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Quality Management Systems Overview

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0% found this document useful (0 votes)
5 views15 pages

Quality Management Systems Overview

Uploaded by

rajasamikannu053
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd

OTQM

UNIT V
TOPICS
• 7 Old quality control tools
• House of Quality
• Total productive maintenance
• Failure mode and effect Analysis
• POKAYOKE
• Six Sigma - Toyota and Six Sigma and Management systems for TQM
• ISO 9000 and 14000 Quality management systems - Auditing and
certification Process - Korean and American QMS
• Quality Awards – Quality Information System
7 Old quality control tools
• Also known as Ishikawa tools, are a fundamental set of techniques used to identify,
analyze, and solve quality problems
• 7 QC Tools:
• Check Sheet or Tally sheet
• Histogram
• Pareto Chart or 80-20 rule
• Cause and Effect or Fishbone or Ishikawa diagram
• Scatter diagram
• Control or Shewhart or Process-Behaviour Chart
• Stratification
• New QC tools – Affinity diagram, Interrelationship diagram, Tree diagram, Matrix
diagram, Matrix data analysis chart, Arrow or Activity Network diagram, Process
House of Quality
• HOQ is a visual tool used in Quality Function Deployment (QFD) to translate
customer needs into product or service requirements
• It is also known as the Planning or Customer Deployment Matrix
• HOQ resembles a house with a roof, foundation, and several rooms
• Each room represents a different aspect of the product or service development
process
• Roof - Customer Needs (WHATs)
• Foundation - Technical Characteristics (HOWs)
• Left Wall – Importance, Relationships
• Right Wall - Competitive Analysis, Target Values
• Bottom - Technical Correlations, Prioritization
Total Productive Maintenance (TPM)
• Goes beyond traditional reactive maintenance by emphasizing proactive and
preventative measures to ensure equipment operates at peak performance
• Objectives - Eliminate big losses (Breakdowns, Setup and adjustments, Idling and
minor stoppages, Reduced speed, Defects and rework, Yield losses), Optimize
Overall Equipment Effectiveness (OEE), Focus on prevention, Engage everyone
and Continuous improvement
• Activities - Autonomous maintenance, Planned maintenance, Quality
maintenance, Early equipment management
• Process - Establish a clear vision and goals, Create a cross-functional team to
lead the implementation, Assess current equipment performance and identify
losses, Develop a plan for addressing the big losses, Implement core TPM
activities, Monitor progress and measure results, Continuously improve and
refine the program
Failure Mode and Effect Analysis (FMEA)

• A systematic, proactive approach to identifying, analyzing, and mitigating


potential failures in a system, process or design
• Elements or steps:
• Identifying failure modes
• Analyzing effects
• Assessing severity
• Evaluating occurrence
• Determining detection
• Calculating Risk Priority Number (RPN) – (multiplying the severity, occurrence,
and detection scores)
• Developing mitigation strategies
• Types - Design FMEA (DFMEA), Process FMEA (PFMEA), Service FMEA (SFMEA)
POKAYOKE
• Also known as mistake-proofing refers to any device or technique that either
makes it impossible for an error to occur or makes the error immediately obvious
once it has occurred
• Devices and techniques:
• A checklist used to ensure that all steps in a process have been completed
• A template that ensures that all required information is entered correctly
• A physical barrier that prevents an error from being made, such as a guardrail to
prevent someone from falling off a platform
• An automated system that checks for errors, such as a spell checker in a word
processing program
Six Sigma
• Focuses on minimizing defects and variation, leading to significant improvements in
efficiency, cost, and customer satisfaction
• Objectives - Reduce defects - Only 3.4 defects per million opportunities (DPMO),
Minimize variation, Improve efficiency, Enhance customer satisfaction
• Follows a structured, data-driven approach called DMAIC:
• Define: Clearly define the problem or improvement opportunity
• Measure: Collect and analyze data to understand the current state
• Analyze: Identify the root causes of the problem using statistical tools
• Improve: Design and implement solutions to address the root causes
• Control: Monitor and ensure the improvements are sustained over time
• Implementation steps : Define business goals and challenges, Select and train
champions and green belts, Choose projects aligned with strategic goals, Apply the
DMAIC methodology for each project, Monitor progress and track results, Celebrate
Toyota and Six Sigma and Management systems for TQM

