Supporting process audits

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. 

Now that all of the activities that support process validation are in place or have been performed, will the work and effort be appreciated by auditing bodies What measures can be taken to assure that they are There is one other aspect of transdermal validation that will increase the potential for the effort to be appreciated. This element is the protocol. What exactly is a protocol Who should approve this document ... 

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. 

Another supporting process parallel to projeets life cycle is quality assurance. All projeets are submitted to internal audit periodieally, once or twice a year. The seope of the processes and activities audited differs depending on the charaeteris-ties and on the risk level of the projeet. 

Among the supporting processes, the vendor control process is also risk based die tasks requested for vendor and product classification depend on the purpose of the product to be acquired the more critical for the development process or the final product is the purchased part, the more the checks and frequency. A software component to be embedded or used in conjunction with medical software may affect safety they are pre-validated and follow a strict configuration control process. Whenever possible, the vendor development process is audited. 

Step 1.1 Getting Ready. A thorough preparation for a P2 audit is a prerequisite for an efficient and cost-effective evaluation. Gaining support for the assessment from top-level management, and for the implementation of results, is particularly important. Otherwise, there will be no real action on recommendations. Early in the process, management needs to accept that, at a bare minimum, the audit is a worthwhile exercise and that resources - human and financial - should be diverted from other activities to the task of auditing. 

GLP regulations require QA personnel to inspect/audit each study conducted, but the extent to which QA personnel are involved in software development and the val-idation/verification process varies from company to company. In some companies, there is little or no QA involvement in these processes, whereas in others QA personnel are involved. QA personnel can provide assistance in the area of vendor audits for purchased software or can conduct inspections of in-house software development to ensure that internal procedures are being followed. QA personnel, who conduct in-process inspections and review the resulting data and validation report for accuracy, could provide inspection support during the validation and verification process. During system development and validation, properly trained QA personnel can provide the regulatory advice needed to ensure that the system will meet government standards. QA personnel become more familiar with the system(s) that will be used when they are involved early in the validation process. 

Thus, the process of model testing and validation (considered synonymous) should ideally include the steps of calibration (if necessary), verification, and post-audit analyses. I indicate "ideally" because in many applications existing data will not support performance of all steps. In chemical fate modeling, chemical data for verification is often lacking and post-audit analyses are rare (unfortunately) for any type of modeling exercise. 

Design, development, and system build is normally a period of intense activity, in which a supplier will be involved in life-cycle activities and will need to provide a set of auditable design and development documentation to support the validation program. For this, the entire design and development process should be carried out to written and approved procedures, and all design, development, testing, and verification activities should be documented and approved in order to provide a level of computer system documentation that can be used to support the pharmaceutical manufacturer s life-cycle qualification activities. 

In addition to data gathering, QA will want the validation batches made entirely by the production department. When this stipulation is satisfied, it will be demonstrated that the process control is independent of the technical background of the operating personnel. This kind of approach demonstrates that the manufacturing process will support the soon-to-be-marketed product s volume demands. This approach also allows QA to have a baseline activity with which it can compare future audit activities. 

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