Machines or systems used in pharmaceutical finishing (weighing, shaping, filling, checking, packaging, etc.) are often planned, acquired and installed as package units for investment projects. The package unit is a machine with an integrated control system. These individual systems or lines consisting of several individual systems must be integrated into an overall system after delivery by the manufacturer. To ensure that the integration runs smoothly and does not bring the entire project to a standstill, it is essential to accompany the machine manufacturer during the planning and implementation phases of the machine or line, what is also known as “expediting”.
This article is intended to provide the reader an overview of the following:
- What exactly does the term "expediting" cover?
- What is to be achieved with the expediting and what procedure is used during the (overall) project?
- What tools can I use to assist and implement the expediting?
- How can the effort required for expediting be estimated early on?
- What are the possible risks associated with expediting?
Imagine the following scenario: The great hall in the theater, the venue is sold out, and the key scene of the last act is coming up. All actors have taken up their positions, and the curtain is just about to raise. But stop! One of them is missing: And none other than the main character! The eyes of the entire theater company are now resting upon you. Because you are the director. It is your job to make sure that everything runs smoothly, that everyone involved is in place at the right time, and that everyone knows his or her lines. And all eyes are asking the same thing: And now? Where is the main character? When is he coming? What will happen next?
This is what it must feel like when you learn that your planned process equipment cannot be delivered on time for your pharmaceutical project. The clean room ceiling is waiting to be closed over. The ventilation could actually already be in a position to be regulated. If only the ceiling could be closed over. And if the ventilation were running, the clean room status could already be validated. And this goes on and on ... where the delivery date of the process plant is only one of the three critical factors of time, cost and quality.
Many machines or production lines for the pharmaceutical industry, especially in the field of pharmaceutical finishing (shaping, filling, packaging etc.) are delivered as a packaged unit, i.e. as a package including its control system. This must then be integrated into the overall plant at the manufacturer. To make sure that this can happen smoothly and that the overall project does not come to a standstill, accompaniment by the machine manufacturer in the form of a strict expediting by the constructor is indispensable.
As commonly used in industry, the term expediting means in the narrower sense that one should “walk out of the company” (the latin “ex” meaning “out”, and “pedes” meaning feet) to check that the progress of the ordered goods is in line with expectations. [1] So in this case you should not just stand by and wait for the systems to come to you. You should instead go to your suppliers early on to check the progress of the order. The expediting includes all the external activities of a company that need to be carried out to check the ordered backlog of its suppliers. Within this process, objects are checked that require a long lead time for their production and which are therefore critical for completing an overall project on time. Quality and timing are usually considered during the inspections.
For the pharmaceutical or plant construction project, expediting includes all the measures from the ordering of a product and / or service that need to be taken to ensure that what has been ordered is delivered to the construction site on time, in a timely manner and in the required quality.
Figure 1: Expediting ensures that the ordered services or goods are delivered on time, on budget and in the required quality
The measures taken as part of the expediting process represent a complete package, which allows a comprehensive view of the status of the system ordered during the entire planning and manufacturing process. To this end, two main goals are pursued: In addition to avoiding deadline problems during the planning, design, manufacture and delivery at the system supplier, early expediting activities on the part of the constructor (or a company commissioned by it) should also help to avoid conflicts of interest between the client and the system supplier. If everyone involved agrees on the scope of delivery right from the onset, many unpleasant discussions about expectations from the customer and the necessary effort on the part of the supplier can be avoided as soon as the project starts.
In order to achieve these goals, the project at the supplier should be supervised by the constructor or its delegate through the entire project phase from ordering to delivery. In this way, any threatening deviations during planning and implementation can be compared to the agreed scope of delivery and prevented by timely countermeasures. Early initiation of preventive measures defined together with the system supplier will assist a smooth project process.
The typical services in expediting vary depending on the complexity of the system to be procured or the size and scope of the overall project. In principle, the following services are provided during an expediting:
- Early support for technical purchasing, for example through participation in technical clarification or tendering meetings
- Support for sub-project managers, system managers and planning engineers
- Supervision of the supplier regarding delivery dates, quality of implementation and documentation
- Coordination and implementation of supplier visits and approvals
- Implementation of reporting to monitor progress
Figure 2: The four core topics of expediting resulting in the required activities
The document in which the agreed and thus expected scope of delivery is bindingly recorded between the system supplier and the customer is the written order or order confirmation of the supplier. These contract documents therefore also form the basis for the expediting. The starting point for expediting is therefore the completed order process. Using the scope of the order, the planner should make an initial estimate of the expected effort for the upcoming expediting. This can be done by setting different control levels, with a higher control level can be selected depending on the complexity of the system ordered. One rule of thumb is: The higher the control level, the more extensive will be the required measures. As one example, if only individual components are supplemented or replaced for an existing system, expediting may be restricted just to a normal telephone call and an incoming goods inspection upon delivery. As another, if a complex filling or packaging line is procured, the effort will be much higher and will certainly include regular fixed date meetings, progress checks at the supplier and detailed reporting on the project progress.
