Unlocking Hidden Potential: The Art of Assessing Team Capability

For managers in an organization it is critical to understand and nurture the capabilities of our team members. I spend a lot of time on this blog talking about capability and competence frankly because they are an elusive concept, invisible to the naked eye. We can only perceive it through its manifestations – the tangible outputs and results produced by our team. This presents a unique challenge: how do we accurately gauge a team member’s highest level of capability?

The Evidence-Based Approach

The key to unraveling this mystery lies in evidence. We must adopt a systematic, iterative approach to testing and challenging our team members through carefully designed project work. This method allows us to gradually uncover the true extent of their competence.

Step 1: Initial Assessment

The journey begins with a quick assessment of the team member’s current applied capability. This involves examining the fruits of their labor – the tangible outcomes of their work. As managers, we must rely on our intuitive judgment to evaluate these results. I strongly recommend this is a conversation with the individual as well.

Step 2: Incremental Complexity

Once we have established a baseline, the next step is to marginally increase the complexity of the task. This takes the form of a new project, slightly more challenging than the previous one. Crucially, we must promise a project debrief upon completion. This debrief serves as a valuable learning opportunity for both the team member and the manager.

Step 3: Continuous Iteration

If the project is successful, it becomes a springboard for the next challenge. We continue this process, incrementally increasing the complexity with each new project, always ensuring a debrief follows. This cycle persists until we reach a point of failure.

The Point of Failure: A Revelatory Moment

When a team member encounters failure, we gain invaluable insights into their competence. This moment of truth illuminates both their strengths and limitations. We now have a clearer understanding of where they excel and where they struggle.

However, this is not the end of the journey. After allowing some time for reflection and growth, we must challenge them again. This process of continual challenge and assessment should persist throughout the team member’s tenure with the organization.

The Role of Deliberate Practice

This approach aligns closely with the concept of deliberate practice, which is fundamental to the development of expertise. By providing our team members with guided practice, observation opportunities, problem-solving challenges, and experimentation, we create an environment conducive to skill development.

Building Competence

Remember, competence is a combination of capability and skill. While we cannot directly observe capability, we can nurture it through this process of continual challenge and assessment. By doing so, we also develop the skill component, as team members gain more opportunities for practice.

The Manager’s Toolkit

To effectively implement this approach, managers should cultivate several key attributes:

  1. System thinking: Understanding the interdependencies within projects and anticipating consequences.
  2. Judgment: Making rapid, wise decisions about when to increase complexity.
  3. Context awareness: Taking into account the unique circumstances of each team member and project.
  4. Interpersonal skills: Motivating and leading team members through challenges.
  5. Communication: Constructing and delivering clear, persuasive messages about project goals and expectations.

By embracing this evidence-based, iterative approach to assessing capability, managers can unlock the hidden potential within their teams. It’s a continuous journey of discovery, challenge, and growth – one that benefits both the individual team members and the organization as a whole.

Deep Rules

In his column “What You Still Can’t Say at Work” Jim Detert explores the concept of “deep rules” in organizations and their impact on workplace communication and culture. He convincingly argues that despite efforts to improve workplace communication and psychological safety, there are still unwritten “deep rules” that prevent employees from expressing certain thoughts and concerns, particularly those that challenge existing power structures or leadership practices.

To his very good list, I’d add a few around quality:

  • “Our leaders talk about quality but don’t actually prioritize it when making key decisions.”
  • “Employees aren’t truly empowered to make quality-related decisions, despite what our policy states.”
  • “We have processes in place mainly to pass audits, not because they actually improve quality.”
  • “Quality data is often manipulated or selectively presented to paint a more positive picture.”
  • “We make decisions based on politics or personal preferences rather than quality data and analysis.”

