization. ConclusionIn conclusion,independent thinking is a critical skill that contributes to personal growth, better decisionmaking,and societal advancement.It is essential to cultivate this ability, especially in a world where information is abundant,and the need for innovative solutions is everpresent.By fostering independent thinking,we can empower individuals to contribute positively to the world around them.。

Application of Taguchi coupled Fuzzy Multi Attribute Decision Making (FMADM)for optimizing surface quality in turning austenitic and duplex stainlesssteelsRastee D.Koyee a ,⇑,Rocco Eisseler a ,Siegfried Schmauder ba Institute for Machine Tools,University of Stuttgart,Holzgartenstr.17,D-70174Stuttgart,Germany bIMWF,University of Stuttgart,Pfaffenwaldring 32,D-70569Stuttgart,Germanya r t i c l e i n f o Article history:Received 27May 2014Received in revised form 23July 2014Accepted 5September 2014Available online 16September 2014Keywords:Stainless steel Taguchi methodMADM optimization Surface qualityFuzzy simple additive weighta b s t r a c tIn the present study,Taguchi approach is coupled with fuzzy-multiple attribute decision making methods for achieving better surface quality in constant cutting speed face turning of EN 1.4404austenitic,EN 1.4462standard duplex and EN 1.4410super duplex stainless steels.Two typical multiple attribute decision making techniques were simultaneously adopted to determine multi-surface quality characteristics indices.The differences in rank-ings among derived indices are solved through converting each crisp values into trapezoi-dal fuzzy number and unifying them using fuzzy simple additive weight method.The fuzzy numbers are then deffuzified into crisp values employing techniques like;the spread,mode and area between centroid of centroids.Through this procedure,the decision maker is pro-vided with necessary decision tools to optimize the cutting conditions with less sensitivity to the change of weights and no difference in ranking among the deffuzification tech-niques.Additionally,results of analyses of means and the validation experiments confirm that the optimum cutting conditions derived by this method produce far better surface fin-ish than the best finish obtained during the course of experimentation.Analyses of vari-ance results have shown the predominant effect of feed rate on surface quality.Finally,the collected chip at constant cutting speed and varying feed rates and depth of cuts has shown that friendlier-to-machine chips are obtained when machining austenitic stainless steels than duplex stainless steel grades.Ó2014Elsevier Ltd.All rights reserved.1.IntroductionIt is without a doubt that stainless steels are an impor-tant class of alloys.Their importance is manifested in the plenitude of applications that rely on their use.From low-end applications,like cooking utensils and furniture,to very sophisticated ones,such as space vehicles,the use of stainless steels is indispensable.In fact,the omnipres-ence of stainless steels in our daily life makes it impossible to enumerate their applications.The importance of stain-less steels may be more appreciated by looking at the ton-nages of their production and consumption in some of the major economies as listed in Table 1[1].Out of the five know categories of stainless steels,austenitic grades repre-sent the largest group of used stainless steels,making up 65–70%of the total for the past several years [2].Austenitic grade AISI 316is widely used to produce critical structural components in chemical industries and nuclear power sta-tions because they provide a unique combination of high mechanical properties and corrosion resistance [3].On/10.1016/j.measurement.2014.09.0150263-2241/Ó2014Elsevier Ltd.All rights reserved.⇑Corresponding author.Tel.:+4971168584558;fax:+4971168583858.E-mail addresses:rastee.ali@ifw.uni-stuttgart.de (R.D.Koyee),rocco.eisseler@ifw.uni-stuttgart.de (R.Eisseler),siegfried.schmauder@imwf.uni-stuttgart.de (S.Schmauder).the other hand,due to the ferritic-austenitic bi-phased microstructure,duplex stainless steels possess higher mechanical strength and better corrosion resistance than austenitic stainless steels.The applications and markets of duplex stainless steels are increasing continuously,due to their outstanding properties and their relatively low cost[4].Machining stainless steels is a complex operation.Not only does a shop need the correct supporting equipment and suppliers,a better understanding of material itself is paring the machinability of stainless steels with other materials such as carbon steels,brass, or aluminum,there are some striking differences.In gen-eral,stainless steels have:low thermal conductivity,high work-hardening rates,high tensile strengths,high tough-ness,high ductility and large spreads between the yield and tensile strengths.Each stainless steel family brings its own general set of machining rules.The austenitic grades,the300series stainless grades,are more difficult to machine than the ferritic and martensitic families. Austenitic stainless steels are more highly alloyed and are more prone to higher work-hardening rates.Duplex