Once the necessary measures for the expediting have been set, a schedule for the expediting activities can be formulated as a next step. A track proven approach includes a definition of milestones of progress for
- Construction
- Mechanical manufacturing
- Electrical installation
- Programming / Automation
- Qualification documentation as well as technical documentation.
These milestones in turn are used to plan various design reviews for different purposes. On the one hand, the supplier can present the project progress to the customer at more or less regular intervals during the planning phase while at the same time coordinating open remaining issues. On the other hand, they also provide the customer with an initial idea of what his system will look like at an early stage, with an increasingly more detailed picture emerging at each further design review. Typical topics for design reviews include
- Construction design reviews
- 3D design reviews
- Automation design reviews
- Documentation design reviews
The FAT and, in the case of a more complex system, a potentially planned and implemented pre-FAT represent components of the expediting. If the pre-FAT serves to determine that the system is FAT ready, the FAT itself represent the approval through which the supplier generally receives the delivery release where it exists. Frequently, issues relevant to qualification are also already checked during the FAT. A corresponding overlap of project phases is possible, but it must be ensured that there are no overlaps in test points or responsibilities. The expediting phase ends with a documented incoming goods inspection on the construction site.
Figure 3: The expediting starts with the order, accompanies the entire planning and manufacturing phase of the corresponding system and ends with the documented incoming goods inspection at the construction site
In addition to the complexity of the planned system, the efforts expended on expediting depend on a variety of dynamic factors. As one example, efforts tend to increase as project timelines approach: As long as the progress proceeds as planned, no intervention is necessary. However, if there are signs that milestones (e.g. a previously defined design review) cannot be kept, corrective action by the expediting manager is required. The same applies for the current situation at the supplier. If sufficient capacities are available in the design, production and documentation, it can be assumed that the project will run smoothly. However, if there is a risk of bottlenecking (e.g. due to frequent sick leave during the flu season), timely countermeasures are necessary to ensure that the final deadlines are not threatened.
Figure 4: The efforts expended on expediting depend not only on the complexity of the system, but also on dynamic factors such as compliance with milestones or the available capacities at the supplier
Periodic checking of whether the measures set are still adequate
Once the control levels have been set, they may not be regarded as fixed during the course of the project, but must be constantly questioned and adjusted by the expediting manager. This applies in both directions of course: If it is determined that the project progress complies with the original schedule, it can be considered the extent to which fewer measures may suffice. If there is a risk that the project might stall, further measures must be set and implemented.
Figure 5: Expediting measures must be set, but also regularly checked and, where necessary, corrected
One of the biggest risks in expediting is the incorrect assessment of the efforts required before the project starts. If too few activities are planned before the start, the current project may not have sufficient capacities at its disposal for the expediting manager (in the form of resources or budgets). If the required effort is overestimated, this can lead to the required expediting taking an excessive proportion of the overall project budget. The control levels already described offer the possibility of being able to make an initial assessment already at an early stage. The more precisely the control levels are set, the better will be the resulting first setting of the required expediting measures. Another risk for a successful expediting is any unexpectedly large increase in effort over the course of the project. Possible causes for such an increase are frequent, late and / or extensive changes to the ordered system, or the already mentioned unexpected bottlenecks due to absences of key personnel or delivery bottlenecks of system components or purchased parts. In order to recognize any undesirable developments or deviations from the originally planned expediting in good time, it is necessary to track the project progress accordingly. If this does not happen to the necessary extent, it is not necessarily immediately recognizable. There is much more a risk that actually necessary activities may not materialize so that issues build up which will eventually stall the project implementation. The build-up of such a "bow wave" must therefore be avoided from the start.
Success factor: Everybody “plays along“
The expediting manager should show the right finesse when implementing and tracking the activities. The system supplier should not find the client's expediting disruptive, and any additional effort on top of the normal course of the project should be kept within limits. Ideally, the client should already be informed about the expediting requirements when making an inquiry or during the offer phase. This avoids additional costs for any required activities and services on the supplier side and, in the worst case, even a refusal to provide them.
Expediting is an independent process in the streamlining of a project which ensures the manufacturing and delivery of goods and services within the specified deadlines, at the agreed costs and in the required quality. Expediting entails a certain expenditure of effort, but this can easily be planned in early on. In any case, the time planned fin or expediting from the start is a good investment that pays off later.
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