Change control is a typical part of traditional quality management in highly regulated industries. Change control refers to changes in processes, equipment or, for example, raw materials that may have an impact on product quality or affect regulated parts of the product. A good example of this is if, for example, an additive in a medicine is changed for another one or a machine used in a food production process is replaced by a new one.

Such change processes must always be well controlled. The risks and effects of changes are assessed in advance and carefully documented. So too is the change itself, that the associated measures and, for example, contingency plans are documented.

Change also occurs through continuous improvement.

The change control process usually starts when an anomaly is detected in a process or some other legitimate reason for change is identified. Once an anomaly is identified, further investigation is undertaken by going through the process in its entirety to identify the cause of the anomaly. Following this investigation, a proposal for improvement is made. The change must be reviewed and approved before it can be implemented. The change can also be rejected if it is found to be unnecessary, have a negative impact on quality or have other negative effects. It is important to remember that change also happens through continuous improvement.

Another important part of the change control process is traceability, which allows you to see what changes have been made since the last one. A good example of this is a computer software update; when a new update is applied to a computer, it will show, for example, the version number of the new software and the features that have changed since the previous version. It is important to describe change control as a process and include a process description in the project plan.

A good change control process therefore takes the following steps:

  • Presentation of change needs in documented form as “change proposals”.
  • Assessment of the change proposals in terms of cost, quality and other risks and impacts, schedule implications and necessity.
  • Decision to implement or reject the proposed change
  • Communication of the change to the implementers, if it is decided to implement the change
  • Contract amendments
  • Documentation of the change, disaster recovery, maintenance
  • Execution and verification of the change

How these steps are carried out depends on the implementing organisation, the project and the quality objectives.

In the current environment, for example, there is an increasing tendency to change suppliers due to sanctions or country risks.

In the current environment, for example, there is an increasing tendency to change suppliers because of sanctions or country risks. Sanctions against Russia, for example, have led to further changes in many companies. In turn, these changes in activity result in more change management, which in all its brevity can be a headache for many.

With NordCheck’s solutions, change management is part of compliance, allowing changes to be managed efficiently and securely. Let us take care of the change for you.