Query Resolution Across the Grid

ACTIVITIES IN THE DOCUMENT CONTROL PROCESS

PREPARATION OF DOCUMENTS

II.1. Individuals preparing, revising, reviewing or approving documents should have access to the appropriate information.

II.2. When documents are in their preparatory phase, they should be marked and controlled so that their draft status clearly distinguishes them from documents that have already been issued.

II.3. An appropriate document identification system should be established.

Each document should be uniquely identified.

II.4. Standard forms should be identified and controlled, whether the document is to be taken alone or as part of another document.

II.5. The need for traceability of a document to related hardware or software should be determined.

II.6. During preparation, the activities described by the documents should be assessed using the grading process, so that the appropriate controls are chosen and included.

REVIEW OF DOCUMENTS AND CONFIRMATION OF ACCEPTABILITY

II.7. Documents should be reviewed before issue. The review should comprise a critical examination of the need for and the adequacy of the document, with respect to prescribed requirements, guidelines and relevant modifications.

Account should be taken of the safety significance of the document.

II.8. The document review process should identify the organizations and individuals involved in the review process and the levels of independence necessary for reviewing the documents.

II.9. The reviewing organization or individuals should have access to the relevant information upon which to base an effective review, to ensure that safety considerations are adequately addressed.

II.10. The reviewing organization or individuals should be competent in the specific topic that they are being asked to review.

II.11. A record of the review should be prepared showing the date of the review and the name of the reviewer and including the reviewer’s comments and their resolution.

II.12. One aspect of review can involve validating the implementation of the document through simulation, a mock-up of the proposed product, a walk-through of the proposed procedure or a similar activity. This validating process is usually applied to significant working level instructions and procedures.

APPROVAL OF DOCUMENTS

II.13. Documents should be approved according to a prescribed method before they are issued for use. The responsibilities for approval should be clearly defined by senior management. Acceptance by, or the approval of, the regulatory body should be obtained where this is required.

ISSUE AND DISTRIBUTION OF DOCUMENTS

II.14. An issue and distribution process for documents that uses up to date distribution lists should be established. Those individuals who participate in an activity should be aware of, should have access to and should use the documents that have been approved for performing the activity. The process should ensure that changes to documents are relayed to all affected individuals and organizations. Copies subject to revision updating (controlled copies) should be identifiable.

II.15. The documents issued should be marked so that the nature of their use is made clear, especially if their use is restricted to a certain purpose. Examples of marking include ‘approved for use’ or ‘for test purposes only’.

II.16. Controlled documents should be distributed to and used by the individual performing the activity. Obsolete documents should be removed from circulation to prevent their inadvertent use.

II.17. To preclude the use of inapplicable documents and to ensure the control of current documents, the distributor should employ a written acknowledgement system. The recipient should indicate receipt of the document and should return or dispose of the previous issue.

II.18. Master copies of documents should be retained until they are superseded or withdrawn. The need for archiving master copies of documents should be considered.

II.19. Uncontrolled copies of documents may be supplied, provided that they clearly indicate that they will not be automatically updated and are valid on the day of issue only. In these circumstances it is the responsibility of those using the information contained in the documents to check before use that the documents are still current.

TEMPORARY DOCUMENTS

II.20. Under certain circumstances, a temporary document may be necessary to cover an activity for a limited period. This will be necessary when an immediate amendment to an existing document cannot be justified. Temporary documents should be subject to the same controls as permanent documents.

II.21. Temporary documents should have a defined period of validity. When this period expires, the document should be withdrawn or its contents should be integrated into an appropriate document, or the temporary period of validity should be renewed.

CONTROL OF MODIFICATIONS TO DOCUMENTS

II.22. Modifications to documents should be subject to the same level of review and approval as the original documents. A modification to one document may affect other documents and affected documents should be revised accordingly. Where practicable, modifications to documents should be highlighted in the documents by the use of sidelining (marking clearly in the margin any text that should be modified or deleted) or other suitable means.

SUSPENSION OR CANCELLATION OF A DOCUMENT

II.23. When a document is to be suspended or cancelled, it should be removed from use. Suspension and cancellation notices should identify uniquely the reference and issue numbers of the document to which they apply and should give the document’s effective date of application and the reasons for its suspension or cancellation. In the case of suspension notices, the duration of suspension should also be provided.

II.24. Suspension and cancellation notices should be subject to approval at the same level as the original document, and should be distributed to all controlled copy holders, to preclude the use of suspended or cancelled documents.

DOCUMENTS EXTERNAL TO THE ORGANIZATION

II.25. A registration system should be established and maintained to record and control the receipt and amendment of documents that are generated and controlled externally. The registration system should, as a minimum, register the receipt date of the document, its reference number, title, date of issue and/

or issue status, and the individual or individuals to whom it was passed for distribution or, if appropriate, review.

II.26. Documents from external sources should be reviewed to ensure their suitability before acceptance and use.

DOCUMENT ARCHIVES

II.27. When documents such as procedures and drawings that were subjected to the formal issue process are withdrawn from use, the master copies should be archived as records, following the guidance in this Safety Guide.