• Reactive management can happen due to a crisis or unexpected situation arising in the company. But a habitual reactive management style is not that good. Reactive management tends to result sometimes in poor quality also you may miss to identify…   Read more»

  • The risk management plan becomes a very important part of such situations. Having a substitute member trained on essential skills performed by a key player in the team is important. Also having appropriate contingency plans helps. Having identified each team…   Read more»

  • Six sigma is very popular as it reduces waste by minimizing variations in processes. In a bell curve distribution, 6 sigma ultimately means 3.4 defects for every one million opportunities, or in other words 99.99966% success.  Similarly, another method of…   Read more»

  • This is my first class with Dr. Simon. I had taken a course in project management and another course in production planning and control from my home school in Sri Lanka. But this the very first time that I am…   Read more»

  • nr473 replied to the topic "Closing Phase"3 days, 14 hours ago

    As many have already described the steps that happen during the closing phase I would like to discuss the importance of the closing phase in a project. At first, the project closure might seem like an obvious and effortless phase…   Read more»

  • nr473 replied to the topic "project Coast"3 days, 15 hours ago

    Risk management and agile project management are two things that come to my mind when thinking of cost overruns. In most cases, cost overruns occur due to unexpected expenditures which most of the time are resulting from unassessed risks in…   Read more»

  • nr473 replied to the topic "Gantt chart"2 weeks, 5 days ago

    To add to the discussion on Gantt charts I would like to discuss a little about the history. Henry Laurence Gantt who was an American mechanical engineer is credited with the invention of the Gantt chart. It was introduced by…   Read more»

  • If the change involves the device or the manufacturing of the device, the technical aspects of the change have to be reviewed. The most important factor will be making sure that patient health and safety will not be impacted in…   Read more»

  • nr473 replied to the topic "Testing"2 weeks, 6 days ago

    It is very important to understand the product ecosystem. The tests have to start to be designed as product specs are being developed. The tests have to be treated like a subproject. While defining the acceptance criteria ensuring there is…   Read more»

  • Sometimes milestones are missed when there is project scope change, in this case, it is vital to start realizing that the defined scope should be reclarified and roles and responsibilities should be reiterated to make sure that there is no…   Read more»

  • A good starting point might be to check whether your test conditions are just too strict, what if over-verification is performed. I think that it is always valid to ask yourself after a test failure whether that test was absolutely…   Read more»

  • Understanding the requirements and establishing a robust project definition is paramount for the success of the project. Spending more time on the initiation and planning phases is a long time investment and should be encouraged by the PM and high-level…   Read more»

  • Earned Value Management highly depends on quantitative project planning. This is not practical for some novel and agile projects. Some modern projects which are always open to change utilize methods such as scrum or agileEVM. EVM also has other limitations…   Read more»

  • In addition to fault tree analysis and FMECA which are widely used, revealing severe hazard potential as early as possible is very important. Preliminary hazard analysis conducted as early as in the conceptual design stage could help save time and…   Read more»

  • As I do not have any experience to share here, I would like to discuss a few new terms related to the topic. The tendency of an organization or group to take risks in a given situation can be termed…   Read more»

  • I can recall a machine design project from college where we had to design a Cam Tester together as a total class. In the beginning, bringing everyone together was a hard job for the team leader. Everyone had different opinions,…   Read more»

  • Being a project manager in the medical device industry requires being able to cope with ambiguity and the ability to be able to handle constraints in budget, scope, and time. Most of the projects will require cross-functional operations. Therefore while…   Read more»

  • nr473 replied to the topic "Design Change Request"2 months ago

    Procedures need to be established and maintained by the company to document design changes. This is a requirement of the FDA. These procedures have to cover both direct design changes (these are set down through Document control) and verification deficiencies…   Read more»

  • As various interpersonal skills and traits of a good project manager have already been well discussed in this topic I would like to introduce some management strategies that project managers can follow based on the context.  Authoritative – In this…   Read more»

  • nr473 replied to the topic "Medical device"2 months, 1 week ago

    About 47 percent of authorized devices in the market are class 1 devices. These devices should comply with general Controls (the basic provisions (authorities) of the May 28, 1976 Medical Device Amendments). The general controls include the provisions of the…   Read more»

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