Product recalls, inventory delays and unnecessary OOS investigations are enormous drains on profitability, and every pharmaceutical company can benefit from leaner methods in manufacturing. However, many organizations fail to understand the large, long-term savings they can achieve through more efficient quality control processes. Most manufacturers are still using the century-old manual method for counting colonies and detecting contamination, but rapid microbial enumeration can drastically reduce the time, labor and money Micro QC departments currently spend.
Making the case for rapid microbial testing isn't always easy, though. Many stakeholders are far-removed from the quality control process, and it can be tough to convey both quantitative and qualitative benefits. Plus, the preventative nature of QC makes it difficult to present rapid testing as the solution to an ongoing problem. Here are a few tips for techs, directors and other personnel who need to present a solid business case for rapid methods.
Understand the Stakeholders
Rapid enumeration has far-reaching benefits, and it's crucial to convey its upside to stakeholders with different interests. For most executives, the critical issue will be profitability: How much money is currently being spent on micro quality control testing, and how much can they save by switching to rapid methods? Similarly, they'll need to understand the current frequencies and costs of recalls, delays and investigations, and to what degree those processes can be avoided in the future. It might not seem like a big deal to save one full-time employee position on the enumeration itself, but the prospect of avoiding multiple investigations per year – each of which can cost tens of thousands of dollars – will turn a few heads.
Aside from the C-suite, it's important to engage inventory managers, quality assurance personnel and anyone else who will benefit from faster times to market and fewer investigations. These stakeholders may not see the immediate benefits of a more efficient enumeration process, but they'll become far more productive in the long run.
Discuss Immediate Savings
Executive teams will want to see substantial short-term savings when making significant investments. For automated, rapid enumeration, these immediate benefits include:
- Faster final product testing, which leads to quick reductions in necessary inventory.
- Quicker contaminant detection in raw ingredients and unfinished batches allows for reductions in manufacturing downtime, non-productive labor costs and costs of rejected works-in-progress.
- Faster contaminant identification reduces the time required to restart production after shutdowns.
- Enumeration automation reduces the time microbiologists spend analyzing, reporting and auditing test results.
Convey Long-Term Benefits
To sell automated enumeration as a comprehensive solution with a significant ROI, it's critical to convey the long-term savings across multiple departments, as well as the “soft” benefits that aren't so easy to quantify. The most important are:
- Saving FTEs: By automating most enumeration tasks, manufacturers can reallocate entire positions. In an era where businesses are expanding testing, this may mean eliminating the need to bring on additional staff to support higher testing volumes.
- Greater reliability: With less downtime, fewer recalls and faster times to market, pharmaceutical companies can instill greater faith and loyalty in their customers. This can have a direct impact on the corporate brand.
- Efficient use of space: Rapid equipment can be located directly on manufacturing lines, eliminating the need for additional clean rooms and cross-campus travel.
Use A Structured Approach
No matter which benefits are most appealing to a given group of stakeholders, an organized approach is necessary to build a compelling business case. Typical steps to building a business case include:
1. Introduction. Introduce the scope and goals of the project, focusing on the key objectives of individual departments and the company as a whole. Identify stakeholders outside of the microbial quality control testing lab that may be impacted. For example, Quality Assurance and Manufacturing may realize improvements from automated rapid detection.
2. Initial Data Collection: Identify the potential short- and long-term benefits of automated rapid enumeration, and discuss the data and investigations necessary to determine if an ROI is associated with the benefit.
3. Internal Stakeholder Discussion: Work with other internal areas to understand the approval process for new technologies and what components are required in a formal business case. Tour the rapid enumeration process, brainstorm savings and discuss the processes of approval, contracting, installation and validation.
4. Build the Case: Align the ROI data points from step 2 with the requirements in step 3 to build an ROI document.
5. Final Report: Present findings to executives and other stakeholders, and initiate the approval process if appropriate.
Get Help from Vendors
Vendor support can make all the difference in obtaining the budget approval for automated, rapid technologies. Experienced vendors will quickly assess ROIs and implementation time frames, and they'll be able to relate the positive experiences of their established customers. Nothing will make the case for automated, rapid enumeration better than the knowledge that other manufacturers – and potential competitors – are achieving groundbreaking growth and savings.
Learn more about the ROI of automated rapid enumeration with our free guide—download it here.