Document control workflow

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  • Publicado : 6 de junio de 2011
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Compliance adds requirements that transform document management into a document control issue. Document control is a regulatory requirement within accounting (e.g., 8th EU Directive,Sarbanes-Oxley), food safety (e.g., Food Safety Modernization Act), ISO (mentioned above), Medical device manufacturing (FDA), Healthcare (JCAHO), and Information technology (ITIL)[8]. Yourdocuments — procedures, work instructions, policy statements, etc. — provide evidence of documents under control . Failing to comply could cause fines, the loss of business, or damage toyour business reputation.

The basic requirement for document control require that you establish and document a procedure for:

Reviewing and approving documents prior to releaseReviews and approvals
Ensuring changes and revisions are clearly identified
Ensuring that relevant versions of applicable documents are available at their “points of use”Ensuring that documents remain legible and identifiable
Ensuring that external documents like customer supplied documents or supplier manuals are identified and controlledPreventing “unintended” use of obsolete documents

START

1.Identify the need to create a new document

10.Is it correct?

NO

11.Review document and modify

2.Define document type(User guides, procedures..)

YES 12.Is it external? YES 5

13.Archive document, request approval 3.Is it external? YES NO 4.Define how we will obtain the document 14.Obtain approvalprior to document publication

NO

7

6.Define who will create the document 5.Request new document or updates from vendor 15.Was the document approved? NO 11

7.Elaborate/Modifydocument

YES 13 16.Publish document, post the document title and control number in documents control file

8.Collate documents and document drafts

9.Verify document content

END

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