Prima Strategies

"We work with organizations to achieve operational and process excellence"

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

2 Days

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