A Change Is Gonna Come: Why Controlling Change Is The Best Way To Ensure GxP Compliance
Benjamin Disraeli said “Change is inevitable. Change is constant.” Even well-established products and processes are defined by constant change. All products evolve; regulations change; processes adapt. What’s critical is to manage change effectively and efficiently to manage risks and ensure compliance.
The key to successfully managing change is recognising the change and understanding in detail the impact that change will have across functions. If there is one thing that will guarantee disharmony, downtime and cost overruns it is working in silos. Cross functional change control combats that silo mentality.
So what is change control? Change control is a systematic approach to managing all changes made to a product or system. Change control ensures that no unnecessary changes are made, that services and activities are not unnecessarily disrupted and that resources are used efficiently and effectively.
EU GMP guidance requires that “Arrangements are in place for the prospective evaluation of planned changes and their approval prior to implementation taking into account regulatory notification and approval where required” and also that “After implementation of any change, an evaluation is undertaken to confirm the quality objectives were achieved and that there was no unintended deleterious impact on product quality”.
“Change Control” is a formal process. It is set up to enable teams to change ways of working using specified controls and policies. Change involves anything that would impact the project or process: scope; time; budget; resources; equipment; premises; ingredients. Any change to any aspect of a product, process or project can have an impact on quality.
You might not necessarily think of change control when you think of a Formula One team but these really successful pit teams are the epitome of an effective cross functional change control team. Changing all four wheels during a three second pit stop requires a team of individuals to have absolute focus on managing changes precisely, predictability and in unison. Indeed, Formula One acts as a helpful reference point for anyone interested in understanding the true power and potential of change control. An F1 team requires seamless collaboration, fully integrating human and technical assets, and a laser sharp focus on delivery. Every F1 car is capable of accelerating to 100mph and back again in less than 5 seconds. An F1 car can turn sharp corners flat out at over 150mph. Approximately 80,000 components make up an F1 car. The cars have to be assembled with 100% accuracy. If it were assembled 99.9% correctly, it would go on the track with 80 components fitted incorrectly. Add in over 20 races around different tracks, in very different climates and quickly you conclude that working in an F1 team is about manging change. Change control is the difference between success and failure on the grid.
So for all you budding F1 owners, engineers and drivers; here are the key characteristics of an effective change control process to help garner you the chequered flag. If F1 does not float your boat then see these as the steps that will break down the silo mentality that frustrates so many.
1. Define the Change Request
A Change Request is the documentation used to request the actual change. Whoever owns the request needs to explain it so that the team understands it well enough to define it. The request should be made through documentation. It can be as simple as an email or as complex as a specified company form. In any event, it’s important to fully detail the need for the change or the reason for the request. It’s also important to define the conditions of success or otherwise how will you know whether the change has been successful? The team or individual requesting the change should also provide a target date for the change to be completed. The Change Request is effectively the request made to the engineers in the F1 garage.
2. Submit and Review the Change Request
The Change Request must be submitted to a cross-functional team. Ideally, a change control meeting should be held which provides the proper forum for the request to be reviewed and all team members and reviewers to have the opportunity to ask questions and help make decisions. The most important element of the review process is the discussion of impacts and agreement of actions required. This is the meeting of the F1 engineers to determine what needs doing to the F1 car.
3. Final Decision and Approval
Key sponsors, cross functional stakeholders and decision makers must be defined. The change control reviewers should provide a timely response. Whatever decision results from all this needs to be formally documented and officially approved. The final decision and approval is the green light from the F1 Team Principal.
4. Change Execution and Effectiveness Check
The change owner must ensure that the change is enacted in accordance with the plan. Following execution it is vital that the effectiveness of the change is reviewed, to ensure that the change was conducted as planned, that all actions required to ensure compliance and performance have been completed and that evidence of their completion is available. Did the change result in other actions being required that were not considered at the start of the change process? Were there valuable lessons learned that could be applicable to other projects? Execution is what takes place in the F1 garage; the focus on excellence that drives performance.
John C. Maxwell said that “Change is inevitable. Growth is optional.” Managing change effectively and cross functionally guarantees progress, learning and improved collaboration. Ensuring a cross functional and detailed approach to change is one of the most important and enabling quality system and business tools. To make change successful it is important to know where you are coming from, to be clear about where you are heading, and to have a sound approach to managing the transformations that ensure you get there. Change Control provides the answers to all these questions.