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GLOBAL QUALITY SERVICESWELCOMES TO THE

ISO 9001:2008 INTERNAL AUDIT

AWARENESS PROGRAMMEAgenda

Understanding the ISO 9001:2008

Auditing Methodology

Auditor Evaluation

Date : 10th May 2012

Global Quality Services www.gqsindia.com 1

Certification Process

Documentation

Implementation

Training and Internal Audit

Certification


ISO 9001: 2008

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION

Acronyms…”ISO” in Greek means EQUAL


QUALITYDegree to which a set of inherent characteristics fulfills requirements


Quality in Different Sectors

Sectors What is Quality

Health Care Correct diagnoses, minimum wait time, lower cost

IT On time, low cost, zero bugs or errors

Food Services Hygienic food, fast delivery, good environment.

Postal ServiceFast delivery, correct delivery, low cost, free fromdamage

Academics InstitutionsOn-time knowledge delivery., low cost, qualityeducation, good infrastructure, experienced faculty

Insurance Payoff on time, reasonable cost.

Military Rapid deployment, win over the enemy

AutomotiveLess maintenance, good pick up, Less fuelconsumption


Quality management


ISO 9001 is for quality management. Quality refers to all those features of a product (or project)

which are required by the customer. Quality management means what the organization does to

ensure that its products or services satisfy the customer's requirements and Enhance customer satisfaction,

comply with any regulations applicable to those products or services.

Achieve continual improvement of its performance.

ISO 9001 in brief


ISO 9001 is the ISO's most well known standards ever.

ISO 9001 are implemented by over a million organizations in 175 countries.

ISO 9001 helps organizations to implement quality management.

Generic standards ISO 9001 is generic standard.Generic means that the same standards can be

applied: to any organization, large or small, whatever its

product or service, in any sector of activity, and whether it is a business enterprise, a public

administration, or a government department.

8Global Quality Services

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Benefits of ISO 9001

International, state-of-the-art practices for quality and environmental management.

Common language for dealing with customers and suppliers worldwide in B2B.

Increase efficiency and effectiveness. Model for continual improvement.


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Benefits of ISO 9001

Model for satisfying customers and other stakeholders.

Build quality into products and services from design onwards.


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ISO Registration and Accreditation

• The American National Standards Institute (ANSI) and the Registrar Accreditation Board (RAB), a subsidiary of the American Society for Quality Control (ASQC) have established the America National Accreditation Program for Registrars of Quality Systems

• ANSI/RAB will accredit QMS Registrars / Certification bodies and QMS Auditor Training Courses

AccreditationBodies

Registrars Supplier/Companies

Provide Accreditation to Who Register / Suppliers

Directory of Registrars Directory of Registrars / Certification Bodies


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Types of ISO Standard ISO 9000: Fundamentals and

Vocabulary

ISO 9001: Quality Management Systems Requirement

ISO 9004: Guideline to improve the Performance of ISO 9001


QMPPresents

EIGHTQUALITY MANAGEMENT PRINCIPLES


Quality Management Principles


Principle# 1 Customer Focused Organization

“Organizations depend on their customers and therefore should understand current and future customer needs, meet customers requirements and strive to exceed customer expectations.”


Principle# 2 Leadership

“ Leaders establish unity of purpose and directions of the organizations.They should create and maintain the internal environment in which people can become fully involved in achieving the organizations objectives.”


Principle# 3Involvement of People

“People at al levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit”


Principle# 4 Process Approach

“ A desired result is achieved more efficiently when related resources and activities are managed as a process.”


