DOCUMENT

CONTROL
Basics of Good Documentation
and Document Control Systems

Presented By:
Engr. Lyne Lerin-Osorio
(QMR)
Course Objectives:

• To enable participants to understand the basics of good

documentation.

• To understand the ISO 9001:2000 requirements on

Control of Documents and Control of Records.

• To enable participants to deploy an efficient and

effective document control in their respective processes
in accordance to the established Document Control
Procedure of NTC.

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 Course Content
Unit 1 Basics of Good Documentation
Unit 2 QMS Requirements for Document
Control and Records Control
Unit 3 Life Cycle of Documents
Unit 4 Complying the Requirements
Unit 5 Managing Document Requests
Unit 6 Developing and Implementing the
Document Control Procedure
Unit 7 Checking the Level of Understanding
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Unit 1

Basics of Good
Documentation
Step One in Building an
Effective System is:

To Have Good
Documentation!
 Good Documentation is:
• Clear
• Concise
• User friendly

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 Avoid Drowning in Detail…..

• “The purpose of this procedure is to document

the aforementioned activities, herein after
referred to as the prescribed tasks in terms that
preclude their execution in an inconsistent
manner, wherein such inconsistency may
potentially result in the prescribed tasks
delivering a result that is not repeatable or
reproducible”

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 And poorly written procedures
• Why use ten words when one will do?

– “The items hereinunder referenced in some

cases fell excessively outside normal
parameters.”

» “The procedures contained herein

are applicable to all operations in the
following departments within their
functional ambit”

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Make procedures user friendly
• Use short sentences starting with a verb.
• Avoid using the passive voice. Make it
clear who is performing the task.
• Use white space for easy reading.

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Have the Right Amount
of Documentation

But how much

documentation do I
need?
 Avoid Creating too Much:
• Work instructions written for virtually
everything
• Overlap and repetition - Including a
process in more than one work instruction.

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 Or too little:
• Lack of work instructions where the
process affects the quality of the product.
• Employees have their own way of
performing processes
• There is variation in the process because
it is not well documented

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 Documentation:
The right amount

• Remember that the goal here is

consistency for your processes.
• If two trained employees were to perform
this task, would they do it the same way?
• If the answer to this is “Maybe not” a work
instruction is appropriate.

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 Clarify Your Terminology:
• Procedure Procedure: Describes the
• Work Instruction process.

• Attachments Work Instructions: Tells

how to perform the
• Forms process.
Attachment: Information
attached to the procedure
to help clarify the
procedure.

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UNIT 2

QMS REQUIREMENTS
FOR DOCUMENT
CONTROL AND
RECORDS CONTROL
 Unit 2 Summary

• 4.2.1 Documentation Requirements

QMS Documentation Structure

• 4.2.3 Control of Documents

• 4.2.4 Control of Records

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 4.2.1 Documentation
Requirement - General
5 levels of Documentation

The quality management system documentation shall include

a. documented statements of a quality policy and quality objectives,

b. a quality manual,
c. documented procedures required by this International Standard,
d. documents needed by the organization to ensure the effective planning,
operation and control of its processes, and
e. records required by this International Standard (see 4.2.4).

NOTE 1 Where the term “documented procedure” appears within this

International Standard, this means that the procedure is established,
documented, implemented and maintained.

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 QMS Documentation Structure

QUALITY
POLICY
&
QUALITY OBJECTIVES

QUALITY MANUAL

STANDARD MANDATORY PROCEDURES

OPERATIONAL DOCUMENTS

RECORDS

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Six Mandatory Procedures

1. Control of Documents
2. Control of Records
3. Internal Quality Audit
4. Control of Nonconforming Products
5. Corrective Action
6. Preventive Action

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 ISO 9001 – Clause 4.2.3
CONTROL OF DOCUMENTS
• Documents required by the quality
management system shall be controlled.
Records are a special type of document
and shall be controlled according to the
requirements given in 4.2.4.

