PRODUCT SAFETY

A NEW PLC MODEL TO INTEGRATE

SAFETY CONCERNS
Joseph Antony Reneesh
M.Tech Industrial Engineering

ABSTRACT
Product Safety
A new Model to integrate Safety concerns
Safety has now become one of the major criteria in the
selection of products. Many of the products available on the
market are said to have high level of safety. Still products cause
harm to humans, environment and assets.
This article describes a new product life cycle model that
can be used by producers to improve safety and to prevent
defective products from being placed on market. The model was
proposed by Murthy et al (2008). The model comprises of 8
phases, and this articles describes and discusses the required
safety related issues in each phase. The article is based on
European Product Safety Legislation, but the topic is generic and
is applicable for a much larger geographical audience.

Proposed New Model of PLC

INTRODUCTION
Every day, we are in contact with a high number of products
(e.g., cellular phones, computers, cars), and our lives and our
perceived well-being depend on the functions and properties of
these products. In developed countries, most products placed on
the market generally have a high level of safety, but still some
products cause harm to humans, the environment, and/or
financial assets. This lack of safety is sometimes explained by (i)
the increasing complexity of many products, (ii) the time- and
cost pressure during product development caused by the fierce
competition, (iii) new technology being put on the market before
all features are known, (iv) designers and/or producers who cut
corners to save time or money, or because of lack of knowledge,
(v) products being used in other ways and for other purposes
than anticipated, and so forth.
Most producers are striving to increase the safety of their
products to enhance their competitive power, reduce warranty
cost, and prevent liability claims and product recalls. It may be
relevant to ask why producers still have problems making
products safe. Unfortunately, there is no simple answer to this
question. Hasan et al. (2003) classify literature, studies and
research work on product design into the categories; design
methods, design approaches, process and models, design
paradigms and reasoning, and product sizing and representation.
They claim that safety is hardly included in any of these
categories, and that there is no commonly used method for
integrating safety into the design process. However, standards,
like ISO 12100-1, ISO 14121-1, ISO/TR 14121-2 are made to give
guidance on achieving the essential requirements to health and
safety in European legislation. Product development models and
methods are described in several textbooks, e.g., Roozenburg and
Eekels (1995), Murthy et al. (2008), Eder and Hosnedl (2008).
The main objective of this article is to address this question
by describing a new model that contributes to efficient product

safety performance, specification, and decision making. The

model is developed to assist producers in accomplishing the
desired product performance, which means that safety aspects
are considered for the whole life cycle of the product; from
conception to final disposal. The structure of the model is
proposed by Murthy et al. (2008), and the model consists of three
stages (pre-development, development, and post-development),
three levels (business, product, and component), and eight
phases.
The article is biased towards European law and practices, but
the proposed model is generic and should be of interest for a
much larger geographical audience. The main part of the article
discusses how safe design evolves in the new product life cycle
model. Regarding the term product, we focus on physical
consumer and industrial products and mainly on their
consequences to human health.

What is product safety?

The term product safety consists of two parts: product and
safety. According to Roozenburg and Eekels (1995), products are
artifacts conceived, produced, transacted and used by people
because of their properties and the functions they may perform.
Products may be divided into tangible (physical) and intangible
(e.g., software), non-durables (e. g., food) and durables (e.g.,
cellular phone), commercial/industrial (e.g., cranes) and
specialized products (e.g., military vessels). Many products may
also be considered as systems.
Safety is a term with many different definitions. Safety can
be defined as freedom from those conditions that can cause
death, injury, occupational illness, damage to or loss of equipment
or property, or damage to the environment. According to the EU
general product safety directive (GPSD, 2001), absolute safety is

not attainable, and safety is therefore a relative term that implies

a level of risk that is both perceived and accepted.

