Storage and Distribution Part I

This blog talks about storage and distribution portion of the medical device. The storage and distribution areas had to be managed carefully and systematically with proper documentation. A great Enterprise Computer system will help.

1) Storage Areas

1.1 There should be two separate storage areas, one for the materials which make the medical device and the other area is specifically for finished product stockroom. In addition, there should be holding and quarantine areas in the production areas which are used for the receiving, shipping, inspection, material staging, in-process products, nonconforming materials and products, tooling, small equipment, supplies, etc.

For example, quarantine areas are important to ensure no out of specification raw materials being used to make the medical device and finished products being sent to customers.

1.2 The production and engineering groups are responsible for operating the storage, receiving and shipping areas, as well as various storages and holding areas on the production floor. It is prudent to organize the product floor to be logical and sequential. Normally, Quality Assurance is responsible for nonconforming product holding and quarantine areas.

1.3 Storage and holding areas are always maintained in good condition to prevent damage or deterioration of stored products. You do not want any of the products exposed to undue rain, humidity or insect infestation to be destroyed and damaged causing a lot of money. Product return or recall can be costly as well.

All products in storage are identified and arranged in groups according to their type. When product deteriorates or expired over time the stock is rotated; i.e., oldest deliveries are used first (“first-in-first-out” or FIFO system). For example, if the medical device in question has an expiration period of two years, you need to ensure the product with the shortest expiration date to be sold first rather than the other way around.

2) Inventory Management System

2.1 Material and finished product warehouses are controlled using an inventory management system. In this day and age, there are many such inventory management system out there. The inventory management system also controls the in and out movement of all stock materials used in production and all finished products shipped to customers.

2.2 Materials and parts are entered into the system with their part number, serial number, description, quantity, location in the warehouse, and purchase order number or job number when applicable. For products with limited shelf life the product expiration date is also recorded and to be sold first.

2.3 The inventory management system can report available in-stock quantities and turn-over times. The system is used to minimize inventory levels, optimize turn-over time, and assure stock rotation. This system can be deployed as a way to manage production more efficiently.

2.4 Once every six months or any other period deem appropriate, the warehouses are inventoried and the stock count is reconciled with the inventory management system. In many large medical device company, millions worth of products are missing and unaccounted for due to theft, misplacement or other reasons.

3) Assessment of Stock

3.1 Every six months or so, storage areas are inspected and cleaned. The stock is assessed for damaged or deteriorated products. Identification of products is checked. A product nonconformity report is issued when damaged, deteriorated, or unidentified products are found. Inventory levels of stock are also checked. The Production Supervisor records results of the assessment. This is a time to use a suitable computer system.

4) Receipt and Dispatch Authorization

4.1 Products are authorized to be received to, and dispatched from, various storage, holding and quarantine areas only when they have appropriate production and acceptance status. The QA or QC persons who determines and identifies the production and acceptance status of a product implicitly gives the authorization with objective evidence.

4.2 Only products that have passed receiving inspection are authorized to be placed in, or dispatched from, the material warehouse and the material staging areas in production. They must be objective evidence of the products or parts passing the inspection.

4.3 Only products that have passed specified in-process inspections are authorized to be released from inspection holding areas and be moved to the next processing stage.

4.4 Only products that have passed the final acceptance inspection are authorized to be received in the finished product storage, or be moved to the shipping area and dispatched to customers. Perhaps, it is a good idea to have a system like the QC manager need to sign them off in every stage to prevent potential problems.

4.5 Nonconforming products with unknown inspection status are not authorized to be received in the material warehouse, staged for production, or dispatched to subcontractors or customers. Products with such negative or unknown acceptance status are placed in appropriate quarantine or holding areas and locations. When such nonconforming products are found and they must be quarantined VERY qucikly and must be marked conspicuously.

Reference	Criteria
820.130	Does the company ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution?
820.140	Has the company established and maintained procedures to ensure that mix-ups, damage, deterioration, contamination, or other adverse effects to product do not occur during handling?
820.150 (a)	Has the company established and maintained procedures for the control of storage areas and stock rooms for product to prevent mix-ups, damage, deterioration, contamination, or other adverse effects pending use or distribution?
820.150 (a)	Has the company established and maintained procedures to ensure that no obsolete, rejected, or deteriorated product is used or distributed?
820.150 (a)	For product that deteriorates or becomes obsolete over time, is product stored in a manner to facilitate proper stock rotation, and is the condition assessed as appropriate?
820.150 (b)	Has the company established and maintained procedures that describe the methods for authorizing receipt from and dispatch to storage areas and stock rooms?
820.160 (a)	Has the company established and maintained procedures for control and distribution of finished devices to ensure that only those devices approved for release are distributed?
820.160 (a)	Has the company established and maintained procedures to ensure that purchase orders are reviewed to ensure that ambiguities and errors are resolved before devices are released for distribution?
820.160 (a)	Where a device's fitness for use or quality deteriorates over time, do the procedures ensure that expired devices or devices deteriorated beyond acceptable fitness for use are not distributed?
820.160 (b)	Does the company maintain distribution records that include or refer to the location of appropriate information?

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.