Planning for Success

Demand volatility is only one source of deviation from forecast or target revenues. New product development can be thrown off track by unexpected difficulties in scale-up. Your customer can be acquired by another company that decides to scale back or even discontinue the line of business on which you were counting. An unexpected breakthrough at a customer may suddenly ramp up the demand for one of your products. You need to have at least considered what you might do should any of these events take place, requiring that you react in a timely way. A range of plans— you don f need to be too detailed— will answer this need and allow you to move into action. 

Plans are not merely a collection of goals and the considered tactics to reach them. They must include the resources required to execute them, both human and hardware. As described in Chapter 7, you also need to assess how you will utilize those resomces by their quality the best must be assigned to the most productive projects. 

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Depending upon why a company chose to let a toll, the ability to scale up production may be an important factor. If a toll project was designed to meet a specific, short-term need for a known quantity of material, scale-up capability may not be an issue. However if the goal was to develop a wider market and eventually increase production, a small toller that meets all other criteria for selection could be excluded based upon this factor. Planning for success is essential. 

There are at least two approaches for defining the order of the activities. The first is the "plan for success" approach in which as many activities as possible are conducted in parallel to provide the shortest time path to the Go/No-Go decisions (proof of mechanism/ proof of concept/ etc.) and to the project completion. The second approach is used when there are very scarce resources or when there is a low probability of project success. This second approach defers expensive activities until a proof of concept (POC) has been achieved for the project. Once the POC has been achieved/ then a plan-for-success-style development plan for the project will be developed and implemented. One can also stage the development of lower prioritized projects in a portfolio/ if resources are limited/ or if the risk is still high and the project needs to be managed more conservatively by the organization. 

If, in the following, I speak of models" or "exemplars" and of "copies" and "imitators", I will not use these terms as if there were master plans for successful development, and that in simply following them, anybody else would become equally successful. Rather the perception of success by competitors led them to seek the reasons behind it, and to the conviction that by creating similar business structures they would become equally successful. Therefore, I do not state that there is a general model for promising development or for lasting profit but I will show how industrialists, politicians and competitors in different branches and countries perceived that there might be a model or exemplar. 

Compliance test procedures for steady-state availability Reliability of systems, equipment and components. Guide to reliability testing. Compliance test plans for success ratio... 

All participants need to know about changes in procedures. It may be important to implement the change for everyone at the same time so different procedures are not in place. The change-over will require detailed planning for successful implementation. People using new procedures will need feedback to reinforce the changes. 

FIELD TRIP PLANNING FOR SUCCESSFUL TEACHING AND LEARNING... 

Asia is rising as a competitive threat to the older biotech communities and hopes their biotech sectors will become magnets for foreign investment. The breadth of activities is uneven, as is facility quality, and few countries have a sophisticated plan for successful development. Nevertheless, the region is changing too rapidly to prognosticate beyond the short term. 

Pilot-plant design specifications should be estabUshed only after careful consideration of the experimental program because decisions on the accuracy of instmments, analyzers, and other equipment should be based on the requirements of the experiments planned for the unit. FlexibiUty and versatihty ate important but costly when provided unnecessarily or too profusely they can result in a unit that is difficult or impossible to operate successfully... 

Is R D s role in the business understood Are technology plans developed and broadly understood Are R D resources organized in the best way to carry out its mission Is the organizational climate assessed Does the organization have measures for success Does the organization learn Audits in place ... 

Defining responsibilities and levels of authorities should be specified in the contractual agreement. This fundamental strategy is essential for success. The more complicated the task, the more in depth the contractual agreements and site-specific plans will need to be. 

Prepare business plans for each aspect of the business where performance is critical to its success. 

The dotted lines in the diagram indicate the various feedback paths that exist to enable the individual to identify if a particular stage of the processing chain was executed correctly. Thus, if the operating team had planned a strategy to handle a complex plant problem, they would eventually obtain feedback with regard to whether or not the plan was successful. Similar feedback loops exist at the rule and skill-based levels, and indicate opportunities for error correction. The application of the stepladder model to a process industry example is given in Appendix 2A at the end of this chapter. 

Evaluation of the program. The main point to note with regard to this topic is that evaluation was taken very seriously across the schemes. Thus, it was carried out (or there were plans to carry it out) in virtually all cases, and if the results showed that certain aspects needed to be improved, this was typically done. This is great news, since the purpose of evaluation is, in a nutshell, just that continuous improvement for success. 

Information on implementation of GMP inspection plans is available in only some of the countries. Where data exist, they indicate that plans were successfully followed or even exceeded their targets. This applies to Cuba, Malaysia, the Netherlands, Uganda, Venezuela and Zimbabwe. For Cyprus, however, inspections of domestic plants fell short of the planned values. Cyprus has 10 domestic manufacturers, and nine inspections were planned, but in 1997 only seven were carried out. The Netherlands has 86 manufacturers and 28 inspections were planned in 1998 all of them were carried out. Venezuela has 41 manufacturers and 23 inspections were planned in 1997, of which 35 were carried out. So a low implementation rate does not necessarily indicate a low inspection rate. Enforcement measures are available in case of non-compliance in Cyprus, Estonia, Malaysia, Tunisia, Uganda, Venezuela and Zimbabwe. In Cuba, no enforcement measures are specified for failure to comply with GMP standards. Comparatively speaking, there is less likely to be a workplan for inspection of distribution channels than there is for GMP inspection. Only four countries — Cyprus, Estonia, Uganda and Venezuela — carry out inspection of distribution channels based on such a plan. 

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