Management should ensure that there is a documented training programme encompassing all aspects of QA work including the development of auditing and inspection skills and communication techniques .sx The training programme should , where possible , include on-the-job experience under the supervision of competent and trained staff .sx Attendance at in-house and external seminars and courses may also be relevant .sx Development should be continuous and subject to periodic review .sx The training of QA personnel must be documented and their competence appropriately endorsed .sx Records should be kept up to date and be subsequently archived .sx To enable QA personnel to function effectively , Management should provide appropriate office facilities with sufficient secure storage for data and documentation .sx In addition , where the Testing Facility uses computerised methods for data collection and storage , QA personnel should have ready , independent , and at least read-only access to computer databases .sx 4 .sx IMPLEMENTATION OF THE QA PROGRAMME .sx ( i ) The Master Schedule .sx GLP Principles require the Testing Facility to maintain a listing of all studies planned , in progress or completed .sx This 'Master Schedule' should normally provide the following information on each study :sx Unique study identification .sx Test substance , test system , and nature of the study .sx Name of the Study Director .sx Start and completion dates .sx The inclusion of further information such as the date of issue of the final report and the date of archiving can be useful .sx The Master Schedule can be used by QA personnel ( and by Compliance Monitoring Inspectors ) to assess the volume of work being performed by the Testing Facility and by individuals within it and enables them to maintain awareness of studies planned and in progress .sx Management must therefore ensure that QA staff have ready access to the Master Schedule .sx Responsibility for maintaining a Master Schedule rests with Testing Facility Management ; however , this task may be advantageously performed by QA staff .sx GLP Compliance Monitoring Inspectors will wish to identify studies for which GLP Compliance is claimed .sx The Master Schedule should clearly identify these studies .sx Management are reminded that GLP studies must be identified as such before they are initiated .sx This does not prevent Management from subsequently down-grading or terminating a GLP study providing its change of status is noted in the Master Schedule and any data that have been generated are retained in accordance with GLP Principles .sx ( ii ) Study Protocol ( Plan ) .sx Management must ensure that the study protocol ( sometimes referred to as the Study Plan ) is available to QA before a study starts .sx This will permit QA personnel :sx - to assure compliance of the protocol with GLP Principles ; .sx - to assure the completeness , clarity and consistency of the protocol ; .sx - to identify the critical phases of the study and to plan its QA monitoring programme in relation to the study ; .sx - to enter the study in the Master Schedule if their responsibilities include this function .sx To facilitate effective study monitoring , protocol amendments must be forwarded promptly to QA .sx ( iii ) Standard Operating Procedures ( SOPs ) .sx Where QA has , in addition to QA SOPs , involvement with the production of Testing Facility SOPs or with maintenance of the Master Schedule this must be detailed in relevant SOPs .sx It is desirable that QA personnel review Testing Facility SOPs before issue in order to assess their clarity and GLP compliance as the quality of the documentation has a bearing on the effectiveness of the QA function .sx Management may charge QA with the responsibility for assuring that SOPs are periodically reviewed by the relevant personnel ; for assuring that the production and issue of SOPs is controlled to discourage the taking of unauthorised copies ; and for ensuring that all copies of superseded SOP editions are removed from the working areas and a copy of each retained in the archives .sx QA should be required to keep readily available copies of all SOPs relevant to the procedures that it monitors .sx ( iv ) Planning and Recording of Inspections and Audits .sx QA is responsible for the regular monitoring of the test facility's operations and procedures and the periodic monitoring of studies .sx In order to function effectively , QA personnel must document the schedule of intended audits and inspections for all studies and processes under surveillance and , subsequently , keep records of all their activities .sx It is a Management responsibility to ensure by reference to such records that QA personnel are properly meeting their commitments .sx Such records include a list of the phases that are to be inspected for each study type or process covered .sx The intended frequency of the inspections should also be defined , but this should not preclude additional inspections if unanticipated problems arise .sx ( v ) Objectives of an Inspection .sx Management should specify for QA personnel the principal objectives of their monitoring activities .sx These will include , but may not be limited to , assurance that :sx - the protocol and approved amendments are available to relevant study personnel and that its requirements are being followed ; .sx - the relevant SOPs are readily available in the operational areas ; that staff concerned are familiar with their content ; and that the procedures are being performed in accordance with the SOP , or that deviations have been documented , explained and authorised by the Study Director or relevant line manager ; .sx - all data being generated are recorded in accordance with GLP requirements ; .sx - the facilities are adequate for the proper conduct of the procedure and the equipment properly maintained and calibrated ; .sx - all test systems and specimens , test substances , reagents and solutions are properly identified and housed or stored to maintain their integrity ; .sx - documentation exists showing that all personnel involved in the study have sufficient training and experience to perform their duties .sx QA should pay particular attention to the flow of information and the chain of custody of samples across the interfaces of contributing disciplines and work groups .sx To assist them in conducting inspections and audits , QA personnel can prepare checklists to remind them of the specific aspects which may need to be examined in each case .sx However , checklists should not be used in such a way as to exclude initiative and flexibility of approach .sx Management should ensure QA personnel are informed of developments or proposed expansions within the organisation it is monitoring , and of changes in procedures or techniques within departments .sx ( vi ) Study-based , Process-based and Facility Inspections .sx QA personnel should be required by Management to conduct inspections which may be study , process or facility based , as appropriate .sx - Study-based inspections are those related to specific events occurring during a study ; they usually include monitoring of 'critical phases' of the study .sx - Process-based inspections are those unrelated to specific studies , and which are carried out periodically .sx They may be applied to aspects of studies that are conducted as repetitive ( routine ) processes , or where a given type of operation or study is undertaken in large numbers by the facility and each study is of such short duration that monitoring of each individually is impracticable .sx In such cases , monitoring on a random sample basis may be appropriate although the basis for such sample monitoring should be defined .sx - Facility inspections are those conducted to cover the general facilities and support services , including installations , computer systems , staff training , environmental monitoring and maintenance .sx In some testing facilities , Management require the Archive to be administered by QA .sx Where this is so , inspection procedures must be laid down which ensure that conflicts of interest are avoided .sx It is essential to avoid situations whereby QA personnel report the outcome of Archive inspections only to their own line management or monitor their own activities .sx ( vii ) Audits of Data and Financial Reports .sx GLP Principles require that Management ensures that raw data are reviewed by QA personnel .sx This can be accomplished in a number of ways .sx For example , the records may be examined by QA personnel during process based inspections ; during audits of final reports ; or may be reviewed by them at specially conducted data audits during the live phases of the study .sx Management must ensure that all Final Reports for which GLP Compliance is claimed are audited by QA and the findings reported , as appropriate , to Management and the Study Director .sx This audit should be conducted at the final draft stage , when all of the raw data have been gathered together and no major changes are intended .sx The aims of the final report audit should be to determine whether or not :sx - the study was carried out in accordance with the protocol ; .sx - the study has been accurately and completely reported ; .sx - the report contains all the elements required by GLP ; .sx - the report is internally consistent ; .sx - the raw data are complete and compliant with GLP Principles .sx QA may find it useful in any subsequent discussions which they may have with Management or the Study Director if their final report audit has been recorded in sufficient detail to enable the audit to be reconstructed .sx Procedures must be established to ensure that QA personnel are made aware of all additions or changes to the study data and study report made during the audit phase .sx Before signing the Quality Assurance Statement , QA should be required to check the Final Report to ensure that all issues raised in the QA audit have been appropriately addressed , that all agreed actions have been completed and that no changes to the report have been made which would require a further audit .sx Any correction or addition to a fully authorised and signed Final Report must be audited by QA .sx A revised or additional Quality Assurance Statement must then be provided .sx ( viii ) QA Involvement with Computer Systems .sx GLP Principles require that procedures exist to ensure that computer systems that are used in regulatory studies are suitably designed , controlled , operated and maintained in order to properly accommodate their intended function .sx Management may consider it desirable to involve QA in an advisory capacity during the development of the system to ensure that it complies with GLP Principles .sx However , QA personnel need not validate computer systems themselves although they should assure themselves that the system has been validated and formally accepted .sx Management should be aware that computer systems installed before the facility became GLP compliant must be evaluated to demonstrate acceptability for continued use under a GLP regime .sx Once a system has been accepted , QA personnel should be required to monitor continued effectiveness , including the performance of staff , and to confirm that adequate documents , records and procedures exist .sx This will involve any or all of the following :sx - Confirmation that adequate SOPs exist and that they are being followed .sx - Inspection of the system during operation to check accuracy of data capture and effectiveness of back-up procedures .sx - Inspection of change control procedures for compliance with SOPs and to confirm that documentation is adequate .sx - Inspection of the computer facility to audit maintenance and security procedures together with archive procedures and maintenance of copies against accidental loss of data .sx - Confirmation that users and operators have received appropriate training and that documentation to that effect exists .sx - Periodical verification of the integrity of the data retrieval system .sx ( ix ) QA Monitoring of Specialist Disciplines .sx There are no aspects of a GLP regulated study that are exempt from the remit of QA .sx Management must therefore ensure that QA monitoring extends to all areas including those that are by convention regarded as professional specialisms .sx That QA personnel do not have professional experience in all fields is not relevant as it is not part of the role of QA to evaluate or confirm professional judgements .sx Rather , the function of QA is to assure that the judgements are made in respect of the correct specimens , measurements , or observations , that they are properly recorded and accurately reflected in the Final Report .sx Management must require QA to report to them inconsistencies in subjective assessments .sx Management should consider whether a documented peer-review mechanism in addition to QA is appropriate or expressly required by a Regulatory Authority for particular specialisms ; QA should have an involvement in such review mechanisms and their role should be documented .sx 5 .sx REPORTING OF AUDIT AND INSPECTION FINDINGS .sx Management should require that the conclusions of QA inspections and audits are reported promptly to them in writing .sx The procedures adopted must permit timely and effective corrective action on any adverse findings .sx Management should ensure that for study-based inspections and final report audits , the QA reports are also sent to the Study Director .sx