Medical Device Academy released a new webinar this week for training companies on good documentation practices.
Have you ever wondered where the FDA regulation is that says, “…shall not use white-out to correct quality system records.”
Don’t bother looking, because you won’t find it. You also won’t find any regulations against the use of red pens, highlighters, pencils, or markers. You can’t even find a guidance document that tells you not to put a single line through mistakes, initial and date it.
The applicable regulation is 21 CFR 820.180, but the regulation doesn’t specifically say these things. Instead, the regulation states: “Records shall be legible and shall be stored to minimize deterioration and to prevent loss.” The ISO 13485 Standard is not much different. It states that you must establish a procedure that will “Define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.”
Over time medical device companies have developed some standard approaches to meet the requirements for Document Control, Control of Records, and Training. These are the three core processes that I call “good documentation practices.” If you need training or you need tools for training employees, click on the link below to purchase our new webinar on good documentation practices.
The webpage also includes an exam for training people on good documentation practices. The exam serves as a useful check for the training, but we recommend that process owners monitor these processes–especially if the process is manual. For example, QC inspectors will complete inspection records and file the record as a quality system record. The QC supervisor, or process owner, should periodically review these records for completeness and accuracy. If the supervisor notices an error, the supervisor should notify the inspector and have them correct the mistake. The supervisor should also track how many times each error is made and specifically where errors are occurring. The collection of this data gives the supervisor trend data to help them identify which forms need to be updated to prevent mistakes and which employees require retraining. This data also provides evidence of competency for each employee concerning good documentation practices.
After you have completed the training, you might also be interested in downloading our procedures for Document Control, Control of Records and Training: