Project Quality Plan

Project Quality Plan Software Quality Assurance Program Functional Design Specification Hardware Design Specification Software Design Specification Software Module Design Specification Software Review Software Module Test Records Hardware Test Records Integration Test Records Instrument Spccs/Data Sheets Instrument Calibration Records Material Certificates... 

Pharmaceutical and healthcare companies may consider conducting predelivery checks on their suppliers to verify that Supplier Project/Quality Plans have been implemented. Computer systems should not be accepted at their user sites if outstanding and agreed issues from the Supplier Audit have not been resolved to the satisfaction of the pharmaceutical or healthcare company. 

Operator instruction Maintenance procedures User manuals Training materials Validation documents/package Supplier project quality plan... 

Appendix 8A Example Contents for Supplier Project/Quality Plans.206... 

EXAMPLE CONTENTS FOR SUPPLIER PROJECT/QUALITY PLANS... 

Automated testing tools can be used to great effect during System Testing and are discussed in detail in Chapter 5. The use of any automatic testing tools must be agreed upon with the pharmaceuhcal or healthcare company, preferably in the Suppher Project/Quality Plan. 

Any deviations and interventions to the pharmaceutical or healthcare company s Validation Plan or Supplier s Project/Quality Plan must be recorded, their impact on validation assessed, and their true cause investigated. Deviations and interventions may include changes to SOPs during validation, concessions on the acceptability of unexpected test results, or modifications to the life-cycle model to make it more appropriate. 

The project plan should be reviewed to ensure that all tasks have been defined, and that the estimates are realistic and will not compromise the delivery and quality of the information system. Ongoing monitoring of the project plan is essential as project slippage and the associated commercial implications generally lead to shortcuts in key quality controls such as application of procedures, detailed design, reviews, and testing. The earlier that project slippage can be detected, the earlier corrective action can be taken to minimize the risk to project delivery and quality. Table 31.7 provides the typical content of the project quality plan. 

Project Quality Plan details what documents are to be provided, how the various documents are related and how change control and testing will take place. 

The careful selection of programming and software tools, the establishment of software conventions and standards and the enforcement of such standards should therefore be a part of every project and may be included in the Project Quality Plan. A review of these standards and the resulting software should also be part of the overall risk assessment and Hazard Analysis. 

Auditors must assure themselves that there is sufficient documentary evidence available to demonstrate that quality controls appropriate to the pharmaceutical industry are in place and are being routinely applied. The supplier should have produced Project Quality Plans for all projects, similar in objective to the VMP produced by the pharmaceutical organization. 

Project Quality Plan. Where a Project Quality Plan exists, it will often be used as a guide to the audit. Specific activities and documentation stated in the Project Quality Plan should be reviewed against their controlling procedures. The Project Quality Plan should also reference the project plan, usually presented as a Gantt chart that defines... 

The VMP forms a firm basis for the scope of LIMS validation. The VMP will work in tandem with the Project Quality Plan produced by the supplier of the LIMS. 

The LIMS supplier s response to the Validation Plan will be the Project Quality Plan. This document is the LIMS supplier s response to the pharmaceutical manufacturer s Validation Master Pian (Figure 9.3) and will provide the following details ... 

The LIMS supplier is responsible for all construction and installation activities as defined in the Project Quality Plan. The IQ Protocol will provide coverage of the LIMS hardware and software and all analytical equipment interface hardware and software integrated into the LIMS. The environment into which the LIMS and analytical equipment interface is installed may need to be controlled in terms of temperature/humidity, electrical interference and so on. In addition, the provision of services will need to be assessed, for example, electrical supplies and earthing. The IQ Protocol will typically cover the items listed in Table 9.3. 

Completion of the Validation Plan will usually accompany the preparation of a detailed Project Quality Plan. The quality representatives on the... 

WEC, UKP-GW-GL-045, Rev. 0, Project Quality Plan forthe U.K Generic Design Assessment, 2008. 

The project quality plan and its documentation (case by case)... 

In other words, the result of a project quality plan is adequate project quality documentation. This includes procedures and instructions developed mainly for the given project. It is apparent that in the following subsections, only reference to the project quality plan and its documentation will be made, since the company quality system is beyond the scope of this entry. At the same time, an effort will be made to adapt the general mles in effect mainly for new structures to seismic retrofitting and strengthening of existing buildings and public works. 

For a successful structural intervention, coordinated measures are needed in order to ensure quality of design and construction. The detailed assessment is included in the design procedure. In this respect two separate quality plans must be elaborated, the first for the design and the second for the construction. The first is elaborated by the company that is responsible for the design, the second by the contractor. Both project quality plans must be approved by the project manager and then are added to each company s quality system (see Fig. 6) and to the contract with the owner of the building (Fig. 9). 

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