Pharmaceutical GMP Quality Systems: FDA, ICH Q10 and QMM

Recent LinkedIn discourse got me thinking of the wider pharmaceutical quality system and how it is reflected in ICH Q10 and in the FDA Guidance for Industry on Quality Systems Approach to Pharmaceutical CGMP Regulation.

ICH Q10

The International Conference on Harmonization (ICH) was established to harmonize the technical requirements for pharmaceutical product registration across Europe, Japan, and the United States. ICH Q10, finalized in June 2008, emerged from this initiative as a guideline for a comprehensive Pharmaceutical Quality System (PQS) applicable throughout the product lifecycle. It was adopted by the FDA in April 2009, following its implementation by the European Commission in July 2008.

ICH Q10 aims to provide a model for pharmaceutical manufacturers to develop and maintain effective quality management systems. The guideline emphasizes a lifecycle approach, integrating quality management principles from ISO standards and regional GMP requirements. The primary objectives of ICH Q10 include:

Ensuring consistent product quality that meets customer and regulatory requirements.
Establishing effective monitoring and control systems for process performance and product quality.
Promoting continual improvement and innovation throughout the product lifecycle.

The guideline outlines the key elements of management responsibilities, Corrective and Preventive Action (CAPA) , process performance and product quality monitoring, change management, and management review. ICH Q10 is usually considered part of the “Quality Trio” with ICH Q8 and Q9. Quality by design is only possible through proper risk management and a robust quality system.

FDA Guidance for Industry on Quality Systems Approach to Pharmaceutical CGMP Regulation

The FDA developed guidance on implementing modern quality systems and risk management practices to align with the CGMP (Current Good Manufacturing Practice) requirements outlined in parts 210 and 211 of the FDA regulations. These regulations govern the manufacturing of human and veterinary drugs, including biological products. Published in 2006, this guidance should be viewed as part of a continuum of thought with ICH Q10 and not as an earlier draft.

This guidance aims to assist manufacturers in meeting cGMP requirements by adopting a comprehensive quality systems model. It emphasizes the integration of quality systems with regulatory requirements to ensure full compliance without imposing new expectations on manufacturers. Key aspects of the guidance include:

Highlighting the consistency of the quality systems model with cGMP regulations.
Encouraging the use of risk management and quality systems to enhance compliance and product quality.
Providing a framework for manufacturers to gain control over their manufacturing processes.

Six-System Inspection Model

The FDA’s Six-System Inspection Model is a framework introduced in this guidance to ensure compliance with current Good Manufacturing Practice (CGMP) regulations in the pharmaceutical industry. This model helps FDA inspectors evaluate the robustness of a company’s quality management system by focusing on six key subsystems.

I am a huge fan of the six subsystem approach. Basically we have here the organization of the quality manual, a guide to what standards you need to write in a bigger company, and a franework for understanding the cGMPs as a whole (great for education purposes).

Here’s a detailed explanation of each subsystem:

1. Quality System

Role: Acts as the central hub for all other systems, ensuring overall quality management.
Focus: Management responsibilities, internal audits, CAPA (Corrective and Preventive Actions), and continuous improvement.
Importance: Ensures that all other systems are effectively integrated and managed to maintain product quality and regulatory compliance.

2. Facilities and Equipment System

Role: Ensures that facilities and equipment are suitable for their intended use and maintained properly.
Focus: Design, maintenance, cleaning, and calibration of facilities and equipment.
Importance: Prevents contamination and ensures consistent manufacturing conditions.

3. Materials System

Role: Manages the control of raw materials, components, and packaging materials.
Focus: Supplier qualification, receipt, storage, inventory control, and testing of materials.
Importance: Ensures that only high-quality materials are used in the manufacturing process, reducing the risk of product defects.

4. Production System

Role: Oversees the actual manufacturing processes.
Focus: Process controls, batch records, in-process controls, and validation.
Importance: Ensures that products are manufactured consistently and meet predefined quality criteria.

