Internal Audit

ISO 9001:2000 QUALITY MANAGEMENT SYSTEM INTERNAL AUDIT

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What is Quality ??  Fitness for use  Conformance to requirements  Accuracy  Perfection  Zero Defect  Adequacy  Cost Effectiveness

“ THE TOTALITY OF FEATURES AND CHARACTERISTICS OF A PRODUCT OR SERVICE THAT BEAR UPON ITS ABILITY TO SATISFY STATED OR IMPLIED NEEDS “ 2

Quality Customers’ expectations of quality are not the same for different classes of products or services. Best-in-Class Quality Best-in-class quality means being the best product or service in a particular class of products or services. World-Class Company Being a world-class company means that each of its products and services are considered best-in-class by its customers.

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ISO

International Organization for Standardization Founded in 1946 in Geneva , Switzerland ISO is a non-governmental organization that forms a bridge between the public and private sectors. World's largest developer and publisher of International Standards. ISO is composed of more than 90 members countries

"ISO", derived from the Greek. ISO, meaning "equal". Whatever the country, whatever the language, the short form of the organization's name is always ISO. "ISO", is a system audit not for product audit

ISO 9001:2000 ISO

- International Organization for Standardization

9001

- Number assigned by ISO 4

? 5

OBJECTIVES OF ISO 9000:2000 requirements

EXPECTED QUALITY by the Customer

PLANNED QUALITY by the Company

Measurement of the Customer’s satisfaction

Measurement of the Performance of the Company

PERCEIVED QUALITY by the Customer

PRODUCED QUALITY by the Company

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The 8 principles of QMS …

• • • • • • • •

Customer focus Leadership Involvement of people Process approach System approach to management Continual improvement Decisions based on facts Relationship with suppliers mutually beneficiary

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The 8 principles of QMS …

Customer Focus Organizations Depends on

Determine customer needs & expectations

Customers . Requirements

Principle 1

Customer satisfaction 8

The 8 principles of QMS … Applying the principle of Customer Focus typically leads to  Researching and understanding customer needs and expectations  Ensuring that the objectives of the organization are linked to customer needs and expectations  Communicating customer needs and expectations throughout the organization  Measuring customer satisfaction and acting on the results.  Systematically managing customer relationships.  Ensuring a balanced approach between satisfying customers and other interested parties (such as owners, employees, suppliers, financiers, local communities and society as a whole). 9

The 8 principles of QMS …

Leadership Leaders must set the direction of the organization Leaders must create and maintain internal environment that encourages people to achieve the organization’s objectives

Principle 2 10

The 8 principles of QMS … Applying the principle of Leadership typically leads to

 Establishing a clear vision of the organization's future  Establishing trust and eliminating fear.  Setting challenging goals and targets.  Providing people with the required resources, training and freedom to act with responsibility and accountability  Inspiring, encouraging and recognizing people's contributions.

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The 8 principles of QMS …

Involvement of people Must encourage the involvement of people at all level Must help people to develop and use their abilities

Principle 3 12

The 8 principles of QMS … Applying the principle of Involvement of people typically leads to

 People understanding the importance of their contribution and role in the organization.  People accepting ownership of problems and their responsibility for solving them.  People freely sharing knowledge and experience.  People openly discussing problems and issues.  People identifying constraints to their performance.

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The 8 principles of QMS …

Process Approach Control Input

Activities + Resources

Output

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

Principle 4 14

The 8 principles of QMS …

Processes – understand interaction Process C

Process A

Process B

Process D

Input Output Control 15

The 8 principles of QMS … Applying the principle of Process approach typically leads to

 Identifying the interfaces of key activities within and between the functions of the organization.  Focusing on the factors such as resources, methods, and materials that will improve key activities of the organization.  Systematically defining the activities necessary to obtain a desired result.  Establishing clear responsibility and accountability for managing key activities.

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The 8 principles of QMS …

System Approach to Management Identifying, understanding and managing interrelated processes as a system contributes to the organization's effectiveness and efficiency in achieving its objectives.

Principle 5 17

The 8 principles of QMS … Applying the principle of System approach to management typically leads to

 Structuring a system to achieve the organization's objectives in the most effective and efficient way.  Providing a better understanding of the roles and responsibilities necessary for achieving common objectives and thereby reducing cross-functional barriers  Targeting and defining how specific activities within a system should operate  Continually improving the system through measurement and evaluation 18

The 8 principles of QMS …

Continual Improvement Customer Focus Deming’s wheel (P.D.C.A.)

PLAN

DO

CHECK

Principle 6

ISO 9000

ACT

Continual Improvement

Continual improvement of the organization's overall performance should be a permanent objective of the organization. 19

The 8 principles of QMS … Applying the principle of continual improvement typically leads to

 Providing people with training in the methods and tools of continual improvement.  Making continual improvement of products, processes and systems an objective for every individual in the organization  Establishing goals to guide, and measures to track, continual improvement.  Establishing goals to guide, and measures to track, continual improvement.

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The 8 principles of QMS …

Decision based on facts Effective decisions are based on the analysis of data and information

Principle 7 21

The 8 principles of QMS … Applying the principle of Decision based on the facts typically leads to

 Ensuring that data and information are sufficiently accurate and reliable.  Making data accessible to those who need it.  Analyzing data and information using valid methods.  Making decisions and taking action based on factual analysis, balanced with experience and intuition.

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The 8 principles of QMS …

Mutually beneficial supplier relationships

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

Principle 8 23

The 8 principles of QMS … Applying the principle of mutually beneficial relationships typically leads to

 Inspiring, encouraging and recognizing improvements and achievements by suppliers.  Clear and open communication.  Establishing joint development and improvement activities  Identifying and selecting key suppliers.

