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Validation Master Plan


Please explain me:

Is Gantt chart strict requirement to VMP document?
If the Planned activities in the Gantt chart are not par with the real time executed activities, what will be the effect/affect?

No. A Gantt chart only tells when (expected). The VMP tells what and how.

If you are not meeting your schedule (Gantt), you are only ‘risking’ business goals. This may be an indication of poor management / insufficient quality system. If auditors see that you are consistently missing deadlines, they will likely probe deeper and end up issuing a non-conformance to one of the management objectives (e.g., management commitment, planning, etc.).

Thank you very much for the information.

Further clarification regarding this, what will be the impact of Gantt chart ( i.e.,not meeting its scheduled activities) on Quality system?

Again, it’s possible there is no impact on the quality system from not meeting schedule unless, maybe, you have meeting schedule as a quality objective.

What I’ve seen though, is that missing schedule is typically an indicator of a management problem. Either schedules are unrealistic or there are deeper issues that lead to missed deadlines (e.g., underqualified staff creating issues that lead to schedule delays). If this is an obvious systemic issue (consistently missing deadlines), an astute auditor is likely to dig deeper, looking for the cause and you might get an NC from the findings.

Then again, you might have an auditor that feels missing deadlines is not an indicator of any problems at all!

As you may have determined from my response, this is not a question that has a clear answer. Compliance aside, you should be feeding the information back into your management review and should take actions to ensure future schedules can be met. Otherwise, you may end up losing customers because you may become viewed as an unreliable provider!