The Importance of a Manufacturing Quality Plan

What is a Manufacturing Quality Plan?

The importance of a manufacturing quality plan can’t be understated in any field, but it’s particularly important in the medical device industry. A quality plan for medical device design and manufacturing is required by the FDA and the ISO 13485 framework. Viewing and agreeing upon a manufacturing quality plan before product development ensures greater regulatory compliance, the avoidance of costly issues, and a greater likelihood that the final product will be safe and effective for the end-user.

When looking for a contract manufacturer to partner with, companies are often seeking the highest quality at an affordable price. Without meeting the standard of quality required to produce a safe and effective product, the product is likely to fail. Any manufacturer making medical or drug delivery devices must abide by a quality plan, regardless of whether the project is commercializing an entirely new device or making a slight alteration to an existing one.

So, what is a manufacturing quality plan? It’s different from Standard Operating Procedures (SOPs) in that it is more granular and project-specific. A manufacturing quality plan is documentation that lays out the workmanship standards, practices, resources, specifications, and processes related to the development of a product, service, or other project. It’s almost like a manufacturing project blueprint, a set of guidelines to be followed to ensure the proper result. This type of plan is typically created by the engineering and quality teams within a manufacturing organization and should be viewed and agreed upon by all project stakeholders prior to device development.

Why Make a Manufacturing Quality Plan?

First, a manufacturing quality plan says a lot about a manufacturer. It provides insight into the manufacturer’s overall quality management system and can help ensure that the manufacturer is aligned with design specifications and project requirements. The quality plan also serves as documentation for what’s expected in the event that these requirements aren’t met and can be used as a valuable training tool. This documentation is critical to success in medical device manufacturing.

What Should a Manufacturing Quality Plan Include?

The contents of a manufacturing quality plan can vary by situation and industry. There are quality plan templates online that can be followed, but these are the basic elements that are most often included in the development of medical devices.

• Objective – This should lay out the expected result and how this will be achieved. Include product specifications, materials, cost, and other important preliminary information.
• Process – Detail how development will be carried out.
• Responsibilities – List who will do what and when. An organizational chart of team members and roles can be valuable here.
• Standards – Describe the practices that will be followed in order to achieve the expected quality for each deliverable.
• Testing parameters – Confirm what testing types are required as well as where and when the testing will take place.
• Modifications procedure – This will be used for tracking any changes needed to the product or project as you go along.
• Quality process measurement – This is needed to determine the effectiveness of the document itself.
• Related materials – Include any performance ratings or reports, or other related materials.

This is by no means a complete list. Evaluate the contents needed for your industry and the product to create an effective plan.

How do you Create a Quality Plan for Manufacturing?

The process for creating a manufacturing quality plan can be broken down into three main steps.

1.  Supplier Audits
All suppliers that a manufacturer intends to use on the project must be audited to ensure capabilities match the project expectations and meet quality standards. An audit should evaluate a factory’s equipment, materials, processes, workforce, and quality plan in detail.

2.  Supplier Capability Studies
An important part of the quality plan is confirming whether or not suppliers can meet the exact specifications required to produce the product in question. First article inspections and process capability studies, usually performed by on-site engineers, will help to evaluate the proficiency of each supplier.

3.  Quality Inspections
A manufacturing quality plan should include a lot-level quality inspection of every production run of every product before it is shipped off from the facility. An in-house quality inspector will confirm raw material certifications and key process data while performing any required inspections outlined in the quality plan. Inspections typically examine order and shipment quantities, packaging and aesthetics, product specifications, and final performance attributes. The details of the inspection are written up in a report and submitted to the quality manager before any shipments are authorized. This inspection report is a critical part of managing ongoing quality metrics that measure supplier performance.

Creating a manufacturing quality plan is an essential part of the commercialization process, though it’s not a one-time effort. A manufacturer’s quality plan should evolve over time. It is important to continue to look for potential improvements that will lead to better project results.

Gilero provides design, development, and contract manufacturing services for the medical device and pharmaceutical industries. Our manufacturing expertise ranges from single-use medical devices to complex electromechanical drug delivery systems. Manufacturing service offerings include cleanroom manufacturing, plastic injection molding, injection mold tool building, complex assembly, packaging, and kitting. With a proven capacity to innovate, scale, and commercialize, our domestic and international facilities are equipped to develop unique manufacturing solutions and accelerate device commercialization timelines. Learn more about our contract manufacturing services.