When undertaking a project to enhance your validation program, it’s crucial to have a robust method for measuring success. This is especially important as you aim to increase maturity and address organizational challenges, with a significant focus on training and personnel qualification. The Kirkpatrick model, originally designed for evaluating training programs, can be effectively adapted to assess the success of your validation program improvements.
Level 1: Reaction
This level measures how participants react to the validation program.
Survey validation team members on their satisfaction with the validation approach
Gather feedback on the clarity of risk-based validation concepts
Assess perceived relevance and applicability of the new validation methodology
Level 2: Learning
This level evaluates the knowledge and skills acquired.
Conduct assessments to measure understanding of key principles
Test ability to perform risk assessments and develop verification strategies
Evaluate comprehension of good engineering practices (GEP) and their integration into validation activities
Level 3: Behavior
This level examines how participants apply what they’ve learned on the job.
Observe validation team members implementing risk-based approaches in actual projects
Review documentation to ensure proper application of methodologies and assess the quality of user requirements, risk assessments, and verification plans. This is where I would use a rubric.
Create some key behavior indicators, such as right-the-first time.
I use IMPACT as a tool here.
And then come up with a set of leading and lagging quality and behavioral indicators.
Leading
Measure and report attendance at risk assessments and project team meetings
Number of employee/team improvement suggestions implemented
This level measures the impact on the organization.
Track reduction in validation cycle times and associated costs
Monitor improvements in product quality and reduction in deviations
Assess regulatory inspection outcomes and feedback on validation approach
Evaluate overall efficiency gains in the validation process
By applying the Kirkpatrick Model to a validation program improvements we can systematically evaluate the effectiveness of their implementation and identify areas for continuous improvement.
The more I think about it, the more I am thinking I would want to organize a collaborative learning event around Validation like the one I spelled out in the article “A Collaborative Learning Event I Might Run” in June.
Maturity models offer significant benefits to organizations by providing a structured framework for benchmarking and assessment. Organizations can clearly understand their strengths and weaknesses by evaluating their current performance and maturity level in specific areas or processes. This assessment helps identify areas for improvement and sets a baseline for measuring progress over time. Benchmarking against industry standards or best practices also allows organizations to see how they compare to their peers, fostering a competitive edge.
One of the primary advantages of maturity models is their role in fostering a culture of continuous improvement. They provide a roadmap for growth and development, encouraging organizations to strive for higher maturity levels. This continuous improvement mindset helps organizations stay agile and adaptable in a rapidly changing business environment. By setting clear goals and milestones, maturity models guide organizations in systematically addressing deficiencies and enhancing their capabilities.
Standardization and consistency are also key benefits of maturity models. They help establish standardized practices across teams and departments, ensuring that processes are executed with the same level of quality and precision. This standardization reduces variability and errors, leading to more reliable and predictable outcomes. Maturity models create a common language and framework for communication, fostering collaboration and alignment toward shared organizational goals.
The use of maturity models significantly enhances efficiency and effectiveness. Organizations can increase productivity and use their resources by identifying areas for streamlining operations and optimizing workflows. This leads to reduced errors, minimized rework, and improved process efficiency. The focus on continuous improvement also means that organizations are constantly seeking ways to refine and enhance their operations, leading to sustained gains in efficiency.
Maturity models play a crucial role in risk reduction and compliance. They assist organizations in identifying potential risks and implementing measures to mitigate them, ensuring compliance with relevant regulations and standards. This proactive approach to risk management helps organizations avoid costly penalties and reputational damage. Moreover, maturity models improve strategic planning and decision-making by providing a data-backed foundation for setting priorities and making informed choices.
Finally, maturity models improve communication and transparency within organizations. Providing a common communication framework increases transparency and builds trust among employees. This improved communication fosters a sense of shared purpose and collaboration, essential for achieving organizational goals. Overall, maturity models serve as valuable tools for driving continuous improvement, enhancing efficiency, and fostering a culture of excellence within organizations.
Business Process Maturity Model (BPMM)
A structured framework used to assess and improve the maturity of an organization’s business processes, it provides a systematic methodology to evaluate the effectiveness, efficiency, and adaptability of processes within an organization, guiding continuous improvement efforts.
Key Characteristics of BPMM
Assessment and Classification: BPMM helps organizations understand their current process maturity level and identify areas for improvement. It classifies processes into different maturity levels, each representing a progressive improvement in process management.
