A Flexible Approach to 21 CFR 820 Compliance

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 an opportunity to the manufacturers of these devices to incorporate their 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 demonstrates to the Agency that a company is controlling its 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 is one that performs as expected while meeting projected market impact in addition to being safe and effective. To the maximum 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, and production processes, and “allows for the top-level management to have a good overview of the general compliance status of the company.

The Federal regulations and harmonized EU and ISO policy guidance documents 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. However, prompt and thorough complaint processing can provide information on non-conforming products, thereby building a record of timely action accompanied by 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, the pursuit of an error-free production process, diligent after-sale oversight, 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 output from design and development is the primary input for production.

In production, the instances of nonconforming products require corrections, but they also present opportunities 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 disappears and resolves into a fluid process.

Corrections trigger corrective actions, rigorous assessments, and evaluation. This process should involve top management commitment, for it is the crucible of product quality, the discovery of errors, and the refinement of production processes.

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 distributing work amongst internal divisions that are outside of the central quality management system. In each of these instances, the responsibility for compliance does not shift; and the 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 sizes and compositions 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.

Contact us today to discover ways to engineer 21 CFR 820 Quality Assurance values into the design development and production processes of your organization.