Change Management is Bigger than Change Control So Think Beyond Individual Changes

As a pharmaceutical GXP professional with one foot in the GXP Quality camp and another in the organizational change management camp, I have a few pet peeves. And one of my biggest is whenever someone uses a phrase like “Change management may be known by different terminologies (e.g., change control, change requests, change orders).” That’s a reductionist statement that can really lead to a lot of confusion in an organization.

Change management is the how of change – assess, handle and release. Change control is the what, the execution steps. Change management is a big picture system that looks systematically at people, technology, process, and organization. Change control is the set of mechanisms for controlling the introduction of that change to the organization.

A lot of different systems and processes have change control elements. As many of these processes are supported with specific technologies, it can be very important to think about how they fit together like a puzzle.

This puzzle is usually made up of core requirements. Based on how much the change impacts them decides the rigor of the change control process.

Take for example a pharmaceutical manufacturing site. It is fairly typical to have one process for maintenance, another for IT, another for documents, etc. And then you have a change control system for things that impact established conditions, including validated state and regulatory submissions. Maybe you work at some technological utopia with a single system that manages all changes with all the deliverables, but at most places, you are trying to balance efficiency with effectiveness, and have a real need to avoid unnecessary duplication.

ICH Q12 helps by giving a nice breakdown of the major families of changes.

This helps somewhat, but for the average user it is not very specific. We need to translate it. First, we establish that only one system will be used for regulatory impact (“Tell and Do”, “Do and Tell” “Do and Report” and some of “Do and Record”), then we put the major activities that go into it. This breakdown might look like:

We are utilizing a few major criteria:

  1. Impact of regulated state
  2. Impact of validated state
  3. Risk level of change
  4. Scale of change to the organization

Using these criteria we can even drill down further, for example:

FEU Changes as a flowchart

It is usually a good idea to go down to an even deeper level to help the end-user.

Requires CCR

Does Not Require CCR

Any change that impacts the integrity of controlled classified areas, including all room and equipment surfaces

 

Changes that do not impact integrity of controlled classified areas by meeting the following criteria:

·     Does not change airflow

·     Does not impact structural integrity and maintains a smooth cleanable surface

·     Does not change means of ingress/egress

·     Does not impact current sampling sites from the Environmental Monitoring Program

·     Materials used are resistant to cleaning agents used in the area as defined in the building specifications

·     Materials are included in disinfectant effectiveness study

Any change that impacts air balancing

Work that is part of routine or preventive maintenance or calibration

Changes to equipment or replacements with a functional equivalent or different component

Changes to equipment with an exact component

Changes to facility floor layout

Instrument calibration including adjustments to field instrumentation

Changes to equipment operating and control parameters

Removal/storage of portable equipment

Changes to equipment, material and personnel ingress, egress and flow procedures

Replacement of system instrument hardware with exact components (hardware)

Changes to room classifications

Engineering studies that do not change the validated state or change anything requiring a CCR per this procedure

Changes that impact the environmental integrity of a room

Alarm set point changes that return to the previous qualified/validated state

Replacement and/or decommissioning of equipment, utilities or facilities

Remediation work (such as mechanical polishing, weld repairs, electro-polishing, filling of pits, de-rouging and chemical cleaning with already approved material)

Alarm set point or classification changes

Addition, modification or deletion to Potable Water, Plant Steam, Chilled Water, Cogeneration System, or pre-treatment reverse-osmosis

Changes in intended use of a room or area

Modification to piping tied to Potable Water, Plant Steam, Chilled Water, Cogeneration System, or pre-treatment reverse-osmosis

Changes to Preventive Maintenance that includes:

·     Decreasing frequency of preventive maintenance (i.e. making less frequent)

·     Change in intent of a preventive maintenance task

·     Adding or removing tasks

Changes to Preventive Maintenance that include:

·     Increasing frequency of preventative maintenance (i.e. making more frequent)

·     Administrative changes

·     Adding clarity to a task (e.g. changing instructions on how to execute a task without altering the intent of the task)

·     Reordering task(s) without changing intent of the task(s)

·     Changes of tools needed to execute a task; room dedicated tools must remain in the designated area

