This is why Quality Training is so important!
01 October 2018
Blog by Ruud Lans, Quality and Regulatory Affairs Consultant
In the world of Medical Devices, most people are familiair with quality assurance and the regulatory requirements. But not everyone is known with the ins and outs of quality assurance, and that is why Quality Training is important. Below you can find which quality topics are important and§ which techniques are useful for employers and employees.
The quality awareness training is targeted at helping employees understand the basics. These courses define total quality and its relationship to the corporate culture. Employees are introduced to the quality improvement processes, the costs of quality, problem-solving, teamwork, an emphasis on customer satisfaction, and so on.
These courses stress a cooperative approach to goal setting, identifying and solving problems, project implementation and evaluation, and related topics. Managers learn group dynamic skills and are trained in group leadership.
Process Management Training
Process Management Training sessions help employees and managers learn the tools and techniques which are needed to define, document and continuously improve processes while moving towards the goal of zero defects.
Customer Awareness Training
These courses are designed to help employees and managers become attuned to the demands and expectations of markets and product or service users. The lessons learned can be applied to every employee’s immediate customers, the consumers of that employees’ work, whether they are internal or external customers.
These courses equip employees and managers with the tools to gauge the impact of poor quality on basic processes and functions to establish controls, develop and apply cost systems, and to test activities and processes against internal standards.
These courses are designed to refine the ability of employees and managers to engage in continuous improvements of processes, to design experiments, and to reach decisions based on collections and analysis of data.
The unprecedented investment in quality training reflects toward challenges, one of them more avoidable than the other. Firstly, one cannot get around the fact that quality programs require a paradigm shift. The pursuit of quality required a great deal more than the adoption of a handful of new techniques. All employees should be brought up to speed in the new paradigm. This is a challenging goal: It takes a lot more than a half day seminar to change the way people think about their work. And how longer they have been working under the ‘old‘ management ways; the harder it is to change the way they think.
The second challenge is that companies have not trained new employees to the job force in the skills and concepts needed to participate in quality improvement processes: quality principles and practices represent a branch of knowledge.
Ruud J. Lans, MSc BSc, Consultant Quality & Regulatory Affairs, Certification and Certified Lead Assessor
Sources: ISO 13485:2016, ISO 9001:2015, ISO 14001:2015, 21 CFR 820, 20 QSR, MDSAP, MDD/MDR
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