Ohayou Gozaimasu. This week the term/acronym, specific to Japan, the doctor would like to introduce to the readers, is Registered Certification Body (RCB). The RCB are companies (third-party certification bodies), such as BSI and TUV-R, that have been empowered by MHLW to review and certify certain Class II Devices (specified controlled medical devices). MHLW Notification 252 contains the list of approved RCBs. For those organizations planning on entering Class II devices into the Japanese market, the doctor strongly suggest becoming familiar with the regulatory pathway.

In this week’s guidance, Dr. D will talk about management responsibility requirements. Sometimes using the terms management and responsibility in the same sentence is an oxymoron not unlike military intelligence (the doctor’s humble opinion). However, management responsibility is a fundamental requirement in most regulatory environments, such as the FDA’s Quality System Regulation (QSR) 21 CFR, Part 820; EN ISO 13485:2003; and the subject of this series of Devine Guidance, Ministerial Ordinance 169. Considering MO 169 parallels ISO 13485 in so many areas, I am sure many of my readers are mafficking (look-it-up) with joy at the ability to leverage many of the ISO clauses in achieving compliance. However, do not be drawn into a false sense of security in regards to compliance. There are regulatory requirements intertwined within MO 169 that are not specifically address by ISO 13485. The best advice Dr. D can offer is to be diligent in your organization’s review and mapping of your QMS to MO 169. That being said, the doctor hopes each of you enjoy this week’s guidance.

Ministerial Ordinance Number 169 (2004)

(Management Commitment)

Article 10 The top management shall provide evidence of its commitment to the development and implementation of the quality management system and maintaining its effectiveness by conducting the following duties.

1. To establish the quality policy,
2. To ensure that the quality objectives are established,
3. To conduct the management reviews specified in Paragraph 1 of Article 18,
4. To ensure the availability of the resources, and
5. To communicate to the manufacturing site the importance of meeting the requirements of the marketing authorisation holder and other bodies receiving the products (hereinafter referred to as “customers”) (hereinafter referred to as “customer requirements”) as well as the regulatory requirements.

(Customer Focus)

Article 11 The top management shall ensure that the customer requirements are determined and are met.

Article 12 The top management shall ensure that the quality policy meets the following requirements.

1. To be appropriate to the purpose of the manufacturer, etc.,
2. To include the commitment to comply with the requirements and to maintain the effectiveness of the quality management system,
3. To provide the framework for establishing and reviewing the quality objectives,
4. To be communicated and understood within the manufacturing site, and
5. To be reviewed for continuing suitability.

(Quality Objectives)

Article 13 The top management shall ensure that the quality objectives, including those needed to meet the requirements for the products, are established at relevant departments within the manufacturing site.

(Quality Management System Planning)

Article 14 The top management shall ensure that the planning of the quality management system is carried out in order to meet the requirements specified in Article 5, as well as the quality objectives.

1. The top management shall ensure that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

(Responsibility and Authority)

Article 15 The top management shall ensure that the responsibilities and authorities of the departments and personnel engaged in the duties are defined, documented and communicated within the manufacturing site.

1. The top management shall establish the interrelation of all personnel who manage, perform and verify the work affecting the quality, and shall ensure the independence and authority necessary to perform these tasks.

(Responsible Engineering Manager)

Article 16 The top management shall ensure that the responsible engineering manager specified in Paragraph 5 of Article 17 of Law and the manager controlling the manufacturing of the biological-origin products (the biological-origin products specified in Paragraph 9 of Article 2 of Law, and hereinafter referred to as such) specified in

Paragraph 1 of Article 68-2 of Law (in case of a foreign manufacturer, the person responsible for the manufacturing site which has been recognised in accordance with the provision of Paragraph 1 of Article 13-3 of Law or the person designated beforehand by such a foreign manufacturer) (hereinafter collectively and simply referred to as “responsible engineering manager”) have the responsibility and authority for the following duties.

1. To ensure that the processes needed for the quality management system are established, implemented and maintained,
2. To report to the top management on the performance of the quality management system and any need for improvement, and
3. To ensure the promotion of the awareness of the regulatory and customer requirements throughout the manufacturing site.

(Internal Communication)

Article 17 The top management shall ensure that appropriate communication processes are established within the manufacturing site and that communication takes place regarding the effectiveness of the quality management system.

