Modifications documenting

Prior to commencement of production, design changes do not require any modification documentation, the design changes being incorporated in prototypes by rework or rebuild. However, when product is in production, instructions will need to be provided so that the modification can be embodied in the product. These modification instructions should detail ... 

Manufacturing process modification Document manufacturing changes in annual reports Approval required for every manufacturing change before implementation Submit manufacturing changes and vahdation documents to FDA 30 days prior to product distribution"... 

In the case of modifications, documents or their parts must be replaced by the modified version as soon as possible. Safeguards must exist that obsolete documents can no longer be used. 

All modification documents should be dated, numbered and filed in the listing of software modification controls. 

Requirement specification for the SRCFs Design and integration Verification and validation Modification Documentation... 

Modifications of the various versions of the AMBER parameter sets are implemented in numerous commercial and academic software packages. They are often referred to as AMBER. In every case, the user should read the documentation provided critically, and check the implementation by comparing the results of the implementation with original data. 

A PHA has heen performed for new facilities. The management of change documentation packages and referenced documents should indicate when a process hazard analysis was performed for the modification or new facility. The PSSR Team should verify all of the PHA recommendations have been implemented or otherwise resolved before the toll process can be judged ready to operate. 

EPA has 45 days to review each permit and to object to permits that violate the CAAA. If EPA fails to object to a permit that violates the Act or the implementation plan, any person may petition EPA to object within 60 days following EPA s 45-day review period, and EPA must grant or deny the permit within 60 days. Judicial review of EPA s decision on a citizen s petition can occur in the federal court of appeals. The public is guaranteed the right to inspect and review all permit applicahons and documents. There are provisions for three kinds of permit revisions administrative amendment, minor permit modification, and significant modification. 

The safety status of the process should be periodically reviewed against the guiding principles for the original design. Monitoring of add-ons can detect potentially dangerous modifications. Process hazards analysis or process safety audits are useful tools for this review. Documentation of inherently safer principles is critical to ensure that future changes don t nullify the positive features of the initial installation. 

The most important thing to pay attention to in the case of RP phases is the chain length. It is often forgotten, however, that RP phases are available with differing degrees of surface modification and which also differ in their hydrophobicity and wettability and separation behavior (Rf values, development times). These details should, therefore, also be documented. 

Within the design documentation you will need to provide for the attachment of modification plates on which to denote the modification status of the product. 

The standard requires all design modifications to be documented before their implementation (including changes to proprietary designs). 

The original nonconformity report should indicate the nature of the nonconformity but after rework, or completion of operations, the nonconformity will have been eliminated. Where the nonconformity was accepted as is without rework, repair, or changing the specification then the actual condition is the original condition and this can be specified by the original nonconformity report. If the product has to be repaired or modified, the actual condition can be specified by the repair, salvage, or modification scheme, which is usually a separate document and can either be detailed on the nonconformity report or cross referenced to it. A lot of time can be saved if this information is readily accessible when problems arise later. 

Each PSM system can then be examined to determine what system modifications (if any) are needed to address the new issues. For example, the process hazard assessment system might be modified to include participation by industrial hygienists to identify potential sources of exposure. Some process safety management systems (e.g., process documentation) may require no modification to support a wider scope. 

It is important to remember that unexpected benefits may arise from integration. You should actively look for these benefits and document them. It may be possible to improve some of these benefits by small modifications to the plan or integration framework. Such additional work should be undertaken only with the appropriate approvals. Never the less, if any benefits would only be achieved with the integration project, you should include them in your overall statement of benefits. An example of this might be the better allocation of capital to risk reduction efforts when an integrated risk assessment is done-addressing several different types of risk. 

The Telated alloy system, Al-Zn-Mg-Cn is also well documented " Overageing is reported to be beneficial since modification of the grain boundary precipitate aspect ratio occurs. ... 

The catalytic system used in the Pacol process is either platinum or platinum/ rhenium-doped aluminum oxide which is partially poisoned with tin or sulfur and alkalinized with an alkali base. The latter modification of the catalyst system hinders the formation of large quantities of diolefins and aromatics. The activities of the UOP in the area of catalyst development led to the documentation of 29 patents between 1970 and 1987 (Table 6). Contact DeH-5, used between 1970 and 1982, already produced good results. The reaction product consisted of about 90% /z-monoolefins. On account of the not inconsiderable content of byproducts (4% diolefins and 3% aromatics) and the relatively short lifetime, the economics of the contact had to be improved. Each diolefin molecule binds in the alkylation two benzene molecules to form di-phenylalkanes or rearranges with the benzene to indane and tetralin derivatives the aromatics, formed during the dehydrogenation, also rearrange to form undesirable byproducts. 

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