Checklists Checklist 10.1 - Information needed

For a plant design problem, students will need guidance on the hierarchical levels of decision making to choose a process. Also checklists of information needed for the design of typical parts of commercial processes prove invaluable. These are provided in Dr. Long s student handout. 

The checklist is a tool to help obtain the information needed for internal decision making. The decision to approve the facility for continued use should be based on a number of factors including but not limited to the facility s ability to ... 

In 1993, the Royal Pharmaceutical Society of Great Britain created checklists for pharmacists that served as a guide to the types of communication that should occur between hospital and community pharmacists regarding patients medication and pharmaceutical needs. These checklists contained information that should be completed by the community pharmacist to the hospital pharmacist on hospital admission of a patient, such as the medication history and domiciliary circumstances and known adverse drug reactions (ADRs),... 

Table 15.3 lists information needed to initiate a stability study. These items are the minimum requirements in order to identify the drug product as well as the package used. A checklist could be created to ensure all necessary information is collected. 

The TSCA Coordinator shall assemble all information needed to evaluate potential substantial risk information for reporting under TSCA 8(e). If reporting is directly addressed in the Reporting Checklists attached to this Procedure the TSCA Coordinator shall determine if reporting is required. 

Greatly simplified, 8(e) of the TSCA statute requires any person who learns that certain chemical substances may pose a substantial risk of inj ury to health or the environment to report that information to the EPA. These checklists were designed to help determine what information needs to be reported. This introduction gives background on 8(e) reporting, discusses the information that does not have to be reported, and discusses some aspects of how to submit reports. It does not cover every topic related to TSCA 8(e), and is only intended as a handy reference. 

Discuss if your company has ever had a Focused Inspection. Use the above Focused Inspections in Construction checklist to inform employees of the requirements needed for a Focused Inspection. 

Many companies have adopted an observation-based behavioral safety process to improve compliance with safety procedures, but simply implementing the basic elements of a behavioral safety process does not always work. Companies can encounter problems in getting employees to conduct needed observations, in getting employees to effectively provide feedback to other employees, and in employees filling out observation checklists informally without conducting actual observations. These problems may indicate an overemphasis on the reporting process and inadequate attention to the values required to implement safety improvements successfully. 

Before you can perform a test, it is advisable (and in some cases essential) to obtain the information in Checklist 10.1. The amount of information needed depends on the role the test personnel are expected to play. In some cases, they will be expected only to report results, but in general they have a responsibility to verify that the results are reasonable (so that they can catch errors in their own work) and point out problems or trends to the people who use the data. The test work will be more meaningful, more interesting, and more effective if the test charter includes information on why the tests are being done and at least some interpretation of the results. 

Qualitative results of checklist analyses vary, but generally the analysis produces the answers yes, no, not applicable, or needs more information. The checklist is included in the PrHA report to summarize the noted deficiencies. Understanding these deficiencies leads to sa fety improvement alternatives for consideration, and to identified hazards with suggested actions. I igtires 3.3,1-4 and 3.3.1-5 present checklist analyses of the Dock 8 HF Supply and the Cooling tower chlorination respectively. 

Checklists do not provide any assistance to assess the relative importance of different items or to indicate the degree to which items may fail to meet the criteria. Thus, there is a need to Tindertake some prioritization of checklist failures, in order to avoid misinterpretation of the information. 

The following listing of data to be supplied to manufacturers when ordering motors or requesting bids is based on the requirements and recommendations of a number of representative manufacturers. This list is split into vital and desirable information and is intended as a checklist in preparing both requisitions and purchase orders. By using this list, you will give the manufacturer a clear picture of your needs for most motor applications in the oil and petrochemical industries and eliminate call-backs, requests for supplementary information, and so on. 

As the project progresses, more information is available therefore, the review technique used can be different at each stage of the project. The use of various hazard evaluation techniques, such as checklist analyses, relative rankings, what-if analyses, and hazard and operability studies, is documented in Guidelines for Hazard Evaluation Procedures Second Edition with Worked Examples (CCPS, 1992). The need to use more quantitative techniques for hazard evaluation may be identified during these reviews, and become an action item for the project team. 

