Author: George Zack

Podcasts

Two Harbors Consulting Podcast Episode 5: Audits or Appraisals?

Audits? Appraisals? Is there a difference? George, Becky and Tom of Two Harbors Consulting discuss the differences, similarities and value add of appraisals and audits. Is one better than the other? Can you get a map between the medical device quality system regulation (QSR) and the CMMI? Why aren’t their maturity levels used in the Case for Quality appraisal program? https://twoharborsconsultingpodcast.buzzsprout.com/976369/3676666-2hc-ep-5-appraisals-and-audits Also – check out 2HC at the upcoming Greenlight Guru Virtual Quality Summit:  https://virtual-summit.greenlight.guru/?sc=QVIW4uUc&ac=qbB2QCbS Two Harbors Consulting is proud […]

Podcasts

2HC ep 4: You signed up for a CMMI appraisal! Now what?

Your organization has signed up to do a CMMI appraisal! Now what? Listen in as Two Harbors Consulting CMMI Lead Appraisers and business process improvement consultants Becky Fitzgerald and Tom Klein discuss with George Zack how to prepare (and even how not to prepare) for a CMMI appraisal. What things should you be actively doing and are there certain behaviors you should avoid? https://twoharborsconsultingpodcast.buzzsprout.com/976369/3592465-2hc-ep-4-you-signed-up-for-a-cmmi-appraisal-now-what

Podcasts

Episode 3 of the Two Harbors Consulting Podcast

In Episode 3 of the Two Harbors Consulting podcast: a conversation with Tom Klein and Becky Fitzgerald regarding what are attributes of effective measures. https://twoharborsconsultingpodcast.buzzsprout.com/976369/3401857-2hc-ep-3-attributes-of-an-effective-measure Take a look at the list of possible attributes, some of which were discussed in the podcast at:  https://twoharborsconsulting.com/2020/04/what-are-some-of-the-possible-attributes-of-an-effective-measure/ Are you enjoying this podcast?  If so, please share it with a colleague!  We’d love to have more people engage with us in these conversations.  And we always want your feedback […]

Improvement Tips

What are some of the possible attributes of an effective measure?

In episode 3 of the Two Harbors Consulting podcast, we discussed attributes of measurement. Measurements have attributes – some simple, and some perhaps a bit more complicated.   A complete set of measurement attributes for an organization provide a clear, concise, detailed definition of a measure and the process used to collect it.  They preserve the unambiguous meaning of the metric, and increase: Data quality Understanding and use of measurements Availability of useful historical information Ability to […]

Podcasts

Two Harbors Consulting Podcast Episode 2: what is this estimation thing anyway?

https://twoharborsconsultingpodcast.buzzsprout.com/976369/3325870-2hc-ep-2-what-is-this-estimation-thing-anyway Two Harbors Consulting CMMI Lead Appraisers Becky Fitzgerald and Tom Klein join George Zack to discuss estimation.  What is it?  What are the attributes of it?  Where do organizations struggle with it and what is recommended to address that?  Are there places where estimation is not necessary? Let us know what you think.  What questions, challenges or success stories do you have regarding estimation?  What other process improvement or regulatory topics you’d like to […]

Podcasts

Two Harbors Consulting Podcast Episode 1

Two Harbors Consulting has entered the podcasting world with its first ever episode.  Give it a listen as CMMI lead appraisers Becky Fitzgerald and Tom Klein join their partner at Two Harbors, George Zack discuss how requirements for manufacturing firms should be considered more broadly than just the product requirements. Please let us know what you what you want to hear us discuss and any feedback on the “pod.” https://www.buzzsprout.com/976369/episodes/3200533-2hc-ep-1-considering-requirements-beyond-the-product

Case for Quality

March 12 2020 Case for Quality Forum videos posted

The latest Case for Quality Forum sessions were recorded and the videos are posted now from MDIC:  https://mdic.org/resource/case-for-quality-forum-march-12-2020/  There are sessions posted with updates from CMMI and CDRH.  Let us know if you have any questions on any of the topics discussed at the Forum, or if you are interested in the Voluntary Improvement Program (also known as Medical Device Discovery Appraisal Program or MDDAP).