Document Control
The Best of Both Worlds: The blended use of electronic and manual methods of document control.
2 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.
What is document control?
Document Control
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.
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.
Standard Document Format
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.
Standard Document Format
Procedure Numbering Example
T 2.101 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.
C = Communications Center L= LifePoint CP = Corporate Compliance O = Organ Division D = Donor Family Services PR = Public Education F = Financial Services Q = Quality Systems H = Human Resources S = Safety HD = Hospital Development T = Tissue Division IT = Information Technology
Manual Identifiers
Standard Document Format
Document Numbering
Standard Document Format
Manual Section Numbering
Standard Document Format
Procedure Document Numbering
Attachments/forms are identified by using their governing procedure’s number, followed by a
dash and the attachment sequence number.
e.g. T 2.101-1 is the first attachment to the Tissue divisions procedure T 2.101.
Standard Document Format
Document Numbering
Attachment/Form Numbering
Standard Document Format
Attachment/Form Numbering
Standard Document Format
Document Numbering
Once assigned, procedure and attachment/form numbers are not reused. If a document is retired, its
number is retired with it.
Retired/Obsolete Documents
Standard Document Format
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.
Standard Document Format
Standard Document Format
Header and Footer
LifePoint, Inc. LifePoint Quality Systems Manual Page 1 of 1 Procedure Number: Q 3.500
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
Standard Document Format
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-12-001 is the first change control for the tissue division in the year 2012
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.
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.
Change Control #
(Lead Document: Used for cross-reference to Document Change Log) CCF Assignment Date Initial Target Imp. Date Final Imp./Cancel Date Document # Document Title
TCN-11-032 T 7.700 Tracking 11/1/2011 12/13/2011 TCN-12-001 T 6.150 Post-Preservation Manipulation of Ocular
Transplant Tissue 1/6/2012 2/17/2012 1/12/2012 TCN-12-002 T 2.101-13 Monthly Lab Maintenance Log 1/16/2012 2/27/2012 1/26/2012 TCN-12-003 T 9.100 Ocular Tissue Distribution and Recordkeeping 1/27/2012 3/9/2012 TCN-12-004 T 5.000-1 Ocular Transplant Label 2/10/2012 3/23/2012 2/16/2012 TCN-12-005 T 4.171 Packaging and Transport of Blood for Serology Testing 2/7/2012 3/20/2012 2/16/2012 TCN-12-006 T 7.200. Obtaining and Sharing Serology and Culture
Results 2/10/2012 3/23/2012 2/16/2012 TCN-12-007 T 4.180 Enucleation 2/17/2012 3/30/2012 TCN-12-008 T 4.140 Donor Identification, Physical Assessment and Medical Record Review 2/24/2012 4/6/2012 TCN-12-009 T 4.120 Consent Verification 2/24/2012 4/6/2012
TCN-12-010 0
TCN-12-011 0
TCN-12-012 0
Change Control Log
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
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 email notifications are sent to all listed reviewers.
3. Once the document is reviewed, comments are entered electronically.
4. As reviews are completed, automated email notifications are sent to the DCM who then forwards to the editor.
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.
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. Email 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.
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 Control # Change Initiating
Dept. Doc. # Document Title New, Rev, or Obs? Change Description or Reason
01/12/12 TCN-12-001 Tissue T 4.170 Obtaining Blood Samples for Testing Rev added reference to HBV NAT
01/12/12 TCN-12-001 Tissue T 4.171
Packaging and Transport of Blood for
Serology Testing Rev added reference to HBV NAT
01/12/12 TCN-12-001 Tissue T 6.150
Post-Preservation Manipulation of Ocular
Transplant Tissue Rev removed specific references to the database
01/12/12 TCN-12-001 Tissue T 7.400 Release of Ocular Tissue Rev
removed specific references to the database
01/12/12 TCN-12-001 Tissue T 9.100 Ocular Distribution and Record Keeping Rev
removed specific references to the database
01/12/12 TCN-12-001 Tissue T 10.210 Surgical Ocular Tissue: Imported Rev removed specific references to the database
01/12/12 TCN-12-001 Tissue T 10.210-2 Import QC Checklist Rev changed reference of LPT # to Import #
01/12/12 TCN-12-001 Tissue T 10.210-3 Import Offer Sheet Rev changed reference of LPT # to Import #
01/12/12 TCN-12-001 Tissue T 10.400-1 Distribution Checklist Rev added reference to HBV NAT
01/12/12 TCN-11-034 Tissue DFP-11-039 T 4.250 Thoracic Abdominal Cardiac and
Vascular Tissue Recovery Obs Closes with revision.
01/12/12 TCN-11-034 Tissue T 4.250 Thoracic Abdominal Cardiac and Vascular Tissue Recovery Rev added DFP-11-039
Document Implementation Log
Document Change Files
(Change Control File)
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.
Document Change Files
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 email 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).
A change control file is created for each document listed on a change control.
Filing Change Controls
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
(DFP)
Departure From Procedure
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.
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 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.
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.
Departure From Procedure Form
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. Email 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. Email 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
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 [email protected]
Prepared by: Tommy Bottoms
Manager, Document Control LifePoint, Inc.
Charleston, SC [email protected]