·     Changes to quantity of materials

Changes that decrease the calibration frequency (i.e. make less frequent) for GMP Critical equipment (e.g. directly related to operational control of the product)

·     Changes that increase calibration frequency (i.e. make more frequent) for GMP Non-Critical equipment (e.g. indirectly related to operational control of the product)

Tuning parameter, adjustment to the gain, reset and rate of a PID controller

New or replacement analytical equipment or instruments identified as Category A or Category B-Calibration Only with an exact component

Changes to the calibration frequency of GMP critical equipment (e.g. directly related to operational control of the product)

Changes to manufacturing report properties

Changes to the Environmental Monitoring Program, including addition, deletion or change to a sample location

Changes to alarm paging/notification recipients

Changes to the program for disinfection of a facility or equipment exterior

Creating/modifying individual user accounts

Change of materials of construction or class of polymeric materials (e.g. elastomers, tubing, gaskets and diaphragms)

Add an instrument to the calibration system during pre-commissioning

Changes to hardware or infrastructure associated with a validated system, equipment or utility

Changes to requalification frequency that do not change the intended use or validated state of the equipment or utility

Upgrade of application software or operating system for validated systems, equipment or utility

Corrective changes to an SOP to align it to the validated state

Changes to an SOP to align it to the validated state with impact to one or more regulatory filings

A corrective change to alarm set points to align with the validated state

Creating user groups and/or modifying user group privileges as part of a larger process change associated with validated systems, equipment, or utilities

Addition of a new calibration standard to be used with a new type of instrument at the Alachua site

Creating user groups and/or modifying user group privileges associated with validated systems, equipment, or utilities

Changes to alarm paging/notification recipients

Addition of a new calibration standard to be used with a new type of instrument at the Cambridge and Lexington sites

 

Modifying a phase prompt or message associated with validated systems, equipment, or utilities

 

Addition / change of a graphic associated with validated systems, equipment, or utilities

 

Addition or changing an interlock/permissive trigger

 

Addition/removal of I/O of validated systems

 

Changes to the Environmental Monitoring Program, including addition, deletion or change to a sample location

 

Changes to alarm paging/notification functionality

 

Historical data collection configuration

 

Change of equipment and spare parts storage site, including transfers between facilities and transfers to a contracted third party

 

 

All of this is change management. We utilize multiple change control mechanisms to manage the change.

Also, don’t forget that change controls can nest. For example a change to the EQMS has IT changes, document changes, training changes, and probably more.

Implementing a Quality Ambassador Program

Quality ambassadors can influence their peers to prioritize quality, thereby strengthening the culture of quality in the organization. Quality leaders can use this guide to develop a quality ambassador program by identifying, training, and engaging ambassadors.

Utilizing Kotter’s eight accelerators for change, we can implement a Quality Ambassador program like this:

AcceleratorActions
Create a strong sense of urgency around a big opportunityDemonstrate the organizational value of Ambassadors by performing a needs analysis to assess the current state of employee engagement with quality.
Build and evolve a guiding coalitionBring together key stakeholders from across the organization who will provide input in the program’s design and support its implementation.
Form a change vision and strategic initiativesIdentify the key objectives for implementing a Quality Ambassador program and outline the lines of effort required to successfully design and pilot it.
Enlist a volunteer armyReach out and engage informal leaders at all levels of the organization. Find your current informal Ambassadors and draw them in.
Enable action by removing barriersBe vigilant for factors that impede progress. Work with your Ambassadors and senior leaders to give teams the freedom and support to succeed.
Generate and celebrate short-term winsPilot the program. Create success stories by looking at the successful outcomes of teams that have Quality Ambassadors and by listening to team members and their customers for evidence that quality culture is improving. Your goal will be to create an environment where teams that do not have Quality Ambassadors are asking how they can participate.
Sustain accelerationScale the impact of your program by implementing it more broadly within the organization.

