The Minimal Viable Risk Assessment Team

Ineffective risk management and quality systems revolve around superficial risk management. The core issue? Teams designed for compliance as a check-the-box activity rather than cognitive rigor. These gaps create systematic blind spots that no checklist can fix. The solution isn’t more assessors—it’s fewer, more competent ones anchored in science, patient impact, and lived process reality.

Cognitive Foundations of Risk Management Excellence

Core Roles: The Non-Negotiables

1. Process Owner: The Reality Anchor

Not a title. A lived experience. Superficial ownership creates the “unjustified assumptions.” This role requires daily engagement with the process—not just signature authority. Without it, assumptions go unchallenged.

2. ASTM E2500 Molecule Steward: The Patient’s Advocate

Beyond “SME”—the protein whisperer. This role demands provable knowledge of degradation pathways, critical quality attributes (CQAs), and patient impact. Contrast this with generic “subject matter experts” who lack molecule-specific insights. Without this anchor, assessments overlook patient-centric failure modes.

3. Technical System Owner: The Engineer

The value of the Technical System Owner—often the engineer—lies in their unique ability to bridge the worlds of design, operations, and risk control throughout the pharmaceutical lifecycle. Far from being a mere custodian of equipment, the system owner is the architect who understands not just how a system is built, but how it behaves under real-world conditions and how it integrates with the broader manufacturing program

4. Quality: The Cognitive Warper

Forget the auditor—this is your bias disruptor. Quality’s value lies in forcing cross-functional dialogue, challenging tacit assumptions, and documenting debates. When Quality fails to interrogate assumptions, hazards go unidentified. Their real role: Mandate “assumption logs” where every “We’ve always done it this way” must produce data or die.

A Venn diagram with three overlapping blue circles, each representing a different role: "Process Owner: The Reality Anchor," "Molecule Steward: The Patient’s Advocate," and "Technical System Owner: The Engineer." In the center, where all three circles overlap, is a green dashed circle labeled "Quality: Cognitive Warper." Each role has associated bullet points in colored dots:

Process Owner (top left): "Daily Engagement" and "Lived Experience" (blue dots).

Molecule Steward (top right): "Molecular specific insights" and "Patient-centric" (blue dots).

Technical System Owner (bottom): "The How’s" and "Technical understanding" (blue dots).

Additional points for Technical System Owner (bottom right): "Bias disruptor" and "Interrogate assumptions" (green dots).

The diagram visually emphasizes the intersection of these roles in achieving quality through cognitive diversity.

Team Design as Knowledge Preservation

Team design in the context of risk management is fundamentally an act of knowledge preservation, not just an exercise in filling seats or meeting compliance checklists. Every effective risk team is a living repository of the organization’s critical process insights, technical know-how, and nuanced operational experience. When teams are thoughtfully constructed to include individuals with deep, hands-on familiarity—process owners, technical system engineers, molecule stewards, and quality integrators—they collectively safeguard the hard-won lessons and tacit knowledge that are so often lost when people move on or retire. This approach ensures that risk assessments are not just theoretical exercises but are grounded in the practical realities that only those with lived experience can provide.

Combating organizational forgetting requires more than documentation or digital knowledge bases; it demands intentional, cross-functional team design that fosters active knowledge transfer. When a risk team brings together diverse experts who routinely interact, challenge each other’s assumptions, and share context from their respective domains, they create a dynamic environment where critical information is surfaced, scrutinized, and retained. This living dialogue is far more effective than static records, as it allows for the continuous updating and contextualization of knowledge in response to new challenges, regulatory changes, and operational shifts. In this way, team design becomes a strategic defense against the silent erosion of expertise that can leave organizations exposed to avoidable risks.

Ultimately, investing in team design as a knowledge preservation strategy is about building organizational resilience. It means recognizing that the greatest threats often arise not from what is known, but from what is forgotten or never shared. By prioritizing teams that embody both breadth and depth of experience, organizations create a robust safety net—one that catches subtle warning signs, adapts to evolving risks, and ensures that critical knowledge endures beyond any single individual’s tenure. This is how organizations move from reactive problem-solving to proactive risk management, turning collective memory into a competitive advantage and a foundation for sustained quality.

