Harmonic Bionics

Using Unifize to track Non-Conformances and Deviations

Clarissa Archer · Harmonic Bionics

In this story

Harmonic Bionics

Clarissa explores how Unifize simplifies tracking production deviations and non-conformances. She highlights its ability to generate quality notifications tied to parts, suppliers, and processes, enabling easy identification of recurring issues and streamlined corrective actions. With evident enthusiasm, Clarissa showcases Unifize's impact on improving quality tracking and reviews.

SpeakerClarissa Archer
IndustryMedical Devices
Processes in playNCs / Defects, CAPAs
Runtime3:16

Transcript

9 passages · 3:16
  1. 0:00

    And then okay, so now we have that part, out of specification, so you don't want to throw it away.

  2. 0:06

    You can't just throw it away all the time, you know, You know, we can't all be perfect.

  3. 0:10

    So you get that part and you're able within Unifize to create a deviation or a non conformance or even we created something called a quality notification where, you know, not everybody is an expert in quality system. And so you know, they might not be sure, like, is this a non conformance or is this within the acceptable specifications, especially again, if you don't have Unifize and you can't just pull up your print or material specification or any type of description to show, Oh yeah, it is within here and here.

  4. 0:45

    So you can create a quality notification to say, Hey, I'm not sure about this, but I think this is important. I just want to let you guys know or hey, this is within specification, but it's something that we should look out for, you know, for the future with this vendor. And you can connect non-conformists deviations, corrective and preventative actions (CAPAs).

  5. 1:06

    You can connect those all to each other and to the suppliers and to the lot and to the device itself or the parts itself. So you can see, oh, how many times has the supplier incorrectly machined or made this part? And you can easily go to the supplier process and see, okay, here all the entries or non conformances or deviations that we've had to have with this vendor for various parts.

  6. 1:33

    Or if you want to go by part, you can look at one part and you can.

  7. 1:37

    Okay. This part has had several non conformances or several deviations. Maybe that's something that we internally need to look at and see. You know, if something wrong with our specifications. So it's really huge for lot or not lot tracking for quality, tracking for management review to be able to you'll look at trending you know that's something that we're using it for as well because when you have hundreds or thousands or however many parts that are coming in constantly, you know, if there's a consistent non conformance, it's not necessarily something that you will see right away.

  8. 2:16

    But with Unifize you can and so you can describe the non conformance and then go into the MRB, which is material review board and that can all happen within a conversation and Unifize. So you can have management and other people, you know, come and look at all of the evidence of the non nonconforming specification within Unifize and say, you know, okay, this is acceptable because of this or it's not acceptable and we can rework it.

  9. 2:49

    And, you know, instead of having to go through another meeting or another round of discussions regarding rework processes, you can have that in Unifize where they say, Hey, we can rework it in X, Y or Z way, here's the documentation and it's all within that conversation so that you can move forward really quickly and efficiently

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