Procedure for Document Control and Management Version 12

North Carolina State Crime Laboratory Effective Date: 01/18/2019

Issued by NCSCL Quality Manager

Procedure for Document Control and Management

1.0 Purpose - This procedure provides requirements for the creation, revision, and control of quality documents
used by State Crime Laboratory (Laboratory) employees.

2.0 Scope - This procedure applies to the creation, revision, and control of all documents pertaining to the
Laboratory Quality Management System (QS). QS documents include, but are not limited to, the following:

 Laboratory Quality Manual.

 Laboratory-wide Procedures.
 Laboratory Safety Manual.
 Laboratory-wide Forms.
 Section Administrative Policy and Procedures.
 Section Technical Procedures.
 Section Training Procedures.
 Section Forms and Work Instructions.

3.0 Definitions

 Approver – The employee responsible for the content of the document. Approvers shall be considered the
Issuing Authority. Approvers for the following documents shall be:

Laboratory Quality Manual and Laboratory-wide Procedures –Quality Manager.

Laboratory Safety Manual – Laboratory Safety Manager, or Quality Manager.
Laboratory-wide Forms –Quality Manager
Section Technical Procedures and Section Training Procedures – Forensic Scientist Manager and/or
Technical Leader, or ECU Supervisor.
Section Policy and Procedures – Forensic Scientist Manager, or ECU Supervisor.
Section Forms and Work Instructions– Forensic Scientist Manager, and/or Technical Leader or ECU
Supervisor.

 Author - The employee who writes or revises the document.

 Document Approval Attachment (DAA) - A form to record and authorize the development, change and/or
approval of all controlled, Laboratory generated documents (except forms). Each controlled, Laboratory
generated document shall have a unique DAA. The blank copy of the DAA is located on the Laboratory
internal network server.
 Document Custodian – The employee at either the Laboratory-wide or Section level who is responsible
for ensuring the proper formatting, publishing, distribution, and archiving of controlled documents.
 Form – A document with a fixed arrangement of spaces designed for entering and extracting information.
 Laboratory Procedures - The controlled documents that describe the execution of policies in the Quality
Manual. Procedures describe the means by which activities (tasks, examinations, analyses, etc.) shall be
performed.
 Laboratory Safety Manual - The controlled document that describes the safety program at the Laboratory
(i.e., protection of employees from hazardous chemicals, wastes, and blood borne pathogens; evacuation in
cases of fire, explosion, or natural disaster; etc.). The Safety Manual supplements the North Carolina
Department of Justice Safety and Health Manual (DOJ Safety Manual) to meet the special conditions that
are unique to the State Crime Laboratory.
 Laboratory Quality Manual - The controlled document that describes the QS.

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Procedure for Document Control and Management Version 12
North Carolina State Crime Laboratory Effective Date: 01/18/2019
Issued by NCSCL Quality Manager

 Master List - The list that identifies the current revision status and distribution of Laboratory generated
documents in the management system. For each document, the Master List shall include the title, version
number, issue date, and date for next scheduled review. The Master List of QS documents shall be
maintained by the Laboratory Document Custodian.
 Reviewer – The employee responsible for reviewing documents using reference sources and other pertinent
information to ensure inclusion of all necessary elements and compliance with any associated policies and
procedures. The review may be conducted for technical, legal, or quality assurance purposes.
 Section Technical Procedures – The controlled documents that provide detailed directions for the
performance of technical duties.
 Section Policy and Procedures – The controlled documents that provide written guidance for
administrative functions within the Section.
 Section Training Procedures – The controlled documents that provide instructions for training in specific
skills required for analyses or examinations.

4.0 Procedure

4.1 The official copy of Laboratory generated QS documents shall be the electronic copy that is published on
the Laboratory intranet. Archived copies of these documents shall be stored by the Quality Manager (QM)
on the Laboratory intranet. When a form is revised, the use of the previous version of the form shall be
discontinued.

