Management of Change Section

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. 

This section describes how the facility will follow-up on the recommendations. It can include responsibility assignment guidelines and other information to help ensure the recommendations are addressed. A clear tie to the management of change system should be included here. 

This chapter develops characteristics of high quality recommendations necessary for achieving successful implementation. The first section is a presentation of the major concepts related to recommendations, such as attributes of good recommendations, management of change, and inherent safety. The second section expands on the attributes and presents a systematic discussion of the flowchart for recommendations. 

Never-exceed-limits for critical operating parameters are never to be intentionally exceeded unless a formal review is conducted and all safety concerns are addressed. This occurrence would trigger a Management of Change (See Section 13.)... 

The OSHA Process Safety Management (PSM) standard should be reviewed to properly develop an MOC procedure. The PSM section addressing Management of Change is found in paragraph (/) of OSHA 1910.119 [3] and states ... 

The nonmandatory section of the PSM standard under Management of Change states that organizations must define what is meant by change. Each organization needs definitions that fit their circumstances. Note the definitions and examples. 

The material in this long chapter may not cover the needs of every chemical plant and every petro-chemical plant, but the ten or fifteen Management of Change procedures developed by major corporations and reviewed by me did not seem to exactly fit the needs or culture of my own organization. Trevor Kletz has said many times that improper plant modifications have been a major cause of chemical plant accidents. I have been working in a process safety function for three decades and my experiences have been similar. It just seems appropriate to repeat the first three paragraphs of the second section of this chapter, as a fitting close. 

Note 1 Refer to Management of Change procedures, level of safety review determined by magnitude of change to process (Ref. Section 6.3). 

Another present-day investigator could have attributed this incident in part to the lack of readily available process information. This incident occurred some time after a major expansion in that unit. Most of the chemical process operators had less than 18 months of service and several sections of the unit did not have written operating procedures a ailable. By today s Process Safety Management standards, such vital information as up-to-date standard operating procedures is mandatory. Also by today s standards, a Management of Change procedure would be in place. 

Change control is one of the GMP systems that is applied somewhat differently in clinical supply manufacture than it is in the manufacture of commercial products. Change control does not have a separate and distinct section in the GMP regulations however, the management of change is referenced or mentioned in several GMP sections [see, for example, 21 CFR 211.100(a) and 211.160(a)]. 

Management of change process according to ASME/ANSI B31.8S, section 11. 

Dealing with change during development has much crossover with changes implemented in live service. Section 20.1 discusses the management of change in more detail. 

Contra Costa County, Management of Change for Organizational Changes, Section B, Chapter 7, Contra Costa County, CA,... 

The excerpt above is all that is said in the standard about hazard analysis and risk assessment. The subject is addressed further in Annex A which is informative. However, the intent of the hazard analysis and risk assessment provision is amplified in the shall provision Contained in Section 4.4.7, Management of Change ... 

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