We tend to jumble forms of accountability in an organization, often confusing between a people manager and a technical manager. I think its very important to differentiate between the two.

People managers deal with human resources and team dynamics, while technical managers deal with managing design, execution, and improvement. They can be the same person, but we need to recognize the differences and resource appropriately. Too often we blur the two roles and as a result neither is done well.

I’ve talked on this blog about a few of the technical manager types: Process Owners, the ASTM E2500 SME/Molecule Steward, and Knowledge Owners. There are certainly others out there. In the table below I added two more for comparison:

• a qualified person from OSHA, because I think this is a great generic look at the concept
• The EU Qualifed Person. Industry relevant and one that often gets confused in execution.

Aspect	Qualified Person (OSHA Definition)	Qualified Person (EU)	Knowledge Owner	ASTM E2500 SME	Process Owner
Primary Focus	Ensuring compliance with safety standards and solving technical problems	Certifying that each batch of a medicinal product meets all required provisions	Managing and maintaining knowledge within a specific domain	Ensuring manufacturing systems meet quality and safety standards	Managing and optimizing a specific business process
Key Responsibilities	Solve or resolve problems related to the subject matter, work, or project	Certify batches meet GMP and regulatory standards	Maintain and update knowledge base	Define system needs and identify critical aspects	Define process goals, purpose, and KPIs
	Design and install systems to improve safety	Ensure compliance with market authorization requirements	Validate and broadcast new knowledge	Develop and execute verification strategies	Communicate with key players and stakeholders
	Ensure compliance with laws and standards	Oversee quality control and assurance processes	Provide training and support	Review system designs and manage risks	Analyze process performance and identify improvements
	May not have the authority to stop work	Conduct audits and inspections	Monitor and update knowledge assets	Lead quality risk management efforts	Ensure process compliance with regulations and standards
Skills Required	Technical expertise in the area	Degree in pharmacy, biology, chemistry, or related field	Subject matter expertise in specific knowledge domain	Technical understanding of manufacturing systems and equipment	Leadership and communication skills
	Certification, degree, or other professional recognition	Several years of experience in pharmaceutical manufacturing	Analytical and validation skills	Risk management and verification skills	Analytical and problem-solving skills
	Ability to solve technical problems	Registered with the competent authority in the EU member state	Training and support skills	Continuous improvement and change management skills	Ability to define and monitor KPIs
Authority	Authority to design and install safety systems	Authority to certify batches and ensure compliance	Authority over knowledge management processes and content	Authority to define and verify critical aspects of systems	Authority to make decisions and implement changes in the process
Interaction with Others	Collaborates with production and quality control teams	Works with quality control, assurance, and regulatory teams	Works with various departments to ensure knowledge is shared and utilized	Collaborates with project stakeholders and engineering teams	Communicates with project leaders, process users, and other stakeholders
Examples of Activities	Reviewing batch documentation and certifying products	Certifying each batch of medicinal products before release	Validating new knowledge submissions	Conducting quality risk analyses and verification tests	Defining process objectives and mission statements
	Ensuring compliance with GMP and regulatory standards	Ensuring compliance with GMP and regulatory standards	Providing training on knowledge management systems	Reviewing system designs and managing changes	Monitoring process performance and compliance
	Overseeing investigations related to quality issues	Overseeing quality control and assurance processes	Updating and maintaining knowledge databases	Leading continuous improvement efforts	Identifying and implementing process improvements
Industry Context	Primarily in construction, manufacturing, and safety-critical industries	Pharmaceutical and biotechnology industries within the EU	Applicable across various industries, especially information-heavy sectors	Primarily in pharmaceutical and biotechnology industries	Applicable in any industry with defined business processes

• Qualified Person (OSHA Definition): Focuses on ensuring compliance with safety standards and solving technical problems. They possess technical expertise and professional recognition and are responsible for designing and installing safety systems.
• Qualified Person (EU): Ensures that each batch of medicinal products meets all required provisions before release. They are responsible for compliance with GMP and regulatory standards and must be registered with the competent authority in the EU member state.
• Knowledge Owner: Manages and disseminates knowledge within an organization. They ensure that knowledge is accurate, up-to-date, and accessible, and they provide training and support to facilitate knowledge sharing.
• ASTM E2500 SME: Ensures that manufacturing systems meet quality and safety standards. They define system needs, develop verification strategies, manage risks, and lead continuous improvement efforts.
• Process Owner: Manages and optimizes specific business processes. They define process goals, monitor performance, ensure compliance with standards, and implement improvements to enhance efficiency and effectiveness.

Common Themes

Subject Matter Expertise

• All roles require a high level of subject matter expertise in their respective domains, whether it’s technical knowledge, regulatory compliance, manufacturing processes, or business processes.
• This expertise is typically gained through formal education, certifications, extensive training, and practical experience.

Ensuring Compliance and Quality

• A key responsibility across these roles is ensuring compliance with relevant laws, regulations, standards, and quality requirements.

Risk Identification and Management

• These roles are all responsible for identifying potential risks, hazards, or process inefficiencies.
• They are expected to develop and implement strategies to mitigate or eliminate these risks, ensuring the safety of operations and the quality of products or processes.

Continuous Improvement and Change Management

• They are involved in continuous improvement efforts, identifying areas for optimization and implementing changes to enhance efficiency, quality, and knowledge sharing.
• They are responsible for managing change processes, ensuring smooth transitions, and minimizing disruptions.

Authority and Decision-Making

• Most of these roles have a certain level of authority and decision-making power within their respective domains.

Collaboration and Knowledge Sharing

• Effective collaboration and knowledge sharing are essential for these roles to succeed.

While these roles have distinct responsibilities and focus areas, they share common goals of ensuring compliance, managing risks, driving continuous improvement, and leveraging subject matter expertise to achieve organizational objectives and maintain high standards of quality and safety. They are more similar than dissimilar and should be looked at holistically within the organization.