Document Control Process
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).
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
Form Control Copyright © Ticalion Quality Management Services, LLC. All rights reserved. The contents of this
document are proprietary to Ticalion Quality Management Services, LLC Unauthorized use,
TMP-DOC-01-01-03 v 1.0
disclosure and reproduction are strictly prohibited. Non-transferable, single entity use license
Effective: 00 Jan 0000 provided to purchaser. Proof of purchase required.
Document Number: SOP-DOC-01
Version Number: 1.0
Acronym/Term Definition
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.
Form Control Copyright © Ticalion Quality Management Services, LLC. All rights reserved. The contents of this
document are proprietary to Ticalion Quality Management Services, LLC Unauthorized use,
TMP-DOC-01-01-03 v 1.0
disclosure and reproduction are strictly prohibited. Non-transferable, single entity use license
Effective: 00 Jan 0000 provided to purchaser. Proof of purchase required.
Document Number: SOP-DOC-01
Version Number: 1.0
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
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.
Form Control Copyright © Ticalion Quality Management Services, LLC. All rights reserved. The contents of this
document are proprietary to Ticalion Quality Management Services, LLC Unauthorized use,
TMP-DOC-01-01-03 v 1.0
disclosure and reproduction are strictly prohibited. Non-transferable, single entity use license
Effective: 00 Jan 0000 provided to purchaser. Proof of purchase required.
Document Number: SOP-DOC-01
Version Number: 1.0
7.0 PROCESS
7.1 Controlled Document Hierarchy
o Policy (POL)
o Manual (MAN)
o Plan (PLN)
o Flowchart (FLW)
o Form (FRM)
o Protocol (PCL)
o Template (TMP)
Form Control Copyright © Ticalion Quality Management Services, LLC. All rights reserved. The contents of this
document are proprietary to Ticalion Quality Management Services, LLC Unauthorized use,
TMP-DOC-01-01-03 v 1.0
disclosure and reproduction are strictly prohibited. Non-transferable, single entity use license
Effective: 00 Jan 0000 provided to purchaser. Proof of purchase required.
Document Number: SOP-DOC-01
Version Number: 1.0
Controlled documents exist within a defined controlled document lifecycle. The following are the
primary steps in the controlled document lifecycle.
Writing documents
Refer to Figure 2: Controlled Document Lifecycle, for a general schematic of the controlled
document lifecycle.
Approval Revision
Form Control Copyright © Ticalion Quality Management Services, LLC. All rights reserved. The contents of this
document are proprietary to Ticalion Quality Management Services, LLC Unauthorized use,
TMP-DOC-01-01-03 v 1.0
disclosure and reproduction are strictly prohibited. Non-transferable, single entity use license
Effective: 00 Jan 0000 provided to purchaser. Proof of purchase required.
Document Number: SOP-DOC-01
Version Number: 1.0
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 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.
Effective support documents are made accessible and available for use
Refer to Figure 3, Controlled Document Lifecycle – Level 5 Support Documents, for a general
schematic of the Level 5 support document lifecycle.
Form Control Copyright © Ticalion Quality Management Services, LLC. All rights reserved. The contents of this
document are proprietary to Ticalion Quality Management Services, LLC Unauthorized use,
TMP-DOC-01-01-03 v 1.0
disclosure and reproduction are strictly prohibited. Non-transferable, single entity use license
Effective: 00 Jan 0000 provided to purchaser. Proof of purchase required.
Document Number: SOP-DOC-01
Version Number: 1.0
Record
Write/ Effective/ Archive
Review Approval Execution Review/
Create Available Record
Approval
Note: Level 5 support document periodic reviews occur with the parent Level 3 or 4 controlled
document periodic review.
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.
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.
Form Control Copyright © Ticalion Quality Management Services, LLC. All rights reserved. The contents of this
document are proprietary to Ticalion Quality Management Services, LLC Unauthorized use,
TMP-DOC-01-01-03 v 1.0
disclosure and reproduction are strictly prohibited. Non-transferable, single entity use license
Effective: 00 Jan 0000 provided to purchaser. Proof of purchase required.
Document Number: SOP-DOC-01
Version Number: 1.0
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.
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.
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.
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
Form Control Copyright © Ticalion Quality Management Services, LLC. All rights reserved. The contents of this
document are proprietary to Ticalion Quality Management Services, LLC Unauthorized use,
TMP-DOC-01-01-03 v 1.0
disclosure and reproduction are strictly prohibited. Non-transferable, single entity use license
Effective: 00 Jan 0000 provided to purchaser. Proof of purchase required.
Document Number: SOP-DOC-01
Version Number: 1.0
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.
The Quality Record (e.g. historic records of the quality management system)
Document review and approval records (including EDMS metadata)
Form Control Copyright © Ticalion Quality Management Services, LLC. All rights reserved. The contents of this
document are proprietary to Ticalion Quality Management Services, LLC Unauthorized use,
TMP-DOC-01-01-03 v 1.0
disclosure and reproduction are strictly prohibited. Non-transferable, single entity use license
Effective: 00 Jan 0000 provided to purchaser. Proof of purchase required.