INDIVIDUAL PROCESS MAP

Example : SALES PROCESS

Controls

- Procedures- Limits on margin- Authorization of Quotation / offer

Output

- Quotation

Input

- Customer enquiry

Process activities :

- Review of customer requirements

- Preparation of Quotation

- Costing


TYPICAL PROCESSES

Global Quality Services www.gqsindia.com

Production Process

Design/Development

Sales or Contract Management

Purchasing

Training / Recruitment

Complaint Handling

Internal Audit /MRM

Stores Process

Quality Asssurance

20

Principle# 5 System Approach to management

“ Identifying, understanding and managing a system of interrelated processes for a given objective improves the organization’s effectiveness and efficiency”


Principle# 6 Continual Improvement

“ Continual Improvement should be a permanent objective of the organization”


Improvements

Plant Layout Process Methods Technological Jigs and Fixtures Training/Competencies


Principle# 7 Factual Approach to decision making

“ Effective decision are based on the analysis of data and information”


Principle# 8 Mutually Beneficial Supplier Relationship

“ An organization and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value”


PresentsAN

OVERVIEWOF

ISO 9001: 2008Standards


How to read a standard

The Organization Shall !!! Clause and Sub clause Documented Procedure shall be

established. (6 Times) See 4.2.4 (21 Times)


GLOBAL QUALITY SERVICESpresents

TermsAnd

DefinitionISO 9000:2005


CUSTOMER SATISFACTION Customer perception to which the customer

requirements have been fulfilled

NOTE 1: Customer Complaints are a common indicator of lower customer satisfaction but their absence does not necessarily imply high customer satisfaction.

NOTE 2: Even when customer requirements have been agreed with the customer and fulfilled, this does not necessarily ensure high customer satisfaction.


QUALITY POLICY Overall Intentions and direction of an

organization related to quality as formally expressed by top management.


QUALITY OBJECTIVE Something Sought, or aimed for,

related to qualityNote 1: Quality Objectives are generally specified for

relevant functions and levels in the organization.


Process

Set of Interrelated or Interacting activities which transforms inputs to outputs.

Note 1: Inputs to a process are generally outputs of other processesNote 2: Processes in an organization are generally planned and carried out

under controlled conditions to add value.Note 3: A Process where the conformity of the resulting product cannot be

readily or economically verified is frequently referred to as a “Special Process”


Product

The result of a Process 4 Generic Product Classifications- Hardware (Example: Solar Heater, Pump…)

- Processed Material (Example: Grease, Paint…)

- Software (Example: Computer Program…)

- Services (Example: Transport, Trading…)


PDCA Approach

PLAN, DO, CHECK, ACT Concept introduced by Dr.Deming, also

called as the Deming Cycle. PDCA can be applied to all tiers in the

organization


CONFORMITY Fulfillment of a requirement


NON-CONFORMITY Non-Fulfillment of a requirement


PREVENTIVE ACTION Action to eliminate the cause of a

Potential non-conformity or other undesirable potential situation.


CORRECTIVE ACTION Action to eliminate the cause of a

detected non-conformity or other undesirable situation.


CORRECTION Action to eliminate a detected non-

conformity



DOCUMENT:

Information and its supporting medium

40


Typical Document used in QMS

Organogram Technical Manuals Project Management Plan Method Statements Flows Chart ASL – Approved Suppliers List

41

RECORD Document stating results achieved or

providing evidence of activities performed.



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ISO 9001: 2008 Clause1. Scope2. Normative References3. Terms and Definitions4. Quality Managements Systems5. Management Responsibilities6. Resource Management7. Product Realization—Marketing-7.2, Design-7.3 ,

Purchase-7.4, Production 7.5,Stores 7.5.5 and Calibration 7.6

8. Measurement, Analysis and Improvement

44

Continual Improvement of the Quality Management System

Quality Management System – 4.0

Management Responsibility –5.0

Resource Management –6.0

Product Realization –7.0

Measurement analysis and improvement – 8.0

Product

CUSTOMER

SATISFACTION

CUSTOMER

REQUIREMENTS

Input Out put


OVERALL PROCESS MAP

PLAN Define Quality Policy & Objectives. • Define authorities & responsibilities• Evaluate training needs & competence, organize training.• Identify improvement areas• Management Review

DO

• Review of Customer requirements • Planning of product realization• Purchasing • Product & Service Provision

ACT• Complaint Handling• Corrective & Preventive Actions • Analysis of Data • Continual improvements

CHECK• Customer satisfaction• Internal audits • Inspection of products• Control of Nonconforming Products / Services.

