Understanding Quality Assurance: Beyond Auditing

What is Quality Assurance?

QA stands for Quality Assurance. There is a common misconception that conducting audits alone constitutes quality assurance. If auditing were synonymous with quality assurance, we might simply call it “Quality Audit.” While auditing is certainly an integral component of quality assurance, it does not represent the entirety of QA activities. It is crucial to understand that auditing and quality assurance should never be conflated.

The True Meaning of Assurance

What, then, does “Assurance” truly mean? Assurance involves guidance and advice provided by experienced individuals with specialized skills and knowledge. In other words, quality assurance professionals become deeply involved in processes, effectively standing in for the relevant department to provide their seal of approval on quality matters. They take shared responsibility for the quality outcomes.

Historical Context: GLP and the Evolution of Quality Assurance

The pharmaceutical industry first adopted the concept of Assurance through Good Laboratory Practice (GLP) regulations, which were established in the late 1970s. The U.S. FDA published the final GLP regulations (21 CFR Part 58) on December 22, 1978, following investigations in the early 1970s that uncovered fraudulent activities and poor laboratory practices in toxicology laboratories.

GLP studies are complex and demanding, requiring specialized expertise that not everyone possesses. Consider a scenario where ten different studies need to be conducted. If these studies are divided between two staff members, the results would likely vary in quality—some studies would be executed well while others might fall short. This inconsistency posed a significant problem for regulatory compliance and scientific integrity.

To address this challenge, the GLP framework introduced the role of the Study Director. Under 21 CFR Part 58.33, the Study Director is defined as “a scientist or other professional of appropriate education, training, and experience” who has “overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation and reporting of results, and represents the single point of study control.” This experienced professional guides study personnel on proper protocol development, study execution methodology, and report preparation. Through this guidance and oversight, all studies achieve consistent quality standards regardless of the individual experience levels of the personnel conducting the work.

Quality Assurance Accountability to Stakeholders

Quality assurance personnel bear responsibility and accountability to both customers and regulatory authorities. To illustrate this principle, imagine you have made a purchase but discovered quality issues with the product. When you file a complaint, suppose the company responds by explaining, “An inexperienced new employee manufactured this product, which is why the quality is substandard.” How would you react to such an explanation?

Most customers would reasonably respond: “Rather than blaming the individual employee, I expect the company to provide quality assurance for its products.” This expectation is entirely justified and forms the foundation of organizational quality management.

Every organization inevitably employs individuals with varying levels of experience and aptitude—including new employees, those still developing their skills, and individuals who may not be ideally suited for certain tasks. However, organizations cannot simply exclude these individuals from the workforce or productive activities.

Regardless of which employee performs the manufacturing or service delivery, quality assurance personnel must ultimately stand in for that employee and guarantee the quality of the output. This is the essence of quality assurance responsibility. According to ISO 9000:2015 (Quality management systems—Fundamentals and vocabulary), quality assurance is defined as “part of quality management focused on providing confidence that quality requirements will be fulfilled.”

Quality assurance personnel must monitor and supervise processes closely. When they lack confidence in the quality of a product or service, they must not approve its release to customers. This gatekeeping function is fundamental to protecting both the organization’s reputation and customer safety. In regulated industries such as pharmaceuticals, medical devices, and food production, this responsibility extends beyond business considerations to public health protection, as mandated by regulations including FDA’s current Good Manufacturing Practice (cGMP) regulations (21 CFR Parts 210 and 211) and international standards such as ISO 13485 for medical devices.

A Quality Assurance Case Study: The LASIK Surgery Example

Consider this practical scenario to better understand quality assurance principles. Suppose you are scheduled to undergo LASIK surgery (a laser procedure to correct nearsightedness). When you visit the ophthalmology clinic, you learn that the surgeon assigned to your case has performed fewer than 100 procedures—a relatively limited track record. Naturally, this information would likely make you feel anxious about the outcome.

You also learn that the clinic’s director has performed over 10,000 LASIK procedures and possesses extensive expertise. Given this information, most patients would strongly prefer that the experienced director perform their surgery rather than the less experienced surgeon.

