How can you maintain a secure change control process in digital manufacturing?

1 Use a secure platform

The first step to secure change control is to use a platform that provides encryption, authentication, authorization, and auditing features. Encryption protects your data from unauthorized access or tampering, while authentication and authorization ensure that only authorized users can access and modify the data. Auditing helps you track and record the changes and their impact on the system. A secure platform should also comply with the relevant standards and regulations for your industry, such as ISO 9001, FDA 21 CFR Part 11, or NIST SP 800-53.

2 Follow a clear workflow

The second step to secure change control is to follow a clear and consistent workflow that defines the roles, responsibilities, and procedures for each change. A workflow should include the following stages: initiation, review, approval, implementation, verification, and closure. Each stage should have clear criteria, documentation, and communication requirements. A workflow should also have mechanisms to handle exceptions, deviations, and emergencies. A clear workflow helps you avoid errors, conflicts, and delays in the change process.

3 Implement access control

The third step to secure change control is to implement access control policies and mechanisms that limit the access and modification of the data and systems to the appropriate users and roles. Access control can be based on factors such as identity, role, location, time, device, or context. Access control should also enforce the principle of least privilege, which means that users should only have the minimum level of access and permissions necessary to perform their tasks. Access control helps you prevent unauthorized or malicious changes, as well as reduce the risk of data breaches.

4 Monitor and audit

The fourth step to secure change control is to monitor and audit the change process and its outcomes. Monitoring involves collecting and analyzing data on the performance, status, and impact of the changes. Auditing involves verifying and validating the compliance, quality, and effectiveness of the changes. Monitoring and auditing should be done regularly and systematically, using tools and methods that provide accurate and timely information. Monitoring and auditing help you identify and resolve any issues, errors, or anomalies in the change process.

5 Train and educate

The fifth step to secure change control is to train and educate your staff and stakeholders on the change process and its security aspects. Training and education should cover the objectives, benefits, and risks of the changes, as well as the policies, procedures, and tools involved. Training and education should also include security awareness, best practices, and incident response. Training and education should be tailored to the needs and roles of the participants, and updated as the changes evolve. Training and education help you increase the competence, confidence, and compliance of your staff and stakeholders.

6 Review and improve

The sixth step to secure change control is to review and improve the change process and its security measures. Reviewing involves evaluating and measuring the results, feedback, and lessons learned from the change process. Improving involves identifying and implementing the opportunities, actions, and recommendations for improvement. Reviewing and improving should be done periodically and systematically, using tools and methods that provide relevant and reliable data. Reviewing and improving help you enhance the efficiency, effectiveness, and security of the change process.