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5 sections of requirements to translate in practice

4- QUALITY MANAGEMENT SYSTEMS(QMS, documentation requirements)5- MANAGEMENT RESPONSIBILITY(Management commitment, Customer focus, Quality Policy, Planning, Responsibility, Authority and Communication, Management Review)6- RESOURCE MANAGEMENT(Provision of Resources, Human Resources, Infrastructure, WorkEnvironment)7- PRODUCT REALIZATION(Planning, Customer Related Processes, Design and Development), Purchasing, Production /Service Provision, Control of MeasuringEquipment)8- MEASUREMENT, ANALYSIS AND IMPROVEMENT(Monitoring and Measurement, Control of Non-conforming Product, Analysis of Data, Improvement)

The ISO 9000:2008 requirements


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APPLICATIONS

All requirements of this International Standard are Generic and are Intended to be applicable to all organizations regardless of Type, Size and the Product Provided

Where any requirement of the standard cannot be applied due to the nature of an organization and its products, this can be considered for Exclusion.

Permissible Exclusions are those that do not affect the organizations ability or responsibility to provide product that meets customers and applicable Statutory and Regulatory Requirements.



Elements of standard 1.0 ScopeScope of work carried out at the company. Scope

statements must clearly define the boundaries of the QMS. All activities, products or services within the defined scope must be addressed by the QMS

Ex:Investment advisory and wealth management Services

2.0 Normative Reference:ISO 9001: 2008,ISO 9000:2005, ISO 9004:2009

Justifications for Exclusions

When an Organization Excludes certain Clause and Sub Clauses in 7.0, appropriate Justification need to be given in the Quality Manual.


Most Likely Exclusions

7.3 Design and Development 7.5.3 Identification and Traceabilty 7.5.4 Customer Property 7.6 Control of Monitoring and

Measuring Devices


Initial Clauses

3.0 Terms and Definitions:

4.0 General Requirements4.1 Outsourced processes related to QMS

to be documented


Sr. No.

Outsource Process

Control Parameters

Responsibility for Control

Records

1

Printing, Maintenance,

Utilities,

Purchase Order

HR & Finance Manager

Bills forwarded by Agencies

2Painting, Electroplating

Purchase Order /DC

Purchase Manager

Test /Inspection report

`3 Machining Drawing/POPurchase Manager

Dimensional report

5 Security AgreementHR & Finance Manager

Attendance Register

6 Courier Agreement HR & Finance Manager

Bills / Acknowledgements

7

Maintenance of Generators,UPS, Computers,Compressors

AgreementHead-Operations/CTO

Bills

8Manpower Consultants

Agreement

Head-Business Development

Bills


4.2 Documentation Requirement

4.2.1 GeneralThe Quality Management System Documentation shall include1. Documented Statements of a Quality Policy and Quality Objectives,2. A Quality Manual3. Documented procedures required by this International Standard4. Documents needed by the organization to ensure Effective Planning,

Operation and Control of its Processes.Level 1: Quality Policy and ManualLevel 2: System Procedures (6 Mandatory Procedures)Level 3: Departmental ProceduresLevel 4: Work Instructions /Method Statements/ Formats


Potential Non Conformities

Document Hierarchy not correct Mandatory procedures not available


4.2.2 Quality Manual The Organization shall establish and

maintain a Quality Manual that includes1. The scope of QMS, including details of

and Justification for any exclusions2. The Documented Procedures

established for the QMS, or reference to them; and

3. A description of the interaction between the processes of the QMS.


Levels DocumentationPolicy Policy and and

ManualManual

Systems & Systems & ProceduresProcedures

Work Work Instructions,DrawiInstructions,Drawi

ngsngs, Forms and , Forms and RecordsRecords


Potential Non Conformities Quality Manual not available with concerned

personnel Process Interaction map not available. Justification for exclusion not adequate


4.2.3 Control of Documents Documents required by the Quality

Management System shall be controlled. Quality Records are a special type of document and shall be controlled according to the requirements given in 4.2.4

P r o c e d u r e

W I

W I

W I


Potential Non Conformities List of Documents not Updated Revision status in Controlled Document

not changed Document not approved Controlled document photocopied Document Distribution not available Document Amendment not available


4.2.4 Control of Records Records shall be established and maintained to

provide evident of Conformity to requirements and of the effective operations of the Quality Management Systems.

