Document Control. Document Control. Document Control 6/21/2012. Document Control. What is document control?

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1 Document Control Document Control The Best of Both Worlds: The blended use of electronic and manual methods of document control. What is document control? 1. A process through which documents are managed to ensure: 1. Uniform formatting. 2. Accuracy of process being describe. 3. Review and approval by responsible persons. 4. Controlled access. 5. Accessibility to staff. 2 Document Control 1. Process managed by one or a limited number of people 2. Processes different for each organization. 3. Document control manager (DCM). Document Control Utilize two methods for our document control: 1. Manual methods: 1. Document accessibility. 2. Reviewing documents. 3. For filing change control files and archiving prior versions. 2. Electronic methods: 1. Document accessibility. 2. Editing documents. 3. Reviewing documents. 4. Approving documents. 1

2 Document Control Qualtrax: 1. LifePoint s document management software. 2. Third party. 3. Web-based, secure. 4. Manages the editing, review and approval of controlled documents. 5. Retains prior versions and retired documents. Objectives 1. Standard document format. 2. Document change process. 3. Document review and approval process. 4. Document change implementation. 5. Filing of document change controls. 6. Tracking of document change controls. 7. Departure from procedure process. 1. Document numbering system. 2. Procedure outline. 3. Outline Numbering for procedure documents. 4. Header and Footer format. 5. Document body formatting font, point size, bolding, italicizing, punctuation. Procedure Numbering Example T Facilities Letter to identify the manual T = Tissue manual Number to identify the section of the manual. 2 = section of the Tissue division manual Three digit number, separated by a period, to identify the procedure in the section..101= the number assigned to the document in the section, followed by the procedure title. T Facilities 2

3 Document Numbering Manual Identifiers Manual Section Numbering C = Communications Center CP = Corporate Compliance D = Donor Family Services F = Financial Services H = Human Resources HD = Hospital Development IT = Information Technology L= LifePoint O = Organ Division PR = Public Education Q = Quality Systems S = Safety T = Tissue Division Procedure Document Numbering Document Numbering Attachment/Form Numbering Attachments/forms are identified by using their governing procedure s number, followed by a dash and the attachment sequence number. e.g. T is the first attachment to the Tissue divisions procedure T

4 Attachment/Form Numbering Document Numbering Retired/Obsolete Documents Once assigned, procedure and attachment/form numbers are not reused. If a document is retired, its number is retired with it. Procedure Outline 1. Policy and/or Purpose. 2. Definitions and Acronyms. 3. Scope and Responsibilities. 4. Materials and Equipment. 5. Procedure. 6. Attachments. 7. Related Procedures. 8. Standards and Regulations. Outline Numbering 4

5 Header and Footer LifePoint, Inc. LifePoint Quality Systems Manual Page 1 of 1 Procedure Number: Q Title: Standard Format for Procedures & Attachments Implementation Date: 08/26/10 Header Footer Confidential and Proprietary Information of LifePoint, Inc. Uncontrolled Copy unless stamped in red as Controlled Copy and signed by QS. IMP. 05/25/05, 05/17/07, 08/27/09, 08/26/10 1. Specify Font to be used in the document. 2. Specify the point size of font: 1. e.g. Header and footer are 10pt. Tahoma. 2. Body of procedure is 12pt. Tahoma. 3. Allow flexibility, such as font and point size, in attachment/form document formatting so they may be designed for ease of use. Document Change Process 1. A change is identified. 2. Document editor contacts the DCM to discuss the needed change and request a change control number. 3. DCM assigns the change control number 4. Document editor or DCM creates the change control form. Change Control Numbers Change control numbers consist of: 1. The department's identifying letter(s). 2. Two digit year. 3. Three digit number identifying the next consecutive change control for the department. 4. Each separated by a hyphen. e.g. TCN is the first change control for the tissue division in the year

6 Change Control Form Change Control Form Tracking Change Controls 1. Track change control numbers. 2. Track implemented change controls. 3. May also track other information for reporting purposes. Change Control Log 1.Manually updated spreadsheet used for tracking: 1.Change controls assigned. 2.The documents assigned to those numbers. 3.Number of open change controls by department. 4.Number of days each change control is open. 5.Average number of days change controls are open by department. 6.Number of days to close a change control. 7.Average number of days to close a change control. 8.Reasons for change controls. 6

7 Change Control Log Change Control Log 1. Change controls are assigned by lead document. 2. One change control may involve documents from multiple departments. 3. An editor may initiate a change control for a document belonging to different department, with of course permission of the document owner/manager. This change control number is assigned to the department which owns the document. (Lead Document: Used for cross-reference to Document Change Initial Final Change Control Log) CCF Assignment Target Imp. Imp./Cancel # Date Date Date Document # Document Title TCN T Tracking 11/1/ /13/2011 TCN T Post-Preservation Manipulation of Ocular 1/6/2012 2/17/2012 1/12/2012 Transplant Tissue TCN T Monthly Lab Maintenance Log 1/16/2012 2/27/2012 1/26/2012 TCN T Ocular Tissue Distribution and Recordkeeping 1/27/2012 3/9/2012 TCN T Ocular Transplant Label 2/10/2012 3/23/2012 2/16/2012 TCN T Packaging and Transport of Blood for Serology 2/7/2012 3/20/2012 2/16/2012 Testing TCN T Obtaining and Sharing Serology and Culture 2/10/2012 3/23/2012 2/16/2012 Results TCN T Enucleation 2/17/2012 3/30/2012 TCN T Donor Identification, Physical Assessment and 2/24/2012 4/6/2012 Medical Record Review TCN T Consent Verification 2/24/2012 4/6/2012 TCN TCN TCN Document Change Process 1. All edits of documents are performed within the software. 2. DCM sets-up document: 1. Adds TBD to imp. date in header and footer. 2. Adds DRAFT watermark. 3. Adds line numbering to the document. 4. Ensures Tracked Changes feature is enabled. Document Set-Up Example Header and Footer 7

8 Document Set-Up Example Line numbering & Draft Watermark Document Change Process 1. Document editor makes the necessary changes. 2. Editor notifies DCM the document is ready for review. Editor requests reviewers. The DCM suggests additional reviewers as necessary. 3. The DCM performs a second review of the document for formatting and checks the references to other documents, standards and regulations. Document Review Process Document Reviews may be performed two ways: 1. Electronic reviews via the document management software. 2. Group review meetings. Document Review Process Electronic 1. The document is electronically released for review via the software. 2. Automated notifications are sent to all listed reviewers. 3. Once the document is reviewed, comments are entered electronically. 4. As reviews are completed, automated notifications are sent to the DCM who then forwards to the editor. 8

9 Document Review Process Group Review Meeting 1. Used when the list of reviewers may be large or if the changes warrant discussion. 2. The document is displayed via projector. 3. Proposed changes discussed. 4. Edits performed during the meeting. 5. Change control form is initialed and dated by reviewers. Document Review Process Change Control Form Document Review Process 1. The document editor is responsible for overseeing the progress of the review. 2. Document editor addresses review comments. 3. Editor notifies DCM when document is ready for approval. Document Review to Approval Process 1. The Editor and DCM discuss approvers, training. 2. Once the implementation date is determined the document is released for approval. 3. The document editor is responsible for ensuring training is arranged and completed prior to implementation. 9

10 Document Preparation for Approval 1. The planned implementation date replaces the TBD in the header and footer. 2. A final check of formatting is performed. 3. The document is printed with the tracked changes. 4. The changes are accepted and the line numbering and DRAFT watermark is removed. 5. The document is electronically released for approval. Document Change Notifications 1. Pre-established document implementation dates. 2. notification to full staff the beginning of the week and the morning of implementation. Implementing Document Changes 1. The DCM publishes all documents electronically on the scheduled date. 2. Hard copy document changes are made to the SOP binders and controlled document locations. 3. Other persons may be responsible for changing documents at controlled document locations. Implementing Document Changes 1. A Controlled Copy Memo for satellite offices. 2. CCM is signed by responsible person, and returned to DCM as documentation of their having made the necessary changes. 10

11 Implementing Document Changes Completing the Implementation 1. Notification to staff. 2. Electronic versions published. 3. Hard copies changed. 1. SOP Manuals. 2. Controlled Document Locations. 4. The change control log, mentioned earlier, is updated. 5. The document change log is updated. Imp. Date Change Control # Document Implementation Log New, Initiating Change Description or Doc. # Document Title Rev, or Dept. Reason Obs? Document Change Files (Change Control File) 01/12/12 TCN Tissue T Obtaining Blood Samples for Testing Rev added reference to HBV NAT 01/12/12 TCN Tissue T Packaging and Transport of Blood for Rev added reference to HBV NAT Serology Testing Post-Preservation Manipulation of Ocular removed specific references to 01/12/12 TCN Tissue T Rev Transplant Tissue the database 01/12/12 TCN Tissue T Release of Ocular Tissue Rev removed specific references to the database 01/12/12 TCN Tissue T Ocular Distribution and Record Keeping Rev removed specific references to the database 01/12/12 TCN Tissue T Surgical Ocular Tissue: Imported Rev removed specific references to the database 01/12/12 TCN Tissue T Import QC Checklist Rev changed reference of LPT # to Import # 01/12/12 TCN Tissue T Import Offer Sheet Rev changed reference of LPT # to Import # 01/12/12 TCN Tissue T Distribution Checklist Rev added reference to HBV NAT 1. Documentation of reviews and approvals. 2. Documentation of staff notification of the document changes. 3. Documentation of changes made. 4. Archive prior versions of documents. 01/12/12 TCN Tissue DFP T Thoracic Abdominal Cardiac and Vascular Tissue Recovery Obs Closes with revision. 01/12/12 TCN Tissue T Thoracic Abdominal Cardiac and Vascular Tissue Recovery Rev added DFP /12/

12 Filing Change Controls Document Change Files A change control file is created for each document listed on a change control. The file consist of: 1. The completed, signed change control form. 2. The printout from the software documenting the review comments and approvals. 3. The printed notification to full staff. 4. A copy of the previous version of the document. 5. A copy of the new version of the document (showing tracked changes if applicable). 1. A hanging file folder is labeled with the document number. 2. Each time the document changes, a file folder, labeled with the change control number & document number, is placed into the hanging file folder. Departure From Procedure Departure From Procedure (DFP) 1. Departures from procedure are a PLANNED deviation. 2. Two types, Limited and Interim. 3. Interim DFPs are identified, planned, approved and trained (when applicable) PRIOR to approval and implementation. 4. DFPs should be well thought out, used only when absolutely necessary. 12

13 Departure From Procedure 1. Procedure changes are encouraged over DFPs when possible. 2. We allow six months maximum for a DFP to remain open, however try to close them as soon as possible. 3. Extensions are granted when necessary. Departure From Procedure Form Departure From Procedure Process 1. Initiator completes the DFP form. 2. The form is routed for approval signatures. 3. A DFP may be approved verbally for staff in the field by the Admin. On Call. 4. A DFP may be approved verbally by the Medical Director and documented appropriately. 13

14 Departure From Procedure Process Departure From Procedure Form 1. Initiator completes the DFP form 2. The form is routed for approval signatures. 3. A DFP may be approved verbally for staff in the field by the Admin. On Call. 4. A DFP may be approved verbally by the Medical Director and documented appropriately. Departure From Procedure Process 1. Once approved, forwarded to the DCM for assignment of the next DFP number. 2. Entered onto the DFP log. 3. notification to full staff. 4. Copies to SOP binders. 5. Copies uploaded to document management software. 6. Original filed in DFP binder. Departure From Procedure Closure 1. notification to full staff of closure. 2. Copies are removed from SOP binders and document software. 3. Closure noted on the DFP log. 4. Original removed from the DPF binder and closure date noted. 5. Original DFP filed in the document s change control file. 14

15 Departure From Procedure Log Looking Back 1. Use of manual and electronic methods. 2. Standard document format. 3. Document change process. 4. Document review and approval process. 5. Document change implementation. 6. Filing of document change controls. 7. Tracking document change controls. 8. Departure from procedure process. Thank You Presented by: Mary Cooper Manager, Ocular Services LifePoint, Inc. Charleston, SC Prepared by: Tommy Bottoms Manager, Document Control LifePoint, Inc. Charleston, SC 15