Define the Key Responsibilities of Quality Ambassadors

  
What activities should Quality Ambassadors focus on?  Example: Reinforce key quality messages with co-workers. Drive participation in quality improvement projects. Provide inputs to improve culture of quality. Provide inputs to improve and maintain data integroty
What will Quality Ambassadors need from their managers?    Example: Approval to participate, must be renewed annually
What will Quality Ambassadors receive from the Quality team?    Example: Training on ways to improve employee engagement with quality. Support for any questions/objections that ariseTraining on data integrity  
What are Quality Ambassadors’ unique responsibilities?    Example: Acting as the point of contact for all quality-related queries. Reporting feedback from their teams to the Quality leadership. Conveying to employees the personal impact of quality on their effectiveness. Mitigating employee objections about pursuing quality improvement projects. Tackling obstacles to rolling out quality initiatives
What responsibilities do Quality Ambassadors share with other employees?    Example: Constantly prioritize quality in their day-to-day work  
Expected time commitment    Example: 8-10 hours/month, plus 6 hours of training at launch

Metrics to Measure Success

Type of MetricsList of MetricsDirect Impact of Ambassador’s workRecommendations
Active Participation LevelsPercentage of organizational units adopting culture of quality program.
The number of nominations for quality recognition programs. Quality observations were identified during Gemba walks. Participation or effectiveness of problem-solving or root-cause processes. The number of ongoing quality improvement projects. Percentage of employees receiving quality training  
HighAmbassadors should be directly held responsible for these metrics
Culture of Quality AssessmentsCulture of quality surveys. Culture of quality maturity assessmentsMediumThe Quality Ambassador program is a factor for improvement.
Overall Quality PerformanceKey KPI associated with Quality. Audit scoresCost of poor qualityLowThe Quality Ambassador program is a factor for improvement.

Engaging for Quality

When building a quality organization, we are striving to do three things: get employees (and executives) to feel the need for quality in their bones; get them to understand what quality is and why it is important; and build the process, procedure, and tools to make quality happen. Practitioners in change management often call this heart, head, and hands.

Engage the heart, head and hands to build a quality culture

In our efforts we strive to answer give major themes of questions about why building a culture of quality is critical.

ThemeQuestions
WhyWhy do we need quality? Why is it important? What are the regulatory expectations? What happens if we do nothing?
WhatWhat results are expected for our patients? Our organization? Our people? What does out destination look and feel like?
HowHow will we get there? What’s our plan and process? What new behaviors do we each need to demonstrate?
YouWhat do you need to fulfill your role in quality? What do we need from you?
MeWhat do I commit to as a leader? What will I do to make change a reality? How will I support my team?
Five Themes of Change

The great part of this is that the principles of building a quality culture are the same mindsets we want embedded in our culture. By demonstrating them, we build and strengthen the culture, and will reap the dividends.

Be Preventative: What actions can be taken to prevent undesirable/unintended consequences with employees and other stakeholders. We do this by:

  • Involving end-users in the design process
  • Conduct risk assessments and lessons learned to predict possible failures
  • Ensure the reason for change is holistic and accounts for all internal and external obligations
  • Determine metrics as soon as possible
  • Focus on how the organization is responding to ongoing change
  • Think through how roles need to change and what employees need to be accountable for

Be Proactive: What actions can be taken to successfully meet objectives?

Be Responsive: What evidence-based techniques can be used to respond to issues, including resistance?

This is all about leveraging the 8 change accelerators and effectively developing strategies for change.

Quality, Decision Making and Putting the Human First

Quality stands in a position, sometimes uniquely in an organization, of engaging with stakeholders to understand what objectives and unique positions the organization needs to assume, and the choices that are making in order to achieve such objectives and positions.

