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Process Failure Mode and Effects Analysis
(Process FMEA) Aligned to AS 13004
Process Failure Mode and Effects Analysis (PFMEA) is an analysis of risk, applying conventional FMEA methodology to processes in any organization. The primary purpose of FMEA is to prevent potential failure modes from occurring through the effective use of preventive controls. Process failure modes can lead to safety risks, customer complaints, unplanned operation downtime, reduced output etc. Documenting the FMEA with the use of robustness linkages will help identify the adequacy of existing controls associated with a potential process/operation failure. Finally, improved preventive controls can be recommended to eliminate or mitigate the risks associated with potential failure modes to new and existing processes. AS13004 standard was created to establish a common practice for effective process risk identification, assessment, mitigation and prevention. This standard was defined for the aerospace engine supplier quality sector where stringent quality requirements and advance manufacturing processes and technologies are inherent to the complexity and criticality of the components involved. However, the principles remain identical across all industries and this standard may be equally applied in other segments of the aviation, space & defense industries. It defines a methodology to mitigate risk using Process Flow Diagrams (PFDs), Process Failure Mode and Effects Analysis (PFMEA) and Control Plans. It is to be used by organizations throughout the life cycle of a product. Participants will demonstrate, through team activities and presentations how to develop and document the FMEA, evaluate the adequacy of proposed controls and mitigate potential risks through appropriate recommended actions to prevent failures from reaching the customers and ultimately improving customer satisfaction by making FMEA a key process prevention and improvement tool. The content of this course includes FMEA best practices aligned to the requirements of AS13004.
The course will use relevant process examples to facilitate learning and transfer of knowledge. Participants should be able to effectively deploy the use of FMEA upon completion of this course. At the end of this training, participants will be able to:
Apply the FMEA process to identify potential process failures for new or changed process
Assess risk associated with each process/operation step
Recommend preventive controls to assist with eliminating or significantly reducing theoccurrence/re-occurrence of internal and external customer complaints
Substantiate the completed FMEA through the use of robustness linkages for Process FMEAand alternative analyses such as identification, assessment, mitigation and prevention of risk inthe manufacturing process through the application of Process Flow Diagrams (PFDs),and linkthe controls to the Control Plans throughout the life cycle of a product
Develop, document and review FMEAs and its linkages (linkages between PFD – PFMEA –Control Plan) at appropriate stages of a process lifecycle
Apply the FMEA document on-the-job.
This course is recommended for personnel responsible to develop and deploy FMEA aligned to AS13004requirements