Inspections document review

Is it ensnred that the authorities are kept adequately updated on the progress of the project through status meetings, inspections, document reviews, etc. ... 

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. 

Quality plans are needed when the work you intend to carry out requires detailed planning beyond that already planned for by the quality system. The system will not specify everything you need to do for every job. It will usually specify only general provisions which apply in the majority of situations. You will need to define the specific documentation to be produced, tests, inspections, and reviews to be performed, and resources to be employed. The contract may specify particular standards or requirements that you must meet and these may require additional provisions to those in the quality system. Although ISO/TS 16949 requires the plan to include customers requirements, the intention is not that these requirements are reproduced if provided in a documented form by the customer, but that a cross reference is made in the plan together with any other relevant specifications referred to in the contract. However, when constructing the plan, it would make sense to refer to specific customer requirements and provide a response that indicates your intentions regarding those requirements. 

These lists tell us something about the nature of quality records, especially by what is not included. Absent from the lists are policies, procedures, instructions, plans, specifications, and any other prescriptive documents. The records all have one thing in common they describe the results of some activity - the results of inspections, tests, reviews, audits, assessments, calculations, etc. However, these lists are dominated by records relating to product quality rather than to the operations of the quality system. In addition to audit records, the following records may need to be maintained to demonstrate the effectiveness of the quality system ... 

The first phase of process safety incident investigation involves gathering all the pertinent facts from the collected evidence, whether derived from interviews, site and equipment inspections, or document reviews. At this... 

Upon completion of the review, a written evaluation of the product is prepared in a review document and the comments of the various reviewers are reconciled and reviewed by the division director. The results of the decisions are communicated to the applicant in an approvable or not-approvable letter. In some cases, if the questions have been satisfactorily addressed during the review process, the agency may proceed directly to an approval letter. The scientific review divisions are independent from the district offices that conduct field facility inspections. The review division will wait for assurance that the preapproval inspections are completed satisfactorily prior to issuing... 

CONDUCT OF THE INSPECTION DOCUMENTATION MOST LIKELY TO BE REVIEWED... 

The inspection reports that the documents reviewed did not define the system as being validated but was a qualification document. [FDA Wanting Letter, 2001]... 

The stability data generated from the stability study, the data analysis, interpretations, and conclusions are reported at the end of the study. The stability report contents are an important component in any regulatory submission and the report is one of the documents reviewed in most audits and/or inspections. Figure 13.9 shows sections that contribute to a stability report. 

The inspection itself will consist of interviews with employees and document review. The Multi-Media Manual lists the objectives of inspections for each of the major programs under TSCA. PCB marking is a particularly easy target for an inspector, and most inspectors will inspect any PCB equipment at the facility and note violations. 

Input requirements for MORT analysis, like those for any other detailed, comprehensive analysis, are extensive. Detailed information about the hardware and facilities, environment, procedures, and personnel directly involved is required for full evaluation of the specific control factors, and additional information about the management system is required to evaluate the policies, procedures, implementation plans, risk assessment program, and other upstream factors. Normally, a combination of interviews, physical inspections, and reviews of many procedures and project documents is required. The MORT chart and/or mini-MORT chart can serve as a planning and organizational tool for the collection of evidence and other relevant information. 

Method, short description of inspections made, list of interviewees and documents reviewed, reference documentation, etc. Details can be given in an attachment. 

Develop detailed questions and plan the interviews, document reviews and inspections. 

The most effective specification is that which accomplishes the desired result with the fewest requirements. Properties and performance should be emphasized rather than how the objectives ate to be achieved. Excessive demonstration of emdition on the part of the writer or failure to recognize the usually considerable processing expertise held by the vendor results in a lengthy and overly detailed document that generally is counterproductive. Redundancy may lead to technical inconsistency. A requirement that cannot be assessed by a prescribed test method or quantitative inspection technique never should be included in the specifications. Wherever possible, tests should be easy to perform and highly correctable with service performance. Tests that indicate service life are especially useful. Standard test references, eg, ASTM methods, ate the most desirable, and those that ate needed should be selected carefully and the numbers of such references should be minimized. To eliminate unnecessary review activity by the would-be complier, the description of a standard test should not be paraphrased or condensed unless the original test is referenced. 

