Demystifying Quality Management For Life Sciences: QA, QC, and QMS Explained

Quality assurance (QA), quality control, and the overarching quality management system are the core elements of production consistency. They’re also a manufacturer’s fundamental mechanisms for maintaining regulatory compliance and making continual improvements. In a life sciences industry rife with similar sounding terminologies, however, it’s easy to misinterpret their definitions and misunderstand their unique purposes. The clarifications below demystify the roles of each quality function, the ways they differ, and their impact on one another.

Quality Assurance vs. Quality Management System: Key Distinctions in Life Sciences

Quality assurance tools are used to implement standardized processes that result in reproduceable production outcomes of desired levels of quality. A quality management system refers to an organization’s broader approach to minimizing deficiencies and errors, meeting regulatory compliance standards, and satisfying a specified set of inherent characteristics during the manufacture of products.

Quality Assurance and Quality Control: Complementary Pillars in Life Sciences Manufacturing

While the terms might cause some to believe the association between the two functions is adversarial, there isn’t an inherently antagonistic quality assurance vs. quality control relationship. Rather, they are complementary elements of a manufacturer’s overall quality strategy. In life sciences companies, both functions are reliant on a formal quality management system (QMS). Depending on where a company fits on the digital maturation spectrum, that may entail the use of an modern QMS software solution that integrates all quality data and processes within a holistic platform, or it might mean the company is still using an inefficient and disconnected assortment of spreadsheets and file cabinets full of paper documents.

The Role of Quality Assurance Tools in Life Sciences: Proactive Measures for Product Excellence

Quality assurance tools are used proactively and intended to prevent the manufacture of nonconforming products. They’re designed to eliminate process variation through the creation, revision and implementation of explicitly defined procedures that ensure the quality of a product when followed precisely. This means the QA function must be independent of manufacturing and operations.

To prevent the manufacture of products that do not meet predetermined quality standards, QA groups are responsible for performing continual checks of the quality system’s implementation. They often rely on quality assurance software to do so. The Quality Systems Approach to Pharmaceutical CGMP Regulations guidance provided by the U.S. Food and Drug Administration (FDA) defines QA activities in life sciences manufacturing as those that primarily involve the following:

• Review and approval of all procedures related to production and maintenance.
• Review of associated records.
• Auditing and performing and/or evaluating trend analyses.

Quality assurance tools help preserve the continual reliability of the manufacturing process and are typically focused on actions such as:

• Change control.
• Corrective and preventive actions (CAPA).
• Customer complaints.
• Design control
• Device history records (DHRs)
• Device master records (DMRs).
• Document control.
• Environmental control.
• Finished product release.
• Inspection sampling plan development.
• Internal quality audits.
• Label control.
• Nonconforming material investigation and disposition.
• Quality records control.
• Quality system management review.
• Quality trending.
• Selection of statistical techniques.
• Supplier corrective action.
• Supplier evaluation and monitoring.

Maintaining Independence: The Crucial Position of Quality Assurance in Life Sciences Organizations

According to standards established by the FDA and International Organization for Standardization (ISO), independent authority is what makes QA effectual. While the independence of the QA function requires that it not be subordinate to any other organizational unit, QA leaders in life sciences companies typically report to a chief operations officer (COO) or other senior director, depending on the size of the organization and its quality management system.

No matter who QA leaders report to, they must always maintain a degree of independence from manufacturing operations. That does not necessarily require QA to be a standalone entity, but there can’t be any conflict of interest if the overall quality management system is expected to preserve the integrity of product quality. As a result, it’s typically necessary to segregate QA as a distinct department in most organizations.

The work done by QA personnel has a substantial impact not just on the quality control system and other quality management activities but on the aims of the entire organization. That’s why life sciences companies are always striving to develop and refine a culture of quality that permeates the entire enterprise.

Quality Management Systems and Quality Control: Ensuring Regulatory Compliance in Life Sciences

Think of the overall quality management system as the government and the QA department as the legislative body within the government that sets the rules a specific jurisdiction – in this case, the manufacturing function – must follow. Just as legislators establish laws that are intended to uphold a safe and thriving society, a QA department devises governing standards and guidelines that ensure product quality when followed.

The quality control system supports QA. Quality control activities entail the use of inspection and testing processes for detecting and shelving nonconforming products. The quality control function exists within operations and manufacturing and uses the standards set by QA as the basis for inspecting and testing products. In this way, quality control professionals are like the police who enforce the laws established by legislators and ensure they are appropriately followed.

Examples of the types of reactive responsibilities that commonly fall under the purview of the quality control system in life sciences manufacturing include:

• Control and calibration of monitoring and measuring devices.
• Environmental monitoring.
• Final product inspection.
• In-process product inspection and testing.
• Labeling inspection.
• Material inspection.
• Material handling and storage.
• Nonconforming material inspection and segregation.
• Returned goods authorization.

Learn How an Intelligent Quality Management System  Can Empower Your Company

Whether your job is affected by quality assurance, quality control, or some other aspect of quality management, you can benefit from digitized and integrated quality processes. Check out MasterControl’s quality management solutions page to see how quality assurance software and other advanced quality solutions can streamline your quality processes.