Change procedures

Use chemical interaction matrices to identify potential incompatibilities between combinations of materials (not just binary reactions) and interactions with cleaning solvents, heat transfer fluids and other utilities, equipment lubricants, scrubbing media, materials of construction, etc. Implement management of change procedures for changes in design, operation, equipment and chemistry. 

Review design and construction changes for safety (follow Management of Change procedures). 

A clearance sheet tracks the changes through the management of change procedures. A typical change form may include the description and purpose of the change, the technical basis for... 

Failure investigation procedure Nonconforming material review procedure Customer complaints procedure Quality system document change procedure Specification change procedure Maintenance procedures... 

Training for all plant personnel on the new Management of Change procedure was completed and the procedure became mandatory. 

The Woodlawn Plant has completed installation of its Management of Change procedure, and the Kingston Plant is continuing to implement process hazard assessment. The assignment of a new plant manager to the Winston Plant has delayed their installation efforts by one month. 

At C, change procedures to reflect actual performance, provide checklists, alter worker s perception of the importance and consequences of leaving valves open, and improve the supervision of procedures. Some form of lock system would be of benefit... 

The changing procedure for personnel entering an aseptic area is dealt with in section 3.2.2. 

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. 

Controls and sign-offs in the work order system that ensure Management of Change procedures are followed. 

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 ... 

Specific questions relating to fire prevention and protection and emergency response added to the Management of Change procedure s process for review of potential hazards. 

At this point in the process, the equipment/system is able to be put into routine use. The final Q in the model, Performance Qualification, PQ, is about on-going compliance. Elements of PQ include a regular service programme, performance monitoring with warning and action limits (as defined in OQ). All of these elements need to be documented and individual log books for systems are useful for this purpose. PQ data should be subject to regular peer review. All instrument systems should be subject to a simple change procedure which may well be connected to the equipment log system. 

The Gehman test is also standardised in BS903 Part A1318 and ASTM D105319. The British Standard is identical to the international method but the ASTM has a rather different layout as it covers coated fabrics as well as rubbers and a single point procedure is added for routine inspection. It only specifies a step temperature change procedure. 

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