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 Unit 2 Unit 3 Unit 4 Unit 5 Unit 6 Unit 7
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Basics of Good Documentation QMS Requirements for Document Control and Records Control Life Cycle of Documents Complying the Requirements Managing Document Requests Developing and Implementing the Document Control Procedure 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 Work Instruction Attachments Forms
Procedure: Describes the process.
Work Instructions: Tells how to perform the 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 Control of Documents Control of Records

4.2.3 4.2.4

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4.2.1 Documentation Requirement - General

5 levels of Documentation The quality management system documentation shall include a. b. c. d. documented statements of a quality policy and quality objectives, a quality manual, documented procedures required by this International Standard, 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

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Six Mandatory Procedures

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

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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7.2.2 Review of requirements related to the product

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SECTION
7.3.2 Design and development inputs 7.3.4 Design and development review

DESCRIPTION
Inputs relating to product requirements Results of the reviews and any necessary actions

7.3.5 Design and development verification

7.3.6 Design and development of validation

Results of the verification and any necessary actions

Records of the results of validation and any necessary actions

7.3.7 Control of design and development changes

7.4.1 Purchasing process

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

7.5.2 Validation of processes for production and service provision

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SECTION

DESCRIPTION

7.5.3 Identification and traceability

7.5.4 Customer property 7.6 Control of monitoring and measuring devices

Where traceability is a requirement, the unique identification of the product

Records of customer property that Has been lost, damaged, or unsuitable for use Where no standards exist, bases used for 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
Records indicates the person(s) authorizing the release of the product The nature of nonconformities and any subsequent actions taken, including concessions obtained Records for corrective action results taken

8.2.4 Monitoring and measurement of product 8.3 Control of nonconforming product 8.5.2 Corrective action

8.5.3 Preventive action 2013/10/4

Records for preventive action results taken

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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 organizations 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 ISO 9001 clause 4.2.3 applies Prescriptive: Tells you What/when/ who Records ISO 9001 clause 4.2.4 applies Descriptive: Tells you what has been done. Establish conformance to QMS

/where/how to do

Input information
Document Process Activity

Output information 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 Purchasing Order/ Contracts Procedure Before goods/services are delivered While still current Record After transactions are completed 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
i.e. the requirements to have a retention period

Control of Records

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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) (Process Owner/Originator) (Reviewer) (Approving Officer) (Document Controller/Administrator) (Document Controller/Administrator) (Document Controller/Administrator) (Process Owner/User) (Process Owner/User) (Process Owner/User)
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Review the need to initiate/update document Draft new/revised document Review for adequacy Approve Update/Register Make Copies Distribute/Withdraw Acknowledge Update/Register/Withdraw Use and Maintain
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Document Control Flow External

(User/Process Owner/Administrator) (Document Controller/Administrator) (Document Controller/Administrator) (Document Controller/Administrator) (Process Owner/User) (Process Owner/User) (Process Owner/User) Receive Update/Register Copy

Distribute/Withdraw
Acknowledge Update/Register/Withdraw

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
Quality Manual QMR/ Dept Head

Review
QMR

Approve
MD/CEO

Administer
Doc. Controller Doc. Controller Dept Head

Procedures QMR/ Dept Exec + Support Documents QMR/ Dept Exec +

QMR/ Dept Head QMR/ Dept Head

MD/CEO

QMR/ 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, (backup, 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 Dont 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?