Document Number: SOP-DOC-01

Version Number: 1.0

Effective Date: 00-January 0000

Document Owner: Chief Quality Officer Page: 1 of 10

Title: Document Control Process

1.0 PURPOSE
The purpose of this document is to establish the Ticalion Quality Management Services, LLC
(TQMS) document control process.

2.0 SCOPE
The document control process applies to Policies, Manuals, Standard Operating Procedures,
Job Aids, Templates and Supporting Documents (e.g. quality system controlled documents) that
are governed by the TQMS quality management system (QMS).

3.0 ROLES AND RESPONSIBILITIES

3.1 Document Manager

 Oversee the daily operations of the Document Control Process

 Update the document control process and procedural documents to maintain currency
with best practices and requirements
 Manage controlled documents in accordance with approved procedures for document
control
3.2 Employees and Contractors

 Follow approved procedures for creating, revising, reviewing, approving, controlling, and
accessing controlled documents
 Participate in the controlled document review and approval process
3.3 Quality Assurance

 Establish and operate the Document Control System

 Function as the document owner for the Document Control policies, processes and
procedures
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Title: Document Control Process

 Participate in the controlled document review and approval process

 Establish and manage a system and procedures for managing controlled documents
throughout the document lifecycle
 Maintain the quality record for the document control system in accordance with SOP
Record Management

4.0 RELATED DOCUMENTS

Document Number Document Title

WI-DOC-01-01 Controlled Document Content, Format and Style Requirements

WI-DOC-01-02 Controlled Document Collaboration, Review and Approval

WI-DOC-01-03 Controlled Document Numbering

WI-DOC-01-04 Creating Tests of Understanding

WI-DOC-01-05 Controlled Document Periodic Review

WI-DOC-01-06 Controlled Document Retirement and Archival

WI-DOC-01-07 Controlled Document Release, Access and Availability

SOP-EDM-01 Electronic Document Management System General Use

WI-EDM-01-09 Electronic Document Management System Route Setup and Initiation

WI-EDM-01-01 Managing EDMS User Accounts

SOP-REC-01 Record Management

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 Document Number: SOP-DOC-01
Version Number: 1.0

Effective Date: 00-January 0000

Document Owner: Chief Quality Officer Page: 3 of 10

Title: Document Control Process

5.0 SUPPORTING DOCUMENTS

Document Number Document Title

FLW-DOC-01-01-01 Document Control Process Flowchart

TMP-DOC-01-01-01 Policy (POL) Template

TMP-DOC-01-01-02 Manual (MAN) Template

TMP-DOC-01-01-03 Standard Operating Procedure (SOP) Template

TMP-DOC-01-01-04 Work Instruction (WI) Template

TMP-DOC-01-01-05 Supporting Document (FRM) Template

6.0 DEFINITIONS AND ACRONYMS

Acronym/Term Definition

Approved The status of an item (e.g., controlled document, controlled record)

that has been reviewed, found acceptable and documented as
acceptable by all approvers.

Archive: 1.) A collection, usually of records, that is stored and maintained for
historic reference. 2.) A lasting collection of system data or other
records that are in long term storage.

Change Control The process of identifying, documenting, verifying, reviewing and

approving changes before their implementation.

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Title: Document Control Process

Controlled Document A document that is reviewed and approved prior to use, version
controlled, and has a life cycle.

Document Control The processes that govern the controlled document lifecycle.
System

Quality System Controlled documents whose existence is mandated by the quality

Controlled Document management system requirements. Typically, quality system
(aka Quality System controlled documents consist of policies, manuals, plans, standard
Document) operating procedures, work instructions, forms, and templates.

Record (aka Quality Any written or electronic documentation providing evidence that
Record) activities were performed and their results. Records include original
documents, accurate reproductions of original documents, electronic
data and files. Records do not exist until the activity has been
performed.

Record Management The policies and procedures that govern systematic control of all
records from their creation, or receipt, through their processing,
distribution, organization, storage, retrieval, retention and ultimate
disposition.

Uncontrolled Any copy of a controlled document that exists outside of the EDMS.
Document Examples include desk copies and copies that are transported away
from the controlled source in any manner to any location.

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Title: Document Control Process

7.0 PROCESS
7.1 Controlled Document Hierarchy

The Quality Management System (QMS) is documented through a hierarchical structure of

controlled documents. The levels of controlled documents used and the types of documents
within each level are:

Level 1 – Top-Level policy documents

o Policy (POL)

Level 2 - High-Level plan documents

o Manual (MAN)

o Plan (PLN)

Level 3 – Mid-Level process documents

o Standard Operating Procedure (SOP)

Level 4 – Low-Level detailed instructional documents

o Work Instruction (WI)

Level 5 –Support documents

o Flowchart (FLW)

o Form (FRM)

o Protocol (PCL)

o Template (TMP)

o Test of Understanding (TOU)

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Title: Document Control Process

7.2 Controlled Document Lifecycle

Controlled documents exist within a defined controlled document lifecycle. The following are the
primary steps in the controlled document lifecycle.

