Procedures standard operating

There are major facilities and closely related facilities required to perform a GLP study. In fact, a test facility should be of suitable size, construction, and location to meet these requirements. These characteristics are to minimize disturbances that would interfere with the study validity. The design of the test facility should provide an adequate degree of separation for activities, to ensure the proper conduct of each study. Further, management is responsible for providing personnel, laboratory, materials, equipment, test system, and other facilities for the GLP study. In brief, these may be grouped as (1) personnel (2) laboratory (3) test system (4) archive and (5) disposal. The details of the facilities may be seen in the International Organizations heading of this chapter. 

A test facility should have written SOPs approved by test facility management. Performing studies based on written SOPs is strongly encouraged, since it helps to minimize systematic errors. By following an SOP at each step, the chance of inadvertent mistakes could be avoided. Therefore, each student or worker should be familiar with the SOPs to perform different studies. In fact, adherence to an SOP enhances the quality and integrity of the data generated. 

A typical SOP will induced the following (1) a title (2) SOP number (3) a stated purpose and (4) an outline of the procedure. The lab supervisor or a senior 

Each unit of the test facility should have an immediately available current SOP. SOPs normally include the following  

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Quality control encompasses all activities used to bring a system into statistical control. The most important facet of quality control is written documentation, including statements of good laboratory practices, good measurement practices, standard operating procedures, and protocols for a specific purpose. 

The second aspect of quahty documentation is to detail how the work processes referred to in the manual are performed. The QA unit is often the organization responsible for issuing a set of procedures designed to assure conformance to the appropriate standards or to company poHcy. The procedures, often called standard operation procedures (SOP) or quahty operating procedures (QOP), should include such topics as customer complaints, audit protocols, stabihty testing, preparation of COAs, test method vahdation, etc. 

A specific detailed description and protocol should be written (standard operating procedure (SOP)). 

The standard operating procedures demand great attention as they reflect personnel safety issues, safe operating limits and quality considerations. They should be written simply and clearly. The level of detail is determined by the training and experience of the operations staff but should also take into account the hazards inherent in the process. 

If operating procedures need to be developed from scratch, this could account for a considerable portion of the pre-startup work. If current, valid standard operating procedures exist, and the toll is only introducing a new set of batch instructions, the task becomes simpler. However, it is recommended that the new batch instructions are reviewed simultaneously with the existing startup, shutdown, normal and emergency operating procedures for the equipment to help ensure potential process deviations are examined and addressed. 

Other information may also benefit the PHA. Standard operating procedures for processing equipment, safe work practices, maintenance or job safety analyses, emergency response plans could be appropriate review items for some PHAs depending upon the toll. 

Are appropriate directions for reacting to out-of-specification situations documented m standard operating procedures ... 

Standard operating procedures, maintenance procedures, emergency response plan procedures, administrative procedures, safe work practices... 

If you suspect, or know, that you have a deflected shaft, or know that standard operating procedure in your plant requires controlling the flow in the pipes by opening and closing valves, then you have three options to reduce shaft deflection ... 

Identification of anticipated cleanup activities and standard operating procedures if standard operating procedures are provided elsewhere, they are referenced and not repeated... 

The plan should also address standard operating procedures (SOPs) for site operations to help minimize contact with hazardous materials. 

D. Task-specific hazard analyses must lead to the development of written standard operating procedures (SOPs) that specify the controls necessary to safely perform each task. Detailed hazard analyses conducted for each site task and operation provide the basis for developing SOPs to protect employees from safety and health hazards. Written SOPs provide a mechanism for informing employees of procedures that ensure their safety and for enabling management to enforce hazard control procedures. 

Prevention Program —Management System —Process Hazards Analysis —Process Safety Information —Standard Operating Procedures —Training... 

The form these end products take should be consistent with your company s style for example, if you have specific protocols for project planning or developing Standard Operating Procedures, these will probably apply to comparable tasks within the PSM initiative. 

Many companies have specific protocols for the development and description of standard operating procedures. Like the management systems they detail, these SOPs vary considerably in terms of their otganization and level of detail. While it s clearly premature to develop a specific format within which PSM systems will be described, you can get useful ideas in advance by reviewing written protocols and existing SOPs. 

Higher risk activities will require more forma management systems. For example, a process that uses a highly toxic raw material may require an extensive pre-startup leak check of the process as part of standard operating procedures. 

Documenting the Process. The net effect of these steps is a process description, defined in terms of customers and suppliers and their interaction. Next, the team can summarize that description in the form of a process flowchart, to illustrate the roles and responsibilities of each process stakeholder (see Figure 6-8). This chart provides the basis for developing standard operating procedures, or other process documentation, that the company can incorporate into existing practices. 

What Is the Expected Output or Work Product. The specific form of the finished product will vaiy according to your company s practices and needs. However, it s reasonable to expect that the team s efforts will ultimately produce a set of documented Standard Operating Procedures (SOPs) for the management system, or their equivalent within your organization (see Section 6.3). Interim work products may include progress reports (see Chapter 8), documentation of discussions and analyses, flowcharts, or other materials. 

To gather information about the factors which contributed to the above incident, interviews were held with the workers and their management. Relevant documentation such as standard operating procedures and documentation relating to the incident was also collected. A task analysis (see Case Study 3) of the job of the top floor person was carried out in order to examine the operations involved and the factors which could affect job performance. Two techniques were used for the analysis of this incident, namely variation tree analysis and root cause analysis. 

CASE STUDY 3 DESIGN OF STANDARD OPERATING PROCEDURES FOR TASK IN CASE STUDY 2... 

Standard operating procedures (SOPs) are step-by-step job instructions which can help workers perform their jobs safely and efficiently. When the end users are involved in their design, SOPs can provide a basis for arriving at a method of work agreed-to by different shifts. In this sense, SOPs can be used to develop training programs and specify measures of competence. Because of the importance of SOPs in the work situation, a systematic framework is needed to enable the design of reliable procedures which are acceptable by the workforce. 

Standard Operating Procedures - to ensure Uiat approved procedures covering all aspects of the handling of an EHS are in place for tlie appropriate operators... 

Control measures for tlie eause of eaeh aeeident ean be developed in terms of equipment, instrumentation, and/or standard operating procedures... 

Variations in viscosity of both the incoming and finished products have a dramatic effect on mixer performance. Standard operating procedures should include specific operating guidelines for the range of variation that is acceptable for each application. The recommended range should include adjustments for temperature, flow rates, mixing speeds, and other factors that directly or indirectly affect viscosity. 

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