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ISO 9000:2000 Family

•ISO 9001:2000 – Quality Management Systems: REQUIREMENTS (WHAT ?) ISO 9001 oriented effectiveness and certification, •ISO 9004:2000 - Quality Management Systems: GUIDELINES FOR PERFORMANCE IMPROVEMENTS (HOW ...?) •ISO 9000:2000 – Quality Management Systems: Fundamentals and vocabulary •ISO 19011:200X – Guidelines for quality and/or environmental management systems auditing.

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ISO 9000:2000 Support Documents

TWO TECHNICAL SUPPORT DOCUMENTS : •ISO 1000x – Technical brochure - Selection & Use •ISO 1000y - Principles and application of quality management

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The ISO 9000:2000 requirements

Five Operating Elements 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, Work Environment)

7- PRODUCT REALIZATION (Planning, Customer Related Processes, Design and Development), Purchasing, Service Provision, Control of Measuring Devices)

8- MEASUREMENT, ANALYSIS AND IMPROVEMENT (Monitoring and Measurement, Control of Non-conforming Product, Analysis of Data, Improvement) 27

The ISO 9000:2000 requirements Continual improvement of the Quality Management System

Input Data

Product / Service Realization

Output Data

Product Service

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CUSTOMERS

Requirements

CUSTOMERS

Measurement, Analysis and Improvement

Resource Management

Satisfaction

Management Responsibility

QUALITY MANAGEMENT SYSTEM

4 Quality management system 4.1 General requirements Establish , document , implement and maintain a QMS and continually improve its effectiveness in accordance with the standard

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QUALITY MANAGEMENT SYSTEM

4.1 General Requirements • Identify the processes necessary for QMS • Determine the sequence and interaction of processes • Determine criteria & methods to ensure effective operation & control of the processes • Ensure availability of resources and information needed to support the operation & monitoring of the processes • Measure , monitor and analyze processes • Implement action necessary to achieve planned results & continual improvement

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QUALITY MANAGEMENT SYSTEM

4.1 General Requirements • Manage the processes in accordance with standard • Ensure control of outsourced processes affecting product conformity • Identify control of outsourced processes within the QMS Note: Processes needed for QMS include processes for management activity , provision of resources , product realization and measurement

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QUALITY MANAGEMENT SYSTEM

4.2 Documentation requirements 4.2.1 General QMS documentation must include • Quality Policy • Quality objectives • Documented procedure required by standard • Documents required by organization to ensure effective planning , operation & control processes • Quality records required by the standard

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QUALITY MANAGEMENT SYSTEM

4.2.1 General Basis of Auditing ( Auditor may look for ) Availability of

• Statements of Quality Policy and Objectives • Quality Manual • Availability of Documented Procedure 4.2.3

Control of Documents

4.2.4

Control of records

8.2.2

Internal Audit

8.3

Control of Nonconforming products

8.5.2

Corrective Action

8.5.3

Preventive Action

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QUALITY MANAGEMENT SYSTEM

4.2.2 Quality manual The Organization shall establish and maintain a quality manual that include as minimum : • The scope of QMS including details of , and justification for , and exclusions • Documented procedures or reference • Description of the interaction between the processes of the QMS

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QUALITY MANAGEMENT SYSTEM

4.2.3 Control of Documents Documents required by the quality management system Shall be controlled Documented procedures to: • Approve documents prior to issue • Review , update as necessary and re-approve documents • To identify the changes and the current revision status of documents • To ensure documents remain legible , readily identifiable • Ensure relevant versions of applicable documents are available at points of use • Ensure that the documents of external origin are identified and distribution controlled • Obsolete documents are prevented from unintended use and identified if kept for any reason 35

QUALITY MANAGEMENT SYSTEM

4.2.3 Control of Documents Basis of Auditing (Auditor may look for )

•

Procedures for document approval , document review ,re approval , distribution and control mechanism

• • •

Availability of relevant version of documents at all points of use Mechanism for preservation of obsolete copies usage Systems for control of use external origin documents

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QUALITY MANAGEMENT SYSTEM

4.2.4 Control of Records • •

Records must be established and maintained Records must be legible , readily identifiable and retrievable • Documented procedure for control of identification , storage , retrieval ,retention time and disposition of quality records Basis of Auditing ( Auditor may look for )

•

Procedure for record control

•

Details of retention period

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MANAGEMENT RESPONSIBILITY

5 . Management Responsibility 5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning 5.4.1 Quality objectives 5.4.2 QMS planning

5.5 Responsibility , authority and communication 5.5.1 Responsibility , authority 5.5.2 Management representative 5.5.3 Internal communication

5.6 Management review 5.6.1General 5.6.2 Review input 5.6.3 Review output

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MANAGEMENT RESPONSIBILITY

5.1 Management Commitment Top Management shall provide evidence of commitment to the development implementation and improvement of QMS by: • Communicating the importance of meeting customer and statutory and regulatory requirements • Establishing quality policy & objectives • Conducting Management review • Ensuring the availability of resources

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MANAGEMENT RESPONSIBILITY

5.2 Customer Focus Top Management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction Basis of Auditing ( Auditor may look for )

• Evaluation of customers survey • Market analysis • Complaint documentation

/ analyses

• Customer satisfaction analyses 40

MANAGEMENT RESPONSIBILITY

5.3 Quality policy Top management shall ensure that the quality policy a) is appropriate to the purpose of the organization b) commitment to comply with requirements & continually improve the effectiveness of the QMS c) framework for establishing and understood within the organization d) is reviewed for continuing suitability Basis of Auditing ( Auditor may look for )

•

Documentation of quality policy

•

Able to give frame-work to establish objectives

•

Mechanism for communication of the quality policy – Training schedule and evidence

to the employees 41

MANAGEMENT RESPONSIBILITY

5.4.1 Quality Objectives • Establish quality objectives at relevant functions and level • Objectives must be measurable & consistent with the quality policy • Include those needed to meet requirements for product { see 7.1 (a)} • Documented {see 4.2.1 (a)} Basis of Auditing ( Auditor may look for )

•

Availability of quality objectives at relevant levels of the organization

•

Mechanism for the communication to employees

•

Are there SMART objectives ?

