When designing a new facility there are two ways it can be done.

• The architects build a building and later the owner will have to shoehorn the production process and staff into the defined area.

• Or map out the GMP process flows and diagrams, analyze … and then design, wrapping the building around the actual process.

What would be your preference?

MISSION & VISION

Vipsit has ideas to visioning sessions and has performed several of these from the early start of her career in Denmark. The visioning sessions have a wide range and a specific purpose. It will help the stakeholders to “see” the same picture in their mind, and help all look into the crystal ball and meet the facility 20 years into the future. This is important, because it is THIS facility we are designing right now.

We are trying to answer the questions related to:

• Long term strategy for a new facility to inform schematic design?
• How can your group accommodate and handle big upcoming changes in a new work environment?
• How can the facility adapt, and how should it adapt to technology that has not even been invented yet?
• How should the facility be able to accommodate the fusion of two departments?

Most areas benefit from having a well defined vision indicating where you want to go and what you want to be 5 and 10 and 25 years from now. Do you want to produce for the local child hood vaccine program – or are you aiming at export to other continents?

Most facilities might know what their mission is: diagnostic, research, production of vaccines, insecticides, fertilizers etc. Many facilities might not have a clear picture of what their vision and long term goals are. Will they become the trendsetter and special expertise center? Should they follow and expand with the development of new analytical methods? Will they be the front runner and develop new techniques?

Some of these more hidden aspirations and desires reside in the heads of a few individuals from upper management but are important to uncover early in the design phase. A production facility will stand for 50-70 years – at least – most will serve even longer. Therefore, these hidden aspirations need to be known for the facility design team to be able to design a facility and accommodate the ultimate goals, both immediately and down the road in the future.

PROGRAMMING

Facllity Design Requirements

Do you know how to drive the fact-finding process? Can you sort the facts into needs, wants and aspirations?

Vips has since her first building projects back in the 90’ies continued to refine fact finding templates and developed a systematic methodology to extract and organize stakeholder information and presents it in a way where it is “ready to go” as input to the A&E company.

DESIGN CRITERIA

Stakeholder interviews are a very important tool for defining the design criteria for a new facility. It is important to understand which aspects of the current facility that work right now, and which do not. Equally important is to understand what the future is envisioned to bring, where the science and production technology is going, and in what direction the business is progressing. Single use equipment for large scale production is just one example that has revolutionized the vaccine and pharmaceutical productions during the last 30 years.

It is helpful to have start with templates that uses a systematic, well proven methodology to extract, order and present the facts found during user interviews in the programming phase, and who had bandwidth to do it.

This gives the institution a head start and gives the users time to “get their own house in order” before the designers show up.

STAKEHOLDERS

The stakeholders for a facility design project are a diverse group, with different needs and input. It is often a challenge to keep on top of the different entities and remember to include the right ones at the right time. The A&E company might not know the needs or requirements of all the relevant local stakeholders. Some are regulatory agencies that need to sign off at certain points and approve and issue marketing licenses, while other groups outside the facility might have important input that is not user related as such. Examples could be first responders, local community, etc. In addition there will be the obvious stakeholders: The users, scientists, technicians, maintenance and utility engineers, data and computer related engineers for the building management systems and alarms, the cleaning staff and waste handlers. They should all be heard or informed as needed.

PROJECT STEERING COMMITTEE

The project steering committee makes the final decisions. The composition will vary from project to project but could include individuals such as: Project Manager, Production Director, QA/QC department, Budget responsible, Safety Officer (EHS & BS&S), Operations & Maintenance Staff, Scientific Leadership, and others as needed

IT TAKES A VILLAGE…

Other stakeholders will need to be addressed, either because they have input to the design, need to give authorizations to continue or approve some subset of drawings or design decisions, or need to be kept up to date with facts and progress from the project.

These can be persons with the following positions: Responsible Official, Facility Administrator,  Scientific Users,  Partner Organizations, Regulatory Authorities, Emergency Responders, Community Representatives, Local Architects Design Engineers, External Consultants, Third party Review Teams & Suppliers, Final Decision Making Authority, Responsible Official,  Facility Administrator,  Scientific Users,  and many, many more.

COMMUNICATION PLAN & RACI CHARTS

To keep expectations clear, a communication plan should be developed early and clearly is a necessary tool. The plan should be presented in a RACI chart (Responsible, Accountable, Consulted, and Informed). It will help to eliminate confusion and demonstrate credible and transparent project management where everybody trust that they will be heard, or will be informed, at the relevant points from the early programming phase to the late commissioning phase. It answers the question: “Who is doing what?”

USER REQUIREMENT SPECIFICATIONS (URS)

Vipsit provides templates and assists with reviewing User Requirement Specifications (URS). The URS are documents that list all relevant requirements for a piece of equipment, a utility system, a functionality, a room etc..

The URS is a document that can be and should be used to its ’full potential’ by A&E companies, contractors, tender bidding, procurement, engineering, quality control, operations and validation departments. If written correctly the URS can become the ‘spine’ for both the design and tender process, but also continue to live during the qualification and validation process with added acceptance parameters.

It is an art to write a good URS that has the potential to continue as the basis for automatic generated qualification and GMP validation protocols, IQ, OQ, PQ, FAT and SAT testing and final reporting. If done correctly, many project hours can be saved. The URS documents can like for the multidimensional risk assessments live in a database structure and auto populate the above mentioned documents.

PROTOCOL MAPPING

Vipsit has a very successful track record of facilitating the communication between different stakeholders during the design process.

Scientists, Architects and Engineers (A&E) speak very different languages and it is necessary to recognize this fact and embrace it. None the less, communication is necessary.

“No message has been communicated before it has been understood by the receiver”.

Active listening is obvious one way of trying to ensure this. And writing is another. But even words might be a challenge. Handing off a stack of SOP’s will rarely bring the clear picture the scientists wanted to provide.

SPEAKING A COMMON LANGUAGE

Translating the SOP’s into process and protocol  maps is an important step during the early design phase. By outlining the procedures informed by the SOP’s it becomes clear where there are procedures that do not have an SOP or where a specific SOP was never shared with the A&E company. The protocol maps are important communication tools in the knowledge transfer between the parties. These protocol maps or layouts also assist during risk assessments and finally many of these figures also will end up serving as additional visual explanation in SOP’s and design rationales.