2020 Session 1: Enhanced Forms: Why Configurable Forms Are a Lifesaver

#21

Hi Carina,

If there are any forms that are a particular pain point for your company now, I would start there. If they’re all the same, I would suggest starting at the end of the quality event handling process and working your way backwards. For us, this meant starting with CAPA because for most things, that is the end of the line. Then we went to Issue Review, then Nonconformance, then Deviation, then OOS, then Complaint, and Event Report last. That way, as you add on new forms, you’ve already configured the forms that they could launch into. This attached picture I got from a session at Summit and shows how things all work together. Start at the end (MOC or CAPA) and work your way backwards! Do note that Customer Complaint, OOS/OOT , and Deviation can all flow into Nonconformance.

QEM%20Flowchart
QEM Flowchart.jpg1007×420 59.7 KB

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#22

Hello, Yes, the new version of MOC does have Extension Request capabilities IF you use the Step Due Date option. As I mentioned in the session, unfortunately, we can’t accommodate Extension Request with overall due dates. So you can switch to Step Due Dates for MOC to take advantage of Extension Request.

#23

Hi @christopher.gumpper. We currently are routing our Deviations, Issue Review and CAPAs based on site. It seems that with the new release, we can select site and a department for the site? Is this correct?

#24

Kathleen,
Going with the biggest pain paint for us would be non-conformances. I see there might be value in determining what form would be used most and seeing if that is the best place to start. Thank you for your input.

#25

Our Solution Consultant team would be happy to help with that–just reach out to your account rep!

#26

Yes, that is correct. For Deviations, Issue Reviews, and CAPAs, you can continue to route by Site, or opt to change your configuration to a Site and Department combination.

#27

Hi @Inactive-Member-52980426. For this configuration change, do we need MasterControl support? If yes, do we reach out to Account Rep for a demo.

#28

Hi Jamil - answering your question about trying out Action Item and Extension Request. The new Extension Request can only be launched from one of the updated Enhanced Forms. Action Item, however, can be implemented and used separately. Please talk to your customer account rep about options for trying it out, including purchasing it to be installed on your dev site.

#29

Matthew,

As always, you give me the perfect tools. This image will be very helpful in understanding how it flows!

Thank you.

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#30

Hi Jamil, Yes, you will need MasterControl services support to update to the new Enhanced forms. And yes, reach out to your account rep for a demo.

#31

We’re starting with Complaints as well (currently in-process). We chose this because it is, relatively speaking for our company, the least burdened quality system. So I would suggest choosing the system which can tolerate such a significant change and the learning curve that goes with it (both in use and the act of implementation). And that is our plan for implementing the other forms: least burdened to the most burden. The theory is that as we implement the least burdened first we will be better prepared to implement the most burdened quality system which, as we see, has the most risk when changed.

#32

Kimberly,

We have been working with out rep; however, I haven’t seen a breakdown list of the form options and what they generally cover. We have had a Demo but that isn’t an option for presenting to upper management and wish there was a list breakdown form I can go over with them.

Carina

#33

Hi Carina, Who is your account rep? I’m happy to follow up with them on your behalf.

#34

Thank you @Inactive-Member-52980426 I have kind of dumb question…We currently have MOC, Issue, CAPA in place and are working on Complaints, OOS, Nonconformance. 1) Should we wait and update with Enhanced Forms? and 2) What have you seen customers using the Events form for if Issue and CAPA are in place?

#35

Thank you Christopher.

#36

Perfect thank you Kim! I was a little worried for a moment that we would have a ton of roles to change from “FBS_FORM_ROLE_KEYCODE” to start with “EF” instead of “FBS”…we do literally have hundreds of FBS roles, and I wouldn’t doubt if we’ll have over 1000 in the next year!

#37

Hi Edward, Not a dumb question at all! 1) My recommendation is to wait and update with the enhanced forms–there is some great new features of which I’m sure you’ll want to take advantage. I’d talk to my account rep and project manager–depending on where you are in the project and possibly other factors of which I’m not aware, they may have a strategy for you. 2) Event Report is a fantastic tool for triaging events when you don’t know what they are. This is a tool that customers typically open up to everyone in the company. Anyone can report an event, and quality can disposition it to another, more nuanced event type, or choose to open a broad investigation or escalate to an issue review.

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#38

Hi Matt - Definitely! the existing roles should just keep on trucking as set up without any worry.

#39

@Inactive-Member-52980426, could you please provide a short description of what the Meeting Notes form is? All the other Enhanced Forms are quite clear what process they are for, but meeting notes is not a process. I don’t need a full demo (yet :slight_smile: ) but is the idea that it’s launched independently when needed? Can it be launched from the other enhanced forms? Is it tied into the Communications Log tab? It’s something completely new and I’d like to know how to think about it. Thanks!

#40

Meeting Minutes can be launched from Management of Change or standalone. It allows you to select attendees to the meeting, set agenda topics and owners, and enter notes. You can also launch Action Items from the MInutes. It does not have a communication log, as these meetings are usually self-contained with follow-up actions. One of the primary uses of this, outside of MOC, is with our Product Development Excellence and Regulatory Excellence suites–allowing you to launch a meeting minutes form from a checklist and keeping those necessary notes as part of your file.