Two Harbors Consulting Podcast

Tom and George discuss DAR - the practice area from the CMMI Model - Decision Analysis Resolution, what it is, why it is difficult for organizations to adopt, some things to consider in using it and why.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 about any element of podcast.  Contact us at: info@twohc.com or at http://www.twoharborsconsulting.com or George Zack at george.zack@twohc.com

Tom and George discuss an email that asked them about best practices for driving broader change from appraisals.  They discuss some considerations to help process change stick.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 about any element of podcast.  Contact us at: info@twohc.com or at http://www.twoharborsconsulting.com or George Zack at george.zack@twohc.com

George was invited to converse with Naveen Argarwal on a recent post he put up on Linkedin about seatbelts.  They talk CAPA, risk management, quality culture, and leadership (to name a few!)  Dr. Naveen Agarwal has 20+ years of diverse industry experience in leadership roles ranging from R&D to Product Quality and Business Analytics. He holds a Ph.D. in Polymer Science & Engineering from the University of Massachusetts, Amherst. He is an ASQ certified Quality Engineer, a Manager of Quality and Operational Excellence, and a certified Project Management Professional. In his consulting practice, he works on strategic projects in Risk Management, Design Control, Post-Market Surveillance, and Quality Culture in the Medical Device Industry. In his spare time, he enjoys distance running, community work, and spending time with his family.You can find him and information about his work, especially regarding risk management for medical devices here:   https://www.achievexl.com/https://www.linkedin.com/in/naveenagarwal/You can also watch this episode here:  https://www.youtube.com/watch?v=DERVviyppL0 

Becky, Tom and George reconvene on this podcast after a year long break from it.   They discuss what topics they see coming up in future episodes in this "season 2."  What performance improvement topics do you want to see discussed?   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 about any element of podcast.  Contact us at: info@twohc.com or at http://www.twoharborsconsulting.com or George Zack at george.zack@twohc.com

George is joined again by Lynn Penn (https://www.linkedin.com/in/mlpenn/) from Performance and Methods Consulting.  They dive back into the CMMI appraisal interviews - specifically those for MDDAP appraisals:  what makes for a good interview, what are some challenges, and how to be ready to manage the room.  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 about any element of podcast.  Contact us at: info@twohc.com or at http://www.twoharborsconsulting.com or George Zack at george.zack@twohc.com

George has a conversation with CMMI Lead Appraiser Beth Layman of Layman and Layman Consulting about the intersection of the CMMI Model with the US medical device quality system regulation (the QSR).  Let us know what you think.  What questions, challenges or success stories do you have?  What other process improvement or regulatory topics you'd like to have covered in future podcasts? Contact us at:  http://www.twoharborsconsulting.com or at George Zack george.zack@twohc.comBeth's contact information:  beth.layman@laymanandlayman.com or http://www.laymanandlayman.com/

Becky and George have a conversation with Paul Kimmerly about the observation process of CMMI lead appraisers.  George just went through the observation process and Paul was his observer.  The team discusses why these are done,  common improvement opportunities for new appraisers, what is good about them and what could be improved.  Let us know what you think.  What questions, challenges or success stories do you have?  What other process improvement or regulatory topics you'd like to have covered in future podcasts?  Contact us at:  http://www.twoharborsconsulting.com or atBecky.Fitzgerald@twohc.comTom Klein tom.klein@twohc.comGeorge Zack george.zack@twohc.comPaul's contact information:  paul.kimmerly@doubleplayconsulting.com

Appraisal activities include "the interview."  What is it for?  Why do it?  How is it done in CMMI appraisals?  How should I prepare for an appraisal interview if I am an interviewee?Tom and George discuss all of these and more as they unpack this aspect of appraisals.  Let us know what you think.  What questions, challenges or success stories do you have?  What other process improvement or regulatory topics you'd like to have covered in future podcasts?  Contact us at: info@twohc.com or at http://www.twoharborsconsulting.com.  Tom Klein tom.klein@twohc.comGeorge Zack george.zack@twohc.com

George and  Tom continue a dive into the CMMI model as they discuss the Implementation Infrastructure practice area.  Let us know what you think.  What questions, challenges or success stories do you have?  What other process improvement or regulatory topics you'd like to have covered in future podcasts?  Contact us at: info@twohc.com or at http://www.twoharborsconsulting.com.  Tom Klein tom.klein@twohc.comGeorge Zack george.zack@twohc.com

