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:

Impact of regulated state
Impact of validated state
Risk level of change
Scale of change to the organization

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

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.

Why does McKinsey still exist?

McKinsey paid $600 million as a result of its illegal activities around the sales of opioid drugs. Frankly, I’m amazed that the company has not gone the way of Arthur Anderson, a fate that is well deserved.

Yet the company still exists and continues to do creepy stuff, for example, take a look at Cory Doctorow’s article on their kids’ program.

Hiring McKinsey is basically like hiring the Tony Soprano Consulting Company.

Three things that get in the way of good training

Culture of Delivery

Does training in your organization seem like death by PowerPoint? Is learning viewed as something an expert dumps in the lap of the learner.? However, that’s not what learning is – lectures and one-way delivery end up resulting in very little learning.

For deeper meaning to occur, invest in professionally facilitated experiences that enable staff to form mental models they remember. Get people thinking before and after the training to ensure that the mental model stays fresh in the mind.

Culture of Cutting Time

Avoid the desire for training in shorter and shorter chunks. The demands of the workplace are increasingly complex and stressful, so any time out of the office is a serious cost. The paradox is that by shortening the training, we don’t give the time for structured learning, which sabotages the investment when the training program could be substantially improved by adding the time to allow the learning to be consolidated.

Culture of Un-Fun

We know that learning takes place when people have fun, stress is low, and the environment encourages discovery. Make training cheerful and open rather than dull and quiet. Encourage lots of informal learning opportunities. Give more control to the learner to shape their experience. Have fun!

Stop Brainstorming Already

Matthew Ström recently wrote “Stop brainstorming“, which greatly aligns with my own thoughts on brainstorming “Brainstorming usually sinks your ship” and “Brainstorming and Conflict.”

Read the posts, and please, evolve your practice and develop better ideas and build a better culture.

Pump up the Fun!

People learn and solve problems when they are having fun, stress is low, and the environment encourages discovery. A core part of psychological safety.

I’ve talked before about bringing playfulness to work, about exuberance and excitement. These personal approaches can be turned to the wider organization.

Quality as a profession – not so known for fun. So we need to look for opportunities for fun, whether in our training programs, through initiatives like Quality Days, or any other place we can find it.

Here are some ideas for organizing fun to drive a quality message.

Activity Name	Description	Cost required	Effort required	Impact/ Learning Opportunity	Learning Outcome
Video Competitions	Contest of team videos with stories about how they transfer quality or outline continuous improvement projects. Teams may also record a best practice to be shared with the organization.	Medium	High	High	-Video and poster viewership helps transfer quality behaviors and values to others. -Employee-created messages are more credible, giving them a stronger impact on transferring the culture of quality throughout the organization.
Poster Signing	Teams can sign a poster to make a commitment to quality. They can hold a contest for designing the best Quality Day poster.	Low	Low	Medium
Employee Idea Demonstrations	Make peer idea generation (quality ideas) visible to all employees through the use of regularly refreshed public “progress boards” and idea showcases where projects are publicly evaluated.	Low	Medium	High	-Shows employees that quality focus is something that peers around them prioritize and benefit from. -Provides employees a benchmark for what behaviors are expected from them and encourages the ones whose ideas are recognized.
Quality Awards and Recognition	Publicly recognize individuals and teams with a trophy/certificate for consistently embodying quality in their work. Awarding behaviors, not just outcomes, increases employee engagement.	High	Medium	High	-Helps engage employees in quality improvement efforts by demonstrating that despite other objectives and priorities, quality remains important to leaders.
Client/ Customer Visit	Invite your clients/customers to visit and talk about their experience with the product/service and the importance of quality.	High	High	High	-Helps employees understand how a high-quality mindset avoids customer-facing mistakes and leads to greater customer satisfaction.
Games	Word-Play Games: A group of employees can play games like Scrabble and Bingo with quality terminology.	Low	Low	Medium	-Quick games help employees become aware of quality terms, tests, standards in a fun way.
Games	Trivia Games: Employees can play games such as “Jeopardy” and beer pong with quality standards, tests, tools to educate themselves.	Low	Low	Medium
Articles on Quality	Share blogs and articles on quality.	Low	Medium	Medium	-Increases quality’s visibility across the organization and promotes awareness.
Quality Quiz Competition	Employees can take quizzes on quality-related concepts.	Low	Medium	High	-Tests employees’ awareness and creates a healthy competition to know more.
Quality Merchandise (swag)	Distribute T-shirts, mugs, badges with quality quotes to employees. Reward contest winners with goodies such as chocolates with quality phrases written on them.	High	High	Medium	-Provides more visibility to quality and imparts a sense of pride in employees.

Leveraging fun is a good way to help build a culture of quality.

Building moments of planned fun is work, and should be part of the overall Quality Plan, with activities and milestones clearly marked and executed towards.