Essential Requirements Checklist

The European Union Medical Device Directive (and various other national systems) has adopted a review scheme known as the Essential Requirements Checklist. The manufacturer must meet the essential requirements of the Directive, which is a standardized grouping of attributes for medical products. All devices, regardless of classification or conformity assessment route, must prove that the product meets the essential requirements. Where a harmonized standard exists for the product, and the product meets the standard, it is deemed to automatically meet the essential requirements, but for biotextUes, these are few and far between. One notable device-specific standard for a biotextile vascular graft is ISO 7198 First edition 1998-08-01 Cardiovascular implants - Tubular vascular prostheses, which is recognized by FDA. 

Essential Requirements Checklist, 176 Ethibond, 295 Ethicon SUk, 337,346 Ethicon uncoated polyester, 346 Ethilon, 350,360... 

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... 

A range of standards may be used in combination to show that different essential requirements are satisfied. The checklist is often the crux of... 

Another link exists between the PIF concept and the sociotechnical assessment methods described in Section 2.7 The checklists used in the TRIPOD methodology are essentially binary questions which evaluate whether the sets of PIFs making up each of the general failure types are adequate or not. The hierarchical sets of factors in HRAM are essentially PIFs which are expressed at increasingly finer levels of definition, as required by the analyst. The audit tool which forms MANAGER also comprises items which can be regarded as PIFs which assess both management level and direct PIFs such as procedures. 

An effective management system to ensure process integrity is essential and must include up-to-date operating procedures, product changeover instructions, and checklists that cover instrumentation, equipment arrangement, and procedures procedures must also include adequate checks and reviews to ensure the required changeover modifications have, in fact, been made when required. 

Recording audit observations is an essential part of the audit to enable the auditor to prepare detailed, accurate and complete audit reports which are based on factual observations. Checklists, audit questionnaires and sampling plans are useful tools and should be prepared prior to the audit. Generic checklists may be a good start and can be refined as required for each audit to account for trial-specific issues. Source data verification (SDV) templates are always trial-specific as each clinical trial is unique. Although checklists and questionnaires are very useful to record audit observations, they should never restrict the extent and scope of audit activities and allow for flexibility during the audit. 

Similarly, environmental or seasonal changes may have an impact, where the routine use of local microenvironments during incubation steps has been found to be essential. In such cases, there may be a requirement for using incubators that are capable of maintaining constant ambient temperatures. Such anecdotal issues can be used to develop a checklist that can be used for future method evaluations and/or troubleshooting. 

The importance of requirements specification is now realized as it provides the written definition for the evaluation exercise. The key approach to evaluation is to develop an evaluation checklist for comparison of systems the users should grade each requirement as either mandatory or desirable . All those features falling into the essential category form the minimum requirements of the LIMS and the desirable category features are those that are useful to have but the users do not require them in order to perform their normal role. To aid objectivity, essential items can be given a numeric value this will give a total score for each system on offer. 

The first step in the process is risk identification, which is accomplished by review of the proposal/study by suitably experienced experts using well-considered checklists. These must embrace all facets which may affect the project outcome, such as plant feedstock quality, process reliability, mechanical reliability, potential foundation problems, operational hazards, environmental impact, equipment costs, construction costing and labour, statutory requirements, contractual and legal problems peculiar to the country of construction, eventual decommissioning costs, and so on. Risks due to operational hazard are generally treated separately from commercial risk, and will be discussed in Chapter 12, but they are obviously an essential part of the overall process. 

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