User's guide /

Change control

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Access groups

Access Groups

Each user role in the ProFlow Change Control system plays a key part in the change request process.
Each role is defined by specific responsibilities to ensure a compliant and efficient management of change requests within the organization.

Employees

The Employees role allows users to initiate change requests within the organization.
They are responsible for creating and submitting the request for quality approval.
Employees receive automated notifications regarding the status of their request, such as when a quality review is required or when the request has been approved or rejected.

QA Specialist

The QA Specialist is responsible for reviewing the impact of the change.
Once a change request is submitted, the QA Specialist completes the "Impact Assessment" section and locks Section 1 to generate the next stage of the process.
They are also involved in ensuring that regulatory needs and environmental impacts are evaluated where necessary.

QA Manager

The QA Manager reviews the change request and helps move it through the necessary approval stages.
They receive notifications when a department manager has submitted comments on the impact of the change and ensure that all necessary steps are completed before approval.
The QA Manager coordinates with other reviewers and the QA Director to keep the process on track.

Quality Director

The Quality Director oversees the entire change control process.
They classify changes, determine whether further reviews by the Change Control Committee (CCC) are needed, and approve or reject the overall change.
The Quality Director also evaluates whether a performance assessment is necessary before finalizing any changes.

Health and Safety Specialist

The Health and Safety Specialist is responsible for assessing the environmental and health impacts of the proposed change.
They collaborate with the Quality Director to ensure all safety protocols are met before the change is approved.

Change Control Committee (CCC)

The Change Control Committee (CCC) is involved in in-depth reviews for significant changes that require further scrutiny.
The committee members provide final approval or rejection for complex changes.
They ensure that all aspects of the change, including impact assessments, regulatory compliance, and safety evaluations, are thoroughly reviewed before any implementation occurs.