George, Becky and Tom get together and discuss an idea that GZ has about the CMMI Model - that there are five (well, and maybe 2 or 3 more) practice areas that are more foundational to the model and really shouldn't be skipped over.   Listen in to hear what those practice areas are and the discussion surrounding this topic.  Let us know what you think.  What questions, challenges or success stories do you have?  What other process improvement or regulatory topics you'd like to have covered in future podcasts?  Contact us at: info@twohc.com or at http://www.twoharborsconsulting.com.  Becky Fitzgerald:  becky.fitzgerald@twohc.comTom Klein tom.klein@twohc.comGeorge Zack george.zack@twohc.com

Becky, Tom and George get together for their first episode since January.  What have we been doing for work, dealing with the pandemic, and how have we been improving our craft?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 have covered in future podcasts?  Contact us at: info@twohc.com or at http://www.twoharborsconsulting.com.  Becky Fitzgerald:  becky.fitzgerald@twohc.comTom Klein tom.klein@twohc.comGeorge Zack george.zack@twohc.com

Becky, Tom and George get together to revisit the concept of size in estimation of work and some ideas on how to approach it as an opportunity to improve.  2HC episode 2 (where we originally discussed estimation and size):  https://www.buzzsprout.com/976369/episodes/3325870The CMMI Model At A Glance:  https://cmmiinstitute.com/cmmi-v2-0-model-at-a-glanceLet 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 have covered in future podcasts?  Contact us at: info@twohc.com or at http://www.twoharborsconsulting.com.  Becky Fitzgerald:  becky.fitzgerald@twohc.comTom Klein tom.klein@twohc.comGeorge Zack george.zack@twohc.com

George is joined by the president of regulatory and quality at Greenlight Guru and the host of the Global Medical Device podcast Jon Speer.  Jon gives some of his insights as to what will be hot topics in the quality/regulatory world in 2021.Some reference links:The latest on the QSR migration to 13485 https://medtech.pharmaintelligence.informa.com/MT143243/FDA-Picks-New-Target-Date-For-Releasing-Its-Draft-Harmonized-Quality-System-RegulationThe Payor pilot:https://www.fda.gov/about-fda/cdrh-innovation/payor-communication-task-forceGreenlight Guru:https://www.greenlight.guru/The Global Medical Device Podcast:https://www.greenlight.guru/podcastsAre 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 about any element of podcast.  Contact us at: info@twohc.com or at http://www.twoharborsconsulting.com or George Zack at george.zack@twohc.com

George is joined by Becky and Tom to discuss what happens after an organization has had an appraisal.    Now that you have results, what do should you do with those to get the most value of them?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 about any element of podcast.  Contact us at: info@twohc.com or at http://www.twoharborsconsulting.com or George Zack at george.zack@twohc.com

In this episode, we share a recording of the October 2020 Two Harbors Consulting "Ask An Appraiser Anything" webinar.  Lead Appraiser Tom Klein and George Zack of 2HC took questions on process improvement, the CMMI model, medical device regulation and approaches to appraisals.  This was the first webinar that 2HC held like this - and we think it went well enough that we will look to do more in the future.  Let us know what topics you'd like to see us address. 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 about any element of podcast.  Contact us at: info@twohc.com or at http://www.twoharborsconsulting.com or George Zack at george.zack@twohc.com

Lynn Penn, the president of Performance and Methods Consulting joins the Two Harbors Consulting podcast for a conversation with George Zack.  Lynn is involved in CMM everywhere - from executing appraisals, to being on working groups to help define the next revision of the Model, to chairing Capability Counts Conference - Lynn is there!  They chat Lynn's career history, the Model, appraisals and getting value add, the PAB, maturity and capability levels, and CMMC.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 about any element of podcast.  Contact us at: info@twohc.com or at http://www.twoharborsconsulting.com or George Zack at george.zack@twohc.com

ISACA Chief Architect, Ron Lear and CMMC Board Member, Jeff Dalton join George Zack of Two Harbors Consulting to discuss the current state of CMMC, where it connects with CMMI and where it looks to be going in the future.  We hope you find this conversation to be informative.Follow Ron at his CMMI Institute blog at:  https://cmmiinstitute.com/news/blogFollow Jeff at his Linkedin at https://www.linkedin.com/in/jeffdalton/ or his Twitter at https://twitter.com/CMMIAppraiserAre 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 about any element of podcast.  Contact us at: info@twohc.com or at http://www.twoharborsconsulting.com or George Zack at george.zack@twohc.com

