IES provides the largest move of its kind to the Bio Medical industry

IES is about to complete a ground-breaking project to package and move laboratory equipment, samples of viruses that can affect livestock and other items contained within laboratories at The Pirbright Institute, in Surrey.

The Pirbright Institute is a world leading centre of research and surveillance of viral diseases of farm animals and viruses that spread from animals to humans. Through fundamental and applied research they work to control, contain and eliminate diseases, such as foot-and-mouth, bluetongue and swine flu.

Pirbright has recently opened a new state-of-the-art laboratory facility at their headquarters in Surrey. Expertise from IES was required for a highly delicate and complex move from previous laboratory buildings to the new facility. The BBSRC National Virology Centre: The Plowright Building now houses 150 scientists and staff and will play a vital role in the ongoing fight against some of the world’s most devastating viral diseases

Because of the content within the laboratories – sensitive equipment and highly contagious pathogens- IES was contracted as a specialist packaging and logistics company to plan and carry out the relocation. Pirbright’s project management and biosecurity teams tasked IES to come up with a project plan to package and transfer of all the equipment – the first move of this scale anywhere in Europe.

Tim Patten, Operations Manager at IES was briefed to come up with a packing solution so that all equipment and temperature sensitive samples could be moved without damage. Tim, in conjunction with the project team, devised a detailed 70-page plan about the packing requirements and procedures that would be needed for the move. This included risk assessments, mitigation plans and method statements. The plan for the move also had to meet the requirements of the Department of Environment, Food and Rural Affairs (Defra) and the Health and Safety Executive (HSE).

Testing and collation of data was also carried out by IES to ensure the process would work. All materials, including the clear plastics that were to be used to form a sealed barrier were tested as they had to stand up to various specifications including being impermeable, being robust under duress and being resistant to a disinfectant wipe down. The testing was critical as any failure of the packaging during the move could have jeopardised The Pirbright Institute’s Defra license.

Once testing and the plan was completed, IES carried out the management of the move to the new facility: Coordinating the IES packing staff and The Pirbright Institute’s external contractors to ensure that the agreed method statements and risk assessments were adhered to. Most of the move has now been completed successfully with a final phase due to take place in September/October 2015.

Joan Shadwell, Project Manager for The Pirbright Institute, was responsible for the move and commissioned IES to supply the packing and project management of the move. She said:
“This project was very unusual as we had an enormous amount of equipment that had to be moved from a restricted area. We were looking for a unique wrapping solution and IES were able to provide this. We couldn’t use our normal externalisation methods as this would have taken too long and most of the equipment is too sensitive to the harsh treatments, but HSE and Defra allowed us to wrap materials three times before transporting them across open ground. IES had to write the procedures, then we had to get approval from HSE and Defra and our internal Biosecurity Department. We were very pleased as both the planning and the move went exceedingly well and ran really smoothly. This is the first time we have moved equipment from high containment laboratories, on this scale, to a brand new building. When we did come across any issues, Tim and the team at IES were flexible and able to come up with unique solutions. We found them to be professional, friendly and accommodating and nothing was ever a problem.”

Matt Boyd, Sales Director from IES added:
“This packing and logistics project for The Pirbright Institute was a unique challenge- a task like this had never been done on this scale for such highly sensitive equipment and samples of viral diseases. The packing and project management that we carried out, can now be adapted to meet the requirements of any organisation that has biosecurity requirements, for example in the medical, science or research and development sectors.”

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6 Simple Steps to CE Marking

This is the third in a series of blogs we’ve been posting about CE Marking. It’s obviously a subject that’s important to us at IES, but for a very good reason. A large number of importers and manufacturers do not fully understand the application of, or the implications behind, CE Marking legislation as it is increasingly being implemented. This is not something that can be ignored or easily got over when and if you’re caught!

So, to be clear, the products affected can be found under the Directives listed in our April 2015 blog at http://www.ies.co.uk/news/.  The countries CE Marking applies to are all those in the European Economic Area (EEA), comprising the EU and EFTA countries plus Switzerland and Turkey.