•

Improvement objective related to the product 42

MANAGEMENT RESPONSIBILITY

5.4.2 Quality planning Top management shall ensure that • Planning of the QMS is carried out in order to meet requirements given in 4.1 , as well as the quality objectives • the integrity of the QMS integrity must be maintained when changes are planned and implemented

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MANAGEMENT RESPONSIBILITY

5.5 Responsibility ,authority and communication 5.5.1

Responsibility and authority

Top management shall ensure that the responsibilities and authorities are defined and and communicated within the organization Basis of Auditing ( Auditor may look for )

•

Role , function and responsibility matrices

•

Organizational chart

•

Authorities shall be clearly known to employees along with responsibilities

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MANAGEMENT RESPONSIBILITY

5.5.2 Management Representative Top management shall appoint a member of the management who , irrespective of other responsibility , shall have responsibility and authority that includes

 Ensuring that processes needed for the QMS are established , implemented and maintained

 Reporting on performance of QMS including needs for

improvement

 Ensuring the promotion of awareness of customer needs & requirements Note : Responsibility may include liaison with external parties in relation to QMS

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MANAGEMENT RESPONSIBILITY

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

Basis of Auditing ( Auditor may look for )

 Minutes and reports of meeting  Notice boards , internal magazines and circular letter  Audio-visual and electronic media  Employee suggestion system 46

MANAGEMENT RESPONSIBILITY

5.6 Management Review 5.6.1 General Review of the QMS by top management at planned intervals to:  Ensure QMS suitability , adequacy & effectiveness  Assess opportunities for improvement  Evaluate the need for changes to QMS including policy & objectives

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MANAGEMENT RESPONSIBILITY

5.6 Management Review 5.6.2 Review input Review performance and improvement opportunities related to :  Audit results  Customer feedback  Process performance & product conformity  Status of preventive and corrective actions  Follow up actions from earlier reviews  Changes that could affect the QMS  Recommendation for improvement 48

MANAGEMENT RESPONSIBILITY

5.6 Management Review 5.6.3 Review output Output to include actions related to :  Improvement of the effectiveness of the QMS and its processes  Improvement of product related to customer requirements  resource needs Result of management review must be recorded

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QUALITY MANAGEMENT SYSTEM

5.6 Management Review Basis of Auditing ( Auditor may look for ) Availability of

 Management review meeting reports  Customer complaints  Process data analysis  Product data analysis  Evidence of corrective and preventive action  Resource requirements and application planning  Objectives and targets achievements  Business plan  Investment plan  HR Planning

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RESOURCE MANAGEMENT

6. RESOURCE MANAGEMENT 6.1 Provision of resource 6.2 Human resource 6.2.1 General 6.2.2 Competence , awareness and training 6.3 Infrastructure 6.4 Work environment

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RESOURCE MANAGEMENT

6.1 Provision of Resources The organization shall determine and provide the resources needed to :  Implement , maintain the QMS and continually improve its effectiveness  Enhance customer satisfaction by meeting customer requirements Basis of Auditing ( Auditor may look for )

 Investment planning related to human resource  Staffing schedules  Other target budgets / Equipment enhancement program 52

RESOURCE MANAGEMENT

6.2 Human Resources 6.2.1 General Personnel performing work affecting product quality must be competent on the basis of appropriate education , training , skills and experience Basis of Auditing ( Auditor may look for )

 Job / function profiles – competency requirements at various levels  Competency mapping – minimum requirements v/s actual available

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RESOURCE MANAGEMENT

6.2 Human Resources 6.2.2 Competence , awareness and training The organization shall Determine the necessary competence for personnel performing work affecting product quality Provide training or take other actions to satisfy these needs Evaluate the effectiveness of the actions taken Ensure that its personnel are aware of the relevance and importance of their activities and how contribute to the quality objectives Maintain appropriate records of education , training , skills and experience 54

RESOURCE MANAGEMENT

6.2 Human Resources 6.2.2 Competence , awareness and training

Basis of Auditing ( Auditor may look for )

 Competence needed  Skill gap analysis  Identification of training needs  Provision of training  Evaluation of training effectiveness  Job descriptions  Related records  Employee’s awareness about relevance and importance of their work  Analyses of labor turnover or staff absenteeism 55

RESOURCE MANAGEMENT

6.3 Infrastructure The organization shall Identify ,provide & maintain the infrastructure needed to achieve product conformity . Infrastructure includes as applicable  Building ,workspace & associated utilities  Process equipments (hardware & software )  Supporting services ( Transport , communication ) Basis of Auditing ( Auditor may look for )

 Plants and production facilities  Corrective and Preventive maintenance  Trends of maintenance  Equipment Performance

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RESOURCE MANAGEMENT

6.4 Work Environment The organization shall determine and manage the work environment needed to achieve conformity to product requirements

Physical factors • Heat •Light

• Noise • Pollution

• Vibration • Air flow

• Cleanliness •Hygiene

Basis of Auditing ( Auditor may look for )

