NOTE: Master Control GxP Lifeline first published article on December 4, 2020. Click here to read the original publication.
Quality assurance (QA), quality control and quality management are the core elements of production consistency. They’re also a manufacturer’s fundamental mechanisms for maintaining regulatory compliance and making corrections and continual improvements. Yet, in a life sciences industry overrun with similar sounding terminologies, it’s easy to misinterpret their definitions and misunderstand their various purposes. The answers to the three questions below clarify the roles of each quality function, the ways they differ and their impact on each other.
What Is the Difference Between Quality Assurance and Quality Management?
QA entails the implementation of standardized processes that result in reproduceable production outcomes of desired levels of quality. Quality management 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.
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 management 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 ultramodern QMS software solution that integrates all quality data and processes within a single platform, or it might mean the company is still using an inefficient and disconnected assortment of spreadsheets and file cabinets full of paper documents.
What Is the Difference Between Quality Control and Quality Assurance?
QA activities are proactive and intended to prevent the manufacture of nonconforming products. They’re aimed at eliminating 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. 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.(1)
QA professionals’ specific responsibilities 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.
Think of the QA department as a legislative body setting the rules that govern a jurisdiction, which in this case is the company’s manufacturing activities. 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.
Quality control activities are supportive of QA. They 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 within the realm of quality control 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.
Who Should Quality Assurance Report To?
According to standards established by the FDA and International Organization for Standardization (ISO), independent authority is what makes QA what it is. 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), a specific vice president or some other senior director, depending on the size of the organization.
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 integrity of product quality is to be preserved. 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 quality control and other quality management roles 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.
Contact Enterey Consulting Today
Enterey's life science consultants use proven strategies and best practices to drive improvement across quality & regulatory operations. Contact our team today to learn more about our strategic project consulting services.
Be sure to download our free PPM assessment tool to evaluate potential gaps in your life science organization.