Title: Good Documentation Practices
Course: PW-Course-Import-Test > Section: Module 1: Introduction to Quality Control

Module 1

In the medical device industry all the manufacturing and inspection steps need to be documented to ensure that they are completed correctly. This documentation trail provides detailed information on where the parts came from, who inspected them, what were the inspection results, who assembled them and when, to name a few. Most of this documentation is filled out by hand.

When these documents are filled out, Good Documentation Practices (GDP) need to be followed. This section of the module will help you follow GDP.

Good Documentation Practice has as its goal ‘concise, legible, accurate and traceable records.’ It is a simple statement but encompasses all the requirements of good documentation practices. Now let's talk about what each of these words mean:

- Concise:  The documents should tell the entire story and should be understood by internal/external customers.
- Legible: The handwriting or print on the document should be clear enough to read by internal/external customers.
- Accurate: The document should be error free.
- Traceable: Each aspect of the document should identify who recorded it, where and why so that the history of the document is known by everyone.

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Why should we do this?

This is a great question, and you are not the only one thinking about it. Implementing and maintaining good documentation practices can be time consuming upfront, but it has a lot of benefits, especially in a medical device industry. Remember the medical devices that are being built are saving lives. A good record of this manufacturing and inspection process is essential to ensure that the product was built according to specifications and is going to function as expected when used on a patient.

Documents are objective evidence that the required actions and tasks were performed. If something goes wrong when a patient or doctor is using your medical device, the company can get into a lot of trouble. At this point, if the company has documented evidence that the product was manufactured and inspected correctly, then it can save the company a lot of trouble in court.

But this may not be the only reason to follow good documentation practices. Let me give you another analogy. Think about keeping your car, home or work area neat and tidy. Doesn't it feel good when you do that? It makes the area more presentable and easy to manage. You can find things easily and do not have to spend time looking for it. Everything is in its place and life is good!

Managing good documentation is something similar with one major difference. You can get away with an unclean home, car or work area. But you cannot get away with bad documentation practices. It is required and expected.

The Food and Drug Administration that regulates all the medical device manufactures in the U.S. does not have any specific regulations governing GDP. However it is a industry practice to use GDP. You will sometimes see GDP written as cGDP which simply stands for current Good Documentation Practice. What is considered good documentation practices may change over time with technology improvements and increase in complexity of the products being manufactured.

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The following video further explains good documentation practices and how the practice is implemented in your day-to-day work.

Just for Fun

Have you ever received a hand-written prescription from your doctor? What do you first notice on it? The doctor's handwriting. How legible would you consider this handwriting? Would everyone be able to clearly understand it?  I am pretty sure that the answer is no.

Aren't we all glad that most doctors' offices have moved to printed prescriptions or prescriptions that they can electronically send to the pharmacy? Now this is good documentation practice! How many errors in prescription has this now prevented?