GxP Lifeline
Quality Management Review for Compliance and Improvement
The ultimate responsibility in a business lies at the top. In the regulatory world, this includes ensuring the quality system of a medical device company is effective. The specifics of how and how often the review should be conducted are a bit hard to pin down, but that’s by design. 21 CFR Part 820 has general guidelines, but leaves much of the “how to” up to individual companies.
Doing the bare minimum can certainly let companies pass an inspection, but quality management review can offer so much more than that. Like most regulations involving quality, 21 CFR Part 820.20 can be an item on a checklist or a valuable quality improvement tool.
Quality Management Review Regulations
The regulations define quality management review as follows:
“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 the quality system reviews shall be documented.” (1)
A lot is left up to interpretation here. Sufficient frequency could be once a year, once a quarter, or once a month, depending on the device and if the company is working through known issues. In the words of the U.S. Food and Drug Administration (FDA), “management reviews should be frequent enough to keep them informed of ongoing quality issues and problems.” (2)
Ultimately, the highest level of management is responsible for establishing a quality policy and ensuring that it’s followed.
The Typical Quality Management Review for Medical Device Companies
There are no granular requirements for what a quality management review has to include. The FDA leaves that up to the organization and what best suits its needs. The agency has said a management review may include a review of:
- The organizational structure, including the adequacy of staffing and resources.
- The quality of the finished device in relation to the quality objectives.
- Combined information based on purchaser feedback, internal feedback (such as the results of internal audits), process performance, product (including servicing) performance, among other things.
- Internal audit results and corrective and preventive actions taken. (3)
Similar to other regulations, whether or not a firm is in compliance with the management review revolves around its own procedures. Whatever those procedures entail, they need to include considerations for updating the quality system and the appropriateness of the review frequency.
Quality Management Review as a Tool for Improvement
Continuous improvement involves a candid look at the quality system, specifically areas where there are issues, or something is lacking. However, a business may be hesitant to take this view if it means airing their flaws to the FDA. That’s why the agency has decided only evidence that the review took place is required. The agency wants to see dates and results of the reviews and the procedures used to conduct them. Specifics of what happened during the quality management review are not required.
This frees up businesses to critically evaluate their quality management system (QMS) without fear of regulatory consequences. Manufacturers do not have to make meeting minutes or quality audit reports available to inspectors. The Quality System Regulation preamble explicitly says, “FDA agrees that it will not request to inspect and copy the reports of reviews … when conducting routine inspections to determine compliance.” (4)
Conclusion:
The regulations give companies some wiggle room when it comes to how they perform quality management review, but the FDA wants to see evidence of those reviews. The best way to ensure the reviews happen on schedule and per procedures is through an electronic QMS. Quality management software gives medical device companies the tools to track reviews, record the results, and easily demonstrate compliance to the FDA while not revealing proprietary information.
Sources:
- “21 CFR 820 — Quality System Regulation,” U.S. Food and Drug Administration.
- “Management Controls,” U.S. Food and Drug Administration, Sept. 8, 2014.
- “Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation,” U.S. Food and Drug Administration, March 23, 2018.
- Supra note 3.
Sarah Beale is a content marketing specialist at MasterControl in Salt Lake City, where she writes white papers, web pages, and is a frequent contributor to the company’s blog, GxP Lifeline. Beale has been writing about the life sciences and health care for over five years. Prior to joining MasterControl she worked for a nutraceutical company in Salt Lake City and before that she worked for a third-party health care administrator in Chicago. She has a bachelor’s degree in English from Brigham Young University and a master’s degree in business administration from DeVry University.
