Course overview
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Process Failure Mode and Effects Analysis (PFMEA) is a methodology for identifying, assessing, and prioritizing potential risks introduced in a new or changed production process. Once the risks have been identified, the organization will manage a plan to minimize or eliminate the impact of negative events on the manufacturing/assembly processes.
Control Plans (CP) are documented descriptions of the system for controlling processes and the products they create. The intent of a CP is to control the design characteristics and the process variables to ensure product quality. The goal is to minimise process, and consequently, product variation.
This e-Learning course meets in full the PFMEA requirements of –
AS13100:2021 (Chapter B 16.5.10 plus Chapter C 21.4, 21.5 & 21.6)
RM13004:2021 document (Chapters 3, 4, 5, 6, 7 & 8)
AS9145:2016 (4.5.2, 4.5.3, 4.5.4, 4.5.5, 4.5.6, 4.5.7 & 4.5.8)
J1739:2021 (Chapters 4 & 6)
Both the RM13004 and J1739 ranking criteria for severity, occurrence and detection are included.
After completing this e-Learning course, participants will have learned from scratch how to understand and apply risk-based thinking and risk management to production process design and be able to undertake/facilitate PFMEAs.
a downloadable (pdf) Delegate Workbook is included
Associated ‘PFMEA tools’ are included to ensure that resulting PFMEAs are effective –
DfX approach
Bill of Material (BOM)
System hierarchy structure tree
Preliminary risk assessment matrix
PFMEA plan
Process Flow Diagram (PFD)
Characteristics matrix
PFMEA worksheet
(S), (O), (D) scoring criteria
Risk mitigation improvement strategies
This e-Learning course also addresses ‘Generic/Reference’ PFMEAs to ensure that organizational knowledge is systematically created and recorded as ‘reusable blocks’.
A combination of quizzes, tests, personal assignments and surveys are used to ensure understanding of the principles and practices involved.
Included are downloadable ‘templates’ (MS Excel & Word) to provide the basis of customizable documents/spreadsheets for immediate use.
The objective is to qualify practitioners who will be ‘subject experts’ able to lead cross-function teams to undertake effective PFMEA projects.
Course details
Concepts of risk management & the FMEA process
Definition of risk management
Risk management standards
Test: risk management standards
Risk management strategies
Generic FMEA process
Test: standards relating to PFMEA and/or DFMEA
The FMEA philosophy
Test: purpose of the FMEA philosophy/process_
Overview of the FMEA process
Purpose of the FMEA process
Types of FMEAs
Quiz: FMEA-related acronyms and terminology
Organizing an FMEA Team
FMEA staffing considerations
FMEA process owners
PFMEA cross-functional team
FMEA project time
FMEA training and competency
Test: PFMEA owners, team members, and their competency
FMEA timeline in the PDP/APQP cycle
Timeliness of FMEAs
Scheduling DFMEAs/PFMEAs
Test: FMEA timeliness and timing in the PDP/APQP cycle
Involvement of production in the product design process
The DfX approach
Understanding the ‘Xs’
Concurrent engineering (DfMA)
Test: DFA, DFM and DFMA features and differences
Reviewing the output of the design process
Design outputs
Part requirements, ballooning & DPD
Test: Design outputs and part requirements
GD&T, Ballooned drawings and Part marking
Geometric Dimensioning and Tolerancing
Ballooned drawings
Part marking
Quiz: GD&T, Ballooned drawings and Part marking
Key Characteristics, Critical items and Special requirements
Key Characteristics
Critical Items
Special requirements
Quiz: Key Characteristics, Critical items and Special requirements
Design of the production process
Steps in the design of the production process
(1) Product design review
(2) Material list (BOM)
(3) Sequence of operations
(4) Tool design
(5) Layout
(6) Control system
Test: steps in the design of the manufacturing process
The FMEA methodology
Generic FMEA Process Steps
Test: sequence of the generic FMEA Process Steps
FMEA project planning
Determine the scope of the project
Quiz: product/scope related terminology
Performing preliminary risk assessment
Personal assignment: customizing your own Preliminary Risk Assessment Matrix
Determining the types of FMEA required for the project
Quiz: Types of FMEA
Prioritizing Process FMEAs
Test: prioritization of Process FMEAs
Developing a PFMEA plan for project
PFMEA project preparation
Determining the PFMEA scope
Quiz: inclusions in the PFMEA scope
Process Flow Diagram
Definition of a Process Flow Diagram
Structure of a Process Flow Diagram
Creating a Process Flow Diagram
Identifying sources of variation
Personal assignment: customising your PFD from templates
Characteristic Matrix
Developing a Characteristic Matrix
Relationship between PFD and Characteristic Matrix
Confirming the "deliverables/outputs"
Test: characteristics of a PFD & Characteristics Matrix
Identifying/recording sources of variation
Searching for sources of variation
Identifying 'Special Requirements'
Commencing the search for potential failure modes
Test: elements of the PFD
Summary of PFD activities
Test: understanding Process Flow Diagrams & Characteristics Matrices
PFMEA analysis worksheet
PFMEA worksheet
PFMEAs analysis rules
The PFMEA 'sections'
Personal assignment: download PFMEA worksheet & customize
Sequence of the PFMEA analysis
Analysis sequence
Test: sequence of PFMEA steps/activities
PFMEA risk analysis/assessment activities
(1) Step
Personal assignment: creating examples of verb-adverb-noun thought starters
Quiz: process step/function/requirement/classification terminology
(2) Potential Failure Mode(s)
Test: identifying correctly worded failure modes
(3) Potential Effect(s) of Failure
Test: identifying correctly worded failure effects
(4) Severity (S)
Test: selecting the appropriate severity 'ranking'
(5) Potential Cause(s) of Failure
Quiz: identifying the three ‘levels’ of potential causes
(6) Occurrence (O)
Personal assignment: downloading occurrence evaluation criteria – PFMEA
Test: selecting the appropriate occurrence 'ranking'
(7) Current process controls
(8) Prevention/Detection (D)
Personal assignment: downloading detection evaluation criteria – PFMEA
Test: selecting the appropriate detection ‘ranking’
Tips on selecting the correct (S), (O) & (D) rankings
(9) Risk evaluation (RPN)
Test: calculating RPNs
(10) Prioritize actions
Alternatives to basic RPN prioritization
Test: prioritizing sequence for action using “S~O~D” values
Deploying action plans
Test: prioritizing action plans
Systematizing, delegating and deploying improvement strategies
Systematizing action plans
Delegating responsibility for action plans
Reducing severity (S)
Reducing occurrence (O)
Reducing detection (D)
Quiz: (S), (O), & (D) improvement strategies
Rescoring the RPN and controlling PFMEA documents
Rescoring RPN and implementing new working practices
Revision control of PFMEA documents
Test: PFMEA concepts, data and terminology
Control Plan (CP)
Overview of the control plan
Control plan prerequisites
CP and the PDP/APQP cycle
Quiz: CP and the PDP/APQP cycle
Control plan template and elements
Control Plan template
Personal assignment: downloading & customising a CP template
Explanation of the control plan elements
Control methods
Quiz: typical control methods
Reaction plan
Survey: Reaction plan survey
Revision control of CP
Generic/Reference/Baseline PFMEAs
Building an organization 'knowledge database'
DFMEA-to-PFMEA linkages
Quiz: DFMEA inputs & DFMEA-PFMEA links
Cost savings and benefits of PFMEA
Cost reasons for early deployment of PFMEAs
Benefits of PFMEAs
Survey: identifying the benefits of PFMEAs
Qualifications & benefits
The objective is to qualify practitioners who will be ‘subject experts’ able to create Process Flow Diagrams (PFDs), undertake effective Process Failure Mode and Effects Analysis (PFMEA) and develop Control Plans (CPs).
Having completed this e-Learning course, individuals will be empowered to facilitate value-adding PFMEA projects that will form part of new product introduction (APQP & PPAP) standard AS9145.