. This week the term/phrase specific to Japan, the doctor would like to introduce to the readers is “Arigatou Gozaimasu
” or thank-you very much. This would be the phrase of choice if PMDA has visited your facility for the purpose of performing an inspection and no objectionable conditions were noted. The doctor also believes a slight bow would also be in order.
Chances are most of the big-ticket items consumers purchase such as cars, appliances, even cellular phones, are identified with a model number, serial number, lot number, or some other identification number unique to the item purchased. In fact, the doctor has even seen a CE Mark on an electric guitar. For these same items, there is also a chance of failure and the need for warranty repair work or a warranty replacement. In some cases, potential product failure could result in death or serious industry or a product recall may be in order. Can you say Toyota? Well folks, the medical device industry takes generally accepted identification and traceability requirements and places them on steroids.
In Japan, similar to the United States and Europe, bad devices need to be quickly identified and removed from market, can you say Recall? Can you say Recall in Japanese (リコール)? All kidding aside, identification and traceability are basic foundations associated with product realization and the manufacturing and ultimate distribution of finished medical devices. If your organization is manufacturing capital equipment, then installation and servicing activities will also be driven by proper identification and traceability. Please keep in mind, Dr. D never prefers to employ “dyslogistic” (look-it up) adjectives when providing guidance for a regulation as there is always some level of fundamental need driving the scripting and enforcement of medical device regulations, regardless of country of origin. MO 169 is no different. In fact, the doctor is a big proponent of MO 169 because of its unique alignment with ISO 13485:2003. That being said, Dr. D hopes you enjoy this week’s guidance.
Ministerial Ordinance Number 169 (2004)
Chapter Two “Manufacturing Control and Quality Control in Manufacturing Sites of Medical Device Manufacturers, etc.”
Section Five – Product Realization
Article 47 The manufacturer, etc. shall identify the products by suitable means throughout the product realization.
2. The manufacturer, etc. shall establish the documented procedure for the product identification specified in preceding Paragraph 1.
3. The manufacturer, etc. shall establish the documented procedure to ensure that the products returned to the manufacturer, etc. are identified and distinguished from the conforming products.
Article 48 The manufacturer, etc. shall establish the documented procedure for the traceability.
2. The manufacturer, etc. shall ensure that the documented procedure specified in preceding Paragraph 1 define the extent of the product traceability and the records required.
3. Where the traceability is the requirement, the manufacturer, etc. shall control and record the unique identification of the products.
(Traceability of Specially Designated Medical Devices)
Article 49 In defining the records required for the traceability, the manufacturer, etc. shall include the records of all the constituent parts, etc. and work environment conditions, if these could cause the products concerned with the specially designated medical devices not to satisfy their specified requirements.
2. The manufacturer, etc. shall ensure that the records of the name and address of the shipping package consignee of the products concerned with the specially designated medical devices are maintained.
Article 50 The manufacturer, etc. shall identify the product status with respect to the monitoring and measurement requirements.
2. The manufacturer, etc. shall ensure that the identification of the product status is maintained throughout the production, storage, installation and servicing of the products to ensure that only products that have passed the required inspections and tests (or released under an authorized concession (the permission to use or release the products that do not conform to the specified requirements after the appropriate verification of the manufacturing control and quality control of the products)) are dispatched, used, or installed.
What device manufacturers need to know
For starters, product identification does not mean the blue one, the green one, or the one with the moving parts. That lingo may be appropriate for toys but not so much for medical devices. In fact, similar to the FDA’s QSR and ISO 13485:2003, the regulatory folks in Japan actually would like device manufacturers to establish a written procedure for delineating a practice for product identification throughout the product realization phase. Now granted, the term “suitable means” appears to have some canyon space associated with it; however, the procedure for product identification should contain sufficient granularity to ensure all raw materials, sub-assemblies, non-sterile product, and finished medical devices (sterile and non-sterile) are properly identified. Please keep in mind, Dr. D is a big proponent of placing the requirements for identification and traceability into the same procedure. In fact, it is the doctor’s firm belief that these two requirements go nicely together like peanut butter and jelly, Bonnie and Clyde, and Jack Daniels and Ice.
Another important process that needs to be included in a procedure is the identification and handling of returned product. Not wanting to state the obvious but obliged to do so, returned product that is contaminated needs to be properly identified and handled accordingly, including the segregation and decontamination process. The doctor is sure, well pretty sure, device manufacturers are doing an adequate job of identifying and handling returned-used product as part of their compliant management system. If devices are returned for other reasons such as a recall (リコール), the identification and segregation from conforming products should still be considered a mission-critical event.
Referring back to the analogies, e.g., Jack Daniels and Ice, accurate traceability is rooted in an effective identification process; henceforth, it is impossible to separate the two (ID and Traceability of course). Remember, the level of traceability is ultimately linked to device risk; however, it becomes challenging for device manufacturers to implement varying degrees of traceability to align with device classifications (four in Japan). The best advice Dr. D can offer is just implement the worse-case (most stringent requirement). So for Japan, treat traceability as if all procured materials, influencing the product, packaging, and labeling are being used for Class IV devices. It is always better to proceed with caution.
