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).