Records shall be remain Legible, Readily Identifiable, Retrievable.

A Documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and Disposition of Records.



Records not defined for retention Records not legible Records not identifiable Record retrieval taking a long time Control of Electronic records not defined



QUALITY POLICY Overall Intentions and direction of an

organization related to quality as formally expressed by top management.

62

5.3 Quality Policy


QUALITY POLICYWE ARE COMMITTED TO MANUFACTURE AND SUPPLY HIGH QUALITY PRODUCTS BY CONTINUALLY IMPROVING OUR SYSTEMS & PROCESSES IN ORDER TO MEET CUSTOMER SATISFACTION.

DirectorDate: 12.07.2005Place: Bangalore

63

Check points for Quality Policy

Are the products / process mentioned in the policy ?

Does it address Continual improvement ? Does it address Customer satisfaction ?



Quality Policy not known to Employees. Quality Policy does not meet the

requirement of the standard. Quality Policy not reviewed at suitable

Intervals


Quality Objectives

S = SPECIFIC M = MEASURABLE A = ACHIEVABLE R = REALISTIC / RECORDABLE T = TARGETABLEIDENTIFY FEW OBJECTIVES FOR YOUR

AREA – Group Case StudyGlobal Quality Services

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Quality ObjectivesDepartment Objectives

Marketing Increasing sales from 6.0 crores to 7.5 crores for the financial year 2009-10

Production Enhancing machine utilization to 500 hours every month

Quality Minimizing defects to less than 25 nos every month

Marketing Achieving enquiry conversion of 95% every month

Marketing Achieving on time delivery to 95% every month


Function Objective Target

HRD

No. of employees 150 by 31 Mar 2011Employee attrition Less than 10%Employees enthusiasm survey – 6 monthly

Not less than 75%

Training man hour (average per 6 months per employee on roll)

Not less than 20 hours

67



Marketing (Business Development)

Order booking for 2010-11 Rs. 80 crores

Overseas market penetration in each financial year

To explore 2 new countries

Success rate for quotes to Indian clients (including tenders)

Not less than 60%


Design

Provision of ready to implement design

On Time (delays not more than 5 days for each component)

Errors of vital nature (in internal check process)

Zero

Errors of non-vital nature (in internal checks)

Less than 3%

68


Quality Objective not Specific QO not Measurable QO not Achievable QO not Realistic QO not Targetable


5.5 Responsibility, Authority and Communication.5.5.1 Responsibility

and Authority5.5.2 Management

Representative5.5.3 Internal

CommunicationMD

PRD HR QA



ISO 9001 –2008

REF.

DIR GM &MR

Mgr-Com

Shift I/CFab.

ShiftI/C PC

CNCProg

QI SK ID

Document & Record Control A A,P P

QMS Planning – Quality Policyand Objectives

A, P P P P P

MR Functions PManagement Review Meeting P P

Resource Requirements P S

Human Resources A PMaintenance P P PMarketing A, PPurchasing A P SVerification of PurchasedProduct

P P

Production S P P P PValidation P SIdentification & Traceability P P PCustomer Property P P P PPacking and Stores P P PCalibration P S PContinual Improvement P PCustomer Satisfaction P PInternal Auditing. P P PProcess Measurement andControls

P P P

Product Measurement A P P P P

Control of Non ConformingProduct

A P S S S P

Data Analysis. P P SCorrective and PreventiveActions

P S

71

5.5.2 Management Representative

Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes

1. Implementation and Development QMS 2. Periodic review of QMS With functional Heads3. Reporting to Top Management on status of QMS4. Conducting Internal Audit, Liaison with External

Bodies for certification / surveillance auditsGlobal Quality Services

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5.5.3 Internal communication

Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the QMS


Means of communication

Email facility for all personnel Circulars Review meetings Seminars Group activities to increase morale / for

adherence to business objectives



Responsibility and Authority not defined. M.R not aware about the responsibilities. Organogram not matching the actual

hierarchy. Internal Communication gap between

Production and Quality Control.


