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1、Process FMEA IntroductionThese are extracts from POTENTIAL FMEA REFERENCE MANUAL.Philips Electronic Components(Shanghai)Co.,Ltd.AVOverviewThis manual introduces the topic potential Failure Mode and Effects Analysis(FMEA).An FMEA can be described as a systemized group of activities intended to:1.Reco
2、gnize and evaluate the potential failure of a product/process and its effects,2.Identify actions which could eliminate or reduce the chance of the potential failure occurring,and3.Document the process.It is complementary to the design process of defining positively what a design must do to satisfy t
3、he customer.1.rePhilips Electronic Components(Shanghai)Co.,Ltd.AVHistoryAlthough engineers have always performed an FMEA type of analysis on their designs and manufacturing processes,the first formal application of the PMEA discipline was an innovation of the aerospace industry in the mid-1960s.Phil
4、ips Electronic Components(Shanghai)Co.,Ltd.AVFMEA Implementation 1Because of a companys commitment to continually improve its products whenever possible,the need for using the FMEA as a disciplined technique to identify and help eliminate potential concern is as important as ever.Although responsibi
5、lity for the“preparation”of the FMEA must,of necessity,be assigned to an individual,FMEA input should be a team effort.A team of knowledgeable individuals should be assembled;e.g.,engineers with expertise in Design,Manufacturing,Assembly,Service,Quality,and Reliability.Philips Electronic Components(
6、Shanghai)Co.,Ltd.AVFMEA Implementation 2One of the most important factors for the successful implementation of an FMEA program is timeliness.It is meant to be a“before-the-event”action,not an“after-the-fact”exercise.To achieve the greatest value,the FMEA must be done before a design or process failu
7、re mode has been unknowingly designed into the product.Up front time spent in doing a comprehensive FMEA well,when product/process changed can be most easily and inexpensively implemented,will alleviate late change crises.An FMEA can reduce or eliminate the chance of implementing a corrective change
8、 which could create an even larger concern.Properly applied,it is an interactive process which is never ending.Philips Electronic Components(Shanghai)Co.,Ltd.AVWhats Process FMEA?A Process potential FMEA is an analytical technique utilized by a Manufacturing Responsible Engineer/Team as a means to a
9、ssure that,to the extent possible,potential failure modes and their associated cause/mechanisms have been considered and addressed.In its most rigorous form,an FMEA is a summary of the engineers/teams thoughts(including an analysis of items that could go wrong based on experience and past concerns)a
10、s a process is developed.This systematic approach parallels and formalizes the mental discipline that an engineer normally goes through in any manufacturing planning process.Philips Electronic Components(Shanghai)Co.,Ltd.AVThe Process potential FMEA Identifies potential product related process failu
11、re modes.Assesses the potential customer effects of the failures.Identifies the potential manufacturing or assembly process causes and identifies process variables on which to focus controls for occurrence reduction or detection of the failure conditions.Develops a ranked list of potential failure m
12、odes,thus establishing a priority system for corrective action considerations.Documents the results of the manufacturing or assembly process.Philips Electronic Components(Shanghai)Co.,Ltd.AVCustomer DefinedThe definition of“CUSTOMER”for a Process potential FMEA should normally be seen as the“END USE
13、R”.However,customer can also be a subsequent or downstream manufacturing or assembly operation,as well as a service operation.When fully implemented,the FMEA discipline requires a Process FMEA for all new parts/processes,changed parts/processes,and carryover parts/processes in new applications or en
14、vironments.It is initiated by an engineer from the responsible process engineering department.Philips Electronic Components(Shanghai)Co.,Ltd.AVTeam Effort 1During the initial Process potential FMEA process the responsible engineer is expected to directly and actively involve representatives from all
15、 affected areas.These areas should include,but are not limited to,design,assembly,manufacturing,materials,quality,service and suppliers,as well as the area responsible for the next assembly.The FMEA should be a catalyst to stimulate the interchange of ideas between the functions effected and thus pr
16、omote a team approach.Philips Electronic Components(Shanghai)Co.,Ltd.AVTeam Effort 2The Process FMEA is a living document and should be initiated before or at the feasibility stage,prior to tooling for production,and take into account all manufacturing operations,from individual components to assemb
17、lies.Early review and analysis of new or revised processes concerns during the manufacturing planning stages of a new model or component program.Philips Electronic Components(Shanghai)Co.,Ltd.AVTeam Effort 3The process FMEA assumes the product as designed will meet the design intent.Potential failur
18、es which can occur because of a design weakness need not,but may be included in a Process FMEA.Their effect and avoidance is covered by the Design FMEA.The Process FMEA does not rely on product design changes to overcome weaknesses in the process,but does take into consideration a products design ch
19、aracteristics relative to the planned manufacturing or assembly process to assure that,to the extent possible,the resultant product meets customer needs and expectations.Philips Electronic Components(Shanghai)Co.,Ltd.AVTeam Effort 4The FMEA discipline will also assist in developing new machines or e
20、quipment.The methodology is the same,however,the machine or equipment being designed is considered the product.When potential failure modes are identified,corrective action can be initiated to eliminate them or continuously reduce their potential for occurrence.Philips Electronic Components(Shanghai
21、)Co.,Ltd.AVDevelopment of a Process FMEAA process FMEA should begin with a flow chart/risk assessment of the general process.This flow chart should identify the product/process characteristics associated with each operation.Identification of some product effects from the corresponding Design FMEA,sh
22、ould be included,if available.Copies of the flow chart/risk assessment used in FMEA preparation should accompany the FMEA.In order to facilitate documentation of analysis of potential failures and their consequences a process FMEA form was developed,refer PFMEA form.xls.Philips Electronic Components
23、(Shanghai)Co.,Ltd.AVRecommended Action(s)The need for taking specific,positive corrective actions with quantifiable benefits,recommending actions to other activities and following-up all recommendations cannot be overemphasized.A thoroughly though out and well developed Process FMEA will be of limit
24、ed value without positive and effective corrective actions.It is the responsibility of all affected activities to implement effective follow-up programs to address all recommendations.Philips Electronic Components(Shanghai)Co.,Ltd.AVFollow-upThe responsible engineer is responsible for assuring that all actions recommended have been implemented or adequately addressed.The FMEA is a living document and should always reflect the latest design level,as well as the latest relevant actions,including those occurring after the start of production.Philips Electronic Components(Shanghai)Co.,Ltd.AV