Interim Controls within a Change Control

The PIC/S recommendation on change control section 5.3 “Change Planning & Implementation” recognizes that changes often address issues that need to be remediated:

Potential risks with the current state (until changes are implemented) and any risks that might be temporarily introduced during the change process are adequately assessed.
Interim controls (short-term measures), as needed, are identified and implemented in a timely manner to monitor/mitigate risks associated with the current situation (until change implementation).

This section also recognizes that changes introduce an interim set of conditions that lead to implementation – from opening a machine through massive construction activities, and just about anything else.

A good change control does not just address what is necessary to implement the desired future state. It also contains interim controls for managing the current state until the future is implemented, and addresses all of the potential risks during the process of implementation.

Change plans address current, interim, and future states

Often the change control stems from an action plan in a CAPA record, where the interim controls are specifically called out and detailed. These may be adequate for a relatively brief period but are not realistically sustainable. Remember that these interim controls must also go through the appropriate change control process. Which may have been a separate change control or be part of this change control. In all cases, the change control should either determine that the CAPA plan is adequate or identify additional risks that were identified during change planning.

Risk assessments for change control should really have three basic risk questions:

What are the risks of the current state as we implement the change?
What are the risks of the implementation process?
What are the risks of the future state?

As discussed elsewhere, these questions are really branching trees.

Interim controls in a change are usually little temporary changes in the change plan that either mitigate occurrence or impact.

Interim Control Type	Mitigate Occurrence	Mitigate Impact
Examples	Every record processed will be reviewed for the event error before completion. Revised preventive maintenance procedure to require vibration test at next preventive maintenance. Increase cleaning frequency of incubator.	Add emergency response steps to address a valve that is malfunctioning. Add engineering check for pump prior to each use. Perform cleaning log review prior to use.

As temporary changes, it is important to determine how they will be implemented, if they require monitoring, and how they will go away. Often the process of implementation of the change removes the temporary changes, but that is not always the case.

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.

Changes, Changes Everywhere

It is sometimes unfortunate that ICHQ10 defines Change Management as “A systematic approach to proposing, evaluating, approving, implementing and reviewing changes.” This lifecycle approach can sometimes confuse people as they are used to the definition popular elsewhere that change management is “the discipline that guides how we prepare, equip and support individuals to successfully adopt change in order to drive organizational success and outcomes.”

I tend to think this is an issue of focus and lack of coherence in the organization that stems from:

Not understanding that all changes are to a system that involves people, organization, technology and process
Balkanized change processes leads to changes being atomized or channeled though discrete processes that do not drive system thinking

Both of these can lead to a change going to a default change control process and not appropriately dealing with all aspects of the change. Teams tend to have their default (IT puts everything in as a computer change, facilities always uses a an equipment change) but those defaults are not built to deal with a change holistically.

Change is a movement out of a current state (how things are today), through a transition state, and to a future state (how things will be done). Change management needs to be about how we manage that change from the entire system – people, organization, technology and process. Only by approaching change from a full system perspective do we ensure the full benefit and avoid unintended consequences.

Change Identification

Changes come from everywhere. They are driven by other quality processes, by business needs, by innovation. To quickly address change it is important to have a good funnel system that will get the change to evaluation.

Change Evaluation

All changes should be evaluated for risk and impact. This evaluation is iterative and determines the level and form of evaluation.

Change Control

Right sized change control based on risk and impact. Some changes are one-and-done. But many are multi-faceted, and it is important to structure it appropriately.

I’ve written a lot on change management that covers this in more detail. Explore them here

Changes stems from learning from mistakes

As we build quality culture we need to question our basic assumptions and build new principles of every day interactions. At the heart of this sits a culture where change is viewed as a good thing.

Willingness to change

To what extent are employees willing to continuously review and adapt their own behavior in response to a changing environment? The ideal scenario is for the entire workforce to be willing to change. This willingness to change should not be confined to situations where changes are already being implemented. It means that people should look at environment with open eyes, recognize when there is an opportunity or a need for change and initiate the relevant actions themselves. Willingness to change should be the first principle of culture and is a key enabler of the popular concept often called agility.

Learning Culture

To what extent do employees think that their actions should be guided by data- and fact-based knowledge? The term “knowledge” encompasses any knowledge acquired through targeted observation, by chance, through data-based analysis or from practical experience.

Willingness to make mistakes

Learning cultures attach great importance to mistakes. These organizations have understood that learning and change processes can only be triggered by mistakes. Mistakes provide an opportunity to gain a better understanding of the company’s processes and uncover previously unknown cause-and-effect relationships.

The way an organization deals with mistakes is therefore a key aspect of its culture. Two fundamentally different approaches to mistakes exist.

A negative attitude towards mistakes is reflected in a strategy based on the systematic avoidance of errors, strict penalties for making mistakes and the correction of errors as rapidly and unobtrusively as possible. Employees of companies where this culture prevails are not usually willing to disclose mistakes. This attitude inhibits their willingness to change.
On the other hand, a culture that recognizes the value of mistakes is characterized by open discussion of mistakes when they occur, systematic error documentation and a determination to find both the causes of the mistakes and their solutions. When investigating mistakes, it is critical to focus on understanding the causes rather than on finding out who is to blame.

Openness to Innovation

Openness to innovation and new ways of doing things is an important capability that is required in order to initiate change and adopt the right measures, even if they may sometimes be rather unconventional.

Social Collaboration

An environment characterized by trust and social relationships provides the basis for open, uninhibited knowledge sharing between employees. Social collaboration, helps to accelerate knowledge sharing within the organization. Good strong social networks build resilience and enable the ability to change.

Open Communication

In order for companies to respond rapidly and to be able to effectively change, employees need to have access to the necessary explicit and implicit knowledge. While explicit knowledge can be provided through the appropriate communication technology, the sharing of implicit knowledge calls for direct communication between the people who possess the knowledge and the people seeking it.

An effective organization needs to abandon the “us and them” mentality. Employees have acquired the capability of open communication if, having taken on board the fact that openly sharing knowledge and working together to achieve a vision increases the total sum of knowledge, they then also act
accordingly. Once the organization’s entire workforce is willing to share knowledge with everyone, it becomes possible to significantly accelerate learning processes within the company.

What Does This Look Like?

Social collaboration exists between employees and with customers and partners. Confidence in systems and processes results in high process stability. People are willing to document their acquired knowledge and share it with others. The democratic leadership style values people for the contribution they make and there is a culture of open communication. The workforce is both receptive and willing to change. They learn systematically from the captured data, are open to innovative approaches and participate in shaping change processes. Employees are also conscious of the need to continuously develop their skills and competencies. While mistakes are still made, people recognize that they are valuable because they have the potential to trigger improvements.