This module addresses the history of reliability ans safety technology. The practical mathematical tools of Reliability Block Diagrams, Reliabilty Prediction and Modelling of systems will be utilised. Data analysis and Probability plotting techniques and calculations are included.Repairable and non-repairable systems are addressed. Failure Mode Effects analysis, (FMEAs) and Fault Tree Analysis (FTA) are introduced. The importance of Risk Management is highlighted.

1. Use probability plotting techniques to analyse data and draw conclusions about products
2. Perform simple reliability predictions and modelling
3. Analyse the reliability of a design or a process using FMEA and FTA
4. Communicate the importance of risk management in different environments

5. Perform simple Bayes Theorem calculations

6. Devise a simple risk evaluation study

An overview of the regulatory requirements for validation activities focused on the pharmaceutical, biopharmaceutical, medical device and food sectors.

1. Explain Validation Categories
2. Discuss the importance of Validation in Industry
3. Generate a User Requirement Specification for a new piece of equipment or system.
4. Interpret the Regulatory requirements as they apply to the different categories of validation
5. Write a Validation protocol- DQ,IQ OQ or PQ
6. Apply the concept of risk management to the different areas of validation

This module will provide the student with the tools necessary to plan, conduct and analyse experiments. The analytical interpretation of these results will allow the student to optimise products and processes.

1. Calculate correlation coefficient and conduct a test of significance.
2. Solve simple linear regression and curvilinear regression problems and make predictions.
3. Conduct one way and two-way ANOVA including the analysis of residuals.
4. Conduct and factorial experiments and analyse the resulting data.
5. Apply Taguchi methods involving calculation of loss function and signal-to-noise ratios.
6. Describe when and how to apply the appropriate experimental techniques and models
7. Use a statistical package to analyse and interpret experimental data.

This module introduces the concept of service quality. The role of services and the service perspective are considered. Service quality models and measurement systems are outlined including SERVQUAL, Gap analysis and E-S-QUAL. The service process and how to become a customer-focused organisation is investigated.

1. Describe the characteristics of the service sector
2. Appreciate the different management schools of service quality

3. Identify the differentquality factors and evaluate their impact on customer satisfaction

4. Design a measurement system for service quality
5. Apply the SERVQUAL and/or E-S-QUALmodel

6. Demonstrate an understanding ofservice quality culture and delivery

For this module students are required to undertake a substantial literature review of publications on an approved quality related topic. Under the guidance of their assigned staff supervisor, the student must also complete an element of primary research which should be informed by and built on their literature review.

1. Demonstrate an ability in project identification andspecification

2. Undertake research for an academic project.

3. Relate secondary research findings within their own or another working environment

4. Analyse in a logical and independent manner the primary and secondary research

5. Communicate the research findings in both oral and written form, displaying competency scholarly writing and referencing according to standard conventions.

6. Manage a personal learning process and demonstrate an understanding of scientificresearch.

The project aims to provide students with the opportunity to apply and integrate the skills and knowledge they have gained on the Quality modules they are studying. These modules are Statistics, SPC, Experimental Design and Quality Management.

The student should bring the learning from the modules covered in the course to identifying and leading six sigma projects within their organisation. Black Belts are the leaders in creating project teams, training and mentoring these teams and driving a culture of continuous process improvement within their organisation. A mentor will be assigned to each project.

The mentor will act as a guide in agreeing the relevance, and scope of the project, and monitor the progress on a regular basis. Updates will be sent to the mentor on an agreed basis.

Note: For external *ASQ Six Sigma Black Belt certification, ASQ requires two completed projects with signed affidavits or one completed project with signed affidavit and three years of work experience in one or more areas of the Six Sigma Body of Knowledge.

1. Identify a problem which needs to be addressed of importance to the organisation.
2. Lead the Six Sigma project meeting the goals of Time, Financial Savings and Requirements.
3. Utilise the Six Sigma DMAIC structured approach to manage the project. Apply appropriate Lean and Six sigma statistical tools in reducing process variation, optimising the process and realising financial savings.
4. Prepare a written report which outlines in detail the background to the project, a literature review outlining current knowledge in the project area, the methodology used to address the problem, discussion, conclusions and recommendations.
5. Present project results with Executive Summary, Conclusions and Recommendations and discuss the approach taken and results achieved.