Two Harbors Consulting partner George Zack will present at the Greenlight Guru Virtual Summit on June 4 on the topic of performing remote or “virtual” audits as a part of the COVID 19 track. https://virtual-summit.greenlight.guru/?sc=QVIW4uUc&ac=qbB2QCbS – for more details. We hope to see you there!
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
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: http://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 […]
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 […]
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 […]
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
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).
From the tail of last year, but insightful related to the direction for some of the elements of the Case for Quality. https://www.youtube.com/watch?v=pIvLWQbrTcY&feature=youtu.be
The CMMI Institute has published the FDA written white paper that describes the state of the MDDAP pilot program through September of 2019. Read / download it here: https://cmmiinstitute.com/getattachment/9f083064-60a1-4d2a-be58-3602f60d154f/attachment.aspx