The effectiveness of the team in making good decisions by picking the right choices depends on their ability of analyzing a problem and generating alternatives. As I discussed in my post “Design Lifecycle within PDCA – Planning” experimentation plays a critical part of the decision making process. When designing the solution we always consider:

  • Always include a “do nothing” option: Not every decision or problem demands an action. Sometimes, the best way is to do nothing.
  • How do you know what you think you know? This should be a question everyone is comfortable asking. It allows people to check assumptions and to question claims that, while convenient, are not based on any kind of data, firsthand knowledge, or research.
  • Ask tough questions Be direct and honest. Push hard to get to the core of what the options look like.
  • Have a dissenting option. It is critical to include unpopular but reasonable options. Make sure to include opinions or choices you personally don’t like, but for which good arguments can be made. This keeps you honest and gives anyone who see the pros/cons list a chance to convince you into making a better decision than the one you might have arrived at on your own.
  • Consider hybrid choices. Sometimes it’s possible to take an attribute of one choice and add it to another. Like exploratory design, there are always interesting combinations in decision making. This can explode the number of choices, which can slow things down and create more complexity than you need. Watch for the zone of indifference (options that are not perceived as making any difference or adding any value) and don’t waste time in it.
  • Include all relevant perspectives. Consider if this decision impacts more than just the area the problem is identified in. How does it impact other processes? Systems?

A struggle every organization has is how to think through problems in a truly innovative way.  Installing new processes into an old bureaucracy will only replace one form of control with another. We need to rethink the very matter of control and what it looks like within an organization. It is not about change management, on it sown change management will just shift the patterns of the past. To truly transform we need a new way of thinking. 

One of my favorite books on just how to do this is Humanocracy: Creating Organizations as Amazing as the People Inside Them by Gary Hamel and Michele Zanini. In this book, the authors advocate that business must become more fundamentally human first.  The idea of human ability and how to cultivate and unleash it is an underlying premise of this book.

Visualized by Rose Fastus

it’s possible to capture the benefits of bureaucracy—control, consistency, and coordination—while avoiding the penalties—inflexibility, mediocrity, and apathy.

Gary Hamel and Michele Zanini, Humanocracy, p. 15

The above quote really encapsulates the heart of this book, and why I think it is such a pivotal read for my peers. This books takes the core question of a bureaurcacy is “How do we get human beings to better serve the organization?”. The issue at the heart of humanocracy becomes: “What sort of organization elicits and merits the best that human beings can give?” Seems a simple swap, but the implications are profound.

Bureaucracy versus Humanocracy. Source: Gary Hamel and Michele Zanini, Humanocracy, p. 48

I would hope you, like me, see the promise of many of the central tenets of Quality Management, not least Deming’s 8th point. The very real tendency of quality to devolve to pointless bureaucracy is something we should always be looking to combat.

Humanocracy’s central point is that by truly putting the employee first in our organizations we drive a human-centered organization that powers and thrives on innovation. Humanocracy is particularly relevant as organizations seek to be more resilient, agile, adaptive, innovative, customer centric etc. Leaders pursuing such goals seek to install systems like agile, devops, flexible teams etc.  They will fail, because people are not processes.  Resiliency, agility, efficiency, are not new programming codes for people.  These goals require more than new rules or a corporate initiative.  Agility, resilience, etc. are behaviors, attitudes, ways of thinking that can only work when you change the deep ‘systems and assumptions’ within an organization.  This book discusses those deeper changes.

Humanocracy lays out seven tips for success in experimentation. I find they align nicely with Kotter’s 8 change accelerators.

Humanocracy’s TipKotter’s Accelerator
Keep it SimpleGenerate (and celebrate) short-term wins
Use VolunteersEnlist a volunteer army
Make it FunSustain Acceleration
Start in your own backyardForm a change vision and strategic initiatives
Run the new parallel with the oldEnable action by removing barriers
Refine and RetestSustain acceleration
Stay loyal to the problemCreate a Sense of Urgency around a
Big Opportunity
Comparison to Kotter’s Eight Accelerators for Change

Change Strategies for Accelerating Changes

The five change strategies that leaders can utilize:

  • Directive strategy – the manager uses his authority and imposes change with little or no involvement of other people.
  • Expert strategy – usually involves expertise to manage and solve technical problems that result from the change.
  • Negotiating strategy – manager shows willingness to negotiate and bargain in order to effect change with timely adjustments and concessions.
  • Educative strategy – when the manager plans to change peoples’ values and beliefs.
  • Participative strategy – when the manager stresses the full involvement of all of those involved and affected by the anticipated changes.

These are not mutually exclusive. It is not uncommon to use 2 or 3 or even all five on larger, more complicated changes.