Employees may download and print copies of documents; however, copies shall be uncontrolled. If a
controlled document other than a form is printed, the effective date shall be clearly indicated and it shall be
identified as an uncontrolled copy. Printed copies of electronically controlled documents used for casework
activities may be disposed of within the same work day or retained for future reference. If retained for future
reference, the employee must verify that the uncontrolled printed version is still current prior to use. Forms
may be printed for use and retained in printed format.

4.2 Format of Laboratory Generated Documents

4.2.1 Each QS document (except forms and work instructions) shall have a unique title and each page of the
body of the document shall have a header that includes the following:

 Title.
 Version Number.
 Effective date.
 Section or Discipline identification.
 Issuing authority.

In addition, each page of the body of the document (except forms and work instructions) shall have a
footer that includes the following:

 Pagination (Page _ of _).

 All copies of this document are uncontrolled when printed.

4.2.2 Each QS document (except forms and work instructions) shall be written using the following:

 Microsoft Word.

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Procedure for Document Control and Management Version 12
North Carolina State Crime Laboratory Effective Date: 01/18/2019
Issued by NCSCL Quality Manager

 Times New Roman.

 Font 11.
 Full margin justification.

4.2.3 At the end of the body of each QS document (except forms), a Revision History shall be included to
detail the changes made. The Revision History shall contain the revision number, the effective date,
and the reason(s) for revision. Any typographical and grammatical changes may be summarized in
one statement.

4.2.4 Forms and work instructions shall have the following identifying information:

4.2.4.1 Header

 Title.
 Version Number.
 Effective date.
 Section or Discipline identification.

4.2.4.2 Footer

 Signature of Approver.
 Pagination (Page _ of _) or a mark to signify the end of the document.

4.3 Document Development of Laboratory Generated Documents

4.3.1 QS Documents (except forms and work instructions) shall be created or modified according to the
basic process described below.

4.3.2 The author of a document shall have expertise in the subject matter. The technical details of the
document shall correspond to the complexity of the activity being performed as well as the background
of the intended user. The document shall include enough detail to ensure that the activity conforms
to quality requirements. Documents in draft form shall be labeled as such.

4.3.3 Once the document has been drafted or revised, it may be informally reviewed by other Laboratory
employees with subject matter expertise. When a final draft has been prepared, the document changes
shall be detailed in the Revision History. An original document shall be indicated as such in the
Revision History.

4.3.4 The author shall complete the Requestor sections of the DAA. Any safety, training, or resource
requirements shall be summarized on the DAA. The document and DAA shall be submitted to the
Reviewer(s).

4.3.5 An author shall not review a manual or document that he/she has written. The author shall ensure that
all manuals and documents undergo technical, quality assurance, and legal reviews.

4.4 Document Review of Laboratory Generated Documents

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Procedure for Document Control and Management Version 12
North Carolina State Crime Laboratory Effective Date: 01/18/2019
Issued by NCSCL Quality Manager

4.4.1 Technical review - The technical reviewer shall have knowledge of the procedure to evaluate the
document. The technical reviewer shall evaluate the document for technical accuracy, technical
sufficiency, and clarity of presentation using reference documents and other pertinent information.
(Note: the approver may also conduct this technical review).

4.4.1.1 For revisions to technical procedures or new technical procedures, the technical leader for the
discipline/sub-discipline shall be the author, reviewer or approver.

4.4.2 Quality Assurance Review - The QM shall perform a quality assurance review of the process and of
the document. The quality assurance review shall evaluate the document for the inclusion of quality
requirements, quality sufficiency, and adherence to Laboratory policies and procedures. The
Laboratory Director and appropriate Assistant Director shall also review the document prior to final
release.

4.4.3 Legal Review – The document shall be reviewed by Laboratory Legal Counsel.

4.4.4 If the review of the document is approved, the DAA shall be signed and dated by the reviewer.

4.4.5 If the review of the document is not approved, the author shall be notified of the reasons. Conflicts
shall be resolved between the author and reviewer and any agreed upon modifications shall be
incorporated into the document. The review cycle shall be repeated until such time as each reviewer
has indicated approval on the DAA.

