Storage of quality records

The standard requires the supplier to establish and maintain documented procedures for the storage of quality records and in addition requires quality records to be stored in facilities that provide a suitable environment to prevent damage or deterioration and to prevent loss. 

Linked to the filing and indexing requirement, this requirement addresses the conditions of storage and also provides the reasons i.e. to prevent loss. On the subject of loss, you will need to consider loss by fire, theft, and unauthorized removal. If using computers you will also need to consider loss through computer viruses and unauthorized access, deletion, or the corruption of files. A booking in/out system should be used for completed records when they are in storage, in order to prevent unauthorized removal. 

Records soon grow into a mass of paper and occupy valuable floor space. To overcome this problem you may choose to microfilm the records but keep them in the same location or archive them in some remote location. In both cases you need to control the process and the conditions of storage. With paper archives you will need to maintain records of what is where, and if the archive is under the control of another group inside or outside the organization, you will need adequate controls to prevent loss of identity and inadvertent destruction. 

It is always risky to keep only one copy of a document. If computer generated, you can easily make another copy provided you always save it, but if manually generated, its loss can be very costly. It is therefore prudent to produce additional copies of critical records as an insurance against inadvertent loss. These insurance copies should be stored in a remote location under the control of the same authority that controls the original records. Insurance copies of computer disks should also be kept in case of problems with the hard disk or file server, if you use one. 

The standard requires the supplier to establish and maintain procedures for the maintenance of quality records. In addition it requires records to be retained in such a way that they are readily retrievable and legible. 

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The procedures that require the use or preparation of documents should also specify or invoke the procedures for their control. If the controls are unique to the document, they should be specified in the procedure that requires the document. You can produce one or more common procedures which deal with the controls that apply to all documents. Although ISO 9001 does not address all controls under clause 4.5, the provisions of clause 4.16 relating to the identification, access, filing, and storage of quality records are equally appropriate to documents in general and should be applied although it is not mandatory. 

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