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 Clause 4.2.3
CONTROL OF DOCUMENTS

A documented procedure shall be established

to define the controls needed

a. to approve documents for adequacy prior to issue,

b. to review and update as necessary and re-approve
documents,
c. to ensure that changes and the current revision status
of documents are identified,
d. to ensure that relevant versions of applicable
documents are available at points of use,

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 Clause 4.2.3
CONTROL OF DOCUMENTS

e. to ensure that documents remain legible and

readily identifiable
f. to ensure that documents of external origin are
identified and their distribution controlled, and
g. To prevent the unintended use of obsolete
documents, and to apply suitable identification
to them if they are retained for any purpose.

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 Clause 4.2.4
CONTROL OF RECORDS
• Records (A special type of document, 21 records
needed)

– to provide evidence that system is being followed

and is effective and meets ISO 9001

– shall remain legible, readily identifiable and

retrievable.

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 Clause 4.2.4
CONTROL OF RECORDS

A documented procedure shall be

established to define the controls needed;
– Identification
– Storage
– Protection
– Retrieval
– Retention period
– Disposition

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 Reason for records
• The reason to keep records is for
future use as a reference in case of
questions related to contractual and
legal matters, work techniques,
verification of work done, and other
parts essential to the company running
smoothly.

• The company management should use

sound judgment as to what records are
non-essential and how long to keep a
specific record.

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SECTION
4.2.1 General
4.2.3 Control of documents
4.2.4 Control of records
5.6.1 Management Review –
General
6.2.2 Competence, Awareness,
and Training
7.1 Planning a product realization
7.2.2 Review of requirements
related to the product
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DESCRIPTION
Reference to records required by
the standard
For records are controlled according to
4.2.4
Records are established and maintained to
provide evidence of conformity
Management Review records
Education, training, skills, and experience
Evidence is recorded that the realization
processes and resulting product meet
requirements
Results of the review and actions are
rising from the review
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SECTION
7.3.2 Design and development
inputs
7.3.4 Design and development
review
7.3.5 Design and development
verification
7.3.6 Design and development of
validation
7.3.7 Control of design and
development changes
7.4.1 Purchasing process
7.5.2 Validation of processes for
production and service provision
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DESCRIPTION
Inputs relating to product
requirements
Results of the reviews and any necessary
actions
Results of the verification and any
necessary actions
Records of the results of validation and
any necessary actions
Results of the review of changes in any
necessary actions
Results of supplier evaluations and any
necessary actions are rising from the
valuation
Requirements for records as applicable
27
SECTION DESCRIPTION
7.5.3 Identification and Where traceability is a requirement,
traceability the unique identification of the
product
7.5.4 Customer property Records of customer property that
Has been lost, damaged, or unsuitable for use
7.6 Control of monitoring Where no standards exist, bases used for
and measuring devices calibration is recorded
Records of the results of calibration and
verification are maintained
8.2.2 Internal audit Records of audit results
Implied records for reporting verification follow
up activities and results
8.2.4 Monitoring and Records indicates the person(s) authorizing the
measurement of product release of the product
8.3 Control of non- The nature of nonconformities and any subsequent
conforming product actions taken, including concessions obtained
8.5.2 Corrective action Records for corrective action results taken
8.5.3 Preventive action
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Records for preventive action results taken
28
 ISO 9004
Guidelines for
Performance Improvements

The generation, use and control of

documentation should be evaluated with
respect to the effectiveness and efficiency
of the organization against criteria.

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ISO 9004 : Guidelines for
Performance Improvements

These criteria are:

– Functionality (such as speed of processing),
– User-friendliness,
– Resources needed,
– Policies and objectives,
– Current and future requirements related to
managing knowledge,
– Benchmarking of documentation systems, and
– Interfaces used by organization‟s customers,
suppliers, and other interested parties.

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 Documents vs. Records

• There is often a
confusion between
Documents and Records

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 Definition of Document
ISO 9001:2000
– Meaning data and its supporting medium.

Note: The medium can be paper, magnetic,

electronic or optical computer
disc, photograph or master
sample or a combination thereof.

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 Definition of Records
ISO 9001:2000

– Stating results achieved or providing

evidences of activities performed.