4.4.6 Laboratory and Section forms and work instructions do not require a Technical, Quality Assurance or
Legal Review.

4.5 Document Approval of Laboratory Generated Documents

4.5.1 A Laboratory generated form or work instruction shall be approved before dissemination to staff. The
approver shall review the form or work instruction. If approved, the form or work instruction shall be
signed and dated by the approver and placed on the Laboratory intranet by the QM.

4.5.2 All other Laboratory generated documents shall be approved before dissemination to staff. The
approver shall review the document. Changes and concerns shall be noted and discussed with the
reviewer(s) and author. If there is disagreement, the approver shall determine the final action. After
any changes and identification of additional training and resources or impact to customers or other
Sections, if any, the approver shall perform one of the following:

4.5.2.1 If the document is approved, the DAA shall be signed, dated, and placed in the Documents
Approval Attachments folder on the Laboratory intranet by the Quality Manager or designee.

4.5.2.2 If the document is not approved, the author shall be notified of the reason(s).

4.6 Issuance and Distribution of Laboratory Generated Documents

4.6.1 After approval, the effective date of the document shall be included in the file name. The document
shall be submitted to the QM. The QM shall update the Master List.

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Procedure for Document Control and Management Version 12
North Carolina State Crime Laboratory Effective Date: 01/18/2019
Issued by NCSCL Quality Manager

4.6.2 Documents (except forms) shall be converted to Portable Document Format (PDF) before issuance,
publication on the Laboratory intranet, or distribution. For Laboratory and Section documents, the
QM shall post the approved document on the Laboratory intranet site and the Laboratory shared drive.
The QM shall notify the Section Document Custodian when the process has been completed.

4.6.3 Affected personnel shall be trained on management system documents (except forms). When lab-wide
management system documents are issued, the QM shall ensure that each affected Laboratory
employee signs an Acknowledgement Sheet to indicate review of the document. When Section specific
management system documents are issued, the Section Manager/Supervisor shall ensure that each
affected Laboratory employee signs an Acknowledgement Sheet to indicate review of the document.
The Acknowledgement Sheet(s) shall be scanned and stored on the internal network file server. Forms
do not require the completion of an Acknowledgement Sheet.

4.6.4 The use of new or revised documents shall begin on the effective date.

4.7 Document Removal - The Section Forensic Scientist Manager and/or Technical Leader shall have the
authority for removal of Section documents. The Lab Director shall have the authority for removal of
Laboratory documents. If the decision is made to remove a document, the appropriate authority shall notify
the Document Custodian to remove and archive the document and to update the Master List.

4.8 Monitoring of Laboratory-Generated Documents

4.8.1 The Forensic Scientist Manager or designee shall ensure that all controlled Section documents are
reviewed annually (and revised as necessary) to ensure that the documents reflect current policies,
practices, procedures, and technology. This review shall be documented in a memorandum and posted
on the Laboratory intranet. The QM shall be notified of the posting. Documentation shall include the
name of the reviewer(s), the title(s) of the document(s) reviewed, and the date(s) the documents were
reviewed. Internal or external audits and/or quality reviews do not satisfy this requirement.

4.8.2 The QM shall ensure that all controlled Laboratory policies and practices are reviewed annually and
revised when necessary. This review shall be documented and retained by the QM. Documentation
shall include the name of the reviewer(s), the title(s) of the document(s) reviewed, and the date(s) the
documents were reviewed.

4.8.3 If changes (including administrative/typographical) are required to any document or manual (except
forms), a DAA shall be initiated and the procedure followed for document revisions.

4.8.4 Documents may be updated and reissued as necessary. A new version number (the next whole number)
shall be assigned when a new document version is approved. Amendments or changes to final
documents by hand shall not be permitted.

4.9 Instrumentation Manuals and other Externally Produced Documents

4.9.1 Documents from external sources may be treated as references, QS documents, or case related
information. If treated as a reference material, a copy shall be maintained in the Section. If treated as
a QS document, a record shall be maintained on a Section distribution list to track the use of the
document as part of the quality system. All manuals for critical equipment shall be treated as QS
documents. If an external document is case related information, it shall be imported into the
corresponding Laboratory file.

