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Control of suspect products

Identification and Isolation

Identify the suspect products based on established criteria or indicators.

Immediately separate the suspect products from the rest of the inventory or production line.

Clearly label or mark the suspect products to prevent accidental use or mixing.

Ensure proper documentation of the identification and isolation process.

Investigation and Root Cause Analysis

Initiate a thorough investigation to determine the root cause of suspect products.

Assign responsible personnel or team to conduct the investigation.

Gather relevant data, including production records, quality control reports, and customer complaints.

Analyze the collected data to identify potential causes or contributing factors.

Risk Assessment

Assess the potential impact and risks associated with the suspect products.

Consider factors such as safety hazards, regulatory compliance, customer satisfaction, and financial implications.

Prioritize actions based on the severity of risks and potential consequences.

Corrective Actions

Develop and implement appropriate corrective actions based on the investigation findings.

Establish a timeline for completion of each corrective action.

Assign responsible individuals or departments to carry out the corrective actions.

Monitor and track the progress of each action to ensure timely completion.

Communication and Notification

Notify relevant internal stakeholders, such as quality assurance, production, and management teams.

Communicate the situation to external parties, such as suppliers, customers, and regulatory authorities, if required.

Provide clear and accurate information regarding the suspect products, associated risks, and corrective measures taken.

Documentation and Record-keeping

Maintain comprehensive documentation of the entire process, including identification, investigation, risk assessment, corrective actions, and communication.

Ensure all relevant documents are properly filed and easily retrievable.

Retain records for the specified period as per regulatory requirements or company policies.

Review and Continuous Improvement

Conduct a thorough review of the control of suspect products process to identify any gaps or areas for improvement.

Seek feedback from involved personnel to gather insights and suggestions.

Implement necessary changes or enhancements to prevent future occurrences and enhance the effectiveness of the process.

Regularly review and update the checklist based on new insights, regulations, or organizational changes.

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