This procedure applies to personnel who must work in accordance with Sharklet quality system procedures (i.e. all personnel).
Each person will be trained to QS procedures/topics needed for their job duties.
Have you become aware of a potential product complaint?
Have you discovered a nonconformity, undesirable situation, or improvement opportunity?
Select suppliers from the SOP07 “Approved Supplier List” (ASL) whenever possible.
External documents are regulations, standards, guidances, etc. referenced in internal documents. If referencing an external document, make sure:
Do not disclose PHI unless specifically required or permitted by law.
The following controls are in place at Sharklet:
Errors on paper records are corrected as follows:
Below is a short video demonstration of the proper way to correct errors, as well as some other good documentation tips:
When recording dates, whether typed into documents or entered by hand, use one of the following formats:
Why is this important?
Equipment Controls – Are you using equipment for QS tasks?
Inspection and Testing Controls: