MCT Planning and preparation

1. Examples of outputs from planning and preparation:

• The scope defined
• The objectives set
• The deadline determined
• The list of team members
• Product (process) structure defined

2. FMEA is performed in cases such as:

• Quality problem in production
• New product
• Product improvement
• New regulatory requirements
• Process failure that can lead to hazards

3. Examples of questions to ask yourself before starting a FMEA:

• Why do this FMEA?
• What are the customer's wishes and needs?
• Who will be on the team?
• When to start the FMEA?
• What are the objectives to be achieved?

4. Examples of planning and preparation objectives:

• Identify the project
• Define the scope
• Obtain a global view of the FMEA scope
• Prioritize systems
• Prioritize functions

5. Examples of documents required to start a FMEA:

• The flow diagram
• The control plan
• Regulatory standards
• Capability studies
• The functional specifications
• Similar FMEAs