Documentation checklist

Remember that the CCPS definitions may not fit all companies or situations however, they provide a useful set of guidelines for considering how a management system like PSM can work within your company. Some companies have adopted these guidelines very literally and use a highly documented, checklist approach. Others follow them conceptually, in a less structured manner. 

Document checklist. All documents that should be examined and in proper order prior to the initiation of the validation batches are listed. They are checked for availability and accuracy. Preparation of batches should not commence unless these documents are finalized and signed. An example is shown below ... 

The completed Polish official application form containing, among other information, the administrative data on the name of pharmaceutical product with INN of active ingredient, pharmaceutical form and way of administration, dose, name and address of applicant, mcmufacturer if different, date and signature of applicant with the enclosed appendix of documentation checklist. 

List of software programs with software revisions, disk storage requirements and installation date Accessory and documentation checklist Installation protocol... 

Exercise 3 Qieck out http //physics.nist.gov/Document/checklist.pdfon the Internet for the US government s official view on the rules and style conventions for SI units. Standard rheological nomenclature, as approved by the (American) Society of Rheology may be found at www.umecheme.maine.edu. 

Kanholm, Jack. ISO 14001 Requirements 61 Requirements Checklists and Compliance Guide. Pasadena, Calif. AQA Press, 1998. - Interprets and explains the ISO 14001 standard as 61 distinct requirements and discusses, with respect to each of these requirements, how to implement, required documentation, and what auditors will look for as evidence of compliance. 

Saponara, Anthony, and Randy A. Roig, Ph.D. ISO 14001 Environmental Management Systems A Complete Implementation Guide. Vancouver ERM-West, Inc. and STP Specialty Technical Publishers Inc., 1998. - A very extensive, two-volume ISO 14001 implementation manual containing dozens of checklists, prototype charts, templates, document examples, and other tools. Uses Green Acres Hotel and Resort as a case illustration for presenting implementation principles, techniques, and tools. 

At Site I, the prime contractor s SSAHP required daily site inspections, the documentation of safety and health deficiencies, and the abatement of deficiencies. Records of site deficiencies, however, were kept intermittently, and hazard abatement was not documented. The subcontractor s SSAHP did not address site inspections and hazard abatement, but its TSCA permit application included requirements for site inspections. Inspection documentation, however, was not available on site, and the site manager was unaware of these written requirements. The site manager did, however, indicate that he conducted site inspections using a mental checklist and that he conducted inspections of remediation equipment before each use. 

After preparation, a checklist may be used by less expert engineers than the preparers for inspecting the process areas to compare the process equipment and operations with the checklist oidrcr on hardcopy or laptop computer. The analyst fills in the checklist according to observations from their inspection, process documentation, and interviews with operators and their perceptions. 

When a checklist is made from generic documents, it may be incomplete or erroneous. 

The results of a What-If/Checklist analysis are documented like the results of a What-lf analysis as a table of accident scenarios, consequences, safety levels, and action items. The results may also include a completed checklist or a narrative. The PrHA team may also document the completion of the checklist to illustrate its completeness. The PSM rule requires detailed... 

Specify the documentation requirements and format, such as checklists for recording inspections, startup, and functional performance tests. 

The most common hazards control technique is a checklist. The checklist is prepared by experienced personnel who are familiar with the design, construction and operation of similar facilities. Checklists are relatively easy to use and provide a guide to the evaluator of items to be considered in evaluating hazards. API RP 14J has examples of two checklists which can be used to evaluate facilities of different complexity. Because production facilities are very similar and have been the subject of many hazard analyses, a checklist analysis to assure compliance with standard practice is recommended for most production facilities. The actual procedure by which the checklist is considered and the manner in which the evaluation is documented to assure compliance varies from case-to-case. 

As process plants become more complex, it becomes apparent that it is not possible to rely exclusively on the process worker s skills and memory required to perform the task. Job aids and procedures are devices which aim to reduce the need for human retention of procedures and references as well as the amount of decision making required. Job aids assume a variety of formats including flowcharts, checklists, decision tables, etc., while procedures refer to other systems of documentation such as standard operating instmctions and emergency procedures. 

Figure 5.4 A checklist of documentation to be provided with a Clinical Trial Application.

The requirements for a NADA are set out in 21 CFR 514.1 and summarised in Figure 7.7. A F DA-35 6v form must accompany each submission (see Figure 7.8). This is similar to the form used for human drug submissions in that it captures basic information on the submission and provides a checklist for accompanying documents or materials. The labelling should include instmetions on how to use the drug in the manufacture of medicated feeds, where such use is intended. The CVM may request samples of the dmg product itself reference materials or standards, and samples of food produce from treated animals in order that they can, in conjunction... 

Assembling technical documentation that provides evidence of conformity with the essential requirements is a fundamental part of all conformity assessment procedures. The appropriate essential requirements annex may be used as a checklist, against which documents demonstrating the adopted solutions may be identified... 

You may wish to refer to other documents, eg works rules, safety checklists, training programmes, emergency instructions, etc. 

Archival study This involved a review of relevant documents and records, including dmg laws and executive orders inspection checklists DRA annual reports economic, health and other indicators and reports of other studies available (e.g. opinion surveys, dmg use studies). 

Defined maintenance procedures should include model or manufacturer specifics and a list of parts to be inspected, cleaned, lubricated, replaced, and/or calibrated. The replacement part numbers, cleaning solutions and lubricants, and calibration standards, along with the manufacturer s maintenance procedures to be followed, should be specified. Documentation is easily managed by creating a one-page checklist of instructions or performance parameters that can be checked off as each task is completed. Any issues or comments can be captured directly on the checklist. Provisions for failure or out-of-tolerance notification need to be clearly defined, as the equipment cannot be put back into service until the performance has been verified by conducting a performance qualification. 

In order to audit effectively studies with electronically generated data, QA should create a special checklist or add electronic issues to a current checklist. The checklist should include items such as ensuring that the computer system in use is current and validated and that necessary maintenance is documented. 

It may be desirable to discuss facility siting issues at the beginning of the PrHA sessions. As a minimum, comments and assumptions about siting and plant layout can be included in the PrHA analysis documentation, such as on HAZOP study worksheets. Table 3.2 provides a sample checklist for worker/co-located worker exposures. A sample checklist for facility siting issues is presented in Table 3.3. 

Checklists are limited by their authors experience. They should be developed by individuals who have extensive experience with the processes they are analyzing. Frequently, checklists are created simply by organizing information from current relevant codes, standards, and regulations. Checklists should be viewed as living documents and should be reviewed regularly and updated as required. 

Procurement Fabrication Construction vendor and fabrication documents inspection reports field change documents vendor data on equipment as built data What-If, Checklist... 

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. 

SVA Methodologies There are several SVA techniques and methods available to the industry, all of which share common elements. The following is a list of some available SVA methodologies published by various governments, private, and trade andprofessional organizations. Some are merely chapters or sections of documents that address security or risk assessment/risk management in broader terms. Some are SVA or VA publications by themselves. Some of these methods are complete, systematic analytical techniques, and others are mere checklists. 

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). 

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