JP Power Horizon Sdn Bhd

(901998-H)

ISO 9001:2008 Documentation Management Efficiency (KISS)

JP Power Horizon Sdn Bhd

(901998-H)

Stephen Lim KJ
MD/Principal Consultant &Trainer Auditor B. Sc. (Hons) Biology, Master in Manufacturing Systems Engineering, PhD (Bus Mgt) in-progress Cambridge International Diploma for Teacher & Trainer (CIDTT, UK); Certificate in Vocational Education & Training (CVET, Aus)
IATF ISO/TS 16949 Lead Auditor (since 2003) IRCA ISO 9001 QMS Lead Auditor (since 2002) IRCA ISO 14001 EMS Lead Auditor (since 2004) IRCA ISO 22000 Auditor (since 2008) OHSAS 18001 Auditor (since 2008) (+6012-214 5412) (jp.power.stephen@gmail.com)

Content
Session 1: ISO 9001:2008 QMS

Documentation Requirements Session 2: Document Management Session 3: Record Management

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ISO 9001:2008 QMS DOCUMENTATION REQUIREMENTS

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Two of the Most Important Objectives in the Revision of the ISO 9000- Standard
To develop a simplified set of standards that

will be equally applicable to small as well as medium and large organizations For the amount and detail of documentation required to be more relevant to the desired results of the organizations process activities

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ISO 9001:2008 QMS Documentation Requirements

Significantly reduces documentation

requirements Is much less prescriptive Allows more flexibility in choice of documentation system

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ISO 9001:2008
Enables each organization to develop the

minimum amount of documentation needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its quality management system

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What Is a Document?
Communication of information Evidence of conformity Knowledge sharing

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Communication of Information
The type and extent of the documentation will

depend on the nature of the organizations products and processes The degree of formality of communication systems The level of communication skills The organizational structure

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Evidence of Conformity
Provision of evidence that what was

planned has actually been done. Say what you do, do what you say and prove it.

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Knowledge Sharing
In order to disseminate and preserve the

organizations experiences. Example: a technical specification, which can be used as a base for design and development of a new product.

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Document Mediums
Paper
Magnetic Electronic

Photographic
Master Sample

Other
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Clause 4.1, General Requirements

Documented statements of quality policy and

quality objectives A quality manual Documented procedures required by the international standard Documents needed by the organization to ensure effective planning, operation and control of its processes Records required by the international standard
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Documented Statements of Quality Policy (1 of 2)

Defined in Clause 5.3 Appropriate to the purpose of the organization Includes a commitment to comply with requirements and continually improve the effectiveness of the Quality Management System A framework for establishing and quality objectives
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Documented Statements of Quality Policy (2 of 2)

Defined in Clause 5.3 Is communicated and understood within the organization Is reviewed for continuing suitability

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Documented Statements of Quality Objectives

Defined in Clause 5.4.1 Includes those needed to meet requirements for product [Clause 7.1] Are established at relevant functions and levels within the organization Are measurable and consistent with Quality Policy

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Quality Manual
Minimum content specified in Clause 4.2.2 Scope of the Quality Management System, including details of and justification for any exclusions Documented procedures established for the QMS, or references to them Description of the interaction between processes of the QMS

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Quality Manual-Structure
Structure of the manual is a decision for the organization based on: Organizations size Organizations complexity Organizations culture Controlled in accordance with the requirements of Clause 4.2.3

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Documented Procedures
Required by ISO 9001:2008 Control of documents (Clause 4.2.3) Control of records (Clause 4.2.4) Internal Audit (Clause 8.2.2) Control of nonconforming product (Clause 8.3) Corrective action (Clause 8.5.2) Preventive Action (Clause 8.5.3)
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Documents Needed by the Organization

Specifically referenced in ISO 9001:2008 Quality policy (Clause 4.2.1a) Quality objectives (Clause 4.2.1a) Quality Manual (Clause 4.2.1b)

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Additional Documentation
There are several requirements of ISO 9001:2008 where an organization could add value to its Quality Management System and demonstrate conformity by the preparation of other documents

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Additional Documentation
Process maps, process flow charts,and/or

process descriptions Organization charts Specifications Work and/or test instructions Production schedules Approved suppliers lists Test and inspection plans Quality plans
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Documented Procedures
Controlled in accordance with Clause 4.2.3
May combine the procedure for several

activities into one document May require more than one document for a single procedure May require additional procedures in order to implement an effective QMS

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Records
Requirements for control of records are

different from those for other documents All records have to be controlled in accordance with the requirements of Clause 4.2.4 Organization are free to develop records that may be needed to demonstrate conformity of their processes, products, and QMS

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Required Records (1 0f 2)
Management reviews Results of design and

(5.6.1) Education, training, skills and experience (6.2.2e) Evidence that the realization processes and resulting product fulfill requirements (7.1d) Design and development inputs (7.3.2)

development reviews (7.3.4) Results of design and development verification Results of design and development validation Results of review of design and development changes (7.3.7)
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Required Records (2 of 2)
Results of supplier
Basis for calibration of

evaluations (7.4.1) To demonstrate process validity where output cannot be measured (7.5.2d) The unique identification of a product (7.5.3) Customer property (7.5.4)

measuring equipment (7.6a) Results of calibration (7.6) Internal audits (8.2.2) Release of product (8.2.2) Nonconforming product (8.3) Results of corrective action (8.5.2) Results of preventive action (8.5.3)

