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Leading the Way Toward Standardized Auditing

Life sciences embrace eQMS

Nicola Wilson
Thu, 04/30/2015 - 14:45
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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.

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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.

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Comments

Submitted by Ian Hendra on Thu, 04/30/2015 - 17:10

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. 

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Submitted by dvanputten on Fri, 05/01/2015 - 13:56

In reply to Is auditing the answer here? by Ian Hendra

personalized customer experiences

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

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