PRIME CAP (BD) LTD.

One Prime. Best Prime. Quality Prime.

Hazi Rafiz Uddin Tower, Unique Bus Stand, Ashulia, Dhaka-1349.

DOCUMENT CONTROL PROCEDURE

1.0 PURPOSE

The purpose of this document is to establish PRIME CAP (BD) LTD. 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
PRIME CAP (BD) LTD.

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
 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
HaziRafizUddin Tower, Unique Bus Stand, Ashulia, Dhaka.
www.primecapltd.com
 PRIME CAP (BD) LTD.
One Prime. Best Prime. Quality Prime.
Hazi Rafiz Uddin Tower, Unique Bus Stand, Ashulia, Dhaka-1349.

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

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.

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

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

HaziRafizUddin Tower, Unique Bus Stand, Ashulia, Dhaka.

www.primecapltd.com
 PRIME CAP (BD) LTD.
One Prime. Best Prime. Quality Prime.
Hazi Rafiz Uddin Tower, Unique Bus Stand, Ashulia, Dhaka-1349.

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

Record (aka Quality Any written or electronic documentation providing evidence that activities were
Record) 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. Examples
Document include desk copies and copies that are transported away from the controlled
source in any manner to any location.

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)

HaziRafizUddin Tower, Unique Bus Stand, Ashulia, Dhaka.

www.primecapltd.com
 PRIME CAP (BD) LTD.
One Prime. Best Prime. Quality Prime.
Hazi Rafiz Uddin Tower, Unique Bus Stand, Ashulia, Dhaka-1349.

o Template (TMP)

o Test of Understanding (TOU)

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

07.2 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

HaziRafizUddin Tower, Unique Bus Stand, Ashulia, Dhaka.
www.primecapltd.com
 PRIME CAP (BD) LTD.
One Prime. Best Prime. Quality Prime.
Hazi Rafiz Uddin Tower, Unique Bus Stand, Ashulia, Dhaka-1349.

 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.
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.
7.3 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.
7.4 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.

7.5 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.
7.6 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

HaziRafizUddin Tower, Unique Bus Stand, Ashulia, Dhaka.

www.primecapltd.com
 PRIME CAP (BD) LTD.
One Prime. Best Prime. Quality Prime.
Hazi Rafiz Uddin Tower, Unique Bus Stand, Ashulia, Dhaka-1349.

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.
7.7 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.
7.8 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
7.9 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

HaziRafizUddin Tower, Unique Bus Stand, Ashulia, Dhaka.

www.primecapltd.com