5. Packaging and Labeling System

Role: Manages the packaging and labeling processes to ensure correct and compliant product presentation.
Focus: Label control, packaging operations, and labeling verification.
Importance: Prevents mix-ups and ensures that products are correctly identified and used.

6. Laboratory Controls System

Role: Ensures the reliability of laboratory testing and data integrity.
Focus: Sampling, testing, analytical method validation, and laboratory records.
Importance: Verifies that products meet quality specifications before release.

Integration and Interdependence

Quality System as the Fulcrum: The quality system is the central element that integrates all other subsystems. It ensures that each subsystem functions correctly and is aligned with overall quality objectives.
State of Control: The primary goal of the six-system inspection model is to ensure that each subsystem is in a state of control, meaning it operates within predefined limits and consistently produces the desired outcomes.

The Six-System Inspection Model provides a structured approach for FDA inspectors to assess the compliance and effectiveness of a pharmaceutical company’s quality management system. By focusing on these six subsystems, the FDA ensures that all aspects of manufacturing, from raw materials to final product testing, are adequately controlled and managed to maintain high standards of product quality and safety.

A Complementary and Holistic Approach

Both ICH Q10 and the FDA’s guidance on quality systems approach aim to enhance the quality and safety of pharmaceutical products through robust quality management systems. ICH Q10 provides a harmonized model applicable across the product lifecycle, while the FDA guidance focuses on integrating quality systems with existing CGMP regulations. Together, they support the pharmaceutical industry in achieving consistent product quality and regulatory compliance.

Aspect	ICH Q10	FDA Guidance on CGMP	ISO 13485 and 21 CFR 820	ISO 9000
Purpose and Scope	Comprehensive model for pharmaceutical quality systems across the product lifecycle.	Quality systems approach to ensure CGMP compliance in pharmaceuticals.	Quality management system for medical devices, incorporating ISO 13485 and regulatory requirements of 21 CFR 820.	Fundamentals and vocabulary for quality management systems applicable to any industry.
Industry Focus	Specifically for the pharmaceutical industry.	Specifically for the pharmaceutical industry.	Specifically for the medical device industry.	Applicable to any industry.
Key Elements	Management responsibilities, CAPA, process performance, change management, management review.	Management responsibilities, quality systems, process validation, continuous improvement.	Risk management, quality manual, documentation requirements (e.g., Device Master Records, Device History Records).	Quality management principles, terms, and definitions.
Regulatory Focus	Strong emphasis on regulatory compliance and lifecycle management.	Strong emphasis on regulatory compliance with CGMP.	Incorporates regulatory requirements specific to medical devices (21 CFR 820).	Does not directly address regulatory compliance.
Flexibility	Flexible, adaptable to specific product and process needs.	More prescriptive with specific compliance requirements.	Harmonized with international standards but includes specific regulatory requirements.	Provides a broad framework for customization.
Management Involvement	Emphasizes management’s role in quality and regulatory compliance.	Emphasizes management’s role in quality and CGMP integration.	Emphasizes management’s role in quality and risk-based decision making.	Emphasizes management’s role in quality and customer satisfaction.
Implementation	Tailored to pharmaceutical manufacturing, integrating quality management principles.	Mandates oversight and controls over drug manufacturing processes.	Requires a quality manual and specific documentation practices; aligned with international standards.	Requires customization to specific industry needs.

These two documents were developed at the same time and represents the thinking twenty years ago in laying down an approach that still matters today. I usually regard the six system approach as a deepening and defining of what Q10 means by process performance and product quality monitoring.

What is the current agency thinking?

The FDA and other revulatory agencies haven’t stopped their thinking in 2008. Sixteen years later we see the continued push for quality culture and quality maturity. The FDA continues to make this a top priority, as we’ve been seeing in their annual drug shortage reports to Congress. There are a few themes we continue to see driven home.

The Patient is the Customer

Quality management must be customer-focused, ensuring that all processes and materials meet their intended use. Senior management’s commitment is crucial for a strong QMS, which emphasizes proactive quality assurance over reactive quality control. Robust supplier relationships and oversight programs are essential to manage variability in materials and processes.

