Unit 4: Quality systems

• ISO 9000 family: ISO 9000 (fundamentals and vocabulary), ISO 9001:2015 (requirements — the certifiable standard), ISO 9004 (sustained success), ISO 19011 (auditing).

• Structure (high-level structure): context, leadership, planning (risk-based thinking), support, operation, performance evaluation, improvement — PDCA.
• Certification: by accredited third-party bodies (in India, accreditation by NABCB).

• ISO 14001:2015: environmental management system requirements — environmental policy, aspects and impacts, legal compliance, objectives, operational control, emergency preparedness, monitoring and audit, continual improvement.
• Benefits: compliance, reduced waste and energy costs, stakeholder trust, access to global supply chains.

• Total Quality Management (TQM): a company-wide approach to continuous quality improvement focused on customer satisfaction, involving everyone. Principles: customer focus, continuous improvement (Kaizen), employee involvement, process approach, fact-based decisions and supplier partnerships. Deming's PDCA cycle (plan-do-check-act) drives improvement.
• Six Sigma: a data-driven method to reduce variation and defects to 3.4 defects per million opportunities, using DMAIC — Define, Measure, Analyse, Improve, Control. Experts are certified as Green Belts and Black Belts.

Trade Unions Act, 1926 (now subsumed in the Industrial Relations Code, 2020)

• Registration: any seven or more members may apply; at least 10% or 100 workmen (whichever is less) of the establishment must be members; office bearers — at least half must be actually engaged in the industry.
• Rights of registered unions: body corporate with perpetual succession; immunity from civil and criminal liability for acts in furtherance of a trade dispute (Sections 17–18); separate political fund.
• Obligations: general fund used only for specified purposes; annual returns to the Registrar; books open for inspection.
• Under the IR Code, 2020: recognition of a negotiating union (51% membership) or a negotiating council; central and state-level recognition.

Quality circles

A quality circle is a small group of 6–10 employees from the same work area who meet voluntarily and regularly to identify, analyse and solve work-related problems (Kaoru Ishikawa, Japan, 1962).

• Benefits for IR: participation, communication, team spirit, recognition, improved quality and productivity, reduced conflict.
• In India: BHEL, Maruti Suzuki, Tata Steel; QCFI (Quality Circle Forum of India).

Just-in-Time (JIT) produces and delivers exactly what is needed, when it is needed, in the quantity needed — eliminating waste. Developed at Toyota (Taiichi Ohno). Seven wastes (muda): overproduction, waiting, transport, over-processing, inventory, motion and defects. Kanban is a pull-based signalling system: a card (or bin) signals the previous stage to produce or supply more only when parts are used. Requirements for JIT: reliable suppliers, small lot sizes, quick set-ups, preventive maintenance, flexible workers and good quality.

• Quality loss function: any deviation from the target causes loss to society, increasing with the square of the deviation — L = k(y − T)².
• Robust design: design products and processes insensitive to noise factors (variation in materials, environment, use).
• Design of experiments: orthogonal arrays and signal-to-noise ratios to find the best settings with few experiments.

• Philip Crosby: quality is conformance to requirements; the performance standard is zero defects; the measurement is the cost of non-conformance; "do it right the first time".
• Programme: management commitment, quality improvement team, measurement, cost of quality, awareness, corrective action, zero-defect day, goal setting, error-cause removal, recognition.
• Poka-yoke (Shingo): mistake-proofing devices that prevent errors.

• Benefits: safety, efficiency, fewer defects, visual management; foundation for lean and TPM.

• Industry 4.0 quality: IoT sensors and real-time SPC, machine vision and AI inspection, digital twins, predictive quality analytics.
• Lean Six Sigma and Design for Six Sigma (DMADV); quality 4.0; supplier quality via blockchain traceability; customer-experience metrics (NPS); sustainability and ESG as quality dimensions; ZED (Zero Defect Zero Effect) certification scheme for Indian MSMEs.