alloys have a structure that is roughly a50%mix of austen-ite and ferrite;thus,two hardness materials with different hardness coexist side by side.The tool will alternate cut-ting between soft and hard grains of the duplex structure, leading to an automatic tendency to initiate chatter in the cutting system.Between the duplex structure and high-strength levels,high horsepower is necessary,and highly rigid setups are required[6].Over the last few years,many researchers have investigated the machining of stainless steels[7–10].For instance,Lin[11]has proposed an optimization technique for face milling stainless steel based on the Taguchi method with multiple performance characteristics.Three cutting parameters namely,cutting speed,feed rate,and depth of cut,are optimized with consideration of multiple performance characteristics including removed volume, surface roughness,and burr height.Konkurt et al.[12]have determined the optimum cutting speed when turning an AISI304austenitic stainless steel using cemented carbide cutting tools.The influence of cutting speed on tool wear and surface roughness was investigated.Ciftci[13]pre-sented the results of experimental work in dry turning of austenitic stainless steels.The influences of cutting speed, cutting tool coating top layer and workpiece material were investigated on the machined surface roughness and the cutting forces.The results showed that cutting speed sig-nificantly affected the machined surface roughness values. With increasing cutting speed,the surface roughness val-ues decreased until a minimum value is reached beyond which they increased.Bordinassi et al.[14]studied the main effects of the turning in the superficial integrity of the duplex stainless steel ASTM A890-Gr6A.Theirfindings have shown that the smaller feed rate,smaller cutting speed and the greater cutting depth provided the smaller values for the tensile residual stress,the smaller surface roughness and the greater micro-hardness.Tzeng and Chen[15]applied the fuzzy logic analysis coupled with Taguchi methods to optimize the precision and accuracy of the high-speed electrical discharge machining process.A fuzzy logic system is used to investigate relationships between the machining precision and accuracy for determining the efficiency of each parameter design of the Taguchi dynamic experiments.Dubey[16]has pre-sented a utility-based Taguchi loss function strategy for the multi-response optimization of electro-chemical honing process.Datta and Majumder[17]focused on Multi-objective Evolutionary algorithm based optimization technique,to determine optimal cutting parameters(cut-ting speed,feed,and depth of cut)in turning operation. Two conflicting objectives(operation time and tool life) with three constraints,which depend on the turning parameters,are optimized using Genetic algorithm.Zinati and Razfar[18]coupled a modified optimization algorithm of harmony search with modified harmony search-based neural networks to predict the cutting condition in longi-tudinal turning of X20Cr13stainless steel leading to opti-mum surface roughness.Recent works undertaken by Nomani et al.[19]have conducted machinability tests on duplex alloys SAF2205and SAF2507,while employing aus-tenite stainless steel316L as a benchmark during drilling. Tool wear,cutting forces and machined surfacefinish were compared and analyzed under similar machining condi-tions.Tool wear,cutting forces and machined surfacefinish were compared and analyzed under similar machining conditions.Both duplex alloys displayed poorer machin-ability responses,with2507being worst.Krolczyk et al.[20]have included determining cutting conditions in the process of turning the duplex stainless steels and designat-ing the wear curve.In case of machining greater resistance to abrasive wear of the tools which were coated with Al2O3 has been demonstrated.De Oliveira et al.[21]have studied the turning operation of SAF2507and its influence on the alloy’s corrosion resistance in practical applications.Their results have indicated that turning with PVD-coated inserts under high-pressure cooling resulted in long tool lives,good workpiece roughness and high corrosion resis-tance of the material after machining.The most frequent wear mechanism found during the tests was notch wear, while the main tool wear mechanism was attrition.Kro-lczyk et al.[22]have identified microhardness of surface integrity after turning with wedges of coated sintered car-bide.The microhardness of surface integrity for variousTable1Stainless production in thousand metric tonnes[5].Region20052006200720082009201020112012European Union83169379811578385986749775597455 Americas26882951260423151942260924862368 Asia12,75315,38016,51015,29916,27720,26721,86124,807 World24,54628,70628,14626,21824,90431,09433,62135,363 376R.D.Koyee et al./Measurement58(2014)375–386cutting speeds was compared.It has been shown that wet cutting leads to the decrease of SI hardening depth,while increasing the rounded cutting edge radius of the wedge increases the maximum microhardness values and the hardening depth.Selvaraj et al.