• Toyota Production System (TPS) is a philosophy emphasizing continuous


improvement, waste elimination, and respect for people
• Principles - Just-in-Time (JIT), Jidoka (automation with human touch), Kaizen,
Standardization, Kanban, Poka-Yoke, Andon (Visual communication system to
highlight problems), Teamwork & Respect
• TPS and Six sigma for TQM: Focusses on continuous improvement, Broad scope,
Long-term focus, Emphasis on flow and efficiency, People-centric approach,
Project based approach, metrics driven, aligns with core values, provides tools
and methods, phased approach, employee engagement, applicable for all types
of industries
ISO 9000 and 14000 Quality management systems
• ISO 9000 - Provide a framework for organizations to implement a quality management system that helps them ensure the consistent quality of
their products and services
• ISO 14000: Environmental Management Systems - a framework that enables organizations to manage their environmental impacts
systematically, continuously improve their environmental performance, and comply with relevant environmental regulations
• Core principles - Customer focus, Leadership, Engagement of people, Process approach, System approach, Continual improvement
• ISO types – Quality Management:
• ISO 9001: The most widely recognized standard for quality management systems (QMS), focusing on customer satisfaction, continuous
improvement, and process effectiveness.
• ISO 13485: Specifically for medical devices, ensuring quality and safety throughout the lifecycle.
• ISO/TS 16949: Tailored for the automotive industry, emphasizing supply chain management and product quality.
• Environmental Management:
• ISO 14001: Establishes an environmental management system (EMS) to minimize environmental impact, improve resource efficiency, and
comply with regulations.
• ISO 50001: Specifically for energy management, helping organizations optimize energy use and reduce costs.
• ISO 14064: Provides guidance on greenhouse gas accounting and reporting, a vital aspect of sustainability efforts.
• Information Security:
• ISO 27001: The cornerstone of information security management, guiding organizations in protecting confidential, sensitive data.
• ISO 27002: Offers best practices and controls for implementing various security techniques within an information security management.
• ISO 27018: Specifically for protecting personal data in the cloud, addressing privacy concerns in cloud environments.
Types of ISO 9000 & ISO 14000
• Key Standards within ISO 9000:
• ISO 9001: Generic requirements for a quality management system, applicable to
any organization regardless of size or industry
• ISO 9004: Guidelines for improving the performance of a QMS beyond the
requirements of ISO 9001
• Key Standards within ISO 14000:
• ISO 14001: Specifies the requirements for an environmental management system
• ISO 14004: Provides guidance for improving the performance of an EMS
• ISO 14006: Offers guidance for eco-design and incorporating environmental
considerations into product design
• ISO 14064: Provides guidance for greenhouse gas accounting and reporting
Auditing and Certification Process
• Choosing the Right Standard: Identify your needs and goals, Research relevant ISO standards,
Seek expert advice
• Selecting a Certification Body: Accreditation, Experience and expertise, Cost and service
offerings
• Preparing for the Audit: Gap Analysis, Develop and Document your System, Train Employees,
Conduct Internal Audits
• The Audit Process: Pre – Audit (Selection of Certification Body, Review and Documentation,
Stage 1 Audit (Optional)), Main Audit (On-site Visit, Opening Meeting, Audit Process, Closing
Meeting)
• Addressing Non-Conformities: Non-Conformity Resolution (Develop Corrective Action Plans
(CAPs), Implement CAPs, Verification by Certification Body)
• Certification Decision: Certification Granting, Surveillance Audits
Korean and American QMS
• Similarities:
• Both adhere to international standards: Both countries heavily utilize international quality standards
like ISO 9001 for quality management and ISO 14001 for environmental management
• Focus on continuous improvement: Both cultures emphasize Kaizen and strive for ongoing
enhancements in efficiency, quality, and customer satisfaction
• Data-driven approaches: Both QMS utilize data analysis and statistical tools to identify and address
issues, measure progress, and make informed decisions
• Differences:
• National standards: In addition to international standards, both nations have their own national QMS
standards, like KS Q ISO 9001 in Korea and ANSI/ASQ-ISO 9001 in the USA
• Cultural influences: Korean QMS tends to be more hierarchical and structured, with a strong emphasis
on top-down leadership and employee involvement. American QMS can be more decentralized and
collaborative, with greater emphasis on individual initiative and cross-functional teamwork
• Emphasis areas: Korean QMS often prioritizes defect prevention and process control, while American
QMS places more emphasis on flexibility, innovation, and customer-centricity
• Regulations: Regulatory landscapes differ, impacting QMS implementation and focus areas
Quality Awards
• Prestigious recognitions bestowed upon organizations that demonstrate exceptional commitment to
quality management and continuous improvement
• National Awards:
• USA: Malcolm Baldrige National Quality Award (highest national quality award)
• Japan: Deming Prize
• India: Rajiv Gandhi National Quality Award
• Europe: European Quality Award (EQA)
• South Korea: Korea National Quality Award (KNQA)
• Regional Awards:
• Asia Pacific Quality Award (APQA)
• Americas Business Awards (Quality category)
• European Business Awards (Innovation and growth category)
• Industry-Specific Awards:
• Automotive Industry Excellence Awards (AIA)
• National Association for Home Care & Hospice (NAHC) Quality Award
Quality Information System

• An integrated set of activities and tools used to collect, analyze, interpret, and
utilize quality-related information within an organization
• Features: Data acquisition, Data storage and management, Data analysis tools,
Reporting and dashboards, Alerting and notification systems, Integration with
other systems
• Types: Enterprise-wide QIS, Department-specific QIS, Industry-specific QIS
• Steps: Define clear goals and objectives, Identify relevant data sources, Choose
the right technology, Engage stakeholders, Train employees, Continuously review
and improve

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