Quality - The Key to Complying with the R&TTE Directive

Quality - The Key to Complying with the R&TTE Directive

Manufacturers are now becoming concerned about how they will comply with the new R&TTE Directive. Some see it as an impediment to meeting 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 new 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 will be 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 have declared that they will 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 forecast the level of complaints that may arise, although some industry experts are warning that the European market will be 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 the new 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”, bypasses the drawing control system and gets the change implemented at the manufacturing stage or out in the field. We have even seen hand-marked drawings at the final test area and in the field engineer’s documentation.

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 new Directive demands that a Technical Dossier/Compliance Folder exist and be 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 Directives 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 Directives;

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.

For a summary of the R&TTE directive: http://www.patton-assoc.com/

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