[23]optimized the dry turning parameters of two different grades of nitrogen alloyed duplex stainless steel are by using Taguchi method. The experiments were conducted at three different cutting speeds(80,100and120m/min)with three different feed rates(0.04,0.08and0.12mm/rev)and a constant depth of cut(0.5mm).The cutting parameters are optimized using signal to noise ratio and the analysis of variance. Their results revealed that the feed rate is the more signif-icant parameter influencing the surface roughness and cut-ting force.The cutting speed was identified as the more significant parameter influencing the tool wear.This research aims to develop a new optimization method for effectively performing simultaneous optimiza-tion of well-known surface quality characteristics like arithmetic average(R a),average distance between the highest peak and lowest valley(R z)and maximum height of the profile(R t)using Taguchi approach coupled with Fuzzy Multi Attribute Decision Making(FMADM)methods while face turning EN1.4404austenitic,EN1.4462stan-dard duplex and EN1.4410super duplex stainless steels. The results are further analyzed using analysis of means (ANOM)and analysis of variance(ANOVA).The difference in machinability among machined stainless steels is addi-tionally supported through presenting chip breaking charts.The rest of this paper is organized as follows;the description of Taguchi,MADM methods and operations on fuzzy trapezoidal numbers are introduced in Sections 2–4respectively.Proposed methodology and experimenta-tions are described in Sections5and6respectively.Results and discussions are presented in Section7.Finally,results of confirmation tests and conclusion points are given in Sections8and9respectively.2.Taguchi-based designsThe Taguchi robust design principle is based on matrix experiments.The classical experimental design methods are too complex and are not easy to use.If there are more parameters,a large number of experiments have to be carried out.This problem is overcome in the Taguchi method,which uses a special design of orthogonal arrays (OA)to study the entire major parameter space with only a small number of experiments.In order to minimize the variations in the quality characteristic or response,Tagu-chi introduced a method to transform the repetition data to another value,which is a measure of variation present in the scattered response data.This transformation con-sists of the computation of signal-to-noise(S/N)ratio(g) that consolidates several repetitions into one performance measure which reflects the amount of variation present. The maximization of the S/N ratio simultaneously optimizes the response and minimizes the effect of noise factors.In cutting process,lower values of the surface roughness are desirable for maintaining high cut quality, therefore smaller-the-better S/N ratio can be calculated as:Smaller-the-better type:g¼À10log101rX rt¼1Ob2t()ð1Þwhere Ob t is the t-th observed value of the response,and r is the number of observations in a trial.The S/N ratios are further analyzed using analysis of means(ANOM)and analysis of variance(ANOVA).Thefirst is used to identify the optimal factor level combinations and to estimate the main effects of each factor,while the second term is used to estimate the error variance for the effects and variance of the prediction error.The calcula-tions of ANOM and ANOVA are described in detail in[24].In this study,the control factors are the three known cutting parameters which are cutting speed(m c),feed rate (f r)and depth of cut(a p).Factors and their levels are shown in Table2.3.Multiple Attribute Decision Making(MADM)MADM is an approach employed to solve problems involving selection from among afinite number of alterna-tives.An MADM method specifies how attribute informa-tion is to be processed in order to arrive at a choice. MADM methods require both inner and intra-attribute comparisons,and involve appropriate explicit tradeoffs [25].Out of many MADM methods,two important meth-ods are used in this study.3.1.Graph Theory and Matrix Approach(GTMA)Graph theory is a logical and systematic approach.The advanced theory of graphs and its applications are very well documented[26].Graph/digraph model representations have proved to be useful for modeling and analyzing various kinds of systems and problems in numerousfields of science and technology.The matrix approach is useful in analyzing the graph/digraph models expeditiously to derive the system function and index to meet the objectives[25]. The main procedure of GTMA methodology is as follows:Step1.Structure the problem into(alternative(k)vs.attribute(l))matrix format.In the present workthe attributes are the calculated S/N ratios ofarithmetic average R a,R z and R t.The quantita-tive values of the surface quality attributescould be represented in matrix form as follows:C1C2ÁC lÁC n½D¼A1A2ÁA kÁA m26666666643777777775f11f12ÁÁÁf1nf21f22ÁÁÁf2nÁÁÁÁÁÁÁÁÁf klÁÁÁÁÁÁÁÁfm1fm2ÁÁÁf mn26666666643777777775ð2Þwhere A1,A2,...,A m represent the alternatives which can be recognized by the experimental trials,C1,C2,...,C n rep-resent the criteria(performance characteristics)and f kl isR.D.Koyee et al./Measurement58(2014)375–386377the rating of alternative A k with respect to criterion C l.The next process consists of a normalization process of ele-ments in D matrix(Eq.