THE IMPACT OF VALIDATION

The master plan is finalized during detail engineering. The protocols prepared (IQ s, OQ s and PQ s) and the validation files started during construction. The IQ s (Installation Qualifications) are performable as construction is completing and can be completed by the constructor under supervision. The OQ s (Operational Qualifications) can be performed during the earlier parts of start-up as verification of mechanical completion. The PQ s (Process Qualifications) are performed as start-up completes and continue through the operating life of the plant. For maximum schedule 

REVIEW BEFORE PRELIMINARY MASTER PLAN BEFORE DETAIL PROTOCOLS WITH CONSTRUCTION IQ s FINISH CONSTRUCTION OQ s FINISH START-UP PQ s INTO FULL OPERATION 

WILL THE PROJECT BE PROFITABLE CORPORATE FUNDING LEVEL BRING IT IN ON THE ESTIMATE 

as with most projects, your project is not overly funded or highly profitable, then the approach may be to trend the cost throughout the preliminary and detailed engineering. The reason for trending is to provide up-to-date information for any cost impact decision as the project progresses. 

Whether the formal step approach, or the trending approach with snapshots is used, it is essential that a control estimate be created to be used during construction to control the cost of the constructed project. The result of shortchanging the estimating and cost control effort are a noncurrent cost reality and unhappy surprises as to final cost and schedule. 

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The impact of validation depends on the type of IPC technology and the duty the IPC is performing. A GxP Assessment can be conducted to identify the potential impact on product quality. 

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