Did you miss old doctor? Dr. D is back from a two-week hiatus that included some drinkin’ and thinkin’, and is again ready to continue with the dispensing of guidance for solving the day-to-day challenges associated with the medtech industry. Helping Chief Jailable Officers (CJOs) navigate the often treacherous regulatory waters associated with compliance to quality, regulatory and statutory requirements has always been one Dr. D’s salient goals, along with providing a few chuckles. Besides, there is no better forum then one that allows the readers to laugh and learn at the same time.

For this week’s guidance, Dr. D will explore the value of preventive maintenance and the perils associated with failing to maintain equipment (including accurate documentation) employed for the manufacture, inspection and acceptance testing of medical devices. Next to hiring, training, and retaining a good staff, manufacturing and inspection equipment is the second most important investment device establishments can make (Dr. D’s humble opinion). Depending on the piece of equipment, the initial investment is probably going to cost device establishments thousands of dollars to procure and install. If the equipment malfunctions or even worse crashes, the cost of repairs can be quite expensive. Additionally, the cost of having a labor force sit idle while repairs are made can be equally expensive, especially when the entire manufacturing line comes to a screeching halt. Depending on the severity of the problem and the duration of the down time, a severe interruption in the supply chain quickly becomes a reality. Just ask your sales force. However, there is a viable solution. Can you say preventive maintenance? The establishment referenced in this week’s Devine Guidance had some issues with their preventive maintenance (PM) program (lack of documentation) and as a result, the investigator scripted a Form 483 observation. Unfortunately for this establishment’s CJO, a warning letter was eventually issued. Dr. D strongly believes that CJO’s need to have a panoptic (look-it-up) view of their establishment’s quality management system (QMS) to ensure that compliance to the agency’s quality system regulation (QSR) continues to be sustainable. Enjoy!

Warning Letter – August 5, 2016

Having a well-documented and effective approach for PM activities is a fundamental requirement for ensuring the manufacturing line remains flowing with fabulous medical devices that are safe and effective in their intended use. In fact, Dr. D struggles to understand why device companies would fail to protect their investments. For example, injection molding presses and five-axis CNC milling machines are expensive pieces of capital equipment. Common sense would dictate the need for a robust PM program to protect the investment. Equally important, as this week’s offending establishment found out, is the documentation. As most of you already know, if an activity or event is not documented in writing, in the eyes of the FDA, it never happened.

Warning Letter Excerpt

Observation Five (5) “Failure to establish and maintain schedules for the adjustment, cleaning and other maintenance of equipment to ensure that manufacturing specifications are met, as required by 21 CFR 820.70(g)(1). Specifically, your “Equipment Preventive Maintenance” schedule, 07-SRG-005, revision 4, is not being implemented in that:

a)  The schedule states for the (b)(4) Water, which is used to purify the water used in manufacturing the Hemolysis and Wash Solution, to “Replace Cartridges and sanitize bowl/heads 1 yr or if pressure becomes too high”. Your procedure does not specify a pressure limit but the (b)(4) instruction manual states the cartridge should be changed “with a membrane cartridge installed in Bowl #4, and the pressure differential between #3 exceeds 10 psi”. Device History Records for Lots HW-389-JU and HW-380-JU each showed a 20 psi pressure differential. The cartridge has not been replaced.

b)  The schedule states for the Main Warehouse Refrigerator to “Inspect quarterly (TSMD log)”. There are only 3 “WALK IN COOLER/FREEZER” forms completed in 2015 and there are no forms/records of inspection for 2016.”

FDA Response

“Your response cannot be assessed at this time. You state that you will revise your procedures to reference the appropriate documentation for the (b)(4) system in use; and will review your procedures for the Refrigerator Maintenance and assure the PM is completed by August 30, 2016. Please provide an update regarding your corrective action.”

21 CFR, Part 820.70(g)(1) – Production and Process Controls

(g) Equipment. Each manufacturer shall ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use.

(1) Maintenance schedule. Each manufacturer shall establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met. Maintenance activities, including the date and individual(s) performing the maintenance activities, shall be documented.

Compliance for Dummies

For starters, there are a plethora of software options for managing PM activities, including ones that essentially link the PM and calibration programs. Depending on a piece of equipment’s sophistication level, some form of calibration (i.e., time, temperature, pressure, etc.) may be required, along with the manufacturer’s specified PM schedule. For example, a Swiss turning cell (CNC Lathes for those of you not familiar with the equipment) or injection molding machines will typically have a daily, weekly, monthly, quarterly and annual PMs. Each of these PM activities will have a unique set of requirements that must be documented. Dr. D believes good maintenance types are worth every dollar they earn. However, they will be the first to tell you. “It is not possible to remember when each piece of equipment is scheduled for their PM and the specific PM activities required.” It is imperative that a documented schedule be prepared that captures when each PM is due. Additionally, it is equally important to have work instructions that define how the PMs are performed and data collection forms to collect and capture all of the activities performed. As the doctor previously mentioned, if it is not documented in writing (or captured in a computer file) the event and/or activity never happened. Furthermore, it is an acceptable practice to retain a qualified third-party to perform PMs. If the equipment requiring a PM is complex, bringing in a qualified service technician may be the best option. Just ensure that their work activities are documented.

Meeting §820.70(g)(1) requirements is not a difficult task. For starters, the equipment employed in support of manufacturing must be appropriately designed and suited for the task.  Additionally, the following tasks are required in accordance with the regulation:

• Establishing a PM schedule for adjusting, cleaning and maintaining equipment
• Keeping a documented record of all PM activities performed
• Ensuring the PM records contain the name(s) of the individual performing the PM activities and the date(s) the PM activities were completed

Takeaways

For this week’s guidance, the doctor will leave the readers with three takeaways. One: Create an annual PM schedule that delineates when PM activities are to be performed. Two: Make sure all PM activities (including names and dates) are captured in a permanent record. Three: If an activity or event is not documented in writing, in the eyes of the FDA (and Dr. D) it never happened. In closing, thank you again for joining Dr. D, and I hope you found 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. (April 2015). 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. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
4. FDA. (August 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Tosoh Bioscience, Inc. Accessed August 30, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm516914.htm