Responsibility for securing CE Marking and then for placing it on the product is entirely that of the manufacturer or, if applicable, the importer or distributor into those countries involved. This responsibility involves the initial carrying out of the conformity assessment, the setting up of the technical file, the issue of the EC Declaration of Conformity (DoC) and the placement of  CE Marking on the product concerned.

CE_Marking_6-Steps_Diagram

The process will depend on your product, so:

Step One: Identify the Directive that applies to your product. As mentioned above these Directives can be found on our April 2015 blog. There are 20 of them, and each gives details of the essential requirements that each product needs to meet. These are mostly to do with safety.

Step Two: Make sure your product complies with the essential requirements of the Directive. The responsibility for ensuring compliance rests with you. In essence how you do this is your decision, the easier option is to follow a standard.

Step Three: Check whether you need to have an independent conformity assessment for you product. This depends on the directive you are adhering to, so it’s important to check. If you need what is known as a Notified Body you can find a list of these on the NANDO (New Approach Notified and Designated Organisations) database.

Step Four: Test your product for conformity. This will usually include a risk assessment. By meeting the harmonised European Standard you’ll be fulfilling the essential legal requirements.

Step Five: Prepare and have available all the technical documentation required by the Directive. These should prove the product’s conformity to the technical demands of the Directive, and the risk assessment. This documentation could be demanded at any time by the national authorities of any country the product is being marketed to (not necessarily sold to).

Step Six: CE Marking your product. This is a complicated procedure in itself. Only you or your authorised agent may place the CE Mark on a product. It must be visible, legible, impossible to remove and have the right information printed on it. If a Notified Body was involved at any stage then its reference number must be displayed.

Easy? No, not at all. And whilst it’s possible to undertake this procedure for yourself our experience would strongly advise against it. You’re far better working with experts who will guide you through the entire process, ultimately saving you both time and money.

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CE Marking, What should comply?

If you’re reading this and asking yourself whether your products have to have CE Marking, the answer is most probably “Yes”. This legislation, presented in the form of an EU Directive, covers an extensive range of products.

It’s a reflection on the importance of Europe as a world market that we have been targeted by manufacturers worldwide, all keen to win a slice of our spending, but many of whom have been promoting products that fail to meet our accepted national standards. The CE mark was introduced to show that a product is in compliance with the appropriate directives and standards. As a result any applicable product that does not carry CE Marking should not be sold and similarly CE Marking on a product permits enforcement agencies to withdraw any non-conforming products. Only CE Marked and compliant products may be legally placed on any of the 30 markets that make up the EU and EFTA (plus Switzerland), and move freely amongst them.

So what products are included? The following are some of the directives. Each carries a detailed description, and we’d be happy to help you to unpack the detail should any apply to your product. Please note that more than one directive may be applicable

  • 2001/95/EC – General Product Safety Directive
  •  2006/95/EC – Electrical Equipment designed for use within certain limits
  • 87/404/EEC – Simple Pressure Vessels
  • 88/378/EEC – Safety of Toys
  • 89/106/EEC – Construction Products
  • 2004/108/EC – Electromagnetic compatibility
  • 89/686/EEC – Personal Protective Equipment
  • 90/384/EEC – Non-automatic weighing instruments
  • 90/383/EEC – Active Implantable Medical Devices
  • 90/396/EEC – Appliances Burning Gaseous Fuels
  • 92/42/EC – New hot-water boilers fired with liquid or gaseous fuels
  • 93/15/EEC – Explosives for civil use
  • 93/42/EC – Medical Devices
  • 94/9/EC – Equipment and protective systems intended for use in explosive atmospheres
  • 94/25/EC – Recreational Craft
  • 95/16/EC – Lifts
  • 97/23/EC – Pressure Equipment
  • 2006/42/EC – Machinery
  • 98/79/EC – In Vitro diagnostic medical devices
  • 1999/5/EC – Radio Equipment and telecommunications terminal equipment
  • 2000/9/EC – Cableway Installations designed to carry persons
  • 2004/22/EC – Measuring Instruments

Remember that it’s the manufacturer or their representative who is responsible, so even if you’re importing a product from outside the EU / EFTA you’ll need to make sure that it is CE marked and compliant.

