Operating Procedures and Practices This part of the application review consists of evaluating the standard operating procedures

as well as the actual operating practices. Most production areas maintain some historical data that tracks its performance and practices. These records may consist of logbooks, reports, or computer data. These data should be reviewed to determine the actual production practices that are used to operate the machine or system being investigated. Systems that use a computer-based monitoring and control system will have the best database for this part of the evaluation. Many of these systems automatically store, and in some cases print regular reports, that define the actual process setups for each type of product produced by the system. This is an invaluable source of information that should be carefully evaluated. Standard Operating Procedures. Evaluate the standard operating procedures (SOPs) for the affected area or system to determine if they are consistent and adequate for the application. Two reference sources, the design review report and vendors O&M manuals, are required to complete this task. In addition, evaluate SOPs to determine if they are usable by the operators. Review organization, content, and syntax to determine if the procedure is correct and understandable. Setup Procedures. Special attention should be given to the setup procedures for each product produced by a machine or process system. Improper or inconsistent system setup is a leading cause of poor product quality, capacity restrictions, and equipment unreliability. The procedures should provide clear, easy to understand instructions that ensure accurate, repeatable setup for each product type. If they do not, the deviations should be noted for further evaluation. Transient Procedures. Transient procedures, such as start-up, speed change, and shutdown, also should be carefully evaluated. These are the predominant transients that cause deviations in quality and capacity, and that have a direct impact on equipment reliability. These procedures should be evaluated to ensure that they do not violate the operating envelope or vendors recommendations. All deviations must be clearly defined for further evaluation. Operating Practices. This part of the evaluation should determine if the SOPs were understood and followed before and during the incident or event. The normal tendency of operators is to shortcut procedures, which is a common reason for many problems. In addition, unclear procedures lead to misunderstandings and misuse. Therefore, the investigation must fully evaluate the actual practices that the production team uses to operate the machine or system. The best way to determine compliance with SOPs is to have the operator(s) list the steps used to run the system or machine being investigated. This task should be performed without referring to the SOP manual. The investigator should lead the operator(s) through the process and use their input to develop a sequence diagram. After the diagram is complete, compare it to the SOPs. If the operators actual practices are not the same as those described in the SOPs, the procedures may need to be upgraded or the operat