Investigating deviations offers an unmistakable opportunity to improve the quality of the processes and products of your organisation. Being successful in continuous improvement, strongly stimulated by regulatory authorities, is dependent on how quality investigation is incorporated into your organisation. Adryan believes that the accurate execution of a root cause analysis, a risk assessment, or deviation control using the appropriate tools will play an important role in the prevention of quality issues. In this way, these methods contribute directly to the continuous improvement of your processes and product. Based on this belief, Adryan offers quality investigation integrated into the comprehensive quality awareness of our experienced consultants.
After the occurrence of an unexpected event, for instance during the manufacturing process, a conscientious approach to investigating the possible impact on quality is a mandatory action obliged by GMP regulations. The way the investigation is performed has a decisive role in establishing the real root cause, which is essential for defining corrective and preventative actions. These actions will allow you to ensure that this event will not occur again and demonstrate that your organisation is in control of the production processes.
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Proper execution of one or more risk assessments with respect to quality impact on processes and products is important for obtaining an insight into the severity of the deviation. To prevent time-consuming, fruitless discussions, it is highly recommended to make use of an experienced facilitator to help steer the team of SMEs. An effectiveness check to confirm that the implemented corrective and preventative actions in response to this unexpected event had been efficient is the final step in to resolving the deviation.
Adryan offers support on any aspect of quality investigation to be able for your organisation to use the outcome of root cause analysis and risk assessment for the necessary continuous improvement of your organisation resulting in an effective deviation control.
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