Folks, once again Dr. D is going to be able to provide some insight into a somewhat rare Form 483 observation noted during the doctor’s weekly journey to the agency’s enforcement page. Usually, the management of stockrooms and providing oversight and control over raw materials and finished medical devices is a fairly routine task. Unfortunately, for an Indiana-based device manufacturer the challenges associated with effective material management appeared to be a difficult obstacle to overcome indeed. Can you say “Random In/Random Out” (RIRO)? Remember, from an agency perspective, RIRO should never be confused with FIFO when managing the flow of inventory. That being said, Dr. D can never be accused of wanting to live an “amaranthine” (look-it up) existence; however, the doctor does thoroughly enjoy entertaining and educating the readers. Enjoy!
Warning Letter Excerpt – 30 September 2013
Failure to establish and maintain procedures for the control of storage areas and stock rooms for product to prevent mix-ups, damage, contamination, or other adverse effects pending use or distribution, and to ensure that no obsolete, rejected, or deteriorated product is used or distributed, as required by 21 CFR 820.150(a).
Raw materials in your firm’s warehouse are not stored in a manner that would prevent mix-ups. For example:
a. When warehouse bin locations (b)(4) were reviewed for inventory accuracy, the FDA Investigator observed:
i. Bin (b)(4) contained (b)(4) cases of Cushion 4 (Part 838-222, Lot I15N4) which were not listed on your Physical inventory Count Sheets. Also, the count sheet indicated Bin (b)(4) contained (b)(4) units of Crown 3 (Part 836-028, Lot I1CDC) however; this component was not present in the bin.
ii. Bin (b)(4) contained (b)(4) cases of Crown 3 (Part 836-028, Lot I1CDC) for a total of (b)(4) units however; this part was not listed on the Physical Inventory Count Sheets for this bin.
Subpart L–Handling, Storage, Distribution, and Installation
Sec. 820.150 Storage
(a) Each manufacturer shall establish and maintain procedures for the control of storage areas and stock rooms for product to prevent mixups, damage, deterioration, contamination, or other adverse effects pending use or distribution and to ensure that no obsolete, rejected, or deteriorated product is used or distributed. When the quality of product deteriorates over time, it shall be stored in a manner to facilitate proper stock rotation, and its condition shall be assessed as appropriate.
(b) Each manufacturer shall establish and maintain procedures that describe the methods for authorizing receipt from and dispatch to storage areas and stock rooms.
Managing the stockroom
In this day and age of high-tech ERP/MRP systems, Dr. D is having difficulty fathoming how an organization cannot successfully manage the identification and traceability associated with storing materials, needed for product realization and finished medical devices. One area that the doctor frequently sees as problematic is the control of age-sensitive materials under special storage conditions. Frequently, Dr. D will cite a client for not having adequate monitoring and control over refrigerators being employed to store epoxies, inks and other adhesives or having expired materials in the refrigerators that have not been removed. Conversely, all remaining material and finished devices being managed in the stockrooms are usually being managed in an orderly manner that facilitates FIFO.
The first concept that comes to mind in regards to inventory control is a simple little concept known as; “cycle counts.” Now granted, Dr. D does not profess to be a supply-chain/material management mastermind; however, it will be an insurmountable task to effectively manage manufacturing if inventory accuracies are significantly off. The problem is only exacerbated when raw materials cannot be located. Can you say; “Line down?” Can you say; “part shortages?”
Here comes broken-record time again. The first step to effectively managing the stockroom commences with a well-scripted written procedure that delineates:
- The material storage process, including location;
- Special storage conditions for age-sensitive or UV light sensitive materials;
- Stockroom access;
- Requirements for identification and traceability;
- The kitting process used to move materials to production;
- A process for issuing replacement materials;
- The storage of customer-supplied materials, as applicable;
- Cycle counts;
- Basic stockroom practices such as FIFO;
- Record keeping; and
- The distribution process (the topic of next week’s guidance).
For this edition of DG, the doctor will leave the readers with just one takeaway. Managing materials in the stockroom is not rocket science people. In fact, material management is one of the most basic functions needed to successful manufacture finished medical devices. If adequate controls are not maintained over raw materials and appropriate identification and traceability maintained, then there will probably be a FDA Form 483 observation in your organization’s future.
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.
- Code of Federal Regulation. (2013, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
- FDA’s enforcement page – warning letters. (2013, October). FDA.gov Website. Retrieved November 3, 2013, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm372239.htm.