Operations and procedures

Refresher course on fundamentals of safety, hazard recognition, procedures Participation in hazard and operability studies on existing operations and procedures... 

If your answer to Question 2 is clearly YES, then start at Section 3.2 of this chapter. If your answer is a definite NO, then proceed to Question 3. If you are uncertain whether mixing or combining of different substances takes place or will take place at your facility, you need to determine a definite answer to this question before you go further. This may involve systematically reviewing your facility s operations and procedures, talking with operations and maintenance personnel, and discussing with management what future activities can be anticipated. 

Welding of piping, pressure containing parts, and wetted parts, as well as any weld repairs to such parts, shall be performed and inspected by operators and procedures qualified in accordance with Section VIII, Division 1, and Section IX of the ASME Code. 

In prospective process validation, an experimental plan called the validation protocol is executed (following completion of the qualification trials) before the process is put into commercial use. Most validation efforts require some degree of prospective experimentation to generate validation support data. This particular type of process validation is normally carried out in connection with the introduction of new drug products and their manufacturing processes. The formalized process validation program should never be undertaken unless and until the following operations and procedures have been completed satisfactorily ... 

Of the emissions, 37 percent were due to piping failure, with lined pipe being the largest contributor. Operational and procedural issues accounted for 53 percent of the remainder. 

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