Product safety requirements

Producers are expected to take reasonable care regarding
the safety performance of their products, which means that
products have to fulfill the requirements without being too costly
to produce. The product properties are addressed through the
product development process, when the requirements to the
product are worked out and specified. Safety requirements are
dependent on the type and application of the product, and may be
qualitative and/or quantitative. Product safety requirements are
mainly given in laws, regulations, and standards, or stated by the
customers of specialized products, or come from consumer
organizations or customer interest groups (Murthy et al., 2008).
The increasing focus on a products reliability and safety
aspects has resulted in several laws, regulations, and standards.
In 1985, the European product legislation was radically changed
by the new approach method. By this approach, the essential
requirements to health and safety of products are specified in
Directives, while the European standardization bodies, CEN,
CENELEC, and ETSI, are responsible for making the
corresponding technical specifications to meet these essential
requirements. Standards that are linked to directives in this way
are referred to as harmonized standards.
The General Product Safety Directive
The general product safety directive The EU general product
safety directive (GPSD, 2001) requires producers to place only
safe products on the market, and to inform about any residual
risk. The aim is to ensure that consumer products do not present
any unacceptable risk under normal use or reasonably foreseen
conditions of use. The directive is limited to risk to humans and
covers new, used, and reconditioned products intended for

consumers or likely to be used by consumers, supplied in the

course of commercial activity (European Commission, 2000).
The GPSD (2001) states that dangerous products can be
recalled from the market based on voluntary action or a recall
notice issued by an enforcement authority.
The Machinery Directive
The machinery directive The EU Machinery Directive (2007)
specifies essential health and safety requirements for machinery,
and is supplemented by several hundred harmonized standards.
Some requirements are related to specific hazards (e.g., moving
parts of the machine), other Requirements are related to certain
functions of the machine or to user tasks, like starting and
stopping the machine or carrying out maintenance; requirements
only relevant if the machine has the specific function or user task.
This implies that conformance with the essential requirements
has to be documented for single machinery units (e.g., pumps)
and for complex systems comprising several machines. The
producer designs and manufactures machinery according to the
essential health and safety requirements of the directive,
prepares the technical documentation, and has a type of
examination carried out, if necessary. On the basis of the design
and documentation, the producer signs the declaration of
conformity and fastens the CE mark on the machinery (KivistRahnasto, 2000).
Product liability directive
The EU Product Liability Directive (1985) states that the
producer shall be liable for damage to persons and/or property
caused by a defect in his product. Product liability claims are
usually based on a design defect, a manufacturing defect, or
failure to warn about has used the product incorrectly, as long as
the incorrect use should have been foreseen by the producer. The
directive provides an incentive to producers to ensure the safety
of their products, in order to avoid the costs that liability places
on them when defective products cause damages a specific
hazard. Claims may be raised even when the consumer.

How safe is safe enough?

All products that are placed on the market must, according
to GPSD (2001), be safe. To meet this requirement, the producer
has to identify all possible hazards related to the product during
all its life phases, and to make efforts to eliminate the hazards and
mitigate the risk related to the remaining hazards.
During this risk reduction process, the following factors
must be considered:
Requirements in laws, regulations, and standards.
Recommendations in guidelines on product safety.
Product safety codes of good practice in the sector
concerned.
The state of the art and technology.
Consumer expectations concerning safety.
In addition, the producer must balance these factors against
The cost of the product.
The functional performance of the product.
The schedule of the product development process.
A problem for the producer is to decide when the risk
reduction process can be stopped and the product is safe enough
to be placed on the market. It must be recognized that it is not
always possible to eliminate all hazards from a product. Some
products must, by the nature of their functions, have some
inherent hazards and the consumers must accept this risk in
order to use the products. Among such products are; knives, chain
saws, cars, and so on. For some of these products, it is possible to
reduce the likelihood of hazardous events by including various
safety functions (e.g., ABS brakes and ESP systems in cars) and to
reduce the consequences of such events, if they should occur, by
barriers and safety functions (e.g., seat belts and airbags in cars).
For other products, like knives, the only possibility to
reduce risk may be to ensure an adequate ergonomic design. The

development team has to determine if the safety level is adequate,

and such decisions are sometimes based on the GAMAB principle.
GAMAB is an acronym for Globalement au moins aussi bon (in
French) which means globally (overall) at least as good. New
products must have a safety level that is at least as good as
inherent in similar products available. By similar products we
mean products with a comparable functionality and a similar
price. New products with more functionality or that are
significantly cheaper may be considered to have adequate safety
even if they have a slightly higher risk level than existing
products.
The GAMAB principle implies that the producer has to carry
out detailed risk analyses of the new product and compare the
risk with that of the safest, similar products on the market. For
products based on novel technology and/or new materials (e.g.,
nano-materials), the precautionary principle may be applicable.
The precautionary principle states that where there are threats
of serious or irreversible damage, lack of full scientific certainty
shall not be used as a reason for postponing cost-effective
measures to prevent damage (Morris and editor, 2000). This
means that the producer should make efforts to ensure safety by
mitigating or reducing effects, even if they are not scientifically
proven to cause harm. An example is potential brain tumors
caused by radiation from using cellular phones Life cycle safety
management