 Evidence of instruction in occupational safety  Evidence of the satisfaction of statutory and regulatory requirements or conditions

 Work place investigations

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PRODUCT REALIZATION

7 Product Realization 7.1 Planning of product realization 7.2 Customer related processes 7.3 Design & development 7.4 Purchasing 7.5 Production & service operation 7.6 Control of measuring & monitoring devices

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PRODUCT REALIZATION

7.1 Planning of product realization The organization shall plan and develop the processes needed for product realization . Planning must determine as appropriate :  Quality objectives and requirements for the product  the need for processes , documentation , resources specific to the product  verification and validation activities & acceptance criteria for product acceptance  Records The output of this planning shall be in a form suitable for the organization’s methods of operations. Examples Production Control plan Project Plan 59

PRODUCT REALIZATION

7.2 Customer related process 7.2.1 Determination of requirements related to the products The organization shall determine  Requirements specified by the customer , including the requirements for delivery and post delivery activities  Requirements not stated by the customers but necessary for specified or intended use  Statutory and regulatory requirements related to the products  Any additional requirements determined by the organization Basis of Auditing ( Auditor may look for )

 Customer inquiries  Orders  Records on discussion with customers

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PRODUCT REALIZATION

7.2 Customer related process 7.2.2 Review of requirements related to the products The organization shall review the requirements related to the product. This review shall be conducted prior to the organization’s commitment to supply a product to the customer and shall ensure that  Product requirements are defined  Contract or order requirements differing from those previously expressed are resolved  The organization has the ability to meet the defined requirements Basis of Auditing ( Auditor may look for )

 Evidence of contract review  Documentation of amendments  Order conformation records

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PRODUCT REALIZATION

7.2 Customer related process 7.2.3 Customer Communication The organization shall determine and implement effective arrangements for communication with customers in relation to  Product information  Enquiries , contracts or order handling , including amendments  Customer feedback , including customer complaints Basis of Auditing ( Auditor may look for )

 Customer’s product specification  Contracts  Acknowledgement of order  Customer requests for changes

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PRODUCT REALIZATION

7.3 Design and Development 7.3.1 Design & development planning 7.3.2 Design & development input 7.3.3 Design & development output 7.3.4 Design & development review 7.3.5 Design & development verification 7.3.6 Design & development validation 7.3.7 Control of design & development changes

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PRODUCT REALIZATION

7.3 Design and Development 7.3.1 Design & development planning The organization shall plan and control the design and development of product During the planning to include : * D&D stages * required review , verification and validation activities * responsibilities & authorities for D&D  Interfaces between groups must be managed  Planning output shall be updated as the D&D progresses

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PRODUCT REALIZATION

7.3 Design and Development 7.3.2 Design & development input  Determine & record product requirements including * functional & performance requirements * applicable statutory and regulatory requirements * information from previous similar designs * any other essential requirements  Review input for adequacy

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PRODUCT REALIZATION

7.3 Design and Development 7.3.3 Design & development outputs  D&D output must * meet the input requirements * provide information for purchasing ,production or service provision * contain or reference acceptance criteria * define characteristics essential for proper & safe use  Approve output prior to release

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PRODUCT REALIZATION

7.3 Design and Development 7.3.4 Design & development review  At suitable stages systematic reviews of D&D to * evaluate the ability to fulfill requirements * identify problems and propose follow up  Involve all functions concerned  Record the results and any necessary actions

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PRODUCT REALIZATION

7.3 Design and Development 7.3.5 Design & development verification  Verify D&D to ensure that output meets the input requirements  Record the results of verification and necessary actions

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PRODUCT REALIZATION

7.3 Design and Development 7.3.6 Design & development validation  Perform D&D validation to confirm that product is capable of meeting the requirements for the specified or known intended use  Whenever applicable to be completed prior to delivery  Results of validation and necessary action must be recorded

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PRODUCT REALIZATION

7.3 Design and Development 7.3.7 Control of design and development changes  Design and development changes must be identified and records maintained  Changes must be reviewed , verified and validated as appropriate and approved before implementation  Record results of review of changes and any necessary actions

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PRODUCT REALIZATION

7.3 Design and Development Basis of Auditing ( Auditor may look for )

          

Design and Development plan Milestones and schedule in plan Approval provisions in D&D plan Drawing Quality Plans Design input records D&D review records D&D verification records Test records D&D validation records Validation approval

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PRODUCT REALIZATION

7.4 Purchasing 7.4.1 Purchasing process 7.4.2 Purchasing information 7.4.3 Verification of Purchased product

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PRODUCT REALIZATION

7.4 Purchasing 7.4.1 Purchasing process  Ensure that purchased product meets requirements  Evaluate and selects suppliers based on their ability to supply conforming product  Establish criteria for selection , evaluation and reevaluation of suppliers  Results of evaluation and any necessary actions must be recorded

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PRODUCT REALIZATION

7.4 Purchasing 7.4.2 Purchasing information Purchasing information must describe the product to be purchased including where appropriate : * requirements for approval of product , procedures processes and equipment * requirements for qualification of personnel * quality management system requirements Ensure adequacy of specified purchase requirements prior to their communication to supplier

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PRODUCT REALIZATION

7.4 Purchasing Basis of Auditing ( Auditor may look for )

      

Purchase specification Evidence of supplier evaluation List of approved suppliers Evaluation Criteria Purchase order – clarity in terms of commercial and technical Quality assurance agreements Order approval documents

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PRODUCT REALIZATION

7.4 Purchasing 7.4.3 Verification of Purchased product Establish & implement inspection or other activities needed to ensure purchased product conformity Where organization or its customer propose verification at supplier’s premises , organization must specify in purchasing information : * verification arrangements * method of product release Basis of Auditing ( Auditor may look for )

