Standard operating procedures management system

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

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. 

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. 

Standard operating procedures (SOPs)— The SOPs are controlled in a way similar to that of specification documents and analytical methods. It must be ensured that the correct versions of the SOPs are accessed and used by the scientists. After use, the hard copies should be destroyed and disposed of properly. An added requirement is that the SOPs should be accessible during working hours without interruption. Hard copies should be available at a manageable location so that the SOPs are available when the electronic system is down. 

Today, much more than just data are produced electronically. Many documents needed for studies that fall under the Good Laboratory Practice (GLP) standards regulations are being managed electronically. These records include not only data, such as chromatographic data from automated electronic capture systems and raw data collected in electronic field notebooks, but also other documents, such as methods, protocols, reports and standard operating procedures (SOPs). Frequently, these records are generated, distributed, reviewed, and archived electronically. 

Incident Command System (ICS) An organized system of responsibilities, roles, and standard operating procedures used to manage and direct emergency operations. 

Improvements in the management system for establishing, evaluating, and monitoring standard operating procedures. (Are the procedures adequate, understood, and consistently performed Is the task still necessary )... 

As an example, consider an incident where an employee is exposed while sampling chlorine. One of the root causes is determined to be an inadequate standard operating procedure (SOP) for sampling. A management of change system can provide a mechanism to identify things that... 

The bioanalytical laboratory should have a written set of standard operating procedures (SOPs) to ensure a complete system of quality control and assurance. The SOPs should cover all aspects of analysis from the time the sample is collected and reaches the laboratory until the results of the analysis are reported. All deviations from SOPs must be authorized by the study director and documented in the raw data. Significant changes in established SOPs must be properly authorized in writing by management. 

Every analytical laboratory, governmental, private, or university, has a standard set of procedures that provide both general and specific information to laboratory members. These fall into certain categories, including the laboratory s standard operating procedures (SOPs), quality assurance/quality control manuals (QA/QC manuals), procedural manuals, analytical method files, and laboratory information management systems... 

Standard Operating Procedures for managing security access (including adding and removing authorized users, virus management, and physical security measures) must be specified, tested, and approved before the system is approved for use. Topics to be covered include the following ... 

The documentation supplied with the CDS application or system (both hardware and software), user notes, and user standard operating procedures will not be discussed here as it is too specific and also depends npon the management approach in an individual laboratory. However, the importance of this system-specific docnmentation for validation should not be underestimated. Keeping this docnmentation cnrrent shonld be considered a vital part of ensuring the operational validation of any compnterized system. The nsers should know where to find the current copies of documentation to enable them to do their job. The old versions of user SOPs, system, and user documentation shonld be archived. 

The management and use of the system, and related reference data (e.g., laboratory reference ranges and coding dictionaries), should be controlled by Standard Operating Procedures. Such procedures should include taking data extracts, possibly as predefined reports. Extracts should be validated to demonstrate they correctly identify, combine/merge, and report data requested. At the system level the functionality of a reporting system should ensure that ... 

Table 25.6 lists the Standard Operating Procedures required to manage the ongoing operation of the system. Many of the procedures would normally be in place but each would need to be assessed in relation to the new system. 

An electronic document management system is used for the maintenance of corporate and local standard operating procedures (SOPs). It includes functionality for document control, but also a workflow component for creating drafts, reviewing, approving, and distributing documents and supports electronic signatures... 

The following systems or system components can be distinguished local area network (LAN), wide area network (WAN), network operating system (NOS), operating system (OS), application software, database management software, standard application software, hardware, documentation and Standard Operating Procedures (SOPs). Table 13.1 provides examples of systems and components, and the types of changes that may occur with each system or component. 

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