This application of a core priciple in ISO 9000 may seem to basic to some, but I think it is central to a lot of messaging and should never be taken for granted.

Benefits of Better Quality Performance

A continued focus that a quality-focused culture leads to:

Early problem detection
Enhanced process stability and productivity
Fewer major deviations and failures
Efficient QA release of batches
Reduced customer complaints and returns
Protection of brand and competitiveness

Management Oversight of Drug Quality

Management must address sources of variability, including people, materials, methods, measurements, machines, and environment. Risk management should be dynamic and ongoing, facilitating continual learning and improvement.

Corrective Action and Preventive Action (CAPA)

A structured approach to investigating complaints, product rejections, nonconformances, recalls, deviations, audits, regulatory inspections, and trends is essential. CAPA should determine root causes and implement corrective actions.

Change Management

Timely and effective change management ensures corrections and improvements are undertaken efficiently. This includes implementing product quality improvements, process improvements, variability reduction, innovations, and pharmaceutical quality system enhancements.

Management Review

Management is responsible for quality policy, QMS effectiveness, internal communications, resource management, and supply chain oversight. This includes ensuring the quality of incoming materials and outsourced activities.

Quality Culture Driven by Top Management

A strong corporate quality culture is driven by daily decisions and executive oversight. Sustainable compliance requires aiming for high standards rather than just meeting minimum requirements. Quality management maturity involves proactive and preventive actions, iterative learning, and leveraging modern technologies.

Facility Lifecycle

Senior management must ensure the suitability of operational design, control, and maintenance. This includes addressing infrastructure reliability, appropriateness for new product demands, and mitigating equipment/facility degradation.

Risk Management in Manufacturing

Human factors and manual interventions pose significant risks in pharmaceutical manufacturing. Automation and separation technologies can mitigate these risks, but many facilities still rely on manually intensive processes. Leveraging new technologies and practices is a huge opportunity.

This approach is reflected in the FDA’s Quality Management Maturity (QMM), which promotes advanced quality management practices within drug manufacturing establishments.

Goals of the QMM Program

Foster a Strong Quality Culture Mindset: Encourage establishments to integrate quality deeply into their organizational culture.
Recognize Advanced Quality Management Practices: Acknowledge and reward establishments that go beyond basic CGMP (Current Good Manufacturing Practices) requirements.
Identify Growth Opportunities: Provide suggestions for enhancing quality management practices.
Minimize Risks to Product Availability: Ensure a reliable market supply by reducing quality-related failures and maintaining performance during supply chain disruptions.

Key Components of the QMM Program

Management Commitment to Quality: Leadership must prioritize quality, set clear objectives, and integrate these with business goals. Effective management review processes are crucial.
Business Continuity: Establishments should develop robust plans to handle disruptions, ensuring consistent operations and supply chain reliability.
Advanced Pharmaceutical Quality System (PQS): Implementing quality principles like Quality by Design (QbD) and risk management approaches to maintain system reliability and minimize production disruptions.
Technical Excellence: Emphasizing data management, innovative manufacturing processes, and advanced technologies to enhance quality and operational efficiency.
Employee Engagement and Empowerment: Encouraging employees to take ownership of quality, make suggestions, and understand their impact on product quality and patient safety.

Implementation and Assessment

The FDA has developed a prototype assessment protocol to evaluate QMM. This includes a standardized approach to minimize bias and ensure objectivity. Someday, eventually, it will move away from constant prototyping.
Assessments will focus on qualitative aspects, such as the establishment’s quality culture and how it uses data to drive improvements.

Benefits of QMM

Enhanced Supply Chain Reliability: By adopting mature quality management practices, establishments can reduce the occurrence of quality-related failures. The fact shortages continue to be so damning to our industry is a huge wake-up call.
Proactive Continual Improvement: Encourages a proactive approach to quality management, leveraging technological advancements and integrated business operations.
Long-term Cost Savings: Investing in a mature quality culture can lead to fewer compliance issues, reduced inspection needs, and overall cost reductions.