Guiding Principles: The model emphasizes a process-centric approach focusing on continuous improvement. Key principles include aligning improvements with business goals, standardization, measurement, stakeholder involvement, documentation, training, technology enablement, and governance.
Incremental Levels
BPMM typically consists of five levels, each building on the previous one:
Initial: Processes are ad hoc and chaotic, with little control or consistency.
Managed: Basic processes are established and documented, but results may vary.
Standardized: Processes are well-documented, standardized, and consistently executed across the organization.
Predictable: Processes are quantitatively measured and controlled, with data-driven decision-making.
Optimizing: Continuous process improvement is ingrained in the organization’s culture, focusing on innovation and optimization.
Benefits of BPMM
Improved Process Efficiency: By standardizing and optimizing processes, organizations can achieve higher efficiency and consistency, leading to better resource utilization and reduced errors.
Enhanced Customer Satisfaction: Mature processes lead to higher product and service quality, which improves customer satisfaction.
Better Change Management: Higher process maturity increases an organization’s ability to navigate change and realize project benefits.
Readiness for Technology Deployment: BPMM helps ensure organizational readiness for new technology implementations, reducing the risk of failure.
Usage and Implementation
Assessment: Organizations can conduct BPMM assessments internally or with the help of external appraisers. These assessments involve reviewing process documentation, interviewing employees, and analyzing process outputs to determine maturity levels.
Roadmap for Improvement: Organizations can develop a roadmap for progressing to higher maturity levels based on the assessment results. This roadmap includes specific actions to address identified deficiencies and improve process capabilities.
Continuous monitoring and regular evaluations are crucial to ensure that processes remain effective and improvements are sustained over time.
A BPMM Example: Validation Program based on ASTM E2500
To apply the Business Process Maturity Model (BPMM) to a validation program aligned with ASTM E2500, we need to evaluate the program’s maturity across the five levels of BPMM while incorporating the key principles of ASTM E2500. Here’s how this application might look:
Level 1: Initial
At this level, the validation program is ad hoc and lacks standardization:
Validation activities are performed inconsistently across different projects or departments.
There’s limited understanding of ASTM E2500 principles.
Risk assessment and scientific rationale for validation activities are not systematically applied.
Documentation is inconsistent and often incomplete.
Level 2: Managed
The validation program shows some structure but lacks organization-wide consistency:
Basic validation processes are established but may not fully align with ASTM E2500 guidelines.
Some risk assessment tools are used, but not consistently across all projects.
Subject Matter Experts (SMEs) are involved, but their roles are unclear.
There’s increased awareness of the need for scientific justification in validation activities.
Level 3: Standardized
The validation program is well-defined and consistently implemented:
Validation processes are standardized across the organization and align with ASTM E2500 principles.
Risk-based approaches are consistently used to determine the scope and extent of validation activities.
SMEs are systematically involved in the design review and verification processes.
The concept of “verification” replaces traditional IQ/OQ/PQ, focusing on critical aspects that impact product quality and patient safety.
Quality risk management tools (e.g., impact assessments, risk management) are routinely used to identify critical quality attributes and process parameters.
Level 4: Predictable
The validation program is quantitatively managed and controlled:
Key Performance Indicators (KPIs) for validation activities are established and regularly monitored.
Data-driven decision-making is used to continually improve the efficiency and effectiveness of validation processes.
Advanced risk management techniques are employed to predict and mitigate potential issues before they occur.
There’s a strong focus on leveraging supplier documentation and expertise to streamline validation efforts.
Engineering procedures for quality activities (e.g., vendor technical assessments and installation verification) are formalized and consistently applied.
Level 5: Optimizing
The validation program is characterized by continuous improvement and innovation:
There’s a culture of continuous improvement in validation processes, aligned with the latest industry best practices and regulatory expectations.
Innovation in validation approaches is encouraged, always maintaining alignment with ASTM E2500 principles.
The organization actively contributes to developing industry standards and best practices in validation.
Validation activities are seamless integrated with other quality management systems, supporting a holistic approach to product quality and patient safety.
Advanced technologies (e.g., artificial intelligence, machine learning) may be leveraged to enhance risk assessment and validation strategies.
Key Considerations for Implementation
Risk-Based Approach: At higher maturity levels, the validation program should fully embrace the risk-based approach advocated by ASTM E2500, focusing efforts on aspects critical to product quality and patient safety.
