As pharma develops its own quality systems, and ICH Q-10, it is layering industry-specific requirements over the basic framework of ISO 9001-2000. Many industries have already done this. Some in pharma may feel as if they’re doing something completely new, because drug making is so very different from automotive, aerospace and the other sectors that already have quality guidelines in place.
But safety and risk management offer a common ground, allowing pharmaceutical manufacturers to draw new lessons from some very unexpected sources. Here’s one that may surprise you: defense aviation. The cynics among you might note the waste and outright fraud found among some military contractors in the past, and draw some parallels to sectors, and unfortunate recent events, within pharma. I’d prefer to focus on things like process capability and continuous quality improvement.
For any of you who, like me, thought that pharma’s new “21st Century GMPs” and quality paradigm sprang straight from the minds of Woodcock, Hussain et al at FDA’s CDER, the U.S. Department of Defense beat them to it by at least a decade. In the interest of advancing a continuous improvement culture, DOD promoted a détente (remember that word?) with manufacturers, and established guidelines that would allow them to understand and control their processes, much as FDA is doing now.
Oh, and the process and materials variability, the silos, the lack of visibility into processes and data? The fear of making improvements that would require “revalidating” their processes? Defense aircraft manufacturers and their clients in the military have been there, too. The situation reached a high point in the 1990s, when failures began to be seen in military aircraft that had been designed in built in the 1960s, with a “quality by inspection” rather than a “quality by design” approach.
Aircraft spare parts and components were made available, and bought, using “average quality level” (AQL) as a parameter. Some of them were way below par, causing expensive systems to fail in just hours. To redesign and requalify these aircraft would have taken years, given the raft of expensive tests required, so the temptation was to continue to fly them “as is” and hope for the best. How many of your processes and plants are running that way today?
Consider this excerpt from the DOD’s Test Method Standards, published in 1996. Does it sound familiar? “…The purpose of this standard is to encourage… commercial organizations supplying goods and services… to submit efficient and effective process control (prevention) procedures in place of prescribed sampling requirements.
The goal is to support the movement away from an AQLbased inspection (detection) strategy to implementation of an effective prevention-based strategy including a comprehensive quality system, continuous improvement… The underlying theme is a partnership between DoD and the …supplier, with the requisite competence of both parties, and a clear mutual benefit from processes capable of consistently high quality products and services...”
Here’s the very last sentence in the passage: “…The objective is to create an atmosphere where every noncompliance is an opportunity for corrective action and improvement rather than one where acceptable quality levels are contractually sufficient...” Reports from the army, navy and the U.S. Government Accounting Office in the late 1990s and early 2000’s reveal a picture of unreported failures, missing information on root cause of failure, lack of data transparency and access, as well as insufficient employee training and incentives.
Perhaps it’s assuring, that problems can be resolved, and you’re not alone in tackling the challenges of continuous improvement. We promise to give you more examples from within and outside the industry.