Supervisors reporting responsibilities

In this scenario, key drug development operations are focused under one banner. Peer groups, with similar report structure and supervisors, administer responsibility for corrective and preventative actions. 

In this scenario, key drug development operations are focused under one banner. Peer groups, with similar report structure and supervisors, administer responsibility for corrective and preventative actions. Indeed, in this age, a new corporate scenario (Scenario 3) has emerged. This scenario places the focus of responsibility within the... 

Laboratory supervisors are responsible for reporting safety incidents in their laboratories. A form should be filled out that indicates clearly the name of the person involved, the name of the department, the date and time of the incident, and details of the factors that contributed to it. Penalties for not reporting should be severe enough to discourage hiding safety incidents. 

In some cases, implementation of the recommendation may be outside of the supervisor s responsibility. Top management and the safety professional would have the responsibility to locate the resource and provide the funding. This is another reason why top management should review the investigation reports. They have the authority to assign the necessary resources to achieve some of the more complex corrective actions. 

Once the near miss has been reported, it is the supervisor s responsibility to evaluate the severity and probability of the loss. Near misses with a medium-to-extreme potential severity or a medium-to-extreme likely recurrence are required to be investigated by the supervisor. As part of the investigation, the supervisor shall identify the root/hasic causes of the unsafe act or condition, and then implement corrections to prevent recurrence. The near miss program includes a standardized investigation form that aids the supervisor in the investigation and documentation of the near miss. 

Corrections beyond the authority of the supervisor are forwarded to a safety committee for review and implementation. To facilitate discussion of near misses, supervisors are responsible for tracking reported near misses and posting information on the findings of the investigation and the corrective actions taken. Additionally, the PWSD s Safety Section is copied on all near miss reports to facilitate assistance, where appropriate, and to ensure sufficient follow-up action is taken. 

Two types of forms can be used to report personal injuries, depending on their seriousness. One form would be used for accidents in which the injury does not require a doctor s attention but can be handled by first aid at the job site. This form provides the necessary information in case the injury becomes more serious at a later date. The second from is more detailed in nature and is used when a doctor s attention is required. The employee is responsible for reporting an injury, while the supervisor is responsible for correctly preparing the proper forms. Serious accidents should be investigated by the safety manager, who can determine the corrective actions. 

Simple and well defined reporting responsibilities and routines. It must be made clear that all employees are responsible for reporting accidents to their immediate supervisor. 

The Savannah River Site (SRS) reactor operation has traditionally been controlled by the instructions in detailed operating procedures. In 1975, safety requirements were established in the Technical Specifications and more specific controls were established in the Technical Standards to identify overall plant safety requirements, which were previously determined by supervisors. The supervisor was responsible for understanding and interpreting the technical bases supporting these documents, which were described in other safety documents such as technical reports and technical manuals. It was determined that this process was deficient in human factors considerations, that it lacked an integrated approach, and that the validity of some of the technical bases were not well established and documented. 

It is further stated that any individuals who have an apparent illness or open lesions that could in any way affect the safety and quality of drugs shall be excluded from direct contact with the pharmaceutical products being prepared. It may be necessary to assign these individuals temporarily to other duties until they are in satisfactory health. It is imperative that the employees be instructed to report any of the foregoing conditions to their supervisors. The supervisory personnel have additional responsibility to ensure that this requirement is met. 

Employees performing GMP-related tasks should be trained periodically in the principles of GMP that apply to their operation. At least biennially they should be reminded of the documentation practices noted above as well as their responsibility to follow procedures as prescribed. Employees should also be encouraged to inform their supervisor of any incorrectly performed operations. Finally they should be informed that it is necessary to report to their supervisor any illness, especially open lesions, that they have, which may contaminate the excipient during the performance of their responsibilities. Employee GMP training should also be documented. 

When nonconformances occur, the corrective action plan is activated. Anyone seeing the need for corrective action is responsible for reporting the problem to the proper supervisor or manager. Merely correcting the particular unsatisfactory product does not achieve corrective action. If possible, the root cause of the unsatisfactory condition is determined, and a proposed remedy is put in place. The effectiveness of the corrective action is verified. 

Data reduction, verification, and reporting are always a combined effort of the personnel working in different laboratory sections, their supervisors, and the Data Management Section. Sample preparation technicians and analysts performing analysis are responsible for the correctness of their computerized and manual calculations and for proper reporting of the obtained results. Supervisors verify the correctness of these calculations during data review and approval process. The Data Management Section staff is responsible for the correct conversion of the data entered by hand or transmitted from the data acquisition computers into the LIMS and the production of finished laboratory reports prepared to client s specifications. 

Pharmaceutical manufacturers and cross-disciplinary teams in health systems (e.g., nurses, physicians, pharmacists, and social workers) are particularly well suited for this endeavor. This allows for diversity of ideas and for the best possible solution to emerge. On the negative side, there is little evidence that employees prefer reporting to more than one supervisor, and confusion as to who is responsible for what can develop (Tosi, Rizzo, and Carroll, 1994). 

Personnel Chief. The personnel chief is responsible for accounting for all personnel on the facility at the time of the emergency. Unit emergency programs must include training on how this is accomplished. Unit supervisors initiate the process with headcounts at designated rally points. The success of rescue and medical activities depends on how quickly and thoroughly this information is obtained and reported to the personnel chief. 

Response phase, during which designated staff report to supervisors or the command post for instructions, the response plan is activated, and nonessential services are suspended. 

Table I is a typical daily operating report for the NFS Waste Tank Farm. It shows that temperatures, densities, liquid levels, air flow rates, etc. are observed and recorded at least three times a day. Any equipment malfunction or response to the continuously monitored alarms is reported at least once a day on a supervisor s summary report. With the required initialing of both the operator and the supervisor on each shift, at least six trained individuals are made aware of the operating status of the facilities daily. In addition, these daily reports are distributed to no less than four other responsible members of management for information and review.

Responsibility Person responsible for operating the system or equipment will perform the qualification and record the information. The supervisor will supervise the study, verity the completion of the records and write the Deviation Report and the Performance Qualification Report. Quality Assurance will review and approve the Performance Qualification Protocol and Report. 

Safety is the responsibility of WHO staff supervisors and WHO management. It includes reporting of possible hazards and suspected hazards and taking the necessary precautions and implementing safeguards to minimize safety problems. 

Ambitious chemists may note that fipcos do not lightly give supervisory responsibility to newly graduated and hired employees, if they do so at all. To demonstrate competence, attain some success, and thereby create a need for help, Ph.D. chemists can work alone several years after starting their careers. Policy, which varies across the industry, determines this period as well as the necessary qualifications and the number of chemists reporting to a newly appointed supervisor. 

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