The Quality Systems (QS) Regulations of FDA 21 CFR 820 are general standards that apply to finished devices, that are intended for human use.. Rather than impose strict requirements, the regulations offer manufacturers of these devices an opportunity to incorporate its quality management standards into key organizational processes.
The flexible structure of the regulatory environment provides an opportunity to use quality management principles as tools for the development of safe and effective medical devices.
By engineering compliance values into vital processes, a company can develop a customized program designed to meet the needs of a particular medical device production effort.
Involving Top Management
The letter of the FDA quality assurance regulations requires top-level management involvement in the key processes. The organizational goals drive this demonstrated level of involvement. Regardless of the size, complexity, and vertical layers, top management must demonstrate involvement and commitment to the goal of achieving current good manufacturing practices. This management control is implemented through the introduction and use of management reviews, which should take place at least on a bi-annual basis. The use of management reviews demonstrate to the Agency that a company is controlling their compliance status with respect to the implementation of the QSR within that company.
This role is fundamentally consistent with management goals, and with the overall process of aligning organizational processes to achieve its strategic vision. An excellent product that performs as planned and meets projected market impact also must be safe and effective. To the extent possible, it must be free of defects.
The commitment of top management to the development process from the conception stages to distribution reflects the quality of organizational management. It becomes the hub of a wheel consisting of design controls, correction and prevention, production processes and allows top management a good overview of the general compliance status in the company.
The Federal regulations and harmonized EU and ISO policy guidance add a framework to define sound internal management practices.
Support for Legal Review and Mitigation
Risk management is a priority, and it drives many internal assessments. However, complaints, or the lack thereof, do little to confirm the quality of a medical device. But, prompt and thorough complaint processing can provide information on nonconforming products and will build a record of timely action and diligent efforts to discover and remedy product issues and usage problems.
The documentation requirements of the regulations and the exacting record keeping that underpins the Device Master Record and the Device History Record also provide the basis for a legal foundation. Compliance with a responsive quality management system is evidence of good faith pursuit of an error free production process, diligent after-sale oversight, and prompt action including notices, advisories, and amendments to the previous information.
Corrective and Preventative Actions
The results in the planning and production processes are a function of the effectiveness of the design and development phase. The design and development output is the primary input for production.
In production, the instances of nonconforming products require corrections, but they also present an opportunity for corrective actions that examine the entire record and assess relevant systems. Systemic causes of error and nonconforming products are vital findings for successful production processes.
Software validation is a key part of system evaluation. While there is an important regulatory distinction between corrective actions and product corrections in the organizational environment, it is vital that the distinction disappear and resolve into a fluid process.
Corrections trigger corrective actions, a rigorous assessment, and evaluation. This process should involve top management commitment, for it is the crucible of product quality, the ability to discover errors and refine the production process.
Validation, Outsourcing and Globalization
As the entity that puts the product into the marketplace, there are non-transferable responsibilities that attach and are not relieved by outsourcing, subcontracting, or spreading work among internal divisions that are outside of the central quality management system. In each of these instances, the responsibility for compliance does not shift; management responsibility remains with the device manufacturer. In the global economy, this requirement creates an additional management oversight responsibility.
Organizations must find an effective assurance of compliance from sometimes distant and independent sources of supply, services, and components. Compliance includes both standard and customized software, i.e. compliance includes all GAMP software categories.
The efficient integration of outside components and entities presents a unique challenge in a regulated environment, but it is made easier by the freedom within the regulations to form workable contract relationships that integrate compliance standards.
Pursuing Excellence and Compliance
The medical device regulatory standards were developed at the onset of the current information technology era and in the early stages of economic globalization. In that era companies frequently handled product development, from conception to distribution, in-house with force resources. Today, that is a rare exception in the global economy based on lean and versatile business models and extensive use of software, outsourcing, and contracting. However, the flexible regulatory approach works well with current Good Manufacturing Practices (cGMP).
Organizations of varying size and composition can develop and produce a nearly infinite range of medical devices under the broad FDA and globally harmonized quality management framework. They can build compliance values into an overall approach that produces excellent products, profits, and organizational success.
GxP-CC is keenly adept in guiding medical device manufacturers through the many FDA regulations which must be met through the lifecycle of a device.