Ohayou Gozaimasu. This week the term/phrase specific to Japan, the doctor would like to introduce to the readers, is “Tetsudatte kuremasuka” (手伝ってくれますか？). The literal translation, can you help me? If your organization is struggling with the comprehension of or the execution of mapping your QMS to Ministerial Ordinance 169 (MO 169), do not be afraid to ask for help. Obviously, Dr. D is available to help but so are organizations like The Emergo Group. In fact, do not be afraid to approach PMDA or MHLW if you have questions. The Japanese regulatory authorities are very gracious and will provide useful information upon request. Regardless of the path pursued, while attempting to find help in the pursuit of complying with MO 169, the doctor will always be willing to bestow an Irish “benison” (look-it-up) and offer some Devine Guidance in an effort to light the way. Dr. D hopes the readers 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 51 The manufacturer, etc. shall identify, verify, protect and safeguard the customer property provided for the use or incorporation into the products.
2. The manufacturer, etc. shall ensure that, if any property of the customer is lost or otherwise found to be unsuitable for use, the details are reported to the customer and records thereof are maintained.
(Preservation of Products)
Article 52 The manufacturer, etc. shall establish the documented procedure or documented work instructions for preserving the conformity of the products (including the identification, handling, packaging, storage and protection) during the internal processing and delivery to the intended destination. The preservation shall also apply to the constituent parts of the products.
2. The manufacturer, etc. shall establish the documented procedure or documented work instructions for the control of the products with the limited shelf life or requiring the special storage conditions.
3. The manufacturer, etc. shall ensure that the special storage conditions specified in preceding Paragraph 2 are controlled and recorded.
What device manufacturers need to know
For readers familiar with the FDA’s QSR (21 CFR, Part 820), the QSR does not speak to customer-supplied property or material; however, EN ISO 13485:2012, 7.5.4 does. One of the obvious reasons behind the QSR is that the regulation provides oversight for medical device manufacturers, period! In fact, under the QSR all materials, regardless of origin, should be properly identified, protected, preserved, and safeguarded. Since MO 169 is clearly aligned with 13485, it only makes sense to align all requirements with the standard. Does that make sense? The scary thing is it makes absolute sense to the doctor. That being said, if customer-supplier material is being managed and eventually incorporated into a finished medical device (typically contract manufacturers) then some level of control is required. As a minimum:
- Material receipt;
- Material inspection;
- Material storage;
- Material traceability; and
- A process for customer notification for non-conforming customer-supplied material is required.
Similar to the QSR and identical to ISO 13485 requirements, the Japanese expect: (a) material identification; (b) material handling, (c) material packaging, (d) material storage; and (e) material protection to be adequately applied during the manufacturing process. In fact, the expectation is that proper material handling occurs throughout the entire supply chain. After all, physicians at Okusawa Hospital and Clinic, expect to have the medical devices that they procure, in one piece and fully functional out of the package. For all of you packaging engineers (hint, hint) that means the packaging schemes that you design and employ need to be robust. Can you say ISO 11607-2 & -2?
If medical devices or the raw materials employed in the manufacturer of medical devices require special handling, storage conditions, or are age-sensitive, the requirements for the handling and storage of this material must be defined within a procedure, the material adequately identified, and special conditions monitored. For example, medical grade adhesives are often stored at reduced temperatures to facilitate and prolong shelf-life. If a refrigerator is employed for storage, please do not forget to place a calibrated thermocouple, attached to a calibrated thermometer, to facilitate the monitoring. Even better, a calibrated chart recorded will reduce the reliance on hand-written entries onto a log sheet.
What device manufacturers need to do
If you already guessed that the doctor was going to insist that you create a requirements matrix (reference Table 1.0), thank you for reading Dr. D’s rants and paying attention. For those of you astute enough to notice that the doctor has been building the matrix for you since inception of this series on MO 169, you are welcome. All kidding aside, a QMS is only as robust as the written procedures and the personnel tasked with executing their duties in accordance with the written procedures. Articles 51 and 52 are no difference in regards to establishing written procedures. Granted, managing customer property and customer-supplied material is not a salient requirement for the FDA; however, for the MHLW it is very much so. The doctor recommends that the procedure created clearly define:
- Customer-supplied material receipt practices;
- Customer-supplied material inspection practices;
- Customer-supplied material identification practices;
- Customer-supplied material traceability practices;
- Customer-supplied material handling practices;
- Customer-supplied material inventory practices;
- Customer-supplied material non-conforming material practices; and
- Customer-supplier material customer notification practices.
Now before you go off on a tangent and commence with the cursing of Dr. D under your breath, the doctor has seen far too many organizations attempt to nestle these requirements into multiple procedures in an effort to save on the number of SOPs an organization scripts. This approach almost always leads to compliance issues. The management of customer property is important enough to warrant a stand-alone SOP.
Speaking of stand-alone SOPs, the preservation of product is another prime candidate where organizations attempt to spread the requirement though existing SOPs and work instructions. Once again, it is the doctor’s humble opinion that a stand-alone SOP should be generated. Now granted, identification, handling, packaging, storage and protection of material and finished devices will probably have their own SOP or work instruction for each element, e.g., packaging, requirements associated with special handing or age-sensitive material is often missed. Dr. D is going let you in on a little secret, properly managing age-sensitive material or monitoring special storage conditions are often cited as minor non-conformances when Dr. D performs audits for my clients. In fact, properly managing age-sensitive material is cited by the doctor a whopping 70 percent of the time. Man that is a lot of deviations being generated by Dr. D. The moral of the story here is quite simple, establish a robust approach to product preservation and avoid the audit deviations from Dr. D or some other regulatory body (like PMDA).
||21 CFR, Part 820
| EN ISO 13485: 2003
|MHLW MO 169
| 1263-1 Rev A
|| Management of Customer Property
|| Customer Property
|| Article 51
| 1264-1 Rev A
|| Preservation of Products
|| Preservation of Products
|| Article 52
The doctor will leave the readers with just two takeaways for this week. One – although customer property and the management and handling of customer-supplied material is not important for the FDA, that is clearly not the case for MHLW. Make sure that your organization establishes a dedicated and robust procedure for addressing the Customer Property requirement delineated within MO 169, Article 51. Two – preservation of products is important in all regulatory environments. Once again, it is important to create a robust SOP with sufficient granularity to address all Article 52 requirements. Make sure the control of age-sensitive materials and special storage requirement (including environments) are adequately addressed in the procedure.
Until the next edition of DG, when the doctor provides guidance on MO 169 – Chapter 2, Section 5 “Product Realization” (Article 53 – Control of Monitoring and Measuring Devices), 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 13485:2012. (2012, February). Medical devices – quality management systems – requirements for regulatory purposes (EN ISO 13485:2012).
- Linguanaut the Japanese phrases and expressions. (2012). Retrieved September 8, 2012, from http://www.linguanaut.com/english_japanese.htm
- 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.
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.
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.
Training is one of the areas that result in many non-conformances being issued during quality system audits.