QA within the development process QG, Design Reviews & FMEA Flashcards
Project management
Milestones with results (quality gates)
Milestones are no tasks!
They mark the beginning and the end of a process or a task!
Types of milestones:
• Decision milestones (management)
• Quality milestones (save intermediate results)
• Payment milestones (release funds)
• Contract milestones (ensure time schedule)
Milestones allow the formation of phases and the control of:
• required intermediate results
• time requirements
• financial requirements
• forecasting
• progress
Quality Gates Definition
Quality Gates are clearly defined checkpoints between Product Life Cycle (PLC) phases. They describe dates and contents (quantitative & qualitative).
Quality Gates check the performance, targets in terms of quality and completeness agreed on by suppliers and customers.
Quality Gates support the assessment of the work progress and make it transparent
so that decisions (e.g. “STOP”, “CONTINUE” or “MODIFY” the project) can be made.
Design Review
Definition
DR = formal and systematic review of the current development status
(… it is the so-called evaluation of the design process)
Purpose:
• to detect problems and difficulties which have an effect on the use and usage
conditions of the product.
• Furthermore, corrective actions will be defined and started to eliminate
failures and risks in the development phase.
Methods like QFD, FMEA shall be used in addition!
To define before DR - project leader, team members, schedule - research objects - cost & effort estimation - distribution of tasks
To provide during DR
- current situation
- checklists
- design evaluation
- actions, responsibilities
- deadlines, etc.
To ensure after DR
- action monitoring
- check status
- documentation
Design Review Targets
- the product meets the specified requirements incl. cost targets
- plan to demonstrate the required performance and cost optimisation
- draft of the interface requirements
- recommendation to improve the development process
- check of the completeness of development documents
- ensure that performance and load limit of the components are not exceeded
- consideration of previous recommendations
- guarantee the rapid and safe removal (recycling)
Methods of Quality Engineering
QFD – customer requirements vs. quality characteristics of products or services
FMEA – risk analysis with regard to the fulfilment of requirements
DOE (Design of Experiment) – optimisation of products und processes by systematic experimentation
SPC (Statistical Process Control) – regulation and improvement of processes by statistical models and methods
Failure Mode and Effect Analysis
(FMEA) - Basics
• FMEA = structured tool for identifying, analysing, handling and avoiding of risks.
• There can be risks in products, services, in their development, production or allocation.
• The basic idea of the FMEA is the prevention of errors in an early Product Life Cycle (PLC)
phase.
FMEA
Management within the product lifecycle
Phases of the Product Life Cycle (PLC) vs failure rate
Definition, Development, Production planning, Fabrication, Testing, Usage
FMEA Essentials
- Content: risk analysis of products, processes, systems, etc.
- Starting point: a product, a process, a system but also a function
- Error definition: failure (negative effect, no function or malfunction, etc.)
Start FMEA -> Analysis of the product’s/process’/system’s function(s) etc. -> Result FMEA (Cause of the failure, Prevention and inspection activities (existing tasks of failure prevention and discovery), Consequences
of the failure)
The FMEA-Model & Project Targets
FMEA-Model => linking the possible failure with its causes and its effects.
Targets of the FMEA Project: • Preventive recognition of relations between potential failures, causes and consequences. • Prioritising cause-effect chains with regards to their risks. • Preventive introduction of actions for improvement of high risk cause-effect chains.
Timeline:
Cause of the failure -> Failure -> Effects of the failure
FMEA – Failure Mode Effects & Criticality Analysis (FME&CA)
The FME&CA consist of two main directions of analysis:
• Failure Mode and Effect Analysis (FMEA)
• Criticality Analysis (CA) to evaluate the occurrence frequency of identified
failures.
Definition (according to QS-9000)
The FMEA is a systematic sequence of activities with the following propositions:
- potential failure of a product/process and its consequences to be identified and evaluated,
- displaying of all activities that can prevent and/or can reduce the occurrence of possible failure and
- the documentation of this procedures.
Trigger for a FMEA Project
Process change, new product, new process, product change, system change, intro to a new system
Types of FMEA
Product-FMEA (also called Design- or Development-FMEA)
• risk management for all products or for individual
modules or components of a product.
Process-FMEA
• risk management for production & assembly processes,
logistics or business processes in general.
• 4Ms ( ……………………………………. ) => starting point for possible failure!
System-FMEA
• risk management for complex systems,
• interaction of the individual system elements with each other,
• analysis of important functional relationships of the system elements.
• Application: Systems Engineering, Product and Process Development.
FMEA Bottom-Up
- What is the effect, if
the function of the
component failed? - What is the effect, if the
function of the module
failed? - What is the effect to the whole
system, if the whole unit failed?
FMEA The Procedure
• To create an FMEA a specialised team of experts (optimal 4 to 6 people) is
needed.
• A moderator takes over the management of the team, brings together the
individual results and documents of the overall results.
• Using an FMEA official form the team answers the following questions:
- where can failure occur?
- How would the failure show and how does the problem occur?
- Why can the failure or its consequence occur?
• After that, the team specifies activities in order to:
- avoid the causes of failures,
- reduce the probability of the occurrence of the failure,
- reduce the significance of the failure.
• Finally, the success of the activities carried out are evaluated.
