Devine Guidance
Management Review

Dr. Christopher Joseph Devine, President, Devine Guidance International

Folks, this week Dr. D is going to talk about a topic that is almost never cited as a Form 483 observation or in an agency warning letter, Management Responsibility and specifically, Management Review.

Frequently, the doctor likes to throw around one of his favorite terms, the Chief Jailable Officer (CJO), typically the most senior quality/regulatory person at a company. However, there can be more than one. In fact, if you are part of the executive management team, you should be orange-jumpsuit ready if you or your organization is not doing the right things. So why management review Dr. D? During my weekly visit to the FDA warning letter database, the doctor came across a warning letter that cited a device manufacturer for not performing management reviews. People, holding a management review meeting is one of the most basic elements of an effective quality management system (QMS), period! If your organization is not actively pursuing management review meetings then the doctor “importunes” (look-it-up) you to start by holding one as soon as humanly possible. For all you CJOs that are struggling to get your management team to attend management reviews; please reinforce the requirement with your team. Feel free to share the warning letter from this week’s guidance and remember: “The buck stops with the management team!” Enjoy.

Subpart B–Quality System Requirements
Sec. 820.20 Management responsibility 
(a) Quality policy. Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization.
 
(b) Organization. Each manufacturer shall establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of this part.
 
1.  Responsibility and authority. Each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks. 
2. Resources. Each manufacturer shall provide adequate resources, including the assignment of trained personnel, for management, performance of work, and assessment activities, including internal quality audits, to meet the requirements of this part.
3. Management representative. Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for:
i. Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and
ii. Reporting on the performance of the quality system to management with executive responsibility for review.
 
(c) Management review. Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer’s established quality policy and objectives. The dates and results of quality system reviews shall be documented.
 
(d) Quality planning. Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met.
 
(e) Quality system procedures. Each manufacturer shall establish quality system procedures and instructions. An outline of the structure of the documentation used in the quality system shall be established where appropriate.
Warning Letter Excerpt – 09 August 2013
Folks, as Dr. D mentioned in the introduction, management responsibility is one of the lesser cited issues by the FDA as a Form 483 observation or in a warning letter. However, that doesn’t mean it is not important. In fact, management responsibility and the management review requirement are immensely important. Just in case your organization needs a friendly reminder, Dr. D has taken the liberty to share an excerpt from a recently issued warning letter.
 
“Failure of management with executive responsibility to review the suitability of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure the quality system satisfies the requirements of this part, as required by 21 CFR 820.20(c). For example, your firm failed to establish management review procedures and conduct management reviews as a manufacturer of a medical device.”
 
Management responsibility
From a requirements perspective, complying with management responsibility is child’s play in the doctor’s humble opinion. The regulation breaks management responsibility down into five buckets: (a) quality policy; (b) organization; (c) management review; (d) quality planning; and (e) quality system procedures. Considering the quality policy, organizational structure, planning, and the scripting of procedures is a given for any organization, how can management review or should Dr. D state; “lack of management review” be an issue. From an FDA’s perspective, organizations do not even have to share the content of the management review meeting. All that is required is evidence of a meeting being held and an agenda. Can you say meeting sign-in sheet?
Management review
The doctor is a big proponent of the ISO 13485:2003, Clause 5.6 for use as a blueprint for the management review process. As previously stated by the doctor, evidence of compliance to the management review requirement must be provided, upon request, when asked for by an FDA investigator. If you garner any useful information from this week’s diatribe, please let it be that “establishments do not have to provide the content of management reviews to FDA!” If you do not believe Dr. D, the doctor suggests reading §820.180(c) (Exceptions).
 
(c) Exceptions. This section does not apply to the reports required by 820.20(c) Management review, 820.22 Quality audits, and supplier audit reports used to meet the requirements of 820.50(a) Evaluation of suppliers, contractors, and consultants, but does apply to procedures established under these provisions. Upon request of a designated employee of FDA, an employee in management with executive responsibility shall certify in writing that the management reviews and quality audits required under this part, and supplier audits where applicable, have been performed and documented, the dates on which they were performed, and that any required corrective action has been undertaken.
 
Since establishments do not have to share the contents of management review, it is incumbent among establishments to establish a sign-in sheet and an agenda that reflects management review content. Why, because if an event or activity is not documented in writing, in the eyes of our friends at the agency, it never happened. Can you say objective evidence? Since the quality system regulation does not contain much granularity around what is required to be placed into management review, the doctor strongly suggests visiting ISO 13485, Clause 5.6 and specifically 5.6.2 and 5.6.3. As a minimum, management review input should contain:
  • Audit results (internal, external, and supplier);
  • Customer feedback (including complaints);
  • The performance of processes and  results of product conformity;
  • Corrective and preventive action (CAPA);
  • Follow-up on activities and action items assigned during previous management reviews;
  • Changes influencing the quality management system;
  • Recommendations for improvement; and
  • New or revised regulatory requirements.

At a minimum, the output of management review should include all decisions and activities associated with:

  • All improvements required to maintain QMS effectiveness, including supporting processes;
  • Product improvements related to customer requirements;
  • Assessment of resource needs; and
  • A determination if quality objectives are being attained and the quality policy still relevant an applicable (as scripted) for the establishment.
Management review frequency
Dr. D would like to ask the readers a question: Do you know the FDA’s required frequency for management review? If your answer is “annually,” you would be wrong.  If your answer was “semi-annually, quarterly, monthly, weekly, daily, or hourly,” you would be equally wrong. The requirement is, “at defined intervals and with sufficient frequency.” From the doctor’s perspective, although annually usually meets the ISO 13485 requirement, holding a review once a year is not effective. Dr. D recommends holding management review quarterly.
Takeaways
For this edition of DG, the doctor will leave the readers with three takeaways.
  • Management review content does not need to be shared with FDA during an inspection. In fact, it would be considered a bad practice to do so.
  • Use ISO 13485, Clauses 5.6.2 and 5.6.3 as guidance when scripting your management review procedure and specifically review inputs and outputs; and
  • At a minimum, hold management review meetings quarterly.

In closing, thank you again for joining Dr. D and I hope you find 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. (2013, April). 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. ISO 13485:2003. (2004, February). Medical devices – quality management systems – requirements for regulatory purposes (ISO 13485:2003).
 

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