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Meetings formal process

Internal and external audits will be examined, usually annually, to check that the quality system meets current needs and/or that the procedures arc being implemented. This formal process is known as management review. [Pg.60]

For over 25 years, the FDA has had a formal process for holding meetings with sponsors to discuss... [Pg.520]

The driver initiates the formal process through a meeting or discussion with his or her supervisor. During this meeting or discussion, the driver states why he or she believes an incorrect decision was initially made, and requests that the case be brought before the Accident Review Committee. [Pg.734]

Change management Formal process to maintain the accuracy of the zone and how to change the security policy to meet the security goal without any... [Pg.866]

All tollers should eventually be assessed regarding their own quality improvement programs as well as meeting requirements. This can be done either formally, such as with an assessment process and form, or informally through normal communications. In either case, the results of the toller assessment should be documented and well understood within the organization. [Pg.194]

Quality products are products that meet customer needs and expectations but, as has already been said, quality does not happen by chance. A quality system is the means by which organizations produce products that meet customer needs and expectations. Even if that system is not formalized, it is the combination of processes, resources, and organization that will deliver quality products. All ISO/TS 16949 does is define a minimum set of requirements which if met will enable an organization to satisfy its customers. It is a kind of framework for achieving product quality. [Pg.43]

The standards require that formal design review meetings be conducted at appropriate stages in the process. The meetings should be attended by representatives of persoimel responsible for the design stage, together with other experts as appropriate... [Pg.183]

Before a device can be legally placed on the market in Europe, it must go through an appropriate conformity assessment process to establish that it meets all the essential requirements of the applicable directive. This enables the manufacturer to make a formal declaration of conformity and apply the CE mark of conformity to the device. The manufacturer, or an authorised representative (EC Rep), who takes on the responsibilities imposed by the directives on behalf of the manufacturer, must be established in the EU. [Pg.194]

The team members must represent the various scientific disciplines that are associated with the experimental processes of Interest. The methodology requires the design team to meet several times over a period of several weeks to carry out a set of formal agendas described below and to conclude Its efforts with a formal document. The document will contain either a detailed experimental design that meets the constraints of the envisioned test program, or the document will show that an acceptable experimental design does not exist and the envisioned experiment should not be Implemented. In either case, the detailed documentation permits subsequent peer review. [Pg.67]

OSHA uses this term to indicate that the PrHA leader must have competence in the selected PrHA method as applied to process systems. However, OSHA has not formally defined "knowledgeable". A minimum interpretation could include completion of a "hands-on" type workshop on the PrHA method chosen experience in an actual PrHA, led by another experienced PrHA leader, using the chosen method and ability to effectively lead a technical brain-storming type meeting. [Pg.13]

It is only comparatively recently that we have become acutely aware of the need to utilize resources in a sustainable manner. The concept of sustainability began to receive attention during the 1970s and was first formalized internationally in the World Conservation Strategy of 1980. The initial concepts were taken from the idea of sustainable yield, as applied in forestry and agriculture. This is defined as the amount of crop that can be harvested without compromising the capacity of future harvests to produce an equal crop. The level of consumption of a resource to support an activity should meet the needs of the present, whilst ensuring that sufficient resources are available to meet the needs of the future. The concepts of sustainability include social, economic and environmental factors. All three must be taken into account if the absolute sustainability of a process is to be determined. [Pg.1]

In the control of outsourced operations, the cGMP regulations require that the QU approve or reject products or services provided under a contract. Under current quality system models, the organization must follow a formal vendor qualification process to qualify outsource providers and verify through inspection or other appropriate means that the provider is capable of meeting the requirements of the organization. To comply with the regulation, these operations should be conducted by the QU. [Pg.211]


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See also in sourсe #XX -- [ Pg.66 ]




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