As many others have mentioned, this would be considered a major change. If a product failed to meet the regulations needed by the country in which the product would be sold in, this is something that ...

@dev-doshi completely agree. I work in a medical device manufacturer. And for us, the name of the game isn't pure avoidance, but risk mitigation. By the time we start planning out the manufacture of a...

Similarly to what others have mentioned, in my job, the go-to is Microsoft Team's messages and Outlook for sending emails and setting up emails. Teams allows for quick communication--messaging and eve...

Absolutely agree with many of the viewpoints here, meet about it, meet about it, meet about it! The team should have a final Lessons Learned meeting at the conclusion of a project, and the biggest iss...

@dev-doshi Very valid input. However, to comment on one of your suggestions, in order to make the 'nooks and crannies' check easier, the team should be aligned and clear on what their roles and expect...

@vanshamin This is an interesting/insightful perspective. By mentioning that the metric itself shouldn't become a target, might you mean essentially that the PM should ensure they shouldn't put on 'bl...

Several of the comments on here touched on good points including communication and research. However, the best path may be to source the document directly from an ERP system that has revisions of a do...

This is a fun one! I work as a process dev engineer in manufacturing and my company heavily manufactures medical devices. Often there's no way to really anticipate scrap turnout and issues. What helps...

I noticed several others have pointed out that changes typically shouldn't be done all at once; agreed, this is true. Typically changes are made to a machine/tool or process in a controlled way. Howev...

@at644, while usually true, having documented procedures does not always guarantee compliance. Procedures can and will help avoid the pitfalls of treating design control and project management as two ...

When you mention the product life cycle, that can apply to a variety of things as there are several different components that make up the product life cycle. There is the development phase, introducti...

To ensure that the DHF is done properly and completely a PM would need to be cognizant and responsible for all nine steps involved throughout the entirety of the project. While they wouldn't be respon...

Various people agree with the concept that roles should not only be clearly defined, but defined early in a project, or even before the project commences. This is essential to promote a sense of owner...

Reading through the responses, I agree with many of what was proposed; there are several good options for how to control expectations including consistent communication with shareholders, clearly defi...

Reading through the responses, I noticed that many suggested having team meetings as a whole as well as additional individual meetings with those involved to try and resolve the conflicts. While this ...