PRODUCT LIFE CYCLE(PLC)

Conventional PLC
Product life cycle could be defined as the period of time
passed from the birth of a product meant to satisfy a certain need
(even an idea may be considered a product) and the moment
when it comes out from the market. In its classical form, as it

results from Figure 1, the Product Life Cycle is composed from

four stages: launch, growth, maturity and decline.

Fig 1 : Product lifecycle and its stages

Launch :
It refers to the initial stage of product. A new product is
introduced into the market. At this stage the product is relatively
unknown to the potential clients, and this accounts for the low
volume of sales. In this case, the profit curve may be under the
abscissa axis (this means a negative profit) due to high production
costs and low selling volume. This slow rhythm of selling growth
could be explained by technical complex problems, by a specific
resistance of consumers to changing selling behaviour, by a lack
of distributors to accept to retail the new product. The promotion
effort is at its peak (as a rule) when the product is launched just
because the potential consumers need to be well informed about
the new product, to stimulate them to buy it (at least to try it) and
after that to distribute it through retailers.

Growth :
The growth stage refers to penetrating the market followed
by a very high growth (at the beginning) and a slower one (after
that) of profit and turnover. The product is better and better
known, the first buyers continue to ask for it and recommend it to
other people. As a result of the diffusion, the new buyers are more
and more (due to firms effort). Higher exigencies of clients
determines producer to continuously improve the product. This
self competition is to be preferred to competition made by others.
Maturity :
Most products on the market are at this stage they are
mature products. As a rule, this stage lasts more than the
previous ones, raising very complex and delicate questions to
marketers. Maturity is characterized by a quite visible slow down
of the growing rhythm of selling and profit (even a zero growth
may appear). In this stage, the turnover and profit reach their
maximum. The product is very well known by consumers (and by
competitors, as well), it becomes a very common thing and, in
most cases is quite easy to compete with it. That is why the
product should be further improved and diversified. Advertising
becomes a maintenance one, just to keep alive the consumers
interest for product. The price is diminishing or remains at a
certain level (in most cases at a level chosen by competitors as
well)
Decline :
This stage of Product Life Cycle is defined by the continuous
decrease of selling and profit, until zero. The commercial death of
products is a quite normal thing, so it must be treated normally.
To discover that an old product is not profitable, nonperforming
compared with those of the competitors, a hardly marketable one
etc., is an essential thing to the producing firm, but the decision to
abandon the old product is very complicated due to the large
range of criteria of deciding the abandon moment and their
consequences are quite heterogeneous (production management,
stock management, distribution etc.).

A products life cycle ranges from the time the product is

conceived until it is finally disposed (Hammer, 1993). The length
of the life cycle depends on the type of product, and may vary
from very short (e.g., high-tech gadgets) to very long (e.g., heavy
industrial equipment). Extensive care, maintenance, and
modifications can extend the life cycle of a product far beyond the
life length anticipated by the producer. In some cases, equipment
have been modified, resold, and remodified, and then many years
later it has been involved in an accident, giving the original
producer problems in terms of lawsuits (Hammer, 1993).
A products life cycle is quite different for consumers and for
producers. For consumers or users, the product life cycle lasts
from product purchase to discard, and may involve several phases
(e.g., operation, maintenance). For producers, several more
phases are included, such as design, development testing,
manufacture, transport, installation, testing, operation, cleaning,
and maintenance

PLC- MODEL PROPOSED BY MURTHY ET AL

Fig. 1 shows a new product life cycle model as seen from the
producers point of view.

