Baseline documents

So if we say that the hazard analysis is the baseline document, then a preliminary hazard analysis (PHA) is the initial hazard assessment conducted on the system. It identifies safety-critical areas within the system and starts evaluating hazards and identifying safety design criteria and applicable safety requirements. 

Keep the worksheets in the database updated. If you can do that, then the next time you do a safety analysis, use the database as a baseline document and just change what needs to be modified. Be careful not to assume that two systems are exactly alike. We all know that they are not. 

Baseline documents shall include information about the operation and maintenance of the waste incineration system and components, the discharge of effluents, and the monitoring and assessment of radiological impact. 

CM involves the systematic control and evaluation of all changes to baseline documentation and subsequent changes to that documentation which define the original scope of effort to be accomplished and the systematic control, identification, status accounting, and verification of all CIs. Typically, a formal CM plan is developed for a project, which specifies and documents all aspects of the process, including system safety. 

USRC is required to assure that TBP documents are properly updated and controlled. RP5.1303 (Reference 18) was reviewed and determined to contain sufficient information to enable users to implement design controls to update Technical Baseline documents in a manner consistent with the site QA requirements for restart. 

The procedure assigns authority for the Technical Baseline Documents to Reactor Engineering, requires changes be initiated, evaluated, reviewed, approved, and Incorporated as needed. The procedure further requires a full review and update as needed every three years. 

J. L. Hendrix, WSRC, Director, Technical Baseline Document Program, September 22, 1988. 

SRTB-88-067, "Task 9 - System Evaluation and Development of Draft Technical Baseline Document," T. 6. Clark, Revision 1, June 15, 1989. 

The audit team, through its systematic analysis, should document areas that require corrective action as well as where the process safety management system is effective. This provides a record of the audit procedures and findings and serves as a baseline of operation data for future audits. It will assist in determining changes or trends in future audits. 

Set Objectives > Document Critical End Product Parameters > Confirm Measurement System Baseline End-Product Parameters Process Potential Diagnostics... 

Before administering the drug, the nurse assesses the respiratory status of the patient. The nurse documents lung sounds, amount of dyspnea (if any), and consistency of sputum (if present). A description of the sputum is important as a baseline for future comparison. 

When die miscellaneous drugs are administered, die nurse documents die symptoms the patient is experiencing to provide a baseline for future assessment. The nurse assesses for and documents pain, urinary frequency, bladder distension, or other symptoms associated widi die urinary system... 

CWRT (2005) Baseline metric and other documents posted on the website of the Centre for Waste Reduction Technologies, www.aiche.org/cwrt/. Accessed 2005. 

AD s baseline physical examination was unremarkable. Family history is positive for cardiovascular disease, and there is no documented history of ADHD in the family. Patient weight 20 kg (44 lbs)... 

It is important to carefully document core ADHD symptoms at baseline to provide a reference point from which to evaluate effectiveness of treatment. Improvement in individualized patient outcomes are desired, such as (1) family and social relationships, (2) disruptive behavior, (3) completing required tasks, (4) self-motivation, (5) appearance, and (6) self-esteem. It is very important to elicit evaluations of the patient s behavior from family, school, and social environments in order to assess the preceding. Using standardized rating scales (e.g., Conners Rating Scales-Revised, Brown Attention-Deficit Disorder Scale, and IOWA Conners Scale) in both children and adults with ADHD helps to minimize variability in evaluation.29 After initiation of therapy, evaluations should be done every 2 to 4 weeks to determine efficacy of treatment, height, weight, pulse, and blood pressure. Physical examination or liver function tests may be used to monitor for adverse effects. 

In guidance document ICH E3, Structure and Content of Clinical Study Reports, the FDA defines treatment-emergent signs and symptoms (TESS) as events not seen at baseline and events that worsened even if present at baseline. As simple as that may sound, it can sometimes be quite difficult to program. The important data variables that come into play are dosing record dates and times, adverse event start and stop times, and adverse event severity. All of these data variables need to be completed accurately for TESS to be calculated properly. 

A draft RI report should be produced for review by the support agency and submitted to the Agency for Toxic Substances and Disease Registry (ATSDR) for its use in preparing a health assessment and also to serve as documentation of data collection and analysis in support of the FS. The draft RI report can be prepared any time between the completion of the baseline risk assessment and the completion of the draft FS. Therefore, the draft RI report should not delay the initiation or execution of the FS. 

Baseline radiographs can document the extent of joint involvement and follow disease progression with therapy. 

Baseline assessment should define therapeutic goals and document cognitive status, physical status, functional performance, mood, thought processes, and behavior. Both the patient and caregiver should be interviewed. 

Discussion This was first adequately documented study of the exposure of military volunteers to BZ. More extended baselines were used, as well as scheduled observations at 1, 2, 3, 4, 5, 6, 10, 24, 48 and 72 hours after administration of the drug. Vital signs and neurological status were recorded at approximately the same intervals. The examining physician recorded mental status changes whenever they occurred. The data were less than optimal due to the infrequency of observations after 10 hours, as well as the brevity of written records of behavioral changes. 

It is well known that in a jet flame blow-out occurs if the air-fuel mixture flow rate is increased beyond a certain limit. Figure 18.3 shows the relationship between the blow-out velocity and the equivalence ratio for a premixed flame. The variation of blow-out velocity is observed for three different cases. First, the suction collar surrounding the burner is removed and the burner baseline performance obtained. Next, the effect of a suction collar itself without suction flow is documented. These experiments show that for the nozzle geometry studied, the free jet flame (without the presence of the collar) blows out at relatively low exit velocities, e.g., 2.15 m/s at T = 1.46, whereas for > 2 flame lift-off occurs. When the collar is present without the counterflow, the flame is anchored to the collar rim and blows out with the velocity of 8.5 m/s at T = 4. Figure 18.4a shows the photograph of the premixed flame anchored to the collar rim. The collar appears to have an effect similar to a bluff-body flame stabilizer. The third... 

The protocol should specify what should be recorded directly into the CRF and what will also be recorded in the medical records. The CRF will contain all the pertinent data associated specifically with the clinical trial but some will be repeated in the medical records, for example, the protocol identification number, date of consent, date of commencement of the study, key baseline medical findings, visit dates, start and finish dates of the study drug/placebo or treatment, concurrent medication, adverse events and key efficacy and any unscheduled or scheduled actions or interventions (such as escape medication). Additional information obtained from biopsy reports, radiographs and similar documents will provide confirmation that the data in the CRF are recorded correctly. Monitors, QA auditors and inspectors need to see all the medical records available to the investigator. It is not appropriate to create copies of data from CRFs or checklists derived from medical records and claim that these are source documents. 

Lead exposure Not a substitute for effective abatement of lead exposure. Neutropenia Mild to moderate neutropenia has been observed in some patients receiving succimer. While a causal relationship to succimer has not been definitely established, neutropenia has been reported with other drugs in the same chemical class. Obtain a complete blood count with white blood cell differential and direct platelet counts prior to and weekly during treatment. Withhold or discontinue therapy if the absolute neutrophil count (ANC) is below 1200/mcL and follow the patient closely to document recovery of the ANC to above 1500/mcL or to the patient s baseline neutrophil count. There is limited experience with reexposure in patients who have developed neutropenia. Therefore, rechallenge such patients only if the benefit of succimer therapy clearly outweighs the potential risk of another episode of... 

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