Data Process Mapping

In a presentation on practical applications of data integrity for laboratories at the March 2019 MHRA Laboratories Symposium held in London, UK, MHRA Lead GCP and GLP Inspector Jason Wakelin-Smith highlighted the important role data process mapping plays in understanding these challenges and moving down the DI pathway.

He pointed out that understanding of processes and systems, which data maps facilitate, is a key theme in MHRA’s GxP data integrity guidance, finalized in March of 2018. The guidance is intended to be broadly applicable across the regulated practices, but excluding the medical device arena, which is regulated in Europe by third-party notified bodies.

IPQ. MHRA Inspectors are Advocating Data Mapping as a Key First Step on the Data Integrity Pilgrimage

Data process maps look at the entire data life-cycle from creation through storage (covering key components of create, modify and delete) and include all operations with both paper and electronic records.   Data maps are cross-functional diagrams (swim-lanes) and have the following sections:

  • Prep/Input
  • Data Creation
  • Data Manipulation (include delete)
  • Data  Use
  • Data Storage

Use a standard symbol for paper record, computer data and process step.

For computer data denote (usually by color) the level of controls:

  • Fully aligned with Part 11 and Data Integrity guidances
  • Gaps in compliance but remediation plan in place (this includes places where paper is considered “true copy”
  • Not compliant, no remediation plan

Data operations are depicted utilizing arrows.  The following data operations are probably most common, and are recommended for consistency:

  • Data Entry – input of process, meta data (e.g. lot ID, operator)
  • Data Store – archival location
  • Data Copy – transcription from another system or paper, transfer of data from one system to another, printing (Indicate if it is a manual process).
  • Data Edit – calculations, processing, reviews, unit changes  (Indicate if it is a manual process)
  • Data Move – movement of paper or electronic records

Data operation arrows should denote (again by color) the current controls in place:

  • Technical Controls – Validated Automated Process
  • Operational Controls – Manual Process with Review/Verified/Witness Requirements
  • No Controls – Automated process that is not validated or Manual process with no Review/Verified/Witness Considerations
Example data map

Top 5 Posts by Views in 2019 (first half)

With June almost over a look at the five top views for 2019. Not all of these were written in 2019, but I find it interesting what folks keep ending up at my blog to read.

  1. FDA signals – no such thing as a planned deviation: Since I wrote this has been a constant source of hits, mostly driven by search engines. I always feel like I should do a follow-up, but not sure what to say beyond – don’t do planned deviations, temporary changes belong in the change control system.
  2. Empathy and Feedback as part of Quality Culture: The continued popularity of this post since I wrote it in March has driven a lot of the things I am writing lately.
  3. Effective Change Management: Change management and change control are part of my core skill set and I’m gratified that this post gets a lot of hits. I wonder if I should build it into some sort of expanded master class, but I keep feeling I already have.
  4. Review of Audit Trails: Data Integrity is so critical these days. I should write more on the subject.
  5. Risk Management is about reducing uncertainty: This post really captures a lot of the stuff I am thinking about and driving action on at work.

Thinking back to my SWOT, and the ACORN test I did at the end of 2018, I feel fairly good about the first six months. I certainly wish I found time to blog more often, but that seems doable. And like most bloggers, I still am looking for ways to increase engagement with my posts and to spark conversations.

Mindsets and Attitudes

Mindsets are lenses or frames of mind that orient individuals to particular sets of associations and expectations. Mindsets help individuals make sense of complex information by offering them simple schematics about themselves and objects in their world. For employees, mindsets provide scaffolding for understanding the broad nature of their work. Mindsets can be intentionally and adaptively changed through targeted interventions, so the goal is to build the processes to assess, monitor and shape as part of our quality systems.

Attitudes are the beliefs and feelings that drive individuals’ intentions and actions. Attitudes are the lens through which individuals make sense of their surroundings and impart consistency to guide their behavior .

Mindset influences attitudes, which influence behaviors, which influence actions, which influence results, which influence performance. And performance leas to changes in mindsets, and is a continuous improvement loop.

Since behaviors drive the actions we want to see, they are often a great pivot point. By thinking and working on mindsets and attitudes we are targeting the fourth and second leverage points.

Another way to think about this is we are developing habits. The same three factors apply:

  1. Start small: If you have ever tried to tackle multiple resolutions all at once, you know it is next to impossible. Often, the habits will lack cohesion with one another, leading to more stress and less progress. The cognitive load increases, and the brain processes things in a more scattered, less congruent manner. It’s better to focus on one new habit at a time.
  2. Enact the new habit daily: We can’t predict how long a specific habit will take to form, but all the research I’ve seen indicates that the more often people account on the new behavior, the more likely it is to become routine.
  3. Weave into existing processes: When we blend the new behavior with current activities, it’s easier to latch on to, which make sit become an unconscious action more quickly.

