Quality Assurance Checklist

Table 6.1 Quality assurance checklist for critical structures...

A timeline or sequence diagram is first developed, and then causal factors identified. Care should be taken to ensure that the checklist is not used too early. Be sure to determine what happened and how it happened before determining why it happened. Otherwise, the team will think that they have identified the right root cause(s), when in reality only one or two of several multiple causes have been determined. The causal factors are then applied one at a time to each page of the checklist(s) to identify relevant root causes. Those pages that are not relevant to the particular incident of interest are discarded. Similar quality assurance checks should be applied as those described for predefined trees. 

This checklist is intended for use in the preparation and submission of Meeting Requests. It is recommended that, prior to transmission to the FDA, a second internal review be conducted by an individual or department not involved (presumably Quality Assurance) in the preparation of the submission. 

The checklist was developed through discussions with consultants and Quality Assurance directors and has been field-tested in final form with five successful requests. 

This FDA Orphan-Drug Review checklist has been designed in consultation with FDA reviewers, industry consultants, and regulatory professionals to serve as a summary tool indicating the evaluative criteria used by the Office of Orphan-Drug Development to critique and assess applications received. It can be used internally as a part of the Quality Assurance process, as a guideline for regulatory development of an application, and/or as a self-assessment tool to predict likely FDA response to an application. 

But that sense of control can be regained and the result made rational and predictable through a careful Quality Assurance process that checks the submission against FDA established criteria and through the use of an internal, self-regulating review process that applies the checklist criteria used by the FDA to the submission development process. 

With the increasing emphasis in quality to all facets of a petroleum and chemical operation, a quality assurance (Q/A) audit checklist should be completed as an essential final step in the review meeting. This helps ensure that an adequate review occurs and that project quality objectives are being met. A suggested checklist is provided as part of this publication as Appendix B. 

Howard Garston-Smith, formerly of Pfizer, has published a book on software quality assurance. It provides a postal audit checklist reproduced in Appendix 7C. If the supplier has already prepared an internal ISO 9000 mapping or an internal audit report on how it aligns to industry standards such as the GAMP Guide, this can be offered as an alternative to the auditor s postal checklist. A reduced postal checklist may be agreed upon, at the very least. Wherever possible, photocopies of actual example documents and test records should be inspected for documentary evidence of validation. Remember that the pharmaceutical and healthcare companies are themselves being inspected for documentary evidence of validation. 

Typically, the validation evidence for a SCADA system is created and approved through system development. Large systems are often formed of smaller subsystems and integrated during development and start-up efforts. Care should be taken to avoid using checklists as a substimte for validation deliverables or quality assurance reviews checklists simply indicate the presence or absence of required validation products. 

Instead of an isolated and formal checklist activity, validation of analytical procedures should be regarded as part of an integrated quality assurance concept to guarantee the accuracy and reliability of the analytical results and therefore quality, safety, and efficacy of pharmaceuticals. 

From the beginning of its monitoring programme, HELCOM took measures to evaluate and improve the recommended methods by intercalibrations between the different partners (HELCOM, 1983 Niemi et al., 1985 HELCOM, 1991). The HELCOM Phytoplankton Expert Group (PEG) takes care of quality assurance in phytoplankton methodology. It published a manual on biovolumes and size-classes of phytoplankton species in the Baltic Sea (Olenina et al., 2006), which is based on the species checklist of Hallfors (2004). We strictly use the species names given by Hallfors (2004). The autotrophic ciliate Mesodinium rubrum Myrionecta rubra) is counted to the phytoplankton. 

Sampling/Analysis Checklist. This module of Risk Assistant, developed specifically for the review of Superfund risk assessments, prompts the user to consider key issues in quality assurance and quality control for sampling conducted at a waste site. It provides a concise summary of whether the standards developed under EPA s Superfund program have been met. 

An audit is a detailed check of the Quality Assurance System by IT specialists. An audit is carried out on the basis of a SOP containing a checklist with the respective questions. Audits conducted by other companies may be referenced. (Supplier audits are discussed in more detail within Chapters 14 and 15.)... 

Many participants meant that the checklists were most suitable as an internal quality assurance to verify that aU relevant HF-aspects in a design solution were covered. Others meant that they were good for workshops as well. It was pointed out that the checklists needed to be adapted to the project type and current project phase in order to be used effectively. 

By the nature of a brief, it is a very useful document when checking the performance of an activity, and thus a formalized brief document is a useful quality assurance tool. The following is a list of activities for which formalized briefs should be considered, including some specific checklist items for the activity. 

Particular attention needs to be paid to establishing an effective system of quality assurance for adhesive connections. Non-destructive test methods based on ultrasound, X-rays or the measurement of electrical or thermal conductivity are available but only of limited value in practice. Specific data on adhesion cannot always be obtained by these methods. This section examines the issue of quality assurance from a practical point of view. Many years of experience have shown that only a quality assurance system that takes into account the specific features of adhesive bonding technology can produce consistently satisfactory results over an extended production period. The information outlined here should be viewed as a general checklist to be adapted to the specific requirements of each manufacturing environment. 

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