Voluntary Standard Organizations and You

A consensus standards organization, also known as a voluntary consensus standards body, is an entity that develops and publishes technical standards through a collaborative, consensus-based process involving various stakeholders. Here are the key characteristics of consensus standards organizations:

  1. Voluntary participation: Involvement in the standards development process is voluntary for interested parties.
  2. Consensus-based approach: Standards are developed through a process that seeks general agreement among participants, considering the views of all parties and reconciling conflicting arguments.
  3. Openness: The procedures and processes for developing standards are open to interested parties, providing meaningful opportunities for participation on a non-discriminatory basis.
  4. Balance: The standards development process aims to achieve balance among different stakeholder groups, ensuring no single interest dominates.
  5. Due process: The organization follows established procedures that include provisions for appeals and addressing objections.
  6. Transparency: The procedures for developing standards and the standards themselves are transparent and accessible.
  7. Non-profit status: Many consensus standards organizations operate as non-profit entities.
  8. Diverse stakeholder involvement: Participants typically include industry experts, government representatives, academics, and consumer groups.
  9. Accreditation: In some cases, these organizations may be accredited by national bodies (e.g., ANSI in the United States) to ensure they follow proper procedures.
  10. Wide range of applications: Consensus standards can cover various fields, including product specifications, testing methods, management systems, and more.

Examples of well-known consensus standards organizations include:

  • International Organization for Standardization (ISO)
  • American National Standards Institute (ANSI)
  • ASTM International (formerly American Society for Testing and Materials)
  • British Standards Institution (BSI)

These organizations play a crucial role in promoting quality, safety, and interoperability across various industries and sectors by developing widely accepted standards through collaborative processes.

The Unique Role of Inter-Governmental Agencies in Pharmaceutical Standards

While discussing consensus standard organizations, it’s important to highlight a distinct category that operates similarly but doesn’t quite fit the traditional mold: inter-governmental agencies like the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

These organizations share some key characteristics with consensus standard bodies:

  1. They focus on harmonization efforts in the pharmaceutical industry.
  2. They operate internationally, involving multiple countries and regulatory authorities.
  3. They provide frameworks for collaboration among stakeholders.

However, ICH and PIC/S differ from typical consensus standard organizations in several ways:

  • Membership: They primarily comprise regulatory authorities rather than a broad range of industry stakeholders.
  • Authority: While not legally binding, their guidelines and standards often carry significant weight with regulatory bodies worldwide.

These organizations play a crucial role in shaping global pharmaceutical regulations, bridging the gap between formal regulatory requirements and industry-led standards. Their work complements that of traditional consensus standard organizations, contributing to a more cohesive and harmonized global regulatory environment for pharmaceuticals.

Good Engineering Practices Under ASTM E2500

ASTM E2500 recognizes that Good Engineering Practices (GEP) are essential for pharmaceutical companies to ensure the consistent and reliable design, delivery, and operation of engineered systems in a manner suitable for their intended purpose.

Key Elements of Good Engineering Practices

  1. Risk Management: Applying systematic processes to identify, assess, and control risks throughout the lifecycle of engineered systems. This includes quality risk management focused on product quality and patient safety.
  2. Cost Management: Estimating, budgeting, monitoring and controlling costs for engineering projects and operations. This helps ensure projects deliver value and stay within budget constraints.
  3. Organization and Control: Establishing clear organizational structures, roles and responsibilities for engineering activities. Implementing monitoring and control mechanisms to track performance.
  4. Innovation and Continual Improvement: Fostering a culture of innovation and continuous improvement in engineering processes and systems.
  5. Lifecycle Management: Applying consistent processes for change management, issue management, and document control throughout a system’s lifecycle from design to decommissioning.
  6. Project Management: Following structured approaches for planning, executing and controlling engineering projects.
  7. Design Practices: Applying systematic processes for requirements definition, design development, review and qualification.
  8. Operational Support: Implementing asset management, calibration, maintenance and other practices to support systems during routine operations.

