Report documents writing

In the case of incident investigation, a major milestone is completed when the final incident investigation report is submitted. The incident report documents the investigation team s findings, conclusions, and recommendations. This chapter describes practical considerations for writing formal incident reports, a discussion of the attributes of quality reports, and the issue of commimicating the report findings to affected persons, both internally and externally. 

For complex incidents or causes, confirmation of all scenarios or causes may require a lengthy period—perhaps years. Rather than waiting for this, the team should write a complete report, indicating open research action points. As the open research items become resolved, this status should be documented. If new information indicates that conclusions on recommendations should be changed, the report document should be updated or annotated as necessary. 

The FDA s review of annual reports will allow the Agency to assess several important issues related to postmarket safety of approved devices. These issues include the nature and adequacy of reported modifications and the adequacy of report documentation. If, after reviewing your annual report, we need additional information or if we believe the device modifications you have reported require a PMA Supplement or a 30-Day Notice, we will notify you in writing. 

Do not write a long, formal report documenting your recommendations with copies to every department in the company. If you have something to tell the operating superintendent, do so in person. Then follow up the conversation with a handwritten note with a single copy to his boss. 

Employers must develop in-house capability to investigate incidents that occur in their facilities. A team should be assembled by the employer and trained in the techniques of investigation, including how to conduct interviews of witnesses, assemble needed documentation, and write reports. A multidisciplinary team is better able to gather the facts of the event and to analyze them and develop plausible scenarios as to what happened and why. Team members should be selected on the basis of their training, knowledge, and ability to contribute to a team effort to fully investigate the incident. 

All formulas are to be written out by hand with the specific numbers in the right places on a sheet provided for the purpose, and the calculations are to be done by calculator. Caution Write the numbers exactly as printed, do not round any digits, or the quality assurance unit (a sort of corporate vice squad) will not approve the report out of fear that someone could have cheated. A validated program can be used. While an Excel spreadsheet as such needs no validation, a simple cell-formula calls for extensive tests and documentation and proof that the sheet is password protected against fraudulent manipulation. On top of that, the analyst s supervisor is required to confirm the calculation and sign off on... 

Review Report. Dr Sally Humphreys, Editor at Rapra, was patient with me during the inadvertently-delayed writing of this document. The SafePharm Laboratories Limited Board of Directors permitted me the necessary resources. Karmel Biring reviewed the manuscript, Vicky Mewett corrected my typing and reformatted the document and Jacqueline Billing dealt with the administration. 

The committee also appreciates the openness and cordiality of the representatives of the technology providers. They and the Army provided it with early drafts of test reports and other documentation to facilitate the writing of this report while work was still in progress. 

The linearity between F and l/t has been documented by experiments to be reported elsewhere. In the case of a composite film, consisting of materials, 1 and 2, (e.g. Kapton and SIN, or PPHMDSO), we can write... 

It can be a challenge to document a method properly. It can be a major challenge to work with a method where the reporter assumed a similar level of knowledge as his own. It is wise to give your write up to someone else and ask to work through it. 

Although every experimentalist develops her/his own habits for recording research observations, maintenance of adequate and timely documentation is still insufficiently stressed. Exceptions to this statement may be cited, especially in industry where laboratory notebooks are read and endorsed on a regular schedule for proprietary motives. Next to the writing of monthly or quarterly progress reports, nothing seems at first glance more inef-... 

Since the collection contains over 100 documents faculty must choose which documents to use in their courses. The most effective mechanism is for faculty to require use of an SME from the very start of a course and build opportunities for students to learn the software as they complete homework and write laboratory reports throughout the semester. Thus one would start with a training exercise for the SME and follow with simple calculations and exercises in every homework assignment. As the semester proceeds one can introduce skills for... 

The principles of GLP require an independent quality assurance (QA) program to ensure that the study is being conducted in compliance with GLP. The QA personnel cannot overlap with those of the study because of the potential conflict of interest, but they may be part-time staff if the size of the study does not warrant a full-time QA section. The responsibilities of the QA unit are to maintain copies of plans, standard operating procedures, and in particular the master schedule of the study, and to verily, in writing, that these conform to GLP. The QA unit is responsible for inspections and audits, which must be documented and the results made available to the study director and the principal investigator. The QA unit also signs off on the final report. Any problems discovered or corrective action that is recommended by the unit must be documented and followed up. 

The bioanalytical laboratory should have a written set of standard operating procedures (SOPs) to ensure a complete system of quality control and assurance. The SOPs should cover all aspects of analysis from the time the sample is collected and reaches the laboratory until the results of the analysis are reported. All deviations from SOPs must be authorized by the study director and documented in the raw data. Significant changes in established SOPs must be properly authorized in writing by management. 

When I coach students writing long technical reports for a senior design project or business plan course, I find that there is a tendency to write overly long sections that are not broken up into subsections. This is a mistake because it makes it harder for busy business-technical readers to skim the text and find what they need. A key element of good business writing is to break up documents into reasonably sized pieces with appropriately chosen headings or titles. 

In addition to preparing and submitting documentation to regulatory agencies, the results of clinical studies are reported to the scientific and clinical communities via clinical communications published in medical journals. It was noted in Chapter 1 that presenting the results of a clinical study to the clinical community falls under the scope of this book s expanded definition of Statistics. This section briefly reviews the skills necessary to write good clinical publications and also introduces the peer-reviewed publishing process. 

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