Primilis Ltd

Quality is all about meeting requirements, even the ones you don’t know about yet.

Recently I have been working with some entrepreneurs and start-ups who have tremendous enthusiasm and great product ideas but are not experienced in placing products on the market. They asked for help with what I call ‘productisation’; this goes beyond the design and manufacture parts of the process, it’s the things that ensure good quality, low risk and cost, and the things that you have to do before you can sell the product in the UK and Europe.

You might be surprised by some of the hoops that you need to, or might want to, jump through, so I thought it was worth listing some of them:

Approvals

• CE Marking – you, not your contract manufacturer, must decide which EU Directives apply and prove you meet them. You can’t sell products until this has been done
• All parts must comply with the Restriction of Hazardous Substances (RoHS) Directive
• You need to put recycling provision in place (the WEEE Directive)
• If you sell more than 200,000 products per year, the Energy Using Product Directive may apply
• Some markets or types of product have their own rigorous approvals regimes (pharmaceuticals, healthcare, food, etc)
• For non-EU sales, other country-specific requirements must be met.

Packaging

• EU Directive-compliant packaging will be needed if you are selling to consumers
• For Business to Business sales, good packaging will still be needed to protect your products; does it?
• Do you need multi-lingual labelling, packaging, user manuals, etc?
• Your packaging and labelling must exactly match the Sales Order, and show the CE mark or other labelling, or it can sit in Customs forever…

Design proving

• Does the product meet all its specifications?
• How do you know that your product is robust and reliable?
• If your product must conform to technical standards or interwork with other equipment (e.g. mobile phones, PC accessories or Operating Systems) how do you know that, in all cases, it does?

Manufacturing

• How do you choose, manage and support a manufacturer? Location – UK, China, or elsewhere?
• What manufacturing services must you pay for and when?
• Do you have processes for supplier and material management?
• Will you need to build for stock?
• How will you stabilise the demand on your manufacturer?
• Who will develop the production test systems? How can you be sure that all products work 100%?
• Are you going to independently sample test your products?
• Cosmetic quality – surface blemishes and colour matching and straight labels, not lipstick and blusher! – what is an acceptable and what must be rejected?
• What Key Performance Indicators (metrics) do you need?
• How will you protect your Intellectual Property?
• Have you provided sufficient samples to Marketing, R&D, etc?

Order processing and customer support

• Do you have processes in place for order processing, invoicing, etc?
• Will any customers have problems with the country of origin; how will you resolve this?
• How will you keep build standard / configuration data?
• Who will repair products in and out of warranty, where, and how?
• If you need to do field repairs or recall products, how will this work?
• Logistics; who will ship units to overseas customers and how? Is your technology subject to US export controls? Is a UK export license required and do you need end user checks or Export Control Compliance Undertakings?
• What tariffs are payable?
• Will you keep Intrastat records?
• How will you provide support to customers / retailers?
• How will you provide consumables and/or spares?

Change control

• How will you manage change control and keep hardware, firmware, and production test aligned?
• Do customers need to upgrade product software? How?
• Have you done regression testing (to prove that modifications don’t introduce new faults)? Have you checked for backward compatibility?
• If your product inter-works with others, how will you track compatibility in the future when new products or variants come on the market?
• How will you manage key component obsolescence?

All these questions can be answered, of course, but if you haven’t done this before, it can come as rather a shock. There’s a lot to be done before you meet all requirements, so don’t be overawed but please don’t cut corners – it will come back to haunt you!

This list isn’t exhaustive, by the way, although it contains many of the key elements that you might like to think about. If you want to know more, I’ve put some extra details in my blog.

15 October 2009

Tom Gaskell offers business quality, product quality and reliability, manufacturing management and trouble-shooting services through the consultancy Primilis Ltd.  Contact him at http://www.primilis.com/contact_us.html, visit the Primilis website at http://www.primilis.com, or read his blog at http://www.qualityandproducts.com.