5.6 Management Review

5.6.1 General5.6.2 Review input5.6.3 Review outputFrequency at Startronix: 3 management reviews

per calendar year


Review Inputs Status of agreed actions from previous reviews Results of internal / external audits Customer feedback / complaints Processes adequacy Performance of various functions versus objectives Status of various corrective and preventive actions

initiated Adequacy of Quality Policy, objectives and the QMS Changes effected to the QMS after previous review

and the consequencesGlobal Quality Services

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Review Outputs Identified resource requirements for particular

functions and the means to be adopted to fulfill such needs

Modifications to the QMS for process improvements Field erection – installation related procedure

enhancements to cater to customer requirements.



Frequency of M.R.M not known to the Top Management / M.R

Agenda not known to the attendees. Output or Minutes describing action

plans by management not defined


6.1 Provision of Resources

The organization shall determine and provide the resources needed

1. To implement and maintain the QMS and continually improve its effectiveness, and

2. To enhance customer satisfaction by meeting customer requirements


6.2.1 General

Personnel performing work affecting product requirements shall be competent on the basis of appropriate education, training, skills and experience


6.2.2 Competence, Training and Awareness

The organization shall1. Determine the necessary competence

for personnel performing work affecting product requirements.

2. Provide training or take other actionsto satisfy these needs,

3. Evaluate the effectiveness of the actions taken,



Training Calendar not available Training Records of Employees not

available / recorded. Training Evaluation not carried out


6.3 InfrastructureThe organization shall determine,

provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable

1. Buildings, workplace and associated utilities,

2. Supporting devices(such as transport or communication).


Potential Non Conformities Infrastructure not adequate for carrying

out the work. Preventive Maintenance not carried out

as per the Schedule. Break down details not available. Pest Control not being done. Health and Hygiene practices not

practiced.Global Quality Services

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6.4 Work Environment

The organization shall determine and manage the work environment to achieve conformity to product requirements.

Proper Light, Noise, Temperature and work environment should be available



First Aid Box not available Fire Extinguishers not charged Emergency exit not available Housekeeping poor.


7.1 Planning of product realizationThe organization shall plan and develop the

processes needed for product realization.planning of product realization shall be consistent with the requirements of the other processes of the QMS.


7.2 Customer- Related processes7.2.1 Determination of

requirements related to the product

7.2.2 Review of requirements related to the product

7.2.3 Customer communication


7.2 Customer- Related processes

7.2.1 Determination of requirements related to the product

Requirements specified by the customer, including the requirements for delivery and post-delivery activities. Contractual obligations such as maintenance services and supplementary services (recycling or disposal) and warranty provisions.

7.2.2 Review of requirements related to the product

(Statutory and Regulatory requirements of product)


7.2.3 Customer communicationThe organization shall determine and

implement effective arrangements for communicating with customers in relation to

1. Product information2. Enquiries, contracts or order handling,

including amendments, and3. Customer feedback, including customer

complaints.


Potential Non Conformities Customer Requirements not adequately

captured. Enquiries not recorded Review of the Customer Order not carried out. Communication with the customer regarding

change in product not recorded.


7.3 Design and development7.3.1 Design and development planning7.3.2 Design and development inputs7.3.3 Design and development outputs7.3.4 Design and development review7.3.5 Design and development verification7.3.6 Design and development validation7.3.7 Control of design and development changes


7.4.1 Purchasing ProcessThe organization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall depend upon the effect of the purchased product on subsequent product realization or the final product.


7.4.1 Contd……Organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization’s requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained.


