QA expert

Task s completion report is under elaboration by a local Consortium s consultant. It will include three mission reports by the Consortium QA expert to Aktau, a small number of documents (programmatic declaration, procedures) produced by the Aktau plant management as a result of these missions, certificates of training of Aktau QA experts by the Bureau Veritas in Moscow, and comments on the national Quality Programme by French QA experts. 

The prototype of QualAId currently in existence is one small part of the total framework needed for a useful expert system. The objective of QualAId is to provide advice on how much and what type of QA/QC is needed for various types of environmental analyses. The rules for determining these needs have been derived from the American Chemical Society (ACS) publication, "Principles of Environmental Analysis, (2) and from various protocols and recommendations of the U.S. Environmental Protection Agency (EPA). 

The purpose of this expert system is to provide consistently good advice in both the types and amounts of QA/QC to use. There are many decisions to make and errors are very expensive in terms of time and money. 

The Validation Plan should also clearly indicate the split of responsibilities between user and supplier. It should be noted that the supplier is normally involved in all levels of testing. The Validation Plan should state that an independent expert (often QA), who will confirm that the testing is being carried out in accordance with the documented test strategy, may witness testing. This is important where the software is developed externally, or where the development is taking place centrally on behalf of several sites. 

Induction training in QA may comprise the general audit procedures employed at the company, key audit SOPs and documentation requirements in QA. A thorough review of the regulatory framework for GCP is recommended, as QA auditors are expected to be experts for clinical trial regulations and all GCP aspects. It would impair the QA auditors credibility if they knew less than the auditees of the requirements that must be adhered to in drug development. 

Effective from 1997, such registration is mandatory for systems used in blood processing other software groups, including LIMS, are likely to be included in the mandatory classification over the next three to five years. W validation performed by a vendor is suspected because of a lack of a QA norm in the industry a validation signed by a credible outside expert has much more weight. 

Constraint-based Representation Scheme. The primary feature of the chemists ability to specify QC criteria based on the QA/QC Objective and other inputs is that the QC criteria are specified as a set of general constraints and limits which the data must adhere to. For example, for a PCB site with a QA/QC Objective level of QA2, the experts could specify constraints for the data such as "the matrix spike duplicate recoveries should be between 801 to 120Z", and that "the PCB detection level must be at least 1.5 ppm." Therefore, a constraint-based representation presents a natural mechanism to emulate the thought process of the chemists in developing QC criteria. 

Processing Characteristics of IQAP. To follow the experts methodology, it appears that the processing within IQAP will be performed in two steps. In the first step, the inputs should be accepted and a constraint-based system will develop a set of constraints and limits that apply to the data. The knowledge embedded in this first system will convert the constraints into an analytical method and the associated set of QC criteria. It is expected that because QA/QC Objectives incorporate considerations regarding the usability of the data, the constraints will be flexible enough to process the inputs into a reasonably structured set of data tables. Therefore, in the second step, the method and its associated QC criteria will be represented in a relational database. The level of detail in the specifications of the QC criteria and the relationships between the data elements will be more specific as the process proceeds from the first step to the second step. 

Participation in PT schemes for analysis is generally requested by the competent authorities when contracting a laboratory and, in most cases, is part of the requirements for accreditation (and authorisation ) of a laboratory. This is in fact nowadays recognised as a very powerful tool for QA/QC and the inclusion of obligatory participation in inter-laboratory studies in the legal documents is regarded by experts in QA/QC and managers as an important requirement. 

Report of the Joint FAO/IAEA Expert Consultation on Practical Procedures to Validate Method Performance of Analysis of Pesticide and Veterinary Drug Residues, and Trace Organic Contaminants in Food, 2000 (available at http //www.iaea.org/trc/pest-qa val2.htm accessed 2/16/10). 

Especially in the nuclear industry and other potentially high consequence endeavors, there are formal sets of rules for the QA and safety audit process. ANSI/ASME NQA-1 (ASME 2001) nuclear quality audits use certified and trained auditors and lead auditors who are also expert in the areas being audited. 

Control points (CPs) are the points in the process where loss of control is not likely to result in unacceptable health or safety risk, but correction is required. The difference between CCPs and CPs requires careful review by quality assurance (QA) and food safety experts experienced in working in HACCP programs (MFSC/NFPA, 1992). 

As the project progresses there will be times when special expertise (systems engineering experts, etc.) is necessary. Additionally, the project resources required typically increase during the verification and validation processes. Management oversight, QA and quahty control will be needed throughout the project. 

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