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.
2013/10/4 2

Course Content
Unit 1 Unit 2 Unit 3 Unit 4 Unit 5 Unit 6 Unit 7

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

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 2013/10/4 6 .

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” 2013/10/4 7 .. • “The purpose of this procedure is to document the aforementioned activities.Avoid Drowning in Detail….

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” 2013/10/4 8 .

• Avoid using the passive voice. • Use white space for easy reading. 2013/10/4 9 .Make procedures user friendly • Use short sentences starting with a verb. Make it clear who is performing the task.

Have the Right Amount of Documentation But how much documentation do I need? .

2013/10/4 11 .Including a process in more than one work instruction.Avoid Creating too Much: • Work instructions written for virtually everything • Overlap and repetition .

• Employees have their own way of performing processes • There is variation in the process because it is not well documented 2013/10/4 12 .Or too little: • Lack of work instructions where the process affects the quality of the product.

Documentation: The right amount • Remember that the goal here is consistency for your processes. • If two trained employees were to perform this task. 2013/10/4 13 . would they do it the same way? • If the answer to this is “Maybe not” a work instruction is appropriate.

2013/10/4 14 . Work Instructions: Tells how to perform the process. Attachment: Information attached to the procedure to help clarify the procedure.Clarify Your Terminology: • • • • Procedure Work Instruction Attachments Forms Procedure: Describes the process.


2.4 2013/10/4 16 .Unit 2 Summary • 4.2.1 Documentation Requirements QMS Documentation Structure Control of Documents Control of Records • 4.3 • 4.2.

2013/10/4 17 .4. records required by this International Standard (see 4.2.2. documents needed by the organization to ensure the effective planning. NOTE 1 Where the term “documented procedure” appears within this International Standard.4). documented procedures required by this International Standard. documented. c. this means that the procedure is established. b. a quality manual. operation and control of its processes.1 Documentation Requirement .General 5 levels of Documentation The quality management system documentation shall include a. and e. documented statements of a quality policy and quality objectives. d. implemented and maintained.


2. Control of Documents Control of Records Internal Quality Audit Control of Nonconforming Products Corrective Action Preventive Action 2013/10/4 19 . 4. 5. 6. 3.Six Mandatory Procedures 1.

2. 2013/10/4 20 .2.4.3 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.ISO 9001 – Clause 4.

3 CONTROL OF DOCUMENTS A documented procedure shall be established to define the controls needed a. c. b. to ensure that relevant versions of applicable documents are available at points of use. d. 2013/10/4 21 . to review and update as necessary and re-approve documents. to approve documents for adequacy prior to issue. to ensure that changes and the current revision status of documents are identified.Clause 4.2.

and g. and to apply suitable identification to them if they are retained for any purpose. to ensure that documents remain legible and readily identifiable f. to ensure that documents of external origin are identified and their distribution controlled. To prevent the unintended use of obsolete documents.2.Clause 4. 2013/10/4 22 .3 CONTROL OF DOCUMENTS e.

readily identifiable and retrievable.4 CONTROL OF RECORDS • Records (A special type of document.2. 21 records needed) – to provide evidence that system is being followed and is effective and meets ISO 9001 – shall remain legible.Clause 4. 2013/10/4 23 .

2.4 CONTROL OF RECORDS A documented procedure shall be established to define the controls needed.Clause 4. – Identification – Storage – Protection – Retrieval – Retention period – Disposition 2013/10/4 24 .

and other parts essential to the company running smoothly.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. • The company management should use sound judgment as to what records are non-essential and how long to keep a specific record. work techniques. 2013/10/4 25 . verification of work done.

2.2 Review of requirements related to the product 2013/10/4 .SECTION General 4.1 Management Review – General 6. 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 26 7. skills. training.2.1 Planning a product realization DESCRIPTION Reference to records required by the standard For records are controlled according to 4.2.3 Control of documents 4.4 Records are established and maintained to provide evidence of conformity Management Review records Education. Awareness.4 Control of records 5.2.6. and Training 7.2 Competence.

