Transcript Document Control & Other Tortures perfected in the 21st

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)
b)
c)
d)
e)
f)
g)
h)
All documents issued to laboratory personnel as part of the quality management system are reviewed and
approved by authorized personnel prior to issue
A list, also referred to as a document control log, identifying the current valid revisions and their distribution is
maintained
Only current authorized versions of appropriate documents are available for active use at relevant locations
Documents are periodically reviewed, revised when necessary, and approved by authorized personnel,
Invalid or obsolete documents are promptly removed from all points of use, or otherwise assured against
inadvertent use,
Retained or archived superseded documents are appropriately identified to prevent their inadvertent use,
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
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)
b)
c)
d)
e)
Title,
Edition or current revision date, or revision number, or all these,
Number of pages (where applicable),
Authority for issue, and
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
Request)
•Title
Draft
. Document
No
Yes
•DocumentOK?
Identifier
CHM1082SOP
Review &
Approval
•Responsible Person/Position
•Authorizer(s)
•Distribution
Scheduled
Review
locations
(Renewal)
Release &
Distribute
Document
Audit
Document Lifecycle
Review
DCR
(Document
Change
Request)
•Does the process or
procedure described
No
work?
OK?
Yes
Approval
•Who has the authority
Scheduled
to place this document
Review
(Renewal)
into operation?
Draft
. Document
Review &
Approval
Release &
Distribute
Document
Audit
Document Lifecycle
Master Index:
DCR
•Title
(Document
Change
•Document Identifier Request)
•Responsible Person/Position
•Authorizer(s)
•Distribution locations
No
OK?
Yes
•Version Number
Draft
. Document
Review &
Approval
•Effective Date
Scheduled
•Next Scheduled
Review
Review Date (Renewal)
Release &
Distribute
Document
Audit
Document Lifecycle
Audit
DCR
(Document
Change
Request)
Controlled (working copies)
of documents need to be
easily identified,
No and in the
location theyOK?
are required
for
Yes
work as identified by the
Master Index
Scheduled
Document Control
Review
(Renewal)
Rules for Organization
Draft
. Document
Review &
Approval
Release &
Distribute
Document
Audit
Document Lifecycle
Master Index:
DCR
New/Modified
•Title
(Document
. Document
Change
•Document Identifier
Request)
•Responsible Person/Position
•Authorizer(s)
•Distribution locationsNo
Review &
•Version Number
Yes
OK
Approval
•Effective Date
?
•Next Scheduled Review Date -updated
Scheduled
Review
Release &
Distribute
(Renewal)
Document
Audit
Document Lifecycle
DCR
(Document
Change
Request)
New/Modified
. Document
No
OK?
Yes
Review
frequency
Scheduled
Review
Review &
Approval
Release &
Distribute
(Renewal)
Document
Audit
Document Lifecycle
Who?
DCR
Document
Change
Request
What?
Why?
CLSI GP2-A5
Laboratory
Documents:
Development &
Control
Appendix R:
Sample
Document
Change
Request Form
New/Modified
. Document
No
OK?
Yes
Scheduled
Review
Review &
Approval
Release &
Distribute
(Renewal)
Document
Audit
Document Lifecycle
6. Document
Archive/Destruction
Process
DCR
(Document
Change
Request)
5. Document Change
Process
New/Modified
. Document
1. Document
Creation &
Approval Process
No
OK?
Yes
Scheduled
Review
(Renewal)
4. Scheduled
Document Review
Process
Review &
Approval
Release &
Distribute
Document
Audit
2. Document
Distribution Process
3. Document
Audit Process
3 ways to get this done…

Manually


Semi-Manually


Paper based
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
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
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
•Document Identifier
•Responsible
Person/Position
•Authorizer(s)
•Distribution locations
•Version Number
•Effective Date
•Next Scheduled Review
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 &
responsibilities for
document users

Write on/make changes to
controlled documents?

White out?

Create additional copies
beyond those distributed?
CLSI GP2-A5
Laboratory
Documents:
Development &
Control
Appendix S:
Ten Rules for
Document
Control
Document Control Dos & Don’ts
DO…





Read
Reference
Vigilant
“Control”
DCR
DO NOT…





Write
White out
Photocopy
Print/retain
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
Documents
1768 Document
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 GP2A5, Pennsylvania USA, 2006
•Canadian Standards Association (CSA), The
ISO 15189:2003 Essentials, Mississauga,
Ontario, Canada, 2004
Thank you
Debbie Penn
[email protected]
•Clinical and Laboratory Standards Institute
(CLSI), HS1-A2 A Quality Management
System Model for Health Care; Approved
Guideline-Second Edition, CLSI document
GP2-A5, Pennsylvania USA, 2004