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 QC Clerk with document production instructions and distribution list for each "DOCUM(b)" distribution.	Documents properly included in DLIST; distribution list provided
b3	QA Clerk	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 Clerk along with obsolete Approved Vendor List.	Approved Vendor List reviewed and vendors rated; Vendor Rating Form and obsolete Approved Vendor List returned to QA Clerk
b5	QA Clerk	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 Clerk	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.