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 7.4 Design and development review DESCRIPTION Inputs relating to product requirements Results of the reviews and any necessary actions 7.3.SECTION 7.5 Design and development verification 7.2 Design and development inputs 7.5.7 Control of design and development changes Design and development of validation Results of the verification and any necessary actions Records of the results of validation and any necessary actions Validation of processes for production and service provision 2013/10/4 27 .

including concessions obtained Records for corrective action results taken 8.SECTION DESCRIPTION 7.3 Identification and traceability 7.4 Monitoring and measurement of product 8. the unique identification of the product Records of customer property that Has been lost.5.2 Corrective action 8. or unsuitable for use Where no standards exist.2. bases used for calibration is recorded Records of the results of calibration and verification are maintained 8.3 Preventive action 2013/10/4 Records for preventive action results taken 28 .5.6 Control of monitoring and measuring devices Where traceability is a requirement.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.4 Customer property 7.5.3 Control of nonconforming product 8. damaged.5.2.

ISO 9004 Guidelines for Performance Improvements The generation. 2013/10/4 29 . use and control of documentation should be evaluated with respect to the effectiveness and efficiency of the organization against criteria.

suppliers. – Resources needed. – User-friendliness. – Benchmarking of documentation systems. and – Interfaces used by organization‟s customers.ISO 9004 : Guidelines for Performance Improvements These criteria are: – Functionality (such as speed of processing). 2013/10/4 30 . – Current and future requirements related to managing knowledge. and other interested parties. – Policies and objectives.

Records • There is often a confusion between Documents and Records 2013/10/4 31 .Documents vs.

magnetic. 2013/10/4 32 .Definition of Document ISO 9001:2000 – Meaning data and its supporting medium. electronic or optical computer disc. photograph or master sample or a combination thereof. Note: The medium can be paper.

2013/10/4 33 .Definition of Records ISO 9001:2000 – Stating results achieved or providing evidences of activities performed.

2.4 applies Descriptive: Tells you what has been done.Documents vs.3 applies Prescriptive: Tells you What/when/ who Records ISO 9001 clause 4. Records Documents ISO 9001 clause 4.2. Establish conformance to QMS /where/how to do Input information Document Process Activity Output information Records 2013/10/4 34 .

Documents vs. Records However… a document may evolve into a record… 2013/10/4 35 .

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) 2013/10/4 36 .

the requirements to have a retention period Control of Records 2013/10/4 37 .e. the requirement to be revision controlled i.Requirements Control of Document i.e.

Controlled Documents • Documents for which there are specified requirements on: – – – – – – – – Initiation Review Approval Registration issuance Revision Obsolescence withdrawal (not all need apply) 2013/10/4 38 .

Control Methods • The recipients are identified and updated when changes occur. • Control status highlighted on the document. 2013/10/4 39 . • User shall not make own copies.


External 2013/10/4 41 .Unit 3 Summary • Document Life Cycle • Document Control Flow – Internal • Document Control Flow .

Document Life Cycle Creation Archiving Approval Removal Issue Approval Update/ Change 2013/10/4 42 .

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) 2013/10/4 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 43 .

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 2013/10/4 44 .


Unit 4 Summary • • • • • Document Control Roles and Responsibilities Availability of Documents Masterlist and Revision Status Document Numbering System 2013/10/4 46 .

during Quality System Audit 2013/10/4 47 .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. paper Not enough : cost of using outdated. wrong information • Non-conformities often raised against. time.

online paperless control • Confidentiality and security classification 2013/10/4 48 .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.

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 2013/10/4 49 .

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! 2013/10/4 50 .

FO ZZ = Serial running number 2013/10/4 51 .g. PU YY = Type of Document e. “QA-WI-01” XX = Department/Function Code e. Example: XX-YY-ZZ e. type of document and number series.Document Numbering System Chosen to reflect originating function (department). WI. PR.g. QA. QM.g.

Document Numbering System Benefits: • Easy to identify document ownership and scope of application • Groups and indexes QMS documents for easy reference 2013/10/4 52 .

Masterlist of Documents and Revision Status 2013/10/4 53 .

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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 57 2013/10/4 .

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 2013/10/4 58 .

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 2013/10/4 59 .Identifying Changes in Document • Use underline and italics to highlight the additions • Use strikethrough. shading .

disable the „print feature‟ 2013/10/4 60 .Preventing Unauthorized Duplication of Documents • Color stamps to indicate „controlled issue‟ • Watermark feature • Special paper (color or grade) • Color printer • If stored on-line.