Key Steps for Implementation

  • Develop and document GEP policies, procedures and standards tailored to the company’s needs
  • Establish an Engineering Quality Process (EQP) to link GEP to the overall Pharmaceutical Quality System
  • Provide training on GEP principles and procedures to engineering staff
  • Implement risk-based approaches to focus efforts on critical systems and processes
  • Use structured project management methodologies for capital projects
  • Apply change control and issue management processes consistently
  • Maintain engineering documentation systems with appropriate controls
  • Conduct periodic audits and reviews of GEP implementation
  • Foster a culture of quality and continuous improvement in engineering
  • Ensure appropriate interfaces between engineering and quality/regulatory functions

The key is to develop a systematic, risk-based approach to GEP that is appropriate for the company’s size, products and operations. When properly implemented, GEP provides a foundation for regulatory compliance, operational efficiency and product quality in pharmaceutical manufacturing.

Invest in a Living, Breathing Engineering Quality Process (EQP)

The EQP establishes the formal connection between GEP and the Pharmaceutical Quality System it resides within, serving as the boundary between Quality oversight and engineering activities, particularly for implementing Quality Risk Management (QRM) based integrated Commissioning and Qualification (C&Q).

It should also provide an interface between engineering activities and other systems like business operations, health/safety/environment, or other site quality systems.

Based on the information provided in the document, here is a suggested table of contents for an Engineering Quality Process (EQP):

Table of Contents – Engineering Quality Process (EQP)

  1. Introduction
    1.1 Purpose
    1.2 Scope
    1.3 Definitions
  2. Application and Context
    2.1 Relationship to Pharmaceutical Quality System (PQS)
    2.2 Relationship to Good Engineering Practice (GEP)
    2.3 Interface with Quality Risk Management (QRM)
  3. EQP Elements
    3.1 Policies and Procedures for the Asset Lifecycle and GEPs
    3.2 Risk Assessment
    3.3 Change Management
    3.4 Document Control
    3.5 Training
    3.6 Auditing
  4. Deliverables
    4.1 GEP Documentation
    4.2 Risk Assessments
    4.3 Change Records
    4.4 Training Records
    4.5 Audit Reports
  5. Roles and Responsibilities
    5.1 Engineering
    5.2 Quality
    5.3 Operations
    5.4 Other Stakeholders
  6. EQP Implementation
    6.1 Establishing the EQP
    6.2 Maintaining the EQP
    6.3 Continuous Improvement
  7. References
  8. Appendices

The Hallway Track at a Conference

BOSCON 2024 starts tomorrow, so in honor of the local section’s juggernaut of a conference, I want to talk about the hallway track, my favorite part of a conference.

The hallway track at a conference refers to the informal networking, discussions, and spontaneous interactions that occur outside of scheduled sessions. It is often considered one of the most valuable aspects of attending a conference, as it facilitates connections that can lead to professional opportunities and insights that are not typically available in formal presentations.

How to Maximize the Hallway Track

To make the most of the hallway track, consider the following strategies:

1. Plan Ahead

  • Review the Agenda: Before the conference, identify key sessions you want to attend but also mark open slots for networking opportunities.
  • Set Goals: Determine what you hope to achieve through networking—whether it’s meeting specific individuals or learning about new trends in your field.

2. Engage with Others

  • Start Conversations: Use simple icebreakers like asking about someone’s favorite session or their plans for the day. This can lead to deeper discussions.
  • Introduce Yourself: Don’t hesitate to approach people you know from social media platforms like LinkedIn or Twitter. This can help solidify online connections in person.

3. Attend Social Events

  • Participate in Informal Gatherings: Join social events or activities that may be outside your comfort zone. These settings often foster more relaxed and meaningful conversations.

4. Be Open to New Experiences

  • Change Your Plans if Necessary: If someone recommends a session or event, be flexible enough to adjust your schedule. You might discover valuable insights or connections by following these leads.

5. Leverage the Environment

  • Use Common Areas: Spend time in hallways, lounges, and vendor areas where informal interactions are likely to occur. These spaces are conducive to spontaneous conversations.

6. Network with Purpose

  • Follow Up After the Conference: Collect contact information and follow up with new connections after the event. This helps solidify relationships formed during the hallway track.

By actively engaging in these practices, attendees can significantly enhance their conference experience and build lasting professional relationships through the hallway track.