Summary

This case outlines how a structured process was used to evaluate options for a pharmaceutical dispensary, where the raw material for prescription and other medications are prepared for manufacturing. The focus on company objectives and criteria helped to achieve consensus among internal stakeholders with slightly different requirements and priorities.

Background

The dispensary project

A pharmaceutical company required a new dispensary at an existing manufacturing facility, to comply with evolving regulations while at the same time improving quality and efficiency in dispensing.

The dispensary performs an important function in pharmaceutical production (Figure 1). It is usually located not far from the warehouse where raw materials are received, or just outside the main manufacturing process facility. In this case the raw materials were primarily active pharmaceutical ingredients (APIs) and excipients, which are inactive materials that serve as binders or fillers in the manufacturing process. In the dispensary the raw materials were removed from their original packaging, weighed and loaded into clean intermediate bulk containers (IBCs) for transfer to the main processing area.

The location and design of the dispensary had been under consideration for several years and many possible options had been generated and refined. Three main design approaches had been developed to concept stage, but each had variants, giving a total of seven options.

While there was consensus about the need to upgrade the dispensary, several internal stakeholders had slightly different requirements and priorities. The company wished to review the options with the interested parties, and then decide on the preferred location and the preferred methods of dispensing, weighing and dispatching.

Selection process

Figure 2 outlines the phases of the option analysis and selection process that was planned. An essential part of the approach was developing a clear definition of the objectives and criteria that supported the selection decision. Setting the context by discussing the objectives and criteria, and gaining agreement to them, was key to the decision made in this instance.

Context

The general aim of the dispensary project was to have a working dispensary that complied with regulations by a specified completion date. This was supported by more detailed objectives (Table 1), grouped into three categories:

• M: Mandatory requirements, imposed by regulators
• F: Fixed constraints, imposed by the company for strategic, operational and marketing reasons
• D: Desirable outcomes, potentially subject to trade-offs during the design process.

There had been many meetings and discussions about the dispensary and its design. General observations and assumptions about the project were classified into facts and criteria. There was a substantial amount of material with which to work; a small number of examples are shown in Table 2 to illustrate the nature of the information.

Configuration options descriptions

Detailed information packages were prepared for each option, with design concept descriptions, equipment lists and preliminary layout diagrams, as inputs to an option selection workshop. The main features were summarised in ‘top sheets’ like Table 3. The information packages were provided to workshop participants in advance.

The option selection workshop

Purpose

The purpose of the selection workshop was to:

• Agree the location of the dispensary in the facility
• Agree the basic functions to be performed in the dispensary
• Assess the functions in more detail to enable the designers to progress.

Initial presentations

To start the workshop, design and operations personnel made short presentations on each of the options, adding detail to the material provided in the information packs. The presentations included a basic description of each option, its advantages and disadvantages, significant risks or matters of concern, and the advantages and disadvantages for the handling of dispensed material in bulk containers. This gave the participants an opportunity to clarify their understanding of the options and ask questions relevant to the decisions that were to be made.

Preliminary screening

During the presentations, the options were compared systematically against the objectives and criteria in Table 1 and the complete form of Table 2. It quickly became clear that five of the seven options were not able to meet the company’s basic requirements.

Options 1A, 1B, 3A, 3B and 2C were eliminated.

• Options 1A and 1B could not comply because of the requirement to move to dispensing into bins, the strong desire to avoid vacuum transfer and constraints on excavation.
• Option 2C involved an expensive conveyor system that was not cost-effective.
• Options 3A and 3B required a duplication of equipment that was not cost-effective.

Options 2A and 2B

The remaining options were 2A and 2B, with option 2B being an evolution from option 2A. Having quickly established that only two options were worth exploring further, it was possible for these to be discussed in detail, concentrating the time available where it was most useful.

Option 2B was similar to option 2A but it included additional scope. In particular, it involved moving packaging lines in the main manufacturing area to achieve operational efficiencies. While this would have considerable advantages, it could not be justified under the dispensary project. Importantly, selecting option 2A would not preclude it from future implementation, either operationally or economically.

It was agreed that Option 2A was the preferred dispensary option. Option 2B was deferred to a potential separate project associated with operational efficiencies in the manufacturing area.

The detailed discussion of options 2A and 2B generated many technical and operational insights that led to useful modifications within the broad design concept. It also helped to resolve a range of key issues that had been subject to debate among the design team.

The modified option 2A was checked against the criteria to ensure it was suitable (Table 4).

The primary outcome had been achieved at this point and it was not necessary to continue the option-selection process.

Walk-through and action planning

A virtual ‘walk-through’ of option 2A was performed to confirm the functionality of the dispensary and identify actions for the design team. The actions were all allocated to managers, and completion dates were agreed.

Lessons

Structure

Having a structure for selecting and discriminating between options is valuable. It need not be complicated – even a simple process can assist decision makers, providing it is structured appropriately to:

• Maintain focus on the objectives and the company’s primary criteria
• Allow the positive and negative aspects of options to be identified, documented and discussed
• Involve the appropriate people with suitable information for discussing and evaluating the options.

Five of the seven options were eliminated on a relatively quick preliminary screen. Differences of opinion and divergent objectives among the stakeholders would have made this highly contentious earlier in the project. However, the systematic group review and comparison of options, against clear company objectives and criteria, made this acceptable. The process helped to forge and consolidate a common view across the design and operations personnel in the project team.

The time of participants in such an exercise is valuable. The clear structure made sure it was invested productively.

Flexibility

While a detailed plan had been prepared for the work described here, in practice it was interpreted flexibly and adjusted as the workshop progressed. For example, once it became obvious that option 2A was preferred, the emphasis shifted quickly to examining it in detail and developing action plans for implementing it.

The main lesson from this is to stop the process when you’ve reached an acceptable resolution and are in a position to make a decision. Don’t continue with further analysis unless it will add value and enhance the outcome.

Process walk-through

A detailed process walk-through helped to identify areas of residual uncertainty where additional design effort would be needed. The focus was on developing a list of the main actions for the design team in the short term.

The walk-through used in the workshop was not as formal as a hazard and operability study (HAZOP), but it was fit-for-purpose in the context of selecting an acceptable option. A more formal quality-in-design exercise was scheduled to confirm and validate the detailed design of the new dispensary once it had advanced beyond the concept stage.