 Verification plan  Acceptance criteria  Test records of suppliers 76

PRODUCT REALIZATION

7.5 Product and service provision 7.5.1 Control of production and service provision 7.5.2 Validation of processes for production and service provision 7.5.3 Identification & traceability 7.5.4 Customer property 7.5.5 Preservation of products

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PRODUCT REALIZATION

7.5 Product and service provision 7.5.1 Control of production and service provision The organization shall plan and carry out production & service provision under controlled conditions . Controlled conditions include as applicable:  availability of information describing product characteristics  availability of work instruction  the use of suitable equipment  availability & use of measuring & monitoring devices  implementation of monitoring and measurement  the implementation of release , delivery and post delivery activities 78

PRODUCT REALIZATION

7.5 Product and service provision 7.5.2 Validation of processes Processes where outcome is not verified and / or where deficiencies may become apparent after delivery must be validated to demonstrate ability to achieve planned results Arrangements must be established for these processes including , as applicable :  criteria for review and approval of the process  approval of equipment  qualification of personnel  use of defined methods & procedures  requirements for records  re-validation 79

PRODUCT REALIZATION

7.5 Product and service provision Basis of Auditing ( Auditor may look for )

    

Maintenance schedule Service Contracts Spare parts management Identification of Special process Availability of validation specification

80

PRODUCT REALIZATION

7.5 Product and service provision 7.5.3 identification & traceability   

Where appropriate identify product by suitable means throughout realization Identify status with respect to measurement & monitoring requirements Where traceability is required control & record unique identification of product

Basis of Auditing ( Auditor may look for )

 Product identification  Routing tag  segregation slips 81

PRODUCT REALIZATION

7.5 Product and service provision 7.5.4 Customer Property   

Care for customer’s property while it is under organization’s control or being used by organization Identification , verification , protection & safeguarding customer property provided for use or incorporation Any customer property that is lost , damaged or found unsuitable must recorded & reported to customer

Note: Customer property includes intellectual property

82

PRODUCT REALIZATION

7.5 Product and service provision 7.5.5 Preservation of product   

Preserve conformity of product during internal processing and final delivery to intended destination Include identification , handling , packaging , storage and protection This applies to constituent parts of a product

Basis of Auditing ( Auditor may look for )

 Inventory list  Dispatch methods  regulation on packing , storage , preservation and delivery 83

PRODUCT REALIZATION

7.6 Control of measuring & monitoring devices 





Determine monitoring and measurement to be made & measurement & monitoring devices needed to provide evidence of conformity of product Ensure measuring and monitoring is carried out consistently with monitoring and measurement requirements Suitability of measuring / monitoring software must be confirmed prior to use

Basis of Auditing ( Auditor may look for )

 Identification of Equipments  Calibration standards and Records  Acceptance Criteria  Calibration instruction

84

PRODUCT REALIZATION

7.6 Control of measuring & monitoring devices      

Calibrate or verify measuring and monitoring devices (MMD)at specified intervals Adjust or re-adjust as necessary Identify to enable the determination of calibration status Safeguard MMD from adjustments invalidating calibration Protect MMD from damage or deterioration during handling , maintenance & storage Record results of calibration

Basis of Auditing ( Auditor may look for )

 Identification of Equipments  Calibration standards and Records  Acceptance Criteria  Calibration instruction

85

MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement 8.1 General 8.2 Monitoring / measurement 8.2.1 Customer satisfaction 8.2.2 Internal Audit 8.2.3 Monitoring & measurement of processes 8.2.4 Monitoring & measurement of product 8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement 8.5.1 Continual Improvement 8.5.2 Corrective action 8.5.3 Preventive action

86

MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement 8.1 General Plan & implement measurement , monitoring analysis and improvement processes needed to : > demonstrate conformity of the product > ensure conformity of QMS > continually improve the effectiveness of the QMS This includes determination of applicable methods including statistical techniques and extend of their use

87

MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement 8.2.1 Customer satisfaction  

Organization shall monitor information related to customer perception as to whether the organization has fulfilled customer requirements The methods for obtaining and using this information must be determined

Basis of Auditing ( Auditor may look for )

 Availability of effective system of customer satisfaction measurements  Customer satisfaction analysis

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MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement 8.2.2 Internal Audit Conduct internal audits as planned intervals to determine if  QMS conform to the planned arrangements, requirements of the standard and organization’s requirements  QMS is effectively implemented & maintained Plan the audit programme considering :  Status and importance of the processes and the areas  Results of previous audits Define audit criteria ,scope ,frequency & methodologies Auditor must not audit own work

89

MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement 8.2.2 Internal Audit Basis of Auditing ( Auditor may look for )

       

Internal auditing procedure Audit plans and schedules Audit reports Audit notes / proof of verified objective evidence Nonconformity report Discussion of audit results in MRM Auditor qualification certificates Corrective actions

90

MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement 8.2.3 Monitoring and measurement of processes Apply suitable methods for monitoring and , where applicable , measurement of QMS processes  These methods shall demonstrate the ability of the processes to achieve planned results  Where planned results are not achieved corrections and corrective actions must be taken to ensure conformity of the product Basis of Auditing ( Auditor may look for )

 Process parameters  Statistical Techniques  KPI / Performance indicators  Are the KPI in line with functional objectives

