When juggling priorities, early-stage life sciences companies often find themselves between a rock and a hard place. Intent on winning FDA approval and bringing new, high-value products to market faster than the competition, small, cash-strapped companies often choose to funnel their limited financial and manpower resources into furthering their research, development and commercial production goals.
However, regulatory compliance—and the development of a robust quality system to handle compliance-related considerations—must also be at the top of the corporate agenda. Smart executives find that they can mitigate risks and avoid unforeseen expenses, product or production delays, or other go-to-market setbacks if they address compliance and quality system effectiveness early in their business planning process.
The mere mention of compliance, however, makes many drug manufacturers apprehensive. Historically, companies of all types and sizes have had a tough time tracking, understanding, and adhering to constantly changing FDA and other agency regulations and quality requirements. Larger firms have tried to manage these complexities by assigning teams of employees to the task or by investing in sophisticated IT systems; even these manufacturers often find themselves struggling to meet regulatory expectations.
Smaller companies, lacking the deep pockets of the bigger players, tend to postpone quality system development until their organizations are better established, have reached critical milestones, or can expand their available resources. This tactic can, and often does, backfire as soon as compliance issues or quality gaps arise.
Although there is no blueprint for quality system development, there are a number of things executives can do to achieve near-term and future business objectives while supporting a compliance-centric environment. This article looks at some of these best practices, from clearly defining the organization’s quality vision to building a pragmatic quality system that can grow over time.
Defining the Quality System Vision
As with most strategic initiatives, devising and implementing a robust and effective quality system depends on the corporate vision behind it, and the commitment senior leaders make to realize that vision. While executives may initially be preoccupied with short-term deliverables and directives during their company’s start-up phase, as the organization gets closer to the launch they’ll want to pay attention to serious compliance risks and quality system gaps that could threaten continued development and commercialization.
The sooner C-level managers can get their heads around big-picture compliance issues, and visualize what’s at stake should the company fail to address them, the more adept the company will be at putting corrective and preventative actions in place and beginning to build a reliable quality system.
This first step need not require major effort and resources. More than anything, it requires forethought among senior managers, who will want to consider the following:
• Is there a better way to operate?
• What can we do to simultaneously achieve speed, efficiency, and compliance?
• How can we develop a scalable, fit-for-purpose quality system that supports our business structure, operations, and targets?
• How can compliance and quality be integrated into our everyday decision-making process?
• How can an effective quality system reduce time to market or improve the organization’s value?
• How can the system add measurable value beyond delivering a level of assurance that regulatory expectations are met?
Once the answers become clear, the senior leadership team must drive the design and implementation of an effective quality system. How well they articulate their vision, align business processes to it, and get the rest of the organization on board will determine the acceptance and success of the proposed quality system.
Creating the Quality System
With the vision defined, companies must create a quality system architecture that will benefit them immediately and yet be flexible enough to adapt to growth and change over the long haul. At its core, an effective quality system establishes what a company says it will do, tracks how well it has done so, and documents the entire process. It’s also a tool that can be used for planning corrective and preventative actions, managing change, and keeping tabs on contract research and manufacturing organizations.
Developing and implementing the system across the enterprise can be inherently frustrating and create a sense of anxiety, but putting an effective quality system in place doesn’t have to be as hard as it sounds. Nor does it have to be burdensome, time consuming, or costly. Organizations can start small and set up an uncomplicated, but comprehensive, base that can be built upon incrementally.
In our experience, there are five rules of thumb that management must follow in the successful implementation of a quality system:
Understand the role of culture. A company’s culture greatly impacts tactical and strategic projects and often determines whether needed changes will become permanent. Executives grappling with quality system design will benefit from accepting this simple truth: the organizational mindset around quality and compliance will determine the kind of system that’s created and adopted.
Culture varies widely from company to company, and past experience can sway senior staff’s natural inclination to either embrace or resist compliance and quality system initiatives. To a large extent, though, executives will be responsible for instilling a compliance- and quality-focused culture.
