In the pharmaceutical and medical device industries, developing auditor competence for internal audits (quality audits) and supplier audits (vendor audits) is critically important for driving continuous quality improvement within an organization. However, many auditors face a significant limitation: they have exposure only to their own company’s processes and lack benchmarking opportunities against other organizations.
To address this gap, supplier audits provide an invaluable opportunity to examine other companies’ quality systems and learn superior approaches to quality management and quality assurance. Through this exposure, auditors can develop a deeper understanding of diverse quality system implementations and bring that knowledge back to enhance their own organization’s practices.
The Balanced Approach to Supplier Audit Planning
When planning supplier audits, many organizations tend to focus their audit schedules primarily on suppliers with known quality issues. While it is certainly important to audit underperforming suppliers and guide them toward improvement, this approach alone has significant limitations for auditor development.
Concentrating audit efforts exclusively on low-quality suppliers does little to enhance auditor competence. In fact, such a narrow focus can be counterproductive. Instead, organizations should actively seek opportunities to audit high-performing suppliers to observe and learn from their effective quality management and quality assurance practices.
This balanced approach serves dual purposes: addressing quality concerns with underperforming suppliers while simultaneously creating learning opportunities that elevate the entire organization’s quality culture.
Learning from Best Practices Across the Industry
Exposure to multiple companies’ quality systems enables auditors to identify best practices and incorporate comparative analysis into their internal audit activities. When conducting internal audits, experienced auditors can evaluate their organization’s processes against the superior practices they have observed at other companies, leading to more valuable audit findings that include meaningful improvement recommendations.
This represents a key advantage available to quality consultants: through conducting audits across numerous organizations, consultants gain exposure to diverse quality systems and develop nuanced understanding of how different companies interpret and implement the same regulatory requirements and international standards. Moreover, they observe the various methodologies organizations employ to construct quality systems aligned with their specific interpretations of these requirements.
The Critical Role of Practical Experience in Auditor Development
In my professional experience, I firmly believe that auditor excellence comes primarily from accumulating extensive audit experience. Simply completing internal auditor training does not automatically produce competent auditors. True auditor development requires substantial hands-on practice across diverse environments and quality systems.
Current Regulatory Landscape and Auditor Competence Requirements
The pharmaceutical and medical device industries operate under increasingly sophisticated quality system requirements that demand highly competent auditors:
For Pharmaceutical Manufacturers:
The International Council for Harmonisation (ICH) Q10 Pharmaceutical Quality System guideline, which complements regional Good Manufacturing Practice (GMP) requirements, emphasizes the importance of effective internal audit programs as a core element of the pharmaceutical quality system. ICH Q10 promotes a lifecycle approach to quality management, integrating quality risk management and knowledge management as key enablers. Recent developments, including the FDA’s Quality Management Maturity (QMM) program launched in 2022, essentially evaluate companies on attributes aligned with ICH Q10 principles, including organizational culture, governance structures, and continual improvement capabilities. Organizations with robust audit programs that demonstrate mature quality systems are increasingly recognized and valued by regulatory authorities.
For Medical Device Manufacturers:
ISO 13485:2016 Medical Devices – Quality Management Systems serves as the foundational standard, with auditor competence specifically addressed in alignment with ISO 19011:2018 Guidelines for Auditing Management Systems. The recent transition from the FDA’s Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR), which harmonizes with ISO 13485, creates new opportunities and challenges for medical device manufacturers globally. The Medical Device Single Audit Program (MDSAP), accepted by regulatory authorities in multiple countries including the United States, Canada, Brazil, Japan, and Australia, further emphasizes the need for auditors with comprehensive understanding of multiple regulatory frameworks.
ISO 19011:2018 dedicates substantial content to auditor competence, emphasizing that auditors must possess appropriate education, training, skills, and experience. The standard specifies that auditors should demonstrate personal attributes including ethical behavior, open-mindedness, diplomacy, observation skills, and courage. They must also possess generic knowledge and skills in audit principles, procedures, and techniques, as well as specific knowledge of the management system discipline, industry sector, and applicable regulations.
