Document Control for Control Freaks

Kristina Martin, MLS(ASCP)CM,MS

Objectives 1. Define document control 2. List components of document control 3. Identify regulatory and standards

associated with document control 4. Describe approaches to managing

documents 5. Identify pitfalls common to managing a

document system

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Document Control Defined

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• Ensures documents pertinent to the work performed are controlled

• Control ensures that the document being used is the most

recent approved version obsolete documents are archived

• Documents are approved by qualified individuals before being put into use

Components of Document Control

• Revision control with archival process

• Creation of new & review of modified procedures by qualified staff with CLIA director sign-off

• Listing of all procedures, policies and related documents

• Numbering/identification convention

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Components of Document Control(cont.)

• Back-up process to ensure availability 24/7

• Process to ensure biennial review • Process to assure staff familiarity

with procedures • Process to track alterations in the

document

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Other Considerations

• Template(s) for document development

• Font style and color • Access to editing • Providing links or references to

related documents e.g. procedures & job aids

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Templates

• Contain header/footer information required by regulatory agencies

• Institution logo

• Options for landscape and portrait

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Header/Footer Example

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Code of Federal Regulations • Procedure Manual Standard CFR 493.1251 &

CFR 493.1105(a)

• Clearly outlines what is required within procedures

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International Quality Systems ISO 9000

• Mapping ISO 9000

• Guidelines to assist with Document Control and/or certification

• Suggestions for fonts & general formatting

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CAP General (GEN.20375) Downloaded 4/21/2014

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Document Control Phase II

The laboratory has a document control system to manage policies, procedures, and forms. NOTE: • Document control applies to all policies, procedures and

forms (including quality management documents) for all processes and activities that are subject to CAP accreditation.

• The document control system must ensure that only current policies, procedures, and forms are in use.

CAP Suggestions • Maintain a control log – listing all current policies, procedures, and forms – with the locations of copies (including derivative

documents such as card files and summary charts). • Log may contain other information – dates policies/procedures placed in service – schedule of review, – identity of reviewer(s), – dates policies/procedures discontinued/superseded.

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Control Log Example

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Control Log Example

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CAP All Common (COM.10000) Downloaded 4/21/2014

Procedure Manual Phase II A complete procedure manual is available at the workbench or in the work area.

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Manufacturer’s Instructions NOTE 1:

Downloaded 4/21/2014

The use of inserts is not acceptable in place of a procedure manual. • Inserts may be used as part of a procedure

description, if the insert accurately and precisely describes the procedure as performed in the laboratory.

• Any variation must be detailed in the procedure manual. – Policy/procedure must match the laboratory's practice, – Laboratory's practice must follow written procedure, and – Appropriate reviews must occur.

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Manufacturer’s Procedure Manual NOTE 2:

Downloaded 4/21/2014

A manufacturer's procedure manual for an instrument/reagent system may be acceptable as a component of the overall departmental procedures.

– Any modification to or deviation from the procedure manual must be clearly documented.

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Card Files and Job Aids NOTE 3:

Downloaded 4/21/2014

Card files or similar systems that summarize key information are acceptable for use as quick reference at the workbench provided that: A complete manual is available for reference The card file or similar system corresponds to

the complete manual and is subject to document control

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Electronic Manuals Note 4

• Electronic (computerized) manuals are fully acceptable. • The electronic versions must be readily available to all personnel • Available even during a computer down

– paper copies or electronic copies on CD or other media • Electronic versions subject to proper document control

– only authorized persons may make changes – changes are dated/signed (manual or electronic)

• There is documentation of biennial review – Statements such as “reviewed by [name of reviewer] on [date of

review]” in the electronic record. – Documentation of review by a secure electronic signature is NOT

required.

All procedures, in either electronic or paper form, must be readily available for review by the inspector at the time of the CAP inspection.

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CAP All Common (COM.10100) Downloaded 4/21/2014

Procedure Manual Review Phase II There is documentation of review of all technical policies and procedures by the current laboratory director or designee at least every two years. • NOTE: The laboratory director** must ensure that the collection of testing policies

and technical protocols is complete, current, and has been thoroughly reviewed by a knowledgeable person.

• Suggested schedule: 1/24 of all procedures are reviewed monthly • Paper/electronic signature review must be at the level of each procedure, or as

multiple signatures on a listing of named procedures. • A single signature on a Title Page or Index of all procedures is not sufficient • Signature or initials on each page of a procedure is not required. • Only policies and procedures are addressed in this requirement. • Biennial review is not required for other controlled documents.