(2))which arrange the alternatives between number0as the worst and1as the best choice using the expression:CÃkl ¼0;f0kðlÞÀminðf0kðlÞÞmax fkðlÞðÞÀmin fkðlÞðÞ1;8>><>>:f0kðlÞ<min f0kðlÞmin f0kðlÞ6f0kðlÞ6max f0kðlÞf0kðlÞ>max f0kðlÞ9>>=>>;ð3Þfor k=1,2,...,m;and l=1,2,...,n.Step2.Assign the values of relative importance of normal-ized attributes C kl⁄.The number of nodes shall be equal to the number of attributes considered in step1above.This is represented by a binary matrix(I ij),where I ij represents the relative importance between any surface quality attributes i and j.The relative importance between i,j and j,i is distributed on a scale0to L,so that if I ij represents the rel-ative importance of the i-th surface quality attribute over the j-th surface quality attribute,then the relative impor-tance of the j-th surface quality attribute over the i-th sur-face quality attribute is evaluated using Eq.(4):I ji¼LÀI ijð4ÞFor example,let the decision maker select the following assignments:C1C2C3ÁÁC n½A k¼C1C2C3ÁÁC n26666666643777777775ÀI12I13ÁÁI1nI21ÀI23ÁÁI2nI31I32ÀÁÁI3nÁÁÁÀÁÁÁÁÁÁÀÁI n1ÁÁÁÁÀ26666666643777777775ð5ÞStep3.Develop the attributes matrix for the attributes digraph.This will be the n⁄n matrix with diagonal ele-ments as C kl*and off-diagonal elements as I ij.Repeat the process for n-number of rows in normalized decision matrix.For example,for thefirst raw of normalized decision matrix the attribute diagraph can be represented by:½C1C2C3ÁÁC nA k¼C1C2C3ÁÁC n26666666643777777775CÃ11lI12I13ÁÁI1nI21CÃ22I23ÁÁI2nI31I32CÃ33ÁÁI3nÁÁÁÀÁÁÁÁÁÁÀÁI n1ÁÁÁÁCÃ1n26666666643777777775ð6ÞStep4.Obtain the permanent function for each attributes matrix.Step 5.Rank the alternatives,sorting by the values of Per(A k).The best alternative is the one with themaximum value of Per(A k).3.2.AHP-TOPSISOne of the most popular analytical techniques for com-plex decision-making problems is the analytic hierarchy process(AHP).It decomposes a decision-making problem into a system of hierarchies of objectives,attributes(or criteria),and alternatives[25].Technique for Order of Preference by Similarity to Ideal Solution(TOPSIS)method on the other hand is based on the concept that the chosen alternative should have the shortest Euclidean distance from the ideal solution.The ideal solution is a hypothetical solution for which all attribute values correspond to the maximum attribute values in the database comprising the satisfying solutions;the negative-ideal solution is the hypothetical solution for which all attribute values corre-spond to the minimum attribute values in the above-men-tioned database.TOPSIS,thus,gives a solution that is not only closest to the hypothetically best,but which is also farthest from the hypothetically worst.The steps involved for calculating the AHP-TOPSIS values are as follows: Step1.Construct the normalized decision matrix,D kl.This can be represented as:D kl¼fklffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiP mi¼1f2klqð7Þfor k=1,2,...,m;and l=1,2,...,n.Step2.Construct a pairwise comparison matrix using scale of relative importance.An attribute compared with itself is always assigned the value1,so the main diagonal entries of the pair-wise comparison matrix are all1.Assuming N attributes,the pair-wise comparison of attribute i with attribute j yields a square matrix B=N⁄N.In the matrix, b ij=1when i=j and b ji=1/b ij.Where b ij denotes the comparative importance of attribute i with respect to attribute j.Table2Cutting parameters and their levels.Cutting parameters Symbol Unit Cutting parameter levels(L)L1L2L3L4 Cutting speed v c m/min50100150200Feed rate f r mm/rev0.10.250.40.55Depth of cut a p mm0.5 1.5 2.5 3.5 378R.D.Koyee et al./Measurement58(2014)375–386C1C2C3ÁÁC n ½B¼C1C2C3ÁÁC n26666666664377777777751b12b13ÁÁb1nb211b23ÁÁb2nb31b321ÁÁb3nÁÁÁ1ÁÁÁÁÁÁ1Áb n1ÁÁÁÁ12666666666437777777775ð8ÞStep3.Find the relative normalized weight(w j)of each attribute by calculating the geometric mean of the i-th row and normalizing the geometric means of rows in the comparison matrix.These can be represented as:G Mj ¼Y nj¼1b ij"#1=nð9Þw l¼G MjP nj¼1G Mjð10ÞStep4.Perform calculations tofind the consistency ratio (CR).A CR of equal or less than0.1indicates that the consistency of individual judgment is acceptable:a.Calculate matrices A3and A4such that A3=B⁄A2andA4=A3/A2,where A2=[w1,w2,ÁÁÁ,w j]T.b.Determine the maximum Eigen value k max that is theaverage of matrix A4.c.Calculate the consistency index(CI)using:CI¼k maxÀnnÀ1ð11Þd.Calculate the CR:CR¼CIRIð12Þwhere RI is the random index and it is equal to0.52for a three attribute problem[25].Step 5.Construct the weighted normalised decision matrix.This is obtained by the multiplication of each element of the column of the matrix D kl with its associ-ated weight w l.Hence,the elements of the weighted normalized matrix v kl are expressed as:mkl¼w l D klð13Þwhere w l is the weight of l th attribute.Step6.Determine the‘‘ideal’’(best)and‘‘negative ideal’’(worst)solutions.The ideal(best)and negative ideal (worst)solution can be