|
US toymaker Mattel has
recalled more than 18 million toys worldwide, the second such recall in two
weeks. Mattel blames the lead paint on a Chinese subcontractor. Nokia is
offering to replace 46 million batteries for its mobile phones after reports
of overheating while charging; the problem battery had been used inside more
than 50 different phones.
Two high profile safety product re-calls focuses the
attention of both manufacturers and testing authorities on the future of
product assessment and surveillance in Europe. This brief article looks at
some of the areas where things can go wrong and what is being done to
improve the situation.
The Technical Assessments Of
Products
For CE marking, the compliance assessment may be either
self-certification or 3rd party. In all cases, 3rd
Party test and inspection can be used, and this is normally the case for
specialist Directives where the manufacturer would have difficulty in
justifying that they have the competence to undertake the assessment
internally. In some cases, where the product represents a higher risk of
causing injury, it may be mandatory to get an EU Notified Body such as
Epsilon involved.
Member States are responsible for selecting the various
laboratories, inspection and certification bodies that have the task of
checking manufactured goods to ensure that they conform to the EU
requirements. For each sector Member States may designate as many bodies as
they wish.
There are now almost 1900 of these ‘official bodies’
deemed competent to carry out the necessary conformity assessment
procedures. The quantity of companies and the competitive market environment
has led to considerable differences in approach, quality and cost. Many
‘official bodies’ do not have the range of technical expertise required to
undertake complex and dynamic assessments but are driven by the commercial
need to take on the work.
The Commission is proposing measures to reinforce the way
in which Member States currently select and monitor these conformity
assessment bodies, possibly using accreditation and/or peer assessment. In
the UK, Notified Bodies are assessed (but not necessarily accredited) by
UKAS on a yearly basis*. This is not necessarily the case in other member
states, and official and even notified bodies may be unregulated
or checked by any competent authority.
*Epsilon are both UKAS Accredited and audited by
UKAS on behalf of the DTI for Notification. In addition, we are 'peer'
audited for IECEx by other National Laboratories.
Quality System Requirements
The New Approach Directive requires that manufacturers
have a Quality System that can address the demanding requirements of CE
Marking. This can be either ‘Internal Control of Production’ (essentially
‘self determined’ quality system requirements) or a ‘Quality Module’ issued
by a Notified Body where the requirements align with Standards such as
ISO9001:2000.
The audit requirements for Notified Bodies has been under
scrutiny and will become more rigorous over time, covering in far more
detail aspects such as Declarations of Conformity (for both the manufacturer
and all suppliers and sub-suppliers) and methods of remaining current with
technical progress.
It is however the ‘Internal Control of Production’ for
Directives where Notified Bodies are not involved where there is the
greatest likelihood of non-compliance and product recall. Internal Control
of Production requires specific and deliberate actions to be undertaken by
the manufacturing company on a regular basis.
Some of these requirements are derived from the Standards
with which they claim compliance (such as routine dielectric strength tests
for electrical safety) and other requirements are ‘quality control’ issues,
such as the requirement to get Declarations of Conformity for the parts of
the product that are subcontracted or bought in (such as lead free paint!)
Ultimately the underlying problem is that people see
Internal Control of Production as ‘no action required’ as there is no 3rd
party audit.
Given the Billions of Pounds
that will be spent on the just the two product recalls listed, it is hoped
that manufactures will assess the real cost of not having an adequate
quality system for CE marked products.
The ‘New’ New Approach Directives
The Directives were initiated at different times over the
last 20 years and sometimes definitions or legal provisions were not
sufficiently precise, leaving room for diverging interpretations of
manufacturers, enforcement authorities and conformity assessment bodies.
These inconsistencies can lead to different interpretations in different
Member States, which undermines the free movement of goods in the Community.
The Commission is currently trying to solve these
problems and to ensure coherence by standardising the various definitions
used in the legislation and by clarifying the obligations of everyone
involved in the process. This includes:
Member States
obligations for product surveillance and only appointing competent and
regulated assessment bodies
Assessment Bodies obligations to be accredited for all assessment activities
undertaken
Manufacturer’s responsibilities to use technically competent recourse for
assessment (internal or external)
Manufacturer’s responsibilities to cover the Quality Assurance requirements
for the entire supply chain
The work currently being undertaken is far reaching and
will represent a major overhaul of the original New Approach Directive
methodology. Many changes, both technical and commercial, are being
considered, and in some cases implemented.
Market Surveillance
Market surveillance, the method for enforcing the function of the
European conformity assessment system, is based on requirements given in the
New Approach directives. These requirements are very general, leaving most
of the practical details of surveillance methods to the discretion of the
member states.
This has led to there being major differences among member states in how
market surveillance is carried out (the Eurobarometer survey in 1997 showed
that 64% of Europeans thought that consumer protection standards differed
among member states). Some countries may not do effective market surveillance,
while others carry out passive market surveillance, reacting only after a
challenge has been made or an injury has occurred. In reality, all member
states should plan and monitor product compliance on an ongoing basis.
Steps are been taken to ensure that market surveillance will become more
effective and consistent and manufacturers will see more obvious, deliberate
and pro-active surveillance of products on the EU Market. The Directives
should also align on to what extent the manufacturer must arrange for
products to be tested or inspected by a competent third party.
The CE mark has become the focus of market surveillance strategies of the
member states. However, since CE marking was adopted in 1993, lack of
confidence in the EU conformity assessment structure has become an issue.
According to government reports, many CE-marked product groups have failed
to meet essential requirements. Some CE-marked products actually have been
shown to be dangerous.
Another reason for lack of confidence in the CE mark is that people are
often unsure of what the mark means, especially as many assessment bodies
list it as a mark ‘they issue’ along side there proprietary trade or
certification marks. The Commission has applied to register
the CE marking as a collective community trade mark and this may help the
situation as it will give the national market surveillance authorities and
competitors greater powers to take legal action against anyone who
abuses the marking.
Market surveillance has finally become an important part of the European
conformity assessment policy. Enormous pressure is being placed on all
member states to make their enforcement organizations more effective.
There will be more
product surveillance....more products being placed on the European Market
will be checked 'randomly' by competent compliance organizations.
Increased
surveillance will undoubtedly be more product recalls- make sure your
product is not one of them, if you have any doubt about anything you are
doing regarding CE Compliance, contact us for a free and confidential
discussion.
| 
