Hi, For those of you in healthcare can you help me please? When you launch a clinical deliverable how do you manage variances? Do you link to your quality/safety committees? That's what I'm doing today, but wanted to learn from my colleagues. Thank you! Saving Changes...
This really depends on the nature of the variance as well as the transition process for the deliverables and who assumed ownership of those. I'd assume critical groups like quality or safety would have been key stakeholders signing off on the launch of the deliverables.
I'd assume that the project team would continue to have responsibility through a reasonable "warranty period" and part of the launch would be a defined procedure for handling such variances.
And if the variance is one which affects patient safety or is tied to the quality objectives established for the deliverable then yes, the health care organization's quality or safety bodies would normally get involved.
That's what I did for a health benefits delivery project. You do have to be careful.
First, get them involved soon so they can add or change quality processes to line up with your expected outcomes/benefits. (In our case, they needed to add a new quality control process in order to get the data for the outcome metric.)
Second, be prepared, on large projects, for outcomes/benefits to be become no longer relevant. It's amazing how far a three-year project can take you from the original intended outcomes! Saving Changes...
Vijay SuryavanshiProject Manager - Engineering| RECARO Aircraft SeatingPlantation, Fl, United States
Agree with Kiron's comments. What is the deliverable ? What are u measuring ? (This is because, it would not make sense to report project variances like cost and schedule variance to be shared with quality/safety committees.) Knowing your requirements both internal and regulatory is very important. For each deliverable, comparing it to regulatory and internal standards helps. (Usually, internal standard is more stringent than regulatory). And if there is any deviation in deliverable that pertains to quality ,safety etc. (outside of cost and schedule) it is important that it must be reported.
Again, I am speaking from the point of view of aviation industry, which is highly regulated. We compare the product to requirements (internal) and regulatory. Any deviation from regulatory requirements must not only be noted, documented (excel sheet works well) but also reported and escalated to the right authorities. like FAA or EASA in our case..
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2 replies by Jill Kordick and Latha Thamma reddi
Dec 20, 2022 4:29 PM
Jill Kordick
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Thank you Vijay!
Jun 07, 2023 2:54 PM
Latha Thamma reddi
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Thanks, Vijay & Kiron, for four valuable comments.
Agree with Kiron's comments. What is the deliverable ? What are u measuring ? (This is because, it would not make sense to report project variances like cost and schedule variance to be shared with quality/safety committees.) Knowing your requirements both internal and regulatory is very important. For each deliverable, comparing it to regulatory and internal standards helps. (Usually, internal standard is more stringent than regulatory). And if there is any deviation in deliverable that pertains to quality ,safety etc. (outside of cost and schedule) it is important that it must be reported.
Again, I am speaking from the point of view of aviation industry, which is highly regulated. We compare the product to requirements (internal) and regulatory. Any deviation from regulatory requirements must not only be noted, documented (excel sheet works well) but also reported and escalated to the right authorities. like FAA or EASA in our case..
Thank you Vijay! Saving Changes...
Latha Thamma reddiSr Product and Portfolio Management (Automation Innovation)| DXC TechnologyMckinney, Tx, United States
Dec 19, 2022 4:31 PM
Replying to Vijay Suryavanshi
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Agree with Kiron's comments. What is the deliverable ? What are u measuring ? (This is because, it would not make sense to report project variances like cost and schedule variance to be shared with quality/safety committees.) Knowing your requirements both internal and regulatory is very important. For each deliverable, comparing it to regulatory and internal standards helps. (Usually, internal standard is more stringent than regulatory). And if there is any deviation in deliverable that pertains to quality ,safety etc. (outside of cost and schedule) it is important that it must be reported.
Again, I am speaking from the point of view of aviation industry, which is highly regulated. We compare the product to requirements (internal) and regulatory. Any deviation from regulatory requirements must not only be noted, documented (excel sheet works well) but also reported and escalated to the right authorities. like FAA or EASA in our case..
Thanks, Vijay & Kiron, for four valuable comments. Saving Changes...
