Quality & the Business
CDER has just released, with very little fanfare, the next publication in their Quality Management Maturity (QMM) series, titled “Quality Management Initiatives in the Pharmaceutical Industry: An Economic Perspective” which is a pretty big deal! This is not considered a ‘Guidance for Industry’, but rather a ‘Whitepaper’ in line with previous QMM publications and others such as Drug Shortages. The primary objective of QMM has and will remain reducing shortages, attempting to argue the business case for Quality and healthy market competition. Whitepapers are typically released to address ongoing public health challenges with incentives vs. outlining minimum expectations, as in traditional Guidance Documents. This one appears to have been largely generated by an AI assistant – probably Elsa, as there are likely terabytes of data on the internet about Quality Management and the business case for Quality (just not necessarily from our industry, unfortunately…).
In this case, the incentives presented by CDER are clear: if you focus on the ‘old school’ principles of Quality Management, financial benefits come naturally. Quality and Profit do not need to be opposing forces. ICH Q9: Quality Risk Management (QRM), was published some 15+ years ago and is a model summary of ‘old school quality’, but still (despite recent revisions) remains bare bones and does not include any practical framework to apply its concepts. Perhaps this Whitepaper is an attempt to provide some structure for how to apply QRM in GXP, as the “Lean Six Sigma” manufacturing theory is mentioned multiple times. Lean Six Sigma is a very specific framework for reducing process variation, and can be very effective when applied to largely automated processes or assembly lines (e.g., FMEA is a primary tool, which results in disaster when used without supporting data sets). Lean, on the other hand, is based on more qualitative tools, and is better equipped to handle manual and hybrid processes, such as those found in abundance in our industry.
This lack of structure within Q9, which is expertly written to address both automated, hybrid and manual processes, is likely the reason many companies have left it on the shelf to accumulate dust, or treated it more as a checkbox compliance activity rather than a guide to achieve excellence in manufacturing. Most GXP management has nightmares of acknowledging GXP process hazards, preferring instead to keep risk in the shadows and instead blame the worker (human error) for any quality lapse. This is absolutely 100% prohibited in Lean theory, as problems must first be attributed to the process design before any human error can be considered.
I have personally not recommended any one Quality theory to adhere to, preferring the flexibility that comes with simple tools and critical thinking – but maybe it’s time to adopt a more structured and formal approach to QRM? Maybe a structured approach, with study materials and certifications, will finally push us in the right direction? I remain skeptical that this approach will work on a large scale within the GXP world (as the tools are too formal). I think the basic ‘old school’ 1950’s Lean principles, combined with Q9, may provide enough structure, without the “six sigma” addition.
The concepts of Data Governance, outlined in the new PIC/s Guide and associated Annex 11 regulation, provide this middle-ground structure vs. flexibility answer we need. Make sure to join us in an upcoming workshop as we discuss the structure and theory necessary to get started, with the goal of long-term compliance/quality and profitability!
Pete
