As technology progresses and multiple capabilities are incorporated into a single product, it is vital that compliance requirements and test approaches are considered from the initial design stage. Pre-compliance work early on in the product design/manufacturing phase, is therefore vitally important, as any changes can be made sooner, rather than later. This approach will avoid retro-fitting at a later stage which is costly and will invariably delay the time to market.
While testing both end products and their components is critical, this can often be duplicated unnecessarily to ‘cover all bases’. This reflects a poor understanding of the intended environment and of the specifications used to determine if testing should be done. Consequently, most will err on the side of caution and often over test their products and systems.
However, you cannot sensibly test for every mode in every configuration that is laid out in the relevant standards, as this would be too expensive and time consuming. Therefore, consider performing testing to establish the “worst case” modes of operation so as to reduce test time and cost.
Take a step back and identify all the possible issues that could occur, but do not take this approach too literally. Are those potential issues mainly mechanical, electrical or EMC/radio emissions or other? For example, the Machinery Directive defines a machine as “an assembly… of linked parts or components, at least one of which moves…”. However, a laptop computer is an assembly of linked parts which move and we would never consider that something that required assessment under this Directive and on closer reading we see there is a specific exclusion for “certain electrical equipment such as IT equipment”.
Counterfeit challenges
The laws of demand and supply are fuelling the significant rise in counterfeit electronic products as consumers increasingly demand cheap goods. This is becoming an issue, particularly for UK and European manufacturers which design and develop products in their own country, but outsource the manufacture to low cost regions.
While they may have checked the quality of their immediate supplier’s operations, they cannot be assured that the various component manufacturers further down the supply chain are as rigorous in their quality control.
Not only can electronic products and components be counterfeit, their testing and compliance documentation can be too. It is therefore essential that those importing goods go beyond just gathering test reports and certification evidence to ensure that their supply chain complies. Indeed, many retailers send out their own experts or sub-contract expert organisations to audit factories abroad regularly.
As a core reason for manufacturing being moved to countries like China is cost, the ideal scenario of fully and regularly auditing all the suppliers in the chain often cannot be justified financially. A more realistic approach is to create a supply chain matrix, and focus the audits on the high-risk suppliers, and on those in the supply chain responsible for supplying safety-critical parts.
It is also important to ensure that any factory you deal with outside the EU has a Quality Management System in place and is regularly audited by an independent third-party. Do also consider pre-shipment and post-shipment inspections, taking random samples from boxes.
Wireless complications
The design of electronic products is becoming increasingly complex and test standards are failing to keep up with these product innovations. Both designers, manufacturers and end users are therefore often confused as to which standard, or multiple standards, should be applied.
For example, many integrating wireless systems into their product are relying on the use of wireless modules which already meet some or all of the Radio Equipment Directive (RED) requirements. However, once these modules are integrated into another product, this changes the regulatory requirements as it is the entire host product itself, and not just the module, which now falls within the scope of the RED.
The assumption that no further action is required because the wireless module is compliant as an independent component is therefore incorrect. Despite this, it is worth remembering that integrating a pre-approved module will save manufacturers time and money when it comes to testing the whole device.
Don’t fall in the trap and treat everything like a wireless product. If you integrate a wireless module into a domestic washing machine, the product is still a domestic washing machine and must be treated as such.
Considering risk
All European product Directives (Radio Equipment Directive, EMC Directive, Low Voltage Directive etc) now incorporate a requirement for risk assessment. Not only does the risk assessment process ensure that products meet regulatory requirements, it reduces the risk of costly non-compliance, which would require product re-designs and re-testing, and cause significant time-to-market delays for new and upgraded products. Risk assessments can also improve product performance and reliability by reducing the chances of failures, helping to strengthen a brand’s market reputation.
Risk assessments should be conducted at the start of the conformity assessment process, and not at the end, and it must be a continual process that is reviewed with every product modification. Where compliance is shown to be affected, the subsequent risk controls should be established and documented in the technical file before updating the declaration of conformity and/or EU-type examination certification as appropriate.
Technical file
A technical file is documented evidence to show that the product properly complies with the requirements of the Directives which apply to it. It can be a traditional paper file, or stored electronically, with hyperlinks to documents. It must also be kept up to date as the product is adapted, which means that the technical file cannot be put away and forgotten, and must be retained for ten years.
The manufacturer must establish the technical documentation, and the importer must ensure the manufacturer has met their obligations. If a product is re-branded, so that there is no traceability to the original manufacturer, then the company which has re-branded and sold the product takes on the responsibilities of the manufacturer, and they must issue their own declaration of conformity and compile the technical documentation to prove compliance.
An innovative approach
To expedite the test process, remember that a test laboratory will not be familiar with individual products. Test laboratories see hundreds of product types of all shapes and sizes using multiple technologies, and every manufacturer has their own implementation of test modes. It is therefore important to prepare user manuals for the test software and operation of test modes, ensuring that instructions are crystal clear, including detail such as screen shots and photographs. Also, where setups are complicated, consider attending testing to assist the laboratory in the early stages.
As electronic products, their components and the supply chain becomes ever more complex, alongside a market that is demanding ever more innovative products at less cost, never has it been more important to have a clear product strategy.
| "Never before has it been so important to match an innovative product design with an innovative approach to testing and compliance" Richard Poate |
This must go beyond design to include target markets, with a compliance test strategy that supports that from the outset. Hoping for the best at the test stage is not a workable solution in this highly competitive marketplace, as re-designs further down the line will be significant both in terms of cost and timescales.
| Author details: Richard Poate, Senior Manager at TÜV SÜD Product Service |