91

MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement 8.2.4 Monitoring and measurement of product  The organization shall monitor & measure characteristics of the product requirements have been met.This shall be carried out at appropriate stages of realization processes in accordance with planned arrangements  Evidence of conformity with the acceptance criteria must be maintained . Records must indicate the person(s) authorizing release of the product  Product release or delivery must not processed until all the planned arrangements have been satisfactorily completed , unless otherwise approved by a relevant authority , and where applicable by the customer

92

MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement 8.2.4 Monitoring and measurement of product Basis of Auditing ( Auditor may look for )

 

Procedure for inspection . Quality plan and test plan Person approving the check and release of the product shall be identified

 

Inspection reports Deviation accepted by customer or approved by designated authorities

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MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement 8.3 Control of nonconforming product    

 

Nonconforming product must be identified and controlled to prevent unintended use or delivery Documented procedure to define controls , responsibility and authority When nonconformance detected after delivery take appropriate action Organization must deal with nonconforming product by one or more of the following ways >action to eliminate detected nonconformity > concession When the nonconforming product is corrected it must be reverified to demonstrate conformity Records of the nature of nonconformity and any subsequent action including concessions must be maintained 94

MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement 8.3 Control of nonconforming product Basis of Auditing ( Auditor may look for )

What options an organization has selected when a non conforming product is detected -

Reworking the product to make it confirm to specification

-

Negotiating with the customers to accept the product as it or after repair

-

Scrapping the product

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MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement 8.4 Analysis of data Determine ,collect & analyze appropriate data to demonstrate the suitability and effectiveness of QMS and to evaluate where continual improvement of the QMS can be made  Data from measurement & monitoring & other relevant sources  Analyze data to provide info on:  Customer satisfaction  Conformance to product requirements  Process , product characteristics and their trends including opportunities for preventive action  Suppliers 

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MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement 8.4 Analysis of data Basis of Auditing ( Auditor may look for )

Analysis that provide information on

-

Customer satisfaction Conformity to product requirements Characteristics and trend of processes and product Suppliers

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MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement 8.5 Improvement 8.5.1 Continual improvement Organization shall continually improve the effectiveness of the QMS through use of :  Quality policy  Quality objectives  Audit results  Analysis of data  Corrective action  Preventive action  Management review

98

MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , Analysis and Improvement Continual Improvement

SPC Benchmarking Quality Circles Risk Assessment

Teamwork for Quali Quality Function Deployme

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MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement Continual Improvement Problem Solving Techniques  Cause & effect diagram  Pareto analysis  Flowcharting  Brain storming

100

MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement 8.5.2 Corrective action Organization shall take action to eliminate the causes of nonconformities to prevent recurrence . Corrective actions appropriate to the impact of the problem Documented procedure shall define requirements for :  Reviewing nonconformities (including customer complaints)  Evaluating the causes of nonconformities  Determining & implementing action needed  Recording results of action taken  Reviewing corrective action taken 101

MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement 8.5.3 Preventive action Organization shall take action to eliminate the causes of potential nonconformities to prevent recurrence . Actions appropriate to the impact of the potential problem Documented procedure shall define requirements for :  Determining potential nonconformance &their causes  Evaluating the need for preventive action  Determining & implementing action needed  Recording results of action taken  Reviewing corrective action taken 102

MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement 8.5.2 ,8.5.3 – Corrective action , Preventive action Basis of Auditing ( Auditor may look for )

      

Non conformity records Instructions related to corrective action Complaints analysis System approach to identify root cause Avoiding nonconformities due to same cause Use of data analysis to identify potential causes Review of trends to identify potential non compliance an necessary preventive action

103

QMS DOCUMENTATION

Quality System Documentation QMS Documentation shall include :  Documentation statement of Quality Policy and Objectives  A Quality Manual  Documented Procedures required by Standard  Documentation needed by the organization to ensure effective planning , operation and control of its processes  Records required by the standard  Records required by the organization

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QMS DOCUMENTATION

Quality Manual Quality Manual: Document specifying the QMS of an organization

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

Record Record : Document stating result achieved or providing evidence of activities performance

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QMS DOCUMENTATION

Document Document : Information and its supporting medium Documentation can be in any format or medium Document provides guidelines Information - Procedure - Specification - Drawing - Standard

Medium Paper Electronic Photographic Magnetic

Document may be established in any form or type of medium - Flow chart - Text - Drawing Sketches - Audio or video tapes 106

QMS DOCUMENTATION

Difference between documents & records Document Record  It provides guidelines  Documents are dynamic and can be revised

 It provides evidence of work done  Records cannot be changed

Examples - Procedure for production planning - Drawing - Part Quality Standard - Work Instruction for Printing

Examples - Production Report - Inspection Results

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QMS DOCUMENTATION

WHY Stated Once

Policy , Manual

Define WHAT will be done

Procedures HOW

Work Instructions Or Practices Records Or

WHO WHEN WHERE

Evidence

Proof

Documentation Pyramid 108

INTERNAL AUDIT

INTERNAL AUDIT

109

INTERNAL AUDIT

INTERNAL AUDIT • • • • •

Audit Definition and criteria Audit objectives Types and stages of Auditing Auditing Process Audit and Assessment

110

INTERNAL AUDIT

What is Audit AUDIT is a

AUDIT is a

Fault Finding Exercise Fact

Finding Exercise

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INTERNAL AUDIT

Audit :

Audit Definition

Systematic , documented verification process of objectively obtaining and evaluating evidence to determine whether specified activities , events , conditions , management systems or information about these matters conform with audit criteria , and communicating these results of this process to the client

Audit Evidence : A statement of facts or other information relevant to audit criteria - based on actual observation - uninfluenced by emotion - stated or documented - verifiable 112

INTERNAL AUDIT

Auditee :

