Effective management of change procedure

Table 11-2 Key Steps in an Effective Management of Change Procedure...

This may require alterations to the Management of Change procedure to improve its effectiveness for identifying and examining changes that effect fire protection. Possible procedure alterations may include addition of the following ... 

The Management Executive Committee, with counsel from the senior safety professional, is responsible for establishing processes to determine when these management of change procedures shall apply, how they are to be implemented and by whom, and to follow the processes through to an effective conclusion. 

To ensure that procedures are accurate and reflect current practices, they must be periodically reviewed. Revisions caused by changes or improvements in equipment, process technology, standard practice, or facility status must be incorporated as they occur. This is a function of your procedure management system. The effect of changes in environmental and safety regulations on procedures must not be overlooked. A Management of Change system directly supports and controls these revisions. 

Documentation controls apply to system development and maintenance as well as to use. Development practices and procedures need to documented according to a Quality Management System (QMS) [4] and controlled in the same way as other GxP documents. Of particular importance is the establishment of an audit trail for documentation and management of change control and the associated records. The FDA needs to be able to establish unequivocally which version of software was running on what equipment, at which time, when every record was created. One of the effects of this rule is clearly to bring the IT Department, traditionally seen as being on the periphery of GxP, firmly within the fold ... 

Management of Change. The work site employer must establish and implement written procedures to manage changes except replacements in kind to facilities that effect a covered process. The standard requires the work site employer and contract employers to inform and train their affected employees on the changes prior to start-up. Process safety information and operating procedures must be updated as necessary. 

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