Responsibilities of management

The relationship between (MSF), p, and 17 in Eq. (9-106) is shown graphically in Fig. 9-27. It is the responsibility of management to decide on an acceptable value of the (MSF) for its company. The value chosen will depend on the company s attitude to risk that can be quantified in the form of a utihty curve such as the one shown in Fig. 9-25, from which a value of equivalent (MSF) can be obtained. 

In any study involving analyses, part of the responsibility of management at the analytical laboratory is the review and approval of intermediate and final reported results. In an LSMBS, such review and approval must take place at each analytical laboratory involved in the study. However, different laboratories may focus on different aspects of the analyses, and some means to ensure that review procedures and approaches are consistent among the laboratories is needed. It is advisable, therefore, to include an additional review, termed here an external review , beyond that conducted by the individual laboratories. 

Implementation of corrective actions is the responsibility of management. In assigning corrective actions, management may consult with the PrHA team to assure full understanding of the hazards identified in the PrHA before corrective actions are taken. 

The person assigned the responsibility of managing the integrity of fire protection equipment and systems must have a general knowledge of the facility and its fire protection needs, be familiar with the facilities fire protection systems, and have access to resources to ensure the equipment and systems are operable. 

The incident investigation team is responsible for developing practical recommendations and submitting them to management. It is then the responsibility of management to approve, modify, reject, communicate, implement, and follow-up on the recommendations, including ... 

The organization mnst consider all management and operational activities as processes and measnre their efficiency and effectiveness. The process owner and process cnstomer of each process as well as management responsible for the processes must be clearly defined. Within each process the responsibilities of management and process owner mnst be conveyed to the persotmel that perform such processes. 

The strategic alignment of related business units and the requirements of operational leadership made it necessary to combine the 23 (later 21) business units in six (later five) divisions. However, previous experience had shown that direct responsibility of management board members for operational branches resulted in two problems ... 

What are the responsibilities of managers in identifying employee personal problems and helping employees obtain the appropriate assistance ... 

For the program to be effective, all employees should be educated about the issue of substance abuse, with special attention paid to early identification, intervention, and responsibilities of management in ensuring intervention and referral for treatment. 

The decision for replacement (or temporary delegation) is the responsibility of management. All decisions should be documented in writing. Two circumstances in which replacement might be considered are important only in longer-term studies, since the presence of a study director during a short study may be assumed. The first circumstance is termination of employment. In the event of termination of a study director, the need for replacement is obvious. In this case, one responsibility of the replacement study director is (with the assistance of QA personnel) to become familiarized with the GLP compliance in the study to date. 

Ensure that a statement exists which identifies the individual(s) within a test facility who fulfil the responsibilities of management as defined by these Principles of Good Laboratory Practice. 

It is also the responsibility of management to estimate the probabilities for the success of individual projects after due consideration of all the data provided by the various departments. The rate of return on investment that is acceptable to management is a function of these responsibilities. Each industry has a reasonably well defined return on investment that reflects the degree of risk inherent in that industry. If management decisions are faulty, the company either will overspend or will miss opportunities. 

As in the case of the (MSF) defined by Reul for research and development projects, it is the responsibility of management in a particular manufacturing company to decide on an acceptable level of (MSF) for... 

A positive and mature safety culture promotes open dialogue on issues, discusses improvement strategies by engaging a broad array of employees, and will not tolerate deviation from established procedures. Many in an organization may not immediately internalize these seemingly soft concepts. It is the responsibility of management from the board of directors and senior executives downward to identify, develop, and nurture attributes of a healthy safety... 

However, the responsibility of management does not end with the appointment of the Study Director it has also to make allowance for the possibility that, once appointed, a Study Director could become temporarily or permanently unavailable for the continuous or continuing supervision of the study. In such cases, the replacement of the Study Director, whether temporary or permanent, will have to be considered by the test facility management, taking into account the prospective duration of absence. If the absence of a Study Director could be foreseen to last for a longer period of time (up to a permanent absence), the need for a permanent replacement would certainly... 

Another very important responsibility of management is to ensure that there is a Quality Assurance Programme with designated personnel and furthermore to assure that the Quality Assurance responsibility is being performed in accordance with these Principles of Good Laboratory Practice . As... 

While it lies in the responsibility of Study Directors (or Principal Investigators) to react to such reports and to take corrective action if necessary, and while it lies in the responsibility of management to ensure that they actually will implement the full corrections required by these Quality Assurance reports, it is nevertheless in the well understood self-interest of... 

It certainly goes without saying that other general responsibilities, of management, of Study Directors, of personnel and of Quality Assurance, will also have to be applied with regard to computerised systems. Thus, personnel should be appropriately trained in the operation and maintenance of computerised systems, adequate facilities for the location of such systems (especially for the central, core hardware of the test facility s computer network) have to be provided by management in the same way as for the localisation of other equipment, and Quality Assurance has to ascertain routinely the GLP compliance in the utilisation of computerised systems. 

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