Discipline is needed. For a compliance culture to thrive, the quality system must be integrated across functional areas, encompassing everything from authoring regulatory documentation to tracking near-term quality targets to long-term planning.
Align business and compliance objectives. For the quality system to be robust and effective, it has to align with the business structure, the company’s culture, and existing operations. That doesn’t mean that it has to be a monstrous, unwieldy IT platform with a vast array of policies and procedures. The quality system can start simple, if that’s what best suits the company’s style and process control functions, and grow as the company expands.
What’s critical is that the quality system take into consideration how employees work, how the company operates, how products will be produced, and how the company intends to deal with problems that crop up along the way. The degree of maturity and flexibility in the quality system should reflect the development stage the company is in.
Build the quality organization around effective decision-making processes. The ability to detect and act on issues and risks is at the heart of an effective quality system. Therefore, policies and procedures must support decision-making processes.
Companies will want to lay out what “good decision-making practices” look like—for example, how corrective and preventive actions can be improved, which improvements will have the most beneficial impact, and how decision-making processes support overarching business goals.
Foster productivity through consistent process-oriented behaviors. Effective and stable business processes tend to boost productivity while reducing risks to the business. Logic follows, then, that a company’s quality system should help drive the business towards efficient and consistent core processes. This requires thoroughly assessing which practices truly move the company forward and which ones seem to keep employees in a constant fire-drill mode. By doing so, the quality system helps to allocate resources and ensure that workers are involved in productive activities.
Maintain momentum through incremental quality system expansion. The quality system will evolve as the organization matures and needs change. Though companies vary in how they build and develop quality systems and practices, a few basic patterns usually apply. Quality systems tend to start with a functional focus and a rules-based “policing” structure that addresses basic compliance needs. As the company matures, the system will expand to handle things like collaboration between functional groups, improved operations procedures, proactive risk management, and end-to-end quality system integration to provide real-time responses to time-critical issues. Figure 1 illustrates these stages.
Figure 1. Qualitative Assessment: Quality Management Stages of Maturity
A pre-commercial company with product candidates in basic research or early development requires a different level of flexibility than a company in clinical development or in early commercialization. Management will have to factor in those flexibility requirements and ensure that the quality system processes match the current stage of product development. At all stages, however, standardized processes provide a much-needed base for resolving issues, minimizing the number of reoccurring problems, and mitigating other risks.
The Quality System in Action: Managing Risks
Quality systems play an important role in managing risk. An effective system provides both an early warning when something veers off course and a chance to shift directions before the problem becomes too big or too risky. Imagine what could happen if company didn’t have a sufficient quality system in place. Any change—from a supplier, customer, contract manufacturer or research partner—could potentially cause significant compliance issues throughout the company. Resources would have to be dedicated to handle the change, source and qualify new materials, or comb through piles of documents to determine what went wrong. In a worst-case scenario, FDA could deny or delay product approval.
To avoid such a situation, the leadership team can apply risk management principles to the quality system design:
Measure effectiveness. In order to determine whether a process is delivering against expectations, the outputs need to be measured. These measurements can come from a number of sources including quality control, audit and inspection observations, training, and customer feedback. Data measurement determines the effectiveness of the quality system and highlights where improvements can be made.
Monitor quality, performance, and compliance data. Key indicators or metrics associated with the quality system’s performance should be monitored. Monitoring the quality system’s performance not only guarantees that the system will identify trends or concerns in business and development processes, it also confirms whether the system is effective at resolving issues in a timely manner.
Mitigate risk and uncertainty. The information generated during the monitoring step will contain a mix of issues and risks that need to be acted upon or mitigated. For regulated processes and products, it’s important to adopt a consistent approach aimed at correcting the observed problem and deploying solutions that will prevent recurrences.
Mentor employees. Finally, improvement practices resulting from risk mitigation can be propagated across the organization through a mentoring program. By ensuring that people understand what the issues and outcomes are, the company may be able to reap additional efficiencies or unexpected gains.