In this edition of Devine Guidance (DG), Dr. D will provide guidance for 21 CFR, Part 820, Subpart – M (Records), specifically 820.186 (Quality System Record).
Not wanting to oversimplify the requirement, the Quality System Record (QSR), not to be confused with the Quality System Regulation (QSR), can be a document/procedure that points to where all documentation, procedures, and other records, required by the regulation are located, within the context of a device manufacturer’s quality system. Yes, Dr. D purposely threw two identical acronyms into the mix for the sole purpose of entertaining the readers, while attempting to make a point on why declaring acronyms is a vital part of writing. The number of acronyms introduced by the QSR alone (ha, ha, ha) is mind-boggling. If the doctor really wanted to confuse readers, this edition of DG would be penned in boustrophedon (look-it-up).
Warning letter violations
I am sorry to disappoint the readers; however, in reviewing 12 months of FDA-issued warning letters, Dr. D was not able to locate a single observation associated with violating 820.186. As I pondered the reason behind this interesting observation, Dr. D was able to hypothesize two possible reasons. In the first scenario, all device manufacturers clearly understand the QSR (the first acronym) requirement and fully comply with the QSR (the second acronym). In the second scenario, FDA writes most of the warning-letter observation against 820.20 and 820.40.
If you guessed that Dr. D settled on scenario number two, you would be correct. Why? Because the agency is able to uncover plenty of cannon fodder and write frequent Form 483s and subsequent warning letters by identifying violations of 820.20 and 820.40.
Quality System Regulation – 21 CFR, Part 820
QSR – Subpart M – Records
Section 820.186 Quality System Record: Each manufacturer shall maintain a quality system record (QSR). The QSR shall include, or refer to the location of, procedures and the documentation of activities required by this part that are not specific to a particular type of device(s), including, but not limited to, the records required by 820.20. Each manufacturer shall ensure that the QSR is prepared and approved in accordance with 820.40.
The doctor’s experience in industry leads him to opine that the creation of a well-written procedure is needed to achieve compliance to the QSR (both acronyms). For starters, all quality system procedures, associated documentation, and records, need to be legible. Dr. D always recommends implementing a strong program for Good Documentation Practices (GDP) supported by training (don’t you just love the acronyms).
Additionally, if a device manufacturer chooses to employ a single procedure to drive compliance to the QSR, the procedure must be all-encompassing. What does that mean Dr. D? The doctor recommends creating a procedure that has three specific sections delineating (a) the types of procedures, documentation, and records; (b) the storage location for procedures, documentation, and records; and (c) the actual planned retention timeframe for procedures, documentation, and records. In fact, Dr. D would label the major sections of this procedure as:
- Types of procedures, documentation, and records;
- Storage location of procedures, documentation, and records; and
- Planned retention time of procedures, documentation, and records.
Additionally, if the QSR (acronym one) is managed electronically, the entire electronic process should be delineated within the procedure. Furthermore, when assigning retention timeframes, ensure the years specified are realistic. For example, Standard Operating Procedures (SOP) should be retained for the duration or as Dr. D would say, “a FOREVER Record!” Other quality system record-retention timeframes should be premised on importance. For example, Dr. D loves the number seven: the doctor recommends retaining most quality-system records for at least seven years.
Remember FDA has its own requirement for record retention. “All records required by this part shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than two years from the date of release for commercial distribution by the manufacturer.” Finally, regardless of the approach pursued for meeting the QSR (both acronyms), “each manufacturer shall ensure that the QSR is prepared and approved in accordance with 820.40.”
Once again, the takeaways from this week’s DG are not rooted in rocket science. The key for compiling a QSR and ongoing compliance with the QSR (yes – two acronyms), is the establishment of a well-written procedure. The agency really wants device manufacturers to have quick access to procedures, documentation, and records compiled as part of a QSR. Dr. D cannot think of a more efficient approach than creating a procedure with tables that accurately identifies (a) the type of procedure, documentation, or record; (b) the location the procedure, documentation, or record is being stored; and (c) the actual retention period for each procedure, documentation, or record.
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, when I begin providing guidance for Subpart – M (Records), specifically 820.198 (Complaint Files – subsections a, b, and c) – cheers from Dr. D. and best wishes for continued professional success.
- Code of Federal Regulation. (2009, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
- Devine. C. (2009, July). Exploring the effectiveness of defensive-receiving inspection for medical device manufacturers: a mixed method study. Published doctoral dissertation. Northcentral University. Prescott Valley, AZ.