Example 1: Automated Processing Line

We provided CE assistance and advice to a UK based company specializing in the design, manufacture and installation of custom automated processing lines. The detailed aspects of these large automated lines were designed and assembled by a sub-contractor in China and installed in Europe. We provided a range of assistance including

• Advice concerning the process and applicable directives

• Initial reviews of design approaches and detailed drawings

• On-site assessment of the machine against identified harmonized standards

• On-site recommendations and assistance resulting in changes to ensure compliance

• Production of all support technical documentation

Example 2: Automated Package Handling Line

We provided CE assistance and advice to a UK based company that had purchased a complete automated package handling system from a manufacturer from Australasia. The system was not CE marked and the manufacturer had no authorized representative within the EU, thus the responsibility for compliance lay with the customer. We provided assistance that enabled them complete the process. The help we provided included the following,

• On-site assessment of the machine against identified harmonized standards which resulted in extensive requirements for corrective actions

• Guidance concerning the options available for remedial action

• Assessment of work carried out by the manufacturers installers

• Recommendations for suitable personnel to complete the task (our associates)

• Production of all support technical documentation

• On-site reviews

• Pragmatic solutions

• All aspects covered

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A well-established high-volume subcontract manufacturer of metal components (T/O ~ £ 6M) had grow slowly since its formation 15 years ago. Over the last 5 years the rate of growth had accelerated dramatically and it had diversified via the purchase of an unrelated product-line from another company.  The systems and processes that had evolved during the slow growth period were unable to cope with the new situation and major quality and supply issues were beginning to emerge.

 We were given the task of doing a complete audit of all of the Company's processes from forecasting through to delivery logistics. To deal with such a broad scope we adopted an approach based on "iterative scoping", that carried out a fast, top-level review, which was followed by in-depth "drill-down" studies in specific areas (reviewed and agreed with the Client, as part of the process). 

The report provided a detailed assessment of all of the critical processes, and our detailed analysis revealed that a few fundamental issues which were responsible for the large (and increasing) number of problems.  Pragmatic and detailed improvement recommendations where given covering a range of areas including sales order forecasting, stock control, design and information control and  production scheduling.

Going for Growth

• Quick, minimal disruption

• Iterative approach

• All aspects considered

• Key issues found 

• Pragmatic recommendations

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A large proportion of specialist, high technology equipment such as scientific instrumentation is designed and produced by small and medium sized companies. It is not unusual for the detailed regulatory requirements to be forgotten about when the time pressures of new product development start to take their toll.

We have built up long term relationships with manufacturers which allow us to provide simple, pragmatic help with such issues as electrical safety and reduction in EM emissions and susceptibility. We also provide a remedial service for products that are about to launch (or have already escaped!) and still have problems.

On example of this was an "emergency" remedial programme undertaken for a UK-based scientific instrument manufacturer. They had developed a new unit as a replacement for an ageing product. A few weeks before launch is was sent to us for assessment; unfortunately after an initial EMC assessment it was apparent that the EM emissions from the unit were at an unacceptable level. It was agreed that we would carry out modification work to remedy the situation and provide a set of detailed corrective actions to bring the existing production unit into compliance. This work was completed quickly ensuring that the launch date did not need to be changed.

• LVD and EMC assessments

• Pragmatic solutions

• Remedial actions

• Quick response

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We were called into a medium sized manufacturer (T/O ~ £15M) of products used in the construction industry. Half of the business was based on standard product that was "build-to-stock" and sold through large trade and retail outlets, this section was well-understood and the owners were happy with its overall performance. The other half of the business was focussed on direct delivery to large scale construction projects. The growth in demand for this sections product was particularly healthy; the problem was that they were unable to satisfy the demand and each month the overall delivery times for these products increased. Initial indications from the owners pointed to errors in the standard build times used to arrive at the overall delivery times. 

An extensive Technical Audit was carried out covering all of the operations relating to this product line.  Numerous problems and issues were identified and these were condensed down to a small number of fundamental issues, primarily associated with the fact that this section was dealing almost exclusively with custom-designed product but this factor had not been accommodated by any of the internal processes from pre-sales through to production scheduling. Tackling these fundamental issues was not a quick job but the owners were really on the ball and realised that the resulting rewards were worth the effort.