Scientific Rationale: As maturity increases, there should be a stronger emphasis on scientific understanding and justification for validation activities, moving away from a checklist-based approach.
SME Involvement: Higher maturity levels should see increased and earlier involvement of SMEs in the validation process, from equipment selection to verification.
Supplier Integration: More mature programs will leverage supplier expertise and documentation effectively, reducing redundant testing and improving efficiency.
Continuous Improvement: At the highest maturity level, the validation program should have mechanisms in place for continuous evaluation and improvement of processes, always aligned with ASTM E2500 principles and the latest regulatory expectations.
Process and Enterprise Maturity Model (PEMM),
The Process and Enterprise Maturity Model (PEMM), developed by Dr. Michael Hammer, is a comprehensive framework designed to help organizations assess and improve their process maturity. It is a corporate roadmap and benchmarking tool for companies aiming to become process-centric enterprises.
Key Components of PEMM
PEMM is structured around two main dimensions: Process Enablers and Organizational Capabilities. Each dimension is evaluated on a scale to determine the maturity level.
Process Enablers
These elements directly impact the performance and effectiveness of individual processes. They include:
Design: The structure and documentation of the process.
Performers: The individuals or teams executing the process.
Owner: The person responsible for the process.
Infrastructure: The tools, systems, and resources supporting the process.
Metrics: The measurements used to evaluate process performance.
Organizational Capabilities
These capabilities create an environment that supports and sustains high-performance processes. They include:
Leadership: The commitment and support from top management.
Culture: The organizational values and behaviors that promote process excellence.
Expertise: The skills and knowledge required to manage and improve processes.
Governance: The mechanisms to oversee and guide process management activities.
Maturity Levels
Both Process Enablers and Organizational Capabilities are assessed on a scale from P0 to P4 (for processes) and E0 to E4 (for enterprise capabilities):
P0/E0: Non-existent or ad hoc processes and capabilities.
P1/E1: Basic, but inconsistent and poorly documented.
P2/E2: Defined and documented, but not fully integrated.
P3/E3: Managed and measured, with consistent performance.
P4/E4: Optimized and continuously improved.
Benefits of PEMM
Self-Assessment: PEMM is designed to be simple enough for organizations to conduct their own assessments without needing external consultants.
Empirical Evidence: It encourages the collection of data to support process improvements rather than relying on intuition.
Engagement: Involves all levels of the organization in the process journey, turning employees into advocates for change.
Roadmap for Improvement: Provides a clear path for organizations to follow in their process improvement efforts.
Application of PEMM
PEMM can be applied to any type of process within an organization, whether customer-facing or internal, core or support, transactional or knowledge-intensive. It helps organizations:
Assess Current Maturity: Identify the current state of process and enterprise capabilities.
Benchmark: Compare against industry standards and best practices.
Identify Improvements: Pinpoint areas that need enhancement.
Track Progress: Monitor the implementation and effectiveness of process improvements.
A PEMM Example: Validation Program based on ASTM E2500
To apply the Process and Enterprise Maturity Model (PEMM) to an ASTM E2500 validation program, we can evaluate the program’s maturity across the five process enablers and four enterprise capabilities defined in PEMM. Here’s how this application might look:
Process Enablers
Design:
P-1: Basic ASTM E2500 approach implemented, but not consistently across all projects
P-2: ASTM E2500 principles applied consistently, with clear definition of requirements, specifications, and verification activities
P-3: Risk-based approach fully integrated into design process, with SME involvement from the start
P-4: Continuous improvement of ASTM E2500 implementation based on lessons learned and industry best practices
Performers:
P-1: Some staff trained on ASTM E2500 principles
P-2: All relevant staff trained and understand their roles in the ASTM E2500 process
P-3: Staff proactively apply risk-based thinking and scientific rationale in validation activities
P-4: Staff contribute to improving the ASTM E2500 process and mentor others
E-3: Leadership drives cultural change to fully embrace risk-based validation approach
E-4: Leadership promotes ASTM E2500 principles beyond the organization, influencing industry standards
Culture:
E-1: Some recognition of the importance of risk-based validation
E-2: Culture of quality and risk-awareness developing across the organization
E-3: Strong culture of scientific thinking and continuous improvement in validation activities
E-4: Innovation in validation approaches encouraged and rewarded
Expertise:
E-1: Basic understanding of ASTM E2500 principles among key staff
E-2: Dedicated team of ASTM E2500 experts established
E-3: Deep expertise in risk-based validation approaches across multiple departments
E-4: Organization recognized as thought leader in ASTM E2500 implementation
Governance:
E-1: Basic governance structure for validation activities in place
E-2: Clear governance model aligning ASTM E2500 with overall quality management system
E-3: Cross-functional governance ensuring consistent application of ASTM E2500 principles
E-4: Governance model that adapts to changing regulatory landscape and emerging best practices
To use this PEMM assessment:
Evaluate your validation program against each enabler and capability, determining the current maturity level (P-1 to P-4 for process enablers, E-1 to E-4 for enterprise capabilities).
