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.
(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; andii. 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.
“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.”
(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.
- 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 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.
- Code of Federal Regulation. (2013, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
- ISO 13485:2003. (2004, February). Medical devices – quality management systems – requirements for regulatory purposes (ISO 13485:2003).