Step 1 in the standardized FMEA method description:
Summary: Planning and preparation
Planning and preparation of FMEA is the first of the seven steps in the standardized FMEA method description. The results are the basis of the analytical work. In practice, this means that in the planning and preparation phase of an FMEA, the FMEA approaches required are identified, including the definition of their respective objectives and scope. In addition, the scope of observation of the system boundaries is defined in this first step, along with the systems, subsystems and components included. The planning and preparation in accordance with the FMEA handbook (step 1), together with the structural analysis (step 2) and the functional analysis (step 3), constitute the system analysis in the standardized FMEA method description.
- Definition of the specific FMEA project
- Planning of the specific FMEA
- Specification of the system boundaries/scope of observation of the FMEA
- Identification of existing base FMEAs and “lessons learned”
- Documentation of a basis for the second step, the structural analysis of the FMEA
Detailed knowledge: Planning and preparation in the FMEA method description
Project identification and system boundaries
As precise a definition as possible of the project in the planning and preparation of the FMEA is so important because it allows a clear delimitation of the scope of the analysis. In this 1st step of the standardized FMEA method description it is first necessary to identify and define the scope of the areas to be analyzed. It is necessary to make decisions in this context, the results of which indicate the sort of FMEA required for the customer’s development program. Moreover, it may be equally important in the planning and preparation step for the FMEA to define the areas that are not to be analyzed and thereby to describe the system boundaries.
Planning and preparation of the FMEA: Delimiting the scope of observation
Answering the following questions can be very helpful in setting out the scope of observation in the context of planning and preparation for the FMEA:
- What deliveries are involved?
- Are there negative answers to the questions about familiarity with and comparability of the project and what emerged from similar FMEAs?
- In which areas does our company have design responsibility?
- In which areas does our company have the responsibility of a system integrator?
- For which interfaces is our company responsible/partly responsible?
- Safety objectives of the system
- Normative, official and statutory requirements
- Requirement specifications with functions and requirements of the system
- Customer expectations
- Block diagrams of the system to be developed
- Solution ideas / conceptual solutions
- Technical documentation for existing and comparable systems
- Complexity of design
- Safety of persons and systems
- Level of innovation of new technology
Planning and preparation of the FMEA: Implementation plan
The detailed description of the project plan is also followed by definition of the implementation plan, also as part of the planning and preparation for the FMEA. This helps to begin and conclude the FMEA on time in the process of development. The individual measures and requirements of the 7 steps in the standardized FMEA method description are set out in both the project plan and the implementation plan.
In the planning and preparation of the FMEA, it is necessary to know what information the team of experts from the various disciplines involved in the process already has. For example, is there a base FMEA for products and developments from the same product group in the company that has previously been used successfully? Can you therefore make use of standardized product boundaries and corresponding functions of an FMEA that have already been defined and build on them? If these are not available, ideally they will be developed and defined in the planning and preparation of the FMEA as the first step in the standardized FMEA method description.