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Myths about CE Marking

1. If all the components are CE Marked, your finished product is too. No! It isn’t. The finished product needs to be assessed.

2. If company’s products are one-offs CE Marking isn’t necessary. You may want to receive expert advice.

3. CE Marking is relatively easy and can be done in- house. CE Marking is an area of considerable expertise and should not be undertaken lightly. Rectification having failed certification first time around may be relatively easy, but re-testing is both costly and time consuming and meanwhile you’re off the market…

4. We don’t know what standards or directives apply to our product or what testing is required, so we’ll wait for someone to tell us. It won’t affect us. It will. If you market a product that requires CE Marking you will need to comply. The danger is that you might think that your products comply when they don’t, and ignorance is no excuse when safety is concerned. The ‘someone’ may be authorities taking action against you!

5. It doesn’t apply to us because we only sell small quantities to B2B. CE marking isn’t just a high volume consumer requirement, even small quantities are covered.

6. We buy products in bulk from China and re-sell in Europe so we aren’t responsible for CE marking. You are placing products on the market in Europe so you are, indeed, responsible.

7. We are offering the product for customers to test, so CE marking is not required. Products don’t have to be purchased, if they are being placed in service they require CE marking.

8. We might want to change the design so we’ll wait for a while after the product has been launched, just in case. CE marking needs to be in place when you launch. (Some design changes may require an amount of re-testing or analysis.)

9. Our contract manufacturer will do it all. The manufacturer may help you with documentation, testing or assessment, but it’s you – not them – that is responsible for CE marking. You sign the Declaration of Conformity.

10. We’ve done Electro-Magnetic Compatibility testing so we can CE mark the product. CE marking covers more than EMC.

11. Once it’s tested that’s it – we pass the test and are free to sell the product. No, there are documentation requirements, labelling requirements, Declarations of Conformity to be produced and, in some instances, third party assessment to be done.

Ignorance could be personally or commercially fatal. Why risk it? Contact us on +44 (0)117 938 0600 and we’ll be able to advise you as to exactly what steps you need to take.

 

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IES forecasts further growth after securing endorsement from the MOD

IES has recently been approved for the prestigious Military Packager Approval Scheme (MPAS) by the Ministry of Defence.

IES is the first company in the country to secure MPAS thrPresentation_Photoough the route of gaining approval from scratch, rather than being transferred over from the MOD’s previous packaging approval scheme, known as DR/14.

MPAS has been awarded to only 26 other companies nationally who meet the MOD’s stringent standards that certify them to package goods for the defence industry. To gain MPAS, an IES packer Piotr Strug undertook various stages of training and assessment. This included intensive online training, then a five-day expert course culminating in a series of practical exams. Meanwhile, IES implemented new ISO 9000 management processes, which were audited by an MOD approved external certification body Lloyds Registered Quality Assurance (LRQA).

IES has been involved with the Export Packing business since 1991 and has supplied this service to companies such as Rolls Royce, GE and Intel. Over the last three years turnover has increased by 30 per cent. More significantly, the business has grown from a £4.5 million turnover in 2005 to a £7.5 million turnover in 2014, an increase of an impressive 66%. At the same time IES has expanded from employing 31 people to 45 people. Having recently taken on new packaging staff, the MPAS registration will enable IES to achieve further business growth and therefore increase the workforce.

Matt Boyd, Sales Director from IES said:
“It is extremely important for our business that we have secured the MPAS registration and certification from the MOD. It will open up a whole new area of business for us and we are confident that we will win some big contracts, which will have a positive impact, both on the local economy and us. We are forecasting high growth over the next three years and predict more recruitment will be needed to help us carry out the extra work required. There are numerous companies in the South West who supply parts to the MOD and they all need a packaging supplier who has this essential MPAS registration.”

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FAQ: CE Marking

CE Marking

Why CE Marking?
We live in an increasingly litigious world where manufacturers are required to justify and prove the capability of their products, and ever more aware consumers want to know what they’re buying. To respond to these commercial needs the ability to meet, prove and then advertise adherence to widely recognized standards is paramount. This is especially true when selling into the huge but savvy consumer world that is Europe, where CE marking is a pre-requisite, where applicable. If you are considering selling into any countries in the European Economic Area (EEA), this could apply to you.

