Nonconformities resolution

Several method performance indicators are tracked, monitored, and recorded, including the date of analysis, identification of equipment, identification of the analyst, number and type of samples analyzed, the system precision, the critical resolution or tailing factor, the recovery at the reporting threshold level, the recovery of a second reference weighing, the recovery for the control references (repeated reference injections for evaluation of system drift), the separation quality, blank issues, out of spec issues, carry over issues, and other nonconformances. The quantitative indicators are additionally visualized by plotting on control charts (Figure 23). 

Once the hardware installation qualification protocol has been completed, the test results, data and documentation are formally evaluated. The written evaluation should be presented clearly and in a manner that can be readily understood. The structure of the report can parallel the structure of the associated protocol. The report should also address any nonconformances encountered during the hardware installation qualification, and their resolution. The hardware installation qualification report summarizes the results of the verification and testing of all hardware technologies that are part of the system. 

If nonconformances or deviations to the project plan or IQ protocol are encountered during the software IQ testing, these must be documented, analyzed, resolved, reviewed, and approved. The resolution process must indicate what additional actions must be taken to provide a conforming product (e.g., return the program to development for error analysis and correction, and re-execute the test script after correction the nonconformance was due to an inaccuracy in the test script, review and update the test script, etc.). After the successful resolution of the nonconformance has been obtained, the original test, the nonconformance information, and the retest must all be retained, approved, and reviewed by the appropriate personal. 

After the successful resolution of the nonconformance, the original test performed, the nonconformance information obtained, and the retest must all be retained, approved, and reviewed by the appropriate personal. 

Criteria and procedure for the identification and resolution of nonconformances that... 

In addition, all the document inspections and technical review results for all the technologies used for the systems must be evaluated. A summary of nonconformances and deviations, their resolution and impact, must also be included. 

Nonconformities May raise May raise, registers and manages May raise, may decide resolution May raise May raise ... 

The resolution and close-out of nonconformities needs rigorous management otherwise they can accumulate to become a significant cause of project delay. The EPCM contractor SQAM or one of his or her assistants must... 

The above is written in terms applicable to materiel or works. For nonconformities centred on documentary or administrative matters, the same general principles apply. Resolution implies applying corrective action to the immediate problem, but also backtracking to find and correct the underlying cause. Preventive action can then be taken to preclude repetition of the same problem. 

Should the problem not be classed as a nonconformity, the QA department shall suggest to the originator an alternative for its resolution. The problem is to be resolved outside of the nonconformity management system. 

The detection of food nonconformities and adulteration is another important challenge that HSI can tackle, thanks to its spatial resolution feature. 

In sub-chapter 18-2, the scope of audits is defined to be applicable to all research, development, design, procurement, construction, fabrication, operation, and decommissioning of the SRS reactors. It further establishes the commitment to report findings as either nonconformances or corrective action reports for tracking and ultimate resolution. Sub-chapter 18-3 sets forth a plan to audit external organizations for their compliance with the QA manual. This allows for the audits of vendors and suppliers and further demonstrates an overall commitment to the assurance of Quality in all aspects of design and its control. The items discussed above demonstrate that the requirements set forth in Restart Criterion 6 are satisfied. 

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