7.4.2 Purchasing InformationPurchasing information shall describe the product to be purchased, including where appropriate1. Requirements for approval of product,

procedures, processes and equipment2. Requirements for qualification of personnel3. Quality Management System requirements4. The organization shall ensure the adequacy of

specified purchase requirements prior to their communication to the supplier.


7.4.3 Verification of Purchased Product

The organization shall establish and implement the inspection or other activities necessary for ensuring that the purchased product meets specified purchase requirements.



Purchase / Work Order not available Purchase Specifications not adequate. List of Suppliers not available Supplier Selection / Evaluation not

carried out. Verification of Purchased Product not

recorded.


7.5 Production and Service Provision Control of Production and Service Provision Validation of Processes for Production and

Service Provision Identification and Traceabilty


7.5.1 Control of Production and Service Provision Control of Production and Service ProvisionThe availability and use of monitoring and

measuring devices equipmentThe implementation of product release, delivery

and post-delivery activities


7.5.2 Validation of Processes for Production and Service Provision

The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement.

This clause is excluded for RH, as all process at RH are verifiable


7.5.3 Identification and Traceability

The organization shall identify the product status with respect to monitoring and measurement requirements through out the product realization.

If Traceability is required, Organization shall control and record the unique identification of the product.



Identification of “Work In Process”/ work status not carried out.

Traceability records not adequate / available.


7.5.4 Customer Property

The Organization shall exercise care with Customer Property while its under the organizations control or being used by the organization. This product shall be identified, verified, protected and safeguarded. Personal data also to be considered.



Customer Property received not recorded.

Customer Property not stored to protect it from damage / loss.

Loss of Customer property not informed to customer.


7.5.5 Preservation of Product The Organization shall preserve the conformity of

product during internal processing and delivery to the intended destination. This preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of the product.



Physical stock versus Stock Ledger not matching.

F.I.F.O (First In First Out) / F.E.F.O (First Expiry First Out) not carried out.

Stacking of goods not adequate for safe handling and storage.


7.6 Control of Monitoring and Measuring Equipment The Organization shall ensure that measuring

equipment shall be calibrated at specific intervals against measurement standards traceable to International / National Standards.

Identification in order to determine its calibration status

Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.



List of Instruments not available Instrument not calibrated. Calibration status not mentioned on the

instrument. Traceability Certificates not available. Error rate of instrument not taken into

consideration for measurement.


8.1 General

To demonstrate conformity to product requirements,


8.2.1 Customer Satisfaction The Organization shall monitor information

relating to customer perception as to whether the Organization has met customer requirements.

Monitoring customer perception can include obtaining input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims and dealer reports.


Measure based on Customer related information Customer and user surveys Feedback on product Customer complaints Market Needs


8.2.2 Internal Audit The organization shall conduct Internal Audits at

planned intervals. A documented procedure shall be established to

define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results



BENEFITS OF INTERNAL AUDIT

Tells you the health of a quality system

Identify the root of a problem and plan for corrective and preventive actions with timeline

Achieve better allocation of resources

Able to avoid potentially big problem

Learn what an auditors look for

Continuous improvement

8.2.3 Monitoring and Measurement of Processes

The organization shall apply suitable methods for monitoring to demonstrate the ability of the processes to achieve planned results.

When determining suitable methods, it is advisable that the organization consider the type and extent of monitoring or measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system



Key performance indicators Desired target

Update for major costs data Once in every quarter

Bid - Order variation report & advice to customer Within 2 working days

Order acceptance to customer (OA) Within 3 working days

Handover of order and files to Projects Within 5 working days from OA

MARKETING KPI EXAMPLES

116


Process of Marketing, Purchase..not defined and measured.

Ex: Yield, Efficiency,Waste reduction


8.2.4 Monitoring and Measurement of Product

The Organization shall monitor and measure the characteristics of the product to verify that product requirements have been met.



Final Inspection not carried out Evaluation / Final Report not authorized

by concerned person.


8.3 Control of Non Conforming Product The Organization shall ensure that the product

which does not conform to product requirements is identified and controlled to prevent its unintended use / delivery.

Taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started



If the following is not carried out. D – Documented I – Identified N – Notified E – Evaluated S – Segregated D – Disposed


8.4 Analysis of Data The Organization shall

determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of Q.M.S and to evaluate where continual improvement of QMS can be made.

0

10

20

30

40

50

60

70

80

90

1st Qtr 2nd Qtr 3rd Qtr 4th Qtr

EastWestNorth



Data Analysis not carried out for the Objectives set.

Data Collected inadequate for an analysis.


8.5.1 Continual Improvement The Organization shall continually improve

the effectiveness of the Q.M.S through the use of Quality Policy, Quality Objectives, Audit Results, Analysis of Data, Corrective and Preventive Actions and Management Review.


Improvement can be incremental (small changes) Breakthrough (New Technology)

Improvement focus should be relevant to risks and benefits.



Continual Improvement as per the Plan set for making Objective not evidenced.


8.5.2 Corrective Action

The organization shall take action to eliminate the causes of Non Conformities in order to prevent Recurrence.

Effectiveness of Corrective action to be monitored.


8.5.3 Preventive Action

The Organization shall determine action to eliminate the causes of Potential Non Conformities in order to prevent their Occurrence. Effectiveness of Preventive Action to be monitored.


Correction / Corrective Action / Preventive Action Correction: Correct the Problem

Corrective Action: Prevent Reoccurrence of the problem by analyzing the cause.

Preventive Action: Prevent Occurrence of the Problem Example: When a Person gets Headache Correction: Take Pain Killer Corrective Action: Diagnose and Cure the Disease Preventive Action: Good Eye Exercise, Meditation, General

Exercise


Fish Bone Diagram

EffectTRAIN ACCIDENT

MAN

METHODS

MACHINE

MATERIAL

UNTRAINED PERSONNELPOOR MAINTENANCE

NO SYSTEM OF CHECKING BRAKES

FAULTY BRAKE PADS


Root Cause Attributed to

Man: Untrained PersonnelMachine: Poor Maintenance

Corrective Action / Preventive Action ???



Corrective / Preventive Action inappropriate.


Group Case Study

Please identify the Root Cause for the following Case Studies

Group has to presenta. Root causeb. Correctionc. Corrective action


Types of Documents used in Q.M.S

Quality Manual: Document specifying the QMS of an Organization

Procedure: Specified way to carry out an activity or a process

CONTROLLED COPY


Documentation Requirement ISO 9001: 2008 Standard Requires• Documented Statement of Quality Policy and Quality

Objectives.• A Quality Manual• Documented Procedures required by the standard• Documents needed by the organization to ensure

effective planning, operation and control of its processes.


Mandatory Procedures

CLAUSE PROCEDURE FOR4.2.3 Control of Documents4.2.4 Control of Records8.2.2 Internal Audit8.3 Control of Non Conforming

Products8.5.2 Corrective Action8.5.3 Preventive Action


VALUES OF DOCUMENTATION Enables Communication of Intent and

Consistency of Action Definition of Roles for Members Enhancement of Understanding Clarity in Processes and various other

Activities Training Needs Helps in Continual Improvement


INTERNAL AUDITINGGUIDELINES


Definition of Audit

Systematic, Independent and Documented Process for obtaining Audit Evidence and evaluating it Objectively to Determine the extent to which Audit Criteria are fulfilled.

ISO 9000: 2005



OVERVIEW OF AUDIT ACTIVITES

Planning and scheduling audit

Conducting document review

Conducting audit

Prepare audit report

Conducting follow-up

Preparing for on-site activities

WHY AUDIT?

