An independent reviewer is an individual who does not have direct
professional responsibility
Professional responsibility is a set of duties within the concept of professional ethics for those who exercise a unique set of knowledge and skill as professionals.
Professional responsibility applies to those professionals making judgments, a ...
for the design stage under
review
A review is an evaluation of a publication, product, service, or company or a critical take on current affairs in literature, politics or culture. In addition to a critical evaluation, the review's author may assign the work a content rating, ...
, assuring an independent and objective review. Within the context of formal design reviews, the practical solution is simply to ensure a fresh perspective, based on the principle that those who are too close to the
design
A design is a plan or specification for the construction of an object or system or for the implementation of an activity or process or the result of that plan or specification in the form of a prototype, product, or process. The verb ''to design'' ...
may
overlook
A scenic viewpoint – also called an observation point, viewpoint, viewing point, vista point, lookout, scenic overlook,These terms are more commonly used in North America. etc. – is an elevated location where people can view scenery (often w ...
design errors. Thus, reviewers should not have been significantly involved in the activities under
review
A review is an evaluation of a publication, product, service, or company or a critical take on current affairs in literature, politics or culture. In addition to a critical evaluation, the review's author may assign the work a content rating, ...
.
US Food and Drug Administration
The US
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
requires that developers of
medical device
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...
follow a system of
design controls Design controls designates the application of a formal methodology to the conduct of product development activities.
It is often mandatory (by regulation) to implement such practice when designing and developing products within regulated industries ...
. A key part of this system is design review, defined in 21CFR820.3 section (h) as "a documented, comprehensive, systematic examination of the design to evaluate the adequacy of the design requirements, to
evaluate
Evaluation is a
systematic determination and assessment of a subject's merit, worth and significance, using criteria governed by a set of standards. It can assist an organization, program, design, project or any other intervention or initiative ...
the capability of the design to meet these
requirements
In product development and process optimization, a requirement is a singular documented physical or functional need that a particular design, product or process aims to satisfy. It is commonly used in a formal sense in engineering design, includi ...
, and to identify problems."
In section (e), it is stated that an independent reviewer is required for any design review. An independent reviewer is an individual who does not have direct
professional responsibility
Professional responsibility is a set of duties within the concept of professional ethics for those who exercise a unique set of knowledge and skill as professionals.
Professional responsibility applies to those professionals making judgments, a ...
for the design stage under
review
A review is an evaluation of a publication, product, service, or company or a critical take on current affairs in literature, politics or culture. In addition to a critical evaluation, the review's author may assign the work a content rating, ...
, assuring an independent and objective review. Within the context of formal design reviews, the practical solution is simply to ensure a fresh perspective, based on the principle that those who are too close to the
design
A design is a plan or specification for the construction of an object or system or for the implementation of an activity or process or the result of that plan or specification in the form of a prototype, product, or process. The verb ''to design'' ...
may
overlook
A scenic viewpoint – also called an observation point, viewpoint, viewing point, vista point, lookout, scenic overlook,These terms are more commonly used in North America. etc. – is an elevated location where people can view scenery (often w ...
design errors. Thus, reviewers should not have been significantly involved in the activities under
review
A review is an evaluation of a publication, product, service, or company or a critical take on current affairs in literature, politics or culture. In addition to a critical evaluation, the review's author may assign the work a content rating, ...
.
UK Anti-terrorism law
The purpose of an independent reviewer in
anti-terrorism legislation
Anti-terrorism legislation are laws with the purpose of fighting terrorism. They usually, if not always, follow specific bombings or assassinations. Anti-terrorism legislation usually includes specific amendments allowing the state to bypass its ...
is much the same as in any design process; to ensure that those working on the project have not blinded themselves to its faults, however, the independent reviewer also ensures that the legislation does not fall foul of anti-discrimination legislation and cause conflict in the law.
References
{{Reflist
Food and Drug Administration