Identify areas for improvement based on gaps between current and desired maturity levels.
Develop action plans to address these gaps, focusing on moving to the next maturity level for each enabler and capability.
Regularly reassess the program to track progress and adjust improvement efforts as needed.
Comparison Table
Aspect
BPMM
PEMM
Creator
Object Management Group (OMG)
Dr. Michael Hammer
Purpose
Assess and improve business process maturity
Roadmap and benchmarking for process-centricity
Structure
Five levels: Initial, Managed, Standardized, Predictable, Optimizing
Two components: Process Enablers (P0-P4), Organizational Capabilities (E0-E4)
Enterprise systems, business process improvement, benchmarking
Process reengineering, organizational engagement, benchmarking
In summary, while both BPMM and PEMM aim to improve business processes, BPMM is more structured and detailed, often requiring external appraisers, and focuses on incremental process improvement across organizational boundaries. In contrast, PEMM is designed for simplicity and self-assessment, emphasizing the role of process enablers and organizational capabilities to foster a supportive environment for process improvement. Both have advantages, and keeping both in mind while developing processes is key.
Follow a systematic process to validate a shipping container by involving the traditional three main stages: Design Qualification (DQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Design Qualification (DQ)
The DQ stage involves establishing that the shipping container design meets the user requirements and regulatory standards. Key steps include:
Define user requirement specifications (URS) for the container, including temperature range, duration of transport, and product-specific needs.
Review the container design specifications provided by the manufacturer.
Assess the container’s compatibility with the pharmaceutical product and its storage requirements.
Evaluate the container’s compliance with relevant regulatory guidelines and standards.
Operational Qualification (OQ)
OQ involves testing the container under controlled conditions to ensure it operates as intended. This stage includes:
Conducting empty container tests to verify basic functionality.
Testing temperature control systems and monitoring devices.
Evaluating the container’s ability to maintain required conditions under various environmental scenarios.
Assessing the ease of use and any potential operational issues.
Performance Qualification (PQ)
PQ is the most critical stage, involving real-world testing to ensure the container performs as required under actual shipping conditions. Steps include:
Develop a detailed PQ protocol that outlines test conditions, acceptance criteria, and data collection methods.
Conduct shipping trials using actual or simulated product loads.
Test the container under worst-case scenarios, including extreme temperature conditions and extended shipping durations.
Monitor and record temperature data throughout the shipping process.
Assess the impact of various handling conditions (e.g., vibration, shock) on container performance.
Evaluate the container’s performance across different shipping lanes and modes of transport.
Additional Considerations
Associated Materials and Equipment: Ensure all associated materials (e.g., coolants, packaging materials) and monitoring equipment are also qualified.
Re-qualification: For reusable containers, establish a process for periodic re-qualification to ensure ongoing performance.
Documentation: Maintain comprehensive documentation of all qualification stages, including test results, data analysis, and conclusions.
Risk Assessment: Conduct a risk assessment to identify potential failure modes and mitigation strategies.
Best Practices
Use a risk-based approach to determine the extent of testing required for each container type and shipping scenario.
Consider seasonal variations in ambient temperature profiles when designing qualification studies.
Utilize pre-qualified containers from reputable suppliers when possible to streamline the validation process.
Implement a robust change control process to manage any container or shipping process modifications post-validation.
Regularly review and update validation documentation to reflect any changes in regulatory requirements or shipping conditions.
Following this comprehensive approach, you can ensure that your shipping containers are properly validated for pharmaceutical transport, maintaining product quality and integrity throughout the supply chain. Validation is an ongoing process, and containers should be periodically reassessed to ensure continued compliance and performance.
A little caveat: I really burnt out on professional obligations last year and have just started to peak my head out. So, it may be a little harder to turn this mad scientist dream into a reality. However, I think it is worth putting out as a thought experiment.
