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.

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.

Vision and Psychology Safety Enable Change

Professor Amy Edmondson in 2016 wrote “Wicked-Problem Solvers” in HBR that laid out four leadership levers for collaboration that fit nicely into quality culture and nestle nicely with Kotter’s Eight Accelerators. Together they help define the leadership behaviors necessary to build quality culture, all informed by the enabler of knowledge management.

Levers and Accelerators of change

Professor Edmondson in this article is discussing cross-industry collaboration, but the central four levers apply in any organization.

Having a vision that strives for a True North of Quality is critical. Make it align to individual needs. Remember that vision grows and adapts as you go, and as others get the opportunity to shape. Vision has six criteria:

  1. Stimulus: Vision needs to include actual benefits for those affected by it. String vision brings people together as community, not as strangers. Stimulus means people see themselves in the vision and understand how they will benefit.
  2. Scale: Vision should be of great breadth and depth with potential for extension at later stages. Vision never leads to or accepts a dead end. It shows multiple potentials for expansion.
  3. Spotlight: Vision assumes responsibility, immediate and extended. The greater the vision, then the greater the responsibility for its impact on people’s lives and the legacy that will be left afterwards. This responsibility needs to bring opportunity for people who are involved. This is part of the vision that will drive the volunteer army.
  4. Scanning: A visionary sees the signs on the way to success. Pay attention to to pain points, spot trends and see where and how value can be added. Gemba walks are critical here.
  5. Simplicity: Vision is elegant thinking about complicated and complex things. A vision is not a vision unless it’s understood. Simplicity lets people believe in vision. If the vision is complicated most people will ignore it. Vision operates and makes execution possible from its simplicity. The simpler the vision in its core meaning, the easier it can be shared with employees, customers and partners and thus, easier to scale inside and outside an organization.
  6. Passion: Vision provokes strong emotions. A strong vision is always accompanied by excitement and passion. Excitement equals passion that gives an emotional power to a vision. A strong vision brings strong excitement that is difficult to contain. Strong excitement and passion are highly contagious. A simple and compelling vision excites more passion than any mere goal.

Psychological safety is the state where employees feel that there is safety in taking risks at work setting. In this safe environment employees will engage in risk-taking actions that are inherent to creative endeavors and if they perceive safety, then they are more comfortable to voice their opinions. This safety makes them more willing to take the chances to own the vision and try to experiment with making that vision a reality which motivates them to develop, promote, and implement new ideas.

This safety will enable knowledge sharing, which can come in many different styles, including combination which creates something new.

Through inclusive, democratic leaders who value the inclusion of employees in a particular work process, employees have the chance to raise their voice for generating, promoting, and implementing useful ideas
Through leveraging vision these inclusive leaders exhibit openness attributes that communicates the importance of taking innovative actions and gives employees the guarantee that in case of negative consequences they will not be punished, experiencing greater psychological safety.

Employees experience non-defensive behavior, and feel high levels of self-worth and self-identity, motivating employees not only to generate new ideas, but also to promote and implement new ideas in the organization.

The organization that is structured to accept these ideas will continue to drive iterative cycles of improvement.

Leaders in the Way

In “How Leaders Get in the Way of Organizational Change” in Harvard Business Review, Ron Carucci discusses ways leaders can create problems in change.

The three main pain points he discusses are:

  • Scope naiveté: Underestimating the work
  • Change laziness: Overestimating the organization’s capacity
  • The perceived pet project: Misjudging how others see you

Great article, I strongly recommend reading it.

For each of these democratic leadership is an effective path to avoiding.

  • Idealized Influence: By holding oneself accountable you spend the time to understand the organization’s capacity
  • Inspirational Motivation: Moving from pet project to what is best for the organization
  • Intellectual Stimulation: Strive to overcome scope naiveté
  • Decentralized decision-making: Get the organization bought in to accelerating the change
Photo by Zen Chung on Pexels.com

Fatal Errors for Change

The change accelerators help us avoid some pretty common errors in change management.

Neglecting Employees’ Individual Interests

It is not enough to present a compelling case for change. Leaders can explain how the specified changes are in the company’s interests and the collective interests of all employees but for individuals to change their behavior, it must be in their individual interests to do so. There are always some costs to employees in any change program, but the behaviors required for change can still be in their individual interests if there are benefits that, on balance, make it rational to get with the program. It’s up to leadership to understand these cost-benefit analyses and tip the scales as needed to make active support of the collective change an individually winning strategy.

This is one the places having a volunteer army is vital. That army will help ensure the individual and well as the collective interests are engaged.

Under-engaging the Extended Leadership Team

It is crucial to get the extended leadership team seriously engaged in cultural transformation. Much of the coalition of change will be drawn from their numbers. What counts as an extended leadership team is different depending on the organization, but as a rule of thumb go to the top and draw a circle down to 3 levels below.

By drawing from the extended leadership team as the guiding coalition, you give them a personal stake in the outcome. Give the extended leadership team members a voice earlier on in the program and they will feel a greater sense of ownership and will contribute more readily. Their involvement should begin as early as the design stage to leverage their knowledge of the workforce and the situation on the ground. Giving them the opportunity for meaningful input will make them feel included in the program and enthusiastic about it, and will also help keep the program free of design flaws.

Allocating “Set-and-Forget” Targets

The hands-off, set-and-forget model for allocating targets has three major shortcomings:

  • If senior management neglects to inspire ambitions, to monitor progress and make proper course corrections, and to show sufficient engagement, then the initiative leaders will have little reason to go the extra mile. Presented with an annual target, they will likely focus on measures that aim simply to meet it – typically, shortsighted measures such as reducing deviations per batch or CAPA cycle time. After all, such measures are far easier to implement, and far less threatening to the delivery of day-to-day business results, than broad long-term measures such as seeking sustainable savings through increased productivity. Taking the simpler path is the rational choice when you understandably want to minimize disruption. Unfortunately, the short-tern measures don’t change culture fundamentally or sustainably. Sooner or later they are discontinued, and when that happens, the benefits evaporate.
  • The initiative leaders will likely seek solutions specific to their own silos rather than pursue opportunities that might contribute to collective, cross-department success. Those promising opportunities remain undiscovered since individual departments left to their own devices have no particular incentive to look beyond their silos. They might even have a disincentive to do so, because they may rightly worry that they wouldn’t get their fair share of credit for the results or that it would be a futile mission and damaging to their prospects.
  • The hands-off model prevents lead-indicator metrics, timely interventions, and course correction. If senior leaders have little visibility into a departmental initiative, they cannot easily realize that things are going off the hands-off model militates against lead-indicator metrics, timely interventions, and course correction. If senior leaders have little visibility into a departmental initiative, they cannot easily realize that things are going off track through the pursuit of unsustainable, short-term measures – until it is too late to do anything about it.
Visualized by Rose Fastus