Call to Action: Build the Risk Team

Moving from compliance theater to true protection starts with assembling a team designed for cognitive rigor, knowledge depth and psychological safety.

Start with a Clear Charter, Not a Checklist

An excellent risk team exists to frame, analyse and communicate uncertainty so that the business can make science-based, patient-centred decisions. Assigning authorities and accountabilities is a leadership duty, not an after-thought. Before naming people, write down:

the decisions the team must enable,
the degree of formality those decisions demand, and
the resources (time, data, tools) management will guarantee.

Without this charter, even star performers will default to box-ticking.

Fill Four Core Seats – And Prove Competence

ICH Q9 is blunt: risk work should be done by interdisciplinary teams that include experts from quality, engineering, operations and regulatory affairs. ASTM E2500 translates that into a requirement for documented subject-matter experts (SMEs) who own critical knowledge throughout the lifecycle. Map those expectations onto four non-negotiable roles.

Process Owner – The Reality Anchor: This individual has lived the operation in the last 90 days, not just signed SOPs. They carry the authority to change methods, budgets and training, and enough hands-on credibility to spot when a theoretical control will never work on the line. Authentic owners dismantle assumptions by grounding every risk statement in current shop-floor facts.
Molecule Steward – The Patient’s Advocate: Too often “SME” is shorthand for “the person available.” The molecule steward is different: a scientist who understands how the specific product fails and can translate deviations into patient impact. When temperature drifts two degrees during freeze-drying, the steward can explain whether a monoclonal antibody will aggregate or merely lose a day of shelf life. Without this anchor, the team inevitably under-scores hazards that never appear in a generic FMEA template.
Technical System Owner – The Engineering Interpreter: Equipment does not care about meeting minutes; it obeys physics. The system owner must articulate functional requirements, design limits and integration logic. Where a tool-focused team may obsess over gasket leaks, the system owner points out that a single-loop PLC has no redundancy and that a brief voltage dip could push an entire batch outside critical parameters—a classic case of method over physics.
Quality Integrator – The Bias Disruptor: Quality’s mission is to force cross-functional dialogue and preserve evidence. That means writing assumption logs, challenging confirmation bias and ensuring that dissenting voices are heard. The quality lead also maintains the knowledge repository so future teams are not condemned to repeat forgotten errors.

Secure Knowledge Accessibility, Not Just Possession

A credentialed expert who cannot be reached when the line is down at 2 a.m. is as useful as no expert at all. Conduct a Knowledge Accessibility Index audit before every major assessment.

Embed Psychological Safety to Unlock the Team’s Brainpower

No amount of SOPs compensates for a culture that punishes bad news. Staff speak up only when leaders are approachable, intolerant of blame and transparent about their own fallibility. Leaders must therefore:

Invite dissent early: begin meetings with “What might we be overlooking?”
Model vulnerability: share personal errors and how the system, not individuals, failed.
Reward candor: recognize the engineer who halted production over a questionable trend.

Psychological safety converts silent observers into active risk sensors.

Choose Methods Last, After Understanding the Science

Excellent teams let the problem dictate the tool, not vice versa. They build a failure-tree or block diagram first, then decide whether FMEA, FTA or bow-tie analysis will illuminate the weak spot. If the team defaults to a method because “it’s in the SOP,” stop and reassess. Tool selection is a decision, not a reflex.

Provide Time and Resources Proportionate to Uncertainty

ICH Q9 asks decision-makers to ensure resources match the risk question. Complex, high-uncertainty topics demand longer workshops, more data and external review, while routine changes may only need a rapid check. Resist the urge to shoehorn every assessment into a one-hour meeting because calendars are overloaded.

Institutionalize Learning Loops

Great teams treat every assessment as both analysis and experiment. They:

Track prediction accuracy: did the “medium”-ranked hazard occur?
Compare expected versus actual detectability: were controls as effective as assumed?
Feed insights into updated templates and training so the next team starts smarter.

