Question

wite a paper on the cost of quality in a medical device company.

Answer 1

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There are three main categories of costs:

Direct costs of ensuring quality from assessing and preventing quality issues by quality and operations personnel. These include quality system support, validation, quality control, testing and inspection, auditing, and other quality activities.

Direct costs of poor quality from

internal and external failures including handling rejects and rework and managing deviations. These include costs related to production quality failures, such as destroyed materials, inventory changes, and fees for compliance and engineering consulting;

remediation including investigations, corrective actions, complaint investigation, submitting reports to regulatory authorities and field actions;

routine external quality failures including warranty costs and the cost of returned and destroyed products. Warranty costs apply especially for small electromechanical devices and capital equipment. The costs of returns and destruction can apply particularly to single-use devices.

Indirect quality costs from loss of revenue and impact on share price due to significant quality and compliance events. These include field actions, significant observations in regulatory inspections, regulatory actions, import restrictions and consumer litigation.

There are significant savings available in reducing the direct costs of poor quality. There are five factors that correlate with good quality:

Product and process design – implementing good practice in designing devices that are straightforward to manufacture consistently;

People – focusing on employee retention and shared quality targets;

Production assets – performing maintenance and renewal of manufacturing processes and equipment;

Quality system – conducting supplier quality activities and fast but thorough investigations;

Quality culture - involving operations personnel in quality activities.