Habits are contagious within social contexts, but scaling positive pressure on an organization level is a big challenge.

Another way to view this is in the framework of experiences, build beliefs, which lead to actions and give us results. By building this into our systems we can make sure the appropriate processes are in place to make sure these new habits stick. Building a quality culture is a multi-year journey requiring incremental, layered and additive formation.

This formation comes through building the mindsets that lead to the behaviors we want to see. Following the ISPE’s recommendations there are four good behaviors we can target (these are not the only ones nor are they exhaustive).

  • Accountability: Employees consistently see quality and compliance as their personal responsibilities. Establishing clear individual accountability for quality and compliance is a foundational step in helping shape quality mindset and cultural excellence. Accountability should be communicated consistently through job descriptions, onboarding, current good manufacturing practice (cGMP) training, and performance goals, and be supported by coaching, capability development programs, rewards, and recognition. Leaders should hold themselves and others accountable for performing to quality and compliance standards
  • Ownership: Employees have sufficient authority to make decisions and feel trusted to do their jobs well. Individual ownership of quality and compliance is a primary driver for shaping quality mindset. When individuals are fully engaged, empowered, and taking action to improve product quality, organizations typically benefit from continuous improvement and faster decision-making.
  • Action orientation: Employees regularly identify issues and intervene to minimize potential negative effects on quality and compliance. Establishing the expectation that individuals demonstrate action orientation helps shape quality mindset and foster cultural excellence. Leaders should promote and leverage proactive efforts (e.g., risk assessments, Gemba walks, employee suggestions) to reinforce support for the desired behavior. Additionally, it is important that rewards and recognition be aligned to support proactive efforts, rather than reactive fire-fighting efforts.
  • Speak up: Employees are not afraid to speak up, identify quality issues, or challenge the status quo for improved quality; they believe management will act on their suggestions. Empowering individuals to speak up and raise quality issues help foster quality mindset. Leaders should support this by modeling the desired behavior, building trust, and creating an environment in which individuals feel comfortable raising quality issues, engaging front-line personnel in problem solving, and involving employees in continuous-improvement activities.

Creating a high level action plan of experience -> Target Belief -> Target Action ->Target Result might look like this:

ISPE, Cultural Excellence Report

Sources

  • Aguire, D., von Post, R & Alpern, M. (2013). Culture’s role in enabling organization change. PWC
  • Ajzen, I. (2005). Attitudes, personality and behavior. (2nd ed.). Berkshire, GBR: McGraw-Hill Professional Publishing
  • Ball, K., Jeffrey, R.W., Abbott, G., McNaughton, S.A. & Crawford, D (2010). Is Healthy behavior contagious: associations with social norms with physical activity and healthy eating. International Journal of Behavioural Nutrition and Physical Activity, 7 (86)
  • Fujita, K., Gollwitzer, P. M., & Oettingen, G. (2007) . Mindsets and pre-conscious open-mindedness to incidental information. Journal of Experimental Social Psychology, 43(1), 48-61.
  • Gollwitzer, P. M. (1990). Action phases and mind-sets. In E. T. Higgins & R. M. Sorrentino (Eds.), Handbook of motivation and cognition: Foundations of social behavior, Vol. 2, pp. 53-92). New York, NY, US: The Guilford Press.

Driving towards a Culture of Excellence

What do we mean when we discuss culture, which is sort of an all-encompassing word that seems difficult to pin down, or can be a rather nebulous way to refer to something bigger than any one individual or team.

Many definitions are available to describe culture. Formally, culture can be defined as “the [predominant] beliefs, values, attitudes, behaviors, and practices that are characteristic of a group of people” (Warrick, 2015).  Culture can usually be described as the symbols, power structures, organisational structures, control systems, rituals & routines, and stories of a group.

Johnson & Scholes Cultural Web (this illustration: www.businessgrowthhub.com)

Why does culture matter, well for starts let’s look at some differences between high and low performing cultures.

