Quality Control vs Quality Assurance in Medical Device Development

We shouldn’t kid ourselves, the most important role of QA and QC in the United States is to satisfy the expectations of FDA 21 CFR Part 820, which outlines quality system requirements for medical device manufacturing, and ensure that we are delivering a product that is safe and effective. This regulation covers all production aspects, ensuring devices meet safety and effectiveness criteria.

While often lumped together as “QA/QC,” each serves a distinct role in ensuring that devices are safe, effective, and compliant with regulatory standards. Understanding these differences is crucial for anyone creating impactful medical devices or consumer health products.

What Are Quality Control (QC) and Quality Assurance (QA)?

Quality Control (QC) is product-oriented. It focuses on identifying defects in the final products or during production to ensure that only high-quality products are released to the market. These processes involve inspecting and testing products during manufacturing to verify they meet the required specifications and standards before they reach the consumer market. If a product does not meet quality expectations, then appropriate corrective actions must be taken.

In contrast, Quality Assurance (QA) is process-oriented. It focuses on developing and maintaining procedures, standards, and processes to ensure that medical devices are designed and produced according to quality standards. QA encompasses systematic planning, process validation, and risk management to ensure consistent product quality. Defects found during QC testing often directly inform future QA processes.

What Are the Key Processes in QC and QA?

Quality Control Processes

Incoming material inspection: Raw materials and components are inspected and tested upon receipt to verify they meet specifications before entering the production line.
In-process monitoring: Production parameters (e.g., temperature, pressure) are continuously measured to check that they remain within specified limits.
Sampling and testing: Products from the production line are regularly sampled and tested for ongoing compliance with quality standards.

Quality Assurance Processes

Design planning: Quality objectives are established and the necessary resources, timelines, and processes are defined to meet those objectives.
Design reviews and change control: Design changes are regularly assessed and documented to identify and mitigate risks and ensure regulatory compliance.
Life cycle risk management: Risks throughout the product lifecycle are identified, assessed, and mitigated to maintain product safety and performance.

Combined Processes

Quality management system (QMS): A QMS is a system that establishes processes, procedures, and responsibilities to achieve quality objectives and ensure you are meeting regulatory expectations.
CAPA (Corrective and Preventive Actions): CAPA processes are implemented to identify and address root causes of issues (Corrective Actions) and to prevent recurrence or occurrence of potential issues (Preventive Actions).

Figure: The differences and overlap of QA and QC processes

The Synergy Between QC and QA in Medical Device Development

QC and QA form a comprehensive approach to quality management in medical device development. QA lays the foundation by ensuring robust design and development processes, while QC verifies that the final product meets all quality standards. This synergy is critical not only for product quality, but also for navigating the complex regulatory landscape.

How to Implement an Effective QA/QC Strategy

Implementing an effective quality strategy involves the integration of QC and QA processes into a cohesive quality management system. Below are the key steps:

1. Develop a unified QMS: Start by implementing a quality management system that meets regulatory standards such as ISO 13485. The QMS should encompass both QC and QA processes, ensuring they work together seamlessly to achieve consistent product quality.
2. Encourage cross-functional collaboration: A problematic misconception is that quality is the job of the quality department. Quality is everyone’s responsibility. Make sure that the product design and development team has a quality plan, that the purchasing department has appropriate inspection processes in place, that the finance or purchasing team can act quickly if alternative suppliers need to be used, and that executive management is paying more than lip service to the importance of quality.
3. Establish clear QA procedures: Ensure that everyone understands the procedures required to ensure agreed upon quality. Ideally, the individuals responsible for executing the procedures write and “own” the procedures.
4. Define Quality objectives: Just like any Key Performance Indicator, defining quality objectives is a critical part of your QMS execution. Make sure that the objectives reinforce your QA procedures.
5. Establish clear roles and responsibilities: Make sure that someone or a team is responsible for ensuring your quality processes evolve as your company and product evolves. Again, the team that established the QA processes should own defining the process and execution of the process and should be held accountable for the performance of the process and quality of the product.
6. Define the quality acceptance criteria for your device: When a product leaves your facility and is put in the hands of the customer, define the level of quality that you expect. Example questions include: what tests need to pass, what level of finish is acceptable, etc.
7. Determine what tools are needed to ensure appropriate quality control: At Simbex, we are often asked to help build test fixtures for manufacturing. These are automated or semi-automated tools that evaluate different aspects of the product to help determine if the product has been manufactured properly.
8. Establish Quality Control processes: Ensure that the evaluation process ensures that the product you are producing meets your acceptance criteria.
9. Make QA/QC part of your culture: This requires you to change your perspective from “meeting regulatory requirements” to “delighting your customers”. The thought pattern should be “In order to delight our customers, we need to…”
10. Mind the basics: The following are essential components of your QA/QC process. If you do this well, you will exceed regulatory expectations and safeguard patient safety
  1. Document thoroughly: Keep detailed records of all QC and QA activities, ensuring comprehensive documentation for audits and inspections.
  2. Implement traceability systems: Track every component and process step to identify and address issues quickly.
  3. Conduct regular audits: Perform routine internal and external audits to ensure ongoing compliance with regulatory standards.
  4. Practice proactive risk management: Identify and mitigate risks throughout the product life cycle. Leverage tools like your CAPA program, DFMEA, etc.
  5. Focus on continuous improvement: Regularly refine QC and QA processes based on audits, feedback, and industry trends, emphasizing adaptability to changing regulations and technologies.

