I’M BACK! HELLO! Ohayou Gozaimasu. This week the term/phrase specific to Japan, the doctor would like to introduce to the readers is: “kishi kaisei” For those of you moderately fluent in Japanese, the phrase is: “起死回生” The literal translation is “Wake from death and return to life” or simply stated, “To come out of a desperate situation and make a complete return in one sudden burst.” As Dr. D likes to say; “Even a blind squirrel finds a nut sometimes.” If this comment is coming from MHLW, device manufacturers should not take this as a compliment. It means it about time the device manufacturer did something right.
For this edition of DG, the doctor will expand on the concept of responsible engineering manager, a requirement somewhat unique to Japan. It is the doctor’s hope; and through the employment of a little bit of “ratiocination” (look-t-up), the readers will come to understand this unique requirement. Dr. D hopes you have your ceremonial swords ready to fall on. Enjoy.
Ministerial Ordinance Number 169 (2004)
Chapter 3 Manufacturing Control and Quality Control in Manufacturing Sites of Labeling, etc. – Category Medical Device Manufacturers, etc.
(Responsible Engineering Manager)
Article 65 The responsible engineering manager shall conduct the following duties.
(1) To supervise the duties of the manufacturing control and quality control, to evaluate properly the results of the manufacturing control and quality control, and to decide whether or not releasing the products from the manufacturing site.
(2) To conduct the duties specified in Articles 68 and 71
(3) To verify that the internal audits have been conducted appropriately based on the documents reported in accordance with the provision of Item (2) Paragraph 1 of Article 70.
2. The labeling, etc.-category medical device manufacturer, etc. shall ensure that the responsible engineering manager can conduct his/her duties without hindrance.
What device manufacturers need to know
In support of meeting this requirement, the Japanese regulatory authorities are looking for a person to be formally named as the Chief Jailable Officer (CJO) or better suited for Japan someone to fall on the proverbial sword, a.k.a., the Chief Impalable Officer (CIO).
Seriously, as described, the responsible engineering manager is nothing more than the device manufacturer’s senior quality person, e.g. VP of Quality, Quality Director, or Manager assigned the responsibilities. Although the position appears similar to the management representative denoted in ISO 13485:2003 or 21 CFR, Part 820, the duties of the responsible engineering manager encompass more than the typical management representative. It is important to remember this individual is responsible for ensuring that only quality medical devices, that are safe and effective, find their way out of the facility and into Japan’s medical device market; otherwise, the sword becomes an option.
Other responsibilities besides the manufacturing control, quality control, and product release, are:
• The control of nonconforming product (Article 68);
• The execution of internal audits of manufacturing and quality (Article 70) just include everything to be safe; and
• The implementation of a training program.
What device manufacturers need to do
The doctor always recommends scripting a procedure that clearly delineates the role and responsibility of the responsible engineering manager. It is also recommended to have a delegation letter and reflect this person’s role on the organizational chart shared with the Japanese regulatory authorities. The letter of delegation should be accompanied with a blood oath that commences with I “name of responsible engineering manager” do solemnly swear to fall on a sword … (just kidding about the oath).
As a minimum, the procedure should contain specific references to: (a) manufacturing control; (b) quality control; (c) product release; (d) internal audits; (e) non-conforming product; (f) training and (g) impaling (just kidding on the impaling piece). It is acceptable to add additional duties and responsibilities, as appropriate for the organization. However, make no mistake, the responsible engineering manager must have the authority to shut down shipments if and when product performances issues occur. If the responsible engineering manager has to get permission to act independently (e.g., stop production), or in the interest of protecting patient safety, then this individual is not have the “juice” (appropriate level of authority within the organization). This will need to be fixed ASAP, let Dr. D repeat – this will need to be fixed ASAP!
Now granted, it is expected that the responsible engineering manage will seek appropriate input prior to making decisions impacting the device manufacturer. No one likes surprises; and Dr. D can tell you from personal experiences there is nothing like greeting the plant’s general manager in the morning with a hardy; “Good morning, by the way I shut your manufacturing line down last night.”
For those of you continuing to build your matrix, Table 1 contains the requirements matrix for this edition of DG. Although there is no direct correlation to 21 CFR, Part 820 or ISO 13485:2003, the doctor has taken the liberty to add pointers to the management representative requirement in these documents.
||21 CFR, Part 820
||EN ISO 13485:2003
||MHLW MO 169
1273-1 Rev A
|Responsible Engineering Manager
||Responsible Engineering Manager
For this edition of DG, the doctor will leave the readers with three takeaways. One – the responsible engineering manager’s role is unique. It is recommended that a procedure be scripted that clearly delineates the responsibilities as they pertain to MO169 and Articles 65, 68, 70, and 71. Two – it is considered a best practice to identify the role of the responsible engineering manager on an organization chart and document the role through the use of a letter of delegation. Three – if the CIO does not own a sword, a fork from the cafeteria will suffice, just kidding on the fork; use a spoon instead.
Until the next edition of DG, when the doctor provides guidance on: MO 169 – Chapter 3 “Manufacturing Control and Quality Control in Manufacturing Sites of Labeling, etc. Category Medical Device Manufacturers, etc.” (Article 66 – Documents Concerned with Manufacturing and Quality Control), 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