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Team:UCL E/Business/Manufacturing
From 2013.igem.org
Contents |
From One to Scale
Developing a prototype poses an interesting set of problems, but manufacturing a new device at scale is a completely different challenge. Whereas we design, build and test our prototypes completely in house, our startup aims to achieve economies of scale for manufacturing. This is only possible with a suitable workflow; specifically we want to turn our prototype devices into technical implementations plans that can be sent to a number of different supplies and manufacturers. In turn, these partners assemble sub-components for us with maximal efficiency reducing our manufacturing works to assembly and testing of the final product.
Manufacturing Costs
Suppliers
During our prototype development, we identified the best suppliers for production scale-up.
Table 1. Suppliers
Regulations and Safety Requirements
To manufacture electrical equipment in the UK, we must meet the Electrical Equipment (Safety) Regulations 1994 which covers all equipment designed for the workplace and domestic electrical equipment. Our responsibility as the manufacturer is to ensure the Darwin Toolbox meets the safety requirements, and declaring this with 3 key components:
- Technical documentation
- a European Conformity Declaration of Conformity
- a European Conformity (CE) mark.
Technical documentation
Manufacturers of new products subject to European product safety Directives must collect and be able to assemble comprehensive information covering the design, construction, conformity assessment and use of the product to demonstrate how their product complies with all applicable Directives. This is known as a technical file. It should be in one or more of the official Community languages and kept available for at least the time specified in the relevant Directive (eg for machinery this means for at least 10 years since last production of the product range).
European Conformity Declaration of Conformity
Our product must be supplied with an European Conformity Declaration of Conformity. This is a written certificate that show that we, as the manufacturer, formally declare that our CE marked equipment meets the requirements of the regulations. In this document we must state:
- identify the manufacturer or the authorised representative
- describe the electrical equipment to which it relates
- where appropriate, specify the harmonised standard(s) or other specifications with which conformity with the safety requirements is declared
- where appropriate, refer to the specifications with which conformity is declared
- identify any signatory empowered to enter into commitments within the EC on behalf of the manufacturer or his authorised representative
- include the last two digits of the year in which the CE marking was affixed
We are not required to provide a copy of the EC DoC with each product, however a copy must be kept with the technical documentation, and within the territory of the EEA by the manufacturer, the authorised representative, or failing that, the importer who first places the equipment on the market in the EEA.
Adapted from Electrical equipment manufacturers: regulations and responsibilities
European Conformity (CE) marking
The CE marking indicates a product’s compliance with EU legislation and so enables the free movement of products within the European market. By affixing the CE marking to a product, a manufacturer declares, on his sole responsibility, that the product meets all the legal requirements for the CE marking, which means that the product can be sold throughout the European Economic Area (EEA, the 28 Member States of the EU and European Free Trade Association (EFTA) countries Iceland, Norway, Liechtenstein). This also applies to products made in other countries which are sold in the EEA.
