FMEA Sessions
Path 1 Development (Failure Modes - Criticality)
Path 2 Development (Causes & Occurrences - Significance)
Path 3 Development (Testing & DV Development - Annoyance)
FMEA Actions
FMEA Systems, Subsystems, Component
FMEA Adjacent Systems
FMEA Partition Ascention and Descention
FMEA Sessions
FMEAs without FMEA Facilitation are often described as tedious, boring, and sluggish. The total time to complete the task considering team time and number of development hours is many times longer than
experienced with a skilled Quality-One facilitator. Our FMEA Facilitation puts those experts to work for you.
FMEA Facilitation is efficient. Organizations rarely measure the total cost and time impact of a poorly executed FMEA. But considering the limited time engineers and technical personnel have when involved
in product or process development activities, it is wise to consider this option.
Our customers report a greater than 70% reduction in development time and therefore their resources are utilized more effectively on the actual design work. The results of the facilitated FMEAs are measured in
mitigation actions on risk discovered during the event and not on Risk Priority Number (RPN) thresholds.
Benefits of FMEA Facilitation
Overall, a Failure Mode and Effects Analysis will help decrease the likelihood of failures and the negative outcomes that result. FMEA Facilitation allows you to do so without expending extra time and money
with in-house resources. The typical benefits that a customer experiences are:
- Greater than 70% reduction in time (resources better utilized)
- Structured Methodology which is more process oriented vs. brainstorming
- FMEA Actions directed at three points in the process based on the Quality-One Three-Path Model and little to no emphasis on the RPN
- Earlier determination of need for Actions
- Less subjective discussion time on items with small risk
- Cross Functional Team (CFT) size is modulated and changed, respecting the valuable time of the development team
- Responsible engineer receives an output which can immediately be used in design activity impacting performance and safety
Design FMEA
Design FMEA (DFMEA) explores the possibility of product malfunctions, reduced product life, and safety and regulatory concerns derived from:
- Material Properties
- Geometry
- Tolerances
- Interfaces with other components and/or systems
- Engineering Noise: environments, user profile, degradation, systems interactions
Process FMEA
Process FMEA (PFMEA) discovers failure that impacts product quality, reduced reliability of the process, customer dissatisfaction, and safety or environmental hazards derived from:
- Human Factors
- Methods followed while processing
- Materials used
- Machines utilized
- Measurement systems impact on acceptance
- Environment Factors on process performance
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Path 1 Development (Failure Modes - Criticality)
Path 1 begins once all prework is completed.
Path 1 consists of inserting the functions, failure modes, effects of failure and Severity rankings. The pre-work documents assist in this task by taking information previously captured to populate the
first few columns (depending on the worksheet selected) of the FMEA.
Functions should be written in verb-noun context. Each function must have an associated measurable. Functions may include:
- Wants, needs and desires translated
- Specifications of a design
- Government regulations
- Program-specific requirements
- Characteristics of product to be analyzed
- Desired process outputs
Failure Modes are written as anti-functions or anti-requirements in five potential ways:
- Full function failure
- Partial / degraded function failure
- Intermittent function failure
- Over function failure
- Unintended function failure
Effects are the results of failure, where each individual effect is given a Severity ranking. Actions are considered at this stage if the Severity is 9 or 10.
Recommended Actions may be considered that impact the product or process design addressing Failure Modes on High Severity Rankings (Safety and Regulatory)
Please click for assistance on FMEA Path 1 Faciliation within your organisation.
Path 2 Development (Causes & Occurrences - Significance)
Causes are selected from the design / process inputs or past failures and placed in the Cause column when applicable to a specific failure mode. The columns completed in Path 2 are:
- Potential Causes / Mechanisms of Failure
- Current Prevention Controls (i.e. standard work, previously successful designs, etc.)
- Occurrence Rankings for each cause
- Classification of Special Characteristics, if indicated
- Actions are developed to address high risk Severity and Occurrence combinations, defined in the Quality-One Criticality Matrix
Please click for assistance on FMEA Path 2 Faciliation within your organisation.
Path 3 Development (Testing & DV Development - Annoyance)
Path 3 Development involves the addition of Detection Controls that verify that the design meets requirements (for Design FMEA) or cause and/or failure mode, if undetected, may reach a customer
(for Process FMEA).
The columns completed in Path 3 are:
- Detection Controls
- Detection Ranking
- Actions are determined to improve the controls if they are insufficient to the Risks determined in Paths 1 and 2. Recommended Actions should address weakness in the testing and/or control strategy.
- Review and updates of the Design Verification Plan and Report (DVP&R) or Control Plans are also possible outcomes of Path 3.
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Actions
Action Priority & Assignment
The Actions that were previously determined in Paths 1, 2 or 3 are assigned a Risk Priority Number (RPN) for action follow-up.
RPN is calculated by multiplying the Severity, Occurrence and Detection Rankings for each potential failure / effect, cause and control combination. Actions should not be determined based on an RPN threshold
value. This is done commonly and is a practice that leads to poor team behavior. The columns completed are:
- Review Recommended Actions and assign RPN for additional follow-up
- Assign Actions to appropriate personnel
- Assign action due dates
Actions Taken / Design Review
FMEA Actions are closed when counter measures have been taken and are successful at reducing risk. The purpose of an FMEA is to discover and mitigate risk. FMEAs which do not find risk are considered to be
weak and non-value added. Effort of the team did not produce improvement and therefore time was wasted in the analysis.
Please click for assistance on FMEA Actions Faciliation within your organisation.
Systems, Subsystems, Component
In general product FMEA development there are three levels of FMEA. System, Sub System and Component. For structured FMEA to occur a link between these levels via the effect of failure, the failure mode and the cause
of failure is required for identification of key component level special characteristics to passed to the PFMEA from the DFMEA. This occurs by the flow of data from the higher level cause indicating the failure mode in
the FMEA of the level below.
This flow of data needs to be followed robustly through the levels of FMEA within the product.
Please click for assistance on FMEA Systems, Subsystems, Component Faciliation within your organisation.
Adjacent Systems
Effect on ajacent systems should be taken into account via the boundary diagram and failure modes from the designated responsible system or component. This should be analysed in pathway 1. The Boundary and Parameter
in FMEA prework will also be a potential input for functions of the responsible system or component as it must be able accept the required interface to function correctly.
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Partition Ascention and Descention
Partition Ascention and Descention, Systems V Engineering or Structure Analysis is the view of robustness throughout the product and the FMEA levels and systems. Through criticality it should be determined the FMEA items
that should be prioritised in analysing and manufacturing the product through product, system, subsystem and component levels.
Please click for assistance on FMEA Partition Structure Analysis Faciliation within your organisation.