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, which I like to call the Winchester House of Quality. Although companies of all sizes and experience levels struggle with this concept, it is rarely discussed in industry circles.
This well-known San Jose, California mansion and tourist attraction is reputed to be haunted. This home was once the residence of Sarah Winchester, the widow of William Wirt Winchester of Winchester Repeating Arms fame, him being most known for the Winchester rifle.
Sara Winchester did not use an architect to design the building, adding rooms and wings haphazardly. This lack of architectural forethought and careful design resulted in a structure with oddities. These oddities include doors and stairs that go nowhere, windows that overlook other rooms, and stairs with odd-sized risers.
What does a poorly designed mansion in California have to do with medical product manufacturing quality standards?
Much like Mrs. Winchester built her home without a design or a plan, too many pharmaceutical and medical device companies similarly cobble together their quality systems incrementally over the years, creating their very own Winchester house of quality.
Instead of proactively designing an architecture aligned to their unique business model and incorporating market-based legal and regulatory requirements, companies react to problems and crises by creating ad hoc policies, procedures, forms, and other documents.
They react this way without considering how these documents will interact with other policies, procedures, and systems throughout corporate operations. The result? Quality systems are comprised of unrelated parts and processes that are confusing, often disconnected, and 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 without carefully planned integration
- Problem-driven policy development focusing more on completing a CAPA than on how the system works together.
Regardless of its origin, this erratic quality system development can have serious consequences with the FDA and other global regulators. Disjointed quality systems can lead to problems manifested in Form 483 observations during FDA inspections or possibly 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. Yet, they still fail to repair the underlying architecture of their quality systems, which puts them at risk of seeing the same problems months or even years later.
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 goals and needs their quality systems need to support. The widely used “evolution” approach to quality systems revisions inevitably leads to gaps and inconsistencies that will cause problems later on.
A first step pharmaceutical and medical device manufacturers should embrace is establishing a quality plan. These plans should, at a minimum, address their broadly characterized gaps and risks. Ideally, these plans will also be forward-looking, incorporating business plans and quality systems architectural needs for several years. 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-designed, comprehensive quality structure and
- Moving organizational thinking away from discrete fixes, essentially plugging holes, and instead focusing 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 eventually create GMP/QMSR 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-built quality system design.
Creating a robust, efficient business-supportive quality system structure 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.
Many medical product manufacturers face the challenge of serving multiple markets. In such cases, it’s generally advised that companies meet the standards of the most rigorous regulatory body and harmonize that approach throughout their operations.
Companies should incorporate comprehensive “regulatory intelligence” processes into their quality systems. Doing this can also facilitate currency of policies and procedures.
Companies must also meet requirements set by their mission statements, business priorities, and goals. A well-designed system will cascade logically and understandably from the top down. For instance, some companies may have a mission statement that broadly defines how they operate.
Other documents that comprise the overall architecture of the quality system would then flow from these broad statements of corporate intent. Some examples of these documents include policies, quality standards, and other operating requirements documents.
No Design is Bad Design
For decades, many companies may have gotten away with an ad hoc approach to quality systems. Despite this, they will face fewer regulatory and business challenges if they consider and embrace comprehensive quality system design.
Returning to architecture, architects specialize in designing and structuring 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, “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 QMSR requirements, pharmaceutical and medical device companies’ quality management should champion 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. Additionally, that design must be predicated on the desired function of the broader system as a whole, along with each component individually.
In the highly regulated medical product manufacturing world, documents define processes. Therefore, the quality system’s structure lies in the written documents that comprise the system. A company with poorly designed documents will likewise have bad processes. A well-designed architecture will focus on broad functional needs such as quality assurance, GMP/QMSR compliance, and business model support for corporate goals.
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 appropriately. It ensures not only the compliance of those processes but also the alignment to business needs and the coherence of the whole structure. From a compliance and business perspective, building quality systems around a comprehensive design plan is preferable. Companies can choose from two different schools of thought:
- Establish fundamental documents 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 “structured flexibility” concept in their quality system document design. In this approach, highly structured and detailed business processes create flexibility and efficiency.
- They do this by eliminating inefficient, “ad hoc” business processes. Most routine operations, especially in FDA-regulated industries, require reproducibility and consistency. This calls for structure and consistency, not the creation of ad hoc work practices on a day-to-day basis.
Ultimately, companies want to ensure consistency with both external and internal requirements. Additionally, they 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 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.
This is 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.
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