Synthetic Automation Specification

Although many excellent commercial systems exist, it is still often necessary to customise these to a particular users needs. It is all too easy for both managers and users to over specify their requirements, making the system more expensive than it needs to be. Consequently a few important considerations taken at the outset of a project can lead to rapid success using the currently available technology. This should usually combine proven techniques and reliable hardware, with flexibility for...

US Differences from the EPO

Because the US is such an important market it is well worth listing separately the special conditions that apply to their patents versus the EPO. 1. Inventors. All US patents must be filed in the names of the inventors. Assignment to the company can subsequently be done. 2. Prior Art. For the EPO this is anything made public by anyone, anywhere. In the US you can still file a patent up to one year after public disclosure by the inventor. All known prior art must be disclosed failure to do so...

Cost Control and Monitoring

Controllable costs, i.e. those that an R& D Manager will be expected to control have been described in Section B, 3.1.1. In large R& D units, expenditure on consumable items, local travel and training costs can be delegated to the more senior scientists. It is still surprising to find that in many companies, even quite senior people are not allowed to sanction small sums of expenditure. A person who is successfully running a home, with all the financial dealing and control involved, when...

Morphological Analysis

Morphological analysis is a good tool to use as an aid in the setting of long term R& D targets either in new business areas, new processes or designs. It is not very useful in answering a problem in short-term innovation targets. Using this method it is possible to generate a large number of ideas in a very short time. The initial step in the method involves breaking the problem down into the important functional areas, dimensions or sequential process. This method is best illustrated using...

The One Stop Shop Super CROs

One stop shopping was a late twentieth century phenomenon, whether it referred to a city superstore or a bank which became a financial services centre. By adopting this idea the chemical services industry has targeted the formation of super CROs as the way forward, especially to service drug companies. Super CROs offer a full range of services aimed to reduce drug development times and make the costs more predictable. They operate by forming active partnerships with the lead compound generating...

HSE and Product Registration

The health, safety and environmental (HSE) aspects of the chemical manufacture should be uppermost in the team's mind throughout the course of the development. However, once the development of the process has reached the stage when only very minor modifications are likely to occur, it is time to look at the formal aspects of HSE. The components of HSE that are internal to the company are Health hazards in the workplace Environmental impact of manufacture The evaluation of the potential hazards...

Project Definition the What When and Constraints

Planning of a project should start only once it has been redefined in specific terms. The Project Team Manager and members having been assigned to the project, their first task is to carry out a complete definition of the project. The team will know the overall goal of the project but its purpose and objectives will need to be clarified and redefined in more specific terms of deliverables, assumptions and constraints. Project definition enables all the stakeholders, both internal and external,...

Environmental Management System ISO 14 000 series

The ISO 14000 Environmental Management Systems (EMS) can be regarded as analogous to the ISO 9000 series, viewing the customer in this case as the environment, and just like ISO 9000, ISO 14 000 requires companies to do what you say and say what you do. The relevant member of this family to chemical companies is the ISO 14 001 standard, which provides a framework on which to build a system that enables an organisation to meet the regulatory requirements. This is achieved by integrating...

Risk Assessment

The chemical laboratory is a potentially hazardous place. With such a potential for danger it is remarkable how few really serious accidents occur. This must be due to the rigorous training scientists receive, especially chemists, building an understanding of the extent and nature of chemical hazards. Under the provisions of the legislation, Managers must ensure that all new recruits are trained and fully familiar with the safety procedures operating in the laboratories. It is also wise to have...

Capital Costs

Capital investment in the R& D facility is a constant requirement, especially in the in-strumentally intensive automated areas. The analytical laboratory is one of those areas where instruments are constantly being updated and new ones introduced. The semi-technical plant is another area where significant costs can be incurred, and these will need to be allocated to a project. These capital requirements must be under constant review and considered during the planning phase of any project....