 Writing documents

 Review of draft documents

 Approval of draft documents resulting in controlled documents

 Access and use of controlled documents

 Periodic review of controlled documents

 Revision of controlled documents, if necessary

 Retirement of controlled documents

 Archival of controlled documents

Refer to Figure 2: Controlled Document Lifecycle, for a general schematic of the controlled
document lifecycle.

Figure 2: Controlled Document Lifecycle

Effective
Write/ Periodic
Review Approval Access / Retire Archive
Create Review
Available

Approval Revision

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Title: Document Control Process

7.3 Controlled Document Lifecycle for Level 5 Support Documents

Level 5 support documents exist within a unique lifecycle that differs from the lifecycle of Level 1
through Level 4 controlled documents. Level 5 support documents do not require a periodic
review because one or more of the following apply:

 they are reviewed and approved with their parent procedure (including periodic review)

 they are intended for one-time use and/or

 they are approved by qualified personnel prior to and/or in conjunction with their use

The following are the primary steps in the Level 5 support document lifecycle.

 Writing support documents

 Review of draft support documents

 Approval of draft support documents resulting in controlled documents

 Effective support documents are made accessible and available for use

 Execution of a support document

 Review and approval of the completed support document

 Archival of completed support documents as controlled records

Refer to Figure 3, Controlled Document Lifecycle – Level 5 Support Documents, for a general
schematic of the Level 5 support document lifecycle.

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Title: Document Control Process

Record
Write/ Effective/ Archive
Review Approval Execution Review/
Create Available Record
Approval

Figure 3: Controlled Document Lifecycle – Level 5 Highly Specific Support Documents

Note: Level 5 support document periodic reviews occur with the parent Level 3 or 4 controlled
document periodic review.

7.4 Creating Controlled Documents

Controlled documents are created in a consistent format and style according to the work
instruction Controlled Document Content, Format and Style Requirements

The document author is required to create all necessary Level 5 supporting documents.
Submission of Level 5 supporting documents may be delayed until the parent controlled
document is ready for approval review. At the approval review stage, Level 5 supporting
documents must be submitted for review along with the parent controlled document.

The document author is required to create a test of understanding for every SOP and WI that
impacts safety to persons, critical to quality activities and critical to business activities for use in
providing training on SOPs and WIs. Tests of understanding are created after collaborative
reviews have completed and the document is ready for approval routing. Tests of
Understanding are created according to the work instruction Creating Tests of Understanding.

7.5 Controlled Document Collaboration

After drafting a new controlled document, including supporting documents and tests of
understanding, the document author will coordinate a collaborative peer review of the document
set. The peer review will include review by technical content subject matter experts and
stakeholders whose work areas will be impacted by the new document. Collaboration and
review is performed according to the work instruction Controlled Document Review and
Approval.

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Title: Document Control Process

7.6 Controlled Document Numbering and Approval

When collaboration and review is complete, the document author makes the necessary edits to
the document and submits the final document to the Quality Assurance Document Management
department. A document manager assigns a unique identifying number and routes the
document for final approval signatures according to the work instruction Controlled Document
Numbering and work instruction Controlled Document Review and Approval.

7.7 Controlled Document Release, Access and Availability

Once all required approval signatures are obtained, the document manager makes any previous
version of the document obsolete and releases the new document for use according to work
instruction Controlled Document Release, Access and Availability

The electronic document management system (EDMS) is the source for controlled documents.
Any copy of a controlled document that exists outside of the EDMS is by definition an
uncontrolled document. Controlled documents are accessed through the electronic document
management system according to work instruction Managing EDMS User Accounts and
Standard Operating Procedure General Use of the EDMS.

7.8 Controlled Document Periodic Review

Controlled documents may be reviewed and revised at any time, however, controlled
documents are subject to an automatic periodic review every two years from the effective date
of the document. The Quality Assurance document management department initiates and
manages periodic review according to the work instruction Controlled Document Periodic
Review.

7.9 Controlled Document Retirement

There are two pathways to controlled document retirement. Upon release of a new version of a
controlled document, the previous version is retired. During periodic review or any interim
review, a controlled document may be identified for retirement. In some circumstances, a
controlled document may be retired with no replacement. The Quality Assurance document
management department retires documents in accordance with work instruction Controlled
Document Retirement and Archiving

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Title: Document Control Process

7.10 Controlled Document Archival

Retired controlled documents are retained as part of the quality record. Retired controlled
documents will be retained in accordance with the requirements and methods established in the
record management process.

8.0 EXCEPTIONS
 Documents that are not identified as controlled documents in the quality manual and
which are not required to be managed under the document control system are exempt
from the requirements of this SOP. Such documents frequently include but are not
limited to documents and records that are created and pertain to company financial
information, marketing activities, and business development activities inasmuch as they
are not required to be maintained under the quality system for compliance to federal,
state or local law.

9.0 QUALITY RECORDS

 The Quality Record (e.g. historic records of the quality management system)
 Document review and approval records (including EDMS metadata)

10.0 DOCUMENT HISTORY

Date Version Description of Change

00-00-00 1.0 New SOP

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