Quality - The
Key to Complying with the R&TTE Directive
Manufacturers
are now becoming concerned about how they will comply with or continue to meet
the requirements of the R&TTE Directive. Some see the R&TTE Directive as
an impediment to meeting the commercial aims concerned with manufacturing
profit. This article seeks to explain how the two objectives of Product
Compliance and Profit are in no way mutually exclusive.
BACKGROUND
In
the past, telecom and radio products have had to undergo regulatory test and
assessment before they can be granted a license and go on to be sold in the
European Union. The R&TTE Directive
removes this requirement and places the onus on the manufacturer to self declare
compliance and then be subject to scrutiny by Surveillance Authorities in each
Member State of the EU.
The
Directive defines the Essential Requirements for product Safety and EMC and may,
in future, generate other telecom or radio based requirements. For radio
equipment, the Directive demands that apparatus be so constructed that it
effectively uses the spectrum allocated so as to avoid harmful interference,
regardless of whether the frequency bands to be used are harmonized or
non-harmonized throughout Europe. It also mandates that all products must
interwork with the networks for which they are designed.
Network
Operators are required to publish specifications for their individual network
interfaces to enable designers and manufacturers to build compliant product.
Whilst no specific telecom interface testing is demanded, failure of any type of
equipment to interwork successfully with the networks for which apparatus has
been designed will attract complaints from customers, Network Operators and
Surveillance Authorities. The latter will demand to see proof of compliance
contained in a Technical Dossier.
MARKET
SURVEILLANCE
A number of Member States actively police the
marketplace to ensure that Radio and Telecommunications Terminal Equipment
product complies with and continues to meet the essential requirements of the
Directive. In the UK, it has been decided
that surveillance will be complaint driven.
No
one has yet gauged the level of complaints that have arisen, although some
industry experts have warned that the European market is being flooded with
inferior equipment which would never have met the requirements of previous
Directives. If this is so, the level of complaints from users and Network
Operators is likely to spur the Surveillance Authorities into action, regardless
of the approach of the individual Member States.
BENEFIT
OR BURDEN
Some
manufacturers may perceive compliance with this Directive as being an additional
burden that prevents them meeting their objectives of maximum quality, minimal
field returns and maximum profit. However, it can be shown that time taken now to ensure continuing
compliance of product with the requirements of the new Directive will reduce the
likelihood of complaints from the market place.
Manufacturers
must develop a strategy that will head off customer complaints, be they to the
manufacturer or to the Surveillance Authority. It
will be seen that this objective
dovetails nicely with those of any right-thinking Quality Manager wishing to
maximize product quality and minimize field returns, whilst keeping the
shareholders nicely in profit.
QUALITY – THE KEY
Under
previous Directives designed to ensure compliance of R&TTE, a measurement of
product quality was always a key factor. Even the new R&TTE Directive
contains options for voluntary compliance with “Full
Quality Assurance Standards”, based on ISO 9000 requirements. With the emergence of TL 9000 as a telecom industry manufacturer’s
super-standard, the trend for respectable telecoms manufacturers is further
towards improved quality.
This
does not have to be the province of the “big boys”; all manufacturers can
achieve these objectives and save themselves brushes with the Surveillance
Authorities, minimize field returns and maximize quality and profit by following
the principles previously laid down by these quality standards.
COMPLIANCE
USING QUALITY
This article would resemble a
tome, were the author to go on to detail all of the steps that must be taken to
achieve ISO 9000 style quality standards compliance. However, there now follow a
few pointers:
Common
Pitfalls:
Common
pitfalls for manufacturers occur when:
1.
A designer designs-in an “improvement” (perhaps
bypassing the drawing control system) and gets the change implemented at the
manufacturing stage or out in the field.
2.
An over-zealous purchasing agent “discovers” a “cheaper”, but
non-compliant, component which turns out to be safety or network critical.
3.