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 Documents vs. Records
Documents Records

ISO 9001 clause 4.2.3 applies ISO 9001 clause 4.2.4 applies

Prescriptive: Descriptive:
Tells you What/when/ who Tells you what has been done.
/where/how to do Establish conformance to QMS

Input information Output information

Document Process Activity Records

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 Documents vs. Records

However…

a document may evolve into a record…

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 Documents vs. Records
Examples:
Document Record

Purchasing Before After

Order/ goods/services are transactions are
Contracts delivered completed
Procedure While still current When obsolete
and archived
Forms Before it is used After it is used
(filled up)

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 Requirements

Control of Document i.e. the requirement

to be revision
controlled

Control of Records i.e. the

requirements to
have a retention
period

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 Controlled Documents
• Documents for which there are specified
requirements on:

– Initiation
– Review
– Approval
– Registration
– issuance
– Revision
– Obsolescence
– withdrawal
(not all need apply)

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 Control Methods
• The recipients are identified and updated
when changes occur.
• Control status highlighted on the
document.
• User shall not make own copies.

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UNIT 3

LIFE CYCLE OF
DOCUMENTS
 Unit 3 Summary
• Document Life Cycle
• Document Control Flow – Internal
• Document Control Flow - External

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 Document Life Cycle

Creation
Archiving
Approval

Removal
Issue

Approval Update/
Change

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Document Control Flow – Internal
(Management/Process Owner) Review the need to initiate/update document

(Process Owner/Originator) Draft new/revised document

(Reviewer)
Review for adequacy

(Approving Officer)
Approve
(Document Controller/Administrator)
Update/Register

(Document Controller/Administrator)
Make Copies
(Document Controller/Administrator)
Distribute/Withdraw

(Process Owner/User)
Acknowledge

(Process Owner/User)
Update/Register/Withdraw

(Process Owner/User)
Use and Maintain

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Document Control Flow – External

(User/Process Owner/Administrator) Receive

(Document Controller/Administrator) Update/Register

(Document Controller/Administrator) Copy

(Document Controller/Administrator)
Distribute/Withdraw

(Process Owner/User)
Acknowledge

(Process Owner/User)
Update/Register/Withdraw

(Process Owner/User)
Use and Maintain

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UNIT 4

COMPLYING WITH THE

REQUIREMENTS
 Unit 4 Summary
• Document Control
• Roles and Responsibilities
• Availability of Documents
• Masterlist and Revision Status
• Document Numbering System

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 What is Document Control?
It is
It is actually the control of information

• Increasing awareness in many organizations

• Misunderstood the requirements
• Overdone : cost of labor, time, paper
• Not enough : cost of using outdated, wrong
information
• Non-conformities often raised against, during
Quality System Audit

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 How elaborate should a
Document Control System be?
It depends on:
• Organization size and hierarchy
• Organization culture
• Number of locations (branches/field sites)
• Resource availability (e.g. full time Document
Controller)
• Technology (paper-based vs. online paperless
control
• Confidentiality and security classification

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 Defining Roles and Responsibilities
Examples
Prepare Review Approve Administer
Quality QMR/ QMR MD/CEO Doc.
Manual Dept Head Controller

Procedures QMR/ QMR/ MD/CEO Doc.

Dept Exec + Dept Head Controller

Support QMR/ QMR/ QMR/ Dept Head

Documents Dept Exec + Dept Head Dept Head

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 Availability of Documents
• Pertinent Issues (not necessarily the latest
issues)
• Appropriate documents (not necessary all)
• At all locations “where operations
essential to the effective functioning of the
system” are performed
– Usually at place of work, or within reasonable
access
– Not necessarily for every worker to get a
copy!
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 Document Numbering System
Chosen to reflect originating function (department),
type of document and number series.

Example:
XX-YY-ZZ e.g. “QA-WI-01”
XX = Department/Function Code e.g. QA, PU
YY = Type of Document e.g. QM, PR, WI, FO
ZZ = Serial running number

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 Document Numbering System
Benefits:
• Easy to identify
document ownership
and scope of
application
• Groups and indexes
QMS documents for
easy reference

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 Masterlist of Documents
and Revision Status

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UNIT 5

MANAGING DOCUMENT
CHANGES
 Unit 5 Summary
• Updating Document Changes
• Identifying Changes in Document
• Duplication of Documents
• Obsolete/Invalid Documents
• Documents on Electronic Media
• Control of Documents
• Maintaining the Validity of Documents
• Code of Practice in Using Documents

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 Updating Document Changes
• Update by replacing the entire document
• Update by replacing only the affected sections
• Use only a “Change Notice” to be attached to
the relevant document

