Introduction to Quality Management

Introduction to Productivity and Quality Management

• The presentation is about productivity and quality management.
• It includes a quote: "Talking about goodness is easy; achieving it is difficult". (Chinese proverb)

Chapter 3: QM Models and Frameworks

• The chapter discusses quality management (QM) models and frameworks.
• The presentation outlines the following content:
  • Quality Management System
  • ISO
  • 5S
  • TQM, Q-Based System, GMP, HACCP

Quality Management: Concept

• Quality management is coordinated activities to direct and control an organization regarding quality.

• This includes:

  • Quality planning
  • Quality control
  • Quality improvement
  • Quality assurance

• This has a hierarchical structure: Quality Management, with four branches: Quality Planning, Quality Control, Quality Improvement, and Quality Assurance.

• Each branch has a reference, for examples, Juran's Trilogy and Juran's handbook.

Quality Planning (QP)

• ISO 9000 focuses on setting quality objectives and specifying operational processes and resources to meet those objectives.

• Planning has two levels:

  • Strategic: long-range goals, vision, mission, values, etc.
  • Operational: product goals and means to reach them.

• Quality planning steps:

  • Establish goals.
  • Identify stakeholders.
  • Determine stakeholder needs and prioritize.
  • Develop products/services meeting stakeholder needs.
  • Develop processes for production, promotion, and distribution.
  • Establish process controls and communicate plans to operators.

Quality Control (QC)

• Quality control is about fulfilling requirements.

• Controls regulate performance, removing undesirable freedom.

• Key purpose of QC is to ensure predictability in operations.

• Quality control steps:

  • Statement of requirements
  • Checking requirements
  • Assessing conformity
  • Planning and checking plans
  • Performing work and checking conformity
  • Remedial actions

• Universal steps for quality control:

  • Identify the subject of control.
  • Define a unit of measure.
  • Establish a standard level of performance.
  • Select a sensor to sense variation from specifications.
  • Install the sensor for the relevant stage of the process.
  • Gather and analyze the data.
  • Verify, assess variance range for stable processes.
  • Diagnose the cause of variance beyond the expected range.
  • Propose remedies and decide on necessary actions.
  • Take action and confirm process stability.

Quality Improvement (QI)

• Quality improvement aims to increase the ability to fulfill quality requirements.
• QI strategies consist of:
  • Root-cause analysis
  • Continuous improvement, visualized through a graph displaying performance improvement over time.
  • Adjusting processes to meet expectations.

Quality Assurance (QA)

• Quality assurance provides confidence that quality requirements will be met.
• It's often a separate department.
• QA should be integrated into all organizational processes.

Quality Management Systems (QMS)

• A mechanism for continuously improving core processes to achieve maximum customer satisfaction at the lowest overall cost.
• Provides a basis for documenting processes used to drive innovation and achieve objectives. Results in: Higher product conformity, less variation, fewer defects, waste, rework, human error; improved productivity, efficiency, and effectiveness.
• Elements of a quality system include: quality policy, organizational structure, quality manual, and internal audits for system maintenance.

ISO 9000 Family of Standards

• Five objectives:
  • Achieve, maintain, and seek to continuously improve product quality (including services).
  • Improve the quality of operations to continually meet customer and stakeholder needs.
  • Provide confidence to internal management and other employees on quality fulfillment and improvement.
  • Provide customer confidence that quality requirements are being achieved in the delivered product.
  • Provide confidence that quality system requirements are fulfilled.
• Key documents include ISO 9000 (fundamentals, background, key terms), and ISO 9001 (specific requirements for a quality management system).
• Basic quality assurance structure: Quality management system, management responsibility, resource management, product realization, measurement, analysis, and improvement.

Principle Elements of ISO 9001

• Quality management system (general requirements).
• Management responsibility.
  • Management commitment
  • Customer focus
  • Quality policy
  • Planning
  • Responsibility, authority, communication
• Resource management.
  • Provision of resources
  • Human resources
  • Infrastructure
  • Work environment
• Product realization.
  • Planning product realization
  • Customer-related processes
  • Design & development
  • Purchasing
  • Production & service provision
  • Control of monitoring devices
• Measurement, analysis, and improvement.
  • Monitoring, measurement, analysis and improvement.
  • Monitoring & measurement
  • Control of non-conforming products
  • Analysis of data
  • Improvement.

Benefits & Limitations of ISO 9001

• Increased controls, discipline, procedures, documentation, and communication.
• Reduced errors, customer complaints, non-conforming products, services and costs.
• Improved customer retention
• Assistance with trade liberalization
• Placing responsibility for quality where it belongs
• Reduction in the number of customer audits (time saving)
• Identification of ineffective and surplus procedures.
• Limitations include: lack of flexibility, perceived restrictions on creativity, lack of relevance to real business needs, time and resources needed for procedures and training, and bureaucracy in documentation and accreditation, and cost involved achieving and maintaining ISO 9001.