Subcontractor/supplier performance will be evident from audit reports, surveillance visit reports, and receipt inspections carried out by you or the third party if one has been employed. You need to examine these documents for evidence that the subcontractor s quality system is controlling the quality of the products and services supplied. You can determine the effectiveness of these controls by periodic review of the subcontractor s performance what some firms call vendor rating . By collecting data on the performance of subcontractors/suppliers over a long period you can measure their effectiveness and rate them on a scale from excellent to poor. In such cases you should measure at least three characteristics quality, delivery, and service. Quality would be measured by the ratio of defective conforming products received delivery would be measured by the number of days early or late and service would be measured by the responsiveness to actions requested by you on scale of excellent to poor. The output of these reviews should be in the form of updates to the list of assessed subcontractors/suppliers. 

This report evaluates recent performance of DGs and all DG vendors with the exception of Transamerica Delaval, Inc. (TDl), because of the emphasis already being given to TDI diesels in other studies. For the period 1980 through 1983 inclusive, BNL reviewed and evaluated DG failure data, DG vendor inspection reports, the TDI lessons learned as they related to the other vendors, and previous pertinent studies. The data sources used for DG failure analysis were LERs, 10 CFR 50.55E, Part 21, NPRDS, and EPRI document files. The DG failures were classified relative to the DG component that failed (e.g., main bearings, starting system). The failures were also categorized and analyzed by mode, manufacturer, and cause. Manufacturers with significant failures are identified in the report. 

Archival study This involved a review of relevant documents and records, including dmg laws and executive orders inspection checklists DRA annual reports economic, health and other indicators and reports of other studies available (e.g. opinion surveys, dmg use studies). 

The responsibility of the QA unit should not be limited to in-process inspections and data and report audits. To be in full compliance with GLP, the QA unit should review all procedures for storing and archiving electronic as well as paper raw data. This review should include ensuring that back up and archiving procedures were performed as specified in the SOPs, that archiving was documented properly, and that long-term storage procedures were followed. 

Specifications A specification describes actions using postconditions (perhaps drawn with state charts) the postconditions are written in terms of a vocabulary of objects and their static relationships, which is described in a type model. These documents must be inspected at external design reviews. Types, rather than classes, are the main focus. 

GR-6.2.2.3 Subcontractor Control. The subcontractor services shall be controlled by the processes of procurement, quality review, and surveillance, including receiving inspection, supported by the proper documentation. The subcontractor shall provide a Quality Control System (manual), documented procedures, and applicable work instructions. The construction organization shall be responsible for approval of all subcontract services. 

To illustrate a complete decomposition for a process represented by a large number of equations is not feasible in this review because of the practical difficulties of printing the resulting matrices. Also, the problem statements would probably be longer than the review itself. Consequently, decomposition of two modest-sized processes is illustrated in this section, one a process of sufficient scale to be quite impracticable to decompose by inspection. The first example model has been taken from Analog Simulation of the Hanford N-Reactor Plant (S5), a documentation readily available from the Clearinghouse for Technical and Scientific Information as well as AEC depositories. 

Inspectors will visit the investigator site and may possibly wish to visit the sponsor s office. They will review the documentation of the study file (see Box 7.1). Approval documents of the lEC will be compared with any amendments made to the protocol or to the subject s information sheet/ICR Consent forms for the study subjects will be inspected to establish who actually gave consent and whether this was before entry into the clinical study. A thorough source data verification of the CRF with the source documents, including the medical records, will be undertaken. Documentation relating to drug accormtability wiU be matched with each subject s CRF The facilities wiU be reviewed and the site staff interviewed. Further information can be obtained from... 

As well as GCP site inspections, an examination is imdertaken of the raw or source data and records of Chemistry Manufacturing and Control (CMC), non-clinical and clinical reports that are the basis of the application. This is to ensure that the application dossier accurately reflects the source data. The procedure issued by PMDA details that list of raw data and records must be provided. The applicant is required to bring the data and records to PMDA on the specified days and when the examination finishes they should be retrieved. Therefore, the raw data and records stored at overseas sites are usually categorised as documents not to be submitted and not subject to reliability review by PMDA. Instead, the MHLW may investigate the data from non-Japanese studies at the site of storage since submission of a photocopy of the data is not permitted. 

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