Fail to Respond to Form 483 Observations and Win a Warning Letter
A monumental screw up, complete with bad quality, regulatory and statutory practices.
A monumental screw up, complete with bad quality, regulatory and statutory practices.
A look into the importance of high-quality software in the medical device industry.
Much of this involves communicating with your customer, and doing it often.
Medtronic repeatedly fails to correct manufacturing violations related to its Synchromed II Implantable Infusion Pump Systems.
Medtronic repeatedly fails to correct manufacturing violations related to its Synchromed II Implantable Infusion Pump Systems.
Defiant minds can conceptualize embodiment that customers actually want. But determining methods to best define what the customer wants with novel technologies can be challenging as many of the methods published just don’t fit early stage work. How can we then manage the process of quality function deployment?
Defiant minds can conceptualize embodiment that customers actually want. But determining methods to best define what the customer wants with novel technologies can be challenging as many of the methods published just don’t fit early stage work. How can we then manage the process of quality function deployment?
Mistake proofing is used in product, process, and service design and development as well as in ongoing operations and improvement applications. The goal with mistake-proofing is to find and correct mistakes, errors, or omissions as close to the source as possible, when the mistakes cost less to correct than if found later.
A root cause investigation may be formal or informal. Things happen, at work, at home, anywhere. The investigation methodology remains the same. Only the level of documentation changes to fit the situation.
A root cause investigation may be formal or informal. Things happen, at work, at home, anywhere. The investigation methodology remains the same. Only the level of documentation changes to fit the situation.
We now test the possible causes against the facts in the IS / IS NOT Diagram to see which ones make sense. This is where the investments made in defining the problem and getting the facts pay off!
The third step of the investigation is to develop a list of possible causes. All too often investigators stumble at this point as they rely solely on the fish-bone diagram.
In this third of a series of articles on conducting a root cause investigation, we explore a second key investment every investigator should make: assuring you have the facts! Unfortunately, investigators are often under tremendous pressure to complete the investigation and assume the information they have is entirely correct. As a result days, or weeks, are wasted going down the wrong path.