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ISO 9001:2008ISO 9001:2008Documentation ManagementDocumentation Management
Efficiency (KISS)Efficiency (KISS)
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)
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 organization’s 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 organization’s 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 organization’s 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 ObjectivesDefined 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:
Organization’s size Organization’s complexity Organization’s 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 (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)
Results of design and 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 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)
Basis for calibration of 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
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Basics of Good Documentationand
Document Control Systems
• Review / Approval prior to issue.
• Identification and Retrievable• Current Revision Status• Available at all Essential
Locations• Control Obsolete Documents• Control Document Changes
• NEW: Control of External Origin documents require for the management system
•Documentation•PIC: Document Controller
Purpose•To control QMS formats of such documents - QP, QM, forms, methods, etc•Prevent unauthorized alteration, usage & distribution of QMS documents•Prevent usage of obsolete documents•External documents like customer drawings/specs/standards/etc must be controlled (identification, distribution, registration, etc.)
CLAUSE 4 : QUALITY MANAGEMENT CLAUSE 4 : QUALITY MANAGEMENT SYSTEMSYSTEM
4.2.3 Control of Documents4.2.3 Control of Documents
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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 (Cont’d)
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 (Cont’d)
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?
Avoid Creating too much:
Work instructions written for virtually everything
Overlap and repetition - Including a process in more than one work instruction.
Ask yourself: Will it really Impact Customer Requirements?
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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
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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 ProblemsEmployees 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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4.2.4 Control of Records4.2.4 Control of Records Identification Legible StorageStorage Retrieval ProtectionProtection Retention timeRetention time DispositionDisposition
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 to regulate their use
CLAUSE 4 : QUALITY MANAGEMENT CLAUSE 4 : QUALITY MANAGEMENT SYSTEM SYSTEM
•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
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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 interested parties
Laboratory & Test Reports
Production & quality reports
Printouts from 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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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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Principles of Good Record Keeping
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 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)
Storage of Records
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.
Smartcards or passwords to access information systems must not be shared. Similarly, do not leave systems open to access when you have finished using them.
You should take reasonable measures to check that your organisation’s 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 for each record type (days – permanently)
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QUESTIONS ?
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Stephen LimManaging Director / Principal Consultant & Trainer
012-2145412 / [email protected]
www.jp-power.com.my