By following these steps, companies ensure that the quality of their product meets the company’s and its clients expectations, enhances efficiency, reduces risks, and ultimately wins repeat customers.

Comparing the Tools and Techniques Used in QC and QA

QC and QA each rely on specific tools and techniques to ensure that medical devices meet the highest quality and safety standards. Understanding the differences in these tools can provide valuable insights into how each function contributes to the overall quality management system.

Tools and Techniques Commonly Used in QC

Quality Control monitors and controls the manufacturing process to identify and correct defects. The following tools are commonly used in QC:

Statistical process control (SPC): Monitors the consistency of the manufacturing process using control charts and statistical methods to detect variations that could lead to defects.
Inspection tools: Manual or automated tools, such as calipers and micrometers, measure components and products and allow workers to verify they meet specifications.
Testing equipment: Off-the-shelf or custom rigs that measure product performance against predefined criteria, ensuring the final product functions as intended.

Tools and Techniques Commonly Used in QA

On the other hand, QA, is more focused on ensuring that the processes used to develop and manufacture the product are robust and capable of producing consistent, high-quality results. The following tools are frequently used in QA:

Quality audits: Regular checks of all processes to confirm they comply with regulatory standards, helping identify improvement areas.
Process checklists: Used during product design and updates to ensure that all necessary steps are followed, maintaining consistency and preventing omissions.
Quality Management System (QMS) software: Software packages that follow standards like ISO 13485 to align development and manufacturing processes with industry requirements, ensuring that every aspect of production is documented, traceable, and compliant with regulatory standards.

Implementing Exceptional QA and QC Processes Give You a Distinct Advantage Over Your Competition

The Benefits of Implementing QA/QC

Improved product consistency: QC confirms that each product adheres to design and quality standards, minimizing variations during manufacturing and maintaining reliability and safety.
Defect reduction: QC identifies and corrects defects during manufacturing, reducing the likelihood of defective products reaching the market and lowering the risk of recalls.
Enhanced customer satisfaction: QC builds customer trust and satisfaction by delivering high-quality products, therefore strengthening the company’s reputation.
Improved process efficiency: QA focuses on creating robust processes that produce consistent product quality, reduce waste, shorten time to market, and encourage effective resource use.
Compliance with regulatory standards: A well-implemented QA system verifies that all processes meet regulatory requirements, which is crucial for gaining approval and maintaining global market access.
Reduced costs and risk mitigation: QA helps prevent defects before they occur, reducing costs related to rework, recalls, and warranty claims and mitigating potential issues early in the development process.

Implementing QC and QA Requires an Investment of Time and Money

Implementing comprehensive QC and QA processes is necessary to support the quality and safety of medical devices, and it requires time, focus and money to do it well. Here are a few things to consider:

High implementation costs and time requirements: Implementing comprehensive QC and QA processes can be resource-intensive. Don’t underestimate the effort and develop a plan early. QA/QC can often be an after-thought; don’t make it an afterthought. Build the QA/QC planning early in the product development process.
Don’t underestimate the impact of regular training: Continuous training is essential to keep staff updated on standards, technologies, and best practices. Consider implementing training in different ways (Hint: Read and Understand is not that effective of an approach). Be creative in your training approaches.
Achieving buy-in from employees: Implementing or enhancing QC/QA often requires a cultural shift within the organization. Make sure that the staff is invested in developing a high quality product.

To support effective QA/QC implementation at your company:

Invest in employee resources: Provide ongoing training to update employees on QC and QA practices. Most importantly, ensure they have the necessary time and support to apply their skills effectively, reducing stress and enhancing productivity in implementing quality processes.
Foster a culture of quality: Promote a company-wide commitment to quality, with leadership modeling this commitment and sharing success stories to demonstrate the positive impact of QC and QA.
Leverage technology: Invest in advanced tools and software that streamline QC and QA processes, reduce manual effort, and improve accuracy.

By recognizing the importance of QA/QC and committing to quality organizations can implement QC and QA processes that not only meet regulatory requirements and ensure continuous improvement, but create products that customers value.

Conclusion

QC and QA are essential components of medical device development aimed at product quality and reliability. They not only ensure products are safe, effective, reliable, and compliant with regulatory standards, but they also instill confidence among stakeholders and accelerate the delivery of products to end users.

As the medical device industry evolves, companies must remain adaptable, continuously refining their QC and QA processes to meet new challenges and leverage emerging technologies and drive innovation in quality management. Ultimately, a robust quality system reduces human error, minimizes liability risks, and boosts confidence in the final product, leading to greater success in the market.