Can be further classified as:

• Minor change
• Major change

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 Identifying Changes in
Document
• Use underline and italics to highlight the
additions
• Use strikethrough, shading , to highlight
obsolete information
• Use „revision history log‟ to indicate the changes
• Use symbols ( ) to highlight changed
specification
• Make reference to relevant Document Request
Record

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 Preventing Unauthorized
Duplication of Documents
• Color stamps to
indicate „controlled
issue‟
• Watermark feature
• Special paper (color
or grade)
• Color printer
• If stored on-line,
disable the „print
feature‟

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 Preventing Unauthorized
Duplication of Documents

• Intentions:
– Highlight awareness to prevent causal
duplication
– To guard against fraud/sabotage/theft

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 Obsolete/Invalid Document
• Obsolete – being superseded, or reach expiry
date
• Invalid – wrong, unauthorized, illegal, etc.

Disposition options for obsolete documents:

– Mark and file for reference
– Mark and recycle paper
…can be done by users directly or retrieved by
Document Controller

If recycled – need to mark obsolete

If retained – should specify retention period
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Document on Electronic Media
Additional controls which may be required:

• Protection against data corruption, virus, (back-

up, antivirus scan)
• Unauthorized read/write access (password
protection)
• Authentication of user ID
• Audit trail (log) of access transaction

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 Electronic System

• Allows effective centralized document control.

– All past and current documents in one location.
– Ease of revision and editing process allows quality
team to focus on improvement rather than
maintenance of paper documents.

– Easy access to document reviewers and

approvers list.

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 Electronic System
• Allows effective centralized document control

– Automatic document routing (Review/Approval)

– Automatic notification of Changes.

– Accurate reflection of approval time and date

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 Electronic System

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 Electronic System

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 Control of Application-Specific
Document
Best dealt within the procedure or work
instruction for that process.

Examples:
• Purchasing documents – via „Purchasing
Procedure‟
• Audit Schedule – via „Internal Quality Audit‟
procedure.
• Quotation/Proposal – via „Order Inquiry and
Processing‟ procedure.

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 Code of Practice in Using
Documents

• Should be intact.
• Printed on appropriate material.
• No unauthorized copying of „controlled
issue‟
• Able to identify who authorize the issuance.

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 Code of Practice in Using
Documents

• Able to identify issue/revision status

• Obsolete ones should be destroyed or
stamped/marked
• Don‟t remove from designated reference
location

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Maintaining Validity of Documents

Changes (addition, removal, modification) in

– Organization structure, responsibility
– Process, products, services
– Reference standards, specifications,
customer requirements

… should trigger review of relevant

documentation.

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Maintaining Validity of Documents

• Owner and users should proactively

review and update.
• Internal/external audit must also look into
it!

“ Do what you right, write what you do???”

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 DIFFERENCE BET. CONTROLLED
AND UNCONTROLLED DOCUMENT
CONTROLLED
• Controlled documents are appropriately marked with
“Master copy”, “Controlled Copy”, “Uncontrolled Copy”,
“ISSUED”. These are properly controlled thru document
code, revision no. and effectivity date, stamping,
signatures and distribution log (master list).

– Uncontrolled Copy – controlled document stamped with

“Uncontrolled Copy” which is issued for information purposes
only and will not be updated with any revision.

– Controlled Copy – controlled document stamped with “Controlled

Copy” and issued to authorized registered holders and will be
updated whenever there are revisions.

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 DIFFERENCE BET. CONTROLLED
AND UNCONTROLLED DOCUMENT

Uncontrolled Documents
• Uncontrolled documents are those documents that are not physically
within the current hard copies and do not have proper control
attached to it. It includes the proposed format (draft) of new or
revised documents that may be in soft or hard copy, photocopy of
manuals.

• Note: Internal or local controlled documents may not be controlled

as prescribed provided it will not be kept as quality record.

