Validation is required for a new fixture within the company I work for, its not a yes or no question. When dealing with class III medical devices, we rely on validation for new fixtures and processes....

I never came across an expiration date for a validation. If an equipment was validated 30+ years ago and is still operational without any new changes to the fixture than the original validation is sti...

From a medical device company perspective, it is better to have preventative CAPAs than reactive CAPAs. At my current employment, we have both preventative and reactive CAPAs. In recent meetings our m...

Technical Writing courses are not given to students as a priority when in actuality the work industry requires an individual with good technical writing skills. When starting a full-time position as a...

When a fixture fails on the production floor at work, the priority is to determine if it affected any products what were in contact with that fixture. If so, then it can escalate to a CAPA through the...

Being that I am a fairly new engineer that entered the work industry, this course has helped me transition from a student to worker. After taking one of Dr.Simon’s courses my spring semester I knew th...

As many of you know, when you get hired as an engineer the first couple of weeks are dedicated to being trained per the SOP’s of the company. Therefore, as a startup company, the employees will learn ...

While completing this week’s simulation I realized that all references to a specific document also references the revision level of that document. This does create traceability however it ends up crea...

SOPs layout the details for the standards a company implements in the procedures and processes. SOPs that I have worked with include a purpose, procedure, documents/ fixtures affected, forms and atta...

SOPs are grilled into engineers minds ever since their first day at work. Within the medical company I work at it is mandated to have SOPs for every fixture or process that is in place. It is not jus...

The current company that I work for uses ECOs in the form of change notices as Julienne has stated above. The process of implementing a change within an SOP requires engineering to supply a redline an...

One advice that my manager told me when dealing with a complete rewrite of an SOP or creating and SOP is to make it “idiot proof”. This terminology is used to make it clear that whatever is being sta...

The company I work for does utilize a Design Specification document as Dr. Simon had described in this week’s lecture. It includes a design matrix that traces the entire process of the design. It is ...

From prior experience, when a verification/validation had failed I was obligated to redo the verification and validation per the updated specification. Yes, this is time consuming and can be costly, b...

Document History File is more useful than a Tech File in terms of traceability. Document History File is a living document, it contains any mistakes or scrapped information that were made along the pr...