Conclusion

The FDA’s QMM program aims to transform how pharmaceutical quality is perceived, measured, and rewarded. The program seeks to ensure a more reliable drug supply and better patient outcomes by fostering a strong quality culture and recognizing advanced practices. It should be seen as part of a 20-year commitment from the agency in alignment with its international partners.

Best Ways to Address a Deviation Backlog

A deviation backlog in a regulated industry, such as pharmaceuticals, can pose significant risks to compliance, product quality, and overall operational efficiency. Addressing this backlog effectively requires a structured approach that prioritizes risk management, resource allocation, and continuous improvement.

You need to do two things first:

Prioritize Urgent Requests

Identify Critical Issues: Focus on resolving high-priority and time-sensitive deviations first to drive compliance.

Isolate and Organize

Separate Backlog from Ongoing Deviations: Create distinct queues for backlog deviations and new deviations to streamline management.
Create a Backlog Team: Assign a dedicated team to tackle the backlog, ensuring that regular support operations continue smoothly.

From there, you can then proceed into the next steps to tackle a deviation backlog:

1. Prioritize Based on Risk

Not all deviations have the same impact. Prioritizing the backlog based on the severity and risk part of each deviation is crucial. This involves:

Assessing Severity: Evaluate the potential impact of each deviation on product quality, patient safety, and regulatory compliance. Ideally you already classify deviations into categories such as minor, moderate, and major. based on those you will need to additional work to prioritize the backlog.
Risk-Based Approach: Focus on resolving high-risk deviations first to mitigate the most critical issues promptly.

2. Allocate Adequate Resources

Addressing a backlog efficiently often requires additional resources. Consider the following actions:

Increase Staffing: Temporarily augment your team with additional personnel or external consultants to handle the increased workload.
Specialized Teams: Form dedicated teams to focus solely on backlog reduction, ensuring that regular operations are not disrupted.

3. Improve and Make Robust Deviation Management Processes

A systematic approach to deviation management helps prevent backlogs from recurring. Key steps include:

Root Cause Analysis (RCA): Conduct thorough investigations to identify the underlying causes of deviations.
Corrective and Preventive Actions (CAPA): Develop and implement CAPA plans to address root causes and prevent future deviations. Ensure these plans are reviewed and approved by relevant stakeholders.

4. Regular Monitoring and Review

Continuous monitoring and regular reviews are essential to keep the backlog under control:

Track Progress: Use metrics and key performance indicators (KPIs) to monitor the progress of backlog reduction efforts. Tools like burndown charts can be helpful.
Periodic Reviews: Conduct regular review meetings to assess the status of the backlog and make necessary adjustments to the plan.

5. Enhance Deviation Management Systems

Improving your deviation management system can prevent future backlogs and streamline the resolution process:

Automation and Software Tools: Implement a eQMS or evaluate and improve the current one.
Training and Education: Ensure that all employees are well-trained in deviation management processes and understand the importance of timely reporting and resolution.

6. Foster a Culture of Continuous Improvement

Promote a culture that values continuous improvement and proactive problem-solving:

Encourage Reporting: Create an environment where employees feel comfortable reporting deviations without fear of retribution.
Learn from Deviations: Analyze deviation trends to identify areas for process improvement and implement changes to prevent recurrence.

7. Set Clear Goals and Deadlines

Establish clear goals and deadlines for backlog reduction:

Set Due Dates: Assign due dates for resolving backlog items to ensure timely action. Items that exceed their due dates should be reviewed and either expedited or reassessed for relevance.
Regular Updates: Keep all stakeholders informed about the progress and any changes to the plan through regular updates and communication.

Conclusion

Addressing a deviation backlog effectively requires a combination of prioritization, resource allocation, robust processes, continuous monitoring, and a culture of improvement. By implementing these strategies, organizations can reduce their backlog, improve compliance, and enhance overall product quality and safety.

When the FDA Describes a CAPA Program, Listen

Occasionally the FDA writes a Warning Letter that is a succinct lesson in what is important about a quality system. In this Warning Letter they masterfully describe what a CAPA Program is. As this one further describes how to deal with an inadequate cleaning program it is near and dear to my heart.

