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Document Control _ Other Tortures perfected in the 21st Century

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					Document Control

      DAP Quality Conference
                  May 12, 2008
                Debbie Penn
Why Document?

Documenting policies, processes,
  and procedures communicates
  how to do a quality job to all
  workers.
Patient Safety -def
“The prevention and mitigation of unsafe acts
  within the health-care system. Strategies for
  improving patient safety include:
  Creating a culture that supports the identification
   and reporting of unsafe acts;
  Effective measurement of patient injuries and
   other relevant outcome indicators; and
  Tools for developing or adapting structures and
   processes to reduce reliance on individual
   vigilance.”


 Definition: Canadian Council on Health Services Accreditation (CCHSA) 2003
Why Document Control?

  Controlling documents ensures
   that workers access and use
   only the most current versions of
   documents.
   Do you
    know
 where all
   of your
 important
documents
     are
  located?
ISO 15189
4.3 Document Control
4.3.1 The laboratory shall define, document and maintain procedures to control all documents
    and information that form its quality documentation. A copy of each of the controlled
    documents shall be archived for later reference and the laboratory director shall define the
    retention period.

4.3.2 Procedures shall be adopted to ensure that
    a)   All documents issued to laboratory personnel as part of the quality management system are reviewed and
         approved by authorized personnel prior to issue
    b)   A list, also referred to as a document control log, identifying the current valid revisions and their distribution is
         maintained
    c)   Only current authorized versions of appropriate documents are available for active use at relevant locations
    d)   Documents are periodically reviewed, revised when necessary, and approved by authorized personnel,
    e)   Invalid or obsolete documents are promptly removed from all points of use, or otherwise assured against
         inadvertent use,
    f)   Retained or archived superseded documents are appropriately identified to prevent their inadvertent use,
    g)   If the laboratory’s documentation control system allows for the amendment of documents by hand pending the
         re-issue of documents, the procedures and authorities for such amendments are defined, while amendments
         are clearly marked, initialed and dated, and a revised document is formally re-issued as soon as practicable,
         and
    h)   Procedures are established to describe how changes to documents maintained in computerized systems are to
         be made and controlled

4.3.3 All documents relevant to the quality management system shall be uniquely identified, to
    include
    a)   Title,
    b)   Edition or current revision date, or revision number, or all these,
    c)   Number of pages (where applicable),
    d)   Authority for issue, and
    e)   Source identification.
  Lab Standards: DAP
X2.0 Procedures and processes are documented, current, accurate, and
   controlled.
   x2.1 The laboratory uses documentation to ensure consistency of analysis
   x2.2 Documentation contains all the relevant material necessary to perform the
      procedure
   x2.3 The laboratory defines and maintains procedures to control documents:
         Documents are reviewed and approved by the medical leader or designate prior to issue
         There is evidence of document review at regular intervals by the medical leader and
          technical staff
         All documents are uniquely identified
         Invalid or obsolete documents are promptly removed from all points of use
         Copies of master documents are archived
         Archival time for master documents is defined by the medical leader
         Version identification ensures that the latest approved version is in use
         Only current authorized versions of documents are available for active use
         A master index of all laboratory documents identifying current version and distribution is in
          place
         Procedures are established to control document changes in computerized systems
         There are processes to address the amendments of documents by hand
Document Lifecycle

                    DCR
 Master Index      (Document
                    Change
                                           Draft
                                       . Document
                    Request)

  •Title     No

  •Document Identifier
          OK?   Yes            CHM1082SOP
                                        Review &
                                        Approval
  •Responsible Person/Position
  •Authorizer(s)
                   Scheduled      Release &
  •Distribution     Review
                  locations
                   (Renewal)
                                  Distribute



                                        Document
                                        Audit
Document Lifecycle
  Review           DCR                 Draft
                  (Document        . Document
  •Does the process or
                   Change
                   Request)

  procedure described
  work?     No
                    Yes              Review &
            OK?
                                     Approval
  Approval
  •Who has the authority
                Scheduled     Release &
  to place this document
                 Review       Distribute
                 (Renewal)
  into operation?
                                    Document
                                    Audit
Document Lifecycle
Master Index:
                         DCR                Draft
•Title                  (Document       . Document
•Document Identifier Request)
                         Change

•Responsible Person/Position
•Authorizer(s)
•Distribution locations
                  No
                          Yes             Review &
                  OK?
•Version Number                           Approval


•Effective Date
             Scheduled
•Next Scheduled
              Review
                                    Release &
                                    Distribute
Review Date (Renewal)

                                         Document
                                         Audit
Document Lifecycle

 Audit             DCR
                  (Document
                                          Draft
                   Change
                                      . Document
 Controlled (working copies)
                   Request)

 of documents need to be
 easily identified, and in the
                No
 location they are required for
               OK?   Yes                 Review &
                                         Approval
 work as identified by the
 Master Index