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**Lab director is defined as the director listed on the CLIA license for that laboratory.

CAP All Common (COM.10200) Downloaded 4/21/2014

New Procedure Review Phase II The laboratory director reviews and approves all new technical policies and procedures, as well as substantial changes to existing documents, before implementation. NOTE: This review may not be delegated to designees in laboratories subject to the CLIA regulations. Paper/electronic signature review is required. A secure electronic signature is desirable, but not required. Evidence of Compliance: ✓ Policy on procedure review AND ✓ Records of policy/procedure approval

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CAP All Common (COM.10500) Downloaded 4/21/2014

Discontinued Procedure Phase II When a procedure is discontinued, • copy is maintained for at least 2 years, • recording initial date of use, • retirement date. NOTE 1: In transfusion medicine maintained for 5 years. NOTE 2: For genetic testing, at least 23 years (to cover the interval from fetal period to age 21).

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CAP All Common (COM.10300) Downloaded 4/21/2014

Knowledge of Procedures Phase II The laboratory has a system documenting that all personnel are knowledgeable about the contents of procedure manuals (including changes) relevant to the scope of their testing activities. NOTE: The form of this system is at the discretion of the laboratory director. Annual procedure sign-off by testing personnel is not specifically required. Evidence of Compliance: ✓ Records indicating that the testing personnel have read the procedures, new and revised, OR ✓ Records of another documented method approved by the laboratory director

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Resources • SharePoint or other • Microsoft products like Excel • 3rd Party Document Control Vendors

(not an all-inclusive list)

AccuCore Iron Mountain MasterControl Paradigm 3 Rainbow Scientific-iPassport And many others on the market

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Considerations if Opting for 3rd Party Vendor

• Who hosts server? • How licensing works (concurrent or all staff)? • PDF conversion • Interaction with common document software

e.g. Microsoft Office suite • Security levels for users • Online access or remote access

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3rd Party Considerations (cont.)

• Linking procedures or other documents (e.g. CAP checklists)

• Report generation to monitor staff compliance with reviews & sign-off

• Email notifications • FDA validated system • LDAP authentication (for access)

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3rd Party Considerations (cont.)

• Technical support • Alternate workflow options for document

approval based on lab preferences • Template Creation • Auto-generation of pertinent document

control information (e.g. title, version, document #)

• Ability modify document and maintain active current version for users

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3rd Party Considerations (cont.)

• Task list

• Recording & retrieval of change history

• Ability to link related documents (e.g. procedure & form)

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Common Pitfalls

Job Aids

• Job aids are an extension of a procedure

• Subject to document control

• Commonly printed at the bench

• Temptation to manually modify

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Climbing out of the Job Aid Pit

• Create a log of all printed job aids or instances where the document is made available online

• Perform periodic audits of the work area to ensure rouge documents haven’t appeared

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Biennial Review

• Lack of process or schedule • Appropriately qualified individuals for the

review • Reviews can be delegated by CLIA director to

a technical supervisor • Delegated responsibilities should be in

writing

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Printed Copies or Electronic Links

• Tracking method for printed copies and links on webpages

• Training or bench manuals

• Audits of work areas to ensure most recent versions are posted /in use

• List of controlled copies

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Controlled Copy Log Example for a Procedure

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Ensuring Staff Familiarity with New or Revised Procedures

• Record of “Read & Understand” Sign-off

• Training before procedure implementation or working related bench

• Testing comprehension

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Summary

• Controlling documents can seem daunting • Organization and solid tracking can help ensure

compliance • Ensure all staff that edit or use procedures are

familiar with standards • Perform period auditing to ensure everything is

in control

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Questions

Contact: Kristina Martin martkris@umich.edu 734-615-8863 5221 Medical Science I 1301 Catherine Street Ann Arbor, MI 48109-5602

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References

1.All Common Checklist College of American Pathologists April 21, 2014 325 Waukegan Road Section/Department: Chemistry Northfield, IL 60093-2750 www.cap.org

2.http://en.wikipedia.org/wiki/Document_management_system November 26, 2014.

3.http://www.gpo.gov/fdsys/granule/CFR-2011-title42-vol5/CFR-2011-title42-vol5-sec493-1251/content-detail.html November 26, 2014.

4.Clinical and Laboratory Standards Institute QMSO2-A6 February 2013 Vol 33 No 3

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