Managing Events Systematically

Being good at problem-solving is critical to success in an organization. I’ve written quite a bit on problem-solving, but here I want to tackle the amount of effort we should apply.

Not all problems should be treated the same. There are also levels of problems. And these two aspects can contribute to some poor problem-solving practices.

It helps to look at problems systematically across our organization. The iceberg analogy is a pretty popular way to break this done focusing on Events, Patterns, Underlying Structure, and Mental Model.

Events

Events start with the observation or discovery of a situation that is different in some way. What is being observed is a symptom and we want to quickly identify the problem and then determine the effort needed to address it.

This is where Art Smalley’s Four Types of Problems comes in handy to help us take a risk-based approach to determining our level of effort.

Type 1 problems, Troubleshooting, allows us to set problems with a clear understanding of the issue and a clear pathway. Have a flat tire? Fix it. Have a document error, fix it using good documentation practices.

It is valuable to work the way through common troubleshooting and ensure the appropriate linkages between the different processes, to ensure a system-wide approach to problem solving.

Corrective maintenance is a great example of troubleshooting as it involved restoring the original state of an asset. It includes documentation, a return to service and analysis of data. From that analysis of data problems are identified which require going deeper into problem-solving. It should have appropriate tie-ins to evaluate when the impact of an asset breaking leads to other problems (for example, impact to product) which can also require additional problem-solving.

It can be helpful for the organization to build decision trees that can help folks decide if a given problem stays as troubleshooting or if it it also requires going to type 2, “gap from standard.”

Type 2 problems, gap from standard, means that the actual result does not meet the expected and there is a potential of not meeting the core requirements (objectives) of the process, product, or service. This is the place we start deeper problem-solving, including root cause analysis.

Please note that often troubleshooting is done in a type 2 problem. We often call that a correction. If the bioreactor cannot maintain temperature during a run, that is a type 2 problem but I am certainly going to immediately apply troubleshooting as well. This is called a correction.

Take documentation errors. There is a practice in place, part of good documentation practices, for addressing troubleshooting around documents (how to correct, how to record a comment, etc). By working through the various ways documentation can go wrong, applying which ones are solved through troubleshooting and don’t involve type 2 problems, we can create a lot of noise in our system.

Trends/Patterns

Core to the quality system is trending, looking for possible signals that require additional effort. Trending can help determine where problems lay and can also drive up the level of effort necessary.

Underlying Structure

Root Cause Analysis is about finding the underlying structure of the problem that defines the work applied to a type 2 problem.

Not all problems require the same amount of effort, and type 2 problems really have a scale based on consequences, that can help drive the level of effort. This should be based on the impact to the organization’s ability to meet the quality objectives, the requirements behind the product or service.

For example, in the pharma world there are three major criteria:

safety, rights, or well-being of patients (including subjects and participants human and non-human)
data integrity (includes confidence in the results, outcome, or decision dependent on the data)
ability to meet regulatory requirements (which stem from but can be a lot broader than the first two)

These three criteria can be sliced and diced a lot of ways, but serve our example well.

To these three criteria we add a scale of possible harm to derive our criticality, an example can look like this:

Classification	Description
Critical	The event has resulted in, or is clearly likely to result in, any one of the following outcomes: significant harm to the safety, rights, or well-being of subjects or participants (human or non-human), or patients; compromised data integrity to the extent that confidence in the results, outcome, or decision dependent on the data is significantly impacted; or regulatory action against the company.
Major	The event(s), were they to persist over time or become more serious, could potentially, though not imminently, result in any one of the following outcomes: harm to the safety, rights, or well-being of subjects or participants (human or non-human), or patients; compromised data integrity to the extent that confidence in the results, outcome, or decision dependent on the data is significantly impacted.
Minor	An isolated or recurring triggering event that does not otherwise meet the definitions of Critical or Major quality impacts.

Example of Classification of Events in a Pharmaceutical Quality System

This level of classification will drive the level of effort on the investigation, as well as drive if the CAPA addresses underlying structures alone or drives to addressing the mental models and thus driving culture change.