What does having a CE Mark actually mean?
It’s a declaration made by the supplier that all applicable conformity assessment procedures have been completed and that the product conforms to EU Directives. There are numerous product categories presently covered including:
• Electromagnetic Compatibility  (EMC)
• Low voltage electrical equipment (LV)
• Machinery

Is CE Marking Obligatory?
Yes, under European Law, as well as the national laws of each EU Member State.
European Union directives, known as the “New Approach Directives”, define “essential requirements” related to health, safety and environmental issues. All products covered by these New Approach Directives must be CE marked unless a specific Directive says otherwise. Note too that the same product may be subject to several CE Marking Directives.

Use of a CE mark is a declaration of conformity; it follows that a product should not be CE marked if it only applies to the general product directive. Note that, when applicable the CE Mark should be attached to
• All new products, whether manufactured in the Member States or in third countries
• Used and second-hand products imported from third countries; and
• To products that have been substantially modified, unless the applicable Directives specifically excludes this requirement.

CE Mark

How should I apply the CE Mark?
Only the manufacturer, or his authorised representative within the EEA may apply CE Marking, which must take the form described in Directive 93/68/EEC. The manufacturer assumes ultimate responsibility for applying the mark or the manufacturer may appoint an authorised representative who should be based within the Community to act on their behalf. This person or organisation then assumes the responsibilities of the manufacturer.

When is the CE Mark applied?
Only once all assessment procedures covering conformity have been completed and the product is completely compliant.

Can we be sure that a product affixed with the CE marking is safe?
There is never a 100% guarantee that a product bearing the CE marking is safe. However, with the adoption of Regulation 765/2008pdf and Decision 768/2008pdf, the obligations of the manufacturer are spelled out and it is clear that by affixing the CE marking to a product, the manufacturer assumes full responsibility for its compliance with all applicable requirements in EU legislation.

It is the system behind the CE marking that ensures its proper functioning. The entire system, consisting of manufacturers, importers, distributors, notified bodies and market surveillance authorities, has been strengthened through the New Legislative Framework, which aims to further reduce burdens on trade while, at the same time ensuring a high level of safety and protection of other public interests.

Can I, as a manufacturer, affix the CE marking to my products?
Yes, the CE marking is always affixed by the manufacturer or by their authorised representative after the necessary conformity assessment procedure has been performed.

What is a manufacturer’s Declaration of Conformity (DoC)?
This document indicates that the product in question meets all the necessary requirements stipulated in the applicable directive. It can only be issued by the manufacturer or his representative, as detailed above.

Who supervises the correct use of the CE marking?
Public authorities in EU Member States in cooperation with the European Commission.

What are the penalties for counterfeiting the CE marking?
It varies by Member State but Economic operators may be liable to a fine and, in some circumstances, imprisonment and products may be withdrawn or recalled from the market.

Where can I find more information?
On the European Commission website. You can download the ‘Guide to the Implementation of Directives based on the New Approach and the Global Approach’, (often referred to as “The Blue Guide“). You can also contact the Enterprise Europe Network.

For the full version of this article or any other questions please contact IES.

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Factory Relocation: The Increasing Attraction of Re-shoring

It’s called reshoring, and it’s the process by which companies manufacturing in what have in the past been considered as cheaper overseas countries decide to move their product back home. It’s an awkward sounding word, but we believe that it’s one that will increasingly become part of our global trading language as the true and mounting cost of overseas manufacturing is recognised and factored in to the sales cycle.

The statistics are persuasive. According to the Manufacturers’ Organization, the EEF, one in six British companies manufacturing in China re-shored in the last three years, and of these around 40% reported that turnover increased as a direct result, with 3% reporting a fall. Around 60% reported a moderate rise in profits and employment, with the main reason given for moving production back being to improve the quality of products and components being produced, an increase in the certainty of timely delivery, the speed of delivery, and cost.

But there are more reasons than these. As Niels Morch, IES MD says, “IES’ customers are re-investing in UK manufacturing not just because of rising costs in developing economies but because there is a huge wealth of experience and expertise here that is simply not available in these countries.”

And will the trend increase in speed? Niels again, “We provide factory relocation and field engineering support worldwide so we have a very good feel for how global economies are fairing. What we’ve seen in the last fifteen years or so are our customers moving production to countries with lower labour costs such as China, Eastern Europe and also South America. We’re witness to this trend slowing and the reverse happening. We’re seeing high value added producers expanding production capability here in the UK, particularly in high technology sectors, and in some cases we are reinstalling lines that we had previously moved out of the country.

Experience has shown that there are a number of factors that should be worked out in detail before action is taken, including:

1. Planning and scheduling: It’s vital to have a clear overview and defined plan of everything that needs to happen, how it’s going to happen, when and what costs will be incurred.

2. Information: It’s all in the detail. Collect and collate as much information as possible in advance. Decide what is to be relocated and what is involved in doing this. Are there specific problems attached? What additional support is required?

3. Communications: Ensure that all the parties involved receive adequate, appropriate and regular information and updates to enable them to do their job.

4. Expertise: Call in the experts! Engage with knowledgeable and experienced relocation people as soon as possible.

5. Project management: Make sure you have a robust project management team in place with the authority and structure to allow good decision making with strong communications

And if you’re thinking of re-shoring why not give us a call; we’d be happy to advise.

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Cost effective Electro Magnetic Capability (EMC) Testing

“Visitors are requested to turn off mobile phones when in this hospital.”

“All devices must be turned off during take off and landing.”

It’s a bore, but we have to do it, and the risk is that our phones will somehow interfere with their electronics. And that’s the last thing you want, or for a large robot to go berserk because of electrical corruption…so there has to be a control on the amount of interference, “noise”, that all electrical and electronic machines emit, it makes sense.

The trouble is that EMC is still viewed as an expensive process that is not really required, and this article identifies the real need for EMC and how the cost of meeting EMC requirements can be kept to a minimum.

Electro Magnetic Compatibility, EMC. means the ability of modern electronic equipment to function properly within the electrical environment that exists today, both from the point of view of withstanding ‘noise’ from other equipment (Immunity) and not itself generating excessive ‘noise’, (Emissions) to create interference with the devices around it. It’s important that electrical and electronic devices are able to cope with low signal conditions, high levels of noise and still function as required.

And that’s the challenge:

It doesn’t take much imagination to see how, in today’s industrial environment and with lots of heavy electrical and electronic devices all working in close proximity, it becomes vital for EMC to be adhered to. There’s also a legal requirement to ensure that all products conforms to the current European Directives and associated Standards, it’s an important element of CE marking and a complete set of test results and information must be provided within the Technical File.

So, how can we help?

This type of noise uses some complex test equipment to measure it and produces information that requires an experience engineer to interpret the results. Interestingly experience shows that most of the costs associated with EMC testing are caused through not getting things right in the first place and all the work involved in fixing faults and retesting. It doesn’t have to be like this, and we’ve prepared the following list as guidance:

1. Ensure that an experienced EMC engineer look at all designs prior to manufacture and that their advise on potential problem areas and actions to take are acted on. If this is done at the design stage the cost is low but the end results prove very cost effective.
2. Use CE marked components.
3. Always follow the manufacturer’s installation instructions.
4. Have experienced engineers design and build the equipment, keeping power and control cabling separate, do not cross input and output signals, ensure good earthing practises, etc..
5. If possible perform mini uncontrolled tests on products at the pre-production stage to check if any problems are likely, reducing the potential for issues before production starts.
6. Always aim for large margins of clearance from legal limits to actual performance to allow for slight variations in component specifications.
7. On high volume products carry out regular tests during production. By the time a complaint is made it’s generally is too late and expensive to remedy.
8. Prepare and record proper tests results to be included in your Technical File.
Needless to say, IES can provide advice at all stages of manufacture; we can undertake any testing and provide appropriate and full test results.

