Improving Quality Assurance In A Pharmaceutical Manufacturing Environment - A Case Study

1. Background

A medicine manufacturer has been through a number of costly mistakes that led to a loss of a major market. Some of the mistakes were due to contamination during the production process. This sparked a detailed analysis of the quality control and revealed a number of planning and operational errors. Fortunately, these did not impact on the final product instead, they generated large amounts of expensive waste. The board of directors decided that a new, more structured approach to quality control, quality management and quality assurance was urgently required. As a second objective, the new approach was also to decrease quality related cost in the form of waste and overtime.

2. Setting Up a Quality Assurance Improvement Project

To make the required operational initiative a reality, the manufacturer decided to bring in external advisors specialising in operational excellence. They started this process by involving the Quality Unit and Production heads in the project. Then the work on defining of the core quality assurance elements also commenced. The idea was that if a clear definition of what is meant by quality assurance existed, then the implementation would have a set goal and be easier to understand. To do this, a number of workshops were held for managers and supervisors from both the Quality and Production departments using the following core elements as a starting point for the discussions. The result was a model of quality operations defined by the organisation itself. It described expectations on standards, quality performance goals, interactions between departments and attitudes towards quality. Next, a project team was put together to: 1) develop the high level quality assurance definition into a functional operating model (using operational excellence methodologies) and, 2) to implement the model ensuring that it generates financial benefits to the company.

3. Designing Quality Assurance and Quality Control Using the Operational Excellence Approach

The team started by analysing how the current Quality Unit performs in its current setup. They reviewed all aspects of the existing quality management system: test scheduling, process for sample storage, information flows between production and quality unit, standards, roles and responsibilities, quality rounds, quality control etc.
The "as is" analysis showed that some of the expectations set by the target model for quality assurance would require major operational changes. The collaboration between Production and Quality was until now, more of "quality control via policing" than partnership. To change this, both organisations would have to transform their attitudes and open the lines of communication.
A second major challenge would be more detailed and visualised planning and scheduling of work within the different Quality department sections. In some cases, there was almost no activity planning at all. Every day was perceived as identical to the previous one using the same sequence of tests regardless of the requirements or the fact that sample batching would make testing more efficient and cost effective. At one stage, a senior consultant on the project referred to the testing that took place as "one giant shoe that fits all".
Setting up operational KPIs that would measure quality assurance performance was also seen as a major challenge. This would be a revolution for the Quality department as until now, the performance of the Quality Unit was never measured or evaluated.
The challenge turned out to be much more than originally expected. It would require changing ingrained behaviours. Interestingly, the analysis also revealed that a number of costly tests were performed when they were not actually required. The standards were constantly updated with new tests. However, the tests that were no longer required were not removed.
The quality assurance operating model was then further developed by filling in the gap from "as is" to "to be" , defining all interaction points, batch planning, headcount requirement, meetings structure, KPIs, roles and responsibilities, new updated quality standards etc. As a last step an implementation plan was developed.

4. Implementing Redesigned Quality Control Operations

The implementation started with a global communication meeting informing all supervisors and managers of the quality assurance model with regards to the impact on operations. A time frame was also presented. The changes and implementation took place in phases, starting with quality assurance and scheduling process, sample handling and batching and, Production and Quality interaction redesign.
In the next step new "quality rounds" system was developed, jointly for the production and Quality Unit. This was aimed to create a continuous quality control within the production area and was based on using "walk the job checklists". This new activity would ensure that production based mistakes would be reduced by two thirds. The walks were to be done jointly by Quality staff and production supervisors.
Finally, the new operational KPIs were developed, describing operational efficiency of quality assurance. These would be used by the heads of quality sections to both manage and evaluate section's performance.

5. Challenges While Implementing New Quality Management System

One of the major challenges during the implementation turned out to be the scheduling and planning. The organisation, even though on paper was very willing to change and implement detailed daily scheduling, didn't really see the need for activity scheduling. The supervisors that were supposed to plan came up with every possible excuse not to plan. The most common reason given for using this same structure over and over again was "it has worked well until now, so why should we make a schedule?". Unfortunately no amount of coaching or explanation made any real difference. To tackle this issue, the heads of departments and plant managers had to be notified and involved. A system was created where they had to inspect the 7 day rolling plan every day, focusing on sample batching. In short, something that took a mere 3 minutes to achieve, ensured vast efficiency increase.
The second major difficulty encountered was using operational KPIs to measure Quality Units performance. Until now, Quality perceived itself as the one measuring other; it was a challenge for the organisation to measure their own performance. The managers and supervisors refused to use the KPIs to measure themselves. Once again, the plant management had to be involved. They were asked to review and challenge the numbers on a weekly basis.

6. The Outcome

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