document control dap quality conference may 12, 2008 debbie penn

Document Control

DAP Quality ConferenceMay 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 151894.3 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 thata) All documents issued to laboratory personnel as part of the quality management system are reviewed and

approved by authorized personnel prior to issueb) A list, also referred to as a document control log, identifying the current valid revisions and their distribution is

maintainedc) Only current authorized versions of appropriate documents are available for active use at relevant locationsd) 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inadvertent use,f) Retained or archived superseded documents are appropriately identified to prevent their inadvertent use,g) If the laboratory’s documentation control system allows for the amendment of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 includea) 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: DAPX2.0 Procedures and processes are documented, current, accurate, and

controlled. x2.1 The laboratory uses documentation to ensure consistency of analysisx2.2 Documentation contains all the relevant material necessary to perform the

procedurex2.3 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

.

Review & Approval

DCR(Document

ChangeRequest)

ScheduledReview(Renewal)

Release &Distribute

OK?

DraftDocument

No

Yes

Document Audit

•Title

•Document Identifier

•Responsible Person/Position

•Authorizer(s)

•Distribution locations

Document Lifecycle

Master Index

CHM1082SOP

Document Lifecycle

.

Review & Approval

DCR(Document

ChangeRequest)


Release &Distribute

OK?

DraftDocument

No

Yes

Document Audit

Review

•Does the process or procedure described work?

Approval

•Who has the authority to place this document into operation?

Document Lifecycle

.

Review & Approval

DCR(Document

ChangeRequest)


Release & Distribute

OK?

DraftDocument

No

Yes

Document Audit

Master Index:•Title•Document Identifier •Responsible Person/Position•Authorizer(s)•Distribution locations

•Version Number

•Effective Date

•Next Scheduled Review Date

Document Lifecycle

.

Review & Approval

DCR(Document

ChangeRequest)


Release & Distribute

OK?

DraftDocument

No

Yes

Document Audit

Audit

Controlled (working copies) of documents need to be easily identified, and in the location they are required for work as identified by the Master Index

Document Control Rules for Organization

Document Lifecycle

.

Review & Approval

DCR(Document

ChangeRequest)

ScheduledReview

(Renewal)

Release &Distribute

OK?

New/ModifiedDocument

No

Yes

Document Audit

Master Index:•Title•Document Identifier •Responsible Person/Position•Authorizer(s)•Distribution locations•Version Number•Effective Date•Next Scheduled Review Date -updated

Document Lifecycle

.

Review & Approval

DCR(Document

ChangeRequest)


Release &Distribute

OK?


No

Yes

Document Audit

Review frequency

Document Lifecycle

.

Review & Approval

DCRDocument

ChangeRequest


Release &Distribute

OK?


No

Yes

Document Audit

Who?

What?

Why?

CLSI GP2-A5 Laboratory Documents: Development & Control

Appendix R: Sample Document Change Request Form

Document Lifecycle

.

Review & Approval

DCR(Document

ChangeRequest)


Release &Distribute

OK?


No

Yes

Document Audit

1. Document Creation & Approval Process

2. Document Distribution Process

3. Document Audit Process

4. Scheduled Document Review Process

6. Document Archive/Destruction Process

5. Document Change 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•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…


Appendix S: Ten Rules for Document Control


Appendix S: Ten Rules for Document Control

8. Develop roles & responsibilities for document users

Write on/make changes to controlled documents?

White out?

Create additional copies beyond those distributed?

Document Control Dos & Don’ts

DO… Read Reference Vigilant “Control” DCR

DO NOT… Write White out Photocopy Print/retain Release

What I have

learned along the

way…

Tips & Warnings

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

•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 (CLSI), HS1-A2 A Quality Management System Model for Health Care; Approved Guideline-Second Edition, CLSI document GP2-A5, Pennsylvania USA, 2004

References:

Thank youDebbie Penn

[email protected]