Please contact IES if you require any testing, manufacturing support or assistance with the compilation of the technical files.

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IES – Semiconductor Training (Equipment Training, Process Training and Consulting)

A short search on Google under the term “Semiconductor courses” quickly reveals that unless you’re prepared to go to university or live in the USA, the opportunities to receive third party instruction and training in semiconductor processes and disciplines are thin on the ground. The good news is that IES offers precisely this, a variety of courses that cover a wide range of topics central to the semiconductor industry.

To those who know us this will come as no great surprise; IES has been providing programme management and specialist services for semiconductor equipment and factory relocation since 1991 and have a diverse and experienced team of engineers, programme managers and equipment specialists, between them with more than 150 man-years experience, all more than keen to share their knowledge and enthusiasm for semiconductors with others eager to learn. It’s also an opportunity for us to express our commitment to this industry by providing a quality engineering resource.

How do we do this? Two ways: Firstly we offer a range of both process and tool based training courses, these include:

  • Ion implanter Equipment Training – Maintenance and diagnostic trouble shooting, including for AMAT, Axcellis and (formally) Varian tools
  • AMAT P5000 Equipment Training – Maintenance and diagnostic trouble shooting
  • Process Development – Tungsten (Wolfram) Chemical Vapour Disposition, Low Pressure CVD, Wet Clean and Plasma Etching, including for AMAT,Centura and Endura
  • Furnace training – multiple system types, horizontal, vertical, RTP.

Secondly, we can work with you to assess your specific training needs and from that develop a bespoke training plan to cover the subject/s to the depth required in the time available. These courses can be held at your own premises to minimise your travel and down time or at our premises in Bristol.

Who are they for? Anyone in the industry! In essence our courses are designed for the effective professional development of technical professionals in the semiconductor and integrated circuit manufacturing industry, be they new to or experienced. They can be matched to your specific toolset – providing your process engineers with the knowledge of which parameters to modify to produce the desired effect.

Less specific training can also be provided in robust process module design, process integration and design of experiments.

Delegates to our training courses could well include:

  • Process engineers in the manufacturing environment
  • Process development engineers and scientists
  • Device engineers
  • Product engineers
  • IC Designers
  • Failure Analysis Engineers
  • Process Equipment Engineers
  • Manufacturing managers and key decision makers
  • Senior level technicians
  • Reliability and yield enhancement engineers

Next step? Why not get in touch to discuss your requirements and to find out how we could help?

 

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Wooden Packaging: Legal considerations when Exporting or Importing

Purchasers of packaging are always in the hands of their packaging suppliers when it comes to meeting the many and varied pieces of legislation that cover this activity. This isn’t helped by the fact that legislation can change from country to country, and whilst Timcon, the timber packaging and pallet confederation, gives invaluable help with guidance and legislative updates, it remains the responsibility of the exporter / importer and, inter alia, their packaging supplier to ensure their shipments meet all the requirements.

A good place to start is with the International Standards for Phytosanitary Measures No.15 (or ISPM15 for short), which was first introduced in 2002 to reduce the global spread of plant diseases and pests associated with the international movement of wooden packaging. Updated several times, the most recent being in April 2013, a copy of the latest specification can be found here. ISPM15 is subscribed to by 48 countries, including the EU and so is likely to apply to most of the places the reader is trading with, but is important to note that specific terms may apply to each subscribing country and a check on the Timcon website (www.timcon.org) will always be worthwhile.

Export Crate LegislationCloser to home the EU Timber Regulations (EUTR) came into force in March ’13. This acts to ban the use of illegal timber in the EU and requires that due diligence in the form of a risk assessment be performed prior to any wood or wood products being introduced. Risk, in this case, would include an illegal source, but extends to acting to mitigate any other identified risks.

EUTR also demands that as a packaging supplier we keep a record of the supplier, the product species, the source and the amount bought in each transaction, and we have to record our risk assessment on the product, based on the evidence we have collected.

How do we do that? We have to use credible information about the country of origin, the supplier, the product and anything else pertinent before an order is placed, and we have to record what actions we’re taking to mitigate risk going forward.

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