Process auditing

Preventive maintenance (clause 4.9.1.5) Measurement systems analysis (clause 4.11.1.2) Process audit (clause 4.17.2.3)... 

The process audit to verify that the result-producing processes control products and service within the defined limits. This is now required in ISO/TS 16949 clause... 

Customers are likely to require internal auditors to at least have taken an Internal Auditor Training Course that meets the requirements of ISO 10011 but are unlikely to require Lead Auditor Registration. VDA 6.3 on Process audits requires the auditor to have at least two years practical experience in process management in the automotive industry and to have performed at least three process audits with the support of a technical expert from the process area. 

Perform Audit Quality System and Facility Evaluation Process Audit... 

The QA unit should have written procedures (SOPs) for the conduct of inspections and audits. These procedures should incorporate all considerations for the review of electronic data systems. The QA unit SOPs should address the role and responsibilities of the QA unit in software development, purchase, and validation activities, in-process audit procedures for data collected on line, procedures for on-line review of data (i.e., what will be verified and how much data will be reviewed), and the procedure for auditing reports using on-line data. 

Audit Process Audits in the chemical process industry can be focused on process safety, process safety management, environmental, and health areas. The discussion in this section will focus on the process safety and process safety management area, but it should be recognized that the process can be applied to the other areas as well. "Process safety audits are intended to provide management with increased assurance that operating facilities and process units have... 

Anderson CA. Approach to data processing auditing. In The Interpreter. Durham, NC Insurance Accounting and Statistical Association, April 1975, pp. 23-26. 

QAI will perform the in-process audit checks hourly for the packaging of products according to SOP (provide number) and record the observations on form. See attachment no. 1700.30(1). 

Is responsible for process audits and recommendations for optimisation at both companies. 

Conduct in-process audit activities associated with the technical design process... 

During the development process a set of inspections (i.e., in-process audits) are... 

Closely related to preventive action is the process audit. Such an audit is performed as part of a laboratory assessment for each test on the proposed scope of accreditation. Performance of a test procedure is observed relative not only to the requirements of the ISO 17025 standard (or ISO Guide 25) but also with respect to performing the ASTM or ISO test method properly. As a minimum, the laboratory must have properly calibrated equipment, the current test method, and trained testing personnel. In addition, a representative number of test demonstrations will reveal whether good laboratory practices are observed in sample preparation, using the correct test parameters and calculating the results. When operators and technicians accept responsibility through such demonstrations, they tend to commit to the quality process. Real improvement occurs with involvement at all levels. 

In addition to these, systems audits and process audits can be undertaken. 

Process audits, on the other hand, have specifically been addressed in the revised 1997 GLPs, and these are basically aimed at auditing short-term studies of a repetitive nature, generally undertaken by similar teams of people. Here, that the system is working and that parts of the process are reviewed over a quoted period in the QA SOP are assured. The aim is to ensure that all critical aspects of this process are reviewed through different studies over a period of time. This, then, does not necessitate QA review of all short-term studies on every occasion, nor does it require the review of such areas as analytical analysis on a batch-by-batch basis or the analysis of hematology or biochemistry samples each time these come up for analysis. 

Quality assurance (QA) testing and recertification of LAF systems and other engineering controls, which support the aseptic process (process auditing), irrespective of quality control, or procedures to demonstrate conformance with product specifications of identity, purity, sterility, and apyrogenicity (product auditing). 

Engineering Development Manufacturing Quality assurance Qualifies for plant, facilities, equipment, and support systems Qualifies for products and their specific manufacturing processes Operates plant, facilities, equipment, support systems and the various manufacturing processes Audits plant, facilities, equipment, support systems, the various manufacturing processes, and their products... 

Involvement of the supervisors and workers is another key factor in the success of such programs. They have the hands-on involvement with each of the individual activities of the factory. In order to make the best use of their day-to-day experience with the machineries, processes, and a myriad of issues with the factory processes, audit exercise should be carried out with their full involvement and support. Typically, the barrier to such an involvement is fear on the part of certain supervisors and workers that a waste audit will expose inefficiencies that lead to job cuts. In order to overcome such a barrier, supervisors and workers should be assured of their job security, barring evidence of Fraud or sabotage. 

Make process audit for visible foam white-water trays, silo, tanks and sewer. 

Human factors audits can be applied, as can human factors itself, to both products and processes. Both applications have much in common, as any process can be considered as a product of a design procedure, but this chapter emphasizes process audits because product evaluation is covered in detail in Chapter 49. Product usability audits have their own history (e.g., Malde 1992), which is best accessed through the product design and evaluation literature (e.g., McQelland 1990). 

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