However, the director no longer performs many surgeries personally, being occupied with managing the clinic’s operations, supervising staff, maintaining regulatory compliance, and handling administrative responsibilities. Furthermore, if the director continued to perform all surgeries personally, the less experienced surgeons would never have the opportunity to develop their skills and expertise. This creates a dilemma common across many professional fields.

In such situations, patients typically make a reasonable request: “If the director cannot perform my surgery, I would at least like the director to be present during the procedure to supervise and guide the less experienced surgeon.” This arrangement addresses the patient’s concerns while allowing for skill development.

In this scenario, the director observes the surgery as it progresses, providing advice and guidance to prevent errors, and helping navigate the procedure to a successful outcome. This supervisory role—where an expert guides and supports a less experienced practitioner to ensure quality results—is the essence of Quality Assurance.

Quality Assurance in Modern Practice

Today’s quality assurance practices have evolved significantly and are supported by comprehensive international standards and regulations:

ISO 9001:2015 (Quality management systems—Requirements) provides the most widely recognized framework for quality management systems globally, with over one million organizations certified worldwide. The standard emphasizes customer focus, process approach, and continuous improvement.

Risk-Based Approach: Modern QA incorporates risk management principles, as reflected in ISO 31000 (Risk management—Guidelines) and integrated into ISO 9001:2015. Quality assurance professionals must identify potential quality risks and implement preventive controls rather than simply detecting defects after they occur.

Good Manufacturing Practice (GMP): In pharmaceutical and medical device manufacturing, GMP regulations (such as FDA 21 CFR Parts 210, 211, and 820, EU GMP guidelines, and WHO GMP) mandate that quality assurance extends throughout the entire product lifecycle—from raw material sourcing through manufacturing, packaging, storage, and distribution.

Quality Assurance Unit (QAU): Under GLP regulations (21 CFR Part 58.35), facilities must maintain an independent Quality Assurance Unit that monitors studies “to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the regulations.” This organizational independence is critical—the QAU must be “entirely separate from and independent of the personnel engaged in the direction and conduct of that study.”

Data Integrity: Contemporary quality assurance increasingly focuses on ensuring data integrity throughout the product lifecycle, following ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available). Regulatory authorities worldwide, including FDA, EMA, and WHO, have issued guidance emphasizing that quality assurance must verify that data is reliable and traceable.

The Seven Quality Management Principles

According to ISO 9000:2015, quality assurance systems should be built upon seven fundamental quality management principles:

1. Customer Focus: Understanding and meeting customer requirements and striving to exceed expectations
2. Leadership: Establishing unity of purpose and creating conditions for people to achieve quality objectives
3. Engagement of People: Ensuring competent, empowered, and engaged people throughout the organization
4. Process Approach: Managing activities as interrelated processes that function as a coherent system
5. Improvement: Maintaining focus on continual improvement as a permanent organizational objective
6. Evidence-Based Decision Making: Making decisions based on analysis and evaluation of data and information
7. Relationship Management: Managing relationships with interested parties to optimize their impact on performance

Conclusion

Quality assurance is fundamentally about building quality into processes rather than simply inspecting for defects after the fact. It requires experienced professionals who actively guide, mentor, and take shared responsibility for quality outcomes. Whether in GLP-regulated nonclinical studies, GMP-regulated pharmaceutical manufacturing, or any other quality-critical operation, effective quality assurance means ensuring that regardless of who performs the work, the output consistently meets established quality standards.

The QA professional serves as the organization’s quality guardian—someone who can confidently stand before customers, regulatory authorities, and other stakeholders to assure them that quality requirements have been fulfilled. This assurance is not merely based on after-the-fact inspection, but on deep process involvement, proactive guidance, risk-based oversight, and genuine accountability for quality outcomes.

In today’s regulated environment, with increasing complexity in global supply chains, advancing technology including electronic records and computerized systems, and heightened regulatory scrutiny around data integrity, the role of quality assurance has never been more critical. Quality assurance professionals must combine technical expertise with regulatory knowledge, understand both scientific principles and business operations, and maintain the independence and integrity necessary to protect both public health and organizational reputation.