Gather the Documentation

Every facility has its own approach to maintaining plant information that may help a PSSR team complete its assigned tasks. And every PSSR may have slightly different needs in regard to the information necessary for a thorough review. 

For some simple PSSRs, the team may only need access to the work order for a small change. For more complex PSSRs, the team may need to see P IDs, schematics, MSDS, operating procedures, maintenance procedures, and safe work practices. 

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Different than other antidiscrimination laws, safety professionals should be aware that an employee may file a complaint with the U.S. Department of Labor, Wage and Hour Division, or with the EEOC.t However, safety professionals should be aware that the EEOC will conduct the investigation and gather the documents from the employer and other sources regarding the wages, hours, employment practices, conditions in order to determine whether or not a violation of the Equal Pay Act has occurred. Safety professionals should also be aware that the EEOC may request to inspect the company s operations, conduct interviews of anployees and acquire copies or take notes from various company documents which may be on file at the company or organization. ... 

Adequate support from the facility staff is absolutely essential. The facility staff must help the analysis team gather pertinent documents (e.g., PSilDs, procedures, software descriptions, material inventories, meteorological data, population data) and must describe current operating and maintenance practices. The facility staff must then critique the logic model(s) and calculation(s) to ensure that the assumptions are correct and that the results seem reasonable. The facility staff should also be involved in developing any recommendations to reduce risk so they will fully understand the rationale behind all proposed improvements and can help ensure that the proposed improvements are feasible. Table 12 summarizes the types of facility resources and personnel needed for a typical QRA. 

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. 

While the term adequacy is a little vague it should be taken as meaning that the document is fit for its purpose. If the objective is stated in the document, does it fulfill that objective If it is stated that the document applies to a certain equipment, area, or activity, does it cover that equipment, area, or activity to the depth expected for such a document One of the difficulties in soliciting comments to documents is that you will gather comments on what you have written but not on what you have omitted. One useful method is to ensure that the procedures requiring the document specify the required content so that the reviewers can check the document against an agreed standard. 

The OECD Task Force on Environmental Exposure Assessment is developing OECD-wide ESDs, in order to make it possible to reflect conditions on production, use, etc. that are different between countries, and to avoid duplicative efforts by Member countries and industry in gathering exposure information. The hrst process for developing OECD-wide ESDs is a submission of a project proposal from member countries. The proposal specifies the industry categories and/or use categories that the documents will cover. Once approved by the Task Force, the lead country drafts the document, and the draft will then be circulated to the member countries for their comments. Taking the comments into account, the drafts are amended and published by the OECD. 

For the specifically esoteric connections, see Bohan, especially chapter 2, Dreier s Artistic Philosophy. Even though Bohan has usefully gathered the necessary documentation to prove Dreier s involvement with Occultism, she does not quite appear to realize the complete or even potential implications of such esoteric allegiances for the course of American Modernism as a whole, not to mention Dreier s particular involvement with Marcel Duchamp. 

Validation requires money, time, planning, and documentation. It also, however, requires human resources to push the buttons, collect the data, submit the samples, analyze the collected samples, summarize the reports, and gather the required signatures. Most validations are very resource-intensive undertakings. Somehow companies must assure that the requisite resources are available. Although not recommended, these resources may be external (contracted laboratory, consultants, etc.). With the exception of a qualified contract laboratory, the... 

The documentation gathered for the PQ review must provide evidence to ensure that as a minimum ... 

Gather the requirements for the systems including functional (e.g. operational checks) requirements, nonfunctional (e.g., coding standards) requirements, users, company-wide regulatory compliance (e.g., Part 11 technical control), safety, process, and other applicable requirements Characterize information, assess its value to the organization, and incorporate information quality as part of the project plan Conduct a system (hardware, software, and process) risk analysis. New requirements may be found as the result of the risk analysis. Any new requirements must be documented in the requirements specification deliverable... 

After an OSHA inspection of the workplace, the investigator(s) will review the evidence gathered via documents, interviews, and observations. If the OSHA inspector believes there has been a violation of a standard, he can use a standard citation form that identifies the site inspected, the date, the type of violation, a description of the violation, the proposed penalty, and other requirements. The citation must be issued within the first six months after the alleged violation occurred. 

The documentation system at Bayer AG was invaluable in gathering the important facts for this book. Numerous colleagues have assisted us ... 

The administration system AHEAD manages the resources of a design process, which also include the representation of the involved project members. By implementing a connection to AHEAD, information about designers and their contact data is transparently gathered by KomPaKt. Additionally, the documents used in a work session can be identified and used in a conferencing session. 

At this point it is important to make a distinction between two types of multimedia conferences. Planned conferences, e.g. meetings for discussing about intermediate results obtained in the design process, can be modeled as tasks in the process management of AHEAD. Thus, KomPaKt can be initiated, like any other tool, through the work context for a task, directly gathering all documents and contact information of the assigned project members for this task. 

The development and approval process is presented in Fig. 19.2. In the preclinical phase, the sponsor conducts the short-term animal testing and begins more extensive long-term animal studies. It is advisable to meet with the appropriate division of CDER in a pre-IND meeting to clarify the content of an application. When a sufficient amount of necessary data is gathered into an IND document, the application is filed with the FDA. The Agency has 30 days from the date the document is received to review the IND application, request additional information, and reach the... 

Long before a test plant is built, that is, already during the constmction of the laboratory apparatus and at the beginning of the planning phase, the first consideration of the safety concept must be made. The first step is to gather the relevant substance data (Section 3.2). Then the necessary auxiliary substances are considered (must an AI liquid be used, or is a B classified solvent adequate ). For the transition from alabora-tory to a pilot plant, a detailed safety concept must be provided and discussed with the relevant departments (head of pilot plant, safety department, etc.). At the end of process development all safety-relevant aspects must be documented. This document is the basis of the safety studies (Section 5.2.2) in the framework of the feasibility study (Section 5.1). 

One special mention yet should be made of the regulatory framework, where a quite complete set of the documents in force in Kazakhstan was gathered, copied and provided by NTSC in CD-ROM format. This however occurred 16 months after project initialisation. 

If the equipment is classified as a SIS, then the next task is equipment justification. This must be done by either a "prior use" justification or equipment must be assessed per lEC 61508 (Ref. 2). Most choose the lEC 61508 certification route, especially for the logic solver, since the documentation burden is high and data gathering can be painful and fruitless when good systems are not in place. This is discussed in detail in Chapter 7. 

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