The model involves three stages and three levels:

Stage I (pre-development): This stage is concerned with a
nonphysical (or abstract) conceptualization of the product
with increasing level of detail.
Stage II (development): This stage deals with the physical
embodiment of the product through research and
development and prototyping.
Stage III (post-development): This stage is concerned with
the remainder of the product life cycle (e.g., production, sale,
use) subsequent to the new product development.
The three levels are as follows:
Level I (business level): This level is concerned with linking
the business objectives for a new product to desired product
attributes. The attributes represent the customers view of
the product.
Level II (product level): This level links product attributes to
product characteristics. The product characteristics
represent the engineers view of the product. At this level,
the product is treated as a black-box.
Level III (component level): This level is concerned with
linking product characteristics to lower level product
characteristics, at an increasing level of detail.
The model has eight phases with different activities
depending on stage and level. In each phase, the producer must
carry out specific tasks to achieve the desired product
performance. The remainder of this section discusses the safetyrelated activities in the various phases in order to obtain a safe
product.
Phase 1
Phase 1 involves identifying the need for a new product or
the need for modifications of an existing product. A desired
performance of the new product is set up to reflect the business

objectives and strategies of the company and the customers

needs for the product (Murthy et al., 2008).
The following safety-related issues are important in phase 1:
Maintain and enforce a corporate safety policy and a general
safety plan for product development projects. There are a
wide range of safety requirements in laws, regulations, and
standards. To be aware of all these requirements, and to
realize in which phase they should be addressed, require a
rather detailed plan. The safety policy should also include
risk acceptance considerations, related to aspects like
product liability, warranties, and so on.
Maintain a hazard list where experienced and assessed
hazards and harms caused by similar products are recorded
and evaluated. Such a list may divide the hazards into
different categories for increased structure and clarity, for
example, product hazards, human factor hazards, and
environmental hazards.
Maintain documentation of assessments of probability of
occurrence, including assessments of exposure.
Establish a product specific safety plan that includes safety
requirements and necessary actions for the product to be
developed.
Make visible top managements commitment to safety, and
enforce this by making it clear to all parties involved that
cutting corners to save time or money will not be tolerated
if it impacts the products safety performance.
Specify a desired safety performance for the product (e.g.,
our new car shall get five stars in the NCAP test).
Safety requirements may add additional costs to the design.
The decisions will be based on trade-offs between the costs and
benefits of safe design, as the added costs may reduce profit
margins and cause market share loss if competitors have less safe,
but cheaper designs. Besides, the customer may also be unwilling
to accept safe products if they impose constraints on their use.

Phase 2
Phase 2 is, along with phase 3, the most important phases
from a product safety point of view. Based on the desired
performance from phase 1, the product characteristics are
decided in phase 2. The characteristics are technical in nature,
and include product safety requirements to ensure customer
satisfaction. At this point it is also important to consider possible
misuse of the product.
A functional analysis may be useful for allocating the desired
performance and the requirements for the functions of the
product. The design of the product evolves as detailed analyses of
the functions lead to the design solutions necessary to achieve the
functions.

The main safety-related tasks in phase 2 are:

Carry out hazard and failure analyses to identify all hazards.
The analyses should be updated as design activities
progress. Relevant analytical methods include: FMECA,
preliminary hazard analysis, HAZOP, human factors analysis,
and so on (e.g., see Vincoli, 2006; Ericson, 2005; EuroSafe,
2007).
Carry out evaluation of probability of occurrence, including
exposure assessment (e.g., see EuroSafe (2007) and ISO
14121- 1).
Establish and maintain a critical items and hazard list. This
list should be based on the hazard list in phase 1 and results
from the analyses mentioned above, and should be a living
document during the remaining phases.
Make a safety assessment and design review with focus on
safety aspects during the various activities in the operational
phase (e.g., installation, operation, cleaning, maintenance,
disposal).
Decide whether or not the safety of the product is adequate
to proceed to the next phase.

 Update the product safety specification as a requirement for

the next phase.
Phase 3
Phase 3 involves the detailed design of the product. All
functions identified in phase 2 are transformed into a design
specification describing the individual components and their
relevant properties (Murthy et al., 2008).
Safety-related activities in phase 3 are:
Control the materials of the components and assure that
potential hazardous effects during use and disposal are
acceptable.
Control design features (e.g., sharp edges, gaps) of
components and assemblies and assure that these do not
cause unnecessary hazards.
Update the hazard and failure analysis, as well as the
exposure assessment, from phase 2 with component focus.
Maintain and update the critical items and hazard list.
Assess the safety and follow-up components and subsystems that are purchased from other parties.
Decide whether or not the safety of the product is adequate
to proceed to the next phase.
Update the product safety specification as a requirement for
the next phase.
Unacceptable risk may be reduced by the designer based on
a four-step safety improvement strategy (ISO/TR 14121-2) in this
order of priority:
Elimination of hazards by design. This may be accomplished
by choosing other types of materials, other energy sources,
and so on, or by eliminating the need for doing specific,
hazardous tasks (e.g., cleaning).
Risk reduction by design. This can be obtained by reducing
energy (e.g., lower speed, lower force), using more reliable
components, and so on.

