For one of the company’s projects, myself and other colleagues had to sign an NDA regarding the project circumstances and to not disclose information or penalties will be enacted. Before signing, we had a small forum to discuss and deem…   Read more»

I would form a project team based on the recommendations from my manager. I would utilize my manager’s experience within the company to create a team that in theory can best perform to execute actions. As the project manager, I…   Read more»

The organizational type that is most effective (best) depends on the team members associated with the project. Coming from a matrix organization, I believe that having a strong foundation from management will allow for flexibility of scheduling, however, this is…   Read more»

I work as a Quality Engineer in a company that runs as a matrix organization. The management provides excellent guidance to their team on various aspects. Also, the directors amongst the different departments are always willing to collaborate with each…   Read more»

As a Quality Engineer, we have AQL levels in place in our drawings for the Quality Inspectors to use when inspecting incoming product that is to be used on the manufacturing floor. As neb2 stated, AQLs are Acceptance Quality Limits…   Read more»

My company utilizes FMEA while the planning phase to assess risk. As mentioned in the lecture, FMEA is Failure Mode Effects Analysis. This systematic approach allows primarily those within the healthcare industry to evaluate a process to identify how failure…   Read more»

To deal with the high severity of risk would be to assess the potential outcomes that could arise. If at all possible, I would prefer to avoid the risk. This can be established through protocols that aim to move around…   Read more»

In the company I work for, I’ve seen several user requirements documents as well as risk analysis forms which include user requirements embedded with defined risk levels. User requirements documents help define the product because they come from the customer’s…   Read more»

Working in industry I’ve had the chance to utilize gaant charts to structure a project which is focused around transitioning our documents to the latest ISO 13485:2016 standard before audits this month. By doing so, I had to make sure…   Read more»

Design review meetings are essential to ensure that the design adheres to both each stage of the Product Development Process as well as provide feedback per each stage. One of the design meetings I went discussed the whereabouts of the…   Read more»

To add to the discussion I believe that a complete Design Control System maintains the established feedback loop where the product is documented adequately while providing room for improvement along the development stages. The FDA, as previously mentioned, looks to…   Read more»

To add to the discussion, meeting minutes allows the team to ensure that every action is accounted for. Also a missing member can be brought up to speed with the meeting minutes and then briefly supplemented with a 5-10 minute…   Read more»

When making a gantt chart, it is crucial to have met certain criteria. In my current job, I had to develop a gaant chart in order to facilitate a steady transition of ISO 13485:2003 to 2016. There the gaant chart…   Read more»

A mission statement describes the company’s reason as to why they exist. This differs from the vision statement where the company states what the future successful state of the company would be. These are important in goal-setting because they serve…   Read more»

Emotional Intelligence primarily focuses on how an individual is able to identify, consider and control their internal emotions as well as identify these in others. This involves various aspects of self-awareness, self-management, social awareness and relationship management that can be…   Read more»

The company that I chose to focus on is Stryker Corporation. Stryker is best known for their development of orthopedic products and implants, patient handling and emergency medical equipment, to name a few. SWOT Analysis is a way of evaluating…   Read more»

Main difference between a public and private company is that a public company sells a part of its business to the public through public offerings. A private company is owned by a handful of people. This handful of people usually…   Read more»

A sole proprietor owns the entire business assets as personal property, as mentioned above. With that being said, it is possible to transfer the company to another person. The sole proprietor is allowed to transfer the business by selling its…   Read more»

Personally, I have thought about the possibility of a start-up company but within the biologics/pharmaceutical side. With that being said, I would prefer to create an LLC business. With a Limited Liability Company, I am protected from any liabilities within…   Read more»

Ways to abide to procedure for all departments can be to collaboratively implement a procedure which all voices partake in the creation of such procedure. That way, upper management involved can hear each others opinions and reach a consensus. Quality…   Read more»