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Procedure for Document Control and Management Version 12
North Carolina State Crime Laboratory Effective Date: 01/18/2019
Issued by NCSCL Quality Manager

4.9.2 The Forensic Scientist Manager shall review and approve the use of externally produced QS documents
by approving the Section Distribution List. The Section distribution list shall be maintained by the
Forensic Scientist Manager or Section Document Custodian. The document title, date, version
number, distribution date, and the location of the copies shall be included on the list.

4.9.3 After an externally produced QS document has been issued, the Forensic Scientist Manager or Section
Document Custodian shall distribute the manual/document or a copy to the appropriate party or
location.

4.10 Document Retention and Archival

4.10.1 Superseded documents shall be removed from use; however, one electronic copy of the document
shall be retained as an archived copy.

4.10.2 Archived copies of Laboratory generated documents shall be maintained by the QM.

4.10.3 Instrumentation manuals or externally produced quality documents shall become superseded when
the entity that produced the manual/document issues a new version or the manual/document becomes
obsolete. Archived instrumentation manuals/external documents shall be retained by the Section
Document Custodian.

4.10.4 The superseded manual or document shall be labeled (Ex. “Archived on…” or “Superseded on…”).
If the archived copy is maintained in electronic format, the effective range shall be added to the
filename (e.g., TRACE XRF 2008.8.11 – 2010.10.15).

4.10.5 Externally produced documents containing case related information shall be maintained in the
Laboratory file in Forensic Advantage. Once the document has been imported and approved in the
FA System, it becomes the official copy and any other copy may be discarded.

NOTE: The imported file shall be an exact duplicate of the documents received (i.e., if document is
in color, it shall be scanned in color before being added to the file).

5.0 Records

 Master list
 Document Approval Attachment
 Section Distribution lists

6.0 Attachments – N/A

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Procedure for Document Control and Management Version 12
North Carolina State Crime Laboratory Effective Date: 01/18/2019
Issued by NCSCL Quality Manager

Revision History

Effective Date Version Reason

Number
09/17/2012 1 Original Document
10/26/2012 2 Modified 4.6.2 to show the QCO posting lab-wide and Section
documents to the intranet and shared drive. Modified Definition for
DAA - removed sentence referring to Appendix A. 4.10.3 - archived
copies of ISO of procedures maintained by QCO, previous policy and
procedures shall be maintained by the Section Document Custodian.
12/07/2012 3 Modified 4.1 to agree with 4.10.3
05/30/2013 4 2.0 - modified scope; 3.0 - added approvers for forms, revised DAA
definition; 4.1, 4.2, 4.2.3, 4.2.4, 4.3, 4.3.1, 4.4, 4.4.6, 4.5, 4.5.1, 4.5.2,
4.6, 4.6.2, 4.8, 4.8.3,4.9, 4.9.1, 4.9.2, 4.9.3 and 5.0 were modified to
control forms; 4.10.3 - updated to reflect ISO implementation
10/16/2013 5 2.0 - added wide to laboratory procedures and laboratory forms; 3.0 -
clarified definition for approver; 4.2.1 - added issuing authority; added
issuing authority to header; added 4.4.1.1
04/18/2014 6 4.4.1.1 - added revision; 4.5.2.1 - revised return to appropriate document
custodian to place on L drive
08/29/2014 7 4.9.1 - added case related information; added 4.10.6
12/19/2014 8 Throughout document - consolidated QCO and QM duties to QM; 4.8.1
- removed Lab Director and electronically
10/19/2015 9 4.2.1 and 4.2.4.1 - added or discipline; 4.6.3 – exempted forms from the
acknowledgment sheet requirement
04/28/2017 10 4.4.2- Added appropriate Assistant Director and Laboratory Director
review
4.10.2 and 4.10.3 – updated responsibility to maintain archived
documents to QM
12/18/2017 11 3.0– added work instructions under approver definition
4.2.1, 4.2.2, 4.2.4, 4.3.1, 4.4.6, 4.5.1 – added work instructions
4.5.2.1 changed L: drive to Laboratory intranet.
01/18/2019 12 4.1 – allowed for retention of printed documents.

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