![]()
![]()
|
Understanding your processes |
Working with one or two people who know what the business is in business for, I find out what the 'subject matter' of the organisation is and then apply two simple rules to turn it into a map of the organisation's processes and how they fit together. This process architecture then becomes the solid foundation of all subsequent work on the organisation's processes using Riva. Using Riva's powerful concepts, the process architecture of an organisation can normally be prepared in just two days, sometimes just two hours. Once all the activity of the organisation has been cleanly divided into the processes in the process architecture, existing processes can be modelled as a first step towards their understanding and improvement. Working with the group responsible for managing and carrying it out, I expect to be able to model a process in a workshop that takes no more than a day. If it takes longer it is generally because there is disagreement about the process - which may be what we want to reveal! In some cases a model from a workshop needs to be validated or refined by watching the process in action, by examining materials used or produced during the process, or by referring to the 'official' statement of how the process is intended to work in a Quality Manual or similar. Riva process models are very compact - it would be unusual for one to extend to more than an A3 sheet. |
|
Analysing and diagnosing your processes |
Often the aim of a process modelling activity is simply to understand the process and to generate a shared understanding of it across the organisation. The interactive workshop can achieve this on its own. As often though, there is a need to improve a failing or inefficient process, and it is here that the underlying modelling concepts used in a Riva process model prove their power. As the process is revealed during the workshop, so are its shortcomings and so are potential solutions. And very often the imagination and knowledge of the participants suggest opportunities beyond the fixing of problems. Because a Riva process model (in the form of a Role Activity Diagram) captures the roles involved, how they interact and collaborate, and the decisions they make, participants relate directly to it. Diagnosis and solution follow quickly. I can then draw together the work and help the group prepare its proposals for change. |
|
Designing new processes |
Where an organisation is responding to a new business environment - perhaps a new product - it needs new processes and again an interactive workshop using a Riva process model proves quick and powerful. Techniques within Riva allow the group at first to work at an abstract level, without worrying about existing organisational constraints. As the process design takes shape so the group can move from the abstract to the concrete, defining posts and roles, how they will collaborate and interact, where decisions will be made, what quality controls will be put in place and so on. My role is to help the group towards a sound definition of their new process, together with a description of the resulting new roles, communication channels, IT requirements, job specifications, training and competency requirements. |
|
Building a business-focussed IS strategy |
Working with senior management in the organisation, I use workshops to help them to connect their current business drivers to their processes (as determined by the process architecture), and their processes to the information needed for those processes. I use standard matrix-driven techniques to help the participants to build their understanding of how IS should be supporting the needs of their business today and where the priorities are. This proves a powerful preliminary step before traditional 'as-is' and 'to-be' analyses of the business's IS architecture. Equally, a Riva process architecture gives the IS department a powerful tool to analyse what systems are supporting which processes in the business and to discuss with their customers - senior management - where the gaps and opportunities are or will be as the business changes. I can prepare the process architecture with the IS group and carry out the initial analysis of which systems support which processes and how successfully, through both interview and survey. In this way, I can give IS and the business a common ground, rooted in the business, for jointly developing a business-focussed IS strategy. |
|
Designing and building a quality management system |
I have had many years experience in the development and evolution of Quality Management Systems, particularly in software development. I have been involved in process definition across the pharmaceutical industry, in both R&D and in manufacturing. I have helped groups diagnose and design their processes in the areas of portfolio planning, batch production, clinical trials, clinical trial supplies, data management, and adverse event reporting, as well as of the IT and infrastructure services necessary to support the mainstream business. I have developed pharmaceutical Standard Operating Procedures (SOPs) using Riva Role Activity Diagrams, and prepared Quality Management Systems and Validation Systems for pharmaceutical software. I can combine a broad knowledge of the pharmaceutical environment and its validation needs, powerful methods for process design, and my experience as a Quality Director in an ISO 9001 environment, to build SOPs and entire QMSs that are pragmatic, effective and soundly based. |
![]()