Article 18 The top management shall review the manufacturing site’s quality management system, at the interval defined in the plan specified in Paragraph 1 of Article 14, to ensure its continuing suitability, adequacy and effectiveness. This review (hereinafter referred to as “management review”) shall include assessing the opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.

1. The manufacturer, etc. shall ensure that the records from the management reviews are maintained.

(Review Input)

Article 19 The manufacturer, etc. shall ensure that the input to the management review includes the information on the following items.

1. The results of the audits,
2. The customer feedback,
3. The process performance and product conformity to the product requirements,
4. The status of the corrective actions (the actions taken to eliminate the cause of the detected non-conformity or other undesirable situation, and hereinafter referred to as such) and the preventive actions (the actions to eliminate the cause of the potential non-conformity or other undesirable potential situation, and hereinafter referred to as such),
5. The follow-up actions from the previous management reviews,
6. The changes that could affect the quality management system,
7. The recommendations for improvement, and
8. New or revised regulatory requirements.

(Review Output)

Article 20 The manufacturer, etc. shall ensure that the output from the management review includes any decisions and actions related to the following items.

1. The improvements needed to maintain the effectiveness of the quality management system and its processes,
2. The improvement of the products related to the customer requirements, and
3. The resource needs to ensure continuing suitability, adequacy and effectiveness of the quality management system.

Similar to the QSR (820.20) and EN ISO 13485:2003 (5), the Management Responsibility is a salient requirement of MO 169. Device manufacturers wishing to play in Japan’s device industry sandbox are expected to:

1. Have an established quality policy;
2. Establish realistic quality objectives;
3. Actually hold a value-added management review;
4. Hire and retain adequate resources to actually run the business (including QA and RA); and
5. Communicate the importance of meeting requirements (product, regulatory, and quality) to all employees.

Please feel free to remind the management team the proverbial buck stops with them as they own the responsibility for ensuring customer requirements are achieved.

MO 169 also requires that the quality policy, established by an organization, to be more than just hollow words. For example, if your policy is “our devices save lives” then you need to ensure the quality policy is woven into the fabric of the QMS, including the identification of quality objectives that align with the policy. Additionally, documented training to the quality policy is a fundamental requirement, as is the ongoing review of the policy (typically during management review) to determine the policy’s ongoing adequacy and appropriateness. Simply stated, Article 12 is all about “the policy, the whole policy and nothing but the policy.” 

Furthermore, once the quality objectives are established, they actually have to be measureable. What, we have to actual collect data in support of determining the accuracy and effectiveness of the quality objectives Dr. D? Who knew? Seriously folks, if one of the quality objectives is to have a 99 percent outgoing quality level for products, you actually have to collect data and prove the objective is being achieved. Ensure that a review of these objectives becomes an inherent part of the management review process.

An area that the doctor often sees overlooked when auditing QMS’s for clients, is the QMS planning piece required not only by the QSR and ISO, but also required by MO 169.  Obviously, regulations seldom if ever remain in a steady state, so one would expect a QMS to be equally dynamic. That being said, QMS procedures cannot be arbitrarily revised. When changes are made to the QMS, the impact and overall effectiveness of these changes must be assessed. Changes and potential changes to policies and procedures that influence the QMS must be considered inputs into the management review process.

Folks, whether you like it or not, someone has to be in charge. Similar to ISO and QSR requirements; and United States Marine Corps 101, there must be a competent leader(s). The people in charge must have the appropriate authority and responsibility to effectively execute within their functional areas of responsibility. For example, the person in charge of quality must be able to take appropriate action to ensure ongoing product safety and efficacy is sustained. If a quality manager is also the manufacturing manager, the independence required by MO 169 is probably not going to be achieved. Additionally, similar to ISO and the QSR, a management representative (responsible engineering manager) for quality is a basic requirement.   This deputized individual is responsible for keeping the management team informed of all quality results; including the good, the bad, and the ugly (not the movie). If an organization pursues the “Emperor’s New Clothes” approach and only blows the proverbial sunshine onto the backsides of management, then an effective approach to quality management is not going to be realized. As a minimum, the management representative is expected to:

1. Ensure the device manufacturer has correctly established and implemented the QMS;
2. Report QMS effectiveness to management; and
3. Ensure all employees are continuously made aware of regulatory and customer requirements (remember – requirements will never be static).