• Multiple problems reviewed

• Causes unearthed

• Line now under control

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Example 1: Small electrical equipment

A US manufacturer of electrical equipment used in skin care service sector was looking to export to Europe and required its equipment to be CE marked. It had investigated getting local assistance but this proved both difficult and potentially very expensive. They contacted us and following initial discussions it was agreed that a unit would be set for initial evaluation (free of charge). Following the initial review it was apparent that he unit would not be acceptable in the original form. It was proposed that remedial action be carried out before the detailed assessments, this was agreed in advance.  We subsequently provided the following,

• Rewiring and replacement of key components

• Detailed LVD assessment and EMC testing

• Production of detailed information concerning required changes

• Production of all support technical documentation

The Company has now established a European representative and it starting to promote the units in the UK.

Example 2: Electrically controlled, hydraulically powered platforms 

Working with a UK representative we provided CE assistance and advice to a US based company that manufactures large powered platforms for use in a range of industrial applications such as for accessing chemical tankers during unloading etc. The units are classified as machines and can be operated in potentially explosive atmospheres. We provided a range of assistance including

• Advice concerning the process and applicable directives

• Initial reviews of design approaches and detailed drawings

• On-site assessment of the machine against identified harmonized standards

• On-site recommendations and assistance resulting in changes to ensure compliance

• Production of all support technical documentation

• Remedial actions

• Pragmatic solutions

• Detailed assessments

• Complete solutions

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A business had been formed to develop, market and manufacture a novel version of a well-established product. The company had grown rapidly during this initial phase to the stage where is employed around 30 people. Following the demonstration of working prototypes, there was a lot of interest in the marketplace and production began to gear-up following the official launch.

We were brought in to assist with one aspect of the introduction process. We spent some time with the company trying to determine the exact needs, following a number of discussions with various individuals it was apparent that there was a problem. Following discussions with the senior management it was agreed that we should undertake a brief technical audit on the product release status. A formal audit was carried out which took less than 5 days, the result was a real shock to the management and a majority of the people involved. The bottom line was that the product had to undergo further basic development, extensive engineering and a substantial effort was required to bring the product information up to scratch. Overall the launch was delayed by 4 months. Had the review not taken place the resulting problems in production, and support would have cost the company of cash and resources, at worst it may well have stopped the company gaining a foothold in this competitive market. The business has now adopted a formal review process for all development projects and is continuing to improve its internal processes.

New problems!

• Underdeveloped product

• Confused information

• Poor communication

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Class 1 devices - CE Marking

Although the requirements are relatively straightforward, CE marking for low risk medical devices can still provide a number of headaches for small businesses, we have helped in a variety of ways including,

• Providing a complete service from initial assessments through to advise on MHRA registration

• General guidance and assistance

• Preparation of templates for assessments of multiple products

• On-site training of staff

Higher Class devices - CE Marking, ISO 13485 etc.

The compliance requirements are more complex for Class 1 devices that are Sterile or have a measuring function and for all higher Class devices, . One requirement is to show that the "manufacturer" has an "appropriate Quality system in place. The normal method of demonstrating that a suitable system is in place is to ensure that it complies with the requirements of ISO 13485. We have provided advice and assistance for Class 1 sterile and an Class 2A devices, these have included the following,

• Advice concerning the process and applicable directives

• Initial reviews of documentation and records

• Detailed help with putting together a quality system that complies with ISO 13485

• Provision of "internal" audits

• Review of all detailed technical documentation or production of such technical documentation

• On-site reviews

• Pragmatic solutions

• Detailed assessments

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A majority of businesses (both  manufacturing and service providers) grow organically over an extended period of time. As the organization grows,  a variety of Information handling tools are developed to deal handle local issues, each of these "point solutions" assists the people involved but as the complexity grows it soon becomes apparent that the overall "system" is non-optimal. At this stage the business (or usually a very limited part of it) will decide that an overall Management Information System (MIS) is required.

Unfortunately the success rate for implementing these systems has never been very good. In survey after survey, in the USA, Europe and elsewhere, less than one third meet the basic criteria set out at the start of the implementation. In many cases the implementation has been directly responsible for a serious degradation in effectiveness and efficiency. It is not that these systems are bad it is just that they are often not implemented correctly due to a basic lack of understanding concerning the actual operation of the business itself.

We have been involved numerous Technical Audits designed to detail the requirements for a suitable MIS and to make detailed recommendations concerning the improvement of internal processes that are required to make the most of the system when it is  finally operational. Listed below are some of the types business for whom we have provided this service.

• Distribution/warehouse business (T/O ~ £1M)

• Construction and shop fitting business (T/O ~ £2M)

• Electronic sub-contact manufacturer (T/O ~ £1M)

• Manufacturer of industrial gas-handling products (T/O ~ £ 4M)

• High volume manufacturer metal components (T/O ~ £ 6M)

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