Ron Lear is ISACA's chief architect and director of IP development for the CMMI Framework.  In this episode - as our first ever guest to the podcast - Ron shares with George what is going well with CMMI version 2.0 (as it is now 2 years old), where the framework and supporting tools are going in the near term, the performance report, connections to CMMC and more.  For those in the CMMI community, we are sure you will find this to be an informative episode.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 about any element of podcast.  Contact us at: info@twohc.com or at http://www.twoharborsconsulting.com or George Zack at george.zack@twohc.com

Becky, Tom and George had a topic to discuss but break from that script and speak to some aspects of process improvement that are more at their top of mind.  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 about any element of podcast.  Contact us at: info@twohc.com or at http://www.twoharborsconsulting.com.  The "Science of Running" podcast referenced in this show is here: https://podcasts.apple.com/us/podcast/episode-110-endurance-speed-or-speed-endurance-which/Replays of the Greenlight Guru Virtual Summit are at:  https://virtual-summit.greenlight.guru/replays/ including George's presentation on performing remote quality audits and appraisals (also on Youtube at:  https://www.youtube.com/watch?v=TGHlwwDv9BMBecky Fitzgerald:  becky.fitzgerald@twohc.comTom Klein tom.klein@twohc.comGeorge Zack george.zack@twohc.com

Becky and Tom ask George to discuss some of the lessons he has learned from performing some recent audit and appraisal work remotely ("virtually") due to COVID19.  What worked?  What didn't?  George will be presenting more on this topic at the upcoming Greenlight Guru Virtual Quality Summit:  Register for this fully free and fully virtual content packed Summit at https://virtual-summit.greenlight.guru/?sc=QVIW4uUc&ac=qbB2QCbS Two Harbors Consulting is proud to partner with the great team at Greenlight on this amazing conference.  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 about any element of podcast.  Contact us at: info@twohc.com or at http://www.twoharborsconsulting.com.  Becky Fitzgerald:  becky.fitzgerald@twohc.comTom Klein tom.klein@twohc.comGeorge Zack george.zack@twohc.com

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?A few concepts referred to in the episode:CMMI:  https://cmmiinstitute.com/The Medical Device Discovery Appraisal Program or MDDAP (also referred to as the Case For Quality Voluntary Improvement Program): https://cmmiinstitute.com/medicaldeviceMedical Device Innovation Consortium (MDIC) Case For Quality:  https://mdic.org/program/case-for-quality/Quality System Regulation (820): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820Also - 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 to partner with the great team at Greenlight on this amazing conference coming up in June.  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 about any element of podcast.  Contact us at: info@twohc.com or at http://www.twoharborsconsulting.com.  Becky Fitzgerald:  becky.fitzgerald@twohc.comTom Klein tom.klein@twohc.comGeorge Zack george.zack@twohc.com

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?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 about any element of podcast.  Contact us at: info@twohc.com or at http://www.twoharborsconsulting.com.  Becky Fitzgerald:  becky.fitzgerald@twohc.comTom Klein tom.klein@twohc.comGeorge Zack george.zack@twohc.com

Two Harbors Consulting CMMI Lead Appraisers Becky Fitzgerald and Tom Klein connect this week with George Zack to discuss what are the elements or attributes of an effective measure.  Take a look at the list of possible attributes 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 about any element of podcast.  Contact us at: info@twohc.com or at http://www.twoharborsconsulting.com.  Becky Fitzgerald:  becky.fitzgerald@twohc.comTom Klein tom.klein@twohc.comGeorge Zack george.zack@twohc.com

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 have covered in future podcasts?  Contact us at: info@twohc.com or at http://www.twoharborsconsulting.com.  Becky Fitzgerald:  becky.fitzgerald@twohc.comTom Klein tom.klein@twohc.comGeorge Zack george.zack@twohc.com

Two Harbors Consulting CMMI Lead Appraisers Becky Fitzgerald and Tom Klein join George Zack for their first podcast to discuss requirements.  Specifically, how do you consider requirements for the manufacturing organization that gets product requirements handed to them?Let us know what you think and what topics you'd like to have covered in future podcasts.  Contact us at: info@twohc.com or at http://www.twoharborsconsulting.com.  Becky Fitzgerald:  becky.fitzgerald@twohc.comTom Klein tom.klein@twohc.comGeorge Zack george.zack@twohc.com