expressed as:Aüf max kðv klÞif l2J;min kðv klÞif l2J0;¼1;2;::;m g Positiveidealsolution¼f vÃ1;vÃ2;...;vÃl;...vÃn gð14ÞAÀ¼f min kðv klÞif l2J;max kðv klÞif l2J0;¼1;2;...;m g Negative ideal solution¼f vÀ1;vÀ2;...;vÀl;...vÀn gð15ÞwhereJ¼fðl¼1;2;...;nÞl associatedwith beneficialattributesj g J0¼fðl¼1;2;...;nÞl associatedwith non-beneficialattributesj g Step7.Obtain the separation measures.The separation of each alternative from the ideal one is given by Euclid-ean distance.Therefore,the separation from positive ideal alternative is:SÃk¼ffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiX nl¼1ðv klÀvÃkÞ2v uu tð16ÞSimilarly,the separation from the negative ideal alter-native is:SÀk¼ffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiX nl¼1ðv klÀvÀkÞ2v uu tð17ÞStep8.The relative closeness of a particular alternative to the ideal solution T k*can be evaluated as:TÃk¼SÀkSÀkþSÃkð18Þk¼1;2;...;m;06TÃk1Step9.Rank the preference order,so that the alternative with the largest relative closeness is rankedfirst[27].4.Operations on fuzzy trapezoidal numbersThe merit of using a fuzzy approach is to assign the rel-ative importance of attributes using fuzzy numbers instead of crisp numbers[28].In this paper,we use trapezoidal fuzzy numbers for the ratings with predefined criteria weights as their weight.A fuzzy trapezoidal number is defined as follows:^bðxÞ¼0;for x<c1wÂxÀc1c2Àc1;for c16x6c2w;for c26x6c3wÂc4Àx43;for c36x6c40;for x>c48>>>>>>><>>>>>>>:ð19ÞFor practical purpose,a trapezoidal fuzzy number can be represented as^bðxÞ¼ðc1;c2;c3;c4;wÞ.The basic arith-metic operations on generalized fuzzy trapezoidal num-bers like^biand^bjcould be defined as:Addition:^biÈ^b j¼ðc1iþc1j;c2iþc2j;c3iþc3j;c4iþc4j;minðw i;w jÞÞ,Subtraction:^biÉ^b j¼ðc1iÀc4j;c2iÀc3j;c3iÀc2j;c4iÀc1j;minðw i;w jÞÞ,Multiplication:^bi^b j¼ðc1iÂc1j;c2iÂc2j;c3iÂc3j;c4iÂc4j;minðw i;w jÞÞif c1i,c2i,c3i,c4i,c1j,c2j,c3j,c4j are all positive real numbers andDivision:^b iø^b j¼ðc1i=c4j;c2i=c3j;c3i=c2j;c4i=c4j;minðw i;w jÞÞif c1i,c2i,c3i,c4i,c1j,c2j,c3j,c4j are all non-zero posi-tive real numbers.5.Proposed methodologyThe novel approach proposed in this study can be summarized intofive stages as shown in Fig.1.AfterR.D.Koyee et al./Measurement58(2014)375–386379determination of MSQCI values for each alternative using described MADM approaches,the MSQCI values are con-verted into fuzzy numbers.The reason behind the conver-sion into fuzzy refers to the fact that none of MADM methods can be considered as the ‘super method’appropri-ate to all decision making situations.This implies that it is critical to select the most appropriate method to solve the problem under consideration,since the use of unsuitable method always leads to misleading decisions.Therefore,to avoid risking,a level of uncertainty in each computed MSQCI is accounted for,so that the decision maker is uncertain or partially certain based on the values of adopted membership function.The fuzzification process of crisp MSQCI values (CV)into fuzzy number MSQCI ða 1;a 2;a 3;a 4Þis governed by the following expressions:a 1¼ 1Àq 2CV a 2¼ 1Àq 4CV a 3¼ 1þq 4CV a 4¼ 1þq 2CV ð20ÞThe value of q which defines the degree of uncertaintyamong the crisp MSQCI ranks has to be assumed by deci-sion maker.Typical 10%value of q is supposed to give sat-isfactory results.Consider the generalized trapezoidal function shown in Fig.2,the centroids of the three planes are G 1,G 2and G 3respectively.These centroids are taken as the point of reference to define the ranking of generalized trapezoidal fuzzy numbers.The reason for selecting this point as a point of reference is that each centroid point rep-resents balancing points of each individual plane figure and the centroid of these centroid points i.e.G 0is a much more balancing point for a generalized trapezoidal fuzzy number.Thus,the ranking function of the generalized trapezoidal fuzzy number MSQCI (a 1,a 2,a 3,a 4)isexpressed in terms of its centroid (e R),mode and spread as follow:e R ðMSQCI Þ¼2a 1þ7a 2þ7a 3þ2a 4187V 18 ð21ÞMode ¼V2 ða 2þa 3Þð22ÞSpread ¼ðV Þða 4Àa 1Þð23ÞLeftspread ¼ðV Þða 2Àa 1Þð24ÞRight spread ¼ðV Þða 4Àa 3Þð25ÞUsing the above definitions,the ranking procedure of two generalized trapezoidal fuzzy numbers,say MSQCI i (a 1i ,a 2i ,a 3i ,a 4i )and MSQCI j (a 1j ,a 2j ,a 3j ,a 4j )as follow:Step 1:Find e R(MSQCI)i and e R (MSQCI)j :a.If e R(MSQCI)i >e R (MSQCI)j then (MSQCI)i outper-forms (MSQCI)j .b.If e R(MSQCI)i <e R (MSQCI)j then (MSQCI)j outperforms(MSQCI)i .Otherwise,comparisons are not possible and proceed to the next step.Step 2:Find Mode (MSQCI)i and Mode(MSQCI)j :a.If Mode (MSQCI)i >Mode(MSQCI)j then (MSQCI)ioutperforms (MSQCI)j .b.If Mode (MSQCI)i <Mode(MSQCI)j then (MSQCI)joutperforms (MSQCI)i .Otherwise,comparisons are not possible and proceed to the next step.Step 3:Find Spread (MSQCI)i and Spread (MSQCI)j :a.If Spread (MSQCI)i >Spread(MSQCI)j then (MSQCI)joutperforms (MSQCI)i .b.If Spread (MSQCI)i <Spread (MSQCI)j then (MSQCI)ioutperforms (MSQCI)j .Otherwise,comparisons are not possible and proceed to the nextstep.Fig.1.Framework of the research.58(2014)375–386。

