Medical devices have rigid standards all manufacturers must meet. It’s crucial to ensure you create durable, reliable products that benefit the consumer. At MDI, we pride ourselves on meeting industry certifications that ensure we deliver the best products to customers. We have a medical device quality plan for the entire operation to meet that goal.
What Is a Medical Device Quality Plan?
A medical device quality plan outlines the standards, specifications, and processes related to the development of medical devices. The manufacturer can determine whether they need a comprehensive document or group plans according to product purpose.
A manufacturing organization’s engineering and quality teams typically oversee the medical device quality plan creation. It’s essential for ensuring regulatory compliance and provides documentation for issues that may arise during production.
Why Are Quality Plans Important for Medical Device Manufacturers?
Quality plans allow manufacturers to focus on their company’s mission while detailing the production process. This approach provides transparency to stakeholders and consumers and streamlines manufacturing. If you’re wondering, “What is quality planning?” the following sections explain everything.
A quality plan outlines who is responsible for each task or activity to ensure effective communication between all parties. The document establishes clear protocols depending on the nature of the plan.
It also helps define a methodology for receiving and implementing feedback or complaints from customers or stakeholders. Manufacturers can continuously review inputs to make adjustments where necessary, ensuring it remains effective over time.
When you develop a manufacturing quality plan, you identify the activities and resources required for implementation. The goal of quality objectives is to:
- Decrease product nonconformities and defects
- Improve product performance
- Increase efficiency
- Ensure the safety of products and processes
- Increase customer satisfaction through efficient delivery and customer service
The objectives section of the plan will help establish clear roles and responsibilities for management, employees, distributors, and customers. It also outlines the resources needed, including equipment, materials, and funding.
Additionally, quality objectives provide an overview of the organization’s structure, so everyone knows their role in achieving quality objectives. A flow chart or similar type of diagram helps visualize this structure.
Are Medical Device Quality Plans Required?
Yes, any company that manufactures medical devices must have a quality plan. The US Food and Drug Administration (FDA) clearly outlines quality regulations for all medical devices. Beyond the legal requirement, having a quality plan for your equipment is ideal. A quality plan ensures a device is safe and meets industry standards. It gives healthcare professionals and consumers insight into the manufacturer’s overall quality management system to help meet requirements.
Quality Plan Overview
Quality plans are critical to success in medical device manufacturing because they help meet regulations, optimize resource usage, measure compliance, and put established guidelines in place. A quality plan can identify potential risks before they become issues impacting patient safety or product performance.
By thoroughly understanding all aspects of production in a quality plan, organizations can identify potential risks and take appropriate measures to mitigate them. The process ensures product safety while enabling manufacturers to meet consumers’ needs.
A quality plan helps to ensure that a device is consistent from batch to batch by issuing specifications, such as:
- Quality standards
- Best practices
- Optimizing resources
- Developing and processes related to product development
It documents what happens if you fail to meet these requirements. Additionally, it helps ensure regulatory compliance with standards such as ISO 13485:2016 and ensures that products are safe and effective for end-users.
By having a quality plan, manufacturers ensure their products are consistent across all batches. This documentation also serves as training material for new employees to guarantee their actions meet the company’s quality goal.
The medical device quality assurance section provides a roadmap for achieving these objectives and monitors and measures all steps of the manufacturing process against specific requirements.
With a practical quality plan, organizations ensure that their products or services meet customer and regulatory requirements while optimizing resources used in manufacturing. Additionally, it’s a tool for measuring compliance against specific needs and helps organizations establish effective quality management systems.
This plan helps ensure that all project stakeholders know what to do to uphold quality and compliance with regulatory requirements. Though the engineering and quality teams create the plan, all project stakeholders should agree before implementation begins.
Beyond the company’s scope, a quality plan helps manufacturers comply with regulatory requirements such as those outlined in the FDA’s Quality System Regulation.
A quality plan ensures a company conducts quality audits by defining the extent of the audit, how to use the results, and who to involve in the process.
