PHRM06005 2019 Total Quality Management

To describe the strategic importance of operations and how operations relate to other business functions, basic issues - capabilities and limitations of the operations function.

To describe the impact of operations on other functions within a firm.

To demonstrate an understanding of the concepts and methods related to designing and managing operations

• the basic steps involved in bringing a product to market, from receipt of material through production to delivery
• skills as how to forecast demand
• layout facility
• manage a project
• schedule production

To develop a skilllset for organizing activities as part of a project / process - from conception of system interrelation, to organize activites effectively, to analyzing processes critically, to make decisions based on data, and continual process improvement.

To be able to conduct SPC of opertions/system and analyse the data using appropriate experimental techniques and models.

To demonstrate a working knowledge of the MIS utilized in the pharmaceutical industry, e.g. ERP, JIT, LEAN.

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A.         Operations

1. product plan development, production and distribution, material reconciliation
2. Management Information Systems (MIS)

MRP / ERP / excel - computerized system control.

1. Scheduling, forecasting, inventory control. Suppliers/Contractor/Customer, relationship development, structure, auditing, delivery inspection process.
2. Work instruction/documentation control, review and approval, SOPs.
3. Facilites

B.         Operations Methodology - Quality and performance

1. Process capability CpK, improvements, Problem solving.
2. Lean operations - MF, Lab, IT
3. JIT - methods of organizations
4. Output SPC, KPI's (customer satisfaction, deviations, rework, complaints).
5. Total Quality Management
6. Six Sigma, Process Reengineering methodologies
7. Process Flow manufacturing, Value Stream Mapping

C.         Operations Personnel and HR

1. Team development - working cell, cross-functional team
2. Skills matrix creation
3. Review and appraisals, conflict resolution.
4. operator input: better ergonomics, more variety, higher job satisfaction, job security, and improvements in safety, methods, equipment layout, tools, etc

D.         Additional responsibilities

1. Product Regulatory compliance, distribution requirements, material segregation, cold chain maintenance
2. Department, capital Budgeting requirements.
3. projects management and tools (visio, project)
4. Documentation: URS, FDS, GxP, RA, I,O,PQ GAMP4.