 Safeguarding. This may be done by, for example, preventing

access to hazardous parts of the product, automatic stop
systems, also called barriers.
Information for use. This may include information provided
on the product (e.g., red lights, alarms) and information
provided with the product (e.g., users manuals).
Phase 4
Phase 4 and phase 5 constitute the main development of the
product, based on prototypes and test specimens. The safety
objective of phase 4 is to make sure that the desired safety is
achieved through testing, analysis of the results, and
modifications to the design in an iterative manner. The process
starts at the component level, before continuing with all
subsystem levels until the product as a whole is finally reached
(Murthy et al., 2008).
The main safety-related activities in phase 4 include:
Stress testing to reveal if the product can lead to harm in
overstress situations.
Safety testing related to all subsequent activities and
foreseeable misuse (e.g., installation, operation, cleaning,
maintenance, disposal).
Design review with respect to safety (IEC 61160).
Follow up of the critical items and hazard list.
Deciding whether or not the safety of the product is
adequate to proceed to the next phase.
The testing done in phase 4 is limited, because it is most
often carried out in controlled conditions, such as in a laboratory.
Thus, the safety performance is reflected through the predicted
performance of the product. When developing custom built
products, produced in very few numbers, the costs for complete
product tests may be unreasonable. Then the safety
characteristics or procedures are tested, for example, by use of
engineering analyses, analogy, laboratory test, functional

mockups, or model simulation. In such cases, phase 4 is the last

phase before the production starts in phase 6.
Phase 5
Phase 5 consists of operational testing, which means that
some selected customers keep a log of the relevant information
about how the product works. This information is used to assess
field safety performance and to make design changes, if
necessary. Influence from factors like the usage intensity and the
operating environment may reveal additional hazards,
contributing to a more complete picture of the actual product
field performance. For some products, like cars, the products are
tested in a wide span of environments to reveal hazards and
operational problems.
The main safety-related activities in phase 5 are:
Perform operational testing under various operational and
environmental conditions.
Carry out a design review with respect to safety (IEC 61160).
Follow up critical items and hazard list.
Decide whether or not the safety is adequate to proceed to
start producing the product.
All hazards and critical items identified through the analyses
and tests have to be eliminated or reduced until the product
reaches an adequate safety level. This process or risk reduction
may lead to changes in the product design, which means that the
design review, including the critical items and hazard list, has to
be considered and updated on a regular basis. A critical design
review is usually conducted to verify the final design before the
production of the product starts (Murthy et al., 2008). When the
product performance, evaluated in the prototype testing, matches
the desired performance, the product specification is complete
and can be used to start production of the product.

Phase 6
Phase 6 covers the physical production of the product, and is
most relevant for standard products. The production process has
to be adapted so that the product achieves the desired
performance. When the production process is fine tuned, the full
scale production of the product can start (Murthy et al., 2008).
Safety-related tasks in this phase are:
Ensure quality control and management.
Do conformance checking to weed out non-conforming
items.
Decide whether or not the product safety is adequate to be
launched on the market.
Finalize users instruction manual.
To ensure that the actual performance of the product
matches the desired performance, quality assurance is important.
An effective quality control system is considered from the early
design phases, and covers all parts of the production process.
Product batches are tested to eliminate defects, assembly errors,
and early failures. If, during testing, a significant number of items
are found not to conform with the desired safety standards, the
root causes should be found. Root causes may be related to
component quality or to the production process, and corrective
action should be taken.
Acceptance testing is used to test raw materials, parts and
components when received from suppliers to decide if the items
are acceptable or not with respect to product performance
requirements. Specialized and complex products may be subject
to a series of tests before they are delivered to the customer
(Murthy et al., 2008).
Phase 7
Phase 7 marks the start of the product life cycle for the
customer. This phase can be divided into several sub-phases

 Transport, assembly, and installation.