The RD Portfolio

The projects within the R& D portfolio, and hence the targets to be worked upon by R& D fall into the following three main categories 1. The further development of existing products and processes in terms of cost, quality and environmental impact. 2. The invention of new products and processes for existing businesses. 3. Strategic Research, i.e. new business and technology or competency building to support or underpin the longer-term business goals. The process that is used to generate...

RD Work Groups

In R& D departments, work groups are organised usually in a very similar way to that adopted by the company for its component businesses or functions, and to meet its strategic objectives. The work groups can therefore be organised by function, i.e. grouped according to disciplines, such as organic chemistry, process engineering, biochemistry, the groups being managed by people with the same technical background. This pure functional discipline organisational method is now largely out of...

Project Management of Innovation

The selection of innovation projects is of great importance to a company that wants to stay at the front of the race with its competitors. Hence the need for innovation to be clearly defined in the company's strategy and its role in meeting the ambitions of the business to be understood at all levels in the organisation. At the strategic level there needs to be a formal mechanism for identifying any gaps in the current innovation requirements, required to meet the growth targets of the...

RD Management Issues

Speeding up the delivery of new products to the market involves intelligent risk and resource management. The overall objectives of time compression management, within which an R& D Manager must work, are simply stated as get products into the market more quickly. In order for this to be achievable the R& D Manager should have some overall targets set by senior management as part of the company strategy. At this level of management the targets do not need to be specific and can be as...

The Faster and Increased Return on Investment

Whilst there are external restrictions on the speed a new product can be introduced into the market, as outlined in Section D, 2.3.1, the major limitations are set by a company's own internal systems and methods of project management. A goal for every R& D Manager must be to overcome these internal limitations, and to get a faster return on the company's investment in R& D. The financial returns to the company, from a more rapid development, can be easily quantified and the figures used...

The Matrix

Use a matrix in the time management of cross-functional projects. The final organisational structure to be considered is the matrix. Matrix organisations grew out of the need to have a compromise between the functional grouping responsible for competence and resource utilisation, and the product grouping responsible for coordination, control and goal accountability. There are three basic types of matrix organisation. Managerial authority retained by department heads (HODs). Project Manager (PM)...

Kirton Adaption Innovation Inventory

Another widely used metric is the Kirton Adaption-Innovation Inventory. This is based on the Kirton Adaption-Innovation Theory, which considers that, before people can feel comfortable when tackling a problem they will differ amongst them on what structure they require and whether there is a need for a consensus on that structure. Another important factor is how important is the outcome of the problem solving, what is the reward or alternatively the punishment to be felt by the people...

Performance Appraisal Schemes

Performance appraisal schemes fall into the four generic classes shown below. The traditional appraisal scheme involves the manager appraising the performance of staff members on a one to one basis. These can be well-conducted conversations on an individual's performance but do have the capacity to become authoritarian and dictatorial. Competency based appraisals are those where performance is appraised against clearly identified competencies and are not concerned with personality or character...

Internal Records

Several times in the preceding items the need to record and securely store information relating to intellectual property has been mentioned. The more important information produced by R& D is recorded in several ways, the most common being the following. Laboratory notebooks, both hard copy and electronic, for experimental work Results from the application testing of materials Analytical results and information on chemical structures (LIMS) Project folders, containing data on individual...

Sources of Innovation

Exploitation of the unexpected is a difficult activity but one which has the potential for high rewards. There are many ways in which innovations can arise and be brought to the market within companies and Drucker exemplifies seven such sources C-5 . 1. Areas of Unexpected Innovative Opportunity Unexpected Success, e.g. the discovery of the nylons (DuPont). Reaction to unexpected failure, e.g. temporary adhesives (3M). Reaction to unexpected outside adjacent event, e.g. development of ink jet...

Lateral Thinking

For most of our education we are taught to think in a logical manner. This is called vertical thinking because the process involves proceeding directly from one state of information to another, and in this sense is continuous. Lateral thinking is a discontinuous process and depends on the ability to escape form the rules of vertical thinking. The essential differences between the two types of thinking are given in Table C3 C-10 . Lateral thinking is something that is used sparingly. In fact the...

