Assigning Specific Responsibilities

Now that you have determined who should participate in your safety program, you need to develop written statements that specify what each position must do to help meet any stated goals and objectives. This corresponds to the last entry on the worksheet presented in Rgure 8-1 [2]. 

When developing responsibilities for non-supervisory employees, be careful not to confuse these responsibilities with specific work rules and 

Department of Labor, Office of Cooperative Programs, Occupational Safety and 

Health Administration (OSHA), Managing Worker Safety and Health, November 1994, 

You should assign the details of carrying out your management system to the same individuals who are responsible for plant operations, the office environment, production, and other areas that should be included. In this way, you build safety into the management structure as firmly as into the production environment. Be sure that each assigned responsibility comes with the authority and resources needed to fulfill the requirements [2]. 

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Figure 6-15. Example of an Emergency Operating Procedure which assigns specific responsibilities...

Manual collection requires a great effort from employees (Few 2005). If a manual collection is going to function adequately, some of the employees need to be assigned specific responsibility for filling in the different forms. When each form has a dedicated owner, it will be easier to follow up if forms are insufficient filled in. 

A major step in developing the lubrication program is to assign specific responsibility and authority for the lubrication program to a competent maintainability or maintenance engineer. The primary functions and steps involved in developing the program are to ... 

Involve every member of the research staff, including students, in some aspect of the safety program, and assign specific responsibilities to each. 

It is important to assign both authority and specific responsibility to implement each protective measure. A safety engineer may need to provide the training the manager should provide safe tools and equipment and the employees should inspect their tools to ensure that they are in safe condition. 

Standard programs must be broken into smaller pieces to run on a hypercube. Each processor is assigned the responsibility for calculations for a specific piece of a problem. For example, in petroleum reservoir simulation, each processor might be assigned a different section of the reservoir to model. In modeling a complex chemical plant, each processor might be assigned a different piece of equipment. As each processor proceeds, it informs the other processors of its results, so that all the other processors can incorporate the information into their respective portions of the overall calculation. 

There should be specific responsibility assigned for the maintenance of historical records. Issues of importance, which should be addressed by the management system, include specifying who will keep the records, where and how they will be maintained, and how they can be retrieved and used at both the facility and company-wide levels. In addition, there should be adequate consideration for backing up critical records and protecting the records against loss. 

This group must be familiar with the concepts, policies, extent of commitment from upper-level management, and specific assignments of responsibility associated with process safety incident investigation. 

Specific responsibilities for testing, inspecting, cleaning, and maintaining equipment must be assigned in writing and should distinguish between various hardware devices in the laboratory site. 

The cGMP regulations assign specific duties to the quality control unit. The unit is required to have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material,... 

The cGMP does not specifically assign management responsibility for these actions, although actions of this nature are required by the regulation. Table 1 from the pharmaceutical QS guidance document shows this relationship. 

The JECFA expert assigned the responsibility for preparing the specifications for identity and purity for the food additive prepares a Chemical and Technical Assessment (CTA) document. The CTA contains the chemistry, manufacturing process, technological justification, and intended use of the food additive (FAO CTA Guideline, 2003) (12). The CTD guideline should be used for submission of chemical and technical information to JECFA. 

Other organizational groups are essential to safe and efficient operations. However, except for line management, other functional groups are assigned specific areas of responsibility such as product or process research, engineering, technical service, industrial health, environmental services, analytical development, safety and loss prevention, security, and so on. 

Assigned security responsibility The assignment of responsibility for security to a specific individual or organization. ... 

There is no formal system to ensure that corrective and preventative measures resulting from OOS investigations are carried out. There is no written procedure assigning specific roles and responsibilities to designated personnel. There was no documented evidence that the CAPA (Corrective and Preventative Actions) was actually implemented. 

The senior manager responsible for validation is expected to recruit appropriately qualified and experienced staff to conduct the validation tasks and ensure that these are properly and effectively carried out. Specific responsibility for validating computer systems should be assigned to a manager who is suitably qualified — someone with relevant computer systems experience and appropriate training. 

Specific responsibilities assigned to the QA/QC group of the company sponsoring the trial (the sponsor ) are as follows ... 

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