Draft =proposed new/revised documents that is not stamped with

either “controlled copy” or “uncontrolled copy” but is appropriately
mark as “DRAFT”

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 DIFFERENCE BET. CONTROLLED
AND UNCONTROLLED DOCUMENT

• QUESTIONS TO ASK WHEN DETERMINING WHETHER A DOCUMENT

SHOULD BE CONTROLLED: (procedures, work instructions and forms)
– Does the document guide the production of products provided by the
organization?
– Does the document guide the verification, inspection or testing of products
provided by the organization?
– Does the document define customer and/or product requirements?
– Is the document used for controlling processes?
– Is the document used for decision making by the production personnel?
– Is the document used for collecting data that could be used later for decision
making within the scope of QMS
– Is the information on the document is so critical that failure to keep it updated
would pose a risk to the organization or its customers?
– Does the document address or relate to requirement from the ISO 9001:2000

• If the answer to one or more of these questions is yes, then the

document should be controlled.

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 DIFFERENCE BET. CONTROLLED
AND UNCONTROLLED DOCUMENT
CONTROLLING FORMS

All forms must include:

• Document Code
• Title
• Revision No.
• Effectivity Date

NOTES:
• Information written shall be legible. In case of alterations/erasures, a single line
across the word's) and shall be initialed. Pentel Pen & pencil are not allowed in filling
up a form.
• Rewrite damage form.
• Only relevant versions of form shall be used in the process.
• Controlled format & requirements shall not be modified.
• Must be properly filled up.
• If the old version may be used as scratch, put an “X” across the page and used the
back portion of the form.

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 INADVERTENT USE OF
OBSOLETE DOCUMENTS:
• Updated Master list of Internally generated
documents
• Distribution list

NOTES:
• Document controller must ensure the
distribution of Document to determine the
location of obsolete document.

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 MODES IN FILING DOCUMENTS:

• Chronological – arrangement
according to Date

• Alphabetical – arrangement
from A to Z or vice-versa

• Numerical – arrangement
according to control number

• Subject – arrangement
according to name.
Mostly applied to suppliers.

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UNIT 5

DEVELOPING THE
DOCUMENT CONTROL
PROCEDURE
 UNIT 5 Summary
• Common Problems with Document Control
• Things to Consider in Developing the
Procedure
• NTC Document and Records Control
System

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Common Problems with
Document Control
 Common Problems
• Employees writing documents do not
understand the difference between a Procedure
and a Work Instruction.
• Terminology has not been defined, and is not
used in a consistent manner.
• Revisions take too long, documents are not kept
current.

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 Common Problems

• There is no process for tracking changes

or training on changes
• Inconsistent use of other documents such
as:
– forms
– attachments
– drawings
– documents of external origin

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 Common Problems
• Approval
• Distribution
• Keeping distribution
current

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 Common Problems

• Too many documents are

distributed. The system
cannot be maintained.
• Lack of control of
documents of External
Origin.

Avoid these problems by planning ahead..….

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 And All the pieces will fall
in place.

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 Unit 5 Workshop
• Objective: To know and provide solutions to the common
problem encountered in the implementation of Document
Control.

• Description: The class will be divided into groups. Their

task is to identify, by brainstorming the top two problems
they are encountering in the implementation of document
control and to come up with solutions on how to address
such problems. A representative of each group will
discuss their output to the rest of the class.

• Duration: 15 minutes preparation, 10 minutes

presentation
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 Things to Consider in Developing
the Procedure
• Ensure the Document Control Procedure
meets ISO 9001 requirements.
• Make use of the Document Change
Request Form you designed earlier in the
procedure.
• Ensure that the controls for the problems
discussed were included in the procedure.
• Remember, it is a system-wide procedure,
therefore, cascade it to all process owners.
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NTC Document and Records Control System

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 DOCUMENT AND CONTROL
CHANGES
Identify Improvement
and/or Amendment to
the Quality System

Prepare Draft of the

Improvement or
Amendment

Fill
Fillup
upDCRF
DCRF

Submit DCRF and its

attachment to Document
Controller for
Review and Approval

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UNIT 6
CHECKING THE LEVEL
OF UNDERSTANDING
Clause 4.2.3 Control of Document

• Documents related to the Standard +

External documents
• Control Procedures – establish document
and maintain
• Documents – review and approve prior to
issue for new and changes

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Clause 4.2.3 Control of Document
• Current revision status/changes are identified
• Pertinent Issues – available
• Document remain legible and readily
identifiable
• Obsolete documents – remove or identify

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What are your Views?

What are your Concerns?