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Preparing to Implement a QMS

Process approach Identify the processes necessary for effective implementation Understand interactions between these processes Document the processes to assure effective operation and control

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Processes Include
Management Resources

Product realization
Measurement

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Process Analysis
Should be driving force for defining

amount of documentation, taking into account the requirements of ISO 9001:2008 Should not be the documentation that drives the processes

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Demonstrating Conformity With ISO 9001:2008

May not need extensive documentation Must be able to provide objective

evidence of effectiveness of processes and quality management system

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Objective Evidence
Data supporting the existence or verity of

something (Clause 3.8.1 of ISO 9000:2000) May be obtained through observation, measurement, test or other means Does not necessarily depend on documented procedures, records or other documents except where specifically required by ISO 9001:2008

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Objective Evidence
Where the organization has no specific

procedure for a particular activity, and this is not required by specification, it is acceptable for this activity to be conducted using as a basis the relevant clause of ISO 9001:2008 Example: Internal and external audits

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Terms and Definitions

Document - information and its supporting

medium (ISO 9000:2000 Clause 3.7.2) Procedure Specified way to carry out an activity (3.7.4) Quality Manual Document specifying the quality management system of an organization

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Terms and Definitions

Quality Plan document specifying which

procedures and associated resources shall be applied, by whom and when to a specific project (3.7.5) Record document stating results achieved or providing evidence of activities performed (3.7.6) Specification document stating requirements

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DOCUMENTS MANAGEMENT
Basics of Good Documentation and Document Control Systems

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CLAUSE 4 : QUALITY MANAGEMENT SYSTEM

4.2.3 Control of Documents
Review / Approval prior to issue. Identification and Retrievable Current Revision Status Available at all Essential Locations

Documentation PIC: Document Controller

Purpose To control QMS formats of such documents - QP, QM, forms, Control Obsolete Documents methods, etc Prevent unauthorized alteration, Control Document Changes usage & distribution of QMS NEW: Control of documents External Origin Prevent usage of obsolete documents documents require for External documents like customer the management drawings/specs/standards/etc must be system controlled (identification, distribution, registration, etc.) JP Power 2009 36

How to Control Documents

Use a standard format for procedures

Include: title, author/originator organization, department, function purpose, scope, definitions procedure, persons responsible records, forms, related documents, references authorized approval signature initial date, and dates of revisions

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How to Control Documents

(Contd)
Identify all printed copies as

uncontrolled

Store controlled versions of documents

electronically (e.g., networked computer files)

On-line read only access by employees Changes to documents made only by

authorized personnel - restricted access

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How to Control Documents

(Contd)
Schedule regular review and revision of

procedures
Notify all relevant personnel when a

procedure is changed
Keep a register of paper copies of key

documents held by individuals

Educate personnel about document controls

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Steps to Building an Effective System

Elements of Good Documentation How Much do I Need? Outline Your Document Control System Maintaining Documentation Manual Filing/Word Processing Software Manage in a Database Document Control Software Packages Common Problems with Documentation
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Annual Quality Survey Report

Identifies Document Control as the

most difficult clause to implement...

And the most difficult clause to

maintain.
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Step 1 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, therein 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 herin 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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Step 2: Have the Right Amount of Documentation

But how much documentation do I need?

Ask yourself: Will it really Impact Customer Requirements?

Avoid Creating too much:
Work instructions written for virtually

everything
Overlap and repetition - Including a

process in more than one work instruction. JP Power 2011

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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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Step 3: Outline Your Document Control System

Outline document control system

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Clarify Your Terminology:

Procedure: Describes the process. Work Instructions: Tells how to perform the process. Attachment: Information attached to the procedure to help clarify the procedure. Forms, Tables, etc.: Places to record the results of tests, audits, etc.
Procedures describe an overall process such as "Purchasing", where as work instructions would describe a more detailed portion of the procedure such as "Completing a PO" or "Ordering supplies".
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What Will You Control?

Procedures Work Instructions Forms Attachments External Docs:

Customer Drawings Prints Drawings Routers/Traveler

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Step 4: Where will you keep your documents?

Planning Your Infrastructure

ISO gives you the specs You prepare your own blue print

You may choose: A simple word processing program. An existing database program A packaged document control software.
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What Will be Best for Your Company?

Choose a system for your company based on:
Company size Computer set-up and availability Number of different processes performed Rate of change for your processes or documents
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Your company may need more than one type of system.

For example:
One for quality system documents, and One for engineering documents
These documents may be different enough to

make it best to have two distinct systems.

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Example Systems

Simple Hardcopy System

The master electronic documents are stored in Word. A Master list is prepared and kept in Excel. Hard copies are copied on to paper that is marked CONTROLLED.

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Simple Hardcopy System

The hardcopies are distributed to 3-ring notebooks throughout the facility.

