REVIEW PROCEDURE

When reviewing the plant procedures, it is important to ask yourself the following four questions  

Only by reviewing the procedures, interviewing the plant personnel, reviewing the records and conducting a field audit will the auditors gain the answer to these questions. 

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Are operating procedures reviewed regularly by a technically qualified professional If so, how often ... 

Capital project review and design procedures Reviews of major equipment acquisition apply... 

Procedural Review Any relevant procedures/instructional documents were reviewed (there were virtually none concerning blowdown). 

Much attention has recently been focused on organoboronic acids and their esters because of their practical usefulness for synthetic organic reactions including asymmetric synthesis, combinatorial synthesis, and polymer synthesis [1, 3, 7-9], molecular recognition such as host-guest compounds [10], and neutron capture therapy in treatment of malignant melanoma and brain tumor ]11]. New synthetic procedures reviewed in this article wiU serve to find further appHcations of organoboron compounds. 

The need for the use of safety procedures by contract personnel will require additonal training and higher priorities in procedural reviews. 

Note This experiment assumes that a permanent log and a quality control chart are constantly maintained for each analytical balance in use in the laboratory. Each day you use a given analytical balance and log in with your name and date. The following calibration check should be performed weekly on all balances. If, according to the log, the calibration of the balance you want to use has not been checked in over a week, perform this procedure. Review Section 3.3 for basic information concerning the analytical balance. 

Alternative staining procedures (reviewed in refs. 1—3) utilize Coomassie blue, Ponceau S, Amido black, India drawing ink, colloidal gold, or silver. A highly sensitive technique utilizing eosin Y has also been described (18)... 

Documentation that describes the procedure, review, approval, and basis for formal revalidation studies... 

Incorrect system operation and air-release procedures Review procedures for starting vacuum system. 

Inorganic chemical literature. Named compounds named minerals laboratory procedure review of theory. 

Schuhmann, W. (2002) Amperometric enzyme biosensors based on optimised electron-transfer pathways and non-manual immobilisation procedures. Reviews in Molecular Biotechnology, 82, 425-441. 

Procedure writers, procedure reviewers, and procedure evaluators all use the procedure checklist ... 

At a small facility, procedure review may not present a problem. "We just let Julie and Jeff have a shot at it " is a typical response. Julie and Jeff may test the procedure, mark up the draft, and send it back for approval and publishing. That was an easy example just review one procedure at a time, and get it through the system. However, large facilities or small, multiproduct facilities writing lots of procedures face different problems. There may be dozens of procedures in different phases of development and revision at any time. How do you control this ... 

The first thing to do is set the criteria for procedure reviews. Determine the following ... 

Workers skilled in doing the job are the first logical resource for a procedure review team. Operators review operating procedures. Maintenance mechanics review maintenance procedures. Laboratory technicians and chemists review laboratory procedures. This promotes employee participation and ownership in the procedure development process. 

In order to avoid a lengthy wait during the procedure review process, a standard review period should be specified. If you are responsible for implementing a given number of procedures by a certain date, you need some way to get reviewers to do their part on time. One way to do this is to use a document review form. This form fills two needs first, it lets you establish a reasonable review period (typically 5, 10 or 15 workdays) and second, it gives you a way to document each reviewer s concerns for eventual resolution. A typical review form is shown in Figure 7-3. This form records data such as when a document was sent, to whom it was sent, why it was sent, and when it should return. Specific comments can be added or attached, and you can use the form to document employee participation in the procedure process. 

It is essential that the reviewers understand your facility s procedure program and procedure management system, as well as what their role is as reviewers. Procedure reviewers benefit from receiving the same training as the writers. The result is faster, more thorough reviews and higher quahty procedures. 

Periodic review scheduling. An electronic document management system can act as a tickler system to assist in scheduling periodic procedure reviews. An electronic database system can automatically start a clock each time a procedure is approved and provide a monthly or weekly report on which procedures require review. 

Conduct periodic procedure review and revision incorporation... 

Who are your procedure reviewers and approvers Procedure reviewers and approvers must have specific training and skills as defined in your procedure management system. Even with this internal guideline, you still must put thought into selecting the specific individuals who will review and evaluate the documents. 

Manual of Policies and Procedures. Review Management Priority Review Policy, MAPP 6020.3. Center for Drug Evaluation and Research, Food and Drug Administration Rockville MD, 1996. 

Bond, R. (Ed.), 1982. Surveillance Field Procedures Review for the Great Lakes International Surveillance Plan. International Joint Commission, Windsor, Ontario. 

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