Checks and monitoring of critical component suppliers and vigilance
at incoming inspection are relaxed, meaning that the quarantine cage remains
empty.
4.
Complacency within the product test area sets in, because no faults
have been found for a particular test.
5.
Different versions of product are allowed to exist in the field with
no documented method of determining the revision level or differences from
originally approved product.
Any
of the above will result in reduced product quality, increasing field
returns and customer complaints.
Documentation
Control:
Many
medium sized manufacturers trip themselves up by not maintaining control of
documentation from the design stage, through manufacturing, to field
engineering. Relevant documentation that must be controlled includes:
Product
Specifications
Design
Drawing
Accurate
Procurement Information
Layout,
Assembly Detail and Build Instructions
Change
Control Procedures
A procedure must exist to ensure that, after
documentation release, the engineering change procedure is under high-level
control. The documentation package should freeze the design at the point
when the product was certified against the requirements of the R&TTE
Directive. Changes should not be implemented until the sign-off loop has
included the Quality Manager and a senior Compliance Engineer.
Product Changes and Ongoing
Compliance:
By including the Compliance Engineer in the
documentation change sign-off loop, safety and network affecting changes
will be recorded and, where necessary, retest organized to ensure
that the product remains compliant.
Simple systems are easy to
set up, which communicate the current design and engineering change status
of product to all personnel, including those in field service.
The
R&TTE Directive demands that a Technical Dossier/Compliance Folder exist
and is available to any European Surveillance Authority to prove compliance
with the new Directive. This Technical Dossier must contain documented proof
that product in the field continues to be compliant with the Directive(s)
against which the product has been declared to be compliant.
STORM
WARNING
Rules governing manufacturer-generated
Declarations of Conformity and CE marking make it easier for Surveillance
Authorities and Customs Agents to trace product to the organization or
individual responsible for placing product on the market, and to determine its
compliance status.
SUMMARY
The easement of mandatory product assessment could
open the floodgates for poor quality. The policing of new Directives by market
surveillance should uncover or prevent poor quality. This should leave the field
clear for quality product to get to market quicker and stay in market longer.
-
The
key to achieving these objectives lies in quality of manufacture. In
particular:
-
Preparation
and maintenance of documentation;
-
Continuing
compliance with the essential requirements of appropriate Directive(s);
-
Periodic
assessment of product and maintenance of Technical Dossier / Compliance
Folder;
-
Quality
system maintenance and, if possible, certification.
A
manufacturer does not have to be “Blue Chip” in order to produce quality
compliant product. The time spent introducing a few simple measures is an
investment which will more than compensate for the time and cost it would take
to deal with poor quality, let alone the loss of customer base, product
liability issues (the subject of a separate European Directive) and brushes with
the market Surveillance Authorities.
A copy of The R&TTE
directive may
be downloaded at: http://www.patton-assoc.com/
History
of Legislation. The
legislation that has affected R&TTE emerged from different sciences and
disciplines. The EC-wide Low Voltage Directive 73/23/EEC (1973) covered safety
of all ITE. This Directive was eventually designated by all Member States to
cover nationally approved TTE as well as EC-wide approved apparatus. Similarly,
the EMC Directive 89/336/EEC replaced national legislation to cover all ITE and
TTE. The TTE Directive 91/263/EEC (later to become 98/13/EC) currently covers
approval of technically harmonized TTE.
The
full title of the R&TTE Directive is:
Directive
1995/5/EC of the European Parliament and Council
of 9th March 1999 on Radio Equipment and
Telecommunications Terminal Equipment and the
mutual recognition of their conformity.
Author
biography
– John Roche is Managing
Director of Patton & Associates (UK) – the European office of Patton &
Associates Inc. of Prescott Arizona. Patton & Associates provide
Telecommunications Consulting, Design and Type Approval services for Europe,
North America and The Pacific Rim.
John
Roche can be reached at: roche@patton-assoc.com
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