Responsibility and competence
Define the organisation, duties and cover arrangements. The responsible person needs the required qualifications and sufficient authority to perform the role. Train staff for their actual tasks and record training effectiveness. Outsourcing an activity does not remove the contract giver's responsibility.
Write procedures around goods flows
SOPs should describe actual receiving, storage, dispatch, cleaning, returns and recall processes. Documents need approval, version control and controlled availability. In a multilingual Cheb team, staff must understand instructions; having an English template alone does not demonstrate understanding.
Manage deviations, CAPA and changes
Record the event, affected products and immediate action. Root-cause investigation and corrective and preventive actions identify owners and follow-up. Check effectiveness. Assess changes to equipment, premises and processes before implementation, including their effect on quality and authorisation scope.
Control partners, IT and self-inspection
Assess suppliers, customers and service providers according to their roles. Quality agreements define interfaces, data access and escalation. Warehouse and monitoring systems need appropriate validation or verification, access permissions and backups. Self-inspections and management review turn findings into improvements.
Prepare for site planning
The planning lists below are practical recommendations for your site project; they do not replace project-specific qualification or a regulatory decision.
- Confirm responsibilities and cover arrangements
- Derive the SOP list from actual activities
- Plan training and task authorisation
- Implement deviation, CAPA and change control processes
- Provide partner qualification, IT controls and an audit programme