Remember, the foundation of any traceability starts with the assignment of a lot/batch number. Considering the technologies available in support of state-of-the-art ERP/MRP systems such as SAP, the issuance of a lot/batch number is an automated process premised on the initial receipt of a procured item against a purchase order. However, many smaller device manufacturers are still running ERP/MRB the old-fashion way, manually. There is nothing wrong with a manual system; however, attention to detail is critical to ensure the assignment and management of lot/batch numbers is accurate. One final thought, BOMS, Routers, and Travelers must also capture lot/batch numbers that are accurate, including the most important number, the lot/batch number assigned to finished medical devices.
Although Article 49 is very specific in regards traceability for specially designated medical devices, chances are your organization is going to want to ensure these requirements are met for all products entered into commerce into Japan (the doctor’s humble opinion). As a minimum, the device manufacturer must ensure records relating to shipping, storage, distribution, list of medical devices at each location (accurate inventory), etc. are retained, including name(s) address(es), etc.
Finally, Article 50 falls into the category of a Dr. D “no-brainer.” Device manufacturers must only introduce into commerce medical devices that actually pass all of their testing and inspection requirements, including final acceptance. Now granted, there is a “concession clause” built into Article 50. The doctor’s best advice is not to ship product accepted by concession. Why? Because shipping product premised on a concession can be considered a design change by most regulatory bodies; i.e., FDA, the Competent Authorities, oh yes, and MHLW. Another point Dr. D would like to make, only a competent member of the quality organization, with the authority to approve/sign release documentation, should be permitted to authorize the release of finished medical devices. If the production folks are making the decision to release finished medical devices, rest-assured, bad things are in your organization’s future (remember the doctor is clairvoyant).
What device manufacturers need to do
For starters, try listening to Dr. D for a change, because the doctor has a track record in keeping Chief Jailable Officers (CJOs) from rotting in some prison. Quick note: continue to work on your organization’s traceability matrix (reference Table 1.0) mapping MO 169 to your QMS. As the doctor stated earlier, it is strongly recommended to establish a stand-alone procedure for Identification and Traceability. The doctor often sees medical device manufacturers bury the ID and Traceability requirement either into a broad-based product realization SOP or nestle it into an Inventory Management SOP. Folks, regulators do not like to dig for evidence of compliance in device manufacturers procedures. You really need to make the lives of the regulators easier. The best way to do so is clear and concise procedures that align with their regulations or in the case of this series of articles MO 169.
Additionally, it is best to create one system for traceability and stick with it. If the traceability process contains too many variables, it is inevitable that Murphy will eventually raise his ugly head (code for human error). The doctor always preaches PPL. Parts, Packaging, and Labeling employed in the manufacture of finished medical devices, should be controlled and traceable through the use of a batch/lot number. Believing in Dr. D’s preaching will pay dividend should a recall (リコール) become necessary. Man the doctor loves that six-letter word.
| Procedure Name
||21 CFR Part 820
|EN ISO 13485: 2003
| MHLW MO 169
| 1261-1 Rev A
|| ID & Traceability
|| Article 47
| 1261-1 Rev A
|| ID & Traceability
| 1261-1 Rev A
|| ID & Traceability
|| Traceability of Specially Designed Medical Devices
1261-1 Rev D
| Acceptance Status
|| Status Identification
For this edition of DG, the doctor will leave the readers with just two takeaways. One – establish just one stand-alone procedure for Identification and Traceability. ID and Traceability go together like pretzels and beer so it only makes sense to combine the requirements into one SOP. Two – parts, packaging, and labeling should be included in the traceability system. Having immaculate traceability will pay dividends should a product recall (リコール) become necessary.
Until the next edition of DG, when the doctor begins providing guidance on MO 169 – Chapter 2, Section 5 “Product Realization” (Articles 51 and 52 – Customer Property and Preservation of Products), sayonara from Dr. D and best wishes for continued professional success.
- Code of Federal Regulation. (2011, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
- EN ISO 13485:2003. (2004, February). Medical devices – quality management systems – requirements for regulatory purposes (ISO 13485:2003).
- Ministerial Ordinance 169. (2004). MHLW ministerial ordinance 169 on standards for manufacturing control and quality control for medical devices and in-vitro diagnostic reagents. Retrieved June 1, 2012, from http://www.pmda.go.jp/english/service/pdf/ministerial/050909betsu3.pdf.
Instead of attempting to rationalize why your current approach to identification and traceability is acceptable, just bite the bullet and script a high-level SOP.
Make sure that the procedure scripted by your organization addresses all of the requirements associated with “Improvement” (Article 62). Since most medical device manufacturers get the complaint management piece right, let’s focus on what is often missed.
The most important piece of information that you can garner for Article 80 is the change in time-period duration for record retention.
There are some unique record-retention requirements associated with Ministerial Ordinance 169: So employ a little bit of common sense and script just one well-written SOP for all of your organization’s needs.