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Quality Management System
ISO 9001:2008
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Quality
Quality
Fitness for use
Least Variability
Loss to society
Conformance to specifications/requirements
Customer Satisfaction/Interested PartiesSatisfaction
Degree to which inherent characteristics of aproduct or service meets requirements
Ability to fulfill stated and implied needs
Cost of poor quality
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Quality Management Principles
QualityManagement
Principles
Customer Focus
Leadership
Involvement of People
Continual Improvement
Facts based Decisions
Mutually Beneficial Supplier Relationship
Process Approach
System Approach
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Process Perspectives for QMS
PROCESSset of interrelated or
interacting activitieswhich transformsinputs into outputs
INPUT OUTPUT
RESOURCES
CONTROLS
PRODUCT
AdjustmentsMeasurements
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Process Approach
Process
A
ProcessD
ProcessB
Process
C
InputOutput
Controls
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QMS Documentation
Policy
Processes
Procedures
Forms/ Data/ Records/
Information
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ISO 9001 QMS model
CUSTOMERS
CUSTOM
ERS
Managementresponsibility
Resourcemanagement
Measurement, analysis,improvement
Service/Product
Product/ Servicerealisation
Continual Improvement of theQuality Management System
Requir
ements
Sa
tisfacti
on
InputOutput
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Improvements
Ground Fruits
Low Hanging Fruits
Bulk Fruits
Sweet Fruits
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Maturity Levels of Implementation
Level5Optimized
Level4Quantitatively
Managed
Level 3Defined
Level 2Some How Managed
Level 1Chaos/ Uncertain
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4.0 Quality Management System
Processes
Technical Processes
Commercial Process
Quality SystemsProcess
OutsourcedProcesses
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4.0 Quality Management System
Procedures
Documents Control
Record Control
Auditing
Handling Non Conforming Situations
Solving Problems Occurred to avoidre-occurrence
Solving Anticipated Problems to avoidoccurrence
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4.0 Quality Management System
Procedures, as required byindustry/ customers/ Law/
Management
Planning
Marketing
Design
Purchase
Production
Packing
Finished Goods/ Other Stores
Dispatch
Services
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4.0 Quality Management System
Quality Manual
Scope
Exclusions
Processes Description
Procedures Reference
Any other information, asnecessary
Quality ManagementApproach
Quality Policy
Objectives
Organization Chart
Strengths/ Capability
Market
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4.0 Quality Management System
Departmental Manual
Departmental Activities
Departmental Objectives
Processes Description/Flow Charts
Procedures/ SOPs/ SampleFormats
Any other information, asnecessary
List of Documents
List of Records/ Softwares
List ofEquipments/Instruments
Organization Chart/Responsibilities
List of Suppliers/ ServiceProviders
Audit Checklist
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4.0 Quality Management System
DocumentControl
Approval
Review
Update
Reapprove
Changes identification
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
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4.0 Quality Management System
Records Controls
Records ofConformity
Records ofEffectiveness
Hard Copy/Electronic Records
Identification
Legibility
Storage
Protection
Retrieval
Retention
Disposition
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4.0 Quality Management System
Records
Management ReviewsCompetence RelatedProduct Requirements Review
Design RelatedSuppliers evaluation
TraceabilityCustomers Property related Communications
CalibrationAuditsNon Conforming Products
Corrective ActionsPreventive Actions
Reports
Quality Objectives AchievementData Analysis
Complaint ReportsProcess Performance
Maintenance ReportsService Reports
Test ReportsCustomer Satisfaction
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5.0 Management ResponsibilityCommitment
Customer Focus
Quality Policy
Objectives
Planning for Achievement
Managing Changes
Responsibility & Authorities Management Representative
Internal Communication
Management Review
Process
Inputs
Outputs
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5.0 Management Responsibility
Management Commitment forQMS
Development
Implementation