It is extremely important that organizations can effectively communicate. The communication channels established between internal customers is just as important as communication channels with external customers. No one ever wants to hear the famous quote from the 1967 move Cool Hand Luke; “What we have here is a failure to communicate.”

 Similar to ISO and the QSR, MO 169 has a fundamental requirement for device manufacturers to actually hold management reviews. Remember, management reviews should be much more than a one-hour meeting where the QA and RA folks show MS Power Point™ slides. The management review meeting should be an interactive discussion on an organization’s performance (past, present, and future). Dr. D recommends creating an agenda that aligns with defined management review inputs and outputs requirements. As for the review inputs and outputs, they exactly mirror EN ISO 13485:2003. If necessary, cut and paste the requirements right from MO 169, as there is no need to reinvent the proverbial wheel. Additionally, do not forget the actual sign-in sheet needed to support evidence of compliance. As for the frequency of meetings, the requirement is annually. However, the doctor believes that holding a once-per-year meeting is really not effective. Holding meetings semi-annually is better, quarterly even better yet, and monthly would be considered best-in-class.

What device manufacturers need to do

Dr. D is going to begin this section with a brief story. A friend of mine sent me an email emphatically stating that PMDA has never showed up at their facility to perform a QMS assessment against MO 169. In fact, he actually called out the old doctor and said I was wrong to suggest a visit from PMDA would ever occur. The doctor quickly provided evidence that PMDA has in fact audited foreign manufactures shipping Class III and IV devices into Japan. After an apology was given (and accepted), the doctor offered to contact PMDA on behalf of my friend’s company. He politely declined. The moral of this story is simple. PMDA retains the right to visit foreign device manufacturers, and they do perform audits on occasion.

By now I am sure you have already reached the conclusion that the doctor believes that there is no such thing as minimum compliance or maximum compliance, just compliance. If the readers have a firm grip of this concept then they are clearly ahead in the medical device manufacturing game. Similar to the past editions of DG, the doctor implores the readers to adopt a requirements matrix to ensure MO 169 requirements are accurately mapped to the QMS.

Since all of Section 3 (Management Responsibility) is a salient requirement of MO 169, compliance is not optional. The good news is that the requirements do in fact mirror EN ISO 13485:2003. If your organization’s notified body has approved your QMS and issued a certificate stating the compliance; your organization should be okay in regards to complying with Section 3.   

Table 1.0 – Sample Matrix
Procedure	Requirement	21 CFR, Part 820	EN ISO 13485:2003	MHLW MO 169
1243-1 Rev A	Management Responsibility	820.20	5	Article 10
1243-1 Rev A	Customer Focus	N/A	5.2	Article 11
1243-1 Rev A	Quality Policy	820.20(a)	4.2.2	Article 12
1243-1 Rev A	Quality Objectives	820.20(a)	5.4.1	Article 13
1244-1 Rev B	QMS Planning	820.20(d)	5.4.3	Article 14
1243-1 Rev A	Responsibility & Authority	820.20(b)(1)	5.5	Article 15
1243-1 Rev A	Responsible Engineering Manager	820.20(b)(3)	5.5.2	Article 16
1243-1 Rev A	Internal Communication	820.20	5.5.3	Article 17
1245-1 Rev C	Management Review	820.20(c)	5.6	Article 18
1245-1 Rev C	Review Input	820.20(c)	5.6.2	Article 19
1245-1 Rev C	Review Output	820.20(c)	5.6.3	Article 20

Takeaways

In support of ensuring an effective QMS is sustained in accordance with MO 169, management responsibility should be considered a mission-critical requirement. That being said, Dr. D will leave the readers with three takeaways. One – management review meetings are extremely important. Establish a schedule for the reviews and adhere to it. Two – the organization’s management representative must be a dedicated resource. Having a representative tasked with quality and manufacturing duties never works. Finally, establishing the quality policy is immensely important. Once the policy is established, ensure all employs are trained to it. In fact, the doctor firmly believes that posting the quality policy throughout a manufacturing facility (multiple languages if necessary) is a great practice.

Until the next edition of DG, when the doctor provides guidance on MO 169 – Chapter 2, Section 4 “Resource Management” (Articles 21 through 25), sayonara from Dr. D and best wishes for continued professional success.

References: 

1. Code of Federal Regulation. (2011, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
2. EN ISO 13485:2003. (2004, February). Medical devices – quality management systems – requirements for regulatory purposes (ISO 13485:2003).
3. 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