Programme overview
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.
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.
Programme 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
Programme 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.
This e-Learning course has identical content to TEC’s face-to-face course which has been formally approved by PROBITAS Authentication on behalf of the AESQ.