7s管理知识30问 7S Management Knowledge 30 Questions. English Answer:1. What are the 7Ss of management?> Shared Values.> Strategy.> Structure.> Systems.> Staff.> Style.> Skills.2. How do the 7Ss interact with each other?> The 7Ss are interconnected and interdependent,forming a holistic view of an organization.3. What is the role of shared values in an organization?> Shared values guide the organization's behavior and decision-making.4. How does strategy influence the other 6Ss?> Strategy sets the direction for the organization and aligns the other 6Ss.5. What is the purpose of organizational structure?> Structure defines the relationships andresponsibilities within the organization.6. How do systems support organizational goals?> Systems provide the processes and procedures to achieve organizational objectives.7. What is the importance of staff in an organization?> Staff are the human resources that carry out the organization's activities.8. How does leadership style affect organizational performance?> Leadership style influences the way the organization is managed and employees are motivated.9. Why are skills essential for organizational success?> Skills enable the organization to execute its strategy and achieve its goals.10. How can the 7Ss be used to improve organizational performance?> By aligning and optimizing the 7Ss, organizations can enhance their effectiveness and efficiency.11. What are the benefits of using the 7S framework?> The 7S framework provides a comprehensive understanding of an organization and facilitates change management.12. How can organizations assess their 7Ss?> Organizations can use various tools and techniques to evaluate their 7Ss.13. What are some common challenges in implementing the 7Ss?> Challenges include resistance to change, lack of alignment, and resource constraints.14. How can organizations overcome challenges inimplementing the 7Ss?> Organizations can overcome challenges through communication, stakeholder involvement, and gradual implementation.15. What are the implications of the 7Ss for organizational culture?> The 7Ss shape and reflect the organization's culture.16. How can the 7Ss be used to diagnose organizational problems?> By examining the alignment and effectiveness of the7Ss, organizations can identify areas for improvement.17. What is the relationship between the 7Ss and organizational change?> The 7Ss provide a framework for understanding and managing organizational change.18. How can the 7Ss be used to create a sustainable organization?> By integrating environmental and social considerations into the 7Ss, organizations can promote sustainability.19. What are some best practices for implementing the 7Ss effectively?> Best practices include stakeholder involvement, continuous monitoring, and flexibility.20. How can organizations leverage technology to support the 7Ss?> Technology can enhance communication, collaboration, and data analysis for the 7Ss.21. What is the role of leadership in implementing the 7Ss?> Leadership plays a crucial role in communicating, facilitating, and sustaining the 7Ss.22. How can the 7Ss be used to promote innovation in an organization?> By fostering a culture of experimentation, risk-taking, and cross-functional collaboration, the 7Ss can support innovation.23. What are some ethical considerations in implementing the 7Ss?> Organizations must ensure that the 7Ss are implemented in an ethical and responsible manner.24. How can the 7Ss be used to build a learning organization?> By creating a culture of continuous learning, sharing, and knowledge management, the 7Ss can foster a learningorganization.25. What is the impact of globalization on the 7Ss?> Globalization influences the 7Ss by increasing interconnectedness, competition, and cultural diversity.26. How can organizations use the 7Ss to adapt to a rapidly changing environment?> By aligning the 7Ss with the external environment, organizations can enhance their adaptability.27. What are the key performance indicators for measuring the effectiveness of the 7Ss?> KPIs include employee satisfaction, customer satisfaction, financial performance, and innovation metrics.28. How can organizations create a balanced and aligned 7Ss?> By considering the interdependencies and trade-offs between the 7Ss, organizations can achieve balance and alignment.29. What is the future of the 7S framework?> The 7S framework continues to evolve and adapt to changes in the business landscape.30. How can organizations leverage the 7Ss to gain a competitive advantage?> By aligning and optimizing the 7Ss, organizations can differentiate themselves and enhance their competitiveness.中文回答：1. 7s管理知识包括哪些方面？> 战略（Strategy）。

智慧树知到《学术英语写作》章节测试答案第一章1、我不需要做研究，所以我不需要学习学术英语写作。

A:对B:错答案: 错2、做旅游攻略的过程，就是一个简单的research过程。

A:对B:错答案: 对3、et al就是and others的意思。

A:对B:错答案: 对4、下面哪些选项是学术英语写作的原因？A:To report on a piece of research the writer has conducted;B:To answer a question the writer has been given or chosen;C:To discuss a subject of common interest and give the writer’s view;D:To synthesize research done by others on a topic.答案: To report on a piece of research the writer has conducted;,To answer a question the writer has been given or chosen;,To discuss a subject of common interest and give the writer’s view;,To synthesize research done by others on a topic.5、学术英语写作中的一般文本特征包括：A:sentenceB:headingC:sub-titleD:paragraphE:titleF:phrase答案: sentence,heading ,sub-title,paragraph,title,phrase第二章1、在细化主题时，需要考虑你的写作目的是什么以及预期读者是谁。

