94 7 Project Quality Management
Early Problem Detector Prototyping (EPDP) exploits prototypes to identify the
problems and defects of a given design as soon as possible. The prototypes may
be similar to the end product or only perform some functions, each of which must be
tested separately.
Prototyping, when not rapid/virtual, requires pilot runs and can be carried out
while the previous product is being manufactured, to then gradually extend to the
other stages of production (step-by-step prototyping).
It is important to detect problems as soon as possible, because the cost of change
increases exponentially as product development advances; for this reason, it is
advisable to prepare a wide range of solutions during the first stages of design,
which should be then screened, to narrow down the options. This procedure is like
a funnel, and the wider it is at the top and the sooner it becomes narrow, the less it
will cost to revise the project.
A dilemma thus arises: whether to make a decision that will have a fundamental
impact on the performances of the product/plant at an early stage, relying on uncer-
tain and incomplete data, or postpone the choice, awaiting more detailed informa-
tion and clearer opportunities.
FMEA, also known as Failure Mode Effect and Criticality Analysis (FMECA),
is a technique used to assess the reliability of a product. It was first defined by the
US Army to determine equipment failures and their consequences on the system
(military procedure MIL-P-1629 dated 11 September 1949). FMEA, comprising
both a product FMEA and a process FMEA, became the standard method (and pro-
cedure) applied in the field of Advanced Product Quality Planning (APQP), in
compliance with TS16949 norms.
The importance of reliability as an intrinsic performance of the product (together
with its features and functionality) requires great care during the stages of design,
where possible causes of product failure must be identified, studied and eliminated.
FMEA considers the possible types of failure (of the whole product, and due to
faults arising from wear, incorrect handling, etc.), their effects and causes, verifying
whether they can be ascribed to the materials used or the manufacturing processes.
Both product and process FMEA follow the procedure described in Fig. 7.12.
The starting point is the identification of the functions, i.e. the intended scope of the
product or the process, which must be analysed; the following step consists in the
identification of failure modes and their effects, their severity being ranked on a
scale from 1 to 10 (the latter value being the most severe, i.e. that in which the life
of the person – either the user or the process operator – may suddenly be in
jeopardy).
After identifying possible causes of failure and analysing their potential conse-
quences, it is necessary to calculate the likelihood of failure occurrence, once again
on a scale from 1 to 10 (1 being a fault occurring with a probability lower than
1/1,500,000 and 10 with a probability greater than ½).
When its criticality, namely the severity of failure multiplied by the likelihood
of its occurrence, has been determined, it is time to define the tests to be carried out
both on the product and on the process. There are three types of test: (1) type 1, to
avoid the occurrence of a failure cause or mode, thus reducing the likelihood of