Because even a conforming product can become unsafe or nonconforming if it is damaged, contaminated, exposed to wrong temperatures, or improperly packaged. Preservation safeguards product integrity and patient safety while meeting regulatory and customer requirements.

It’s a shared responsibility:

• Production and Warehouse teams – handle and store products properly.

• Quality Assurance – defines controls, verifies implementation, and reviews records.

• Management – ensures adequate resources, environment, and training.

• Use validated packaging and transport methods to protect the device.

• Maintain temperature control if required.

• Inspect containers before shipment.

• Retain shipping and transport logs as quality records.

Risks such as contamination, mix-ups, exposure to wrong environmental conditions, or physical damage are identified through ISO 14971-based risk assessment. Controls are implemented to mitigate these risks (e.g., alarms, segregation, validation).

Common findings include:

• Inadequate segregation of quarantined products

• Missing temperature or humidity records

• Damaged packaging not recorded or investigated

• Lack of packaging validation

• Expired materials in released stock

• Incomplete transport records

• Document the deviation.

• Assess potential impact on product quality.

• Quarantine affected materials.

• Initiate a risk-based impact analysis and CAPA if needed.

• Report to QA and update records.