ERPs do not necessarily need to be one document. They may consist of an overview document, individual emergency action procedures, checklists, additions to existing operations manuals, appendices, etc. There may be separate, more detailed plans for specific incidents. There may be plans that do not include particularly sensitive information and those that do. Existing applicable documents should be referenced in the ERP (e.g., chemical Risk Management Program, contamination response). 

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. 

An item of major importance to the preparation of an applications campaign is a complete and easily understood checklist for the collection of all the information that will ultimately be needed by both technical and market-research personnel at his home office. This form should include space for observations on the total size of the market, the share enjoyed by the company interviewed, and the probable influence of selling price of the new material within that market. Only when the interviewer brings back information from which the technical obstacles, market size, and potential profitability can all be judged realistically on a preliminary basis—only then can a commercial development manager make the necessary decisions on the future for his material. 

A checklist review helps stimulate the risk analysis thought process to help determine who (if anyone) needs to perform subsequent reviews. This first-step risk analysis should help determine if specialists should be consulted or if additional information should be developed. A form such as Form 11—2 can help. 

The outline in Figure 17.2 can be used as a checklist to help gather all the needed information. 

But if you wish to own your own natural foods store, you will have many tasks to accomplish before the store is even open. Experts recommend that you make a checklist of the steps you will need to take toward opening your own business. Two of the best resources for this information are the Small Business Administration (www.sba.gov) and SCORE,(www.score.org), which offers information from former business owners. 

An inventory of systems and knowledge, of which one is GMP-critical, must be maintained and available for inspections. An MHRA preinspection checklist has this as one of its opening topics. The availability or otherwise of this information is a clear indicator of whether management is in control of its computer systems validation. The use of an inventory need not be limited to inspection readiness it could also be used for determining supplier audits and periodic reviews, etc. Many pharmaceutical and healthcare companies use a spreadsheet or database to maintain this data. Where a site s inventory is managed between a number of such applications (perhaps one per laboratory, one for process control systems, one for IT systems), care must be taken that duplicate entries are avoided and, equally, that some systems are missed and not listed anywhere. It should be borne in mind that where spreadsheets and databases are used to manage an inventory, it should be validated just like any other GxP computer application. 

The key to the process is to understand the system that is being proposed. It is good practice for the auditor to spend time reviewing the User Requirement Specification and the system descriptions and understanding of what software categories exist for the proposed system. This should be followed up, with the postal audit checklist. This will also provide valuable information to enable the auditor to plan the audit. Available information should be used to customize the audit checklist to address the specific issues that are relevant to both the supplier and proposed project. Consider, for example, a system that includes hardware and software, where some of the software is custom, other parts are configurable and yet others are part of a standard package. The auditor will need to establish how each part of the system will be developed, and how the build phase will be controlled. There may even be more than one supplier. The auditor would need to split up the main elements and examine how each part of the system will be built. 

If you notice plants that don t look healthy or aren t growing the way you d expected, take time to examine them more closely. Look for signs of the problems you listed, and go over your plan to see what steps you need to take. Use the "Pest Patrol Checklist on the opposite page to gather the information you need to diagnose the problem. Once you ve diagnosed the problem and identified the ways to control it. add the necessary information to your garden plan. 

This system establishes the presenting complaint and whether or not the patient has had it before. It can be used to find the necessary information for making a diagnosis. Remember that not all questions will necessarily need to be asked and that the order of questioning is not that critical. Use the mnemonic as a checklist or aide memoir. 

They give an overview and some guidance on the processes that staff involved in marketing products at the European, global or international level need to consider when planning the above. They contain checklists and also reference where the information can be found in other chapters of this book. 

Some investigators and sponsors provide specific checklists for a clinical trial, which they claim are an alternative to the medical records. Information relating to medical history will be copied from the permanent records onto these checklists and most of the key parameters required to be recorded in the CRF will also be present on these checklists. However, monitors, QA auditors and inspectors need to see all the medical records available to the investigator. Some investigator sites, in particular those in outpatient departments, have no available medical records for individual subjects. The study subject may have not have a personal physician. In this situation, the subject may be the only person to provide any information about his/her medical history. 

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