Formal Reporting

Examining a candidate toller s records of formal reporting and follow-up on mechanical deficiencies or hazardous conditions is imperative. The assessor should verify whether such a system is in place and is effective. 

Because of this, it s sensible to consider regular documentation as opposed to relying solely on oral reports or informal hallway updates. Even if your sponsors don t require much formal reporting, internal documentation of the group process can help keep the process itself on track and can also provide the foundation for documentation of the end results. 

As an unrepentant heretic, Balsamo was buried in an unmarked pit at the extreme western end of the fortezza, between two sentry redoubts. He might have been proud to hear himself described in the formal report of the archpriest of San Leo as follows, A heretic famous for his wicked ways, after having spread through various countries in Europe the impious doctrines of Egyptian Freemasonry, to which he made by subtle deception an infinite number of converts, fell into many vicissitudes, from which he escaped without injury thanks to his shrewdness and ability. ... 

As discussed, the major purpose of the investigation is prevention. The tone and choice of words used in the formal report should reflect the attitude of preventing a repeat of a similar incident rather than affixing the blame. 

The first was a report Testimony of His Excellency, NH Giovanni Gradenigo, member of the Council of Three. Clearly he had made a formal report to his brother inquisitors, and the secretary had written it as if he were any ordinary witness. The man who had summoned me to his deathbed was about to speak to me from the grave. 

Afantitis et al. investigated the use of radial basis function (RBF) neural networks for the prediction of Tg [140]. Radial basis functions are real-valued functions, whose value only depends on their distance from an origin. Using the dataset and descriptors described in Cao s work [130] (see above), RBF networks were trained. The best performing network models showed high correlations between predicted and experimental values. Unfortunately the authors do not formally report an RMS error, but a cursory inspection of the reported data in the paper would suggest approximate errors of around 10 K. 

Enjay Chemical Co Elastomers Department, Houston, Texas USA, Enjay Polymer Laboratories Technical Information Sheets, Formal Reports-Compounding. 

E I du Pont Nemours Co Elastomer Chemicals Dept, Wilmington Delaware, USA, R M Murray and D C Thompson, The Neoprenes, Formal Reports-Basic Principles of Compounding, Informal reports-Basic Details of Compounding and Test data, Hypalon Reports, Viton Bulletins, Adiprene Bulletins and Extensive reports on various Specialty Rubbers. 

An audit report will serve as the formal record of the audit and its findings, and is a major input into selecting the supplier and determining any necessary corrective action. To complete the quotation review exercise the pharmaceutical manufacturer (or its main contractor) should produce a formal report that summarizes the quotation compliance, the key points of the audit report, and the main benefits of each system. The chosen suppher and reasons for the supplier selection should be clearly stated. 

Each qualification must be formally reported to ensure an approved and audit-able transition to subsequent life-cycle phases. Qualification summary reports for the system must be prepared by the pharmaceutical manufacturer and should be kept in the validation file. Each qualification report should confirm the qualification test acceptance and review associated change control records. The report must present a documented record that clearly states the basis for concluding that the qualification is acceptable, particularly if there are any minor conditions or actions outstanding. 

On satisfactory completion of the computer system qualifications, with PQ conducted in conjunction with a successful process validation, a final report must be prepared by the pharmaceutical manufacturer s validation team. This is normally referred to as the validation report. The objective of the report is to give an overview of the results of the execution of the validation program for the computerized operation and to draw a conclusion as to the suitability of the computerized operation for pharmaceutical manufacturing. This may be unconditional use or there may be restrictions. In the latter case the proposed remedial ac-tion(s) must be approved and, as applicable, considered under change control. A schedule to complete any outstanding actions must be documented and progress formally reported. 

The formal audit report is the product of the audit. The lead auditor is responsible for the report content and accuracy and for submitting the formal report in a timely fashion. After completion of the audit, the work on the formal audit report should begin immediately, while audit details are still fresh. In addition, the longer the audit report is put off, the less interested the vendor will be in pursuing corrective actions. It is good practice to complete the final audit report within 2 weeks from the date of the audit. 

A formal report containing all information relating to the investigation of the OOS result and the corresponding batch, as well as other batches or lots that have been deemed to be related in this regard, should be reviewed by all investigation participants and approved by the quality assurance unit. 

The output of Hazard Study 1 is a formal report with the following sections ... 

The organization of a formal report requires careful sectioning and the use of subheadings in order to maintain a clear and effective presentation. To a lesser... 

The final report should be submitted in a neat and businesslike form. Formal reports are usually bound with a heavy cover, and the information shown in the... 

Please submit this information as a complete formal report. Include a short section outlining what further calculations would have been necessary if the specification of 100 tubes in a one-pass exchanger had not been given. 

The group leader has asked you to determine the optimum size of the SO, absorption tower. Specifically, he has asked you to determine the height and cross-sectional area of the optimum absorption tower and to present your recommendations in the form of a formal report. 

Vent the system and remove the vials from the reactor. Note color changes, turbidity, and phases i.e., is there one liquid present, or does there appear to be a layer of two liquids ) of both solutions. Remove both vials and keep tightly sealed until characterization studies are performed. Comment on what you observe in the Results and Discussion section of your formal report. 

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