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TOP-DOCUM: Document Control & Distribution
REV:2/27/09

SCOPE: This procedure covers control and distribution of the documents listed in DLIST as well as any other document generated at managerial discretion. Section (a) of this procedure describes the minimum control necessary for any document, although other TOPs may impose additional control requirements (see DLIST). Section (b) gives the specific control procedures for those documents which are identified in DLIST as requiring TOP-DOCUM(b) control.

STEP WHO WHEN INFO TO USE WHAT TO DO RESULTS
Section (a): How to choose appropriate section of TOP-DOCUM

Use Section (b) for frequently issued documents. All Other documents fall under section (c)
'---Section (b): Frequently-Produced Operational Documents Only (fully controlled, hereafter called "DOCUM(b)"
b1 Anyone As a need for a new "DOCUM(b)" document is identified Need for controlled document Notify Audit Manager of Need as well as the appropriate distribution list. "DOCUM(b)" documents identified and reported
b2 Audit Manager Upon notification that a "DOCUM(b)" is required DLIST; documents; request Verify document is listed in DLIST; provide QA Assistant with document production instructions and distribution list for each "DOCUM(b)" distribution. Documents properly included in DLIST; distribution list provided

b3 QA Assistant Monthly Document(s); DOC.xls Print any "DOCUM(b)" document; have responsible manager review, initial, and approve document; place label that says "return when replaced" on each copy and mark recipient's name on each copy; route documents per DOC.xls. Documents distributed in controlled manner
b4 Recipients of Approved Vendor List and Vendor Rating Form When receive Approved Vendor List and Vendor Rating Form Approved Vendor List and Vendor Rating Form; own knowledge Review list; rate each of your vendors on Vendor Rating Form; return you ratings to QA Assistant along with obsolete Approved Vendor List. Approved Vendor List reviewed and vendors rated; Vendor Rating Form and obsolete Approved Vendor List returned to QA Assistant
b5 QA Assistant Upon receiving an obsolete "DOCUM(b)" document back Document; DOC.xls Dispose of obsolete "DOCUM(b) documents using an appropriate method (see step b6) so documents cannot reenter service; record vendor ratings in vendor's online file. Obsolete copies of documents removed from service and destroyed; vendor ratings recorded
b6 QA Assistant Monthly DOC.xls Review file for any obsolete documents still out more than 2 days after its replacement and remind the recipient of the need to return the document; if anyone fails to return an obsolete document within 5 days of replacement, notify Audit Manager. Obsolete documents prevented from remaining in service
b7 Anyone primarily responsible for a document* As documents become obsolete or removed from service Document; DOC.xls Destroy any document removed from service by one of the following methods: Running through a paper shredder (paper), incinerate (microfiche), breaking (disk/hard drive); erase from server (may require IT Manager's help). Documents or files removed from service and destroyed. Data erased from server.
Section c - all documents
c1 Anyone Upon producing a controlled document DLIST; discretion of manager or supervisor Ensure that the document is produced, distributed and controlled as directed by applicable TOPs and by the person given primary responsibility for the document (see step c2) Documents controlled as required
c2 Anyone primarily responsible for a document* As document is produced The document itself Either personally review document for adequacy or ensure that the document is reviewed by someone to whom you delegate the authority (ALL documents require review, even though it may in some cases be as simple as ensuring that all pages have been printed by the computer); until you or your designee approve** the document, do not allow it to be placed into use; ensure that the document is available everywhere that it is needed for effective functioning of the quality system; ensure that all obsolete copies of the document are removed from use Documents reviewed, approved, and issued in controlled manner
c3 Anyone primarily responsible for a document* If a document needs to be modified after it is issued DLIST; the document itself *Note: unless a TOP specifically gives someone else the authority to change a document, only the person who was responsible for its creation or his/her designee may authorize a document change, or take the document out of service; if feasible, reissue a printed document rather than modifying it, and do not make modification a habit. Make changes to the document as needed; clearly identify the changes made if any confusion might be expected from the change; review, approve and distribute the modified document as described for a newly issued document in step c2. Documents taken out of service or modified, approved and reissued in a controlled manner

* A person "primarily responsible for a document" is as specified in DLIST, or, where not so covered, a supervisor or manager with responsibility for all areas affected by the document. This responsibility may be delegated.

** Document approval is recorded as described in applicable TOPs or, where not so covered, by signing and dating the face of the document. Alternate methods of recording approval may be used with permission of the Audit Manager.

For information on a document or record, including definition, primary responsibility and retention, refer to the Document and Record Master List.

Documents are controlled only when viewed on-line in the original English -- printed copies or translations are not controlled documents.
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