Management of change documentation

A PHA has heen performed for new facilities. The management of change documentation packages and referenced documents should indicate when a process hazard analysis was performed for the modification or new facility. The PSSR Team should verify all of the PHA recommendations have been implemented or otherwise resolved before the toll process can be judged ready to operate. 

An overall review of the management of change documentation package should be performed to ensure documentation update items (including material safety data sheets) are addressed and that PHA action items are complete. This can be done by one person but is often best achieved by a PSSR Team. The process needs to account for ... 

If a product has not been tolled for an extended period (some companies use six months), it is essential to check the management of change documentation packages for all of the equipment involved. This review should focus on ensuring changes made between the new request to toll and the last time the product was tolled do not... 

The team also reviews management-of-change documentation associated with the existing SIS. If changes have been made to the process that might impact the expected performance requirements for... 

It is incumbent upon the toller to develop and follow internal management systems as appropriate to support business needs, production needs, process safety, environmental responsibility, and worker health. The selection process should have considered whether or not satisfactory systems are in place. Nevertheless, the contract or auxiliary documents may be the vehicle used to help ensure that the system reviewed is the system actually used for completing the toll in question. Within the process safety management system, the management of change and training elements are essential subsystems. 

A primary objective of any safety program is to maintain or reduce the level of risk in the process. The design basis, especially inherently safer features that are built into the installation, must be documented. Management of change programs must preserve and keep the base record current and protect against elimination of inherently safer features. For identical substitution, the level of risk in the process is... 

Woodlawn is concentrating on its process documentation system, while Kingston continues to work on process hazard assessment. Winston and Highgate continue to work on Management of Change. 

Under the management of change section of the PSM standard employees are required to develop and implement documented procedures to manage changes in the process chemistry, process equipment, and operating procedures. Before a change occurs (except for replacement-in-kind), it must be reviewed to ascertain that it will not affect the safety of the operation. After the change has been made, all the affected employees are trained, and a pre-startup review is conducted. 

Pre-start-up Safety Review (PSSR) approval of the SIS establishes the point where the SIS design and construction is considered complete. All documentation should be formally updated to as-built status, incorporating any modifications made since the last formal drawing or document revision. Once the PSSR has approved the SIS for process unit start-up, formal management of change procedures should be followed to address proposed modification to the SIS or its associated documentation. Any deviation from the approved design basis should be reviewed and approved by appropriate parties prior to change implementation. 

It is important to document the assumptions used in determining the inventories for the FHA. The inventory list should be maintained throughout the lifecycle of the facility by the Management of Change (MOC) process. 

Is a formal documented system in place that assures each recommendation is evaluated through the management of change program before being implemented ... 

An existing and documented management of change process is followed during the... 

An FDA investigator will identify both procedural critical control points and critical parameters in formulation that are delineated in this report and proceed to inspect these areas. Appropriate documentation and management of changes to critical parameters and critical controls is essential during development. If there is ever a time that change is welcomed and constant, it is during development. 

In specific extraordinary situations it may be necessary to temporarily increase the setpoint or bypass or deactivate some type of instrumentation or other equipment safeguard. However, this should only be done in an established manner, according to appropriate Management of Change procedures with proper approval. Furthermore, any special defeat to a safeguard should be properly signaled for the operators and documented in a special way. Operators and supervisors must regularly review that out-of-compliance log or alarm point summary so that the defeated system can be properly restored at the earliest possible time. 

Requirements may be identified that will need to be addressed before the Management of Change procedure is complete. The second-level supervisor or department head is responsible to assure that suspended items within the PSSR are completed. Suspended items could include updating master drawings with the hand-corrected as built mark-ups, completing the documentation to set up proof tests or vessel inspections or other important items that should not necessarily delay a startup. 

---