Upper management

Quahty assurance must remain independent of manufacturing so that problems can be reported freely to upper management without fear of retribution. QA should have oversight responsibihty for QC. A reporting stmcture helps to ensure the independence of both quahty units and conforms to both Good Manufacturing Practice (GMP) and ISO 9000 requirements. 

The implementation audit to verify that the documented practices are being followed and that there are no undocumented practices employed that affect quality. This can be divided into two parts, one addressing upper management and their implementation of the strategic plans and one addressing staff and their implementation of the procedures. 

Conduct project review with upper management. 0 18. Declare the project complete. 

Potential mentors are selected from the ranks of female junior and middle management. The mentees were initially those in upper management, but the scheme has been extended to include male managers at middle and junior management level with equally positive results. In the first instance mentoring participation was voluntary, but it is now expected that all eligible male senior level and female junior level managers will take part. 

There is no systematic approach to exploiting flexibility. Upper management tends to make decisions that are too fixed and does not communicate well the trade-offs that should be applied when the future is different from its central assumption. For example, those implementing decisions may receive a deadline for completion of a trial, rather than a target completion date with guidelines on the value of different completion dates to the business and how to respond accordingly. 

Hartville s upper management is largely unaware of the dissatisfaction of employees. There is evidence that middle management withholds vital information leading to upper management s underestimation of the severity of employee discontent. 

According to the passage, one reason that the Hartville upper management is unresponsive is that... 

Keeping upper management advised of status, progress, and plans Initiating formal requests for information, witness interviews, laboratory tests, and technical or administrative support Controlling proprietary information and other sensitive information... 

Are appropriate levels of upper management aware of and involved in monitoring the implementation or resolution of recommendations and resultant action plans ... 

Upper management Environmental scientists Plant managers... 

Under a comprehensive quality system the QU can expect an expanded and more visible role within the organization with greater accountability to and interaction with upper management. The QU should ideally be independent of the other organizational units to assure clear delineation of responsibility and authority and avoid conflicts. In certain instances, such as auditing, independence or objectivity is central... 

Once the metrics program is in place, the system and process metrics require visibility to process owners, upper management, and stakeholders. Process owners require understanding of the metrics trends, issues, and associated risks. Stakeholders must work with the process owner to identify and propose process improvement opportunities. Leadership is accountable to understand the issues and associated risks and responsibly apply resources for remediation efforts. 

Process owners should be aware of all the metrics affecting their process and have a conduit to present the critical metrics to upper management. There are examples in the industry where process owners responsible for execution of a process are not aware of the metrics being collected, if any are, and have no basis for judging the adequacy of their process or its performance. 

At the end of the audit, a Final Report Narrative is written by the QAU to the Project Manager. The format of the Narrative is similar to that of the Inspection Report. Once again the Project Manager responds in writing, thus establishing a loop the completed Narrative is then forwarded to upper management. 

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