Monitoring the Environment
In addition, the site’s environmental monitoring (EM) results showed potential contamination, but because the results were segregated in the tracking system, personnel in the area where the problem occurred were unaware that 42% of deviations were EM-related. Missed EM tests, which were responsible for much of the problem, were then reduced by addressing a key informatics interface and by moving routine testing out of operations and into EM to improve oversight. Because a significant amount of deviations were also related to positive EM test results, the quality and site sterility assurance groups worked to improve aseptic practices.
The resulting gains in efficiency were significant. At the beginning of the program, right-first-time performance in batch records stood at 32%. Within four months, the organization raised that figure to almost 60% and shortly thereafter exceeded the stretch goal for the second quarter of year two of the program. The number of errors per page dropped from a high of 3.4 to 0.9, surpassing the target of one error per page. The number of deviations caused by human error dropped to zero. In addition, improvements in EM and aseptic practices resulted in a reduction in total deviations within that operation.
Cost savings were also significant. Labor savings from this project were an estimated 4.3 effort-years of investigating and writing deviations. In addition to those labor-cost savings, the organization avoided the costs of minor and major deviations, and the cost of destroying materials and products. The estimated annual true cost avoidance was in excess of $8 million, a figure that would climb to $40 million annually if the program were rolled out to the entire site. Eliminating critical deviations avoided distribution center withdrawals and product recalls.
While the gains in efficiency and reduction in costs were significant, the outcomes in quality/compliance were crucial. The recurring problems that the company was experiencing had attracted the attention of FDA, resulting in 483 observations and, ultimately, a warning letter. Due to the importance of the manufacturer’s vaccines to public health, the agency required biweekly meetings with the company for progress reports. Just three months into the program, the company was able to demonstrate to FDA that the site would be able to deliver the needed compliance improvements.
The vaccine maker’s program not only generated the immediate cost, efficiency, and quality/compliance goals—all three legs of the stool—but created sustainable benefits. As a result of the program, employees were motivated to consistently strive for the highest level of quality, establishing what we called in a previous article in this space a “quality culture” (1). At the site, operational excellence is now seen as a process of continuous operational, quality, and compliance improvement, where everyone understands the organization’s objectives, policies, and procedures and their individual roles in helping achieving them.
Life-sciences organizations will need such hardy cultures of quality to withstand stepped-up regulatory scrutiny. FDA Commissioner Margaret Hamburg told participants at the Annual Meeting of the Generic Pharmaceutical Manufacturers Association that the agency will increasingly focus on GMPs to improve drug quality. In addition, she said that the agency is exploring the creation of a new Office of Pharmaceutical Quality charged with overseeing quality through the life cycle of the product. “To address the increasing complexity of products, we will optimize the use of staff talent and review expertise to improve consistency and regulatory certainty across the wide span of drug quality review,” she said (2).
It is possible, of course, to satisfy quality and compliance imperatives by gold-plating processes and systems. However, that approach forgoes the improvements in efficiency, reliability, and the reductions in costs biopharmaceutical organizations can ill afford to sacrifice. And the result of gold plating will be less a quality culture than a sort of “quality castle” that depends more on implementing costly fortifications than on developing quality-conscious people. At the other extreme, myopically focusing only on process and efficiency improvements in the design and implementation of OpEx programs--particularly regarding cost reduction and “right sizing” staff--can result in increased quality and compliance issues that, if not addressed early, can cripple an organization and lead to serious and expensive remediation efforts. By taking an approach to operational excellence that simultaneously embraces efficiency and quality, biopharmaceutical organizations can make sure they get the best of both worlds: working better and better work.
References
1. I. Uydess and C. Meyers, “Developing and Sustaining a Quality Culture,” BioPharm Intl 24. 20-22 (2011).
2. M. A. Hamburg, Annual Meeting Generic Pharmaceutical Manufacturers Association, Orlando, Fla., Feb. 22, 2013.