Preservation of Product is crucial in every corporate Quality System. Without proper procedures to describes route on actual practice applied, it’s going to be a problem if being audited by Quality auditors and customers or even regulatory bodies audit.Procedures for handling, storage, packaging, preservation and delivery of products shall be established and maintained.Below are some ideas on what to include the procedures to cover preservation of Product.
Getting ISO 9001 Quality Management System Approved
1. Materials and products are suitably handled to prevent damage, deterioration, mix or contamination.
2. Procedures ensure materials and products are properly controlled in terms of issue, receipt and storage life requirements, as applicable.
3. Returned goods have systems set up for handling and appropriate disposition.
4. Products and materials are stored in such a way as to prevent contamination, damage, deterioration and allow stock rotation on a first in, first out basis.
5. Materials are stored off the floor on pallets, racks, shelves or containers. All storage equipment is maintained in a state of good repair to avoid damage to containers, contamination or damage to materials.
6. Systems are established for control of product/material with a limited shelf life or requiring special storage conditions. Special storage conditions are controlled and recorded.
7. Product packaging is designed to prevent damage or deterioration and to maintain sterility for sterile products during storage and delivery to the customer.
8. Damaged cartons of sterile products are examined for breach of sterility barrier.
9. The procedure is established to ensure that adequate controls exist to prevent labelling errors or mix-ups.
10. Labels are not released for use until a designated individual has examined the labelling for accuracy.
11. The release, including the date, name and signature of the individuals performing the label review is documented.
12. Labels are stored and maintained in a manner that provides proper identification and is designed to prevent mix-ups.
13. Access to labels is restricted to authorised personnel.
14. Established procedures define acceptable methods of product delivery. The product is shipped per contractual requirements where specified.
15. Only released products are distributed to customers. Records are maintained on the original customer (consignee) name, address, product identification, quantity shipped and date of shipment.
16. Procedures are in place to ensure that products which have expired or deteriorated beyond acceptable use are not shipped.
Servicing and Installation
There are no documented procedures for servicing and installation as they are not applicable to company products.