Continual Improvement
ManagementCommitment
by
Communication for meetingrequirements
Quality Policy
Objectives
Management Reviews
Resources
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5.0 Management Reviews
ManagementReviews
Top ManagementInvolvement
Planned (not equal)intervals
Review of QMS
Suitability
Adequacy
Effectiveness
ImprovementOpportunity
Need for Changes
Quality Policy
Quality Objectives
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5.0 Management Reviews
ManagementReviews
Inputs
Audits
Customer Feedback
Process Performance
Product Conformity
Actions Status
Corrective
Preventive
Previous ActionsChanges Expected
Recommendations forImprovement
Outputs
Improvement in QMS
Improvements in Processes
Improvement in Product
Resources Needs
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6.0 Resource Management
Resources
Human Resources
Allocation
CompetenceImprovement
Training
Plan
Do
CheckEffectiveness
Take ActionsAwareness
Infrastructure
Machines
Equipments
Buildings
Communication
Software
Hardware
WorkEnvironment
Physical Factors
Human Factors
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7.0 Product RealizationPlanning Process
Process Planning
Process Development
Planning considerations
Product Requirements
New/ Changed Processes
Criteria of Acceptance
Quality Objectives
Documents
Resources
Verification
Validation
Monitoring
Measurement
Inspection
Testing
Quality Plan
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7.0 Product Realization
Product/ ServiceRequirements
DetermineRequirements
Specified
Implied
Statutory
Management
Review Requirements
Any ambiguities
resolved
Capability Assessment
Agreement
Verbal RequirementsConfirmation
Changed RequirementsManagement
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7.0 Product Realization
CustomerCommunication
Product Information
Enquiry Handling
Contracts Handling
Amendments Handling
Feedback
Complaints
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7.0 Product Realization
Design andDevelopment
Planning
Inputs
Reviews
Verification
Validation
Outputs
Changes
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7.0 Product Realization
Purchase Considerations
Purchase Requirements
Control over supplier
Control over purchased product
Criteria and Process for
Evaluation of Suppliers
Selection of Suppliers
Re-evaluation of Suppliers
Accurate Purchase Information
Arrangements of Verification ofPurchased Products
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7.0 Product Realization
Production andService Provision
ControlledConditions
Specifications
Work Instruction
Suitable Equipments
Monitoring and Measurement
Release/ Delivery and PostDelivery
Validation ofProcesses
Qualifying processes toguarantee required outcome
Revalidation
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7.0 Product Realization
Production and ServiceProvision
Product Identification
Product Status Identification
Traceability
Customer Property Control
Lost
Damaged
Unsuitable
Preservation
Packing
Storage
Handling
Delivery
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7.0 Product Realization
Measuring Instruments/Systems Control
Measuring Instrument
Selection
Calibration
Calibration Statusidentification
Instruments Handling
Instruments Maintenance
Instruments Storage
Validation of Softwaresupporting monitoring
activities
Evaluate situation wheninstruments are found out of
calibration
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8 0 Measurement Analysis and
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8.0 Measurement, Analysis and
Improvement
Measurement
Plan
Statistical Techniques
Customer Satisfaction
Direct Methods
Indirect Methods
Internal Audit
Plan
Do
Follow-up
Action CompletionProcess Monitoring
Product Monitoring
Product Release
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8 0 Measurement Analysis and
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8.0 Measurement, Analysis and
Improvement
Non ConformingProduct/ Complaints/
Returns/ Penalties
Identification
Control to avoid mix-up
Decide for
Acceptance onConcession
Rework & Re-inspection
Re-grade for differentapplication
Scrap
What to do if alreadydelivered
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8 0 Measurement Analysis and
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8.0 Measurement, Analysis and
Improvement
Continual Improvement using
Analysis of Data
Internal Audits
Management reviews
Quality Policy
Quality Objectives
Corrective Actions (No Repetition ofProblems)
Preventive Actions (Right First Time)
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