a) An approx. 3% defect rate (i.e. 0.03 x 300m units) = 9m units per year.

b) A apparent definition of Quality Assurance should be awarded, e.g. the management process of guaranteeing (assuring) the consumer of a product's quality. This guarantee can be secured by meeting international quality standards such as the ISO 9000. QA is important to Durex for several reasons, including:

• Condoms must be fit for their purpose, perhaps more so than for most products (for safety and health issues and to prevent unwanted pregnancies, for example)
• QA aims to eliminate/reduce defects thereby giving customers a sense of security (peace of mind) in purchasing the product
• Quality assurance will undoubtedly affect the corporate image and reputation of Durex
• QA can help Durex to maintain to prevent brand switching and customer loyalty (Durex has 25% market share only)

• QA can be a form of product differentiation for Durex, thereby improving its competitiveness
• QA helps to decrease wastage, therefore raising profit margins

Any two valid factors, explained in the context of Durex, would warrant maximum marks.

c) An appropriate definition of TQM should be awarded: the belief in and process of removing inefficiencies and wastage in all forms of business activities, requiring the commitment of everyone in the business to achieve quality standards. Features of TQM that might help Durex to reduce its 3% defect rate include:

• TQM aims for zero defects - perhaps a defect rate of 3% (or 9m units) is rather too high for this kind of product
• Testing - tests such as the artificial ageing of condoms or the air/water pressure tests are key aspects of TQM
• 'Right first time' culture - helps to decrease defect rates
• TQM involves the workforce (e.g. empowerment, motivation and responsibility) striving for reduced or zero defects
• Since all workers are accountable for quality control and QA, substandard products are less likely to occur
• The role of CAM/CAD/automation in reducing defect rates could also be outlined.