                 Scheduled        Release &
 Document Control
              Review              Distribute
 Rules for Organization
              (Renewal)




                                       Document
                                       Audit
Document Lifecycle
Master Index:
                           DCR       New/Modified
•Title                   (Document   . Document
•Document Identifier       Change
                          Request)
•Responsible Person/Position
•Authorizer(s)
•Distribution locations
                      No
•Version Number             Yes         Review &
                      OK
•Effective Date        ?
                                         Approval
•Next Scheduled Review Date -updated


                    Scheduled     Release &
                    Review        Distribute
                      (Renewal)



                                         Document
                                         Audit
Document Lifecycle

                DCR              New/Modified
               (Document         . Document
                Change
                Request)




         No
                 Yes                Review &
        OK?
                                    Approval
                Review
                frequency




              Scheduled     Release &
               Review       Distribute
               (Renewal)



                                  Document
                                  Audit
 Document Lifecycle
   Who?
                        DCR             New/Modified
                      Document
   What?               Change
                                        . Document
                       Request
   Why?
CLSI GP2-A5     No
Laboratory               Yes               Review &
                OK?
Documents:                                 Approval
Development &
Control
Appendix R:
Sample                Scheduled    Release &
Document               Review      Distribute
                       (Renewal)
Change
Request Form
                                         Document
                                         Audit
  Document Lifecycle
6. Document
Archive/Destruction
Process                       DCR             New/Modified
                             (Document        . Document
                              Change
5. Document Change            Request)
Process                                                       1. Document
                                                              Creation &
                      No                                      Approval Process

                               Yes               Review &
                      OK?
                                                 Approval




                            Scheduled    Release &          2. Document
                             Review      Distribute         Distribution Process
                             (Renewal)
 4. Scheduled
 Document Review
 Process                                       Document       3. Document
                                               Audit          Audit Process
3 ways to get this done…
        Manually
            Paper based

        Semi-Manually
            Common network to
             store/make available
             documents electronically

        Document Control
         Application
Where do I start?

1. Create an Identification Number and
   versioning convention for your
   documents

       …and document it…
What do I do next?

2. Create a Master Index
   Database or spreadsheet
   Divide/delegate by process or department if it is
    too large to manage in a consolidated fashion
   Identify responsibility for the Master Index



             …and document it…
What do I do next?
3. Gather your documents
   Apply the document identifier
   Determine where all copies of the document are in
    use

4. Create a master document file
   Place the master into that file with all of the
    appropriate authorization and scheduled review
    signatures
   Apply the “Control” mechanism to controlled
    working copies of the master document
Then What?

5. Complete the Master Index
    Transfer the document attributes to the
     Master Index

      •Title                 •Distribution locations
      •Document Identifier   •Version Number
      •Responsible           •Effective Date
      Person/Position        •Next Scheduled Review
      •Authorizer(s)         Date
That takes care of documents
you already have, now what?
6. Create your document processes
    Document Creation, Review & Approval
    Document Versioning, Distribution & Audit
    Document Change
    Document Archive



           …and document them
Create instructions:

7. Write relevant document control
   procedures including:
      How to write a procedure (templates, etc.)
      Assign an identification number
      Register the document on the Master Index
      Identify “Controlled” documents
And finally…
8. Develop roles &                CLSI GP2-A5
  responsibilities for            Laboratory
  document users                  Documents:
                                  Development &
     Write on/make changes to    Control
      controlled documents?       Appendix S:
                                  Ten Rules for
     White out?                  Document
     Create additional copies    Control
      beyond those distributed?
Document Control Dos & Don’ts
   DO…             DO NOT…
      Read           Write
      Reference      White out
      Vigilant       Photocopy
      “Control”      Print/retain
      DCR            Release
 Tips &
Warnings

  What I
   have
 learned
along the
  way…
   Share the “Whys”
New Employee Orientation
Be prepared to make changes to
documents
  4401 Controlled   1768 Document
     Documents      Change Requests
Draft your document processes, then
automate if possible
You’re not alone - delegate
References:        •Berte,L., Nevalainen,D., Quality Systems for
                   the Laboratory, American Society of Clinical
                   Pathologists, Chicago, USA, 2000


                   •Clinical and Laboratory Standards Institute
                   (CLSI), GP2-A5 Laboratory Documents:
                   Development and Control; Approved
                   Guideline-Fifth Edition, CLSI document GP2-
                   A5, Pennsylvania USA, 2006


                   •Canadian Standards Association (CSA), The
                   ISO 15189:2003 Essentials, Mississauga,
                   Ontario, Canada, 2004


                   •Clinical and Laboratory Standards Institute
Thank you          (CLSI), HS1-A2 A Quality Management
                   System Model for Health Care; Approved
   Debbie Penn
                   Guideline-Second Edition, CLSI document
 dpenn@bcbio.com   GP2-A5, Pennsylvania USA, 2004

				
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