Building Effective Quality Management Systems

• Integrating QMS with enterprise systems (ERP, MES, SCM) is crucial.
• Emphasizing actionable decision-making.
• Root cause analysis, problem identification, process and system improvement.

5S Basic Training

• A structured approach to workplace organization (Sort, Set in Order, Shine, Standardize, Sustain).
• Based on visual controls, information systems, Kaizen (continuous improvement), and Lean Manufacturing principles (waste reduction).

Some New Words

• Red Tag: identifying, removing, and disposing of unnecessary items in an area.
• Lean Manufacturing: continuous improvement through waste reduction in processes.
• Kaizen: continuous improvement
• Kaizen Event, 5S Event: planned improvements to a specific area or process.
• Muda: waste
• Gemba: workplace
• Kanban: pull-type inventory control system.
• Value Stream Map: diagram of processes for making and delivering a product. (Examples provided illustrating before and after 5S implementation).

HACCP

• Hazard Analysis and Critical Control Points (HACCP)
• A collaborative approach between industry and government for ensuring consistent food quality.
• Hazard analysis
• Critical control points
• Monitoring and control procedures
• Establishing corrective actions
• Safety regulations of critical limits for CCP

GMP

• Good Manufacturing Practices
• Build quality into the organization and processes in manufacture.
• GMP covers all aspects of manufacturing including collection, transportation, processing, storage, quality control, and delivery of the finished product.
• Importance for profit, production, training
• part of QA, ensuring consistently produced goods, adequate quality standards.
• GMP is for solid, semisolid, liquid orals, parenteral production, Ayurvedic, Biotechnological products, Nutraceuticals, cosmeceuticals, and Homeopathic medicines.
• Ten GMP principles include: Designing, constructing facilities, following written procedures, documenting work, validating work, monitoring facilities, writing operating procedures, demonstrating job competence, preventing contamination, controlling components, and conducting planned periodic audits.

Beyond GMP

• Pollution reduction - Zero discharge: adapting environment-friendly methods.
• Consideration for better & healthier life tomorrow.
• Ethics in life - begin with the end in mind to avoid detrimental effects.

The Head of QM (QA)

• The head of QM should be qualified and trained in the relevant field (e.g. pharmacist).
• Full responsibility and authority for quality systems and assurance duties.

Premises

• Requirements of location, design, construction, and maintenance of manufacturing premises.
• Contamination prevention (from environment and pests).
• Prevention of mix-up of materials.
• Suitable facilities (toilets, changing rooms, sampling areas, QC labs).
• Defined areas for specific activities.
• Structural elements (walls, ceilings, drains, air intake, exhaust, lighting, ventilation, pipe work, light fittings).
• Storage areas with adequate space
• Physical Separation from production areas.

Building & Facilities

• Design and construction features (critical for product safety and efficiency).
• Lighting, ventilation, air filtration, air heating, cooling, plumbing, sewage and refuse disposal, washing and toilet facilities.
• Sanitation and regular maintenance.

Paint Finish

• Building paint and equipment paint should follow specifications and guidelines.

Building Finishes

• Acceptable and unacceptable building finish materials. (Examples provided to visually illustrate differences in finish types).

Poor & Good Windows

• Examples showing contrasting types of windows, illustrating poor and adequate types of window design for production environments.

HACCP Today

• Hazard analysis and critical control points (HACCP) methodology.
• Steps for applying and controlling HACCP principles.
• Used in various manufacturing contexts.

Other Models

• Models of Quality Management (other models) such as Six sigma, JIT(Just in time), Benchmarking, SA 8000, TQM

Six sigma

• Six sigma is a set of specific methods used in improving manufacturing quality, by focusing on the common causes of error.
• 68.26% of the population is within ±1 standard deviation around the mean
• 95.46% of the population is within ±2 standard deviations around the mean
• 99.74% of the population is within ±3 standard deviations around the mean
• DPMO: Defects per Million Opportunities
• Example data illustrating the impact of using six sigma methodologies in various industries.

Practice

• Applying 5S methodology to a selected restaurant/food shop/cafeteria

Work In Team

• Presenting systems including ISO 14000, SA 8000 (ISO 26000), ISO 31000, HACCP (ISO 22000), GMP, 6 Sigma, and 5S.

This quiz covers the essential concepts of productivity and quality management. It delves into Quality Management Systems, frameworks like ISO and TQM, and emphasizes the importance of coordinated activities for quality control, assurance, and improvement. Perfect for those studying quality management principles.