Category Archives: Quality in Pharmaceutical

How can Lean support Quality and Compliance in Pharma?

The pharmaceutical industry is a strong and growing segment of the global economy, represented by organizations responsible for making, patenting and selling drugs to distributors. The global industry is expected to be worth more than $1 trillion in 2014 according to research from Urch Publishing. Part of the growing challenges for organizations in this industry, are the changes in regulations (very strict) and possible compliance issues which can lead to substantial law suits, high costs for correction of issues (fines, penalties and recalls) and most importantly, damaging the relationship (reputation) with customers, potentially putting their health at risk. Thus, for any manufacturer of pharmaceutical products today, Quality and Compliance should be the focus.

Quality and Compliance are often misunderstood as the same. Quality, i.e. the specifications of the final product, is a result of the internal and external processes, procedures and resources used to manufacture, package and distribute it. These are planned based on what the customer demands. Compliance is the way these processes are controlled to achieve Quality. Compliance standards are defined in the Good Manufacturing Practices (GMP) and used by regulatory bodies such as the Food and Drug Administration (FDA) responsible for the countries’ public safety.

With changes in compliance regulations and an observed continuous rising in the number of issued FDA 483s, so-called non-conformities/non-compliances, pharmaceutical manufacturers have come under increasing pressure to improve current processes and procedures and thereby their overall Quality and Compliance efforts. This shift in focus falls directly in line with the Lean thinking way, more specifically, with Lean Quality Assurance (QA).

To consistently achieve robust Quality and repeatable Compliance it is necessary to have:

  • Standardized work, highly formalized operations, including maintenance but also batch release and process re-validation
  • Structured high-speed problem solving, specifically Lean A3 – Practical Problem Solving
  • Process confirmation – Lean layered process audit or Kamishibai
  • High level of transparency in the system which can be achieved through Lean Visual Management (VM).

The implementation of Visual Management (VM) requires Lean standards which, not only facilitate measuring performance and identifying any deviations in the system (premises for problem solving and continuous improvement), but are also the basis for Lean Job Instruction Training. For this system to work, the organizations’ leadership must be capable of effectively measuring performance, anticipating risks and enabling change. ‘By defining standards and setting up Lean Visual Management with a robust review process (process confirmation), we have witnessed many organizations making a dramatic improvement in Quality within the first 6 months’ says David Hurst, Director of Lean Coaching ‘We have seen reductions of as much as 20% in non-conformity items (e.g. FDA 483s) through focused problem solving and Visual Management’ he adds.

So, how can Lean Visual Management support QA and improve Quality and Compliance?

It all starts with Hoshin Kanri. The Quality and Compliance strategy needs to be deployed into the fewest relevant key performance indicators (KPIs) aligned and cascaded down the organization. These KPIs must be clearly displayed and reviewed on a regular basis. The frequency is defined based on the deviation to target – higher the deviation, higher the frequency. A review process needs to be created involving all relevant parties; this will help driving the right behaviors. ‘Part of the difficulties in setting up Lean VM relies on the people – the system is only as good as the people managing it’ says Nick Rowson-Jones, Lean Coaching’s Senior Project Manager. ‘Coaching behaviors is the biggest part of our job as Lean coaches – the right behaviors enable the sustainability of the system, our ultimate goal’ he complements.

Reviewing the KPIs with frequency allows management to quickly react to problems, to observe trends and analyze common causations. In the case of non-conformities, a tight control with clear visualization of the problems and their resolution process status (step by step), is a crucial part in driving results and meeting GMP and FDA requirements. ‘We have to eliminate the “culture of blame” by establishing a process, where problems are analyzed objectively and countermeasures are agreed. This promotes a culture where problems are seen as improvement opportunities for the common good’ says Nick.

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The difficulty of implementing Lean in Pharmaceutical organizations does not rely only on people; but also on the process, more specifically on process change. There are strict limitations on performing Kaizen in these organizations. Since processes are controlled and required validation, any change request (CR) can take months to complete depending on its complexity. This limitation inhibits the Management team’s ability to ‘challenge the process’, hence being easier to accept the current situation instead. A change request usually has to be validated by an engineer and approved by QA before being implemented. For major process change validation, it may take many cycles of production to certify that there are no secondary effects. As a result, the window of opportunity to implement and test may only be able during closures and shutdowns.

An alternative that Lean Coaching has been working on with its Pharmaceutical clients is supporting Kaizen practices by forming “focus groups”. These groups (teams) should contain all relevant individuals responsible for process’ changes and subsequent validation, such as operators, engineers, chemists, QA and Maintenance representatives. Through these teams, Kaizen activities can be prioritized, considering the ‘effort versus benefit’ factor; the trial and implementation process is coordinated and obstacles/issues are resolved quicker. With a more robust continuous improvement foundation, organizations are more certain to be compliant and to efficiently produce quality products.

Despite the difficulties of applying Lean to Pharmaceutical companies, its positive outcomes are definite. Pharmaceutical companies who develop a robust Lean Quality system (validated to GMP) – i.e. standardized, transparent (visual) and closely measured, with a capable management team, high-frequency problem-solving and a continuous improvement culture – experience a significant reduction in non-conformities, setting new standards for attainable Compliance and Quality levels providing them with a distinctive competitive edge.

 

Posted in Quality in Pharmaceutical.