Psychometric Tests and Assessment Centres

Support for the evaluation of the non-technical make up of a candidate is very commonly sought by carrying out some form of psychometric tests on the candidates. Psychometric tests are designed to assess either ability (cognitive tests) or personality characteristics and there are three basic types ones to assess a specific ability, e.g. numeracy, verbal and spatial perception ones to test general mental ability, e.g. an alytical reasoning, creative thinking and those to asses general...

Good Manufacturing Practice GMP

Good Manufacturing Practices, known internationally by the acronym GMP, are regulations that describe a set of principles and procedures covering the methods, equipment, facilities, and controls required for producing human and veterinary products, medical devices and processed food to the required quality. They are used by pharmaceutical, medical device, and food manufacturers as they produce and test products that people use. In the United States (U.S.), the Food and Drug Administration (FDA)...

Business Strategy and the Innovation Portfolio

The innovation portfolio is designed to fill the innovation gap. There are three important elements involved in understanding the role of a business and its objectives. 1. Having a Mission. Often expressed in a Mission Statement. 2. Having a Vision. Knowing where the business wants to be in the future. 3. Having a Strategy. How to get from where we are now to where we want to be achieving the Vision. Figure D2. The Formulation of a Business Strategy Figure D2. The Formulation of a Business...

Joint Venture

Sometimes it is apparent that opportunities arising from the results of R& D work, especially those related to new business ventures or from research of a more strategic nature cannot be exploited effectively by the company on its own. In these cases it may be that the innovation can be introduced to the market by jointly working with another partner. This is the joint venture route to exploitation. Having the right partner is of crucial importance, the wrong choice being the cause of most...

Setting Performance Objectives

The basic task for the R& D Manager is to make sure that performance objectives and criteria for success, whilst being sufficiently difficult to stretch the individual, are achievable within the desired time frame. There is no point in setting performance criteria that are so easily achieved as to be meaningless, nor so difficult as to be un reasonable. These criteria must be agreed with the individual concerned, and are best set by the person's immediate supervisor. Problems will arise if...

A B C D

Cause and Effect Diagram (Ishikawa, Fishbone) Figure B19. Cause and Effect Diagram (Ishikawa, Fishbone) Cause and effect diagram. This is also known as the Ishikawa diagram. This was introduced as a formal way of representing a specific effect and the possible causes that influence this effect. They are used to display all the possible causes of a specific problem and are usually constructed around two sets of four basic causes. 1. Manpower, Machines, Methods and Materials (see...

Monitoring and Controlling the Project

The Project Manager has to have a good system for monitoring and controlling the project. Fortunately, most project management software packages contain such a system. However, slavishly following these systems, without a basic understanding of how they work, can lead to problems for the unwary. The basic tenets for these methods are Having a clear knowledge of the criteria by which the performance of the project is going to be judged. Having a system for providing an early and accurate warning...

Explicit and Tacit Knowledge

In a business context there are two working definitions of knowledge knowledge as a body of information and knowledge as know-how. These are often referred to as explicit knowledge and tacit knowledge. The generation of these two types of knowledge in an individual is described in the Learning Cycle devised by Kolb in 1974 and illustrated in Figure C11. As can be seen tacit knowledge is attained by acquaintance with a topic and involves divergent think- Apprehension - Knowledge by Acquaintance...

The Stage Gate Process

As mentioned earlier the odds of failure for a new product are high. For every eleven new products in the pipeline only three enter the development phase, only 1.3 are launched and only one is successful. One way of improving the chances of those entering into development getting through to launch and then becoming successful products is to use an effective project management methodology. The majority of companies use some form of stage-gate process, the most common of which was devised by Bob...

