Design authority

The system should assure all changes are reviewed and approved by a designated authority. All personnel need to understand their role in this updating process and whether they have authority to deviate from procedures. Formal review and update should be part of this system. 

Modification instructions should be produced after approval for the change has been granted and should be submitted to the change control board or design authority for approval before release. 

Although the standard does not recognize any classification of nonconformities, the practical application of nonconformity controls requires controls to be balanced with the severity of the nonconformity. It is not necessary to seek concessions from a customer against requirements that have not been specified, or seek design authority approval for workmanship imperfections. The definition of the term defect in ISO 8402, and the fact that there are many requirements other than those specified in a contract or needed to satisfy market needs, demands that it is sensible to classify nonconformities into three categories ... 

Concessions are any relaxations granted by the customer, design authority, inspection authority, or other body authorized to accept nonconforming product. 

The off-site consequence analysis must be reviewed and updated every five years. However, if process changes might reasonably be expected to cause the worst-case scenario footprint or signature to increase or decrease by a factor of two or more, then the OCA must be revised and the risk management plan must be resubmitted to USEPA or designated authority within six months. 

Viewpoint As is System Analyst, System Designer To be System Analyst, System Designer Authoring Team Members Ranky, with... 

In 1993 Witte et al. [28] and in 1994 Rauws and Groen [29] reviewed the status of the regulation of chiral medicinal products on the pharmaceutical industries in the United States, Japan, and some European countries where designated authorities are responsible for the control and approval of newly developed drugs (both chiral and nonchiral). In the United States, new drug applications are submitted to the Food and Drug Administration (FDA), which requires appro-... 

Send reports of inventory and doses administered to the designated authorities. 

Your department might be able to supply reprint request postcards to be sent to the designated author of a paper. This is an unreliable method of obtaining a copy because it may take some time (allow at least 1-3 months ) and some requests will not receive a reply. Taking into account the waste involved in postage and printing, it is probably best simply to photocopy or send for a copy via inter-library loan. 

The procurement agency should design, authorize and implement a written code of conduct. 

Therefore, the OECD Council, in its Decision-Recommendation on Compliance with Principles of Good Laboratory Practice, adopted on October 2, 1989 [C(89)87(Final)], decided that the member countries should establish national procedures for monitoring compliance with GLP Principles and that they should designate authorities to discharge the functions required by these compliance monitoring procedures. In deciding so, the Council also recommended that the member countries of the OECD should, for the development, implementation and establishment of these authorities and procedures, apply the two documents appended as an integral part to the Decision-Recommendation itself. The two documents were also published separately in the OECD Series on GLP as numbers 2 and 3, and they are reprinted as Appendix I and II to this part, too. 

The role of the chemist in automotive design / author, H.K. Phlegm, p. cm. 

P. Helboe, New designs for stability testing programs Matrix or factorial designs. Authorities viewpoint on the predictive value of such studies, Drug Inform. J. 26, 629-634(1992). 

QUARANTINE (quarantaine) Effective restriction of the availability of material or product for use (physically or by system), until released by a designated authority. 

Engineers have all been likely to be educated with some exposure to the classic book on process design authored by Peters and Timmerhaus, which was recently updated (Peters etal, 2003). Even in this last update, the part dealing with economics contains mostly the same chapter on profitability as earlier editions with small changes. Other available textbooks do not depart from this recipe. The recommended measures of profitability are ... 

Outside the damage size limitations, an engineering decision is requited for the design of the repair scheme by the aitcrafl airworthiness design authority. 

UNEP, founded in 1972, is the designated authority in the United Nations system. UNEP coordinates and supports the environmental activities of the United Nations for the sustainable development of the global environment. UNEP s mission is (Url-5) ... 

Deviation from approved design practices and standards or the approved design is permitted only after review and approval by the designated authority, and the rationale for the decision is documented ... 

Improving Productivity Through Ergonomic Design Author(s) Kerst J... 

An FMEA usefully considers single failure modes only and should be conducted by the Design Authority of the system level (i.e. System, Subsystan, Module or Part) under consideration. 

Note A piece-part FMEA is often only effectively conducted by the design authority of the part being considered. For the purposes of supporting a 2X.1309 System Safety Assessment, the piece-part FMEA is thus seldom applied above System Level 3 and is only conducted(ARP4761 para G.3.2.2) when necessary (eg, when the more conservative results of a functional FMEA will not meet the ETA probability of failure budget). 

Engage with the next higher level design authority to determine/recommend improved redundancy or system monitoring. 

The final aspect of the challenge related to the complicated nature of the design authority for the platforms. The concept of design authority is important because it provides a central point for discussions on how safety issues are to be resolved. 

The challenge with a long-standing platform is that the competence of the original equipment manufacturer can have eroded and other organisations (eg other subsystem maintainers) can have begun to play at least an implicit part in the actual design authority for the platform. 

Domain Statements Properties of the application domain that must be relied upon for the System to bring about the desired change, eg the various companies that together form a platform design authority... 

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