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This article/video features in our final main unit of our online QMS courses and concerns itself with improving our Quality Management System. In order to improve our system we need to monitor and measure.  In order to monitor and measure we need to establish metrics of one form or another – and so, welcome to this article/video concerning GMP Quality Metrics.

Note: This video is taken from Chapter 3 of the seventh Unit of both our online  QP Quality Management Systems course and also our Pharma Quality Management Systems course.

You can view the video now or if you prefer you can read the narrative from the video in the text below.

We have already seen, in earlier chapters, the onus now placed upon us by EU GMP to monitor and measure.  This is necessary to assure ourselves of the effectiveness of the system and in order to promote improvement:

  • In an earlier part of the course we established 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”.
  • ICH 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 need 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 analyse 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 GMP quality metrics employed within the quality management system have, to a large degree, been relatively insular, limited, reactive and reserved – and do little to meet the revised requirements in QMS approach sponsored by the evolved GMP thinking noted in the previous slides.

Often typical GMP quality metrics are limited to deviations, associated CAPAs and complaints and relate to – number issued/ received, number closed within agreed timescales (these timescales being set at an arbitrary limit which often precludes thorough root cause analysis) and number overdue.

Whilst in essence these are important GMP quality metrics there 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 insular and focus almost entirely on GMP-related activities, rather than embracing business or whole QMS elements.

  • Limited in that, primarily they have 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 mind-set and do not embrace the more holistic view of quality encouraged by contemporary GMP thinking itself.

Whilst such traditional metrics undoubtedly have their place and whilst such occurrences should be monitored and analysed 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 inter-relationship or contribution with and to the performance of the business.

We could broaden our measurement system to include metrics related to those economic indicators detailed in previous units such as prevention, appraisal and failure costs.  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 our course but it is in this area that we could be, and perhaps need to be, more imaginative in our approach to GMP 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 the laboratory analysis turn-around time, the documentation review turn-around time, the planned preventive maintenance turn-around time, the batch review turn-around time.

Output requirements such as the availability of purchased 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 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 GMP quality metrics, related to deviations, CAPAs and complaints we could be both more proactive and imaginative in our approach:

  • Not simply the number issued/ received – but trended against a nominal target.
  • Not simply the number overdue – but establish metrics that account for why the close-out 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 on-going 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 this chapter has given you food for thought and some good ideas on how to enhance and develop more traditional GMP metrics.

To see more videos on Quality Management Systems and Medicinal Chemistry visit our Vimeo Homepage

Our 5-day GMP Pharmaceutical GMP Auditor/Lead Auditor Training Course also reviews this topic in some detail.

 

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