Definitions

Organization to be audited

Auditor : A person qualified to perform audits

Lead Auditor : A person qualified to manage and perform audits

Audit Scope : Audit scope provides the extend and boundaries of the audit

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INTERNAL AUDIT

Audit criteria

Audit Criteria :

Policies , practices , procedures or requirements against which the auditor compares the collected evidence about the subject matter

Requirements may include but are not limited to -

Customer requirements ISO 9001:2000 system requirements Organization QMS requirements Statutory and regulatory requirements

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INTERNAL AUDIT

Audit Objectives Objectives of the audit are -

Conformity Effectiveness Opportunity Compliance

wrt wrt wrt wrt

Requirements Objectives Improvements regulatory requirements

115

INTERNAL AUDIT

Type and stages of audit Types of Audit - First party audit Self Audit , by an organization on itself for their own purposes – Internal audit - Second party audit By an interested organization in another organization - Third party audit By an independent organization - Certification audit 116

INTERNAL AUDIT

Type and stages of audit Type of Audit - System wise: a) Quality System Audit Done to verify whether the quality systems are meeting the standard's requirements and whether they are being followed or not. b) Process Quality Audit Done to verify whether a particular production procedure is followed or now to meet the product specification. c) Inspection Audit Done on the product itself to verify whether it meet the specifications or not. It is simply an inspection activity to identify whether the product is conforming or nonconforming. d) Service Quality Audit Done to verify whether the services rendered meet the procedure laid down in the quality manual. (Service to customer satisfaction must be the motto to be established by audit). 117

INTERNAL AUDIT

Type and stages of audit Stages of audit - Adequacy audit / Document review audit An exercise to determine the extend to which the documented quality system represented by the quality manual and the associated procedures. - Compliance audit An audit to establish the extent to which the documented system is implemented

118

INTERNAL AUDIT

Audit Process Audits are expensive Audits must be well managed Audits must not be carried out by surprise Always agree mutually convenient dates well in advance

119

INTERNAL AUDIT

Audit Process Audit Plan Preparation Audit Schedule Preparation Audit schedule Communication Conduct Audit Briefing the findings to auditee Report preparation Hand over Report to MR 120

INTERNAL AUDIT

Audit Checklist  Audit checklists are used during the audit to collect the information / evidence / notes

Benefits  To assist memory  Maintains continuity during the audit  To ensure depth & continuity of the audit  Help in time management  Part of audit report

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INTERNAL AUDIT

Auditing skills and approach Skills required to conduct the effective audit :  Time Management  Fact Finding  Audit Reporting

Relations between AUDITORS and AUDITEES are critical for successful audit and the approach of the audit should ensure that audit is conducted in a POSITIVE ENVIRONMENT

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INTERNAL AUDIT

Time Management  Time is always short – avoid wasting time  Plan well – use check list  Do not allow your audit to get side tracked  Remember an audit is a sampling activity  Do not waste time on over friendly chatting  Do not focus on trivial issues

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INTERNAL AUDIT

Fact Finding Collect Evidence  Sufficient to determine conformance to the audit criteria  Through - Interviews - Examination of documents and records - Observation of activities and conditions

124

INTERNAL AUDIT

Fact Finding Collecting Evidence is one important auditing skill – Done through - Observations - Reading - Communication - Interviews - Listening - Use of check lists 125

INTERNAL AUDIT

Communication ( Important for Fact Finding)  Know your auditee – could range from top management to lowest level  Keep the message simple – avoid complex phrases and words  Ensure the communication meets the objectives  Consider the location and timing factor  Use of most effective medium – could also be usage of local language

126

INTERNAL AUDIT

Communication Skills How do we communicate ? - Verbal - Using Body Language - Through Facial Expressions - Using different styles and sounds Impact of communication is maximum through body language

127

INTERNAL AUDIT

Factors affecting communication  Physical Factors  Environment Factors  Intellectual Factors  Emotional Factors

128

INTERNAL AUDIT

Factors affecting communication Emotional Factors

Intellectual Factors

- Ego

- Concepts

- Confidence

- Terminology

- Fear

- Language

Physical Factors

Environment Factors

- Hunger

- Ventilation

- Thirst

- Lighting

- Rest

- Temperature

- Pain

- Quality of print 129

INTERNAL AUDIT

Communication barriers  Bad word choice  Mumbling  Outside distractions  Poor listening or reading skills  Lack of interest

130

INTERNAL AUDIT

Communication - Interviewing  Hold interviews only during normal working hours  Put the auditee at ease  Communicate the objective of the interview  Show an interest in what THEY do  Always start with open ended questions  Verify the facts and records is as finding  Avoid arguments  Explain your observations  Thank the auditee for participation and opportunity for auditing 131

INTERNAL AUDIT

Communication –

Interviewing Open end question

 Open end question can increase the amount of information offered – start with them  This shall ensure that the responder HAS to give the information -Can you please tell me what to do ? -What are the aspects in your area  Open questions are auditor friends  Ask WHO , WHAT , WHERE , WHEN and HOW questions

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INTERNAL AUDIT

Communication –

Interviewing Closed end question

 Avoid Closed Questions  Closed questions yields only a simple YES / No -Are you responsible for report preparation -Have the objectives targets decided for the year?  Instead of Ask - Who is responsible for report preparation? - What are the objectives and targets for the year ?  Closed questing are limiting and reduce the amount of information offered

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INTERNAL AUDIT

Communication –

Clarifying Questions

Intended to clarify , retrieve full information and prevent misunderstanding , allowing to grasp full picture - can you show me another example please , I think I am beginning to understand ? - Sorry , I do not get you , could you please explain that again please