Efficiency increases because everyone knows their role in the auditing process. Additionally, by setting clear expectations about how to use the results, you can identify potential issues and address them before they become significant problems.
Steps to Create a Medical Device Quality Plan
There are specific steps to follow when creating the ideal medical device quality plan for a manufacturer. Start by determining the quality standards and what procedures you’ll use to check that you’re meeting these criteria, then follow the process below.
Step 1: Determine the Scope of the Quality Plan
You should clearly describe the plan’s purpose, emphasizing how employees should carry out activities. Ideally, the overview references your standard operating procedures where applicable. Add details depending on the objective and activities.
For example, if the objective is to bring a new device onto the market, multiple details, from high level down to production instructions, are necessary for success.
Step 2: Develop Quality Policy Objectives
Determine the purpose of the quality policy and what it should express. Draft a brief statement that outlines your organization’s mission and strategic direction. Identify measurable goals to enhance customer satisfaction, such as reducing product defects, increasing efficiency, ensuring safety, and meeting deadlines.
Since you want to link together production and quality assurance, use the PDCA process:
- Plan: Establish the medical device quality plan
- Do: Manufacture
- Check: Using medical device quality assurance
- Act: Improve the process as needed, based on feedback
Step 3: Identify Inputs for the Quality Plan
You need to identify the inputs for the medical device quality plan. These may include:
- Quality system requirements and standards
- Regulatory requirements and guidelines
- Customer requirements and expectations
- Technical specifications of the product
Reference these inputs in the quality plan, so it’s easy to identify them when needed. All employees and stakeholders should understand the inputs and their roles in the process.
Step 4: Monitor and Evaluate the Plan’s Outputs
After identifying inputs, evaluate the outputs to ensure you meet your goal. Establish and document metrics for measuring the performance of these processes to ensure outputs are consistent. Periodically review inputs to ensure their validity and evaluate their outcomes. This approach will help you track progress toward achieving objectives by monitoring metrics associated with each process.
Step 5: Document Standards and Procedures
Documentation standards and procedures in a medical device quality plan ensure approval before implementation. Outline methods for revising documents, identifying changes, and ensuring employees can access current versions.
Keep employees and stakeholders involved by using procedures for reviewing documentation before implementing changes. You’ll get valuable input and ensure compliance with regulations while optimizing industry best practices.
Step 6: Evaluate Customer Satisfaction
Customer satisfaction with product medical device quality control processes can help create a medical device quality plan because it allows businesses to understand their customers’ needs and expectations.
An effective customer satisfaction strategy ensures that businesses meet the needs of their customers. This section guarantees that medical device quality control processes are up to par so the company delivers safe medical products that perform the necessary tasks.
Companies can use customer feedback to develop strategies for compliance with legal standards while providing high-quality products that meet customer expectations. You comply while gaining customer loyalty by delivering consistent products over time.
Step 7: Strive for Continual Improvement
Always strive to improve your process. You should periodically review your medical device quality plan, whether it’s daily, weekly, or monthly. Keep employee and customer feedback in mind when you edit the document. You want to meet professional standards while also streamlining the production process and meeting customer needs.
Create a plan to implement continual improvement by identifying key areas that need improvement, creating strategies to revise them, setting goals and timelines for each section, and developing metrics to track progress over time.
It’s best to implement changes on a small scale. Test out new processes or procedures in a controlled environment before rolling them out more widely across your organization or facility. This approach also helps ensure that the revisions benefit the manufacturing process.
Anytime you make a change, analyze the results. Use data from before and after the changes to determine if there has been an improvement in results. If so, continue implementing changes on a broader scale. If not, begin the cycle again with different approaches or methodologies.
Enhance Your Medical Device Quality Plan
By creating a quality plan for your medical device, you can ensure that you identify and handle any deviations from the expected output, so they do not affect the overall quality of your products or services. This approach will help maintain customer satisfaction while ensuring compliance with legal standards. Contact MDI today to learn how we can help you improve your medical device quality plan.