A:对B:错答案: 对2、My Most Embarrassing Moment是一个可以写的论文题目。

Selfdiscipline is a crucial trait that can significantly impact ones personal and professional life.It is the ability to control ones emotions,thoughts,and actions in order to achieve a specific goal or adhere to a set of principles.Here are some key points to consider when discussing selfdiscipline in an English composition:1.Definition of SelfDiscipline:Begin by defining what selfdiscipline means.It is the power to control oneself and to resist immediate temptations in order to achieve longterm goals.2.Importance of SelfDiscipline:Explain why selfdiscipline is essential.It helps in achieving academic success,maintaining a healthy lifestyle,and building a strong work ethic.3.Benefits of SelfDiscipline:Improved Time Management:Selfdisciplined individuals are better at managing their time,leading to increased productivity.Enhanced Decision Making:It allows for more thoughtful and less impulsive decisions. Greater Achievement:Those who practice selfdiscipline are more likely to reach their goals and aspirations.4.Cultivating SelfDiscipline:Setting Clear Goals:Having specific,measurable,achievable,relevant,and timebound SMART goals can help in maintaining focus.Developing Routines:Establishing daily routines can create a sense of order and make it easier to stick to a plan.Practicing Mindfulness:Being aware of ones actions and decisions can help in making choices that align with ones goals.5.Overcoming Obstacles:Dealing with Procrastination:Identifying the reasons behind procrastination and finding ways to overcome it is a part of selfdiscipline.Handling Distractions:Learning to minimize distractions and stay focused on tasks is essential.6.Examples of SelfDiscipline:Successful People:Mention examples of successful individuals who are known for their selfdiscipline,such as successful entrepreneurs,athletes,or scholars.Historical Figures:Discuss how historical figures like Benjamin Franklin or Mahatma Gandhi exemplified selfdiscipline.7.Personal Stories:If applicable,share personal anecdotes that demonstrate the impact of selfdiscipline in ones life.8.Conclusion:Summarize the importance of selfdiscipline and encourage readers to develop this trait.Emphasize that while it may be challenging to start,the rewards of selfdiscipline are well worth the effort.9.Call to Action:End the essay with a call to action,urging readers to take steps towards becoming more selfdisciplined.Remember,when writing an essay on selfdiscipline,its important to use clear and concise language,provide relevant examples,and maintain a logical flow of ideas.This will help to engage the reader and convey the message effectively.。

UNIT 8 Principles of Biomedical EthicsTeaching ObjectivesAfter learning Unit 8, Ss are expected to accomplish the following objectives:To know the boundaries between medical research and practice To have a clear understanding of the moral principles and behavioral guidelines for the biomedical research and medical practice To understand the boundaries drawn between medical research and practice To know three basic ethical principles of research involving human subjects To learn the requirements when basic principles are properly applied in research To be more prepared for a life-or-death decision in medical practice To get more insights into the ethical justification of dilemmas in medical practice To know some building blocks in medical terminologyTo be familiar with expressions used to define key termsTo further develop awareness of formal and informal language To get familiar with the Cornell note-taking system To know the two approaches to medical decisions: traditional paternalistic mode and more recent collaborative modeTo learn how to develop a strong conclusion To know the format requirements of the reference listTo be able to make a reference list according to style requirements To be aware of the balance between medical authority and patients ’ autonomyProfessionalknowledgeReadingAcademic vocabulary anddiscourseViewingSpeakingWritingResearchingTeaching Activities and ResourcesPart 1 ReadingText ALead-inSuggested teaching plan1. To draw Ss’ attention and to raise their awareness of the importance ofbiomedical ethics, T is advised to relate the discussion of this unit to the real-world happenings.Before starting the class,search the media for the latest news reports,either at home or abroad,about controversial events in medicine community or healthcare settings.2. Start the class by doing Task / Lead-in and relate the content of the video clip toyour findings in the pre-class searching.Key to the task2) Death4) Patient rightsScriptWell,advancements in medical science have afforded us the opportunity to live decades longer than in previous generations.For every new possibility offered, we now face an equal number of challenges and we find ourselves confronting decisions