Required by ISO 9001 Standard To Identify and Define problems To Initiate Corrective Action To Set Continuous Improvement Directions To Give a Feedback to Management on

Systems Status


Types of Audit

Product Audit** Assessing the Product Quality Systems Audit** Assessing the Quality Management

System Process Audit** Assessing the Manufacturing Process


Categories of Audit** First Party AuditInternal Quality Audit** Second Party AuditQuality Systems assessed by a

Customer or a hired Consultant on a Supplier

** Third Party AuditCertification Audit


Internal Audit Calendar

Calendar describing the whole years’ program

All Relevant Department / Section needs to be covered in the Schedule


Audit Schedule

Who will do the audit? What activities are to be covered? Time and Duration of the Audit? Number of Auditors


Typical Audit ScheduleTime: 9.00 AM to 4.00 PM

Date Auditor Auditee Time Scheduled Function ISO 9001 Clauses

<dd/mm/yy A1 A2 9 AM Production

<dd/mm/yy A1 A2 10 AM Purchase

<dd/mm/yy A1 A2 11 AM Quality Control

<dd/mm/yy A1 A2 2 PM Enquiry and Complaint Handling


MEETING OPENING MEETING

CLOSING MEETING

P: Planning, E: Execution, R: Reporting, C: Corrective Actions, Follow-up and Close out


Who are all Involved?

Auditor – A person who is a Certified Auditor or undergone a Internal Quality Audit Training Program

Auditee – An Organization or a Person who is Audited


Example of Check list

Where is the procedure on purchasing ? How do you select your suppliers? Do you conduct audit at suppliers? What records do you maintain?


Most Preferred way of Questioning

5 Ws and 1 H TheoryLike What, Where, When, Who, Why and

How and SHOW ME


Time Management Planning and

Preparation

Being Punctual

Avoid Time Wasting…..

like Walking around, Smoking, Frequent Tea Breaks, Friendly Chat, Gossip


FACT FINDING

Documents Records Data Summaries Reports Observations of Activities Statements of Workmen or Related

PersonnelGlobal Quality Services

www.gqsindia.com 152

Fact Finding Methods

Reading Communicating Interviewing Listening To and Fro Checking Use of Check List


Communicating with the Auditee Message to be inline with*Purpose, * Audience, *Situation

Use of Simple Language

Structured / Organized Message


Body Language

Eye Contact

Silence at the End of a Question


Judge Content not details Listen for Ideas Be Flexible Work as listening Resist Distraction Capatilizing on fact


Audit Finding

Non conformities Major Minor

Observations (AFI) Potential problems Risks Inefficiencies Failure to apply best practices



Various formats can be used depending on auditee (vendors, management or auditee)

Usually include name and location of auditee, date of audit, audit plan, audit observations, classification of non-compliances, recommendations or expectations

Should write against a standard Focus on deficient conditions and not people Include any positive observations Keep the audit report simple and clear

AUDIT FINDING

Audit Finding Non conformities

Major:The absence of one or more required elements or a situation which raises significant doubt that product meets specified requirements. (system breakdown)

Minor: A lapse of discipline or control during implementation of systems/ procedural requirements which does not indicates that product meets specified requirements.


Non Conformance or Corrective Action Request

Contains Non Conformance along with Associated Objective Evidence and Attribution to Specific ISO 9001: 2008 Clause, in a Pre Designed Format.


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CLOSURE

Follow-up and closing of loop:

• Receive a satisfactory response from auditee and their commitment to correct for any deficiency

• Ensures CAPA identify the root cause and they are satisfactory, accomplished and documented

• Timeframe for CAPA is being followed

• Verify and track CAPA by scheduling a follow-up audit and/or requesting for an updated SOP


Bear in Mind…. Not to Criticize Not to Underestimate any person To be Open minded To be Practical Not to get Distracted To be a Good Listener To have a Fair Knowledge about ISO

9001:2008 Standard !!!!!!


On Completion

Say THANKS !!!!


INTERNAL QUALITY AUDIT TEST

FINAL AUDITOR CERTIFICATION

TEST

TIME : 45 MINUTES


INTERNAL QUALITY AUDIT TEST

Write your findingsDecide which ones are non-

conformities,observation


GLOBAL QUALITY SERVICES THANKS WHOLE HEARTEDLYFOR THE COOPERATION EXTENDED DURING

THE TRAINING PROGRAM.

WISHES YOU A VERY BRIGHT BUSINESS FUTURE !!!!!