Mental Model

Here is where we address building a quality culture. In CAPA lingo this is usually more a preventive action than a corrective action. In the simplest of terms, corrective actions is address the underlying structures of the problem in the process/asset where the event happened. Preventive actions deal with underlying structures in other (usually related) process/assets or get to the Mindsets that allowed the underlying structures to exist in the first place.

By applying this system perspective to our problem solving, by realizing that not everything needs a complete rebuild of the foundation, by looking holistically across our systems, we can ensure that we are driving a level of effort to truly build the house of quality.

Measuring Training Effectiveness for Organizational Performance

When designing training we want to make sure four things happen:

Training is used correctly as a solution to a performance problem
Training has the the right content, objectives or methods
Trainees are sent to training for which they do have the basic skills, prerequisite skills, or confidence needed to learn
Training delivers the expected learning

Training is a useful lever in organization change and improvement. We want to make sure the training drives organization metrics. And like everything, you need to be able to measure it to improve.

The Kirkpatrick model is a simple and fairly accurate way to measure the effectiveness of adult learning events (i.e., training), and while other methods are introduced periodically, the Kirkpatrick model endures because of its simplicity. The model consists of four levels, each designed to measure a specific element of the training. Created by Donald Kirkpatrick, this model has been in use for over 50 years, evolving over multiple decades through application by learning and development professionals around the world. It is the most recognized method of evaluating the effectiveness of training programs. The model has stood the test of time and became popular due to its ability to break down complex subject into manageable levels. It takes into account any style of training, both informal and formal.

Level 1: Reaction

Kirkpatrick’s first level measures the learners’ reaction to the training. A level 1 evaluation is leveraging the strong correlation between learning retention and how much the learners enjoyed the time spent and found it valuable. Level 1 evaluations, euphemistically called a “smile sheet” should delve deeper than merely whether people liked the course. A good course evaluation will concentrate on three elements: course content, the physical environment and the instructor’s presentation/skills.

Level 2: Learning

Level 2 of Kirkpatrick’s model, learning, measures how much of the content attendees learned as a result of the training session. The best way to make this evaluation is through the use of a pre- and posttest. Pre- and posttests are key to ascertaining whether the participants learned anything in the learning event. Identical pre- and posttests are essential because the difference between the pre- and posttest scores indicates the amount of learning that took place. Without a pretest, one does not know if the trainees knew the material before the session, and unless the questions are the same, one cannot be certain that trainees learned the material in the session.

Level 3: Behavior

Level 3 measures whether the learning is transferred into practice in the workplace.

Level 4: Results

Measures the effect on the business environment. Do we meet objectives?