Theme and Scope
I’ve written a bit about the challenges to quality, and these challenges provide a framework for much of what I think and write about.
More specifically drawing from the “Challenges in Validation” focusing on the challenges of navigating a complex validation landscape characterized by rapid technological advancements, evolving regulatory standards, and the development of novel therapies.
This event would ask, “How do we rise to the challenges of validation in the next decade, leveraging technology and a risk management approach and drawing from the best practices of ASTM E2500, GAMP5, and others to meet and exceed changing regulatory requirements.”
Intended Audience
I go to events, and there are a lot of quality people, OR risk management people, OR computer systems (IT and Q) people, OR engineers, OR analytical method folks, OR process development people. Rarely do I see an event that looks at the whole picture. And rarely do I get to attend an event where we are sharing and blurring the lines between the various silos. So let us break down the silos and invite quality, IT, engineers, and process development individuals involved in the full spectrum of pharmaceutical (and possibly medtech) validation.
This holistic event is meant to blend boundaries, share best practices, challenge ourselves, and look across the entire validation lifecycle.
Structure
Opening/Networking (1 hour)
As people arrive, they go right into a poster event. These posters are each for a specific methodology/approach of ASTM E2500, ISPE Baseline Guides, FDA’s Guidance for Process Validation: General Principles and Practices, ICH’s QbD approach, and GAMP5. Maybe some other things.
These posters would each:
Provide an overview of what it is and why it is important
Overview of methodology
What challenges it overcomes
Lessons that can be applied
Challenges/problems inherent in the approach
These posters would be fun to develop and take a good squad of experts.
After an hour of mingling, sharing, and baselining, we could move to the next step.
Fish Bowl Debate (45 minutes)
Having earlier selected a specific topic and a panel of experts, hold a fish bowl debate. This would be excellent as a mock-inspection, maybe of a really challenging topic. Great place to bring those inspectors in.
During a fish bowl, everyone not in the center is taking notes. I love a worksheet to help with this by providing things to look for to get the critical thinking going.
Future Workshop (1.5 hour)
Introduce the activity (10 min)
Ask participants to reflect on their present-day situation, write down all their negative experiences on sticky notes, and place them on the wall. (15 min)
Invite participants to list uncertainties they face by asking, “In your/our operating environment, what factors are impossible to predict or control their direction?” (5 min).
Prioritize the most critical factors by asking, “Which factors threaten your/our ability to operate successfully?” (10 min)
Based on the group’s history and experience, select the two most critical and most uncertain (X and Y). (5 min)
Create a grid with two axes—X & Y—with a “more of <— —> less of” continuum to represent the factor on each axis. For example, suppose new modalities are a critically uncertain factor for the X-axis. In that case, one end of the X-axis is many new modalities, and the other is no new modalities. Repeat for the Y factor and axis. For instance, if patent protection is a critical factor, one end of the Y axis is strong patent protection, and the other has no patent protection. Four quadrants are created. (5 min)
Break into four groups, and each group creatively names and writes a thumbnail scenario for one of the quadrants. (10 min)
The four groups share their scenarios briefly. 2 min. each
Participants fantasize about the desired future situation. How would the ideal situation be for them? At this stage, there are no limitations; everything is possible. Write on stick notes and apply them to the most likely quadrant. (10 minutes)
Do a n/3 activity to find the top ideas (enough for groups of 4-5 each) (3 min)
Explain the next activity (2 min)
Lunch (1 hour)
Open Space Solution (1 hour)
For each top idea, the participants vote with their feet and go to develop the concept. Each group is looking to come up with the challenge solved, a tool/methodology, and an example.
Review the Results of the Open Space Solutions (1 hour)
Each team presents for 5-8 minutes.
1-2-4-All (20 minutes)
Silent self-reflection by individuals on the shared challenge, framed as a question “What opportunities do YOU see for making progress on this challenge? How would you handle this situation? What ideas or actions do you recommend?” (1 min)
Generate ideas in pairs, building on ideas from self-reflection. (2 min)
Share and develop ideas from your pair in foursomes (notice similarities and differences).( 4 min)
Ask, “What is one idea that stood out in your conversation?” Each group shares one important idea with all (15 min)
Closing Commitment (5 min)
Where will this live? What comes next? Make a commitment to follow up electronically.
Networking
Spend an hour or so with drinks and food and discuss everything. Never enough socialization.
Investigations of a Dog 