Disadvantages : If used too often may create impression that you were not listening Are time consuming If you are prepared to listen in full don’t ask them

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INTERNAL AUDIT

Successful approach to audit  Establish suitable climate  Put Auditee at ease  Use proper questioning techniques  Use open questions and avoid closed questions  Be friendly and diplomatic

135

INTERNAL AUDIT

Positive Characteristics of Auditor  Polite

 Open Minded

 Friendly

 Diplomatic

 Helpful

 Honest

 Informative

 Mature

 Judicious

 Tactful

 Trained

 Self disciplined

136

INTERNAL AUDIT

Negative Characteristics of Auditor Argumentative

Inflexible

Opinionated

Lazy

Over conclusive

Impractical

Inconsistent

Know it all

Inconsiderate

Indecisive

Untrained

Uncommunicative

Accepts things at face value

Unprofessional

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INTERNAL AUDIT

Auditor’s Qualities  Auditor must be a good listener . Listen and Listen with full attention  Listen without your own judgment and conclusion  Do not start teaching  Active listening always assist auditee to give more information  Generate questions from what auditee says – this possible only when auditor listens carefully  Auditors should be situation manager

138

INTERNAL AUDIT

Sampling No time to check everything Select representative sample No sampling calculation Sample should represent all activities Should be on random basis Spot checking Take permission before asking / taking samples

139

INTERNAL AUDIT

Observations Keep observing the physical evidence Example –Equipment in Production Area -What is used for ? -Need it to be calibrated ? -Was it calibrated ? -Is there a record ? -What is the reading ? -Is the reading within the acceptable range ? -Identification ? -Status with respect to measurement ? -Storage location and condition 140

INTERNAL AUDIT

Reporting and audit conclusion Definition Requirements

- Need or expectation that is stated , generally implied or obligatory Conformity - Fulfillments of a requirement Non Conformity - Non fulfillment of a requirement Defect - No fulfillment of a requirement related to intended use Corrective Action - Action to eliminate the cause of a detected non conformity

141

INTERNAL AUDIT

Non conformity Non Conformity - Non fulfillment of a requirement

Non Conformity is established by OBJECTIVE EVIDENCE Intent

a requirement has not been addresses

Implementation

practice differs from the defined system

Effectiveness

the practice is not effective

142

INTERNAL AUDIT

Categorizing Non Conformities Major Non Conformity The absence or complete non fulfillment or breakdown of the standard’s stated requirements A failure to achieve legal or statutory requirements Minor Non Conformity - An isolated or sporadic lapse in the content or implementation or procedures or records which could reasonable lead to failure of the system , if not corrected - isolated examples of measuring instrument out of calibration date 143

INTERNAL AUDIT

Non Conformity Report Writing  State the fact with the objective evidence  Statement should be clear , unambiguous  Refer the clause number and audit criteria against which non conformity is established  It should be trace up to verifiable status of facts  Grade the non conformity as major or minor if it is practiced in the organization  It should be agreed , accepted and signed by the auditee  Other relevant details like location , auditee , date etc should be mentioned. 144

INTERNAL AUDIT

Quality characteristics of a report  Informative  Factual  Complete  Accurate  Precise  Legibility  Transparency  Clarity

145

INTERNAL AUDIT

Timely Reporting  Report without delay  Don’t leave writing report till late  Time never becomes available  Prepare NCR’s on the spot  Timely reporting adds value

146

INTERNAL AUDIT

Non Conformance Report  Location / Area  Category  Objective Evidence  Details of Nonconformance  Details of corrective actions  Details of preventive actions  Follow up audit status  Report Status

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G.M.Pens International Pvt Ltd

NON - CONFORMANCE REPORT ( INTERNAL AUDIT )

Area

Category Objective Evidence

Non conformance Details

Department :

NCR No:

Auditee :

Date :

Nature of NonConformity

:

Adequacy

Non-Conformity

Category of Nonconrmance

:

Minor

Major

ISO Clause Ref

: Document Ref : Detail of Non - conformity Nature of Non - Conformity

Signature of Auditee Agreed corrective action

Signature of Auditor Responsibility

Corrective action details

Target Date:

Signature of Auditee Proposed Preventive Action

Preventive action Responsibility

details

Target Date Verification of Corrective Action ( Follow up Audit)

Verification Audit Details Report Status

Signature of Auditee Verified Corrective Actions is

Signature of Auditor( followup audit) Effective / Not Effective

NCR Closed

Yes / No

To be discussed in management review

Yes / No Signature

148

INTERNAL AUDIT

Situation 1 The auditor enters the manufacturing area & identifies lots of filled polythene bags kept.

Auditor : What is there inside these bags?

Auditee : These are moulded items which were manufactured during sample production which is done initially while developing new products.

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INTERNAL AUDIT

Situation 2 While auditing the purchase department, auditor finds that a P.O. for a particular raw material is given to a new source.

Auditor: Why is this new source being identified?

Auditee: The existing source does not meet the required specification of the materials, for which we are facing many quality problems for the past one-month.

150

INTERNAL AUDIT

Situation 3 The Auditor while going through the Training records observed that an employee attended an External Training Programme conducted in May 2006. When enquired about the measurement of effectiveness, Training manager says “ I maintain only record of training. You have to ask the trainee for effectiveness.”

151

INTERNAL AUDIT

Situation 4 Auditor found some packed boxes laying in a corner of the stores without having any identification. When asked, the stores in-charge said that these are meant for transport to godowns. Personnel doing routine truck loading and all the stores personnel are aware of this.

152

INTERNAL AUDIT

Thank You if any body wants more details pl mail me I will reply u [email protected]

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