Well designed and executed quality systems are the foundation of compliance for the highly regulated pharmaceutical and medical device industries. Still, many companies struggle to build strong, functional quality systems, instead creating various regulatory versions of the Winchester Mystery House. Although companies of all sizes and experience levels struggle with this concept, it is not often talked about in industry circles.
This well-known San Jose, Calif. mansion and now tourist attraction, once the residence of Sarah Winchester, the widow of William Wirt Winchester of Winchester Repeating Arms fame, is reputed to be haunted, a claim some experts attribute to the haphazard way in which it was built. Sara Winchester did not use an architect to design the building, adding on rooms and wings in a haphazard fashion. This lack of architectural forethought and careful design resulted in a structure that features oddities like doors and stairs going nowhere, windows that overlook other rooms and stairs with odd-sized riders.
What does a poorly designed mansion in California have to do with medical product manufacturing quality standards? Much as Mrs. Winchester built her home without a design — without a plan — too many pharmaceutical and medical device companies similarly cobble together their quality systems incrementally over the years. Instead of proactively designing an architecture aligned to their unique business model and incorporating market-based legal and regulatory requirements, companies instead react to problems and crises by creating ad-hoc policies, procedures, forms and other documents with little thought to how these documents will interact with other policies, procedures and systems throughout corporate operations. The result? Quality systems comprising unrelated parts and processes that are confusing, often disconnected and that may not meet business needs and regulator expectations.
There are many reasons disjointed quality systems can develop within a company: knee-jerk reactions to regulator citations; quality staff lacking training in design thinking; use of consultants applying audit-response thinking; mergers and acquisitions where companies combine existing policies haphazardly; and problem-driven policy development focused more on completing a CAPA than how the system ultimately works together.
Regardless of how it comes about, this sort of quality system development can have serious consequences with the FDA and other global regulators. Disjointed quality systems can lead to problems that show up as Form 483 observations during FDA inspections, or even as citations in a warning letter. Quality system failures can also lead to product defects that result in recalls. Companies may spend time and money addressing those observations and citations, or conducting a recall, but still fail to repair the underlying architecture of their quality systems, putting them at risk of seeing the same problems later on down the line.
Evolution is Not a Plan
The compliance performance of regulated manufacturers over the years shows that companies cannot effectively fix problems stemming from underlying quality system flaws in this manner. It is essential that they re-architect these systems in a way that considers their specific business models and what the goals and needs their quality systems need to support. The widely-used “evolution” approach to quality control inevitably leads to gaps and inconsistencies that will cause problems later on.
A first step pharmaceutical and medical device manufactures should embrace is to establish a quality plan. These plans should, at a minimum, address their broadly-characterized gaps, risks and issues. Ideally, these plans will also be forward-looking, incorporating business plans and quality systems architectural needs for several years out. Some common benefits that well-structured quality plans can yield include:
- Reduction of reactive activities focused on parts of individual processes at the bottom of the corporate hierarchy, rather than embracing a comprehensive top-down approach;
- Encouraging proactive, design-thinking approaches to developing a well-architected, comprehensive quality structure; and
- Moving organizational thinking away from discrete fixes, essentially plugging holes, and instead, focus on effecting a proper repair, or even replacing the “leaking roof” entirely.
Companies that fail to embrace these approaches may experience unintended consequences leading to inconsistencies among processes that will eventually create GMP/QSR compliance problems. Evolving without a plan over the years evidences a lack of function-focused design. To address this problem, companies should spend the time and money necessary to re-engineer and deploy a comprehensive, well-architected quality system design.
Creating a robust, efficient business-supportive quality system architecture can be challenging. Companies must identify and incorporate both external and internal requirements. External requirements come primarily in the form of regulations and regulator expectations. A particular challenge facing many medical product manufacturers is the need to serve multiple markets. In such cases, it’s generally advised that companies meet the standards of the most rigorous regulatory body and then harmonize that approach throughout their operations. This means they need to incorporate comprehensive “regulatory intelligence” processes into their quality systems; doing this can also support comprehensive design of policies and procedures in a logical way.