Preventing Unauthorized Duplication of Documents • Intentions: – Highlight awareness to prevent causal duplication – To guard against fraud/sabotage/theft 2013/10/4 61 .

etc. illegal. unauthorized.Obsolete/Invalid Document • Obsolete – being superseded. or reach expiry date • Invalid – wrong. 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 2013/10/4 62 .

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



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.



Electronic System
• Allows effective centralized document control
– Automatic document routing (Review/Approval) – Automatic notification of Changes. – Accurate reflection of approval time and date



Electronic System 2013/10/4 66 .

Electronic System 2013/10/4 67 .

2013/10/4 68 .Control of Application-Specific Document Best dealt within the procedure or work instruction for that process. • Quotation/Proposal – via „Order Inquiry and Processing‟ procedure. Examples: • Purchasing documents – via „Purchasing Procedure‟ • Audit Schedule – via „Internal Quality Audit‟ procedure.

• No unauthorized copying of „controlled issue‟ • Able to identify who authorize the issuance. 2013/10/4 69 .Code of Practice in Using Documents • Should be intact. • Printed on appropriate material.

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 2013/10/4 70 .

responsibility – Process.Maintaining Validity of Documents Changes (addition. modification) in – Organization structure. removal. specifications. products. 2013/10/4 71 . customer requirements … should trigger review of relevant documentation. services – Reference standards.

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???” 2013/10/4 72 .

“Controlled Copy”. – Controlled Copy – controlled document stamped with “Controlled Copy” and issued to authorized registered holders and will be updated whenever there are revisions. These are properly controlled thru document code. 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. and effectivity date. stamping. 2013/10/4 73 . CONTROLLED AND UNCONTROLLED DOCUMENT CONTROLLED • Controlled documents are appropriately marked with “Master copy”. revision no. “ISSUED”.DIFFERENCE BET. “Uncontrolled Copy”.

It includes the proposed format (draft) of new or revised documents that may be in soft or hard copy. Draft =proposed new/revised documents that is not stamped with either “controlled copy” or “uncontrolled copy” but is appropriately mark as “DRAFT” 2013/10/4 74 .DIFFERENCE BET. photocopy of manuals. • Note: Internal or local controlled documents may not be controlled as prescribed provided it will not be kept as quality record. 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.

2013/10/4 75 .DIFFERENCE BET. work instructions and forms) – Does the document guide the production of products provided by the organization? – Does the document guide the verification. then the document should be controlled. CONTROLLED AND UNCONTROLLED DOCUMENT • QUESTIONS TO ASK WHEN DETERMINING WHETHER A DOCUMENT SHOULD BE CONTROLLED: (procedures. 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.

a single line across the word's) and shall be initialed. • Must be properly filled up.DIFFERENCE BET. • Controlled format & requirements shall not be modified. 2013/10/4 76 . • Rewrite damage form. In case of alterations/erasures. CONTROLLED AND UNCONTROLLED DOCUMENT CONTROLLING FORMS All • • • • forms must include: Document Code Title Revision No. • Only relevant versions of form shall be used in the process. Pentel Pen & pencil are not allowed in filling up a form. Effectivity Date NOTES: • Information written shall be legible. put an “X” across the page and used the back portion of the form. • If the old version may be used as scratch.

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. 2013/10/4 77 .

2013/10/4 78 . Mostly applied to suppliers.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.


UNIT 5 Summary • Common Problems with Document Control • Things to Consider in Developing the Procedure • NTC Document and Records Control System 2013/10/4 80 .

Common Problems with Document Control .

• Terminology has not been defined. 2013/10/4 82 . documents are not kept current.Common Problems • Employees writing documents do not understand the difference between a Procedure and a Work Instruction. and is not used in a consistent manner. • Revisions take too long.

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 2013/10/4 83 .

Common Problems • Approval • Distribution • Keeping distribution current 2013/10/4 84 .

Avoid these problems by planning ahead. 2013/10/4 85 ..…. The system cannot be maintained.Common Problems • Too many documents are distributed. • Lack of control of documents of External Origin.

And All the pieces will fall in place.



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
2013/10/4 87

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.
2013/10/4 88

NTC Document and Records Control System 2013/10/4 89 .

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 2013/10/4 90 .


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 2013/10/4 92 .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 2013/10/4 93 .2.Clause 4.

What are your Views? What are your Concerns? .

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