4.15. Handling, Storage, Packaging, Preservation, and Delivery

4.15.1. General

All activities related to the handling, storage, packaging, and delivery of the product must have fully documented and maintained procedures.

Therefore:

• You will have documented procedures on how you handle, store, package, preserve, and deliver materials.

4.15.2. Handling

Your methods for handling must ensure that the product remains undamaged and will not suffer from deterioration. This includes full documentation of methods and training to ensure safety of personnel and product.

Therefore:

• You will have procedures on the handling of materials to prevent damage or deterioration.

4.15.3. Storage

You must have a defined storage location for raw and finished materials to prevent deterioration, damage, and mixing. You must also have documented methods for the transfer of the materials. Documented procedures and methods should also include the regular assessment of the stored materials to ensure material integrity. You also must review, at regular intervals, your stock materials to monitor and prevent deterioration.

• You will designate storage areas/stock rooms that will protect the material from damage, deterioration, unplanned use, or inadvertent shipment to a customer.
• You will define methods for receipt or release of materials from stock rooms.
• A review system shall be put in place, to ensure age-sensitive materials are handled appropriately.

4.15.4. Packaging

The operation must maintain formal and documented packaging procedures, marking requirements, and instructions. The packaging instructions must be documented , preservation methods outlined, and equipment used that will not damage the materials. Personnel must be trained in the packaging techniques and equipment used. The product should be marked in accordance with specifications.

To achieve this:

• You will define and control packaging, packing, and markings to ensure conformance to product and customer requirements.

4.15.5. Preservation

Preservation will be documented. The materials must remain segregated and maintained until the product has been accepted by the customer or per contract agreement.

To achieve this:

• You will define your preservation and segregation processes.

4.15.6. Delivery

Delivery of the product is made in accordance with the customer contract. Special protection should be extended to support the intact arrival if specified. The delivery methods and practices must be documented and the employees trained for the task.

To achieve this:

• You will have procedures in place to ensure product conformance after final test. Should your customer request special handling, then your procedures must reflect their requests.