Empower Your Business with Meddic Metrics for Product Quality

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unit seven our final main unit concerns itself with improving our quality management system in order to improve our system we need to monitor and measure in order to monitor a measure we need to establish metrics of one form or another and so welcome to this chapter concerning quality metrics we have already seen in earlier chapters the onus now placed upon us by EU GNP to monitor and measure this is necessary in order for us to assure ourselves of the effectiveness of the system and in order to promote improvement chapter one states that the quality system should facilitate innovation and continual improvement that we should consider the results of product and process monitoring and that we should use periodic management review to identify opportunities for continual improvement of products processes and the system itself IC h q10 suggests that performance indicators should be established monitored communicated regularly and acted upon and that we should use such indicators to promote improvements to the pharmaceutical quality system and related processes this needs to monitor and measure is reflected in the FDA guidance document and in stating that quality systems call for continually monitoring and improving systems and that analysis of data can provide indications that controls are losing effectiveness the FDA's quality system model stresses the need to monitor and measure activities to analyze data for trends to take action to deal with any undesirable trends and to use such analysis and trending as both a corrective and preventive tool traditional metrics employed within the Quality Management System have to a large degree being relatively insular limited reactive and reserved and do little to meet the revised requirements in QMS sponsored by the Evolve GMP thinking noted in the previous slides often typical GMP metrics are limited to deviations associated cappers and complaints and relate to number issued received number closed with an agreed timescales these timescales being set at an arbitrary limit which often precludes for a root cause analysis and number overdue whilst in essence these are important GMP metrics they are real limitations here when it comes to using just these to monitor our whole system these limitations include the fact that these traditional metrics are insula and focus almost entirely on GMP related activities rather than embracing business or whole QMS elements limited in that primarily they have been focused on the effectiveness of the system rather than its efficiency and the need to drive improvement reactive in that they encourage review when something has gone wrong of course we must always do this but far better to be proactive in approach and hopefully prevent failure in the first instance and finally reserved reserved in the sense that we have been constrained in the past and not encouraged to look outside the traditional GMP box these traditional metrics whilst important encourage a traditional GMP mindset and do not embrace the more holistic view of quality encouraged by contemporary GMP thinking itself while such traditional metrics undoubtedly have their place and whilst such a currency should be monitored and analyzed they actually tell us relatively little about the performance of the system the performance of the whole QMS its efficiency as well as effectiveness and its interrelationship or contribution with and to the performance of the business we could broaden our measurement system to include metric related to those economic indicators detailed in previous units such as prevention appraisal and failure costs which we could incorporate statistical indicators and performance indicators related to effectiveness efficiency productivity and value-added we could embrace quality measurements linked to both hard and soft indicators all elements we have previously highlighted and discussed and all of which would move traditional metrics forward in designing and implementing our quality management system we have talked about the adoption of a process based approach an approach focused on effective and efficient transformation of inputs into outputs this is a topic that we will return to in later chapters of this unit but it is in this area that we could be and perhaps need to be more imaginative in our approach to quality metrics key to the adoption of this approach is the efficiency of this transformation and the management of the various input and output interfaces between the different processes that make up our system here we see scope to establish efficiency metrics based around throughput times and actual process output requirements throughput times such as laboratory analysis turnaround time the document review turnaround time the planned preventative maintenance turnaround time the batch review turnaround time output requirements such as yet such as the availability of purchase material for manufacturing the transfer of customer orders into the planning and manufacturing process on-time delivery to the customer and the like remember when we say customer we also mean your internal customer all rather focused on the efficiency of an embracing and whole QMS which serves the business operation and business performance rather than an isolated manufacturing function and the conformity of its product even if we were to stay with our traditional metrics related to deviations cappers and complaints we could both be more proactive and imaginative in our approach not simply the number issued received but trended against the nominal target not simply the number overdue but established metrics that account for why the closeout is overdue not simply the number of customer complaints but the Associated reasons for complaint be it what has caused the complaint late order delivery lack of in full delivery the number of orders chased and so on all such measurements could now be used and trended to sponsor guided and focused continual improvement in establishing our quality metrics we need to be aware of the very rationale behind our quality management system if it is to reflect the evolved and contemporary thought process we have encouraged that of the need for effective and efficient operation the need to drive continual improvement and the need for an embracing system then we need quality metrics that reflect this rationale and help us monitor progress against it we also need to bear in mind the principles associated with the establishment of quality metrics it should be an ongoing and evolving process it should adopt a proactive stance it should be a visual and open activity and one that facilitates ownership and engagement and it should be a process which generates meaningful information which as necessary can be escalated to senior management in a proactive manner our metrics should be valuable to all departments and stakeholders ticking the boxes of all aspects of the QMS we hope that is this chapter has given you food for thought and some good ideas on how to enhance and develop more traditional GMP metrics