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Nicola Wilson


Leading the Way Toward Standardized Auditing

Life sciences embrace eQMS

Published: Thursday, April 30, 2015 - 14:45

With quality the driving force behind innovation and operational improvements in the vast majority of organizations, it’s no surprise that every industry sector has embraced it, from manufacturing to the service. For some sectors, however, quality improvements can be the difference between life and death, and no more so than in the world of bone marrow donation.

This year, the World Marrow Donor Association (WMDA) has focused on auditing collection centers. The idea currently under development by the WMDA Quality and Regulation Working Group is to standardize the approach to auditing so that each registry and donor center (DC) work to the same criteria. A uniformed approach will achieve greater efficiencies and ease compliance, not to mention improve analysis of data and outcomes that will lead to global quality improvements within collection centers and DCs.

Multiple audit methods

At present, registries and DCs in different countries have vastly different approaches to audits. This can be problematic if they operate on a worldwide scale because data captured by one organization comply with the regional or national legal standards and regulations of its own government, but not the standards or regulations of another country. To get around this issue, bone marrow registries and DCs often rely on the services and information held by international partners and suppliers—bodies like the WMDA, which acts as a central guarantor of quality—thus bringing an element of standardization to the process.

However, this isn’t a problem faced just by donor registries or the life science industry specifically; it can be found in any business operating globally. A drive toward standardizing general audit processes, no matter the industry, will lead to higher quality data and analysis capabilities. Geographical uniformity of processes will streamline the audit process and improve the quality of captured data, with structured audit calendars and checklists, for example, ensuring appropriate information is captured the first time with results analyzed and reviewed consistently.

Creating consistency

So, where do you start? It’s all about operational change, and essentially what you’re trying to do is overhaul your organization’s audit processes and practices. A daunting task, perhaps, but with the right system in place, it doesn’t have to be. Establishing a robust annual audit life cycle can be taxing and time-consuming, but there are clear business benefits when the right system is in place. Using an electronic quality management system (eQMS) with audit capability streamlines and centralizes the complete audit life cycle, which in turn makes it easier to meet stringent demands from international regulators and accreditors.

To illustrate this we can compare a manual paper-based system to an electronic offering. Using a manual process, where you manage your audits using spreadsheets and email calendars, you must navigate around a number of systems to schedule and perform your audit. This can lead to audits being carried out late or even missed altogether due to poor visibility. A manual process can be difficult to manage because you must watch your calendar and personally arrange schedules to liaise with participants. With an electronic solution, your full audit calendar is visible and you can schedule, plan, and perform your audit in a single interface, eliminating the need for multiple systems.

How will audit standardization improve your organization? Returning to the topic of the WMDA and the day-to-day administration of collection and apheresis centers, an eQMS with a rigorous audit and nonconformance management capability will save valuable time by eliminating the need for extensive manual tasks. Subsequently, this facilitates opportunities for organizational improvements that can then drive higher-quality stem-cell products and increased donor safety.

The continuous need to improve donor safety is always at the forefront of registries’ concerns, and with a clear focus for quality in 2015, the WMDA is driving improvements that will provide great benefits. In regards to auditing in general, couldn’t standardizing audits per sector increase overall quality levels? If the WMDA has its way, there may be answers in the life sciences sector before too long.


About The Author

Nicola Wilson’s picture

Nicola Wilson

Nicola Wilson is a life-science specialist at Gael Ltd where she helps build mutually beneficial relationships with Gael’s customers to give them personalized customer experiences. Prior to Gael, Wilson worked as an associate scientist at BioReliance, as a safety case coordinator at Chemring Energetics UK Ltd, and as a research technician at The University of Edinburgh.


Is auditing the answer here?

Dr Deming told us that quality has to be designed in...it can't be inspected in afterwards....and it can't be audited in either!

Standardisation starts with setting up agreed standardised processes and then getting dependable commitments to implement them from the service providers. 

Auditing in the absence of both of these is a trivial pursuit, no matter which methodology you choose or who does the audit itself. 

If the problem is variabilty in bone marrow collection processes, it seems to me that there's a whole raft of work to do before audit becomes of any use at all. 

personalized customer experiences

Why do customers get personalized service but auditing is standardized? Are there internal customers with specific and varied needs?