Quality Management System

ISO 9001:2008

10/10/2011

Quality
Fitness for use Least Variability Loss to society Conformance to specifications/requirements

Quality

Customer Satisfaction/Interested Parties Satisfaction

Degree to which inherent characteristics of a product or service meets requirements Ability to fulfill stated and implied needs Cost of poor quality

10/10/2011

Quality Management Principles

Customer Focus Leadership Involvement of People Quality Management Principles Continual Improvement Facts based Decisions

Mutually Beneficial Supplier Relationship

Process Approach System Approach
10/10/2011 3

Process Perspectives for QMS

Adjustments
CONTROLS

Measurements

PROCESS INPUT
set of interrelated or interacting activities which transforms inputs into outputs

OUTPUT

PRODUCT

RESOURCES

Process Approach
Process A Process B
Input Output Controls

Process C Process D

QMS Documentation
Policy

Processes

Procedures Forms/ Data/ Records/ Information

ISO 9001 QMS model

Continual Improvement of the Quality Management System

C U S T O M E R S

R e q u i r e m e n t s

Management responsibility

Resource management

Measurement, analysis, improvement

S a t i s f a c t i o n

C U S T O M E R S

Input

Product/ Service realisation

Service/ Output Product

7

10/10/2011

Improvements

Sweet Fruits

Bulk Fruits
Low Hanging Fruits

Ground Fruits

Maturity Levels of Implementation

Level 5Optimized Level 4Quantitatively Managed

Level 3Defined

Level 2Some How Managed

Level 1Chaos/ Uncertain

10/10/2011 9

4.0 Quality Management System

Technical Processes

Commercial Process Processes

Quality Systems Process

Outsourced Processes
10/10/2011 10

4.0 Quality Management System

Documents Control Record Control Auditing
Procedures

Handling Non Conforming Situations

Solving Problems Occurred to avoid re-occurrence Solving Anticipated Problems to avoid occurrence
10/10/2011 11

4.0 Quality Management System

Planning
Marketing Design Purchase Procedures, as required by industry/ customers/ Law/ Management Production Packing Finished Goods/ Other Stores Dispatch Services
10/10/2011 12

4.0 Quality Management System

Scope Exclusions Quality Management Approach Quality Manual Processes Description Quality Policy Procedures Reference Objectives Any other information, as necessary Organization Chart Strengths/ Capability Market

10/10/2011

13

4.0 Quality Management System

Departmental Activities Departmental Objectives List of Documents Departmental Manual Processes Description/ Flow Charts List of Records/ Softwares

Procedures/ SOPs/ Sample Formats

Any other information, as necessary

List of Equipments/Instruments Organization Chart/ Responsibilities List of Suppliers/ Service Providers Audit Checklist

10/10/2011

14

4.0 Quality Management System

Approval Review Update Reapprove

Changes identification
Document Control

Revision Status identification

Available at point of use Legible Documents Readily identifiable External Origin Documents identification External Origin Documents Distribution Prevention of misuse of obsolete documents

10/10/2011

15

4.0 Quality Management System

Identification Records of Conformity Records Controls Records of Effectiveness Hard Copy/ Electronic Records Legibility Storage Protection

Retrieval
Retention

Disposition
10/10/2011 16

4.0 Quality Management System

Management Reviews Competence Related Product Requirements Review Design Related Suppliers evaluation Traceability Customers Property related Communications Calibration Audits Non Conforming Products Corrective Actions Preventive Actions Quality Objectives Achievement Data Analysis Complaint Reports Process Performance Maintenance Reports Service Reports Test Reports Customer Satisfaction
17

Records

Reports

10/10/2011

5.0 Management Responsibility

Commitment Customer Focus Quality Policy Planning for Achievement Objectives

Managing Changes
Responsibility & Authorities Internal Communication Management Review Management Representative Process Inputs

Outputs
10/10/2011 18

5.0 Management Responsibility

Development Management Commitment for QMS Implementation Continual Improvement Communication for meeting requirements Quality Policy Management Commitment by

Objectives
Management Reviews Resources

10/10/2011

19

5.0 Management Reviews

Suitability Top Management Involvement Management Reviews Planned (not equal) intervals Review of QMS Adequacy

Effectiveness Improvement Opportunity

Need for Changes

Quality Policy

Quality Objectives

10/10/2011

20

5.0 Management Reviews

Audits Customer Feedback

Process Performance

Inputs

Product Conformity Actions Status Changes Expected

Corrective Preventive Previous Actions

Management Reviews

Recommendations for Improvement Improvement in QMS Improvements in Processes

Outputs
Improvement in Product Resources Needs

10/10/2011

21

6.0 Resource Management

Allocation Human Resources

Competence Improvement
Training Awareness Machines Equipments

Plan
Do Check Effectiveness Take Actions

Resources
Infrastructure

Buildings Communication Software Hardware Work Environment Physical Factors Human Factors
22

10/10/2011

7.0 Product Realization

Process Planning Planning Process Process Development Product Requirements New/ Changed Processes Criteria of Acceptance Quality Objectives Documents Resources Planning considerations Verification Validation Monitoring Quality Plan Measurement Inspection Testing

10/10/2011

23

7.0 Product Realization

Specified Implied Product/ Service Requirements Determine Requirements Statutory Any ambiguities resolved Management Capability Assessment

Review Requirements

Agreement Verbal Requirements Confirmation Changed Requirements Management

10/10/2011

24

7.0 Product Realization

Product Information Enquiry Handling Contracts Handling Amendments Handling
Feedback Complaints
10/10/2011 25

Customer Communication

7.0 Product Realization

Planning Inputs Reviews Design and Development Verification

Validation
Outputs

Changes
10/10/2011 26

7.0 Product Realization

Purchase Requirements Purchase Considerations Control over supplier Control over purchased product Evaluation of Suppliers Selection of Suppliers

Criteria and Process for

Re-evaluation of Suppliers
Accurate Purchase Information Arrangements of Verification of Purchased Products

10/10/2011

27

7.0 Product Realization

Specifications Work Instruction Controlled Conditions

Suitable Equipments

Monitoring and Measurement

Production and Service Provision

Release/ Delivery and Post Delivery Qualifying processes to guarantee required outcome Revalidation

Validation of Processes

10/10/2011

28

7.0 Product Realization

Product Identification Production and Service Provision Product Status Identification

Traceability
Lost Customer Property Control Damaged Unsuitable Packing

Storage Preservation
Handling Delivery
10/10/2011 29

7.0 Product Realization

Measuring Instrument Selection

Calibration

Measuring Instruments/ Systems Control Validation of Software supporting monitoring activities Evaluate situation when instruments are found out of calibration

Calibration Status identification

Instruments Handling

Instruments Maintenance

Instruments Storage

10/10/2011

30

8.0 Measurement, Analysis and Improvement

Plan Measurement Statistical Techniques Direct Methods Customer Satisfaction

Indirect Methods
Plan Do Internal Audit Follow-up Process Monitoring Action Completion Product Monitoring Product Release

10/10/2011

31

8.0 Measurement, Analysis and Improvement

Identification Acceptance on Concession Non Conforming Product/ Complaints/ Returns/ Penalties

Control to avoid mixup

Rework & Reinspection

Decide for

Re-grade for different application

Scrap

What to do if already delivered

10/10/2011

32

8.0 Measurement, Analysis and Improvement

Analysis of Data Internal Audits

Management reviews

Continual Improvement using

Quality Policy

Quality Objectives
Corrective Actions (No Repetition of Problems) Preventive Actions (Right First Time)

10/10/2011

33