High Performance CulturesLow Performance Cultures
Leaders are skilled, admired, and build organizations that excel at results and at taking excellent care of their people and their customersLeaders provide minimal leadership, are not trusted and admired, and do little to engage and involve their people
Clear and compelling vision, mission, goals, and strategyVision, mission, goals, and strategy are unclear, not compelling, not used, or do not exist
Core values drive the culture and are used in decision makingCore values are unclear, not compelling, not used, or do not exist
Committed to excellence, ethics, and doing things rightLack of commitment to excellence, questionable ethics, and a reputation for doing what is expedient rather than what is right
Clear roles, responsibilities, and success criteria, and strong commitment to engaging, empowering, and developing peopleUnclear roles and responsibilities and little interest in fully utilizing and developing the capabilities and potential of people
Positive, can-do work environmentNegative, tense, stressful, and/or resistant work environment
Open, candid, straightforward, and transparent communicationGuarded communication, reluctance to be open and straightforward, and consequences for saying things leaders do not want to hear
Teamwork, collaboration, and involvement are the normTop-down decision making with minimal teamwork, collaboration, and involvement
Emphasis on constant improvement and state-of-the-art knowledge and practicesSlow to make needed improvements and behind times in knowledge and practices
Willingness to change, adapt, learn from successes and mistakes, take reasonable risk, and try new thingsPoorly planned change, resistance to change, minimal learning from successes and mistakes, and either risk averse or risk foolish

Culture can either be built in a purposeful way or left to chance. As we strive for excellence we need to be methodical about building and sustaining cultures we want to drive excellence. A few guidelines then:

  1. Make strategy and culture important leadership priorities
  2. Develop a clear understanding of the present culture
  3. Identify, communicate, educate, and engage employees in the cultural ideals
  4. Role model desired behaviors
  5. Recruit and develop for culture
  6. Align for consistency between strategy and culture
  7. Recognize and reward desired behaviors and practices
  8. Use symbols, ceremonies, socialization, and stories to reinforce culture
  9. Appoint a culture team
  10. Monitor and manage the culture

What most of struggle with is how to actually do that. Of the many papers and articles I’ve read on the subject, my favorite might be from the International Society of Pharmaceutical engineers (ISPE).

The ISPE in 2015 introduced a cultural excellence framework which was expanded on in their 2017 Cultural Excellence Report. I’ve returned to this report again and again and continue to mine it for ideas for continual improvement and change in my organization.

ISPE’s Six dimensions of cultural excellence framework

The six dimensions to build and maintain cultural excellence are:

  1. Leadership and vision: Leaders establish and engender the vision for the organization. Their thoughts, words, and actions about quality are critical in establishing and maintaining a culture of operational excellence. Leadership and vision, therefore, play a key role in establishing the culture, either within a local manufacturing site or across the company.
  2. Mindset and attitudes: These play a key role in driving cultural performance, although they can be difficult to define, observe, and measure. Leaders can assess, monitor, and develop the desired cultural excellence mindset and attitudes within their organizations, using the practical and powerful approaches outlined in this report.
  3. Gemba walks: Management engagement on the floor is a powerful way to demonstrate quality commitment to all members of the organization. Gemba walks allow site leaders to communicate clear messages using open and honest dialogue, and provide a real indication of progress toward desired behaviors at all levels. Gemba walks also empower front-line employees by recognizing their contributions to site results and involving them in problem-solving and continuous improvement.
  4. Leading quality indicators and triggers: There are inherent links between culture,
    behavior, and leading quality indicators (LQIs) that drive desired patient-focused
    behaviors. Monitoring and surveillance of key triggers and the design of LQIs are highly recommended practices to help shape cultural excellence.
  5. Oversight and review: Management oversight and review practices that engage both management and employees support a healthy quality culture because they demonstrate transparency, facilitate dialogue, bring attention to issues so they can be addressed, and highlight best practices so they can be replicated.
  6. Structural enablers: These support the desired behaviors, help speed the pace of change, and improve performance over time. They include:
    –– Develop a learning organization
    –– Establish learning teams
    –– Influence and recognize organizational change
    –– Solve problems proactively
    –– Identify true root cause

Sources

  • R.D. Day. Leading and Managing People in the Dynamic Organization. Psychology Press, London, UK (2014)
  • ISPE. Cultural Excellence Report. ISPE, Bethesda (2017)
  • R.N. Lussier, C.F. Achua. Leadership: Theory, application, and skill development (6th ed.), Cengage Learning, Boston (2016)
  • D.D. Warrick, J. Mueller (Eds.), Lessons in changing cultures: Learning from real world cases, RossiSmith Academic Publishing, Oxford, UK (2015)

AI/ML-Based SaMD Framework

The US Food and Drug Administration’s proposed regulatory framework for artificial intelligence- (AI) and machine learning- (ML) based software as a medical device (SaMD) is fascinating in what it exposes about the uncertainty around the near-term future of a lot of industry 4.0 initiatives in pharmaceuticals and medical devices.

While focused on medical devices, this proposal is interesting read for folks interested in applying machine learning and artificial intelligence to other regulated areas, such as manufacturing.

We are seeing is the early stages of consensus building around the concept of Good Machine Learning Practices (GMLP), the idea of applying quality system practices to the unique challenges of machine learning.