Commissioning.
Use:
Setting, teaching/programming or process changeover
Operation
Cleaning
Fault finding
Maintenance
De-commissioning, dismantling and, as far as safety is
concerned, disposal.
Phase 7 mainly focuses on customer evaluation of the
product performance. The products safety aspects and
requirements, that should be integrated from early on in the
product development process, are now challenged and tested in
the field. A safe product reflects a development process in which
safety requirements have been taken seriously.

In this phase, the safety-related activities include:

Data collection and analysis (data from users, distributors,
national injury databases).
Random field testing.
Decisions regarding adequate safety (and possible
required actions if minor adjustments and improvements
are required).
Updating of hazard analyses and safety documentation.
Information to users/distributors regarding unrevealed
hazards.
Important product information comes from warranty claims
data, sale of spares for items not covered under warranty, and
user complaints (Murthy et al., 2008). RAPEX may provide data
for customers wondering about purchase of a product, and for
companies developing new products or assessing existing ones,
in terms of input to hazard identification.

Even after the product has been launched on the market, it

may turn out that the actual products safety performance
deviates too much from the desired performance. Then the causes
have to be found, and modifications may have to be carried out.
The GPSD (article 5.1) requires producers to take appropriate
preventive actions after product release. A producer should keep
himself informed about possible product risks to enable recalls,
withdrawals, and consumer warnings, if necessary. Being
informed includes sample-testing of products in the market to
detect potential hazards and failures, and registration of
complaints in company databases. Distributors should also be
kept informed about company surveillance.
Another obligation of a producer, as stated by the GPSD
(article 5.1), is that producers have to provide customers with
sufficient information about the products risks, where these are
not obvious without a warning. The purpose is to enable
customers to take the necessary precautions, and thereby reduce
risk. Producers are also required to inform the authorities about
dangerous products which do not comply with general safety
requirements, and actions taken to reduce the risk (article 5.3).
Then the authorities can take appropriate steps to reduce risk and
to ensure co-ordinated action.
Phase 8
Phase 8 evaluates the product performance from a business
perspective. Costs, for example warranty expenses, profits from
sale, and business consequences related to inadequate safety,
such as product recalls, bad reputation, and liabilities are
evaluated (Murthy et al., 2008).
Important safety-related issues in phase 8 are:
Analyze data.
Achieve organizational learning (feedback to next product
development).

Phases 7 and 8 are not sequential phases, but occur more or

less in parallel at different levels. Phase 7 encompasses the
specific activities carried out by the responsible engineering and
development team, whereas the business level involves strategic
marketing and management decisions based on results from
phase 7.
The disposal of the product and possible hazards should be
considered in the early development phases. Some products may
contain materials and substances that constitute special problems
to human health and environment. The amount and
characteristics of hazardous materials present in a product when
disposed should therefore be planned for, along with possible
hazards if the product is recycled or reused.

CONCLUSION
Product failures and accidents may result from deficient
methods, but some of the problems are related to deficient use of
methods and from not prioritizing safety equal to, for example,
costs. Safe design is a result from making sure that requirements
to product safety are considered in a life cycle perspective,
integrated into the product performance specification initially,
and treated in a proper manner along with all other aspects of a
product.
Meeting the objectives of safety is a trade-off decision within
the constraints of cost, schedule, and performance. In the
development process, it may be difficult to determine which
safety aspects should be considered in the design process, and
which should not. For example, regarding the cellular phone, it is
claimed that the major cause to traffic accidents is driver
distraction, and that use of cellular telephones is the key source
(Nasar et al., 2008). Further, the use of cellular phones is
restricted in places, such as hospitals, due to possible interference
with sensitive electronic equipment (Small, 2005). In such
circumstances, there may be a chance of the product indirectly

causing accidents, but does this mean that a producer needs to

take these aspects into consideration in the product development
process?
The main contribution of this article is a discussion of how
safety aspects can be accounted for in the new decision making
model for product performance, with emphasis on sufficient
specification of safety performance in the initial phases of the
development process. Safety is a relative condition, and a
perfectly safe product will in many cases not be attainable.
Nevertheless, a products safety performance can be improved by
a systematic approach to product development and business
strategy planning.

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