that are unprecedented in human history.When does life begin?When should life end? How do we define death when we have the ability to keep people technically alive,or we should say,technologically alive long after their discrete body parts no longer function? Welcome to “Matter and Beyond . ” I’m your host MaryLynn Schiavi.In this program we’re going to explore issues around medical science that are forcing us to define life, death, quality of life, patient rights, and confront the moral and ethical questions that arise when facing critical healthcare decisions.3. Introduce the topic of Text A as a natural continuum of Lead-in .Text Comprehension1. Make good use of Lead-in video clip as it serves as a perfect introduction to thetopic of this unit. Elaborate on the connection of its content with the latest events in the real world. Naturally, ask Ss how medicine differs from other branches of natural science, especially when human subjects are involved in the research. Here are some hints:2. Analyze the text and lead Ss to discuss, integrating Task 2 / Critical reading andthinking / Text A into analysis and discussion. The presentation topics should be assigned to individual Ss for preparation at least one week in advance. Ask other Ss to preview the text with the guidance of presentation topics.3. Integrate Task 2 / Language building-up / Text A when a careful definition ofkey terms is covered.4. When analyzing the text, ask Ss to pay special attention to the sentences listed inLanguage focus below.5. If time allows, ask Ss to do Task 1 / Critical reading and thinking / Text A inabout five minutes. Check out the task by asking one or two Ss to read their answers. This is done to get an overview about the text.Language focus 1. … described in a formal protocol that sets forth an objective … (P185, Para.2)set forth 是动词词组，表示用清晰、具体的方式解释或描述，多用于正式的 书面语中。

making decisions英语作文Making decisions is a crucial part of our daily lives, as we are constantly faced with choices that can have a significant impact on our future. Whether it's deciding on what to eat for breakfast or choosing a career path, the decisions we make shape our lives in one way or another. In this essay, I will discuss the factors that influence decision-making and share some strategies for making better decisions.There are several factors that can influence our decision-making process. One of the most common factors is emotions. Emotions can cloud our judgment and lead us to make impulsive decisions that we may later regret. For example, making a decision out of anger or fear can often result in negative outcomes. Another factor that can influence decision-making is cognitive biases. These biases are mental shortcuts that our brains use to simplify the decision-making process, but they can often lead to errors in judgment. For example, confirmation bias is the tendency to search for information that confirms our preexisting beliefs, while ignoring evidence that contradicts them.In addition to emotions and cognitive biases, external factors can also influence our decision-making. These factors can include societal norms, peer pressure, and cultural influences. For example, we may feel pressured to make decisions that align with the expectations of our family or society, even if it goes against our own values or desires. Furthermore, the availability of information can also impact our decision-making process. Having access to accurate and relevant information is crucial for making informed decisions, but the abundance of information can also lead to decision paralysis.Despite the various factors that can influence decision-making, there are strategies that we can use to make better decisions. One important strategy is to take a step back and evaluate the situation from a rational perspective. This involves considering the potential outcomes of each decision and weighing the pros and cons. It can also be helpful to seek advice from others who may have a different perspective on the situation. Additionally, setting clear goals and priorities can help us make decisions that align with our values and long-term objectives.Another strategy for making better decisions is to practice mindfulness and self-awareness. By being aware of our own emotions, biases, and thought patterns, we can make more conscious decisions that are in line with our true desires. Mindfulness techniques, such as meditation anddeep breathing, can help us stay calm and focused whenfaced with difficult decisions. Additionally, taking the time to reflect on past decisions and learn from our mistakes can help us make better choices in the future.In conclusion, decision-making is a complex process that is influenced by a variety of factors. By understanding the factors that influence our decisions and implementing strategies for making better choices, we can navigate through life with greater clarity and confidence. Rememberto take the time to reflect, evaluate, and stay mindful throughout the decision-making process, and you will be better equipped to make decisions that are in alignmentwith your values and goals.做决定是我们日常生活中至关重要的一部分，因为我们经常面临着可能对我们未来产生重大影响的选择。