Operations and procedures summary table

Table 13.8 Summary of design and operating procedure for two polymerization reactors.

System calibration refers to the periodic operational qualification of the HPLC, typically every 6 to 12 months in most regulated laboratories. This calibration procedure is usually coordinated with an annual preventative maintenance (PM) program and is performed immediately after PM. A calibration sticker is placed on the instrument to indicate its calibration status and readiness for GMP work. The reader is referred to the principles and strategies behind HPLC calibration criteria published elsewhere.8 A summary of the calibration procedures and acceptance criteria, including additional procedures recommended for initial operational qualification, is listed in Table 9.3. 

At the time of the study addressed in the present paper, [Pitblado 88] a total of 17 incidents had been reported in the Netherlands over a 4 year period on computer controlled plants, which related to the computer system or to the human interaction with the computer. These failures led mainly to small and medium scale releases from the flare systems, but in one case led to plant damage and in another to a fireball. Table 1 shows a summary checklist indicating the number of failures in each category (hardware, software, human), from which it can be seen that human errors during operations were associated with 59% of the incidents. Errors were mainly due to inadequate, insufficient or incorrect information supplied to the operators (59%) and a failure to correctly follow procedures (47%). Human errors in design were involved in 29% of incidents. Hardware and software failures were less prominent. 

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