The Value Perspective from Regulatory Authorities
From the regulatory authority’s perspective, organizations with competent auditors who conduct thorough self-inspections, identify meaningful findings, and implement effective Corrective and Preventive Actions (CAPA) represent low-risk entities. These organizations demonstrate their commitment to quality through proactive identification and resolution of quality system weaknesses.
Conversely, companies whose audits are conducted by auditors lacking adequate competence, resulting in findings limited to superficial issues such as typographical errors, transcription mistakes, or other minor clerical errors, fail to drive meaningful quality system improvement. Such organizations present higher regulatory risk because their quality systems stagnate without the continuous improvement that effective auditing should provide.
Regulatory inspectors can quickly assess the maturity of an organization’s quality system by reviewing internal audit reports and CAPA records. Organizations that demonstrate robust, insightful audit programs with substantive findings addressing system-level issues earn regulatory confidence, while those with superficial audit programs raise concerns about their overall quality culture and system effectiveness.
Practical Implementation: Building a Strategic Audit Program
To maximize both supplier oversight and auditor development, organizations should implement a strategic supplier audit program that includes the following elements:
Risk-Based Selection Criteria: Utilize a balanced approach that incorporates both risk considerations and learning opportunities. While high-risk suppliers require more frequent audits, allocate dedicated audit resources to examine high-performing suppliers and industry leaders to identify best practices and innovative approaches to quality management.
Structured Knowledge Transfer: Establish formal mechanisms to capture and disseminate learnings from supplier audits throughout the organization. This may include post-audit debriefing sessions, best practice documentation, and incorporation of superior practices into internal procedures and training programs.
Auditor Rotation and Exposure: Ensure that auditors gain exposure to diverse supplier types, quality system approaches, and industry segments. This breadth of experience accelerates auditor development and prevents the narrow perspective that comes from repeated audits of similar organizations.
Competence Development Planning: Treat supplier audits as a key component of auditor competence development programs. Document the learning objectives for each audit, track auditor exposure to different quality system elements, and systematically build auditor capabilities aligned with ISO 19011 competence requirements.
Benchmarking and Continuous Improvement: Actively use supplier audit observations to benchmark internal quality system performance. When superior practices are identified during supplier audits, evaluate their applicability to internal processes and consider adaptation where appropriate.
| Audit Focus | Primary Purpose | Secondary Benefits | Audit Frequency |
|---|---|---|---|
| High-Risk Suppliers | Quality assurance and risk mitigation | Limited auditor development | Frequent (risk-based) |
| Low-Risk, High-Quality Suppliers | Best practice identification and benchmarking | Significant auditor development | Periodic (planned) |
| New Suppliers | Initial qualification and capability assessment | Moderate auditor development | Required before qualification |
| Critical Component Suppliers | Supply chain security and quality verification | Technical knowledge enhancement | Regular (annual or biennial) |
Conclusion: Investing in Comprehensive Supplier Audit Programs
Organizations should recognize supplier audits not merely as a regulatory compliance activity or supplier oversight mechanism, but as a strategic investment in building auditor competence and organizational quality capability. By implementing a balanced supplier audit program that includes both problem suppliers and high-performing organizations, companies can develop auditors with the breadth of experience and depth of knowledge necessary to drive meaningful quality system improvements.
The most successful quality organizations understand that auditor competence represents a critical competitive advantage. These organizations systematically expose their auditors to diverse quality systems through comprehensive supplier audit programs, enabling auditors to bring comparative insights and best practices back to internal audits. This approach creates a virtuous cycle of continuous improvement where internal quality systems are constantly benchmarked against industry best practices and enhanced through the application of proven approaches observed at supplier organizations.
I strongly encourage all pharmaceutical and medical device manufacturers to expand their supplier audit programs beyond the minimum compliance requirements, actively seeking opportunities to audit both underperforming and high-performing suppliers. This investment in auditor development through diverse practical experience will yield substantial returns in the form of enhanced quality systems, improved regulatory performance, and ultimately, better products and outcomes for patients.
The path to auditor excellence lies not in classroom training alone, but in the accumulated wisdom that comes from extensive exposure to diverse quality systems, regulatory interpretations, and implementation approaches across the industry. Organizations that embrace this philosophy and invest accordingly in comprehensive supplier audit programs will develop the auditor competence necessary to drive sustained competitive advantage through superior quality system performance.
Comment