Assessing employee perceptions of quality at Fresenius Kabi Manufacturing South Africa (FKMSA)

The pharmaceutical industry is one of the fastest growing and developing industries in the world today. With the ever advancing technology and manufacturing techniques, quality assurance has become the focus of regulatory bodies all over the world. The implementation of quality management systems (QMS) that ensures that quality is built into every step of the design and manufacturing process has been the focus of many pharmaceutical companies. With the implementation of quality systems, employee’s perception of those systems and overall quality standards of the organisation is very important in establishing the quality culture of the organisation. To benefit from sustainable quality systems the organisations must ensure that employees understand the importance of the systems and that employee’s take personal responsibility for ensuring that their functions are performed correctly the first time. FKMSA has invested in a QMS that seeks to integrate all quality issues. The quality system includes documentation, deviations, corrective and preventative action (CAPA), change controls and quality risk management (QRM) in the entire facility. This system is administered by the quality control department, but each department takes ownership for their quality issues with support and guidance from the quality unit. FKMSA also firmly believes that quality cannot merely rely on the quality control test results; every step of the production process has a quality aspect built in to ensure that quality standards are adhered to. Every employee is trained, assessed and deemed competent before they can perform their duties; this is to ensure that human errors are kept to a minimum. Employee’s perception of quality is an integral part of quality assurance and it is important for the organisation to know what the employees believe to be the company’s standards of quality