SCI09020 2023 Operations Excellence and Risk Management

Describe the strategic importance of operations and how it relates to other business functions; evaluate performance objectives, product life cycle and the volume and variety effect and how these impact strategic decision making.

Demonstrate an awareness of the philosophy of operations excellence and Industry 4.0; analyse continuous improvement tools and datasets such as JIT, Lean, six sigma, statistical process control, error proofing and evaluate appropriate methodologies.

Apply Lean Six Sigma tools such as Value Stream Metrics, SMED, 5S,Visual Management, TPM, Kaizen Events, Creating Continuous Flow, Process Capability etc.

Discuss the regulatory requirements for risk assessment and management and interpret what is required to comply with these requirements. 

Demonstrate use of problem solving (e.g. fishbone, 5 why etc) and risk management tools such as FMEA, HACCP etc. in a simulated scenario

A virtual learning environment (e.g. Moodle) will be used as a repository of educational resources and as a means of assessment. Self‑directed, student‑centred, independent learning is a core aspect through completion of module coursework.

The assessment approach for this module will be 100% Continuous Assessment with a range of assessment methods employed including some of the following: short-form assessment exams incl. MCQ's, project assignments, essays, oral presentations, vivas etc.  Assignments may take the form of solving worked examples, and demonstration of the application of OpEx tools.  Project work will incorporate real or simulated data in an OpEx scenario (e.g. working through a DMAIC or FMEA etc).

Repeat continuous assessment of the failed elements in line with marks and standards.

1. Describe the strategic importance of operations and how it relates to other business functions; evaluate performance objectives, product life cycle and the volume and variety effect and how these impact strategic decision making.

What does Operations Excellence mean and how can companies achieve this competitiveness.  How performance objectives should interact with product life cycles, the volume and variety of products produced and inform design activities and operations decisions.  The role of Operations in achieving social and environmental responsibility. Supply chain management.

2. Demonstrate an awareness of the philosophy of operations excellence and Industry 4.0; analyse continuous improvement tools and datasets such as JIT, Lean, six sigma, statistical process control, error proofing and evaluate appropriate methodologies.

What is means to be Lean / JIT and an evaluation of Lean tools (e.g. 5S, VSM, SIPOC), application of the DMAIC process and analysis of six sigma tools (e.g Pareto, scatter plots), analysis of statistical process control (SPC) and control charts (Cp, Cpk calculation), application of FMEA, failure analysis tools and examination of what is TQM. Industry 4.0; machine learning, artificial intelligence and augmented reality, chain of custody, and new and emerging technologies.

3. Evaluate requirement of facilities and utilities when designing ATMP manufacturing processes.

What is job design, process design, product design and key issues the operations manager faces at each stage of the design process.  Application of design tools, such as flow diagrams, cycle and takt time weighted score diagrams etc for analysing process flow and supply network design. Facilities layout; closed V open systems, HVAC requirements

4. Discuss the regulatory requirements for risk assessment and management and interpret what is required to comply with these requirements. 

ICH guideline Q9 on quality risk management, Risk management; risk identification; risk classification; root cause determination and risk mitigation.

5. Demonstrate use of problem solving (e.g. fishbone, 5 why etc) and risk management tools such as FMEA, HACCP etc. in a simulated scenario

Fishbone, FMEA (Failure Modes and Effects Analysis) and HACCP (Hazard Analysis and Critical Control Point).