Quality Assurance audit planning

Safety Management and Regulation Group. It will cover topics such as worker training, job planning, quality assurance, audit, inspection, operation readiness review, and regulations. 

The test plans, procedures, expected results and reports on the tests should be maintained and should be available for quality assurance audits and third party assessments. The test procedures should present the rationale for each test case and provide for tracing of the test cases to the relevant source documents. The expected test results should be stated (with their method of derivation) in the test documentation prior to execution of the tests. 

In judging the adequacy of provisions you will need to apply the relevant standards, legislation, codes of practice, and other agreed measures for the type of operation, application, and business. These activities are quality assurance activities and may be subdivided into design assurance, procurement assurance, manufacturing assurance, etc. Auditing, planning, analysis, inspection, and test are some of the techniques that may be used. 

In the author s experience, field residue trials can be conducted in Latin America under complete compliance with all ERA guidelines and recommendations. More time does need to be spent in planning and preparation to ensure that the personnel involved in the testing have been trained in GLP and that this training, as well as the compliance of equipment, storage and archival sites, standard operating procedures (SOPs), and quality assurance (QA) audits, are properly documented. 

The inspection is performed according to the quality assurance programme and is based on the audit plan. There can be three types of audit ... 

Preparation In preparing for an audit, all data and documentation for the study are assembled for the inspectors to view (Figure 8.3). The study director, or other designated technical contact, should review the files and prepare to answer any questions. The master schedule and all files assembled by the quality assurance unit should be reviewed. An agenda, a work space, and a test facility floor plan should be prepared for the inspectors. The staff should be fully briefed and prepared for the visit. 

Manufacturers implementing a quality system that conforms to an existing standard may find it helpful to create a table or some other document that shows the relationship between cGMP requirements, requirements of the standard, and the element(s) of the manufacturer s quality system. Such a tool can help assure that all pertinent requirements are covered in the quality system design and that audit plans designs include assessment of all pertinent requirements. 

The principles of GLP require an independent quality assurance (QA) program to ensure that the study is being conducted in compliance with GLP. The QA personnel cannot overlap with those of the study because of the potential conflict of interest, but they may be part-time staff if the size of the study does not warrant a full-time QA section. The responsibilities of the QA unit are to maintain copies of plans, standard operating procedures, and in particular the master schedule of the study, and to verily, in writing, that these conform to GLP. The QA unit is responsible for inspections and audits, which must be documented and the results made available to the study director and the principal investigator. The QA unit also signs off on the final report. Any problems discovered or corrective action that is recommended by the unit must be documented and followed up. 

In many instances operating system software has already been developed and is offered as a fundamental part of the computer system ready for application software to be developed or configured. In such cases it is prudent to establish the existence of the respective software quality assurance plans and procedures and the design, development, and testing records. Identification and examination of this documentation can be conducted and recorded as part of the supplier audit. (See Sec. VI.)... 

Supplier prequalification response Supplier audit report Project and quality plans Software quality assurance plan Commercial and purchasing specs. 

This approach to validation is the clearest example of validation being a QA tool. It appears that this approach will rarely be used for validation today, however, because it s very unlikely that any existing product hasn t been subjected to the PV process. The technique may only be justifiable if it is used for the audit of a validated process. With retrospective validation, the generated data already exist, but must be documented in a manner that clearly demonstrates that the existing process is under control. Quality assurance must first outline a plan for the validation effort, however, which would include the following items ... 

Audit Report. A report of an independent audit of the computer validation process by an internal auditor (i.e. Quality Assurance) should be included with the summary report to management. The audit should compare the SOP and the initial parts of the protocol (what the system should do) with the test plan results (what the system actually does) and the summary report conclusions. 

The Generic Medical Implementation Plan also specifies that the systems contractor s quality assurance unit must conduct regular audits of the systems contractor s occupational health program and that an annual audit of the program must be conducted by PMCD-designated health care professionals. Reports of all audits are forwarded to the clinic medical director and the medical administrator for prompt action. Nonconformance requires a written plan for corrective action. 

Failure to conduct planned and periodic internal audits of the quality assurance program in accordance with written procedures. For example, no internal audit conducted since 1995. Interestingly, this organization had the foresight to establish a quality assurance program that required periodic internal audits. Unfortunately, they not only violated their own internal policy, but violated FDA s requirement that FDA regulated companies as part of their quality assurance, periodically monitor their operations. 

A Source Code Review must be performed on application software unless there is evidence from the Supplier Audit that the source code has been, or will be, developed in a quality assured manner and subjected to review as part of its development life cycle. The decision and justification not to perform a review must be documented within the Validation Plan. 

As stated above, the validation plan is a crucial document. From experience, the best method to create the plan is to set up a small team, consisting of the user, system expert, and quality assurance representative. The plan will include the results of the risk and software category assessments as well as any additional requirements determined by the supplier audit. The plan will state what documents are required, when they will be produced (i.e., in what order), and by whom. The validation plan will state what must be done in order to confirm that a system will be validated. 

There are a number of issues to be addressed in a final report audit which in their entirety would then serve to determine whether the study had indeed been conducted in compliance with the Principles of GLP. Thus, the Quality Assurance inspector performing such an audit should try to determine whether the study was carried out in accordance with the study plan and the applicable SOPs, whether the study has been accurately and completely reported, and finally whether the raw data are complete and have been recorded and compiled in compliance with GLP. There are some points to be addressed which are more of an administrative nature, like the determination of whether the report contains all the elements required by GLP. One important aspect of the report audit will also be the question of whether the report is internally consistent, although this question may be seen to relate more to the scientific side than to the purely GLP aspects of the report on the other hand. 

The Quality Assurance statement has a two-fold function. It firstly serves to demonstrate that Quality Assurance has adequately monitored the conduct and progress of the study, from the first check of the study plan for GLP conformity to the audit of the final report as a second opinion on the completeness of the reporting and the adequacy of raw data coverage. It secondly provides the study with the seal of approval by attesting to the GLP compliant conduct. In this sense the Quality Assurance statement carries as much weight for the assessment of the study s integrity and validity as the Study Director s signature. 

Pre-shipment inspection can be performed along with vendor audits to address issues such as software development and quality assurance plans, operational reports, and specific vendor/purchaser inspection reports. 

The sixth step in the design of an air monitoring survey is the development of a quality assurance and quality control plan. This plan should include specific sampling procedures, calibration procedures and frequency, sample custody, analytical procedures, data reduction, internal quality control checks, performance and system audits, completeness, and corrective action. 

Quality Control is not confined to laboratory operations but must be integrated into the Quality Assurance activities. It is involved in all decisions which may concern the quality of the product (i.e., quality planning, co-ordination and control activities). It further includes the review of all plant systems and procedures, audits, organisation and documentation. 

Validation approach, quality assurance and auditing Specification, design and Source Code Reviews Planning documents... 

V.70. Documented procedures should ensure that internal audits are carried out on a regular basis to verify compliance with all aspects of the quality assurance programme and to confirm its continuing effectiveness. Similarly, when conducting external audits, to verify the quality arrangements of suppliers, they should be planned and carried out in accordance with written procedures. Audits should be conducted by qualified persons selected for their independence from the activity under audit. 

IV.74. For the purposes of Appendix IV, the following terms, as defined in Safety Series No. 113 [IV.3], apply applicant, assessment, audit, controlled document, corrective action, design input, design output, examination, inspection. Item, maintenance/servicing, measuring and test equipment, non-conformance, objective evidence, procedure, procurement document, qualification, quality, quality elements, quality assurance programme, quality plan, repair, services, specification, supplier, traceability, user, and verification. 

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