Keith V. Rohrbach, Ph.D.
The Biomedical Quality Auditor
The world's biomedical technology industry represents over $160 billion annually, with more than half of its products produced in the U.S. The industry encompasses medical devices, instruments, in vitro diagnostics (IVD), and certain biologics. It is a regulated industry with the quality auditor role central to providing management with essential measures of the quality management system.
Quality Assurance professionals and others employed in the biomedical technology industry perform some or most aspects of the biomedical quality auditor role. The new ASQ CQA-Biomedical certification is the first approach to defining this role objectively and offering a corresponding credential to qualified practitioners. To achieve the CQA-Biomedical certification, a candidate must have first completed the CQA certification, possess at least two years of biomedical audit experience, and pass the CQA-Biomedical certification examination.
BIOMEDICAL QUALITY AUDITOR
The biomedical quality auditor, as defined herein, works with medical devices, including in vitro diagnostics and biologics that are regulated as medical devices. This auditor conducts systematic and independent examinations of quality activities and related results encompassing many types of biomedical related entities—manufacturing establishments, clinical research laboratories, testing laboratories, suppliers, and others.
The biomedical quality auditor's principal goal is to accurately and objectively report to management on the effectiveness of business processes to achieve business objectives, including compliance with regulatory requirements. Based on competent auditor assessments, management can judge the completeness and effectiveness of the quality management system and the levels of corresponding business and legal risks. Decisions can then be made and priorities and resources assigned to implement necessary corrections or improvements.
To best fulfill this goal, an effective biomedical quality auditor must be proficient at auditing, audit management, and a series of subject matter areas. The ASQ CQA Body of Knowledge represents primarily the audit and audit management proficiencies. The subject matter areas are more specific regarding biomedical products and technologies:
- Quality systems—design, development, maintenance, improvement, business value and implications of quality systems for medical devices, etc.
- Global standards and regulations—system, analytical/technical, and product regulations and standards as well as proprietary standards
- Product knowledge—product applications and technologies from a customer perspective and the fundamental operational, manufacturing and quality technologies necessary to produce the device
- Information systems—application of information systems for quality-related data, including collection, analysis, maintenance, security, and validity
- Statistical principles and applications—evaluation of performance and conformance: product, process, system, and clinical/customer satisfaction
- Human factors—influence of human performance by physical environment, communications, interpersonal interaction, and work flow
- Analytical tools and techniques—applications and limitations of techniques for assessing environment, processes, and products
The CQA-Biomedical Body of Knowledge focuses on the understanding of national and international concepts and principles of biomedical quality auditing, including related regulations, directives, standards, and guidance. It contains four main knowledge categories that directly address much of the subject matter areas identified above:
- Base law and regulations—U.S. laws/regulations and the European Medical Device Directive
- Standards and guidance—U.S. IVD guidance, design review, and adverse event reporting; international risk management, Global Harmonization Task Force (GHTF) guidances, and quality systems
- Auditing techniques and compliance programs for medical devices—FDA QSIT, Compliance Program, and GHTF guidance for devices
- Technical Knowledge—sterilization, biocompatibility, controlled environments and utilities, software, and laboratory testing.
It is recognized that the scope of subject matter for a particular biomedical quality audit sometimes extends beyond these four knowledge areas, both in terms of geographical regulations or standards and technical matters. Similarly, the scope of a particular audit may exclude some of the four knowledge areas. However, the scope and depth of knowledge included in the CQA-Biomedical Body of Knowledge represents a composite of the knowledge determined by the biomedical quality auditor job analysis (Muenzen 2000) as most important to the auditor role and most frequently used.
The following table compares the contributions of the CQA and CQA-Biomedical Bodies of Knowledge to all knowledge categories important to biomedical quality auditing:
|Knowledge Areas||CQA*||CQA -Biomed*|
|Auditing and Audit Management||+++||+|
|Subject Matter Areas|
|Global standards and regulations||+++|
|Statistical principles and applications||++|
|Analytical tools and techniques||++|
|* Rating (+) is based on the content of the corresponding Body of Knowledge|
The ratings in the table above represent a subjective assessment of each certification's Body of Knowledge against the overall knowledge areas applicable to the Biomedical Quality Auditor. More ?+? signs indicate greater contribution; no "+" sign indicates no contribution. The ratings do not relate to the total knowledge required but instead the relative knowledge contributed by each certification.
As examples, nearly two-thirds of the CQA Body of Knowledge covers audit and audit management related subjects whereas only about 15% of the CQA-Biomedical Body of Knowledge addresses audit related subjects. Conversely, the CQA Body of Knowledge contains virtually no content focused on specific global standards and regulations whereas the CQA-Biomedical has nearly two thirds of its content related to this subject.
Given the breadth of the biomedical technology industry, including government and research institutions, as well as its highly regulated environment, the opportunities for biomedical quality auditors are extensive. They provide to management essential measurements of business process effectiveness, including compliance.
The Biomedical Quality Auditor role requires knowledge in both audit/audit management and a variety of subject matter areas. With availability of the ASQ CQA-Biomedical certification, biomedical quality auditors now have an opportunity to obtain a credential that represents much of the knowledge needed for both auditing and the subject matter areas. As evident in many current job opportunities, the biomedical technology industry continues to seek certified auditors. This add-on subject matter certification will provide not only broader relevant knowledge but much stronger professional credentials to fulfill these opportunities.
- Muenzen, P.M. 2000. Final Report of the Biomedical Quality Auditor Job Analysis. Conducted by Professional Examination Service. New York: ASQ Biomedical Division.
- ASQ 2001. Certified Quality Auditor (CQA) Body of Knowledge. Milwaukee: ASQ website.
- ASQ 2001. CQA—Biomedical Body of Knowledge. Milwaukee: ASQ website.