Performance Standards and Indicators

Performance standards need to be set by management at such a level that the business is able to function whilst minimising hazards and risks to people and the environment at every stage B-22 . In the laboratory these performance standards need to cover three operational aspects. 1. Control of Inputs. The objective is to eliminate hazards and minimise risk associated with equipment, chemicals and materials, information and the people who come into the laboratory. For example HSE performance...

Synectics and Metaphors

Synectics is from the Greek word synectikos defined as the bringing things of a different nature into connection. Originally this was taught by Synectics Incorporated as a procedure for creative thinking through the use of analogies. In this method analogies are used to install in the mind concepts which normally would not be connected by a logical thought process C-16 . There are three fundamental precepts of synectics theory C-17 . 1. Creative output increases when people become aware of the...

Disciplinary Action and Trade Union Representation

Even in the best-managed and highly motivated groups of scientists, there are occasions when disciplinary action will need to be taken with some individual. A case of failure to meet performance criteria over a reasonable period of time will initially be dealt with by the performance related pay system. However, when poor performance persists over an extended period, even after trying the person in other roles and giving an official warning, then termination of employment will be the result....

Mind Maps

Mind Map Drug Industry

Making associations between one image or word is an important activity of the brain when a person is thinking. Each image or word has innumerable links to other words and images leading from one idea to another. Mind maps, developed by Tony Buzan, are designed to model the way the human brain works, i.e. by associative and linear processes, and so assist in the generation of new ideas C-18 . A mind map is made by starting in the centre of a page with the main idea or problem, and then working...

Microscale Experimentation

Micro reactors and devices that can process and analyse very, very small amounts of chemicals is an area that is rapidly advancing, with applications in both the analytical and synthetic laboratories and also in full-scale manufacture B-15, B-16 . This area is also known by the jargon term, lab-on-a-chip, as many of the devices are sub-millimetre scale, integrated chemical systems built by the microfabrication techniques developed in the electronics industry. This reduction in size and the...

Network Diagrams

On the basis of events and activities and the order or sequence in which they will happen within the project the Project Manager can develop what is called a network diagram. The Project Manager also has to determine which activity takes precedence over another, i.e. which must happen before another can take place. These are, except in the simplest of cases, very difficult to construct by hand, unless the person is very experienced, and available software is of a great advantage. Taking the...

Assistant Chemist

British Energy is the largest generator of electricity in the UK, supplying energy to industrial and commercial clients. Employing more than 5000 people, our core business is nuclear generation. We own eight nuclear power stations in the UK with a combined capacity of 9600 MW and a 2000MW coal fired plant in Yorkshire. These stations supply 20 of UK electricity. The work of the Chemistry team is varied and you will be expected to contribute to a wide range of task areas, it is anticipated that...

Quality Management Systems ISO 9000 Series

Iso 9000 Figure

The worldwide standards adopted since the late 1980s are the International Organization for Standardisation (ISO) ISO 9000 series, the most recent version of which is ISO 9000 2005. These are designed to ensure that customers are guaranteed the same quality when purchasing from a company in any country that has adopted these standards, provided that a company has the following Standardised processes of quality assurance A system of corrective actions Management review of the quality systems...

Program Evaluation and Review Technique PERT

In the program evaluation and review technique (PERT), developed by the US Navy in the 1950s as part of the Polaris mobile submarine launched ballistic missile project, network charts depict task, duration, and dependency information. Each chart starts with an initiation node from which the first task, or tasks, originates. If multiple tasks begin at the same time, they are all started from the node or branch, or fork out from the starting point. Each task is represented by a line, which states...

Total Creativity Management

Everybody can contribute to the creative process. All functions within any successful business need to be innovative, but it is only R& D where this is paramount. R& D is the engine room for creativity and innovation within the company and this is its sole reason for existing. Consequently, if the right conditions for encouraging and exploiting creativity and innovation are not in place then the whole exercise will eventually be doomed to failure. Thus an understanding of the creative...

