The safety, efficacy, and reliability of medical devices hinge on two distinct processes: quality assurance (QA) and quality control (QC). Each is vital, distinct, and defined below! Equally important, we’ll discuss the steps that industry leaders are taking to ensure quality standards are met with the help of preventative maintenance software.
Interchangeable Terms? Not Really
QA and QC are often used interchangeably. This is common because although they represent distinct processes, they work in tandem to uphold stringent regulatory standards and meet patient needs.
Understanding the nuance that separates each is important, though, particularly in the medical device industry, where precision and accuracy are everything and where there are several preventative maintenance software options. The distinction is crucial for maintaining compliance and delivering high-quality products.
- Quality assurance is proactive and focuses on the process. Its goal is to prevent defects by identifying and improving manufacturing procedures that will minimize future defects.
- Quality control is reactive and focused on the product. It identifies defects in finished products, so they can be fixed before they reach customers.
QA Uses Preventative Maintenance Software to Meet Standards
At medical device manufacturers, quality assurance programs encompass the processes and systems put in place to ensure that products consistently meet customer expectations and regulatory requirements. As mentioned, it’s a proactive approach. Its focus is on preventing defects and deviations from occurring throughout the entire product lifecycle. It’s a big job.
Quality managers are responsible for quality assurance. They strive to improve both product development and product testing processes to create a seamless and compliant process. The end goal is to eliminate defects before they can happen.
The QA process is very stringent in accomplishing this goal. They are tasked with creating and monitoring activities that impact the final product—and preventative maintenance software helps keep requirements aligned with outcomes.
There are critical aspects of quality assurance in the medical device industry spanning a number of categories, including regulatory compliance, documentation controls, risk management, audits, and education, as detailed below:
Regulatory Compliance: QA teams interpret and implement regulatory standards, FDA regulations, and other international standards. They often establish quality management systems (QMS) that govern all aspects of product development, manufacturing, and distribution.
Documentation Control: QA professionals meticulously document all processes, procedures, and specifications related to product manufacturing. Preventative maintenance software ensures this documentation is readily available when needed, as it serves as evidence of compliance during regulatory audits and inspections.
Risk Management: QA includes identifying, assessing, and mitigating risks associated with medical device manufacturing. This includes conducting risk assessments, implementing risk management plans, and ensuring that risk controls are integrated into product design and manufacturing processes.
Audits and Assessments: QA teams conduct internal audits and assessments to evaluate the effectiveness of quality systems and to identify areas for improvement. They also oversee supplier audits to ensure that external partners meet the same rigorous quality standards.
Training and Education: QA departments train and educate employees on quality procedures, regulations, and best practices. This ensures that all personnel involved in product development and manufacturing are equipped with the necessary knowledge and skills to maintain these quality standards.
The preventative maintenance software on hand, often a Computerized Maintenance Management System (CMMS), is a quality assurance tool in itself. It captures and organizes records and processes, making the manufacturing process more consistent.
QC Monitors and Verifies Product Quality
The quality control side of the equation focuses on inspecting, testing, and verifying products to ensure that they meet predefined quality criteria and specifications. This is a reactive process, the last line of defense before a product is sent out into the world.
The goal is to identify and correct defects before products are released to the market, so getting this right is incredibly important. Having the right preventative maintenance software in place will head off many of these concerns, so defective products are rarely, if ever, produced. It acts as a buffer.
Here are key aspects of quality control in the medical device industry:
Inspection and Testing: QC teams perform rigorous inspections and testing at various stages of the manufacturing process to detect defects and deviations from quality standards. This includes incoming inspection of raw materials, in-process testing during manufacturing, and final product inspection before release.
Statistical Process Control (SPC): QC uses statistical techniques such as control charts, histograms, and Pareto analysis to monitor process variability and identify trends or abnormalities that may affect product quality. SPC helps identify potential issues early, allowing for prompt corrective action to be taken.
Nonconformance Management: When defects or deviations are identified, QC teams initiate nonconformance investigations to determine the root cause and implement corrective and preventive actions (CAPA) to address the issue. These actions might involve quarantining nonconforming products, reworking or scrapping defective units, and updating quality procedures to prevent recurrence.
Calibration and Maintenance: QC ensures that measurement and testing equipment are calibrated and maintained according to established standards. This ensures the accuracy and reliability of test results and promotes consistency in product quality.
Equal Importance, Different Processes
Both quality assurance and quality control are indispensable when it comes to safeguarding medical device product safety and efficacy. QA focuses on establishing robust systems and processes to prevent defects, and QC detects and corrects deviations from quality standards through inspection, testing, and verification.
Integrating QA and QC practices seamlessly is important work, and it can be done. Medical device manufacturers can ensure the highest levels of quality and compliance, earning trust and confidence from regulators, healthcare providers, and, ultimately, their patients. Each piece of that quality assurance puzzle matters.
CERDAAC offers a single source of truth with CMMS software that organizes important data and keeps quality concerns top-of-mind. Reach out for a demo to see it in action!