The master list indicates what procedures and work instructions need to be in each book. Copies are kept to a minimum by only distributing relevant documents to each area.

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Simple Hardcopy System

One person is designated as the

Document Control Coordinator. This person

keeps the master list up-to-date Makes revisions to documents Distributes revised documents Collects the outdated documents
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Simple Hardcopy System

A Change Request Form is available for employees to initiate revisions to documents.

Changes must be approved before they are made. Changes are indicated by using the revision tool in Word. Staff must be aware of revisions.
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Online System
A Database is set-up to hold

procedures and work instructions.

Lotus Notes Packaged System

This may be organized into a Chapter

System with a chapter for each clause of the standard.

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Online System
Procedures and Work Instructions are

written in or loaded into the system. Employees are given Rights

System Administrator Author Editor Approver Read Only
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Online System
Authors write the procedures or work

instructions. The document is sent to the editor and approver for approval. When it is approved it is automatically moved into the Quality Documents and becomes available to all those with read rights.

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Online System
The documents may be viewed on the

screen or printed. Printed documents are controlled by a sunset clause

The date printed appears on all printed documents. Documents are valid only for the day they are printed.

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Online System
Some hardcopy distribution may be

necessary. A master list must be kept for distributed documents. Controlled hardcopies need to be identified.

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Online System
Revisions are made by the author, and must be

reviewed and approved by the editor and approver. The author must determine if the changes affect any process that is being performed that day.

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Engineering Prints
A master list indicating the current

revision of each print is maintained.

This is usually in the manufacturing software.

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Engineering Prints
A master file of the current print

revisions is maintained.
Simple file cabinet system An electronic CAD system

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Engineering Prints
If prints are distributed to each operation

they must be controlled.

Operators verify against electronic master list. Prints are copied and labeled with a job number. The copy is good only for the job number.

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Documents of External Origin

These documents must be included in your

document control system. For example:

Customer Prints Industry Regulations ISO Standards References used for your

documentation.

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Documents of External Origin

Control these by having a section on your

master list for documents of external origin. Include:

Document Name Current Revision Document Location(s) Document Number (Assigned by your company).

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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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RECORDS MANAGEMENT

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CLAUSE 4 : QUALITY MANAGEMENT SYSTEM

4.2.4 Control of Records
Identification Legible Storage

Documentation PIC: All departmental heads Purpose To ensure records are well kept/stored, always available upon request, not damaged, kept for sufficient years Ensure proper disposition

Retrieval
Protection Retention time Disposition
The opening sentence for clause 4.2.4 has expanded from records being "maintained" to having them "controlled". Maintaining records would simply keep them in good condition. Controlling the records means JP Power 2011 to regulate their use

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Ensuring Good Record Keeping

Good record keeping is an integral part of a QMS, and is essential to the provision of quality product & services. It is not an optional extra to be fitted in if circumstances allow.

Types of Records Kept

Handwritten notes
Emails Letters to & from

Printouts from

interested parties
Laboratory & Test

Reports
Production & quality

reports

monitoring equipment Incident reports and statements Photographs Videos Tape-recordings of phone conversations Text messages Others
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Principles of Good Record Keeping

Legible Handwriting All entries should be signed with name and job title printed alongside first entry Date and time on each entry Accurate with clear meaning Factual without abbreviations, jargon, meaningless phrases or irrelevant speculation Relevant Evidence of planned future and ongoing care

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Principles of Good Record Keeping

Identify risks/problems and action taken Communicate effectively Should not be altered or destroyed without authorisation Alterations should be signed with job title, dated and auditable Easily understood language

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Principles of Good Record Keeping

Be photocopied and scanned No coded expressions or abbreviations You should not falsify records Must be completed by trained/ authorised personnel Must be readily retrievable

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Confidentiality
Fully aware of legal requirements and

guidance regarding confidentiality, ensuring your practice is in line with national and local policy. Awareness of the rules in respect of supply and use of data for secondary purpose Follow local & customer policies when using records for work purposes

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Storage of Records
Where should records be stored?
Can notes be kept by the work station? How safe is the storage area?

Are the records safe from damage &

deterioration? Records may be stored on any appropriate medium i.e. electronic, hardcopy, CD, microfilm
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Storage of Records
Storage of quality records - current records

- old records Onsite/ off site (usually warehouse) Facility used must:- be suitable and prevent damage, deterioration, loss or unauthorised access Facilities should be alarmed with sensors (fire/ smoke detection)

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Information Systems

You should be aware of, and know how to use, the information systems and tools that are available to you in your practice. must not be shared. Similarly, do not leave systems open to access when you have finished using them.

Smartcards or passwords to access information systems

You should take reasonable measures to check that your

organisations systems for recording and storing information, whether by computer, email, fax or any other electronic means, are secure. You should ensure you use the system appropriately, particularly in relation to confidentiality.
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Retention of records
Who owns the records? What is the registrants responsibility? How long can records be retained? Are there official guidelines?
Retention times

Must have documented retention times record type (days permanently)

for each

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QUESTIONS ?

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Stephen Lim
Managing Director / Principal Consultant & Trainer 012-2145412 / jp.power.stephen@gmail.com

www.jp-power.com.my