Documentation Shortcomings

Systems depend on accurate data to produce high-quality outputs. For example, the schedule for a poorly documented manufacturing process will have 

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However, this advance has an important shortcoming the lack of context. More than one idea is expressed in a document a patent on oxidation catalysts, for example, could include examples of the oxidation of methanol to formaldehyde and of 2-propanol to acetone. A simple coordinate search for conversion of methanol to acetone would retrieve such a document from a file that provides no context. 

The technical package may specify a scope and frequency for periodic audits and performance criteria that could lead to changing the audit frequency. It may be a general safety and environmental performance audit or a special audit for items such as raw material storage and handling, quality control methods and documentation. The proprietary nature of a process or product or the complexity of the toll could be a reason to establish a more frequent audit schedule for certain tolls. Audits can also be conducted to follow-up on previously identified shortcomings to document that they were addressed properly. 

The systematic evaluation of substance properties and predictable or actual exposure patterns over the entire life-time of a substance within the scope of risk assessment is as yet a relatively recent instrument, for which harmonised scientific rales were created in the EU for the first time in 1997 in the form of the Technical Guidance Documents (TGD). An essential element in this range of instruments is how to deal with shortcomings in knowledge. Wherever information is missing, standardised worst-case scenarios are conceived taking into account appropriate safety factors . If under these worst-case assumptions a rele-... 

If this is not possible, for either practical or theoretical reasons, document trails are needed to show what course of action was considered, and the rationale for the decisions made. A good basic rule is always that the manufacturers should be more aware of the shortcomings of their materials or products than their customers, and should share the knowledge with the public. Product liability lawyers make it their business to care how manufacturers test for flammability to ensure that the public is adequately protected. 

However, an analysis of the existing legal and regulatory documents has revealed a number of shortcomings and bottlenecks in the legislation. The main of them are ... 

Ignore known shortcomings with the core supplier product (how they are tackled should be documented). 

The capabilities of LIBS for determinative applications are also well-documented. Notwithstanding its shortcomings, the LIBS technique can be made a fast tool — whether... 

The clock starts if the documentation submitted meets the requirements of the Law. The validation is performed by the NDI clearing people . If shortcomings or incompleteness are identified during the initial validation, a letter shall be returned to the applicant to make the appropriate amendments. 

Because of these shortcomings, the overall managerial configuration of a process is usually maintained manually. This induces inconsistencies in the administrative configuration, which may lead to, e.g., forgotten tasks or to the use of outdated documents. The risk of inconsistencies emphasizes the need for holistic management support which can be provided by AHEAD. 

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