Quality audits procedure

The characteristics of the downstream pollution discharge must be monitored (see Fig. 13.18). It is essential that the operation and maintenance of the pollution control equipment be included in a quality audit procedure, assisting in determining the operation efficiency of the equipment and the formation of unwanted and possibly toxic compounds in the pollution control steps. Unsuitable operation of an incinerator may result in partial oxidation and formation of unwanted combustion products or excessive formation of MO. 

The audit plan should be consistent with written quality auditing procedures included in the quality manual or other quality system documentation. The plan should include or refer to the objective criteria to be used to evaluate conformance to requirements. The plan should include or refer to other documents that will be used during the audit, including previous audit reports. If the audit is to include the review of batch or production records, such review should be conducted in accordance with a specified sampling plan or other appropriate statistical rationale as specified in a firm s quality system procedures. 

Your firm failed to conduct quality audits at the intervals listed in your Quality Audit Procedure xxxxxxxx, to verify that the quality system is effective. ... 

That set of modules includes alongside the traditional procedures related to product control, quality assurance procedures for conformity assessment. The intervention of a third party in these procedures comprises an initial audit of the manufacturer s quality system which must include both the specific technological aspects of the products concerned and the methodology of the quality assurance procedures. Furthermore the manufacturers are subject to periodic audits to ensure that the systems are maintained. Finally, on the occasion of unexpected visits, the notified body can carry out tests on the products. 

Quality Audit. Another important responsibiUty of quahty assurance is the audit function. Using the quahty audit as a tool, QA can monitor the operation of the manufacturing faciUty a toU, ie, contract, manufacturer or raw material suppHer to assure that written procedures are in place and that there is documentation to indicate the procedures are being followed. Properly executed audits allow QA to spot potential weakness in the quahty system that could allow errors to occur. Once identified, these weaknesses can then be corrected before they result in nonconformance. 

Are internal quality audits planned and implemented in accordance with documented procedures ... 

Within your procedures you need to provide a means of identifying which items have been subject to inspection at the subcontractor s premises and the receipt inspection action to be taken depending on the level of that inspection. In one case, the product may have been accepted by your representative on the subcontractor s premises. In another case, a product from the same batch may have been accepted by your representative but not the one that has been delivered. Alternatively your representative may have only performed a quality audit to gain a level of confidence. You need to specify the inspection to be carried out in all such cases. The standard emphasizes that consideration should also be given to the recorded evidence provided. Even if someone has performed inspection at the subcontractor s premises, if there is no evidence of conformance the inspections are of little value. The fact that an inspection was carried out is insufficient. There has to be a statement of what was checked and what results were obtained and a decision as to whether conformance has been achieved. Without such evidence you may need to repeat some of the inspections carried out on the subcontractor s premises. 

The standard requires the supplier to establish and maintain documented procedures for planning and implementing internal quality audits. 

Although the main thrust of the HSE work is directed to providing inputs to the CPQRA process, the audit procedure generates valuable qualitative information regarding both the quality of the overall plant management and also the specific human factors dimensions which affect risk. 

There is a procedure for Self-Inspection and/or quality audit, which regularly appraises the effectiveness and applicability of the Quality Assurance system. 

There must be systems in place to monitor the study while it is in progress and to check that all systems are working in accordance with GLP requirements, to record any problems identified and to ensure that remedial action is taken. The person responsible for these quality assurance procedures must be independent of the study being audited. In large organizations, there may be a separate Quality Assurance unit but this will not be practical in smaller organizations. 

A system for auditing and reviewing quality procedures is a specific requirement of ISO/IEC 17025, ISO 9001 and GLP. This is a critically important aspect of any quality management system so we will consider these activities in some detail. The first, and most important, thing to realize about Quality Audit and Management Review is that they are two completely different activities. This section deals with auditing while Section 9.5 deals with management review. 

It may seem unnecessary to have audits especially when there seem to be so many different types of audit. However, in spite of all of the documented procedures there are problems that can arise in analytical laboratories due to changes in staff, procedures, equipment, sample type and number of samples. For a laboratory to provide a consistent standard of quality in the face of all of these regular operational changes, Quality Audits need to be carried out. Audits will identify the problems which are expected to emerge, and provide a system to put them right. 

Current quality system models call for audits to be conducted at planned intervals to evaluate effective implementation and maintenance of the quality system and to determine if processes and products meet established parameters and specifications. International standards provide guidance on auditing [13]. Audit procedures should be developed and documented to ensure that the planned audit schedule takes into account the relative risks of the various quality system activities. Factors that can be incorporated into a risk-based approach to planning audit frequency and scope include the following [6] ... 

Any serious software developer will follow a formal software development methodology that includes the documentation necessary to support the software at each development step. A quality audit of the software developer will determine the adequacy of testing performed and whether the tests plan, procedures, and results are properly documented. The quality audit must include an inspection of the unit testing process. 

Standard procedures for conducting the quality audit should also be addressed in the Vendor qualification program. An audit cycle includes the preparation of an audit, performance of the audit, reporting of the results of the audit, and audit closure or follow-up requirements. Figure 2 illustrates the audit process. 

A quality audit has been defined as A systematic, independent examination of a manufacturer s quality system that is performed at defined intervals and sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives 21 CFR 820.2 (t). Another definition is Quality Audit A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives (International Organization for Standardization/American Society for Quality Control). 

