Enterprise Quality Management • January 3, 2017

Why a Quality Management System Isn’t Enough to Satisfy 21 CFR Part 820 and Part 11

iBase-t Experts

Manufacturing Operations Management (MOM) is a key solution for medical device manufacturers striving to satisfy complicated U.S. Food and Drug Administration (FDA) regulations. The FDA requires medical device manufacturers to implement quality systems that meet the regulations found in 21 CFR Part 820 and 21 CFR Part 11. These regulations are similar to ISO 13485 standards for Quality Management Systems (QMS), but are not the same. These regulations outline the practices that govern all methods used in the design, manufacturing, packaging, labeling, storage, installation, and servicing of all medical devices. Although 21 CFR Part 820 and 21 CFR Part 11 spell out the rules and regulations for quality that a medical manufacturer must meet, will a Quality Management System (QMS) alone really satisfy these critical requirements?

Documentation Versus Enforcement: Why QMS Alone is Not Enough

A QMS will document everything the FDA stipulates in its quality regulations, but falls short, because it cannot enforce them on the plant floor. Section 820.72 of the regulation is a good example of the problem. This section covers inspection, maintenance, and testing equipment to provide certification that the proper tooling is being used in the medical manufacturing process.

A QMS will tell the manufacturer that it must always use certified equipment, and indicate the tests and procedures needed for certification, but the reality of the shop floor is that there are often multiple tools at hand, some of which are certified, and some of which are not. When someone on the plant floor grabs a tool to use, they know it must be a certified tool, but nothing in the QMS stops the employee from using a tool that is not certified. This lack of enforcement introduces risk into the process and puts satisfaction of 21 CFR 820 requirements into question, while introducing a potentially time consuming rework to correct the problem.

Manufacturing Operation Management (MOM) as a Solution for Enforcing FDA Regulations in Medical Device Manufacturing

A better solution is to use a Manufacturing Operation Management System (MOM) system, such as iBase-t’s Solumina, to enforce the FDA regulations. Solumina is an integrated, configurable, and easy-to-use Quality Management System (QMS) and a Manufacturing Execution System (MES) software solution that is designed to facilitate compliance with 21 CFR Part 820 and other FDA regulations, including 21 CFR Part 11 electronic signature requirements within a single integrated software suite.

In the case of Section 820.72, Solumina’s Tool and Gauge Management system allows for the establishment of procedures to calibrate, inspect, check, and otherwise maintain tools and measuring equipment. Solumina, for example, will not allow any piece of equipment that is outside of its calibration requirements to be used in any operation. Solumina will also automatically alert operators when they are going to be using a piece of equipment nearing its expiration date or use. Operators can easily check the status of any piece of equipment at any time, including its calibration status, calibration frequency, last date of calibration, physical location of the equipment, and the work center that last checked out the device.

The system generates reports verifying that all tools assigned to a work center are still at their last location and missing tools can be flagged for further investigation. In addition, Solumina maintains the history of every work order each individual tool was used on.

Bottom Line: MOM Solves FDA Compliance for Medical Device Manufacturing

While a QMS gives direction for meeting FDA requirements, an MOM solution such as Solumina gives direction and ensures that the direction is being followed step by step. There’s no way for a QMS alone to verify that work is being done correctly on the shop floor per FDA requirements.

Solumina Software Ensures:

  • The right people are doing the work.
  • The right parts are being used to do the work.
  • The right revision levels are being worked to.

The goal is to eliminate the inefficiency and human error associated with paper-based systems. To do that most effectively, MOM is the choice over QMS for meeting the requirements of 21 CFR Parts 820 and 11.

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