Companies also must meet requirements set by their own mission statements and business priorities and goals. A well-architected system will cascade logically and understandably from the top down. For instance, some companies may have a mission statement that broadly defines how it operates. Other documents—such as policies, quality standards, and other operating requirements’ documents — that comprise the overall architecture of the quality system — would then flow from these broad statements of corporate intent.
No Design is Bad Design
While many companies may have gotten away with an ad hoc approach to quality systems for years, even decades, the fact remains that they will face fewer regulatory and business challenges if they take the time to think about and embrace comprehensive quality system design.
Returning to the notion of architecture, architects specialize in the design and structure of various building types, ranging from commercial buildings to personal residences. They focus on designing spaces that support certain human activities or functions. In the Information Technology (IT) industry, a concept called “process architecture” is frequently used to illustrate the importance of processes, procedures and specific hardware necessary for software products to function properly.
In much the same way an actual industrial / commercial architect might design a facility to be compliant with GMP and QSR requirements, management in pharmaceutical and medical device companies should embrace an architectural approach to the design of their quality system. The process architecture in this space lies in the complex interrelationships among various individual business processes and that design must be predicated on the desired function of the broader system as a whole, as well as each component individually.
In the highly regulated medical product manufacturing world, processes are defined by documents. The structure of the quality system, therefore, lies in the written documents that comprise the system. If a company has poorly designed documents, it will likewise have bad processes. A well-designed architecture, on the other hand, will focus on broad functional needs: quality assurance, GMP/QSR compliance and business model support for corporate goals.
Much in the way good building architecture helps avoid adding a bathroom in an area lacking plumbing access—a problem that is fixable, but only with great effort and expense—good process architecture ensures that individual processes are built out appropriately, ensuring not only the compliance of those processes, but also the alignment to business needs and the coherence of the whole structure. It is preferable, from both a compliance and a business perspective, to build quality systems around a comprehensive design plan. Companies can choose from two different schools of thought:
- Establish documents that are very basic, with little specificity and detail. This is thought to reduce the likelihood of compliance issues (i.e., procedures followed not matching written SOPs) and to add flexibility.
- Embrace the concept of “structured flexibility” in their quality system document design. In this approach, highly-structured and detailed business processes actually create flexibility and efficiency through elimination of inefficient, “ad hoc” business processes. Most routine operations, especially in FDA-regulated industry, require reproducibility and consistency, which calls for structure and consistency, not day-to-day creation of ad hoc work practices.
Ultimately, companies want to ensure consistency with both external and internal requirements, but may also want greater flexibility as they move down into individual business processes. CAPA procedures offer a good example of this idea. While, a company may have a highly structured overall CAPA process, it would also be reasonable for it to leave flexibility within certain activities, such as root cause analyses. Because the facts of each CAPA case will vary, different pathways of investigation will be valid. Highly detailed instructions on how to proceed with root cause analyses, therefore, would be counter-productive.
So what options are open to a manufacturer that identifies problems in its quality systems architecture. Few companies have the luxury of completely shutting down operations to redesign their whole quality system, just as most homeowners cannot just burn a faulty house to the ground and rebuild while living in a hotel for the duration. But companies can simultaneously redesign their quality system architecture while continuing operations. A short version of the steps would include:
- Identifying the scope, extent and impact of known problems;
- Setting a budget for fixing those problems;
- Prioritizing issues to be addressed first based on severity and budget; and
- Incrementally rebuilding the structure based on those priorities.
This process takes longer than starting from scratch, but is a better option for most companies. And while the time and expense to do this can be high, the ROI is equally substantial. Even just applying some of the principles discussed here can yield great benefits.
Compliance ArchitectsⓇ is named to reflect its dedication and focus on helping pharma and device companies build—or rebuild—well-designed, effective, comprehensive quality systems within a strong and solid quality architecture. Compliance Architects® help firms identify where they have put a band-aid on a problem without sorting out the root cause, architect viable solutions, and undo fraught-ridden quality systems based on years of work done without a clear underlying vision.