Evaluation Level	Characteristics	Examples
Level 1: Reaction	Reaction evaluation is how the delegates felt, and their personal reactions to the training or learning experience, for example: ▪ Did trainee consider the training relevant? ▪ Did they like the venue, equipment, timing, domestics, etc? ▪ Did the trainees like and enjoy the training? ▪ Was it a good use of their time? ▪ Level of participation ▪ Ease and comfort of experience	▪ feedback forms based on subjective personal reaction to the training experience ▪ Verbal reaction which can be analyzed ▪ Post-training surveys or questionnaires ▪ Online evaluation or grading by delegates ▪ Subsequent verbal or written reports given by delegates to managers back at their jobs ▪ typically ‘happy sheets’
Level 2: Learning	Learning evaluation is the measurement of the increase in knowledge or intellectual capability from before to after the learning experience: ▪ Did the trainees learn what intended to be taught? ▪ Did the trainee experience what was intended for them to experience? ▪ What is the extent of advancement or change in the trainees after the training, in the direction or area that was intended?	▪ Interview or observation can be used before and after although it is time-consuming and can be inconsistent ▪ Typically assessments or tests before and after the training ▪ Methods of assessment need to be closely related to the aims of the learning ▪ Reliable, clear scoring and measurements need to be established ▪ hard-copy, electronic, online or interview style assessments are all possible
Level 3: Behavior	Behavior evaluation is the extent to which the trainees applied the learning and changed their behavior, and this can be immediately and several months after the training, depending on the situation: ▪ Did the trainees put their learning into effect when back on the job? ▪ Were the relevant skills and knowledge used? ▪ Was there noticeable and measurable change in the activity and performance of the trainees when back in their roles? ▪ Would the trainee be able to transfer their learning to another person? is the trainee aware of their change in behavior, knowledge, skill level? ▪ Was the change in behavior and new level of knowledge sustained?	▪ Observation and interview over time are required to assess change, relevance of change, and sustainability of change ▪ Assessments need to be designed to reduce subjective judgment of the observer ▪ 360-degree feedback is useful method and need not be used before training, because respondents can make a judgment as to change after training, and this can be analyzed for groups of respondents and trainees ▪ Online and electronic assessments are more difficult to incorporate – assessments tend to be more successful when integrated within existing management and coaching protocols
Level 4: Results	Results evaluation is the effect on the business or environment resulting from the improved performance of the trainee – it is the acid test Measures would typically be business or organizational key performance indicators, such as: volumes, values, percentages, timescales, return on investment, and other quantifiable aspects of organizational performance, for instance; numbers of complaints, staff turnover, attrition, failures, wastage, non-compliance, quality ratings, achievement of standards and accreditations, growth, retention, etc.	The challenge is to identify which and how relate to the trainee’s input and influence. Therefore it is important to identify and agree accountability and relevance with the trainee at the start of the training, so they understand what is to be measured ▪ This process overlays normal good management practice – it simply needs linking to the training input ▪ For senior people particularly, annual appraisals and ongoing agreement of key business objectives are integral to measuring business results derived from training

4 Levels of Training Effectiveness

Example in Practice – CAPA

When building a training program, start with the intended behaviors that will drive results. Evaluating our CAPA program, we have two key aims, which we can apply measures against.

Behavior	Measure
Investigate to find root cause	% recurring issues
Implement actions to eliminate root cause	Preventive to corrective action ratio

To support each of these top-level measures we define a set of behavior indicators, such as cycle time, right the first time, etc. To support these, a review rubric is implemented.

Our four levels to measure training effectiveness will now look like this:

Level	Measure
Level 1: Reaction	Personal action plan and a happy sheet
Level 2: Learning	Completion of Rubric on a sample event
Level 3: Behavior	Continued performance and improvement against the Rubric and the key review behavior indicators
Level 4: Results	Improvements in % of recurring issues and an increase in preventive to corrective actions

This is all about measuring the effectiveness of the transfer of behaviors.

Strong Signals of Transfer Expectations in the Organization	Signals that Weaken Transfer Expectations in the Organization
Training participants are required to attend follow-up sesions and other transfer interventions. What is indicates: Individuals and teams are committed to the change and obtaining the intended benefits.	Attending the training is compulsory, but participating in follow-up sessions or oter transfer interventions is voluntary or even resisted by the organization. What is indicates: They key factor of a trainee is attendance, not behavior change.
The training description specifies transfer goals (e.g. “Trainee increases CAPA success by driving down recurrence of root cause”) What is indicates: The organization has a clear vision and expectation on what the training should accomplish.	The training description roughly outlines training goals (e.g. “Trainee improves their root cause analysis skills”) What is indicates: The organization only has a vague idea of what the training should accomplish.
Supervisors take time to support transfer (e.g. through pre- and post-training meetings). Transfer support is part of regular agendas. What is indicates: Transfer is considered important in the organization and supported by supervisors and managers, all the way to the top.	Supervisors do not invest in transfer support. Transfer support is not part of the supervisor role. What is indicates: Transfer is not considered very important in the organziaiton. Managers have more important things to do.
Each training ends with careful planning of individual transfer intentions. What is indicates: Defining transfer intentions is a central component of the training.	Transfer planning at the end of the training does not take place or only sporadically. What is indicates: Defining training intentions is not (or not an essential) part of the training.

Good training, and thus good and consistent transfer, builds that into the process. It is why I such a fan of utilizing a Rubric to drive consistent performance.