Quality and Risk Management in the IVF Laboratory

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Quality and Risk Management in the IVF Laboratory

Table 5.2 (cont.) Department/discipline

Generic explanation

In the IVF Center context

Information technology

Computer systems and software to support all areas of the company’s activities.

Finance

Accounts receivable, accounts payable and financial planning for the company. Self-explanatory.

Just the same functions, although perhaps more important than usual for most commercial businesses in order to achieve efficient management of patients and data handling and analysis for QC/QA, as well as regulatory, purposes. Just the same, although perhaps not as well understood as they should be in smaller IVF Centers (especially in the public sector). Self-explanatory, but perhaps of even greater importance than in many areas of business due to the growing regulation of IVF by government agencies and the expansion of accreditation.

Legal / regulatory

new employees there. We were so impressed by the success of this pilot scheme that we now recommend it to all our clients.

Process control and process analysis

To analyze a process for either quality management or risk management purposes, one must have knowledge of the normal parameters of its operation. This requires both reliable information on the historical performance of the process and knowledge of its inherent variability. It is important to think like a statistician – scary as that might seem! Indeed, TQM (of which risk management is one element) requires that scientific method and statistical thought pervade all considerations of process control, performance, improvement and delivery systems. The technical aspects of undertaking process control will be provided and discussed in Chapter 7. However, examples of process control in the


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