The loop closes when the knowledge base evolves at the same pace as the plant.

When to Escalate – The Abort-Mission Rule

If a risk scenario involves patient safety, novel technology and the molecule steward is unavailable, stop. The assessment waits until a proper team is in the room. Rushing ahead satisfies schedules, not safety.

Conclusion

Excellence in risk management is rarely about adding headcount; it is about curating brains with complementary lenses and giving them the culture, structure and time to think. Build that environment and the monsters stay on the storyboard, never in the plant.

Assessing the Quality of Our Risk Management Activities

The GAMP5 System Owner and Process Owner and Beyond

Defining the accountable individuals in a process is critical. In GAMP5, the technical System Owner role is distinct from the business Process Owner role, which focuses more on the system’s business process and compliance aspects.

The System Owner

The System Owner is responsible for the computerized system’s availability, support, and maintenance throughout its lifecycle. The System owner is the technical side of the equation and is often an IT director/manager or application support manager. Key responsibilities include:

Defining, reviewing, approving, and implementing risk mitigation plans
Ensuring technical requirements are documented
Managing change control for the system
Conducting evaluations for change requests impacting security, maintainability, data integrity, and architecture
Performing system administration tasks like user and privilege maintenance
Handling system patching, documentation of issues, and facilitating vendor support

Frankly, I think too many organizations make the system owner too low level. These lower-level individuals may perform system admin tasks and handle systems patching, but the more significant risk questions require extensive experience.

The System Owner focuses on the technical aspects of validation and ensures adequate procedural controls are in place after validation to maintain the validated state and protect data integrity.

The system owner requires learning and understanding new products and complex system architectures. They are the architect and need to be in charge of the big picture.

The Process Owner

In the context of GAMP5, a Process Owner plays a crucial role in the lifecycle management of computerized systems used in regulated industries such as pharmaceuticals and biotechnology. The Process Owner is ultimately accountable for the system’s implementation, validation, and ongoing compliant use.

I’ve written a lot about Process Owners. This use of process owner is 100% aligned with previous thinking.

Key Responsibilities of a Process Owner

System Implementation and Validation: The Process Owner ensures the system is implemented and validated according to regulatory requirements and company policies. This includes overseeing the creation and maintenance of validation documentation and ensuring the system meets its intended use.
Ongoing Compliance and Maintenance: The Process Owner must ensure the system remains validated throughout its lifecycle. This involves regular reviews, updates, and maintenance activities to ensure continued compliance with regulatory standards.
Data Integrity and Quality: As the data owner maintains the system, the Process Owner is responsible for its integrity, administration, operation, maintenance, and decommissioning. They must ensure that data integrity and quality requirements are met and maintained.
Decision-Making Authority: The Process Owner should be at a level within the organization that allows them to make business and process decisions regarding the system. This often includes roles such as operations director/manager, lab manager, or production manager.
Collaboration with Other Teams: The Process Owner must collaborate with various teams, including Quality (QA), IT, Computer System Validation (CSV), training, HR, system vendors, and system development teams, to ensure that all necessary compliance activities are performed and documented promptly.

Skills and Knowledge Required

Detailed Understanding of the System: The Process Owner should have a comprehensive understanding of the system, its purpose, functions, and use within the organization.
Regulatory Knowledge: A good grasp of regulatory requirements is crucial for ensuring the system complies with all relevant guidelines and standards.
Validation Practices: The Process Owner will sign off on validation documents and ensure that the system is fit for its intended use.

Comparison with the Molecule Steward

While the Molecule Steward, the ASTM E2500 SME role, is not directly equivalent to the GAMP 5 roles, it shares some similarities with both the system owner and process owner, particularly in terms of specialized knowledge and involvement in critical aspects of the system. It’s best to think of the Molecule Steward as the third part of this triad, ensuring the robustness of the scientific approach.

