Obsolete documents

The standard requires that a master list or equivalent document contol procedure identifying the current revision status of documents be established and be readify available to preclude the use of invalid and/or obsolete documents. It is important to note that this requirement only applies to documents and not to data. 

The standard requires the supplier to ensure that invalid and/or obsolete documents are promptly/ removed from all points of issue or use, or otherwise assured against unintended use. Again you should note that this requirement does not apply to data. 

It is unnecessary to remove invalid or obsolete documents if you provide staff with the means of determining the pertinent issues of documents to use. There are often valid reasons for retaining obsolete documents. What may be obsolete in one situation may not be obsolete in another. In simple terms an obsolete document is one which is no longer required for operational purposes. As stated earlier, there are cases where various issues of the same document may need to be used and in such cases none of the documents is obsolete. One may need to remove copies of previous versions of a document but retain the master for reference purposes. You cannot demonstrate to an assessor that you corrected a deficiency if you don t retain the version that contained the deficiency as well as the subsequent version. 

If you do not have a means of readily distinguishing the correct version of a document, amendment instructions should require that the version being replaced is destroyed or returned to the document controller. If you allow uncontrolled copies to be taken, removal of obsolete documents becomes more difficult. However, providing you have a... 

The standard refers to invalid documents as well as obsolete documents. Invalid documents may not be obsolete and may take several forms. They may be ... 

One way of identifying obsolete documents is to write SUPERSEDED or OBSOLETE on the front cover, but doing this requires that the custodian is informed. When a version of a document is replaced with a new version, the withdrawal of the obsolete version can be accomplished in the amendment instructions that accompany the revision. When documents become obsolete by total replacement, their withdrawal can also be accomplished with the amendment instruction. However, where a document becomes obsolete and is not replaced there needs to be a Document Withdrawal Notice which informs the custodian of the action to be taken and the reason for withdrawal. 

Provide document custodians with stamps to mark obsolete documents upon receipt of instructions. 

How do you ensure that invalid and/or obsolete documents are assured against inadvertent use ... 

What means are used to identify obsolete documents retained for legal and/or knowledge preservation purposes ... 

Don t purge every office in search of obsolete documents. 

A master list or an equivalent document control procedure Identifying the current revision status and distribution of documents In the management system shall be established and shall be readily available to preclude the use of Invalid andfor obsolete documents. 

Obsolete documents have to be removed immediately and all outdated authorized copies must be marked. But they also have to be retained in the archive for knowledge preservation, sometimes also for legal reasons. 

The applicable documented procedure is established to dehne the controls needed, to approve documents for adequacy prior to issue, to review and update as necessary and reapprove documents, and to ensure that changes and the current revision status of documents are identihed. It is ensured that relevant versions of applicable documents are available at points of use as appropriate, and remain legible and readily identihable. The documents of external origin are identihed, and their distribution is controlled to prevent the unintended use of obsolete documents and to apply suitable identihcation to them if they are withheld for any purpose. 

The [manufacturing plant procedures] ensure that obsolete documents are promptly removed from all points of issue or use. 

Instructions for removal of superseded and obsolete documents from the point of use... 

To prevent the unidentified use of obsolete documents, suitable identification is assigned if they are retained for any purpose. 

In the case of modifications, documents or their parts must be replaced by the modified version as soon as possible. Safeguards must exist that obsolete documents can no longer be used. 

The supplier must ensure that everybody has the documents needed to do the job. Nobody must have obsolete documents. 

Obsolete documents must be removed or replaced as soon as they are no longer relevant. Removed or replaced documents should be retained on file as evidence fhaf this requirement has been complied with. Some obsolete documents may need to be retained for legal or record purposes to explain why certain courses of action were followed in the past. For example, if a new waste contractor is used, the documentation relating to the previous waste contractor must meet the requirements of fhe Duty of Care Regulations. It will also assist new supervisors on the site to understand what they should examine when they perform Duty of Care audifs on the waste contractor. 

The facility or company will need a policy as to how long documents are to be retained, and how to dispose obsolete documents. 

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