Quality control procedures (5-7) in the field included semiannual audit visits. These procedures were employed to maximize capture of uncontaminated samples, to identify and document them, to preserve their integrity until their arrival at the laboratory, to obtain dynamic blanks and to determine each site s precision and accuracy of pH and conductivity measurement. (The field measurements were used as a quality control to determine if precipitation samples had degraded between the field and laboratory measurements.)... 

Systems of quality control and assurance, including self-auditing procedures. 

Quality assurance and quality control (QA/QC) A system of procedures, checks, and audits to judge and control the quality of measurements and reduce the uncertainty of data. Some quality control procedures include having more than one person review the findings and analyzing a sample at different times or using different laboratories to see if the findings are similar Quantitative risk assessment (QRA) A process that relies on mathematical modeling and estimations usually derived from animal test results and the probability of risk for a chemical substance at the low dose to which the human population is normally exposed Radionuclide A nuclide with radioactive properties... 

There are several reasons why a quality system must be fully documented. Firstly it is a pre-requisite of most quality standards. Secondly, in most laboratories it would be impossible to accurately remember and hence communicate all of the analytical methodology and quality management procedure to staff. This would lead to the quality system becoming compromised due to slalT turnover. Thirdly the process of audit (see Section 5.1) requires a precise definition of the planned quality system. This is provided by the documentation. 

The proval is product specific - to best value for the price. The assurance of product quality and safety are of key importance. The more sensitive materials are, the more in details the whole auditing procedure has to go. For instance, producers of raw materials for baby food have to ensure traceability up to the farm and to the field where a raw material is produced. They also have to prove their capacity to instruct farmers to produce raw materials allowing European Nestis companies to comply with the newly implemented limits for pesticides in baby food, i.e. residues below 10 ppb. 

Failure to adequately establish procedures for quality audits, to conduct such audits, and to determine the effectiveness of the quality system... 

Individual procedures can easily consume 10 to 15 days effort to produce, even with experienced staff. Use should be made of industry guidance when developing procedures, e.g., GAMP example procedures and IEEE standards. Where existing procedures are being revised to secure validation compliance, this estimate of effort could be reduced by about half. As recommended above, this should be supplemented with about 20 days effort across all the procedures, shared among a team of end users. The individuals should contain the core users who are involved in all the procedures in order to ensure consistency. Other end users on the team, however, can be seconded for the development of particular procedures in which they have a specific interest, or can contribute a particular skill or competence. For instance, an end user quality representative may wish to be seconded for the development of the Supplier Audit procedure. 

Establish Quality System procedures Conduct quality audits ... 

Source Code Reviews are used to ensure that controlled development and a consistent programming style have been used. It also checks GMP critical features. Source Code Reviews need a standard against which to check, and programming practices for all programs should be documented. An audit of the supplier s compliance with its own quality management procedures should have been carried out to ensure that appropriate quality is being built into the system. 

At the same time, internal quality control must be carried out to verify the performance stability of the limited-scope performance of the method. Triply redundant verification methods are carried out with regard to control of first, second and/or third line, each set of methods applied to a particular type of test. The first line of verification involves pro forma repetition of all the steps of the test, in order to establish repeatability or reproducibility for quantitative tests, and to verify the range of sensitivity or detection for qualitative tests. This verification is performed by the experimenter himself, as part of the proper performance of the test. A second line of verification is put into operation by administrative decision, and includes testing with blind samples, repetition of samples, internal audit procedures, etc. If necessary, a third line of verification can be set up by the use of certified reference materials (or spiking materials), or through collaborative trials. These procedures are based on external cooperation. External audit procedures and complaints handling procedures are also part of this third line of verification. 

Such test guidelines often form a key part of a laboratory s formal quality assurance procedure (e.g. Good Laboratory Practice or other formal accreditation schemes) and enable test results to be audited. However, to be fully effective these quality assurance procedures need to take account of the performance characteristics of the test (quality control). Such considerations form the basis of the following section. 

Medicinal products must be fit for their intended use, comply with the requirements of Market Authorization and not place patients at risk because of inadequate safety, quality or efficacy. These objectives are easy to state, but to achieve them requires a comprehensively designed and correctly implemented system of quality assurance. It is important that this is documented and its effectiveness monitored. Records must be kept that are open to inspection by validating bodies, and there must also be procedures for selfinspection and quality audit that allow appraisal of the quality assurance system. Management must be adequately trained and their responsibilities minutely defined. Two key posts are the Heads of Production and of Quality Control. These posts are required by the guidelines to be independent of one another. 

Alternatively, if the decision is made to buy only commercially available software, or only commercially developed add-ons or automation scripts, then the pharmacometrician needs to participate in the key processes used to evaluate the vendor. The occurrence of key quality failures in widely used software has been previously documented (14). Therefore, the pharmacometrician should be intimately involved in the vendor audit process. If the vendor is not performing the quality assurance procedures just outlined for internal development, the cost (both in quality and accuracy of future work) will be in jeopardy. As discussed later in the section on validation documentation, the ability to state what the vendor s quality processes are will mitigate the need to perform functional software testing at the same level that has already been executed by the vendor s quality assurance group. 

Flanges Fraudulent, inadequate flanges from other countries escaped detection and were used on domestically produced equipment and piping systems Excessive search and removal from installed equipment and piping systems where catastrophic failure might have resulted Ensure all suppliers pass audit and have adequate quality control procedures for their supply chains... 

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