	System Owner	Process Owner	Molecule Steward
Primary Focus	Technical aspects and maintenance of the system	Business process and compliance aspects	Specialized knowledge of critical aspects
Typical Role	IT director/manager or application support manager	Head of functional unit or department using the system	Subject matter expert in specific field
Key Responsibilities	– System availability, support, and maintenance – Data security – Risk mitigation plans – Technical requirements documentation – Change control management – Evaluating change requests	– Overall system integrity and compliance – Data ownership – User requirements definition – SOP development and maintenance – Ensuring GxP compliance – Approving key documentation – User training	– Defining system needs – Identifying critical aspects – Leading quality risk management – Developing verification strategies – Reviewing system designs – Executing verification tests
Expertise	Strong technical background	Business process knowledge	Specialized technical knowledge
Accountability	System performance and security	Business use and regulatory compliance	Critical aspects impacting product quality and patient safety
Involvement in Validation	Focuses on technical validation aspects	Ensures validation meets business needs	Leads verification activities

Comparison of SO, PO and ASTM E2500 SME

Scale of the System

People make the system too small here. This isn’t equipment A or computer system X. It’s the entire system that produces result Y. For example, it is the manufacturing process for DS (or upstream DS), not the individual bioreactors. Lower-level assistants can help with wrangling, but there should be overall accountability. The system, process, and ASTM E2500 SME must have the power in the organization to be truly accountable.

The Role of Quality

The Quality Unit is responsible for ensuring the right process and procedure are in place, that regulatory requirements are met, and that the system is fit for use and fit for purpose. The Quality Unit in GAMP5 is crucial for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical products and computerized systems.

Ensuring Compliance and Product Quality: Quality is vital in ensuring that computerized systems used in pharmaceutical manufacturing meet regulatory requirements and consistently produce high-quality products. The Quality Unit helps organizations maintain high-quality standards in the various processes.
Risk Management: The Quality Unit champions a science-based risk management approach to system validation and qualification. Quality ensures the identification and assessment of potential risks.
Lifecycle Approach: The Quality Unit ensures that validation activities are conducted throughout the system’s lifecycle, from concept to retirement.
Documentation and Traceability: The Quality Unit oversees comprehensive documentation and traceability throughout the system’s lifecycle. Detailed records enable transparency, facilitate audits, and demonstrate compliance with regulatory requirements.
Change Management: The Quality Unit evaluates and controls system changes to ensure that modifications do not compromise product quality or patient safety.
Data Integrity: Quality is crucial in maintaining data integrity and ensuring records’ accuracy, reliability, and completeness.
Supplier and Internal Audits: Quality regularly audits suppliers and internal processes to ensure compliance and quality. These audits help identify gaps and areas for improvement in system development, implementation, and maintenance.

Beyond GAMP5

I consider this the best practice for handling an ASTM E2500 approach.

Acountable People

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

Comparison table

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.

Subject Matter Expert in Validation

In ASTM E2500, a Subject Matter Expert (SME) is an individual with specialized knowledge and technical understanding of critical aspects of manufacturing systems and equipment. The SME plays a crucial role throughout the project lifecycle, from defining needs to verifying and accepting systems. They are responsible for identifying critical aspects, reviewing system designs, developing verification strategies, and leading quality risk management efforts. SMEs ensure manufacturing systems are designed and verified to meet product quality and patient safety requirements.

In the ASTM E2500 process, the Subject Matter Experts (SME) has several key responsibilities critical to successfully implementing the standard. These responsibilities include:

Definition of Needs: SMEs define the system’s needs and identify critical aspects that impact product quality and patient safety.
Risk Management: SMEs participate in risk management activities, helping to identify, assess, and manage risks throughout the project lifecycle. This includes conducting quality risk analyses and consistently applying risk management principles.
Verification Strategy Development: SMEs are responsible for planning and defining verification strategies. This involves selecting appropriate test methods, defining acceptance criteria, and ensuring that verification activities are aligned with the project’s critical aspects.
System Design Review: SMEs review system designs to ensure they meet specified requirements and address identified risks. This includes participating in design reviews and providing technical input to optimize system functionality and compliance.
Execution of Verification Tests: SMEs lead the execution of verification tests, ensuring that tests are conducted accurately and that results are thoroughly reviewed. They may also leverage vendor documentation and test results as part of the verification process, provided the vendor’s quality system and technical capabilities are deemed acceptable.
Change Management: SMEs play a crucial role in change management, ensuring that any modifications to the system are properly evaluated, documented, and implemented. This helps maintain the system’s validated state and ensures continuous compliance with regulatory requirements.
Continuous Improvement: SMEs are involved in continuous process improvement efforts, using operational and performance data to identify opportunities for enhancements. They also conduct root-cause analyses of failures and implement technically sound improvements based on gained product knowledge and understanding.

These responsibilities highlight the SME’s integral role in ensuring that manufacturing systems are designed, verified, and maintained to meet the highest standards of quality and safety, as outlined in ASTM E2500.

The ASTM E2500 SME is a Process Owner

ASTM E2500 uses the term SME in the same way we discuss process owners, or what is sometimes called product or molecule stewards. The term should probably be changed to reflect the special role of the SME and the relationship with other stakeholders.

A Molecule Steward has a specialized role within pharmaceutical and biotechnology companies and oversees the lifecycle of a specific molecule or drug product. This role involves a range of responsibilities, including:

Technical Expertise: Acting as the subject matter expert per ASTM E2500.
Product Control Strategies: Implementing appropriate product control strategies across development and manufacturing sites based on anticipated needs.
Lifecycle Management: Providing end-to-end accountability for a given molecule, from development to late-stage lifecycle management.

A Molecule Steward ensures a drug product’s successful development, manufacturing, and lifecycle management, maintaining high standards of quality and compliance throughout the process.

The ASTM E2500 SME (Molecule Steward) and Stakeholders

In the ASTM E2500 approach, the Subject Matter Expert (Molecule Steward) collaborates closely with various project players to ensure the successful implementation of manufacturing systems.

Definition of Needs and Requirements

Collaboration with Project Teams: SMEs work with project teams from the beginning to define the system’s needs and requirements. This involves identifying critical aspects that impact product quality and patient safety.
Input from Multiple Departments: SMEs gather input from different departments, including product/process development, engineering, automation, and validation, to ensure that all critical quality attributes (CQAs) and critical process parameters (CPPs) are considered.

Risk Management

Quality Risk Analysis: SMEs lead the quality risk analysis process, collaborating with QA and other stakeholders to identify and assess risks. This helps focus on critical aspects and consistently apply risk management principles.
Vendor Collaboration: SMEs often work with vendors to leverage their expertise in conducting risk assessments and ensuring that vendor documentation meets quality requirements.

System Design Review

Design Review Meetings: SMEs participate in design review meetings with suppliers and project teams to ensure the system design meets the defined needs and critical aspects. This collaborative effort helps in reducing the need for modifications and repeat tests.
Supplier Engagement: SMEs engage with suppliers to ensure their design solutions are understood and integrated into the project. This includes reviewing supplier documentation and ensuring compliance with regulatory requirements.

Verification Strategy Development

Developing Verification Plans: SMEs collaborate with QA and engineering teams to develop verification strategies and plans. This involves selecting appropriate test methods, defining acceptance criteria, and ensuring verification activities align with project goals.
Execution of Verification Tests: SMEs may work with suppliers to conduct verification tests at the supplier’s site, ensuring that tests are performed accurately and efficiently. This collaboration helps achieve the “right test” at the “right time” objective.

Change Management

Managing Changes: SMEs play a crucial role in the change management process, working with project teams to evaluate, document, and implement changes. This ensures that the system remains in a validated state and continues to meet regulatory requirements.
Continuous Improvement: SMEs collaborate with other stakeholders to identify opportunities for process improvements and implement changes based on operational and performance data.

Documentation and Communication

Clear Communication: SMEs ensure clear communication and documentation of all verification activities and acceptance criteria. This involves working closely with QA to validate all critical aspects and ensure compliance with regulatory standards.