Folks, this week Dr. D is going to dive into a topic that can quickly result in a Form 483 observation from my dear friends from FDA or a nonconformance from your well-paid notified bodies. Good Document Practices (GDP) continues to be problematic for device manufacturers and their suppliers. For example, if a device manufacturer starts with a batch size of 100 catheters and during the manufacturing process three catheters fail testing, while an additional two fail mechanical inspection; the remaining quantity to be shipped to sterilization will not be 98. That number folks should be 95.

Yes, the doctor knows that some of the readers are laughing; however, these types of errors occur more frequently than many of you may think. Another area where Dr. D frequently sees issues is neatness. People, just like grade school and the fear of Sister “Mad Dog” Mary’s ruler smashing down across your knuckles, neatness counts. Please have your manufacturing and quality folks slow down when making entries into production travelers, test reports, and inspection reports. GDP, in Dr. D’s humble opinion, is so important it could seriously “encumber” (look-it-up) a device manufacturer’s success during FDA inspections and notified body audits. That being said, the doctor hopes you enjoy this week’s guidance.

GDP – Neatness and accuracy count

For starters, Dr. D strongly recommends that all device manufacturers have a basic training program for GDP. GDP training should be part of the initial employee orientation, with a refresher course given annually. Why? Because GDP continues to be one of the most frequently cited issues noted during one of the doctor’s internal or supplier audits. If Dr. D is seeing GDP as a problem you can bet your organization’s last dollar on the fact that FDA and the notified bodies are seeing similar issues. Heck you will actually be doubling that dollar and become a profit center for your organization.

Here are a few additional steps that device manufacturers can take to preclude any chance of receiving a nonconformance from your notified body or a Form 483 observation from the FDA, for bad GDP.

1. As previously stated, training is imperative. Please ensure the results of all training are documented. Why? Because if the training is not documented, then in the eyes of FDA, it never occurred. Can you say documented evidence?
2. Create a written procedure that defines your organization’s GDP practices. For example; (a) use of white-out correction fluid is prohibited; (b) define how changes are made, e.g., a single-line drawn through the change/correction; (c) initialing of all changes/corrections; and (d) dating all changes/corrections.

3. Example: Access Time: (*2.34)   3.24 seconds * Error in recording results CJD 06/03/13

   Figure 1.0 – Using an Annotation to Correct Error

   Best practice is to annotate all changes/corrections with an actual reason for the change (Reference Figure 1.0). 

4. All entries made in a report, when recording test data, when recording inspection data, when recording results in the production lot traveler, etc. must always be legible. Remember, neatness counts; otherwise, the Doctor will turn Sister “Mad Dog” Mary loose on your organization (note: she is still alive). 

5. Example: Access Time: N/A   CJD 06/03/13

   Figure 2.0 – Using N/A

   Never leave blank spaces in a report, when recording test data, when recording inspection data, when recording results in the production lot traveler, etc. When using an N/A always remember to date and initial each N/A (Reference Figure 2.0). 

6. If red-line changes are made in support of a pending change to a document or form, always make the change employing red-ink. Make sure that the pending document change order (DCO) number is referenced (Reference Figure 3.0) 
   

   Example: Cut catheter to 105 cm total length change to: 95 cm CJD 06/03/13 – DCO 13-03

   Figure 3.0 – Red-Line Changes

Now Dr. D knows that the practical application of GDP sounds pretty easy; however, you would be surprised by the number of organizations that fail to master the art of GDP. Just like anything else, reinforcement of GDP and constant practice makes GDP a non-issue. 

Takeaways

For this week’s guidance, the doctor will leave the readers with just two fundamental takeaways. One – ensure that employees actually receive GDP training. Make sure the training is documented. Why? Because documented evidence is a quality professional’s best friend during an FDA inspection or a notified body audit. Two – take the time and actually script a written procedure for GDP. It does not have to be more than two or three pages. In fact, employ the KISS factor (Keep It Simple Stupid).

In closing, thank you again for joining Dr. D and I hope you find value in the guidance provided. Until the next installment of DG – cheers from Dr. D. and best wishes for continued professional success. 

References: 

1. Code of Federal Regulation. (2012, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
2. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
3. Devine, C. (2012). Devine guidance for complying with the 93/42/EEC – the European Medical Device Directive. Charleston, SC: Amazon.