Document Control - restoresight

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Document Control

The Best of Both Worlds:

The blended use of electronic and

manual methods of document control.

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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.

3. Reviewing documents.

4. Approving documents.

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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.

T 2.101 Facilities

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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.


Document Numbering

Attachment/Form Numbering

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Standard Document Format Attachment/Form Numbering


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 Outline Numbering

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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


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

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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.

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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

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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.

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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.

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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.


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.

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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 #

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


the database

01/12/12 TCN-12-001 Tissue T 9.100 Ocular Distribution and Record Keeping Rev


the database

01/12/12 TCN-12-001 Tissue T 10.210 Surgical Ocular Tissue: Imported Rev


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

1/12/2012

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.

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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)


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.

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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.


Form

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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


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.


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

control file.

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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]