Six Thinking Hats

The Six Thinking Hats, designed by Dr. Edward de Bono, is an ingenious framework to think through a subject in a focused way that makes time and space for creative thinking C-19 . It is used extensively in companies such as DuPont, IBM, Prudential Life Insurance, British Airways and Siemens to have efficient, productive meetings. The underlying principle in the Six Thinking Hats framework is that parallel thinking is more productive than argument. There are six symbolic hats as shown in Figure...

Career Development

Database Data Flow Diagram

Most people want to see a career path stretching in front them. Career development, like monetary rewards, is something that is of concern to everybody in employment, particularly for staff in their early years with a company. Most people in work, with the exception of those nearing retirement age, like to feel that there is a career path stretching in front them. They want to know where this is leading and how they are going to progress along the route. It is the job of any Manager to...

The Dow Chemical Project in Knowledge Exploitation

In the early 1990s Dow Chemical considered that it was not exploiting to the full extent its intellectual capital, generated over many years requiring a high-level of expenditure C-36 . So it set up a small team to examine how it might re-engineer its systems and processes to create more value. The main asset was a disorganised patent portfolio of 29000 that it was spending 30 million each year on maintaining. The team needed to measure the value of those assets, and required new processes,...

Continuous Improvement

Continuous Improvement Any Industry

Having a set of procedures written down and in place is only the very first small step down the road to a Total Quality organisation. The key to going further along this road, is to recognise that all procedures and processes can be continuously improved. The activity of continuous improvement requires the involvement of all staff, at whatever level in the organisation. In this activity nobody is exempt, least of all the Manager, who must lead by example B-32 . Three key groups of people who...

Quality Procedures

Most companies have set in place procedures to meet the requirements of the international quality standard e.g. ISO 9001 or national equivalents, as discussed in Section B, 3.2.2.3. The requirement of these standards are that procedures are in place for all activities carried out in the workplace, that these procedures are recorded and that the activities are carried out, by staff, as described in the procedures. The operation of these procedures is subject to an external audit, to confirm that...

Gantt Charts

A special type of bar chart used for providing a visual representation of the schedule of a project, bears the name of the inventor Henry L Gantt, hence Gantt Charts. In these charts the time frame of the project is represented on the horizontal axis in columns of days, months or years, whichever is appropriate, and the vertical axis has rows listing the tasks to be done during the project. Against each task a bar is drawn covering its duration. Figure D17. Gantt Chart Product X Manufacture by...

The MBTI Creativity Index MBTICI

Having a metric or personality test that could define accurately a creative individual would be of great help in placing people in the correct job. There is one tool, developed by Harrison Gough, which is designed to perform just such a function C-3 . It is called the MBTI Creativity index (MBTI-CI) and is based on the Myers-Briggs Type Indicator (MBTI). MBTI, the most widely used instrument for understanding normal personality differences, was developed by Isabel Briggs Myers and her mother,...

Lead Times and the Development Risks

There is a correlation between the cost to the business of a delay in the lead-time for a new product and any risk to the success of this product in terms of its functional design. This is shown schematically in Figure D15. At one extreme of this correlation, the risks in the development of a product and also the cost of any delay in the lead-time for its introduction to the company are both low. This is a state of happiness for all concerned and occurs very rarely. For this to be the case, a...

Good Laboratory Practice GLP

Good Laboratory Practice GLP is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. Adherence by test facilities to the principles of GLP ensures that there is a proper plan ning of studies and the availability of adequate means to carry out such studies. It facilitates the proper conduct of studies, promotes their full and accurate...

The Interfaces between RD Manufacturing and Marketing

Multi-functional project teams are used to overcome the problems that can occur at the interfaces between functions within the company. Even where such teams exist and are part of the culture, an R amp D Manager should be aware that interfacial problems still exist, that they continue to operate outside the confines of the project team and can hinder its progress. Of particular interest to R amp D Managers are the interfaces between R amp D, manufacturing and marketing, particularly the latter....