Examining an NCR document you note that the rework instructions are clearly explained in the document. You can’t find any evidence, however, that the product was inspected and verified after the rework.

Evaluating 2-recently completed work orders you find that while the product has already shipped, the final acceptance/release step #28 has not yet been signed off by Quality. Quality indicates that they usually sign this off within a week or two of shipment when they can confirm that all other steps in the work order have been properly signed and dated.

In the lab you find two instruments whose calibration sticker is expired by 1-week. The lab manager says that these instruments hold calibration for at least 2-years and so missing calibration by a week or so will have no impact on test results.

Production equipment software that is being developed in-house while it is being used in live production has no version number assigned to it. When you ask why the engineer states that they are still “working out the bugs” and will provide a version number as soon as it is finally “de-bugged”.

The swing shift is responsible for set-up of morning production as the last activity of their shift. Observing the set-up you notice that the steps and methods are very different than those explained in the traveler. The operators performing the set-up indicates that the old methodology in the work instruction hasn’t been followed for over a year. Some of the old maintenance activities really can’t be performed any more.

A validated process, creating angioplasty balloons, has some temporary workers performing night shift work. The shift supervisor indicates that all experienced personnel were just promoted to the day shift and they had to quickly staff the night shift. When they see which of these workers perform well over the next couple of weeks they will then be hired and receive all the appropriate training.

The Quality Manger, a middle-management position, is responsible for communicating and implementing the Quality Policy at all levels of the organization. No other member of the management team has any responsibilities related to the quality policy.

In the pre-production staging area all parts and materials have been “picked” and place on a pallet awaiting the production work order execution. Examining 5-pallets you notice that work orders with batch numbers are found for 3 of the 5 pallets. Two of the 5-pallets have no work orders or tags identifying the batch. The supervisor says “Not to worry, we can tell what to make by the materials on the pallet. Occasionally work orders have to catch-up with the production down-stream.”

A new device PRO-125 rev A has just completed its first production run of 25-units. Examining the DHF you notice that there is no record that this device was ever tested or had any other kind of validation performed.

4.On the receiving dock you find several pallets of your finished class 3 medical devices that have just been returned from your brand new outsourced packaging/labeling company. These pallets are being broken down and re-packed for direct shipment to fulfill orders. There is no evidence of: inspections, certificates of conformance or other records to prove that the packaging/labeling was properly done. The receiving manager says: “We are in a big hurry on these orders processed and had to find a new outsourcing company at the last minute. We will just ship these units and hope for the best.”

In reviewing the Design History File you find ambiguous and seemingly conflicting requirements in Requirements Baseline Rev C and Rev D. Examining the baselines, it is unclear when they were approved or who approved them.

Operators are cleaning work surfaces with a spray cleaner that is NOT the approved cleaner in the Work Instructions. During interviews, none of the employees understand why that might be a problem.

Inspectors are filling out the new inspection form TST-001 rev D approved last week. None of the inspectors understand how to perform the new PSI test and none of them were aware that this change was made prior to the current job run.

A Pre-Market approval from the FDA is generally required for a Class III medical device BEFORE it can be marketed.

Medical devices must be classified as Class I, II or III. This classification determines the applicable regulatory control and proper application of GMPs for any medical device.

A Pre-Market Notification (filed under section 510k) is generally required for Class I medical devices.

Medical device classes are determined based upon the risk associated with the device. A Class I or “first class” risk is considered the highest risk level, a Class III or “third class” risk is considered the lowest risk device.

A Class I medical device generally does NOT require any Pre-Market notification or approval before marketing. Accordingly, there is NO communication needed with the FDA to market most Class I devices.

A 510k PRN must establish “substantial equivalence” with a current legally marketed device. Even though a device may be very similar in “intended use”, it is NOT a SE device if different technology is employed.