7 Compelling Reasons to Plan Summer Mapping This Winter

Leading Minds Network

For managers of pharmaceutical, medical device and other life science facilities, temperature mapping during the summer season provides invaluable data to ensure compliance in these highly regulated environments. Successfully executing large-scale studies requires significant advance planning.

“Beginning summer mapping study preparations during the winter months can result in key advantages that support smooth execution, prevent disruptions, and allow customization to meet operational needs when summer temperatures return,” says Qualification and Validation Engineer Melanie Krüger at ELPRO-BUCHS AG. “Planning early can ensure all details of the project are included and can help you be more strategic in minimizing disruptions to the daily operations within the facilities.”

Here are seven important reasons to get a head start on summer mapping plans this winter:

1. Schedule Around Inventory Flows and Daily Operations

Mapping involves placing data loggers throughout storage areas within your facility. The summer season is short and mapping can take time and can interrupt normal facility workflows. Planning a mapping early allows time to schedule controlled tests when the facility is at its busiest and also avoid interrupting daily business. For example, there may be a need to schedule around other contractors working on the facility or you may need to ensure resources are available at a specific time.

2. Time to Review Previous Mapping Studies for Lessons Learned

Having sufficient time allows you to look back at previous mapping studies to identify trends, consider previous issues with sensor placement, and look at identified critical areas. Historical data can help scope your summer mapping plan. Maybe additional tests would be beneficial, maybe more (or less) data loggers need to be placed, and maybe additional resources, time or tools would be beneficial. Institutional knowledge carries forward.

3. Consider Customized Scenarios: Time to Risk Assess to Define Required Tests

Planning a summer mapping in the winter months allows you time to consider which controlled tests are necessary to qualify your facility. Performing risk assessments on the facility will help to determine which tests are necessary. You will want to also think about times when your facility is busy and also times where activity is lighter. It is crucial to capture critical scenarios like these: when the workplace is busy and a lot of product is moving; when you have high volumes of shipments going in and out; when outside temperatures are at the extremes; and when power to the facility is interrupted. Knowing how your facility operates under the worst-case conditions will give you confidence in the safety of your product. It also enables you to write appropriate SOPs in order to manage critical tasks.

4. Determine Staffing, Training and Resources

Complex facility mapping requires coordination and analysis. How many staff or outside consultants are needed to place sensors and analyze results? Are existing staff and managers adequately trained? Do you need mapping analysis software or data loggers? Use your project lead time to identify gaps in resources or skills that require budget, hiring, procurement and training.

5. Assess Infrastructure Upgrade Opportunities

Qualification and mapping are required on new facilities and on facilities that have gone through significant renovations. In order to have your facility up and running safely under strict deadlines, the initial mapping should be scheduled after construction is finished and critical components are installed, but before any sensitive product is brought into the space. Time constraint is often a critical issue so having sufficient time to schedule around other contractors is crucial. For example, you may need two full weeks where controlled mapping tests are taking place, and you need to ensure that testing is uninterrupted in order to get the data you need. Any delays can push back your go-live date. There is a lot to consider so the more planning time the better.

6. Time to write up plans and gather all the required documentation

Good documentation is fundamental to your project success. Having a strong risk assessment, acquiring accurate and complete floor plans, securing finalized HVAC or cooling equipment documentation, and writing up fully encompassing protocols, all take time. Protocols also need to go through approval processes.

7. Build Alignment and Internal Support

Advanced notice and updates give stakeholders greater visibility into summer mapping plans. These build buy-in across quality, operations, logistics and production teams. Proactively address concerns about potential slowdowns or access restrictions. With alignment, execution goes smoother.

Detailed summer warehouse mapping projects reveal invaluable temperature and quality control insights, but they can present significant logistical hurdles. By planning early during the winter months, mapping study project leaders can schedule intelligently around operations, leverage lessons from past years, tailor scenarios to data needs, verify resources, accommodate infrastructure upgrades, adjust for anticipated changes, and ensure internal alignment. Taking the long view allows smart preparation to achieve qualification more efficiently.

With forethought and flexibility, GxP experts at ELPRO can devise an optimized plan to meet your warehouse qualification needs and help you maintain compliance. Learn more today at ELPRO.com.