Medical Device Regulation – Article 117 Action Required
Company Culture
Company Culture and Quality Culture continue to be hot topics for the pharmaceutical industry into 2018. Culture is anchored in unspoken behaviours, mindsets, and social patterns. It underscores the way personnel interact with each other and with customers. Positive cultural behaviours form the building blocks of sustainable and efficient business behaviour- it is too important an issue to ignore. The pharmaceutical industry has experienced significant globalisation over recent times and to remain globally competitive, operational excellence has really become a key necessity for companies to remain competitive. A strong and positive Quality and Company Culture can help companies achieve change and build organisations that will thrive through the ups and the downs. Company Culture can be defined as the shared values, attitudes, and behavior patterns of all personnel within an organisation. To achieve a healthy quality culture, a company must understand that serving customers and what’s good for the company are in line with each other. This principle must be the corner stone behind what everyone does. This will create a culture where a positive internal environment and satisfied customers go together. There is a changing shift in how culture is viewed and this shift means that a positive culture is a more valuable resource than ever. There is no longer an ‘internal’ culture. Your culture is visible and forms a fundamental part of a company’s brand. It can be a powerful asset if harnessed correctly. However, how do you make sure that all employees minds are focused on delivering a quality product or service? Organisational change is hard. Resistance to change and the fact that so much of culture is anchored in unspoken behaviours, mindsets and values leads to opposition from personnel. Culture is not easy to measure. There is no immediate KPI or metric that can be applied. It must be pointed out that no company’s culture is perfect and static. A positive Quality Culture is an evolving state. Leaders need to take the challenge of culture head on. One of the successful approaches to develop quality culture among the organisation is focusing on the 5 main key behaviours for quality culture: A mentality of “we’re all in this together” (the company, suppliers, and customers) What’s good for the company and for customers comes together and becomes the driving force behind what everyone does. A mentality of “we’re all in this together” (the company, suppliers, and customers) Open, honest communication is vital Create a culture where people listen to each other. This is a culture where open, honest communication is understood as necessary for people to function best. Information is accessible Information accessibility is key to positive culture. Business leaders should be open about sharing information on the company’s strategic goals because this information provides direction for what we will do next and – more importantly – direction for how to improve. Focused on processes Everyone should move away from a “blame the person” mentality to a “blame the process and let’s fix it” approach to problems and improvement There are no successes or failures, just learning experiences An important insight is that failure and success are judgments that are formed after the fact. We can never predict with certainty what will end up as a success or a failure (or a mistake). For further information on how MPI can assist your organisation, please contact us at +353 1 846 47 42 or contactirl@pharmalex.com.
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