This is a fantastic topic. Like @nm523, I have also noticed a push to incorporate diversity in thought in the workplace. The way my company managed this generational gap was to give "Senior" technical...

The first successful example of a "matrix" organization I have seen was when I was a co-op at an ultrasound transducer manufacturing facility. The project was a migration of upstream components to a s...

Like @ag2265 stated, the Matrix Organization is highly beneficial when done properly in an organization maintaining day to day tasks and simultaneously executing projects. I saw a major disconnect bet...

I worked at a small plant in a large company, so a lot of roles that would be defined to one person were assumed and I dabbled in a lot of disciplines. This was kind of the best or worst of both world...

The Design and Development Plan (DDP), as defined by ISO 13485, contains the objectives as @DevDesai pointed out, as well as the assignees and timelines as @veron_perez mentioned. Additionally, as the...

Echoing what @sm2744 stated, you can use either tool to address different conceptual aspects of the project. A network diagram is a good way to brainstorm dependencies between tasks and milestones. Me...

I really admire the commitment to safety; it is an asset in an industry where misunderstandings of risk can have life altering consequences. One scenario I can think of is where a new risk for an exis...

I agree with @ms2768 & @njq3 that prework done by the facilitator of the risk management meeting is extremely helpful to engage the participants. A detailed agenda with as much input as possible f...

I would agree with @njq3 on the potential conflict of interest by sharing personnel with the project team, especially if the project team is incentivized for completion of the project. I think the har...

This is a question I am currently grappling with. My approach is as follows: 1. Define the project goal (what does the finished project look like?) 2. Define the milestones necessary to achieve that g...

@jadebowale 's response was very well phrased. I agree with her assessment that peer review and retrospective external benchmarking both are meaningful and substantial methods to validate an in vivo m...

I really like @srp98 's approach here. From the design specification document, you determine which specifications require testing. In @srp98's case, this was leakage from a gasketed joint. In @anthony...

Echoing @ag2357, I would bring in marketing to all of these interim meetings, especially if the marketing represenation is the product manager. They can solicit information from their sales force as t...

I have worked in a company that produces ultrasound transducers. The company was relatively large, so roles for design control were actually pretty defined. I think of it in terms of change management...

I agree with DevDesai, and would add that there are many different forms of design controls that are performed through the product's life cycle. Initial stages are dominated by the project proposal an...